Navigating Market Access in Europe 2019

NAVIGATING MARKET ACCESS IN EUROPE HANOVER HEALTH

“ I WOULD LIKE TO PROPOSE THE MARKET EXCLUSIVIT Y PERIOD FOR ORPHAN MEDICINES BE REDUCED TO A REASONABLE PERIOD THAT IS PROPORTIONATE TO THE INVESTMENTS MADE. WHY SHOULD A MANUFACTURER HAVE A MONOPOLY FOR 10 YEARS IF THERE ARE NO HIGH INVESTMENT COSTS?” Bruno Bruins Dutch Health Minister, 11 April 2019 “ W E HAVE TRIED TO TALK WITH THE PHARMACEUTICAL INDUSTRY DOZENS OF TIMES ON THIS ISSUE (TRANSPARENCY OF MEDICINES’ PRICES) BUT THERE WAS A LACK OF WILLINGNESS TO NEGOTIATE.” Giulia Grillo Italian Minister of Health, 12 March 2019

“ I WILL ALLOW IRELAND TO EXPLORE OPPORTUNITIES (WITHIN THE BENELUXA COUNTRY COLLABORATION), IN AN INCREASINGLY CHALLENGING ENVIRONMENT OF HIGH PRICING OF MEDICINES BY PHARMACEUTICAL COMPANIES, TO SECURE SUSTAINABLE AND AFFORDABLE ACCESS FOR PATIENTS TO NEW AND INNOVATIVE MEDICINES.” Simon Harris Irish Minister of Health, 13 February 2018

MARKET ACCESS IN EUROPE In Europe, the debate on health has shifted from the need to foster innovation to concerns over the long-term sustainability of healthcare systems. In most cases, the price of medicines is being strongly scrutinised.

European governments are now facing the significant increase in healthcare innovation that they were hoping for just 10 years ago, but which they had not fully anticipated or prepared for. At the governmental level, the market access and policy worlds have come together to mitigate some of the challenges through cost containment.

Following marketing authorisation, Health Technology Assessment (HTA) bodies and payers are regularly delaying or restricting patient access to innovative treatments.

They often lack the information they need to make decisions, particularly with orphan drugs, which leads to requests for companies to develop additional data, and managed access agreements combined with audits and real-world evidence. Policymakers, regulators, payers, HTA bodies and industry increasingly want to engage more regularly, more collaboratively and earlier in the drug development cycle. Indeed, there is an increasing overlap of interests, with regulators looking at access challenges and HTA bodies looking at budget impact.

It is no longer enough to simply present a strong clinical data package to secure a marketing authorisation and then expect policy-makers and pricing and reimbursement authorities to accept a high price. A new approach is needed to ensure that patients have access to the treatments they need.

To adapt to the changing external environment, companies have needed to use compelling arguments about the value and affordability of the recent wave of breakthrough products in Europe. Early engagement with influential decisionmakers is now a key part of company market access strategies. Communications has importance here through disease awareness and value communications to payers and prescribers. Strong patient advocacy is crucial to provide third-party support around value and unmet need.

Companies have fought high-profile and sometimes reputationally damaging battles for access in Europe - ongoing stakeholder engagement and communications helps to manage expectations and alignment of audiences should pricing and reimbursement processes prove challenging.

The consequences of not doing so can lead to significant delays in bringing treatments to patients and can undermine a wellplanned product launch.

“IT IS NO LONGER ENOUGH TO PRESENT A STRONG CLINICAL DATA PACKAGE.�

JOSIE GODFREY HANOVER SENIOR ADVISOR

The emergence of cell and gene therapies and other innovative treatments is creating new challenges for policy-makers, HTA bodies and payers in Europe. They bring with them the promise of revolutionising treatment for severe, disabling or life-limiting conditions.

Healthcare systems are struggling to respond flexibly to such transformative innovations, particularly with one-time treatments.

their home country may need to adapt to increasing patient flows. Similarly, the status of hospital products can impact directly on the ability of companies to successfully launch new therapies.

The complexity of many innovative treatments and the patient pathways that need to be put in place mean companies need to engage early with policy-makers, HTA bodies and payers to ensure that healthcare Policy-makers, HTA bodies, payers, clinicians and patients are all keen to ensure patients in systems will be ready to adopt their new Europe benefit from innovative therapies and treatments. This may include influencing legislative and policy changes to allow for yet the first wave of cell and gene therapies an innovative payment model, agreeing have struggled in Europe, primarily due to requirements for delivering a new treatment pricing and reimbursement issues. and facilitating smooth movement of patients Flexibilities in Health Technology Assessments between treatment centres. and innovative and sustainable payment models are needed to address uncertainties at the time of marketing authorisation. Policies on cross-border healthcare, which allow patients to move to treatment centres across Europe if the treatment is reimbursable in

“ T HE FIRST WAVE OF CELL AND GENE THERAPIES HAVE STRUGGLED IN EUROPE DUE TO PRICING AND REIMBURSEMENT”

Josie Godfrey is a Hanover Senior Adviser and an expert in market access.

Josie has 10 years’ experience working in the commissioning and evaluation of new treatments for rare diseases, having set up and run the NICE Highly Specialised Technologies programme in the UK, as well as the predecessor programme, the Advisory Board for National Specialised Services (AGNSS).

THE CHANGING EUROPEAN LANDSCAPE

Europe has a single licensing system available to companies but access arrangements across Europe are complex, varied and changing fast. Europe leads the world in HTA and managed access agreements are increasingly used to reduce cost or transfer risk onto companies. Payers are continuously adapting assessment and access processes to cope with new innovations, and to avoid repeats of painful budget-busting approvals.

In England and Wales, only 34% of medicines are approved by the HTA body, NICE, for the full licensed patient population or for the full treatment duration. For orphan medicines the figure is lower, with only 13% recommended within their full marketing authorisation between 2013-2017. A recent budget impact test adds a new hurdle to HTA, and the Government is designing a commercial framework of managed access agreement models.

Germany allows free pricing at launch, but pricing ultimately depends on negotiations based on additional clinical benefit. Between 2011 and 2016, 43% of assessments found no additional clinical benefit, and the average price cut by one major insurer is 23% below list price. France is redesigning its assessment framework to a model of relative therapeutic value. In Spain and Italy, regional decisionmaking creates additional barriers to access, and the focus on cost reduction means prices are often negotiated against the cheapest plausible comparator.

Since 2014, countries began voluntary cooperations to control prices of new medicines. In May 2017, 10 countries formed the ‘Valletta Declaration’ collaboration, sharing information and jointly negotiating with companies. The intention is clearly to lower prices, although the impact to date remains uncertain. The ‘BeNeLuxA’ cooperation of Belgium, the Netherlands, Luxembourg and Austria has been the first to show concrete results.

There is also enthusiasm in some countries for collaboration on HTA, which could potentially be formalised after many years of voluntary collaboration through the EUnetHTA initiative.

At an EU level, the European IP framework is being assessed which could lead to greater transparency of pharmaceutical pricing. The European Commission is also considering whether the incentives provided to drive research and development should be reduced, which could lead to a renegotiation of the EU legislation on orphan drugs and paediatric medicines.

Companies need to prepare for and adapt to the fast-evolving environment in Europe.

Governments are determined to control drug prices, and companies need to work harder to prove the value of their medicines and provide innovative solutions for patient access.

COLLABORATIVE APPROACH TO PATIENT ACCESS IN EUROPE CLINICAL TRIALS

POLICY LANDSCAPE MAPPING

ORPHAN DRUG DESIGNATION APPLICATION

EARLY PAYER DIALOGUE

ADVISORY BOARDS AND EXPERT PANELS

VALUE DOSSIER

RESEARCH & DEVELOPMENT

4 PRINCIPLES FOR SUCCESSFUL PRODUCT LAUNCH IN EUROPE

1 U NDERSTAND YOUR OPERATING ENVIRONMENT f I ndividual European countries are responsible for medicines access, but companies should engage at both EU and national level fE urope is not a country - every market is different and companies should tailor their strategies with knowledge of each market, its systems and priorities, and who has influence within a country when engaging fT ake a coordinated approach - countries take decisions individually, yet they cooperate and exchange information with each other f I ncrease your credibility by knowing policy debates at country and EU level and having a clear company position fB e aware of competitor activity and how it could impact your product launch

2 S TART ENGAGING AS EARLY AS POSSIBLE fE arly engagement is key in Europe, particularly if your treatment is innovative and/or is intended to treat a rare disease fT alking to payers and Health Technology Assessment bodies will provide insight into the potential market access barriers you might face and give you time to address them fC ollaboration and co-development of solutions to access challenges can smooth the path for your product launch and facilitate post-marketing authorisation negotiations

REAL WORLD DATA TO SUPPORT MANAGED ACCESS AGREEMENTS AND FURTHER VALUE AND PRICING NEGOTIATIONS

POST-L

AU NC H

PRE-SUBMISSION

There are numerous opportunities for companies to engage with influencers and decision-makers throughout the development and commercialisation of a treatment. Doing so can facilitate patient access to innovative new therapies in the EU.

STAKEHOLDER MAPPING

REGI STR

VALUE MESSAGE DEVELOPMENT

AT IO

ENVIRONMENT AND PATHWAY SHAPING BEGINS

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EV AL UA

ADVOCACY AND MESSAGE TRAININGS

PRODUCT DATA COMMUNICATIONS AND DISEASE AWARENESS

ON TI

PRODUCT LAUNCH AND COMMERCIAL STRATEGY EMA STRATEGY AND MANAGED ACCESS AGREEMENT PLANNING

EUROPEAN MARKET ACCESS TIMELINE

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PRODUCT LAUNCH COMMUNICATIONS

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TI IA

T

GO P & R NE

ALIGN ADVOCATES TO SUPPORT HTA AND PRICE NEGOTIATIONS

CONTINUE ENVIRONMENT SHAPING ENGAGE IN HTA PROCESSES

H LAUNC

NATIONAL AND CROSS-COUNTRY COLLABORATION PRICE NEGOTIATIONS READY TO IMPLEMENT REPUTATION MANAGEMENT STRATEGY

MEDICAL COMMUNICATIONS AND DISEASE AWARENESS CONTINUES

3 L EVERAGE PREVIOUS EXPERIENCE IN PRODUCT LAUNCH f I f you have already launched a product in Europe, build on your learnings and assess what has changed in the European Union since your last launch f I f it is your first product launch in Europe, learn from other companies’ mistakes and be aware that market access strategies that work elsewhere may not translate directly into the European environment

4 GET YOUR MESSAGES ACROSS fT ailor the Value Dossier into simple compelling messages that connect with policy-makers and payers, and others including patient groups and the media fS trike the right balance between Europe-wide messages and messages tailored to the needs of each individual market fU se internal toolkits and other mechanisms to ensure consistency of message and approach

CONTACT EMMA EATWELL SENIOR DIRECTOR, HANOVER HEALTH

eeatwell@hanovercomms.com + 32 473 88 39 34 hanovercomms.com @hanovertweets

HANOVER’S LOCATIONS

Brussels Dublin London

AWARDS

PUBLIC AFFAIRS AWARDS EUROPE WINNER 2018 Best In-House Consultancy Collaboration COMMUNIQUE WINNER 2018 Public Affairs & Policy Agency of the Year SABRE AWARDS WINNER 2017 EMEA Healthcare Agency of the Year SABRE AWARDS WINNER 2017 Global Public Affairs Agency of the Year

ABOUT HANOVER

Hanover Health is an award-winning practice within the Hanover group, offering product and corporate communications, market access, policy and advocacy. We deliver breakthrough strategies and campaigns based on a deep understanding of the operating environment – helping clients to communicate value, drive access, and manage and enhance their reputations.

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