The National Pharmaceutical Council (NPC) today submitted comments to the Institute for Clinical and Economic Review (ICER) on ways to improve its value assessment framework and ensure that patient concerns are better addressed in treatment evaluations.
NPC grounded its comments in its Guiding Practices for Patient-Centered Value Assessment, noting how ICER has three broad areas for improvement: modifications to its framework, enhancements to its assessment process and an expansion of its focus to include the entire health care system, rather than focusing solely on medicines.
NPC recommended several ways that ICER could improve its overall framework. Chief among them: using a collaborative and transparent model development process. The Advisory Committee on Immunization Practices (ACIP) process offers a good example that ICER could follow. As part of its model development process, manufacturers can present their models alongside ACIP’s, highlighting differences in the evidence base, assumptions, and modeling approach.
NPC proposed that ICER use not one, but two base cases — one that uses the payer, and a second that is based on the societal perspective, including such factors as productivity and caregiver burden. ICER currently lists these societal benefits as “additional considerations” at the end of its reports. Instead, ICER should quantitatively incorporate this broad array of benefits that are important to patients and society as part of its assessment process.
NPC also encouraged ICER to more frequently utilize real-world evidence, which shows how treatments may work in patients under everyday conditions. In recent years, there’s been enormous growth in the availability of high-quality, real-world data sources, improvements in analytic methods and broader use of real-world evidence derived from this data. The U.S. Food and Drug Administration has evolved its thinking in its use of real-world data and evidence, and NPC believes it’s time for ICER to evolve in its use of real-world evidence, too.
Improvements to the Assessment Process
When it comes to how assessments are conducted, NPC recommended that ICER:
- Include broader results and context in press releases and report-at-a-glance documents. It’s important to share a complete picture of the full range of pricing scenarios and societal value, rather than implying a false sense of precision.
- Enable full transparency by making the ICER model publicly available. This will enable stakeholders to reproduce assessment results and offer collaborative feedback.
- Extend the length of time for public comment periods to allow for comprehensive review of materials and submission of comments. The timelines ICER follows are much shorter than those used by other health technology assessment groups; many organizations — especially patient groups — need additional time to address the questions in a meaningful way.
- Establish a disease-specific working group of clinicians for each assessment to provide expert clinical guidance for assessment choices, which would improve the credibility and accuracy of ICER assessments.
A Broader Health System Focus
Finally, NPC notes that spending on medicines is just 16% of health spending in the U.S. For ICER to truly achieve its goal of “a more just, more efficient, and more effective health care system,” its assessments must include the other 84%, too. Drugs are a small portion of the U.S. health care dollar, so ICER’s overall impact would be greater if it focused proportionately on other interventions such as devices, surgery and diagnostics.
NPC has asserted that ICER’s framework is still a work in progress, and hopes that the next round of revisions will bring the framework more in line with patient-centered guiding practices.