Industry shift toward systematic access planning during R&D
More pharmaceutical companies are mainstreaming and integrating access planning into their R&D pipelines.
AstraZeneca, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi, Takeda
All diseases and patient populations
Eight companies adopt access planning processes
To ensure all products have access plans at launch
Pharmaceutical companies need to plan ahead to ensure new products are rapidly accessible and affordable once they become available. Eight companies are taking the lead in developing structured approaches for pairing each R&D project with a plan to achieve this aim soon after the first global launch. The following approaches are the most comprehensive, although no company yet has access plans for all their late-stage projects.
AstraZeneca has strengthened its approach to access planning during R&D. Access plans are integrated ahead of resource allocation for Phase II/III development and apply to all R&D projects. Formal access planning is part of the company’s Access to Healthcare framework and considers such factors as licensing, registration, tiered and differential pricing strategies, early access programmes, patient assistance programmes, royalty-free licensing, pricing transparency and innovative reimbursement models.
GSK’s approach is applicable to all R&D projects in its pipeline and considers a variety of access planning strategies, including pricing strategies, IP approaches, product registration strategies, WHO prequalification, out-licencing and systematic or case-by-case access plans. Such approaches are also driven by global health priorities established externally by organisations such as the World Health Organization (WHO) and are guided by global health threats, product type, therapeutic area, development model pursued, target population and geographic scope. Notably, GSK leads in developing a systematic approach to access planning for its late-stage R&D, with 80% of said projects supported by an access plan.
Johnson & Johnson is committed to assessing the affordability of all R&D assets in its pipeline. The company follows a structured approach, developing access and pricing strategies at Phase II of clinical development. These strategies are grounded in Janssen Access and Pricing Principles and include access and affordability considerations across developed markets, middle-income and lower-middle income markets and least developed settings. These access strategies take several factors into account, such as the unmet medical need in a market, relevant price comparisons, the cost burden of the disease and the affordability of the medicine consistent with the gross national income per capita.
Approaches to access planning are systematic, structured and usually part of a dedicated company framework.
Merck has an approach to systematically establish access plans for all its R&D projects developed in-house and in partnership. The development and implementation of access plans for R&D are grounded in the company’s overall approach to access and pricing. To ensure sustainable access to products for vulnerable populations, Merck considers access throughout development and generally begins to introduce access plans into its projects in Phase II or earlier. These plans are informed by, among other factors, the targeted disease indication and the needs of patients in the relevant country.
Novartis has an approach to systematically develop and implement access plans for all its R&D projects. Furthermore, it states it will aim for all innovative drug programs to have the access planning process underway during Phase II. It considers access planning for both in-house and collaborative R&D projects. Novartis’ approach is described in its Novartis Access Principles which consist of three key principles: needs-based R&D, medicine affordability (i.e. tiered pricing, managed entry agreements, outcome-based pricing and non-exclusive voluntary licensing) and health system strengthening.
Sanofi has improved its approach to planning for access during R&D, with a structured access planning framework now encompassing all projects in its pipeline. Planning for access starts at Phase II of clinical development and applies to both in-house and collaborative R&D projects. This approach is outlined in Sanofi’s Access Blueprint which covers all innovative, patent-protected healthcare product types, including collaborative R&D projects. The company aims to price products equitably, with a focus on affordability and patients’ ability to pay as well as access strategies such as tiered pricing, patient assistance programmes and donations. During later stages, country-level access plans are developed in emerging countries that detail in-country access strategies and tactics.
Pfizer has expanded its access planning processes from vaccines to all R&D projects for diseases in scope. The company’s newly launched Global Pricing and Access Strategy also stipulates that access planning for all products begins at least two years prior to launch. Furthermore, access plans include guidance on equitable pricing, innovative arrangements and other approaches to support broad access and affordability.
Takeda has an approach to systematically plan for access for all R&D projects in its pipeline. Access principles are considered in Takeda’s Asset Strategy and access planning starts from early clinical development (pre-Phase II development). For each project, the company considers factors such as registration planning, non-exclusive voluntary licensing, patent waivers, equitable pricing, sufficient supply, WHO prequalification, product donations, access through clinical trials and expanded access programmes.