Perceptions and factors affecting pharmaceutical market access: results from a literature review and survey of stakeholders in different settings. Issue 1 (1st January 2016) - Sendyona, Semukaya
Abstract : Background: A change in the pharmaceutical environment has occurred from previously only needing to convince regulators of a product's safety and efficacy to obtain marketing authorisation to now needing to satisfy the value perceptions of other stakeholders, including payers, to attain market access for products. There is thus the need to understand the concept of market access that may be defined as 'the process that ensures the development and commercial availability of pharmaceutical products with appropriate value propositions, leading to their prescribing and to successful uptake decisions by payers and patients, with the ultimate goal of achieving profitability and best patient outcomes'. The aim of this research therefore was to explore the understanding of market access among various stakeholders and how their understanding of this concept could improve patient access to pharmaceutical products. Methods: A literature review was conducted on MEDLINE by using the term 'market access' to find articles with explicit definitions of market access for pharmaceutical products; non-peer–reviewed and other grey literature sources were also examined. A paper-based interview survey was also conducted in three different settings. The respondents were asked about what factors they think contribute to the successful development of pharmaceutical products, as well as their definition of market access for these medicines. Results: The peer-reviewed literature review did not reveal appropriate comprehensive definitions for market access, although several definitions were proposed from the non-peer–reviewed literature. These definitions ranged from basic to detailed. The survey of 110 respondents revealed differing levels of understanding of market access. Factors considered to influence successful market access, as described by the respondents, included unmet need/burden of disease (68.2%), clinical efficacy (47.3%), comparator choice (36.4%), safety profile (36.4%), and price (35.5%). Conclusion: The concept of market access is still poorly understood, and the definition varies depending on the stakeholders' perspectives. For cost-effective products to be developed and made accessible to patients, there is a need for wider understanding of market access and the value perspectives of the various stakeholders. There is also a need to determine whether and how involved payers should be in the development of pharmaceutical products.