For years, PhRMA has supported policies that ensure health care decisions are grounded in the best available evidence. In our policy solutions for delivering innovative treatments to patients released earlier this year, we reiterate our belief that well-designed tools for value assessment can ease the way for a shift to a value-based health care system. The right tools, including value frameworks, can empower health care decision-making and ensure the right treatments reach the right patients at the right time. Our commitment is further evidenced by PhRMA’s participation in initiatives like the International Society for Pharmacoeconomics and Outcomes Research Special Task Force on Value Assessment and the FasterCures/Avalere Patient Perspective Value Framework.
Frameworks that are not well-constructed or are misused put patient access and continued innovation at risk. We expressed our concerns about the Institute for Clinical and Economic Review’s (ICER) framework in a letter to ICER leadership last year, noting that the approach ICER takes in its framework could confuse decision-makers about the value of new treatments and makes assumptions that create inherent bias against innovation. We also expressed concerns that because the framework does not adequately consider the patient perspective or the heterogeneity of patient populations, its use could result in barriers to high-value, individualized treatment decision-making and patient access to appropriate medical treatments.
This summer, ICER released a national call for stakeholder feedback on its value framework, a step which PhRMA applauds. In response to this call, PhRMA sent ICER a letter outlining several key steps that, if taken, would move ICER’s framework in a more methodologically rigorous, patient-centered direction. These recommendations would also more closely align ICER’s framework with our principles in support of value assessment frameworks, released earlier this year.
Our recommendations to ICER include:
- Development of a transparent, dynamic ratings system that presents information on specific components of the value of health care treatments and interventions, and removal of value-based price benchmarks from all evidence reports.
- Suspension of the use of budget impact estimates until more sound methods are developed and validated.
- Adjustment of the cost-effectiveness component of the framework to reflect the inherent and widely recognized limitations in traditional quality adjusted life years-based cost-effectiveness analysis (CEA), including capturing a wider range of benefits in CEA and presenting a range of care value estimates based on sound assumptions and varied approaches.
- Implementation of a fully transparent process in which ICER meaningfully engages with stakeholders, including stakeholders with disease-specific expertise, in setting priorities for assessment and developing its evidence reports.
We appreciate ICER’s consideration of our recommendations. PhRMA believes that if these recommendations are adopted and ICER’s revised framework is fully validated, the organization could play a positive role in the movement toward better value in health care.
Read more about PhRMA’s policy solutions to promote value-driven health care here.