Delays in reimbursement decision-making can lead to substantial delays in a new innovative product gaining market access. Negative reimbursement decisions by payers however will hinder market access substantially. Delays in reimbursement or negative reimbursement decisions will hinder and even prohibit sales and return on investment.
Furthermore, investors are increasingly becoming aware of market access and asking the key questions around value and value for money before investing in new therapies and companies.
Therefore, it is essential for personnel in small and medium biotech/pharma companies to gain an understanding of payer and HTA requirements and how to implement those into their own programs for their own products to optimise their chances to get reimbursement, sales and thus return of investment.
What can be done?
It is important to consider the evidence needs of payers and reimbursement authorities on when to start designing clinical trials. Generating data within clinical trials is not sufficient enough to satisfy the constantly evolving complex evidence requirements of reimbursement decision makers. The clinical trial data needs to be further analysed and supplemented with additional data on resource utilisation, costs, quality of life and compared with efficacy and safety data for comparator products against which payers and HTA agencies will compare the product.

Besides generating evidence relevant to payers and HTA agencies, companies need to establish a realistic pricing strategy from the outset and evolve it along its clinical data generation.
Throughout the preparation of reimbursement submissions and the appraisal process the company is required to reply to responses and requests from the reimbursement authorities, manage its internal and external stakeholders, and form a contingency plan to cover different recommendations and decisions. 
Specialist consultants and agencies can support the company throughout these activities. 

In summary, to emphasise that for a product to be able to generate return of investment, companies need to consider the evidence needs of reimbursement HTA authorities. For each new product this should start early on and throughout the clinical development process in order to optimise the chances of gaining market access at a good price, which will then unlock return of investment. 

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This article has been provided by Athena Market Access Solutions Ltd., in collaboration with Tolley Heath Economics Ltd.