Joint HTA and Drug Pricing Collaborations in EU: by Whom and When to Be Pursued? Eline Middelburg, Rachel Rowbottom, Dr

Joint HTA and Drug Pricing Collaborations in EU: By whom and when to be pursued? Eline Middelburg, Rachel Rowbottom, Dr. Marc Matar | 1 Plough Place, EC4A 1DE, London, UK INTRODUCTION OBJECTIVES METHODS Over the past years, several cross-country joint Health Tech- This topic will remain relevant in the future, as new The purpose of this research is to: We conducted a qualitative in-depth nology Assessments (HTA) and drug pricing collabora- initiatives are introduced, and the existing bodies evolve analysis of publicly available information to Gain an understanding of pricing and market access im- tions have been developed in the EU with the aim of: analyze the P&MA implications for pharma- For example, a recent proposal was made for steps plications of existing joint HTA and drug price collaborations ceutical companies of joint HTA and drug Improving efficiency of evaluations, and avoiding towards allowing confidential net prices to be shared Identify and share Simon-Kucher’s future outlook on joint pricing collaborations duplication of decisions between members of the Valetta Declaration group HTA and drug price collaborations Based on these insights, we defined the Accelerating patient access Cross-country collaboration remains politically Share Simon-Kucher’s view on next steps pharmaceutical expected future outlook for joint HTA and Making use of combined payer negotiation power attractive, as an indicator of actions to address time to companies should consider when evaluating whether to drug price collaborations, assessing the when discussing prices reimbursement and affordability of new drugs pursue joint HTA and/or drug price collaboration drivers and hurdles for future events Implications of joint HTA and drug pricing collaborations on P&MA varies based on the set-up of the collaboration* Intro date Collaboration Type Description and aims P&MA Implications for pharmaceutical companies 28 assessments completed (across product types and therapeutic areas) EUnetHTA 2006 Facilitates efficient HTA resource use across Europe Provides communication point for HTA information exchange and transparent stakeholder 30 European countries and 80 government appointed organizations consultations (patients, health provider, payer and industry associations) Pharmaceutical company decision to pursue joint negotiation BeNeLuxA-I Drives joint pricing and reimbursement to achieve easier and 2015 Six joint HTA assessments; of which two also started joint price negotiations Austria, Belgium, Ireland, Netherlands, Luxembourg quicker market access for innovative, expensive therapies One finalized joint HTA and joint price negotiation: Spinraza Increases quality of HTA assessments by using best practices from member states Nordic Collaboration/Pharmaceutical Forum Currently in discussion, no concrete output publicly available 2015 Increases effectiveness through joint assessment reports; more HTA information Denmark, Finland, Iceland, Norway, Sweden Decreases the regulatory burden for companies available than from individual national agencies Increases negotiation power for smaller collaboration member countries Valletta Declaration Group Currently in discussion, no concrete output publicly available 2017 Croatia, Cyprus, France (observer status), Greece, Ireland, towards pharmaceutical companies to get “fairer prices” Provides information regarding products, policies, legislative proposals and procedures Italy, Malta, Portugal, Romania, Spain, Slovenia Negotiates joint pricing and conducts joint procurement for member countries Visegrad + Collaboration Part of Visegrad group, covering all social, economic and political topics between members Currently in discussion, no concrete output publicly available 2017 Croatia, Czech republic (observer status), Hungary, Poland, Lithuania, Slovakia Increases negotiation power towards companies Pilot to explore new models for the organization of negotiations at regional level initiated FINOSE initiative Committed to EUnetHTA (EUnetHTA reports are the basis for FINOSE HTA reports) 2018 Six HTA assessments and two pilots on joint pricing concluded Finland, Norway, Sweden Publishes HTA reports based on relative efficacy & health economic analysis Future outlook 1: In 2030 there will be a Europe-wide Health Technology Assessment which is binding for all EU countries Drivers for European-wide HTA Hurdles for European-wide HTA Simon-Kucher outlook assessment Existing HTA collaboration bodies (e.g., EUnetHTA) rope and facilitate joint work rather than country European-wide HTA may not benefit all EU countries; A European-wide HTA is achievable if: are expected to further improve and professional- individual work, especially in countries which lack a well-established European markets (e.g. Germany) argue it It replaces meaningful elements of current nation- ize their assessments in the upcoming 10 years well-structured or established HTA methodology may lower the standard of their established approach al HTA, even in countries with established approaches Tools are in development to realize a standard- Pharmaceutical companies are increasingly European-wide HTA may not eliminate national level HTA, Capacity to conduct assessments significantly ized methodology; e.g. HTA Core Model (framework considering cross-country evaluations by HTA especially where a rapid assessment approach is established increases, or limitations (e.g., to specific therapeutic to share HTA information and evidence/HTA databas- collaborations as a beneficial step in preparation for Quantity of assessments will need to increase to be able areas or treatment classes) are defined 1 2 es (POP & EVIDENT database by EUnetHTA) price negotiations (having similar structured assess- to cover all new products entering the market; e.g., EUnetH- It does not slow time to access for countries with a These tools support efficient use of HTA in Eu- ments with comparable details) TA conducted 28 assessments over 13 years faster assessment approach Future outlook 2: In 5 years, more drugs will undergo joint price negotiations than Future outlook 4: The main reason for limited today, but price negotiations for the majority of drugs will remain at national level implementation of cross-border joint price negotiations is the potential impact on list and net price Drivers for national price negotiation/ Hurdles for national price negotiations / objections towards joint price negotiations advantages of joint price negotiations Drivers for limited Hurdles seen by pharmaceutical Limited success in joint initiatives: Only BeNeLuxA has successfully Showing willingness to cooperate could be implementation of cross-border companies not pursuing completed a joint price negotiation and so far only for one product politically attractive joint price negotiations price negotiations Significant cross-country differences in healthcare systems, mentality and By cooperating in joint price negotiations phar- Informal payer information exchange Manufacturer’s involvement is necessary to willingness to pay generates challenges for both collaboration members and maceutical companies can learn and shape across countries is undesirable for phar- be able to shape an acceptable implemen- pharmaceutical companies the process and their preferred role maceutical companies since this increas- tation of joint price negotiations for pharma- Limited interest in collaboration from major markets which are frequently es the risk of net prices becoming trans- ceutical companies Simon-Kucher outlook assessment referenced (e.g., France, Germany) parent Waiver of involvement does not guarantee Due to the perceived challenges and risks Perceived risks for pharmaceutical companies: Net price leakage may impact trans- informal payer information exchange from by both pharmaceutical companies and payers happening (e.g., net price leakages have been – Formal or informal disclosure of confidential net prices parency of net price negotiations across cross-country joint price negotiations will not found through internet research in Italy/Spain) markets, limiting potential for confiden- – Missing the ability to use country-specific in-house knowledge/infrastructure replace national negotiations tial net price agreements Simon-Kucher outlook assessment – Additional capacity and expertise required; does not automatically To shape their preferred role, pharmaceutical Price leakage increases the risk of exclude negotiations on national/regional level companies should take an active role in the Disclosure of confidential net prices could “spill over”**, limiting pharmaceutical Perceived risks for pharmaceutical companies: development of future joint price negotiations lead to prices below the European price cor- companies in offering a one “deal” to ridor which affect manufacturer’s financial – No guarantee of a “better” price, than when nationally negotiated rather than wait passively gain access in a country which automat- results (e.g., return on investment) ically leads to negative implications Pharmaceutical companies should explore their preferred role and evaluate conse- Future outlook 3: A common healthcare system structure is necessary Conceptual quences of increased price transparency to support joint price negotiations Visible price € 35 International price 1 Optimied list price corridor takes into referencing uro account countries which reference the 30 Drivers for importance of common structure Simon-Kucher outlook assessment e visible (list)

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