On Tuesday,
Health Affairs Forefront published an article recommending 4 steps CMS can take to ensure that patient experiences and perspectives are factored into the implementation of the Medicare Drug Price Negotiation Program (DPNP). To date, CMS has not outlined an explicit process for how it will engage the Medicare beneficiary community, capture patient experience data, or ensure patient perspectives are incorporated into its decision-making.
To address this, the authors recommend multiple actions for CMS to ensure patient experiences and perspectives are reflected in the implementation of the DPNP. For example, the authors suggest the agency establish a formal advisory group to guide and co-develop CMS processes for patient engagement. Additionally, the authors recommend that CMS develop a proactive patient engagement plan to comprehensively consider a drug’s clinical benefit.
The authors also recommend that CMS build on the experiences of others to develop a formalized approach to engage patient communities and integrate patient experience data
before CMS begins its assessments of treatment value. Citing early assessments conducted by the Institute for Clinical and Economic Review (ICER), the authors point to real-world examples of value assessments that did not formally engage the patient community and ultimately resulted in inappropriate cost-effectiveness estimates, inaccurate budget impact estimates, and underestimations of quality-of-life improvements.
Once the DPNP is implemented, there is potential for CMS’s approach to assessing the clinical benefit of prescription drugs to become a model for the health system. Given this possibility, the stakes for CMS getting this right are extraordinarily high, especially for patients. CMS must implement a transparent and collaborative process that engages patients throughout to advance assessments of relative treatment value that reflect patients’ experiences and perspectives.
On Monday, ICER
announced plans to assess the comparative clinical effectiveness and value of sotatercept for pulmonary arterial hypertension. A Biologics License Application is expected to be filed with the FDA later this year. ICER is accepting stakeholder comments on the
Draft Scoping Document through June 5, and the topic will be reviewed by the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in December 2023.
If you need assistance with all things value assessment or ICER-related, please contact
Kimberly Westrich.