Market access and HTAs: the role of ISPOR
Leela Barham explores the International Society for Pharmacoeconomics and Outcomes Researchs role in helping pharmas approach market access.
The mission of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is to promote the science of pharmacoeconomics and outcomes research and facilitate the translation of this research into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely, fairly and efficiently.
John F.P. Bridges, assistant professor in the Department of Health Policy and Management at John Hopkins Bloomberg School of Public Health and a longtime ISPOR member, says the Society, set up in 1995, is focused on improving the efficiency of the healthcare system.
Key guidelines
Payers all face similar issues, Bridges says, and there is scope for them to respond most efficiently by drawing upon ISPOR guidelines.
Many countries have guidelines for HTA, but ISPOR has some of the only guidance on key areas, such as patient reported outcomes, conjoint analysis and discrete choice analysis, and budget impact analysis.
Bridges notes that ISPOR is an all-embracing society, allowing payers, academics, industry, and consultancies to come together.
But ISPOR is not about spreading HTA in any particular form. Instead, he says, members can learn and adapt the myriad approaches and tools within HTA to their local context.
Highlighting policy issues
According to David Grainger, global public policy director at Eli Lilly and Company and a member of ISPOR for the past three years, ISPORs scope has been expanding to cover more policy. He highlights the relevance of ISPOR guidance in specific areas, such as technical approaches to cost utility analysis and exploring QALYs and costing.
ISPOR offers a chance to hear from agencies such as NICE about their thoughts on future directions, Grainger says. That can be taken back into the company and used as part of building our own policy engagement.
Bridges adds that, while some may lament a lack of high scientific standards, there is value in having a forum where people can come along and really take a multi-disciplinary approach.
The relevance to payers and companies
Bridges says payers and companies can both come along to training and interactive sessions to learn, share experience. The parties may not agree, but they can have a meaningful dialogue.
Companies can particularly benefit by drawing on the training courses, which Bridges describes as a fast way for individuals to come up to speed.
Ansgar Hebborn, head of Global Payer and HTA Program Policy at Roche and a member of the Board of Directors at ISPOR, points out the importance of reviewing the actual use and performance of health economics and outcomes research methodology in the decision-making practice of HTA agencies/payers.
There are serious decisions taken on the basis of health economics and outcomes research methodology, Hebborn says.
These methods inform how to allocate opportunities to live longer or healthier and this should be fully understood by the members of professional societies like ISPOR when they engage in the definition of methodological standards.
Pricing and reimbursement
ISPOR also provides resources that can help both payers and companies compare and contrast approaches to pricing and reimbursement.
That includes lessons from HTA around the world, a road map of national healthcare systems and who does what in relation to HTA, comparisons of the guidelines for HTA in different countries, and several special interest groups focusing on particular hot topics.
Unsurprisingly, patient reported outcome measures, comparative effectiveness, and conjoint analysis as a method to incorporate patient preferences are high on the list.
With a continued focus on value for money across the globe, and with experimentation with HTA occurring in almost every country (for good and for ill), it seems that there will be an even greater need for forums where payers and companies can find common ground.
Evidentiary and analytical standards
Hebborn goes further, arguing that ISPOR can continue to develop evidentiary and analytical standards for specific HTA domains, a crucial issue given that HTA is an area where standards are currently either less clearly established or simply different from those established by other stakeholders such as regulatory agencies.
From a personal viewpoint, he hopes ISPOR will provide opportunities for stakeholders to think about how to develop, refine, and agree methods but also be mindful of the important criteria of reasonableness, like the number and requested complexity of clinical trials requested by HTA/payers.
Companies need to invest wisely and balance the needs of national HTA agencies/payers given industrys global perspective, Hebborn says.
Onerous expectations of some HTA agencies/payers could effectively bring drug development in a number of disease areas and indications to a halt; another reason why we need consensus on what is reasonable.
That consensus should be based not just on what industry and HTA agencies/payers demand or can accept, according to Hebborn, but also address the expectations of other stakeholders, including patients and providers.