The Integration of Market Access and Advocacy: The Changing Landscape

The Integration of Market Access and Advocacy: The Changing Landscape

The Integration of Market Access and Advocacy: The Changing Landscape

Introduction Healthcare market access and advocacy landscapes have evolved significantly in recent years. Within companies, these functions are increasingly cooperating early in the development of new treatments, to avoid unnecessary delays in bringing treatments to patients post-marketing authorisation. In this thought piece, we examine how this is happening and the benefits it is bringing to all stakeholders in the healthcare ecosystem.

Where the industry is now – Traditionally, there is a lack of integration of market access and advocacy during drug development and commercialisation How can industry do it better – Market access and advocacy colleagues can work together more effectively to achieve the best possible outcomes for their market access strategies The key success factors – Integrate market access and advocacy, map the policy landscape and initiate early engagement to shape the environment Relevance to your business – Build trust, shape the environment, streamline communications, deepen payer insights and optimise the market access strategy; ultimately, ensure timely access to medicines for patients

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Where the industry is now High profile arguments over the cost-effectiveness and affordability of the recent wave of breakthrough products in Europe has shown the importance of engaging early with influential decision-makers as part of company market access strategies. The consequences of not doing so can lead to significant delays in bringing treatments to patients and can undermine a well-planned product launch.

Companies have traditionally seen market access and advocacy as separate elements in the drug development and marketing process. If a company struggles with bringing a product to market, advocacy is often used as a means to solve the problems faced, for example by engaging with policy-makers and other stakeholders to highlight a lack of access to treatment for patients. We are now seeing a trend of companies coordinating or even joining up these functions, but many still do not interact internally.

There is wide recognition that fundamental changes need to be made to ensure the sustainability of healthcare systems, to enable them to continue to provide the care and treatments required by patients. Following marketing authorisation, Health Technology Assessment (HTA) bodies and payers often lack the information they need to make decisions, which leads to discussions and requests for companies to develop additional data, delaying patient access to innovative treatments.

Policy-makers, regulators, payers, HTA bodies, and industry are increasingly willing to engage more regularly, more collaboratively and earlier in the drug development cycle. This opening up has been a slow, gradual process and it is clear that trust needs to be established on all sides.

As the market access and policy worlds come together externally, as demonstrated by the early dialogue work

between policy-makers, regulatory and HTA bodies in the EU and nationally (figures 1-4), companies are starting to recognise that they need to reflect that interaction internally. It is no longer enough to present a strong clinical data package to secure a marketing authorisation and then to expect policymakers and pricing and reimbursement authorities to accept a high price for innovative treatments and to ensure the optimal uptake of these treatments.

If a company does not analyse the policy landscape into which it expects to launch, does not take the time to understand what may need to be changed, and does not actively engage key influencers early to shape the environment, the potential of the treatment may not be fully realised. If this analysis is left too late, a company may be too close to market launch before it fully understands the challenges that it is facing. The subsequent work needed to shape the environment to address these challenges often takes months and potentially years. As a consequence, the market access strategy and related value tools – which consume a large amount of resources – can lose their impact when operating in a sub-optimal external environment.

Communications can also have an important impact here through disease awareness and product communications to payers and prescribers to drive interest and an understanding of value and unmet need.

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The Integration of Market Access and Advocacy: The Changing Landscape

How industry can do it better KEY SUCCESS FACTOR 1: INTEGRATED WORKFORCE: MARKET ACCESS AND ADVOCACY

Market access and advocacy colleagues can work together more effectively to achieve the best possible outcomes for their market access strategies.

In parallel with the development of a market access strategy, cross-functional teams should analyse the external environment and the policy landscape into which a product is likely to be launched. This should take into account what challenges will be faced from an HTA perspective, what concerns the payers are likely to raise about the value of the product, what market strategy and value tools need to be developed, and what engagement and advocacy campaigns can be beneficial.

The external environment is certainly moving towards this integrated approach. There are several initiatives at EU level intended to engage cross-functional and cross-geographical teams in early dialogue around regulatory, policy, reimbursement, and HTA issues.

Fig 1: Multiple stakeholders collaborating to develop solutions

Multiple actors are coming together at EU level to find solutions to balance access to innovative medicines and affordability for healthcare systems

Regulators Joint HTA Early Dialogue

Mechanism of Coordinated Access to OMPs (MoCA)

Adaptive Pathways

Governments

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Cooperation on P&R by clusters of member states

Parellel Scientific Advice

KEY SUCCESS FACTOR 2: SHAPE POLICY LANDSCAPE BY EARLY ENGAGEMENT

There are a number of factors that make it difficult to secure support for the uptake of a new treatment amongst payers, doctors, patients and politicians.

Some of these can be influenced but only if engagement begins early enough in the development process: a disease may not be perceived as being a policy priority or it may not be seen as an area where new treatments are needed as existing, cheaper treatments are considered adequate. For example, in Germany if a treatment is not included in treatment guidelines, it cannot secure reimbursement. As the treatment guidelines are only changed every two to three years, this could cause significant delays.

By understanding this environment 18 months to two years from launch, there is a possibility to change perceptions and to shape the environment: a joint market access and advocacy force working to identify

evidence gaps and find potential solutions, contributing to a smooth launch and good uptake. If this is left too late, the company enters into fire-fighting mode, often leading to significant delays in patient access. Early engagement enables a company to understand the challenges likely to be faced during a product launch (following marketing authorisation).

Regulators, HTA bodies, payers and industry are testing collaborative, early dialogue approaches, intended to improve the current fragmented approach and bring treatments to patients in a more timely manner.

Fig. 2: Joint EU HTA and Early Dialogue between HTA, regulatory, and industry – EUnetHTA & SEED Mechanism for (multiple) HTA bodies and a company to exchange their views during the development phase of a new medicinal product

Improve quality and adequacy of initial evidence generation to facilitate HTA process and support coverage decisions

2012–15

2016 21 pilot projects involving 14 HTA bodies and, in certain occasions the EMA (observer role)

Leader

Some participants

EUnetHTA JA2 WP7 DELIVERABLE Consolidated Procedure For Early Dialogues (Drug and Non-Drug)

2016-19 Pilot projects to continue under EUnetHTA JA3, with increased commitment to re-use joint work at national level

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The Integration of Market Access and Advocacy: The Changing Landscape

Fig. 3 EU Payer-led Pilot Projects of Early Dialogue: Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA-OMPs) Voluntary payer-led proposal for engagement at all stages of drug development process (test Transparent Value Framework and recommendations from MoCA)

2013–14 4–5 pilot projects carried out (MoCA Force at MEDEV)

Leader

Establish and facilitate early dialogue between companies and competent authorities for pricing and reimbursement on a specific OMP Help speed up access for patients in EU member states

Unique forum for shared dialogue with a group of payers from across Europe

Main participants

Many companies are embracing the opportunities they see through early engagement. Others are sceptical and do not fully see the benefits of testing this new way of operating. There are concerns that the joint dialogue at EU level will not be taken into account nationally, which will merely increase the burden on companies by adding a step to an already complex and time-consuming process. It is worth noting that at national level, payers and HTA bodies have also started early dialogue. For example, in the UK, the National Institute for Health and Care Excellence (NICE) scientific advice services have been

2016 Second stage of pilot projects launched under new terms of reference

Observers

developed since 2009 to provide an opportunity for early dialogue between industry and NICE. Another concern of industry is that the early engagement and advice are conducted so early in the development of a product that the landscape could have changed by the time a marketing authorisation is secured and so the advice and discussions are no longer relevant. However, if there is no engagement early on, opportunities to take a critical role in the evolving environment can be missed.

Fig. 4: NICE Scientific Advice and Early Engagement

National Advice — Standard Process

NICE Scientific Advice

National Advice — SMEs NICE — MHRA EMA — HTA European Joint HTA

Since 2009

SEED & EUnetHTA

Source: E. Gajraj (2016) Joint or parallel scientific advice? Experience and perspectives from NICE

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Educational seminars for Pharma, Medtech and Cell Therapies

Relevance to your business If a company joins the forces of market access and advocacy and engages early with patients, policy-makers, regulators, HTA bodies and payers, there are many benefits that can be realised.

- Trust can be built among internal and external stakeholders based on a shared goal of developing collaborative solutions to challenges that are usually only identified post-marketing authorisation - The external environment can be shaped, to ensure that it is receptive to new treatments in a particular disease area, smoothing the market access path and securing quicker access to treatments for patients - The position for the product can be secured in the healthcare system at time of launch and a clear understanding can be established of how that may change as additional outcomes data become available - A greater understanding of the potential value of an individual product to healthcare systems, to patients and to a company is developed and a company has the opportunity to take this into account during the drug development process - Dialogue provides a unique insight for payers into the realities of drug development (cost, risk, commercial considerations) and for industry into payer concerns, constraints and motivations - The access strategy can be developed and aligned at the global, regional, and local level. The evidence gaps can be assessed, and the data package can be developed, along with the pricing and payer negotiation strategies - A seamless communication strategy can be built internally and externally - Ultimately, patients who can potentially benefit from the product are able to have access to it with as few delays as possible

It is likely that there will be additional burdens for companies at certain points and the benefits of all of the pilot projects are yet to be demonstrated. However, for those companies that are pioneering these new approaches, there are longer-term gains to be made.

By demonstrating that they recognise that the system is under pressure and that the concerns of HTA bodies and payers are real, they set themselves out as companies willing to co-develop practical solutions.

Participating in pilot projects and early dialogue builds relationships that cannot be developed quickly. All parties gain a better understanding of the challenges that exist in drug development and why certain decisions are taken.

The EU landscape is changing and companies can be part of shaping the future. The importance of engaging early with national authorities is increasingly recognised as fundamental to any market access strategy. Industry is looking for expert strategic advice in this field. Companies are keen to understand the possibilities open to them and how their market access strategies can be supported by advocacy at EU and national level.

At EU level and in informal, cross-country groups, authorities are increasingly coming together to exchange ideas on how to solve the challenges they all face in their national markets. These are platforms where essential engagement and dialogue can take place, which will then have a concrete impact at national level.

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As a market access, public affairs, and communications consultancy, Hanover has recognised the importance of early dialogue and the integration of advocacy and market access. With first-hand experience of the pilot projects, we are able to provide insight and advice to companies. With our experience and knowledge of EU and national market access possibilities, Hanover can support you in developing strategies that combine advocacy, market access and communications to help you shape the environment in which you operate.

Contact us to find out more.

List of Hanover’s healthcare services: - Policy landscape and environment-shaping ahead of marketing authorisation - EU and national early dialogue environment and opportunities - Stakeholder mapping and management - Reputation management - Product communication

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Disease awareness Advisory board and expert panels Payer and pricing research Market access and HTA strategy Product launch and commercial strategy - Value dossier, value proposition and messages

Andrew Harrison

Emma Eatwell

Jing Wang-Silvanto

Frances Beves

Richard Sloggett

Managing Director of Healthcare

Director of Healthcare Brussels

Director of Healthcare Market Access

Director of Healthcare Communications

Director of UK Healthcare Policy, Advocacy and Public Affairs

hanovercomms.com @hanovertweets