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Guide to Payor Research

Guide to Payor Research

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All Global Guide to Payor Research

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All Global Guide to Payor Research


Content

4 Introduction 8 France 20 Germany 32 Italy 42 Spain 54 UK 64 USA 74 Why All Global? 76 Qualitative Project Types 77 All Global’s Database Overview 82 Case Studies 87 Recruiter/Moderator Expertise 100 Contact us

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All Global Guide to Payor Research


Content

4 Introduction 8 France 20 Germany 32 Italy 42 Spain 54 UK 64 USA 74 Why All Global? 76 Qualitative Project Types 77 All Global’s Database Overview 82 Case Studies 87 Recruiter/Moderator Expertise 100 Contact us


All Global Guide to Payor Research

Hospital Hierarchy

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Hospital Hierarchy

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About All Global and its relationships with Payors

As international healthcare data specialists, All Global gathers the best quality healthcare data in the industry. With well over a decade of experience, we have cultivated relationships and built trust to gain unsurpassed global, regional, national and niche stakeholder access for you. We have a strong proprietary database of active and engaged members in Europe and the US, and equally excellent ties with Payors around the rest of the world through our local business partners.

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All Global Guide to Payor Research


Payors in Europe

Payors in the US

In European healthcare systems, the Payor community is highly regulated, often bound by governmental confidentiality and contractually obligated toward non-disclosure. Due to these restrictions, contacting this group for any purpose has historically been difficult and time-consuming.

Healthcare in the United States (US) is provided by many separate entities as the geographic region does not have a universal healthcare policy. The US healthcare system relies heavily on private health insurance, which is the primary source of coverage for most Americans

The community consists of the following types of professionals:

The community includes the following types of professionals:

• Key opinion leaders in all therapy areas • Formulary committee members • Budgetary advisors • Heads of pharmacy • Government body representatives • Purchasing managers • Advisors • Insurance companies

• Key opinion leaders in all therapy areas • Budgetary advisors • Pharmacy Directors and/or Clinical Pharmacists • Purchasing managers • Medical Directors • Quality Directors • Advisors • Insurance companies

Introduction

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Why Payors are vital to your research

Payors: • Offer rare and specialized insight into: • Market trends • Governmental and formulary committee decision-making processes • Pricing and reimbursement regulations • The latest drug/treatment information at the highest level. • Are the gateway to understanding country-specific market information before it becomes protocol. • Are responsible for decisionmaking in their market in regard to pharmaceuticals and healthcarerelated devices/therapies, etc. • Are the central influencing base in shaping the healthcare landscape in Europe and a vital part of the healthcare scene in the US.

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All Global Guide to Payor Research


Helpful hints

• Many physicians are familiar with participating in market research. However, this is often not the case for Payors, especially those such as purchasing managers, who are not medically qualified. Therefore, the initial approach may be greeted with suspicion. • Introducing the company first, rather than the nature of the research, will help. Share the URL of your website and any other material that can build the Payors’ trust. • When providing details of the research, emphasis on confidentiality and impartiality is important. • A clear and accurate description of what the research involves and the time involved is essential to get the best responses. • The more generous the honorarium the more likely the participation. • Payors who have previously participated in market research are usually open to further approaches and can be a source of information regarding other experts to target.

• During the research, the clarity of the discussion guide is important – it should be clear and succinct, with probes to elicit the best responses. • Ensure that the language used in the discussion guide respects the local market nuances and terminology. • The guide should be as scientific as possible – respondents can become irritated by “marketing speak.” • The establishment of a rapport between the respondent and the moderator is important to elicit the best responses and to encourage further participation in future market research.

Introduction

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All Global Guide to Payor Research


France System overview • France has the highest per capita consumption of medications in the world and is the fourth largest market of pharmaceutical products. Pharmaceutical spending in France is €19 billion (ex-factory price), or €25.5 billion at retail price.

• There is a two-step pricing and reimbursement process after a new drug has obtained market authorization (AMM). First, the Transparency Commission (TC), which is part of the HAS (Haute Autorité de Santé), handles the reimbursement process. Second, after the TC has given its advice regarding the reimbursement level, CEPS (the Health Products Economic Committee, which depends on the Ministry of Health) sets the price.

• There are two regimens for pricing medications in France: • The first is the “free pricing” segment, including over-thecounter (OTC) drugs and hospital drugs that are included in DRG costs (Groupement Homogène • The pricing and reimbursement de Séjour, or GHS, part of Tarification à l’Activité, or T2A); process in France is at the national hospitals negotiate directly with level only. pharmaceutical companies. • The second is a “regulated” price segment with pharmacyreimbursed drugs and hospital drugs that are not included in the DRG system. They are paid separately by the AssuranceMaladie (a branch of the Social Security) and include all expensive and innovative molecules, including most oncology products and certain medical disposals.

France

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Decision-Makers and Influencers

Established in 2004, the French High Authority for Health (Haute Autorité de Santé, HAS) is made of eight commissions, each in different areas of competence. The main role of HAS and its commissions is to ensure that patients can benefit from a cohesive and effective health system. The activities of the various commissions include: • Evaluation of drugs and medical devices (clinical benefits – price and reimbursement levels) • Evaluation of medical-economic and public health • Promotion and evaluation of good usage and practice of health services • Improvement of quality of care and medical information • Guidance for long-term illnesses (Affectations de Longue Durée, ALD) • Research programs and expert evaluation by key opinion leaders in various therapeutic areas HAS is an independent, nongovernmental public body with financial autonomy (€62 million in 2009). It liaises with government health agencies, national health insurance funds, research organizations, healthcare professional unions and patient representatives.

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All Global Guide to Payor Research

The Transparency Commission (Commission de la Transparence, CT) is part of the HAS and is composed of medical experts such as pharmacists, GPs and specialists. Their role is to evaluate new drugs that have obtained market access (Autorisation de Mise sur le Marché, AMM) when pharmaceutical companies wants them to be on the list of reimbursable medications. The main mission of the CT is to evaluate medical service (Service Médical Rendu, SMR) by considering the severity of the pathology, the efficacy and tolerance profile of the new drug, the positioning in the therapeutic algorithm, and the improvement on medical service (Amélioration du Service Médical Rendu, ASMR). The Economic Committee on Healthcare Products (Comité Economique des Produits de Santé, CEPS) fixes medicine prices and pricevolume agreements. Negotiations with pharmaceutical companies can take place depending on the ASMR rating given by the CT.


The French Health Products Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS), created in 1998, is a public body under the supervision of the Ministry of Health whose main objective is pharmacovigilance of health products for human use to guarantee their efficacy, innocuity and correct usage. The AFSSAPS is the competent authority for all safety decisions taken concerning health products, from manufacturing to marketing. The main missions of the AFSSAPS are: • Laboratory control and inspection • Regulation and information • Scientific and medico-economic evaluation, expertise and deontology • Implementation of preventive and corrective measures The main role of Union Nationale des Caisses d’Assurance Maladie (UNCAM) is coordinating three mandatory sickness funds (Assurance-Maladie, MSA and RSI) and prescription drug and healthcare reimbursement procedures, as well as creating partnerships with healthcare professionals. Its main missions are to:

• Fix reimbursement levels within the parameters set by the Ministry of Health (100%, 65%, 35% or no reimbursement) • Categorize the three categories of medications set by HAS based on the SMR (Service Médical Rendu) • Decide on what will be reimbursed Once a new product has gone through the various national processes of pricing and reimbursement, it will be presented to the Commission du Médicament et des Dispositifs Médicaux Stériles (COMEDIMS), or hospital formulary committees, where it will be evaluated again and granted or denied market access. COMEDIMS are composed of various specialists and hospital pharmacists. A drug or medical device is selected according to its efficacy/tolerance profile, its cost effectiveness and what the hospital already has in a particular class of drugs for a given pathology. Calls for tenders are usually every two to three years.

France

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Decision-Makers and decision-making process diagram

HAS

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1 Market Authorisation

AMM (Authorisation de Mise sur le MarchĂŠ) is given by the AFSSAPS (national level) or the EMEA (European Level)

(National Authority for Health). The CT is a HAS commission

Presentation of Medical dossier

Transparency Committee (CT)

Evaluation of Therapeutic benefits (SMR and ASMR) and recommendation on reimbursement levels ASMR – 5 levels of ASMR 1 Major therapeutic improvement 2 Important improvement in terms of efficacy and/or decrease in side effects 3 Moderate therapeutic improvement. Important improvement in terms of efficacy and/or decrease in side effects 4 Minor therapeutic improvement. Important improvement in terms of efficacy and/or decrease in side effects 5 No improvement

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All Global Guide to Payor Research


UNCAM (Group of Sickness funds)

Presentation of Economical dossier

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Comité Economique des Produits de Santé (CEPS)

Ministry of Health

Price fixing (under the supervision of the Ministry of Health)

AFSSAPS

(French Health Products Safety Agency): Pharmacovigilance

France

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Decision-Making Process The decision process for pharmaceutical pricing and reimbursement has two steps.

Step 1 Involves a technical assessment by the Commission de la Transparence (CT) under the supervision of the Haute Autorité de Santé (HAS). The CT uses two levels of drug evaluation. It gives advice based on the rendered medical service (SMR) to determine the benefit of the drug and the improvement in the rendered medical service (ASMR) to determine the improvement the drug brings compared to existing treatment. There is more emphasis on medical expertise and public health issues, which means involving fewer clinicians and more epidemiologists. The SMR rating is based on the following criteria: • Efficacy/tolerance • Severity of disease • Existence of therapeutic alternatives • Place in the therapeutic strategy (first-line, second-line, etc.) • Public health issues: Impact on the healthcare system as a whole and the impact on the population’s health (e.g. existence of an unmet need or reliable criteria to define the target population)

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All Global Guide to Payor Research

Five levels of ASMR will determine the price and subsequent negotiations: • ASMR I: Major improvement • ASMR II: Important improvement • ASMR III: Moderate improvement • ASMR IV: Minor improvement • ASMR V: No improvement The CT evaluates about 500 dossiers each year. The majority (350 of 500) are concerned with new indications of already commercialized products. The classification based on improved efficacy or a better tolerance profile allows only one or two products to be awarded Level I and up to five products to be awarded Level II per year. Most products are awarded Level III (15–20%), Level IV (around 50%) or Level V (around 30%) each year. Medicines with insufficient level are recommended not to be registered on the reimbursable list. The Health Minister makes the final decision.


Step 2 This involves putting products on lists with prices set by the Comité Economique des Produits de Santé (CEPS) and reimbursement rate set by the Union Nationale des Caisses d’Assurance Maladie (UNCAM).

• Clinical evaluation (i.e. ASMR level) • Market size prices in the top five European markets • Macroeconomic objectives • Parallel exports threat

CEPS is responsible for negotiating prices with companies and regulating drug expenditures at the national level once positive advice for reimbursement has been given. This process is generally based on the following factors:

500 The CT evaluates about 500 dossiers each year.

France

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Reimbursement and Pricing Approval Process

Before reimbursement can be considered, pharmaceutical companies must obtain a market authorization (AMM) from the Commission d’Autorisation de Mise sur le Marché (part of the AFSSAPS) or in some cases from the European Medicines Agency (EMEA). Then the CT evaluates the product and sets the status of reimbursement through the process previously described. The reimbursement rate is fixed by the Union Nationale des Caisses d’Assurance Maladie (UNCAM). Drugs that are 100% reimbursed include expensive drugs (i.e. new oncology molecules), HIV treatments and drugs for patients with chronic and severe illnesses which are on the ALD (Affectation de Longue Durée) list, such as MS.

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All Global Guide to Payor Research

The price is fixed by CEPS and is published in the Official Journal, which publishes texts regarding legislation and regulation in France. Price negotiations can take place; the higher the ASMR level, the higher price the pharmaceutical firm can expect. However, if CEPS does not agree with the price requested by the firm and negotiations fail, the product is simply not accepted. There are no restrictions to limit usage apart from the possible restrictions set in the AMM before the pricing and reimbursement process (prescription by specialists only or hospital setting only, etc.).


Drugs that are 100% reimbursed include expensive drugs (i.e. new oncology molecules), HIV treatments and drugs for patients with chronic and severe illnesses which are on the ALD (Affectation de Longue DurĂŠe) list, such as MS. France

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Recruitment Considerations

Because every process concerning pricing and reimbursement is made at national level, there are no regional Payors in France. The appraisals and recommendations of KOLs in each clinical area inform the Payors regarding their decisions for pricing and reimbursement. Some members of the CT volunteer to take part in research, so they are not off-limits. However, members of CEPS and UNCAM will not participate in research. Largely, highlevel public sector functionaries do not participate in market research studies as it is not ethical. KOLs who contribute to HAS recommendations for a given pathology or about a specific treatment are usually a good source of information. These KOLs can include a department head or a specialist with a particular area of interest and expertise. Clinical trial investigators are very knowledgeable and largely happy to participate. Members of medical associations likewise are good candidates for research projects.

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All Global Guide to Payor Research

Hospital pharmacists generally have an excellent knowledge of the health system as they evaluate products for access on their formularies. They also negotiate prices with pharmaceutical firms and have a good understanding of efficacy-versus-cost issues. Specialists who are members of the COMEDIMS (or who attend the meetings) are also good local respondents.


Field Logistics

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• Allow two to three weeks minimum for TC and central buying groups’ representatives’ recruitment as they run a busy schedule. • Hospital pharmacists are more easily approachable, and 1 to 2 weeks are generally sufficient for recruitment (via email or direct phone contact). • The establishment of a rapport between the respondent and the moderator is important to elicit the best responses and to encourage further participation in future market research. • It is advisable that the discussion guide doesn’t focus too much on pricing as it may irritate the respondent.

HAS http://www.sante.gouv.fr/ Département de Securité Sociale http://www.securite-sociale.fr/institutions/dss/ dss.htm HAS http://www.has-sante.fr/portail/jcms/j_5/home AFSSAPS http://www.afssaps.fr/ CEPS http://www.sante.gouv.fr/comite-economiquedes-produits-de-sante-ceps.html INCAM http://www.ameli.fr/l-assurance-maladie/ connaitre-l-assurance-maladie/missions-etorganisation/l-8217-uncam.php ISPOR www.ispor.org

France

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Germany System overview • Contributions to the statutory health • Hospitals receive a fixed amount fund are split between employers and per patient per treatment (diagnosisemployees. There is no public sector related group, DRG) within which they more neither allowed to decline any have to operate. This amount covers potential customers (i.e. on the notion the usual expenditures associated of “bad risk”) nor to compete against with the treatment of a certain each other by offering different disease and ensures economic products or services. efficiency of the hospitals. • The German healthcare system has • Practice-based physicians have only recently started to tie the prices an allocated budget that takes into of medications to evidence-based account how many patients they treat medicine (further information in other per year. Exceeding this budget may sections). These changes are still in lead to regresses of the healthcare the probation period and have not yet insurance companies. Regular fully entered the German system. inspections are set to oversee costs. • For decades, manufacturers could ask any price deemed appropriate. Market approval/access was the only parameter that determined the reimbursement status.

Germany

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Decision-Makers and Influencers

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) has a legal mandate assigned by the German parliament that requires the committee to issue standardized and binding directives to facilitate the translation of the legal framework into practice. However, the G-BA is not a subordinate authority of the BMG but rather the supreme decision-making body of the so-called self-governing system in Germany. The G-BA comprises 16 members (and many consultants) who represent the various interests of healthcare providers (doctors, dentists, hospitals, psychotherapists), sickness funds and patients. The directives issued by the G-BA determine the benefit package Federal Institute for Drugs and Medical of the statutory health insurers. Devices (Bundesinstitut f端r Arzneimittel Finally, the G-BA is responsible for reimbursement decisions by und Medizinprodukte, BfArM) is composed of physicians, pharmacists, applying evidence-based methods to determine prices of pharmaceuticals. administrative staff and technical assistants. As an independent higher federal authority BfArM is concerned with the prevention of health risks by carefully evaluating the licensing process of pharmaceuticals for the German market. At times BfArM is also consulted by the European Medicines Agency (EMEA) in the licensing of new pharmaceuticals. Federal Ministry of Health (Bundesministerium f端r Gesundheit, BMG) is the overarching legislative body in the healthcare system. The BMG sets the legal framework within which all actors operate. It enacts reforms such as the AMNOG (Act on the Reform of the Market for Medicinal Products, effective January 1, 2011), which for the first time determines the price of a medicine by the added benefit to patients. Among its many other responsibilities, the BMG specifies the amounts employees and employers have to pay toward sustaining the system. It is also the final decision-maker regarding reference pricing groups and reimbursement.

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Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) was set up in 2004 and is somewhat modeled upon NICE in the UK. IQWiG – an independent federal organization – is concerned with the objective examination of the advantages and disadvantages of medicinal products. It follows the principle of evidencebased medicine in its appraisal process of clinical effectiveness. Such a process can either be selfinitiated or requested by the G-BA. The recommendations are not legally binding to the G-BA. In order to exchange basic information and scientific evidence, IQWiG cooperates on an informal level with NICE and France’s HAS.

The German Institute for Health Technology Assessment (Deutsches Institut für medizinische Dokumentation und Information, DAHTA) is a division of the German Institute of Medical Documentation and Information (DIMDI) and may receive requests from IQWiG to produce recommendations on issues related to the German health system. The Federal Association of the Statutory Health Insurances (Gesetzliche Krankenversicherung, GKV-Spitzenverband) represents the interests of statutory health insurance at the federal level. With the introduction of AMNOG in 2011, the position of the GKV has been further strengthened by entrusting the association with responsibilities in price negotiations with pharmaceutical manufacturers for products proven to have therapeutic benefits over its competitors.

Germany

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Decision-Makers and decision-making process diagram

IQWiG

EMA/BfArM

Market Approval?

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All Global Guide to Payor Research

G-BA

G-BA assesses whether therapeutic benefit exist. The G-BA may appoint IQWiG with cost/benefit analysis.


YES

Federal Association of the Statutory Health Insurance (GKV)

The GKV Spitzenverband (overarching body of all statutory health insurers) enters negotiations about the price of the product with the Pharmaceutical Manufacturer.

Therapeutic benefit?

NO

If no thereapeutic benefit could be established, the G-BA/SHI assign a fixed price to the medication.

Germany

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The G-BA comprises 16 members (and many consultants) who represent the various interests of healthcare providers (doctors, dentists, hospitals, psychotherapists), sickness funds and patients. 26

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Decision-Making Process

Access and approval for the German market is granted either by the EMEA or BfArM. In contrast to the majority of other healthcare systems, such an approval automatically means coverage by the German statutory sickness funds. Some exceptions to this rule – such as lifestyle drugs – prevail. This means no other body or legal framework may exclude certain medications from reimbursement. However, the pricing of the medications is subject to an assessment by the G-BA. Even though each medication approved is subject to reimbursement, decision-making processes are happening along the way. On the outpatient front, practice-based physicians are legally responsible for maneuvering within the budget allocated to them. Overstepping this budget may lead to regresses. Consequently, physicians will have to be able to justify the usage of more expensive medications should they want to avoid paying the regress.

Even more striking is the situation for inpatient treatment. Hospitals work within a DRG (diagnosis-related group) budget allocated for the treatment of each patient. As such, hospitals are faced with the question of which medications to list on their formulary. This means walking a tight-rope of offering the best service to the patients while running the hospital cost-efficiently. In special cases where the treatment costs of a patient exceed the DRG, hospitals may qualify for special/additional financial contribution. Either way, the listing (or not listing) of drugs on the hospital formulary is of vital importance. Chief hospital pharmacists and heads of departments are key players in making these decisions.

Germany

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Reimbursement and Pricing Approval Process

The only yardstick for reimbursement is market approval. Unlike in most other countries, the German healthcare system does not exclude certain medications from reimbursement. However, with the introduction of the AMNOG on January 1, 2011 (Arzneimittelneuordnungsgesetz: Act on the Reform of the Market for Medicinal Products), the price of new drugs is now dependent on their therapeutic benefit. These are significant changes to the German market because for decades every new drug was reimbursed at the price the pharmaceutical company considered appropriate.

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With the introduction of AMNOG, the G-BA’s role has become even more important. Now every new drug that enters the German market has to prove a therapeutic benefit or superiority to their competitors to determine its price. The manufacturers themselves are charged with the task of submitting such a dossier upon which the G-BA assesses therapeutic worth. This evaluation may take place in collaboration with IQWiG should the G-BA deem it necessary to secure some non-binding recommendations. The above process is subject to clearly defined steps and timelines. Should the G-BA upon completion of these steps conclude that a new drug possesses a therapeutic benefit the Federal Association of the Statutory Health Insurances (GKV-Spitzenverband) will enter price negotiations with the pharmaceutical manufacturer. Should the negotiations not lead to a settlement an arbitration court will decide on the price.

On the other hand, if the G-BA’s assessment finds no therapeutic benefit, then the price will be set by the GKV-Spitzenverband on the basis of reference prices or the costs of comparable therapies. Furthermore, statutory health insurances may negotiate individual rebate contracts with pharmaceutical companies. This suggests that the GKV acts only as an overarching body laying the framework, but individual sickness funds can enter into further negotiations. Finally, hospitals may negotiate directly with pharmaceutical companies and enter rebate contracts. This is especially sensible considering the vast amount of drugs these institutions administer and prescribe and the huge potential inherent in well-functioning partnerships between manufacturers and hospitals.

Germany

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Recruitment Considerations

Previous and sustained efforts show the difficulty in winning over members of the G-BA and IQWiG to participate in market research. The G-BA has only 16 members but many more consultants working for them. Both organizations’ policies prohibit their members from participating in market research to guarantee the impartiality in their positions. The same is largely applicable for members of GKVSpitzenverband (Federal Association of the Statutory Health Insurances). Only in some cases are the restrictions set in place less severe. G-BA, IQWiG and GKVSpitzenverband aside, members of regional associations of statutory health insurances who are involved in the negotiation of contracts are valuable sources of information. Such contracts may not represent the national scope of the organizations but nevertheless may show certain trends.

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Chief hospital pharmacists, who are involved in the evaluation of clinical benefits versus increased costs, have proven to be insightful sources of information. Their opinion is highly regarded within the formulary committee when deciding which new drugs to list on the hospital formulary. Finally, many specialists work as consultants with direct or indirect ties to organizations such as the G-BA or IQWiG and are possibly less constrained by internal principles regarding participation in market research. Also, other organizations— such as the MDK (Medizinischer Dienst der Krankenkassen, advisory body to the SHIs), the DKG (German Hospital Federation) or the KBV (National Association of Statutory Health Insurance Physicians)—are directly or indirectly involved in the pricing and reimbursement process.


Field Logistics

Sources

• Recruitment of Payors is likely to be most successful if time is available to target the most appropriate respondent—two to three weeks is advisable.

German Ministry of Health http://www.bmg.bund.de/ Federal Joint Committee G-BA http://www.g-ba.de/ International Society for Pharmacoeconomics and Outcomes Research http://www.ispor.org/HTARoadMaps/Germany. asp#Diagram Konrad Adenauer Trust http://www.kas.de/ Bundeszentrale für Politische Bildung http://www.bpb.de/themen/ WZDR7I,0,Gesundheitspolitik_Lernobjekt. html?lt= AAB383&guid=AAB119 Changes to AMNOG http://www.ihsglobalinsight.com/Highlight/ HighlightDetail20291.htm http://www.arbrb.de/media/Entwurf_BMG.pdf http://is.jrc.ec.europa.eu/pages/TFS/ documents/CountryreportGermany_public.pdf http://www.ispor.com

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Italy System overview • Italy’s National Health System guarantees healthcare to all citizens irrespective of gender, residence, age or income. • Although decentralized, Italy’s National Health System is structured according to different levels of responsibility on a national, regional and local level. • In Italy, the Ministry of Health is responsible for determining a healthcare plan (Piano Nazionale Sanitario, PSN) every three years concerning policies and legislations; also it has primary responsibility to provide medical assistance to the general public. • Reimbursement, authorization, registration and national formulary drugs access are always determined on a national level by AIFA.

• Twenty regions execute Italy’s national formulary decisions and criteria. They have their own funds and can make adjustments for region-specific needs; consequently there are differences in terms of healthcare access or the level of co-payments. • Local health units (Azienda Sanitaria Locale, ASL) are local authorities providing services as primary medical services and managing admissions to public hospitals. They cover hospitals, counseling, department of prevention, assistance service, dependencies and addiction service, specialist visits and tests, home care and residential social care, mental health service, booking service performance and GPs.

Italy

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Decision-Makers and Influencers

The Italian Medicines Agency (Agenzia Italiana Del Farmaco, AIFA) is the national authority responsible for drug access and pricing and reimbursement guidelines. It evaluates drug access and reimbursement according to costefficacy criteria, under the direction of the Ministry of Health and the Ministry of Economy. Two committees are involved in this procedure: • Technical and Scientific Committee (Comitato Tecnico-Scientifico, CTS) is responsible for evaluating national and European marketing authorization applications, delivering a consultative opinion and providing assessment for reimbursement. • Institute of Health (Istituto Superiore di Sanita, ISS) is the main technicalscientific organ of the national health system and is responsible of chemical, pharmaceutical, biologic and pharmacotoxicity evaluation of new drugs.

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The Pricing and Reimbursement Committee (Comitato Prezzi e Rimborso, CPR) is responsible for evaluating pharmaceutical company applications and negotiating drug prices for all products reimbursed by the National Health Service. The Regional Pharmaceutical Committee (Prontuario Terapeutico Ospedaliero Regionale, PTOR) makes decisions regarding drug access in regional formularies once they have been authorized by AIFA. Local health authorities (Azienda Sanitaria Locale, ASL) are responsible for territorial distribution of drugs authorized by AIFA. Hospital committees make drug access decisions in the hospital formulary for drugs authorized and registered by AIFA.


Decision-Makers and decision-making process diagram

Pharmaceutical company presents a new product with relevant documentation

CPR negotiates with manufacturer and evaluates submitted applications

CST and ISS expertise assess new product according to efficacy/ safety/impact on budget criteria

AIFA approval; product is registered and authorized; included in National Formulary. It can gain access in PTORs and PTOs

Italy

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Decision-Making Process

A new product must be approved and authorized by AIFA to be included in the national formulary and then in the regional or hospital formulary. In order to obtain authorization and registration of new products, manufacturers must submit detailed documentation that will be reviewed by CTS (internal to AIFA) and ISS (external to AIFA).

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Registration is structured through national and committee procedures, supported by an adequate software system to guarantee transparency and reliability. CPR negotiates with pharmaceutical companies to set prices of medicinal products reimbursed by the National Health Service according to transparent methods, timelines and procedures. This body assesses the manufacturers’ applications and collect information from the National Observatory on the Use of Pharmaceuticals. CTS and ISS evaluate clinical, biologic and pharmacology data and European marketing authorization applications. CTS also provides classification for reimbursement. Once AIFA authorizes and registers a new product it is enclosed in the national formulary.

PTORs decide access and inclusion in regional formularies. Drug access is assessed with reference to clinical needs and regional funding and budget. Reimbursement is always decided on a national level. However, regions can assess pricing. PTOs are responsible for access and inclusion of new drugs according to hospital clinical needs and budget. Local ASLs are responsible for coordinating all the medical and assistance services through the territory on a local level.

Italy

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Reimbursement and Pricing Approval Process

Italy’s National Health System is decentralized, but pricing and reimbursement of new products is decided on a national level. Closing data are published in the official journal (Gazetta Ufficiale). Two boards are involved in this process: CPR and CTS. CPR coordinates and negotiates applications with manufacturers and assesses all the documentation. CTS and the AIFA director ultimately decide reimbursement, local marketing authorization and positive list revisions. Currently there are three levels of reimbursement: • Class A includes essential products and those intended for chronic diseases and are fully reimbursed by Italy’s National Health System. • Class H includes products that are only fully reimbursed in the hospital. • Class C includes other products that do not have the characteristics of Class A and are not reimbursed. CPR will assess the procedure by analyzing the following parameters: • Cost-effectiveness for pharmaceuticals where no effective therapy exists

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• Risk-benefit ratio compared to alternative pharmaceuticals for that indication • Therapy costs per day compared with products of the same efficacy • National health system impact on budget • Estimated market share of the new pharmaceutical • Prices and expenditure data in European countries • Pharmacoeconomic data assessment To have a direct control on expenses, new products are recorded in the AIFA Registry for monitoring through a software system. A product can be required by the hospital pharmacist once it has been registered. This procedure allows tracking of drug efficacy, response rate and tolerability and controlling product distribution and expenditure.


Risk-sharing and payback programs are common to contain budgets. In fact, manufacturers agree to provide products if they meet certain clinical attributes or to provide a free cycle of treatments or payback in the case of product failure.

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Recruitment Considerations

AIFA, CPR, and CTS members are not able to participate in research because of confidentiality agreements; however, it’s beneficial to target Payors advisors who are on subcommittees as well as AIFA’s external consultants. They are valid respondents as they have a good understanding of internal reimbursement/access dynamics. Italy’s health system is decentralized and has a number of different PTORs, which marks differences in terms of products access. In order to have an overall view it’s beneficial to target PTOR members and chief pharmacists from northern, central and southern Italy.

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Field Logistics

Sources

• It’s mainly up to the ability of the recruiter or moderator to show professionalism and confidence to catch the respondent’s attention and interest. • Respondents are busy and have limited time; their schedules are booked up in advance. • Recruitment of Payors is likely to be most successful if time is available to target the most appropriate respondent—two to three weeks is advisable.

Italian Medicines Agency http://www.agenziafarmaco.it/ Ministry of Health http://www.ministerodellasalute.it http://www.ispor.org/HTARoadMaps/Default.asp www.gazzettaufficiale.it/ www.salute.gov.it/ www.saluter.it/documentazione/ptr Information and feedback from Payors from Turin and Rome.

Italy

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Spain System overview • Spain is divided into 17 autonomous communities including the North African regions, the Canary Islands and the Balearics. The healthcare system was historically controlled by the central government, but today each region takes individual responsibility. • Healthcare in Spain is a noncontributory benefit. It is paid for through taxation and is included in the general budget for each autonomous community. Two additional funds are the Cohesion Fund managed by the Ministry of Health and Consumer Affairs and the Savings Program for Temporary Incapacity. • Healthcare is one of the main instruments of policies to redistribute income among Spanish citizens; all citizens pay taxes in line with their financial capacity and receive health services as needed.

• The Spanish healthcare system is organized at two care levels in which accessibility and technological complexity are counterpoised. • Primary healthcare provides basic services within a 15-minute radius from any place of residence. The main facilities are primary care centers that are staffed by multidisciplinary teams comprising general practitioners, pediatricians, nurses and administrative staff and, in some cases, social workers, midwives and physiotherapists. • Specialist care is given in specialist centers and hospitals for both in- and outpatients. Once care is complete, the patient is referred back to the primary healthcare doctor, who uses the full medical history as a basis for subsequent treatment and overall care.

Spain

43


The National Health System SNS (Sistema Nacional de la Salud) provides healthcare to the Spanish population. It is coordinated and supervised by the Ministry of Health and Consumer Affairs MSC (Ministerio de Sanidad y Consumo). However, since the decentralization of healthcare to the seventeen autonomous regions: the MSC focus more on pharmacovigilance, product approvals, cost-containment and long-term policies.

17 Spain is divided into 17 autonomous communities 44

All Global Guide to Payor Research

• HTA process for decision making related to the national catalogue of services in Spain. • The central government and regional governments (autonomous communities) request National HTA Agency (Instituto de Salud Charles III (ISCIII) and Regional HTA Agencies (Madrid, Cataluña, Andalucia, Aragon, Basque country, Galicia) evaluations. • The ISCIII and regional HTA agencies collaborate. • The ISCIII produces the HTA report and submit it to the National Health System Interterritorial Council (Consejo interterritorial del Sistema Nacional de Salud). • National Health System Interterritorial Council decides about the inclusion or exclusion of technologies in the national catalogue. • The decision of the National Health System Interterritorial Council is implemented by the central and regional (autonomous communities) governments. • Although they have decentralized responsibilities, the SNS should function in a harmonious and cohesive manner to ensure that access and healthcare for all citizens are made under effective equal terms and policy health is aimed at overcoming geographical and social imbalances.


Decision-Makers and Influencers

The Ministry of Health and Economy (Ministerio de Economía y Hacienda) and the Ministry of Industry (Ministerio de Industria, Turismo y Comercio) propose the prices for pharmaceuticals to the national government cabinet (Consejo de Ministros), which has the final responsibility for setting pharmaceutical prices. The Interministerial Commission for Pharmaceutical Prices (Comisión Interministerial de Precios de los Medicamentos, CIPM) includes representation of the Ministry of Health and Economy (Ministerio de Economía y Hacienda) and the Ministry of Industry (Ministerio de Industria, Turismo y Comercio). The CIPM proposes the prices for pharmaceuticals to the national government cabinet (Consejo de Ministros), which has the final responsibility for setting pharmaceutical prices.

AEMPS is in the process of establishing an HTA system for evaluating pharmaceuticals. According to the Law 29/2006, the reimbursement decision must consider the following: • severity, duration and sequels of the diseases for which the drug is indicated • therapeutic and social utility of the drug • rationalization of public drug expenditures • alternatives for the indications targeted by the drug • the novelty of the drug. The Ministry of Health has the responsibility for deciding reimbursement of pharmaceuticals by the National Health Service.

The Spanish Medicine and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) prepares a report about the therapeutic utility of pharmaceuticals that must be considered by the CIPM when proposing pharmaceutical prices.

Spain

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Decision-Makers and decision-making process diagram Source: Law 16/2003. Real Decree 1030/2006

National HTA Agency (Instituto de Salud Charles III – ISCIII)

Ministry of Health (Ministerio de Sanidad y Consumo)

Step 1a

Step 2

Step 3

Collaboration

HTA Reports

Step 1b

Regional HTA Agencies Andalucia, Aragon, CataluĂąa, Basque Country, Galicia & Madrid

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Regional Health Departments


Central Government

National Health System Interterritorial Council (Consejo interterritorial del Sistema Nacional de Salud)

Step 4

Step 5

Regional Governments (Autonomous Communities)

Spain

47


Decision-Making Process

The decision-making process occurs at the regional level. HTA organizations participate in the decision-making process at the level of the autonomous community. The regional organizations collaborate with the national agency and support the decision-making process at the regional level.

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The Spanish Constitution of 1978 established a territorial structure that allowed devolution to the autonomous communities of powers in the area of health. As a result, through their respective autonomy statutes, all the autonomous communities have gradually taken on such powers.

The autonomous communities now hold powers for health planning, public health and healthcare. They have taken on functions and services, goods, rights and obligations relating to such powers, as well as the staff and budgets assigned to them.

The devolution of healthcare powers from the SNS began in 1981 and was completed in 2002, with the Central State Administration keeping the responsibility for health management in the autonomous cities of Ceuta and Melilla, through the National Institute for Health Management (INGESA).

1981 The devolution of healthcare powers from the SNS began in 1981

Spain

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Reimbursement and Pricing Approval Process

After market authorization by the European Medicines Agency (EMEA), the manufacturer first needs to go through administrative tasks with AEMPS. The Ministry of Health (MSC) initiates a procedure to decide on reimbursement of this new product on the national reimbursement list.

The manufacturer is invited to provide all relevant information to allow the CIPM, led by MSC, to make a decision. Each company is free to submit as much documentation as considered necessary to support a positive decision; a “price application” is required in which the company establishes the desired price as well as the following information: • Cost per day compared with equivalent products in Spain • Price of the product in other EU countries • Sales forecast • The overall cost of R&D, production, etc.

90

%

reimbursement for pharmaceuticals for the management of chronic illnesses (e.g. diabetes, asthma and epilepsy)

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If the outcome is positive (inclusion in the national reimbursement list), this decision is valid (mandatory) throughout the country. Decision criteria to grant a reimbursement status include: • Price of the product • Severity of the disease • Budget impact for the SNS compared with corresponding product • Therapeutic value and efficacy of the product There are three reimbursement categories: • 60% reimbursement for the majority of prescription-only pharmaceuticals • 90% reimbursement for pharmaceuticals for the management of chronic illnesses (e.g., diabetes, asthma and epilepsy) • 100% reimbursement for hospital pharmaceuticals

The General Directorate of Pharmaceutical and Health Products (Dirección General de Farmacia y Productos Sanitarios, DGFPS) is the body that directs, develops and implements pharmaceutical policy in the department. It performs the duties that fall to the state in public financing and pricing of medicines and medical devices, and special conditions for prescribing and dispensing of medicines in the SNS, including the establishment of visa prior to dispensing. If a reimbursement status is approved, the pricing is decided simultaneously. If the reimbursement decision is negative, the product will be put on the negative list, and price is determined by the manufacturer (“free pricing”), including getting a national product code, before the DGFPS initiates the procedure for pricing and reimbursement. New product prices are published in the Official Journal (Boletín Oficial del Estado) but are effective as soon as they are officially communicated to the company and online by Federal Spanish Pharmacovigilance Database.

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Recruitment Considerations

The 17 autonomous regions make independent decisions to reimburse treatment. Not all regions are equally active, and they vary in the measures taken. For example, Andalusia, Catalonia and the Basque Country have taken the lead in pharmacoeconomic evaluations; Andalusia, the Canaries, Castilla-La Mancha, Castilla y Leon and Valencia have imposed regional reference prices; and Navarra, Extremadura, Catalonia and, soon, La Rioja attempt to shape prescribing and encourage greater use of generics. The role of Spain’s autonomous regions has affected demand. For example, some regions have established agencies to evaluate therapeutic utility as a basis for creating prescribing guidelines. These agencies are comprised of KOLs, heads of pharmacies, Payor experts and freelance consultants in health economics.

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AEMPS members or CIPM members are not able to participate in market research; government bodies are sometimes bound by confidentially agreements. The best option is through KOLs in each disease area, head pharmacists, Payors, heads of hospital departments, GPs who work in hospitals and freelance health economics consultants. These respondents are busy, and their time is limited and schedules are booked up in advance.


Field Logistics

Sources

• Guidelines for medication usage decision-making are considered private information and therefore a significant hurdle for research. • Recruitment of Payors is likely to be the most successful if time is available to target the most appropriate respondent—two to three weeks is advisable

Sistema Nacional de Salud Espanola http://www.aemps.gob.es/en/indFarma/ registroMed/home.htm Ministry of Health Http://www.msm.es/ HTA agency – National Instituto de Salud Carlos III. Agencia de Evaluación de Tecnologías Sanitarias http://www.isciii.es/ National Health System Key Indicators http://www.msps.es/en/estadEstudios/ estadisticas/sisInfSanSNS/inclasSNS_DB.htm Healthcare and safety in Spain http://www.spain.info/en/antes_del_viaje/ consejos-practicos/salud-seguridad/#r6 FEDRA Spanish Pharmacovigilance Database http://www.aemps.gob.es/actividad/ actCongresos/docs/presentacion_INFODAY.pdf The European Medicines Agency http://www.ema.europa.eu/ema/index.jsp?curl=/ pages/home/Home_Page.jsp&jsenabled=true AEMPS Spain http://www.aemps.gob.es/en/indFarma/ registroMed/home.htm Healthcare Technology Evaluation agency, Carlos III Healthcare Institute, Ministry of Science and Innovation, Spain. http://www.ispor.org/HTARoadMaps/Spain.asp Magazines article about: Amate JM, González Enríquez J, Sarría A, MartínMoreno JM. Evaluación de las tecnologías sanitarias y ordenación de las prestaciones en los sistemas sociales avanzados An Sist Sanit Navar. 2002 May-Aug; 25(2):131-46. SNS Spanish National Health System The Spanish Medicines Market Today

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United Kingdom System overview Responsibility for publicly funded healthcare rests with the Secretary of State for Health, who is accountable to the United Kingdom Parliament. The Department of Health is the central government body responsible for setting policy on the National Health Service (NHS), public health, adult social care and other related areas. The Treasury plays a key role through its influence in setting the national budget for publicly funded healthcare. Leadership in the Department of Health is provided by the Permanent Secretary, who is responsible to the Secretary of State and parliament for the way the department functions, and the Chief Executive of the NHS, who provides strategic leadership for the NHS and social care.

Payors in the UK are members of the National Institute for Clinical Excellence (NICE); board members and advisors, often physicians and pharmacists working within the National Health Service; PCT advisors and managers; and anybody who sits on a medicines management group, Drugs & Therapeutics committee or formulary committee. These exist for primary and secondary care along with joint committees representing both. GP consortia are now emerging and will replace primary care trusts (PCTs) by April 2013. A small number of GP consortia are already operating on a trial basis in England, and any GP sitting on one of these would also be a viable target for Payor research.

The UK public healthcare system is relatively complex, with a range of different trusts and authorities delivering and affecting healthcare provision.

UK

55


1 Drug reviewed by NICE based on a cost effectiveness model 2 If cost effective then drug recommended, national guidance developed and drug will be implemented in NHS formulary committees through England 3 If not cost effective, drug rejected. May still be funded at the discretion of regional PCTs

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Decision-Makers and Influencers

National institute of Clinical Excellence (NICE) is the independent national body that reviews all new medications using cost-effectiveness models and will approve or reject a therapy depending on the cost-effectiveness outcome. For therapies that are recommended, NICE will also produce guidelines outlining a treatment pathway using the input of various stakeholders, including pharmacists and specialist consultants. Scottish Medicines Consortium (SMC) is the Scottish equivalent to NICE and typically take their lead from NICE. All Wales Medicines Strategy Group (AWMSG) is the Welsh equivalent to NICE. Primary Care Trusts (PCT) are regional bodies responsible for commissioning primary, secondary and tertiary care services to healthcare providers at a regional level. A healthcare provider can either be an NHS acute trust, a general practice, a dental practice, any NHS walk-in center or a third-party agency. PCTs are being abolished in April 2013 to be replaced by GP consortia. NHS hospital trusts, also known as acute trusts, are commissioned by PCTs to provide services within secondary care health services at the regional level. Medicines management groups, also known as drugs and therapeutics

(D&T) committees, are local bodies that evaluate drug use, decide formulary entry, conduct periodical formulary reviews and determine how drugs are to be used and at what cost. They are also responsible for local NICE implementation. It is mandatory for drugs that have been approved by NICE to be available on formulary, although guidelines may be locally adapted, again using local pharmacists and specialist consultants. Drugs that have been rejected by NICE may still be implemented regionally if commissioned by the PCT or agreed via the medicines management group/D&T committee. Formulary committees, where they exist, tend to be a subgroup of the D&T committee or medicines management group and will only look at new drug applications or review sections of the formulary that need updating. Area prescribing committees are regional committees that tend to be a combination of D&T committees spanning numerous hospitals within the region to promote a united decision-making process. Individual funding request (IFR) panels review IFRs that are submitted by physicians for drugs that have been rejected by NICE and the PCT and therefore have no formulary access. IFR panels typically consist of representatives from both the PCT and the D&T committees. UK

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Decision-Makers and decision-making process diagram

The following diagram is for drugs that may fall under the following scenarios: • Awaiting NICE review • Have been rejected by NICE • Orphan drugs that only treat rare cases and have not been NICE reviewed • Drugs where a physician wishes to prescribe outside of the indication or outside of the NICE guidance • Unlicensed drugs that will not receive a NICE review

1 Consultant physician presents business case to the D&T committee outlining evidence of clinical efficacy, safety, price of drug, number of patients expected to be treated

2 Independent pharmacist will conduct an independent review of business case and conduct a report with recommendations

3 D&T committee will discuss and debate pharmacist report and reject or approve drug accordingly or may approve drug for formulary access under additional caveats or restrictions

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Decision-Making Process

Once a drug is licensed, it will be reviewed at the national level by NICE, which will evaluate the cost effectiveness by looking at the potential number of patients treated, the clinical benefits and the price of the drug. The drug will then be approved or rejected accordingly. If approved, a clinical guidelines panel will be set up using hospital pharmacists, specialist consultants, specialist nurses and patient representatives throughout the UK who will work together to produce guidelines and a treatment pathway.

been NICE-approved or are still under NICE review, they can also be reviewed by the medicines management group. The typical process is as follows:

• Specialist consultant will submit a business case outlining the drug they wish to use, the rationale behind it, and the potential number of patients it would treat, the clinical safety and efficacy evidence, and the cost of the drug. • Independent pharmacist will conduct a review of the drug and the business case and submit a report with All drugs that have been recommended recommendations. by NICE must be commissioned and • D&T committee will invite PCT service included in the regional formularies by commissioners to discuss funding or law. The PCTs will commission the local will look at the possibility of funding hospitals and primary care practices within their own budget or an existing to incorporate the new drug into their contract with the PCT. formularies and devise a strategy to • D&T committee or formulary incorporate this into their budgets. committee will then discuss the Drugs that have been rejected by NICE application and the independent may also be reviewed by the PCTs, pharmacist’s report and either and they may sometimes decide to approve or reject the drug for commission this at regional level. formulary access or approve the In 2013 PCTs will become obsolete, drug with caveats and restrictions. and this role will be taken over by regional GP consortia. For NICE-approved drugs, the D&T committees will then devise strategies to incorporate the drug at the local level and manage budgets accordingly. The NICE guidelines also may be adapted into local guidelines, which can sometimes vary. For drugs that have not UK

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Reimbursement and Pricing Approval Process

Generally NHS prices are controlled by an agreement between pharmaceutical manufacturers and the Department of Health using the Pharmaceutical Price Regulation Scheme (PPRS). The purpose of the scheme is to regulate profit that companies can make from NHS sales and is typically renegotiated every five years; the last PPRS was devised in 2009. The pharmaceutical companies have a profit cap and they can vary the prices for new drugs as long as they do not exceed the overall profit. This is presently under review. QALY (quality-adjusted life year) is a health economics model used by NICE to compare the therapeutic gains of a new drug to existing treatments. QALY is designed to measure the gains in terms of life expectancy and quality of life provided by drugs for different conditions. The rationale for this is that the NHS has a fixed budget; therefore, new drugs would be introduced at the expense of older drugs. Drugs that exceed the cost per QALY are typically deemed to be not cost-effective as they would be displacing too many resources that could go to treating other patients. There are exceptions and all drugs are reviewed on an individual case basis, but typically drugs that are considered to cost more than £20,000 to £30,000 per QALY are not deemed to be costeffective and therefore are unlikely to be recommended by NICE. 60

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Patient access schemes are typically proposed by pharmaceutical companies for drugs that are either awaiting NICE review or may have been rejected by NICE and can either be agreed nationally with the NHS or locally with PCTs or with acute trusts. The nature of access schemes is variable, but typically there are two types of access schemes. • Financially Based – The Company will offer a discount on a drug based on the number of patients treated and dosing required. Examples of this are Tarceva for treating nonsmall cell lung cancer, which has a simple discount scheme, or Lucentis for treating age-related macular degeneration, where the NHS will only pay for the first 14 injections and subsequent injections are funded by the manufacturer. • Outcome Based – When a drug has proven clinical value the manufacturer can negotiate a price increase. Conversely, if a drug yields less than the expected benefit then a rebate is negotiated with the NHS. One example for this is Velcade, a cancer drug for myeloma, whereby the NHS will receive a full rebate for each patient who ceases to benefit.


NHS healthcare is funded by the government, so ultimately reimbursement is in the form of budgets supplied by the Department of Health for the NHS, which are then devolved regionally and locally. These budgets are then broken down and devolved among the various PCTs within the UK. The PCTs will use these budgets to commission services among healthcare providers and will in turn reimburse the providers either through a locally agreed contract or through the PBR (payment by results) tariff. Payment by Results (PBR) Tariff is a national tariff created by the Department of Health for reimbursing hospitals in England using a fixed pricing scheme that is designed to reflect national average costs. The tariff will include a fixed price for each patient procedure, including patient hospital stay, any surgical interventions performed, drugs administered, nursing time and other incurred costs related to the procedure, this fixed cost is then charged to the service providing that procedure, for instance the costs of a cancer surgery procedure would be costed against the oncology budget. In Scotland, Wales and Northern Ireland, the hospitals are reimbursed through locally negotiated schemes with their respective PCTs. It is also worth noting that certain surgical procedures and high-cost drugs are excluded

from the tariff and are reimbursed through locally negotiated contracts between the healthcare provider and the PCT. Mental health trusts, dental surgeries, ambulance services and primary care providers are also excluded from the PBR and negotiate local contracts. These contracts are variable, but typical examples would be block contracts, sophisticated block contracts or cost-per-case contracts. Block contracts are set contracts where the healthcare provider will receive a flat yearly sum of money to care for the patient population regardless of the care provided. These are typically preferred where the variability of cost between services is considered to be small. Sophisticated block contracts are similar to block contracts, but healthcare is monitored by the NHS to ensure that the appropriate healthcare is being provided. Cost-per-case contract are negotiated when the variability of cost between services is deemed to be large. Reimbursement for GP surgeries is much simpler in that they are allocated an annual budget by their respective PCT and the cost of all patient visits to the practice and prescriptions signed by the GP are deducted from their annual budget. UK

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Recruitment Considerations

Medicines management respondents provide useful information on cost/ benefit analysis; they can include medicines management groups for secondary care and primary care depending on whether the drug is expected to be used in secondary care, primary care or both. Payor advisors can include chief pharmacists, other hospital pharmacists, physicians or GPs who sit on either a medicines management group, D&T committee or formulary committee. More often than not, respondents tend to sit on more than one group. These can also include pharmacists, physicians and specialist nurses who may be on a NICE stakeholder guidelines committee. There are also numerous independent advisory boards at the national level set up by the Department of Health, again incorporating physicians and pharmacists who may act as advisors. Numerous regional networks are composed of pharmacists and physicians who have the commissioners’ ear.

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Commissioners are advisors who can provide valuable input but may not always possess the same clinical knowledge. A number of respondents provide a link between commissioners and healthcare providers. GPs who sit on any GP consortium will be valuable respondents to target in the future; currently a limited number of trial consortia are operating within the UK. Members of the NHS commissioning board could also become viable respondents at a national level in 2013.


Field Logistics

Sources

• Recruitment of Payors is likely to be most successful if time is available to target the most appropriate respondent—two to three weeks is advisable. • Those who hold senior positions such as NICE advisors can take longer to recruit due to the inability to contact them directly but via a secretary. They usually run a busy schedule but are open to research, providing the time is available. • It may be possible to contact some Payors directly, such as purchasing managers and departmental budget holders.

http://www.ispor.org/HTARoadMaps http://www.nice.org http://www.nhs.co.uk http://www.nhsconfed.org http://dh.gov.uk

UK

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United States System overview • Healthcare in the United States is provided by many separate entities as it does not have a universal healthcare policy. • The U.S. healthcare system relies heavily on private health insurance, which is the primary source of coverage for most Americans. • Healthcare facilities are largely owned and operated by the private sector.

• Healthcare is now primarily provided by the government in the public sector, with 60–65% of healthcare provision and spending coming from programs such as Medicare, Medicaid, TRICARE, the Children’s Health Insurance Program, and the Veterans Health Administration.

United States

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Decision-Makers and Influencers

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products, medical devices, the food supply, cosmetics, dietary supplements and products that give off radiation. The FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety.

Tricare provides civilian health benefits for military personnel, military retirees, and their dependents, including some members of the Reserve Component.

Medicaid is the program for people and families with low incomes and resources. It is a means-tested program that is jointly funded by the state and federal governments.

The Veterans Health Administration (VHA) is the component of the United States Department of Veterans Affairs (VA) that implements the medical assistance program of the VA through the administration and operation of numerous VA outpatient clinics, hospitals, medical centers and longterm healthcare facilities.

Medicare is a social insurance program administered by the U.S. government, providing health insurance coverage to people aged 65 and over; to those younger than 65 and permanently physically disabled or who have a congenital physical disability; or to those who meet other special criteria.

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Children’s Health Insurance Program (CHIP) is administered by the United States Department of Health and Human Services and provides matching funds to states for health insurance to families with children. The program was designed to cover uninsured children in families with incomes that are modest but too high to qualify for Medicaid.


The Federal Employees Health Benefits is a system through which employee health benefits are provided to civilian government employee. Workers pay one-third of the cost of insurance, and the government pays the other two-thirds. Indian Health Service is responsible for providing medical and public health services to members of federally recognized tribes and Alaska natives. It is the principal federal healthcare provider and health advocate for Indian people, and its goal is to raise their health status to the highest possible level.

Health maintenance organizations (HMOs) are a type of managed care that provides a form of healthcare coverage through hospitals, doctors and other providers with which the HMO has a contract. The Health Maintenance Organization Act of 1973 required employers with 25 or more employees to offer federally certified HMO options if the employer offers traditional healthcare options. Unlike traditional insurance, an HMO covers only care rendered by those doctors who have agreed to treat patients in accordance with their guidelines and restrictions in exchange for a stream of patients.

65 Medicare is a social insurance program administered by the U.S. government, providing health insurance coverage to people aged 65 and over

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Decision-Makers and decision-making process diagram

Medicaid

Medicare

Tricare

Children’s Health Insurance program

Patients Insurance plan

Federal Employees Health Benefits

Veterans Health Administration

Indian Health Service

Physician

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Decision-Making Process

The physician makes the decision on the treatment pathway of the patient. However, the insurance plan dictates whether the patient can afford a particular treatment or test. The role of pharmacy and therapeutics (P&T) committees is to select drugs for formulary listing, to decide on the co-pay and tie structure, to advise other committees and health professionals to maximize rational drug use, to identify problems with drug use and to implement strategies to improve drug use. There are several types of P&T committees in the U.S., including state Medicaid P&T, federal P&T, managed care P&T, and institution P&T.

The state Medicaid P&T decides on the formulary listing at the state level for the Medicaid program. The federal P&T decides on the formulary listing for federally funded programs such as VA and Department of Defense. The managed care P&T represents the private sector and decides on each plan’s formulary coverage. The institution P&T decides on formulary coverage based on hospital needs.

United States

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Reimbursement and Pricing Approval Process

The United States does not have a centralized healthcare industry. Sales of pharmaceutical products depend in significant part on the availability of third-party reimbursement. Third-party Payors include government health administrative authorities, managed care providers, private health insurers and other organizations.

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There are huge discrepancies in the cost of procedures and what the Payor is willing to pay; this may vary from state to state. Therefore, the trend is to get precertification or approval for any treatment or tests from the patient’s insurance plan provider before any treatment or test is carried out. The P&T committee normally evaluates the clinical merit of drug under consideration. If equivalent, then business issues, such as costs, are determining factors.


60–65%

of healthcare provision and spending coming from programs such as Medicare, Medicaid, TRICARE, the Children’s Health Insurance Program, and the Veterans Health Administration. United States

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Recruitment Considerations

Institutions have different pathways to purchase modalities depending on therapy areas. Department directors have input, but the finance executive team makes the ultimate decision based on cost effectiveness and profit return. Physicians are dictated by the patient’s insurance plan on the type of treatment or test they can provide. P&T committees are a key player in what is approved for the hospital formulary. The key members of P&T committee include physicians, pharmacists, administrators, qualityassurance coordinators/legal, and nurses. The chairperson is typically a physician, and pharmacists are typically designated as secretaries.

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•


Field Logistics

Sources

• Screener must be US specific and relate to that market. • Physicians’ and advisors input is not as important into the topic as it is in other markets. • Stakeholders would respond quicker to an email approach than over the phone, like other markets. • Remember that there are several time zones in the US.

http://www.ispor.org/HTARoadMaps/ Default.asp http://www.fda.gov/ http://www.bluebell-consulting.com/en/ trend/trend_070130.htm

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Why All Gobal?

With offices in New York and London, All Global is a leading provider of qualitative and quantitative data collection services to the medical and healthcare market research industry worldwide. Payor qualitative research is a foundational element to our product suite. All Global has been conducting research with Payors and advisors for around 5–6 years now, and was one of the first data collection agencies to offer access to those stakeholders.

6

We have learnt a lot with this and have also built a strong relationship with those stakeholders in different markets and from different levels. We have created a good rapport with them and they have contributed a lot to meet ours and our client’s needs. Staffed with a team of project managers and moderators who focus solely in qualitative healthcare research, All Global runs an average of 160–200 studies that have a Payor component to it every year.

All Global has been conducting research with Payors and advisors for around 5–6 years 74

All Global Guide to Payor Research


All Global runs an average of 160–200 studies that have a Payor component to it every year. Why All Global?

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Qualitative Project Types

We offer the following practical solutions to fielding with Payors: Tele-depth • Full-service tele-depth: recruitment, interviewing and reporting • Recruitment only for English speakers Web-based • Online focus groups • Bulletin boards • WebEx • Webcam Boards/IDI’s Face-to-face • IDI’s • Triads • Dyads • Mini-groups • Focus groups • In-office interviews Bespoke • Multi-European-country all day workshops in English • Mock formulary committees • Focus groups: enable respondents to discuss and dissect new products/best pricing/positioning in their market

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Facilities • All Global Viewing: our own modern facility in the heart of London Modern Facility Hire across the EU5 and US with Remote Viewing Capabilities Qualitative Services • We offer a full range of consultative qualitative services from pricing to final deliverables Value-Added Services • Design guidance and consultation to ensure that we aid in helping shape a research plan that best suits our clients’ needs • Local European and US market expertise • Extensive Payor research experience • Positive and professional working relationships with Payor respondents • Recruiters and Moderators that only work with Payors and other high level stakeholders


All Global’s Database Overview

The European and US Payors professional community is a lowaccess, finite group of professionals. The importance of this community cannot be overstated in any effort to understand the potential for success of a new product in these markets. Given the difficulty involved with accessing this group and the numerous sensitivities involved in the respective systems, it’s vital that any company attempting to conduct research must intelligently navigate issues appropriately to both ensure accurate data and to earn the trust of the Payors themselves. Over the years, All Global has built that expertise and trust.

Below is the size of our qualitative Payors Database in the five major markets in Europe and US. With a strong database and relationship with Payors, All Global still leads the way in the industry. Below is the size of our qualitative Payors Database in the five major markets in Europe and US.

Payors Geographical Level National Regional Local

UK FR DE IT ES US

Overall counts

90 77 71 57 62 205

KOL’s/Advisors Main Therapy areas Cardiovascular Diabetes/Endocrinology Haematology/Oncology Infectious diseases (inc HIV) Rheumatology

80 100 75 50 40 120 59 120 80 75 55 90 6 250 75 55 70 130 25 50 55 75 45 100 25 45 40 40 40 80

Overall counts for all therapy areas

500

14 25 11 9 10 40 21 – 15 13 14 175 55 59 45 35 38 –

650

450

350

450

All Global’s Database Overview

520

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All Global’s Payors Database Profiles

Germany National  • National payor, Member of Drug Committee of the GBA healthcare insurance, deputy general manager supply • GBA member/Advisor of GKV Regional  • Deals with issues of reimbursement at regional level within the BKK. Based in Kornwestheim, South West Germany at the BKK Landesverband. Advises the STIKO on pricing and reimbursement • Member of a regional Sick Fund – Sick Funds (from the Sick Funds Association and big sick fund) Local • Pharmacy Director From German Society Of Hospital Pharmacists

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UK National

• (Medical Director and Director of Primary Care). A budget holder for primary care including medicines management. He has board level medical responsibility and support business cases for new service developments through the integrated commissioning executive. Part of NICE • Consultant Dermatologist – PCT responsible/Part of NICE

Regional

• Committee member of the JCVI. Also the immunisation co-ordinator for the Glasgow NHS board National/ • Formulary Pharmacist for Surrey-Sussex NMS Trust with a Regional national role at NICE. Responsible for managed entry of products into the health economy, three hospitals and two PCT’s; Shared care guidelines from hospitals to GP’s; Looking at the drug budget across the health economy. Sits at the committee responsible for cost impact modelling Local  • Hospital Pharmacy Director – Evaluation of supportive therapies for oncology – hospital treated out-patients • Senior Pharmacist in clinical education & health economy prescribing (Pct responsible) chemotherapy followed by bone marrow transplant

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France National  • advices HSCP is a member of the Transparency Committee (CT) • Professor/Member of transparency Transparency Committee (CT)  • Université Claude Bernard, Lyon, France. Président du comité techniques et vaccinations, – sits on the CTV and is a member • Deputy Head Clerk, Drugs Office – Work for CEPS Local  • Pharmacy Director and president of the Formulary Committee, very knowledgeable about hospital-based infections Spain National

• Member of the Ministry of Health • President of the Spanish Society of Hospital Pharmacy

Regional • Clinical & Economic evaluator for Drugs Vaccines to be included in Protocol. Member of Therapeutic & Pharmaceutical Commission/Barcelona • Pharmacist/Buyer/Private Hospital/Valencia Local

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• Pharmacist University Hospital of Leon Complejo Asistencial • Universitario de León that belongs to the healthcare service from Castilla and León. Head of a drug formulary review board

All Global Guide to Payor Research


Italy National

• Member Of The AIFA Technical Commission, PTOR MEMBER • Ministry of Health/Instituto Nacional del Consumo

Regional

• Director of Drug Policy – Liguria Region • Part of the Committee in limiting the usage of pharmaceutical in the Veneto region (PTOR)

Local

• Head Of Pharmacy in big hospital; part of the PTOR; has influence on the supply of all the drugs to the territory of Naples

USA National

• Managed Care Pharmacy and Medical Directors from companies such as Unimed, Wellcare, Cigna and many others

Regional

• Managed Care Medical and Pharmacy Directors from companies such as BCBS, Providence Health Plans, Horizon, Communycare and many others

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Case Studies

Whether it is a 60-minute tele-depth interview or an all-day focus group with formulary committee members flying to London or Paris, All Global can execute the most complex project.

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Case Study 1 EU Advisory Board Rheumatology and Gastro Study

English Speaking Payors and Advising KOL’s

UK 1

France 1

Total Sample

5

Methodology 7hrs Face to Face Advisory Board Services provided by AG Recruitment, Moderation, Travel and Field Logistics and Report Writing Deliverables Full PPT Report and Digital Recordings Specific Criteria English Speaking Respondents Challenge Our client wanted to understand key product value drivers and the role of oncologists in influencing pricing and market access for new lung and breast cancer therapies and to gain insights on future Payor management and Phase III trial design options. We recruited Payors and advisors from each of the EU5 markets to meet face-to-face in a European city and spend a day on an advisory board that was set up as a mock formulary committee meeting

Germany 1

Italy 1

Spain 1

The Right Stakeholders, the Right Channels… The session had a full representation from the EU5 markets, from Payors themselves to Payor-advising KOLs to guarantee the best level of English in some of the markets. The workshop was conducted in our Central London viewing facility …The Right Result The client got a full perspective of pricing, reimbursement and market access in Europe. The approach was very interesting to the respondents, who had the opportunity to discuss common issues with their peers. They were fully engaged in the exercise, making the entire experience rich for everyone involved “All Global has done a great job in putting this together. It is not an easy task to do it logistically, and we were happy that All Global’s team was as engaged and excited about the opportunity as we were with the entire exercise and the valuable insights we got with it.”

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Case Study 2 Assess the Market for a C. difficile Vaccine

UK English Speaking Payors 6 and Advising KOL’s

Germany 6

Spain 6

Total Sample 18

Methodology Tele-depths: 45–60 mins Services provided by AG Recruitment, Moderation, and Report Writing Deliverables Content Analysis and English Transcripts Criteria UK: At least N=1 Payor from PCT or SMC Germany: At least N=1 Payor at the RKI Spain: At least N=1 Payor or advisor to the Ministry of Health Challenge Our client wanted to get an accurate picture of how C. difficile infections were dealt with in the UK, Germany and Spain

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They wanted to assess whether they should introduce their new product into vaccine schedules or as a drug by determining the decision pathways and funding implications for both options The Right Stakeholders, the Right Channels… We succeeded in getting tele-depths with senior advisors across the geographies, including top advisors to the advisory committees and government health departments …The Right Result “All Global’s experience within that arena has shown that vaccines are dealt with by a different type of Payors and stakeholders than the ones that make decisions on drugs. Identifying that early in the process has allowed us to quickly find the right respondents to target and gave us access to this limited universe of stakeholders.”


Case Study 3 Global Study on Biosimilars

Payors, Advising KOL’s and KOL’s

EU5 US Brazil 40 8 8 Japan Mexico Poland 8 8 8

Total Sample

112

Methodology Tele-depths: 45–60 mins Services provided by AG Recruitment, Moderation, and Report Writing Deliverables Content Analysis and English Transcripts Criteria To be fielded in 3 weeks before end of year break Challenge Our client wanted to understand key product value drivers, and the role of oncologists in influencing pricing and market access for new lung and breast cancer therapies and to gain insights on future payor management and Phase III trial design options. The study discussed the use of biologics with stakeholders from the U.S., EU5, Japan, Brazil, Russia, China, Mexico and Turkey. It was run close to the Christmas period, posing difficulties with access to high-level stakeholders

China India 8 8 Russia Turkey 8 8

The Right Stakeholders, the Right Channels… In fast-turnaround studies such as this, the close and strong relationship All Global has developed with stakeholders is key to making a study such as this successful. In addition, the preferred partners we use for other markets are very much in sync with the standard of work we expect and offer to our clients …The Right Result The client managed to deliver valuable and rich data to their end client at a global scale for a very intriguing topic within a very short timeline on a lastminute commission “We appreciate all the hard work you put into this project, especially within that scale and such a fast turnaround. This just shows that All Global has the right avenues and relationships that can make something like this happen. We look forward to work with All Global again.”

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Case Study 4 Orphan Disease Payors Study

Payors and KOL’s

UK 3

France 3

Total Sample

15

Methodology Tele-depths: 45–60 mins Services provided by AG Recruitment, Moderation, and Report Writing Deliverables Topline Report and English Transcripts Criteria Moderators should be knowledgeable on the Healthcare systems and Market Access Issues of their markets specifically on Orphan Drugs Challenge The client wanted to identify a potential price range and associated clinical data for a new product in an orphan hepatology indication. The research had to be executed within a very short timeline and with high-level stakeholders

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Germany 3

Italy 3

Spain 3

The Right Stakeholders, the Right Channels… We used our strong relationships with stakeholder to recruit four Payors at the regional or national level in each market for this study …The Right Result “Thanks again for making it possible that I could speak to the moderators in 5 EU. I got a very good impression about their strengths and feel that they all are individually very well-informed about pricing and reimbursement in the respective countries. We usually use our own moderators for all projects, but we have realized that All Global’s moderators can get so much out of those stakeholders than we ever did. We will only be using AG’s moderators for all Payors projects from now on.”


Recruiter/Moderator Expertise

These high-level respondents require a sensitive and professional management approach. Our highly trained recruiters: • Are native Europeans • Work from our office in London • Are bilingual • Have local healthcare expertise as well as the experience in recruiting, interviewing and managing these respondents • Have deep understanding of the reimbursement, pricing and market access policies and guidelines of the markets they work with

• Are Report writers trained at the same standards: • Transcriptions • Audio recordings • Summary reports • Content analysis • Top-line findings • Detailed reports in PPT • Global presentations • Are experienced in concept testing, branding, pricing and reimbursement, product development, comparative studies, tracking, etc. We take a flexible and enthusiastic approach to working with these types of respondents. We partner with you on each study to suit your needs. In qualitative Payor research, we are leaders in our field and have learned to stay one step ahead before, during and after fieldwork to support and guide you toward achieving your projects’ objectives and goals.

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A.K. Freelance Moderator/Analyst info@allglobal.com Personal Nationality: British Languages spoken: English Profile 10 years market research experience Main specialization The Medical, Healthcare and Pharmaceutical industry, in the UK, USA, Australia and Canada Certified in Adverse Events training Moderation experience in healthcare includes the following research areas: • Anaesthesia: pain therapy, use of anaesthetics, pre and post-operative treatment • Cardiology: coronary cardiac disorders, hypertension, heart transplants, myocardial infarction, aneurysm, cardiac valves, angina, dyslipidemia, heart failure, pacemakers and defibrillators • Dermatology: psoriasis, herpes, melanoma, warts, eczema, atopic dermatitis • Endocrinology: diabetes, growth hormone deficiency, obesity, metabolic syndrome, thyroid disorders, pituitary disease, hormone replacement therapy

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• Gastroenterology: colitis, gastric carcinoma, gastric ulcers, GIST, GERD, IBD, colostomy • General practice • Geriatric medicine: Parkinson’s disease, Alzheimer’s disease, dementia • Gynaecology: menopause, contraceptives, genital herpes, ovarian carcinoma, cervical cancer, overactive bladder, incontinence, infertility • Haematology: CML, sickle cell disease, thalassemia, iron chelators, haemophilia • Health education – seminars, meetings conferences • Immunology: HPV vaccine • Infectious diseases: HIV, AIDS, genital herpes, fungal infections, bacterial infections, hepatitis • Nephrology: dialysis, nephritis, kidney stones, renal failure, carcinoma of kidney • Neurology: epilepsy, stroke, Parkinson’s disease, multiple sclerosis, migraine, neuropathic pain, carpal tunnel syndrome • Oncology: multiple myeloma, pancreatic cancer, lung cancer, GIST, leukaemia, breast cancer, neuroendocrine tumours, chemotherapy, targeted therapies


• Orthopaedics: pain therapy, osteoporosis, arthritis (rheumatoid and osteo), inflammation • Paediatrics: vaccination, growth hormone deficiency • Psychiatry: depression, schizophrenia, bipolar disorder, anxiety, sleep disorders, ADHD, anorexia, treatment of addiction, Alzheimer’s disease • Pulmonology: asthma, COPD, allergic rhinitis, emphysema, lung cancer, pneumonia, pleurisy • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, fibromyalgia • Sexual health: HPV vaccine, genital herpes, HIV, sexually transmitted disease • Surgery: Surgical procedures and techniques, energy devices, plastic surgery, Botox • Urology: erectile dysfunction, prostate cancer, overactive bladder, incontinence

Services provided include: • Moderation of tele-depths (qualitative and quantitative) • Use of a variety of interview methodology – face to face, online or via phone or webcam • Recruitment (including patients and KOLs, for Focus Groups and IDI’s) • Desk and field research • Pilot testing • Report writing • Transcriptions • Proof reading

Recruiter/Moderator Expertise

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J.C. Freelance Moderator/Analyst info@allglobal.com Personal Nationality: British Languages spoken: English Profile 6 years market research experience Main specialization The Medical, Healthcare and Pharmaceutical industry, in the UK, USA Certified in Adverse Events training Moderation experience in healthcare includes the following research areas: • Anaesthesia: pain therapy, use of anaesthetics, pre and post-operative treatment • Cardiology: coronary cardiac disorders, hypertension, heart transplants, myocardial infarction, aneurysm, cardiac valves, angina, dyslipidemia, heart failure, pacemakers and defibrillators • Dermatology: psoriasis, herpes, melanoma, warts, eczema, atopic dermatitis • Endocrinology: diabetes, growth hormone deficiency, obesity, metabolic syndrome, thyroid disorders, pituitary disease, hormone replacement therapy

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• Gastroenterology: colitis, gastric carcinoma, gastric ulcers, GIST, GERD, IBD, colostomy • General practice • Geriatric medicine: Parkinson’s disease, Alzheimer’s disease, dementia • Gynaecology: menopause, contraceptives, genital herpes, ovarian carcinoma, cervical cancer, overactive bladder, incontinence, infertility • Haematology: CML, sickle cell disease, thalassemia, iron chelators, haemophilia • Health education – seminars, meetings conferences • Immunology: HPV vaccine • Infectious diseases: HIV, AIDS, genital herpes, fungal infections, bacterial infections, hepatitis • Nephrology: dialysis, nephritis, kidney stones, renal failure, carcinoma of kidney • Neurology: epilepsy, stroke, Parkinson’s disease, multiple sclerosis, migraine, neuropathic pain, carpal tunnel syndrome • Oncology: multiple myeloma, pancreatic cancer, lung cancer, GIST, leukaemia, breast cancer, neuroendocrine tumours, chemotherapy, targeted therapies


• Orthopaedics: pain therapy, osteoporosis, arthritis (rheumatoid and osteo), inflammation • Paediatrics: vaccination, growth hormone deficiency • Psychiatry: depression, schizophrenia, bipolar disorder, anxiety, sleep disorders, ADHD, anorexia, treatment of addiction, Alzheimer’s disease • Pulmonology: asthma, COPD, allergic rhinitis, emphysema, lung cancer, pneumonia, pleurisy • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, fibromyalgia • Sexual health: HPV vaccine, genital herpes, HIV, sexually transmitted disease • Surgery: Surgical procedures and techniques, energy devices, plastic surgery, Botox • Urology: erectile dysfunction, prostate cancer, overactive bladder, incontinence

Services provided include: • Moderation of tele-depths (qualitative and quantitative) • Use of a variety of interview methodology – face to face, online or via phone or webcam • Recruitment (including patients and KOLs, for Focus Groups and IDI’s) • Desk and field research • Pilot testing • Report writing • Transcriptions • Proof reading

Recruiter/Moderator Expertise

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S.F. Freelance Moderator/Analyst info@allglobal.com Personal Languages spoken: French (mother tongue), English (fluent), Spanish (conversational) Profile 8 years market research experience Main specialization The Medical, Healthcare and Pharmaceutical industry, both in France and abroad Certified in Adverse Events training Moderation experience in healthcare includes the following research areas: • Anaesthesia: pain therapy, use of anaesthetics, pre and post operative treatment • Cardiology: coronary cardiac disorders, hypertension, heart transplants, myocardial infarction, aneurysm, cardiac valves, angina, heart failure, pacemakers and defibrillators • Dermatology: psoriasis, herpes, melanoma, warts, eczema, atopic dermatitis • Endocrinology: diabetes, dyslipidemia, growth hormone deficiency, obesity, metabolic syndrome, thyroid disorders, pituitary disease • Gastroenterology: colitis, gastric carcinoma, gastric ulcers, GIST, GERD, IBD, colostomy

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• General practice • Geriatric medicine: Parkinson’s disease, Alzheimer’s disease, dementia • Gynaecology: menopause, contraceptives, overactive bladder, incontinence, infertility, hormone replacement therapy • Haematology: sickle cell disease, thalassemia, iron chelators, haemophilia • Health education – seminars, meetings conferences • Immunology: HPV vaccine • Infectious diseases: HIV, AIDS, genital herpes, fungal infections, bacterial infections, hepatitis • Nephrology: dialysis, nephritis, kidney stones, renal failure, carcinoma of kidney • Neurology: epilepsy, stroke, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, migraine, neuropathic pain, carpal tunnel syndrome • Oncology: CML, NHL, multiple myeloma, leukaemia, pancreatic cancer, lungcancer, GIST, leukaemia, breast cancer, neuroendocrine tumours, chemotherapy, ovarian cancer, cervical cancer, targeted therapies • Orthopaedics: pain therapy, osteoporosis, arthritis (rheumatoid and osteo), inflammation • Paediatrics: vaccination, growth hormone deficiency


• Psychiatry: depression, schizophrenia, bipolar disorder, anxiety, sleep disorders, ADHD, anorexia, treatment of addiction • Pulmonology: asthma, COPD, allergic rhinitis, emphysema, pneumonia, pleurisy • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, fibromyalgia • Sexual health: HPV vaccine, genital herpes, HIV, sexually transmitted disease • Surgery: Surgical procedures and techniques, energy devices, plastic surgery, Botox, gadolinium based agent • Urology: erectile dysfunction, prostate cancer, overactive bladder, incontinence Services provided include: • Moderation of in depth qualitative IDIs and focus groups. • Moderation of tele-depth (qualitative and quantitative). • Use of a variety of interview methodology – face to face, online or via phone or webcam • Ethnographic research • Analysis – report writing (topline, content analysis and full report). Presentation in word, power point or excel • Desk and field research • Pilot testing

• Transcriptions • Translations • Proof reading Range and depth of research: • Background and exploratory (identification of unmet needs in the market) • Testing: product concept, messages, advertising concepts • Logos, detail aids and devices • Website design • New product development • Brand development • Positioning • Segmentation • Advertising • Cost effectiveness • Pricing • Ethnographic studies (including observation at home/office/hospital) • Diary studies • Patient and carer interviews • Value of company sales representatives Types of respondents: • GPs • Specialist consultants of all medical specialties. • KOL • Pharmacists • Nurses • Patients and carers • Payors (administrative personnel and government advisors) • Consumers

Recruiter/Moderator Expertise

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S.S. Freelance Moderator/Analyst info@allglobal.com Personal Nationality: Swiss/German Languages spoken: German, English Profile 4 years market research experience Main specialization The Medical, Healthcare and Pharmaceutical industry, both in Germany and abroad Certified in Adverse Events training Moderation experience in healthcare includes the following research areas: • Cardiology: coronary cardiac disorders, hypertension, myocardial infarction, aneurysm, cardiac valves, angina, dyslipidemia, heart failure • Dermatology: psoriasis, herpes, melanoma, eczema, atopic dermatitis • Endocrinology: diabetes, growth hormone deficiency, metabolic syndrome, thyroid disorders, hormone replacement therapy • Gastroenterology: colitis, gastric carcinoma, gastric ulcers • General practice • Geriatric medicine: Alzheimer’s disease, dementia • Gynaecology: menopause, contraceptives, genital herpes, ovarian carcinoma, cervical cancer, overactive bladder, incontinence, infertility

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• Haematology: CML, sickle cell disease, thalassemia, iron chelators, haemophilia • Immunology: HPV vaccine • Infectious diseases: genital herpes, fungal infections, bacterial infections, hepatitis • Nephrology: carcinoma of kidney • Neurology: epilepsy, stroke, Parkinson’s disease, multiple sclerosis, migraine, neuropathic pain, carpal tunnel syndrome • Oncology: multiple myeloma, pancreatic cancer, lung cancer, leukaemia, breast cancer, neuroendocrine tumours, chemotherapy, targeted therapies • Orthopaedics: pain therapy, osteoporosis, arthritis (rheumatoid and osteo), inflammation • Pediatrics: vaccination, growth hormone deficiency • Psychiatry: depression, schizophrenia, Alzheimer’s disease • Pulmonology: asthma, COPD, lung cancer, pneumonia • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, fibromyalgia • Sexual health: HPV vaccine, sexually transmitted disease • Surgery: Surgical procedures and techniques, energy devices, plastic surgery, Botox • Urology: erectile dysfunction, prostate cancer, overactive bladder, incontinence


Services provided include: • Moderation of in depth qualitative IDIs and focus groups • Moderation of tele-depths (qualitative and quantitative) • Use of a variety of interview methodology – face to face, online or via phone or webcam • Ethnographic research • Analysis – report writing (topline, content analysis and full report). Presentation in word, power point or excel • Recruitment (including patients and KOLs) • Desk and field research • Pilot testing • Transcriptions • Proof reading

Range and depth of research: • Background and exploratory (identification of unmet needs in the market) • Testing: product concept, messages, advertising concepts • Logos, detail aids and devices • Website design • New product development • Brand development • Positioning • Segmentation • Advertising • Cost effectiveness • Pricing • Ethnographic studies (including observation at home/office/hospital) • Diary studies • Patient and carers interviews • Value of company sales representatives Types of respondents: • GP’s • Specialist consultants of all medical specialties • KOL • Pharmacists • Nurses • Patients and carers • Payors (administrative personnel and government advisors) • Consumers

Recruiter/Moderator Expertise

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D.R. Moderator/Analyst info@allglobal.com Personal Nationality: Italian Languages spoken: Italian, English Profile 10 years market research experience Main specialization The Medical, Healthcare and Pharmaceutical industry, both in the UK and Italy Certified in Adverse Events training Moderation experience in healthcare includes the following research areas: • Anaesthesia: pain therapy, use of anaesthetics, pre and post-operative treatment • Cardiology: coronary cardiac disorders, hypertension, heart transplants, myocardial infarction, aneurysm, cardiac valves, angina, dyslipidemia, heart failure, pacemakers and defibrillators • Dermatology: psoriasis, herpes, melanoma, warts, eczema, atopic dermatitis • Endocrinology: diabetes, growth hormone deficiency, obesity, metabolic syndrome, thyroid disorders, pituitary disease, hormone replacement therapy • Gastroenterology: colitis, gastric carcinoma, gastric ulcers, GIST, GERD, IBD, colostomy • General practice

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• Geriatric medicine: Parkinson’s disease, Alzheimer’s disease, dementia • Gynaecology: menopause, contraceptives, genital herpes, ovarian carcinoma, cervical cancer, overactive bladder, incontinence, infertility • Haematology: CML, sickle cell disease, thalassemia, iron chelators, haemophilia • Health education – seminars, meetings conferences • Immunology: HPV vaccine • Infectious diseases: HIV, AIDS, genital herpes, fungal infections, bacterial infections, hepatitis • Nephrology: dialysis, nephritis, kidney stones, renal failure, carcinoma of kidney • Neurology: epilepsy, stroke, Parkinson’s disease, multiple sclerosis, migraine, neuropathic pain, carpal tunnel syndrome • Oncology: multiple myeloma, pancreatic cancer, lung cancer, GIST, leukaemia, breast cancer, neuroendocrine tumours, chemotherapy, targeted therapies • Orthopaedics: pain therapy, osteoporosis, arthritis (rheumatoid and osteo), inflammation • Paediatrics: vaccination, growth hormone deficiency • Psychiatry: depression, schizophrenia, bipolar disorder, anxiety, sleep disorders, ADHD, anorexia, treatment of addiction, Alzheimer’s disease


• Pulmonology: asthma, COPD, allergic rhinitis, emphysema, lung cancer, pneumonia, pleurisy • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, fibromyalgia • Sexual health: HPV vaccine, genital herpes, HIV, sexually transmitted disease • Surgery: Surgical procedures and techniques, energy devices, plastic surgery, Botox • Urology: erectile dysfunction, prostate cancer, overactive bladder, incontinence Services provided include: • Moderation of in depth qualitative IDIs and focus groups • Moderation of tele-depths (qualitative and quantitative) • Use of a variety of interview methodology – face to face, online or via phone or webcam • Ethnographic research • Analysis – report writing (topline, content analysis and full report). Presentation in word, power point or excel • Recruitment (including patients and KOLs) • Desk and field research • Pilot testing • Transcriptions • Proof reading

Range and depth of research: • Background and exploratory (identification of unmet needs in the market) • Testing: product concept, messages, advertising concepts • Logos, detail aids and devices • Website design • New product development • Brand development • Positioning • Segmentation • Advertising • Cost effectiveness • Pricing • Ethnographic studies (including observation at home/office/hospital) • Diary studies • Patient and carer interviews • Value of company sales representatives Types of respondents: • GPs • Specialist consultants of all medical specialties. • KOL • Pharmacists • Nurses • Patients and carers • Payors (administrative personnel and government advisors) • Consumers

Recruiter/Moderator Expertise

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V.C. Freelance Moderator/Analyst info@allglobal.com • Gynaecology: menopause, contraceptives, genital herpes, ovarian carcinoma, cervical cancer, overactive bladder, incontinence, infertility Profile • Haematology: hemophilia 10 years market research experience • Immunology: HPV vaccine • Infectious diseases: HIV, AIDS, Main specialization genital herpes, fungal infections, The Medical, Healthcare and bacterial infections, hepatitis, C Diff. Pharmaceutical industry in Spain, • Nephrology: dialysis, nephritis, Mexico & Argentina kidney stones, renal failure, carcinoma of kidney Certified in Adverse Events training • Neurology: epilepsy, stroke, Parkinson’s disease, multiple Moderation experience in healthcare sclerosis, migraine, neuropathic includes the following research areas: pain, carpal tunnel syndrome. • Anaesthesia: pain therapy, • Oncology: multiple myeloma, use of anesthetics, pre and pancreatic cancer, lung cancer, post operative treatment leukaemia, breast cancer, • Cardiology: coronary cardiac chemotherapy disorders, hypertension, heart • Orthopedics: pain therapy, transplants, myocardial infarction, osteoporosis, arthritis (rheumatoid aneurysm, cardiac valves, angina, and osteo), inflammation dyslipidemia, heart failure, • Pediatrics: vaccination, pacemakers and defibrillators growth hormone deficiency • Dermatology: psoriasis, herpes, melanoma, warts, eczema, dermatitis • Psychiatry: depression, schizophrenia, bipolar disorder, • Endocrinology: diabetes, growth anxiety, sleep disorders, anorexia, hormone deficiency, obesity, Alzheimer’s disease metabolic syndrome, thyroid • Pulmonology: asthma, COPD, disorders, pituitary disease, allergic rhinitis, emphysema, lung hormone replacement therapy cancer, pneumonia, pleurisy • Gastroenterology: colitis, gastric carcinoma, gastric ulcers, colostomy • Rheumatology: use of biologics, rheumatoid arthritis, osteoarthritis, • General practice fibromyalgia • Geriatric medicine: Parkinson’s disease, Alzheimer’s disease, dementia Personal Nationality: Argentinean Languages spoken: Spanish, English

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• Sexual health: HPV vaccine, genital herpes, HIV, sexually transmitted disease • Surgery: Surgical procedures • Urology: prostate cancer, overactive bladder, incontinence Services provided include: • Moderation of in depth qualitative IDIs and focus groups • Moderation of tele-depths (qualitative and quantitative) • Use of a variety of interview methodology – face to face, online or via phone or webcam • Analysis – report writing (topline, content analysis and full report) Presentation in word, power point or excel • Recruitment (including patients and KOLs) • Desk and field research • Pilot testing • Transcriptions • Translations • Graphic Design • Brand and corporate identity design

• Positioning • Segmentation • Unmet needs • Advertising • Cost effectiveness • Pricing • Patient and carer interviews • Value of company sales representatives Types of respondents: • GPs • Specialist consultants of all medical specialties • KOL • Pharmacists • Nurses • Patients and carers • Payors (regional and government advisors) • Committee members • Consumers

Range and depth of research: • Background and exploratory (identification of unmet needs in the market) • Testing: product concept, messages, advertising concepts • Logos, detail aids and devices • Brand Identity • New product development • Brand development Recruiter/Moderator Expertise

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Contact us

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All Global Payor Research 2012 Edition