Principles for Patient-centered Engagement

Principles for Patient-centered Engagement When Implementing the Medicare Drug Price Negotiation Program

Meaningful patient engagement is crucial for successful implementation of the Medicare Drug Price Negotiation Program (MDPNP) under the Inflation Reduction Act (IRA). We came together with members of the larger patient advocacy community to align on patient-centered principles to inform a definition of clinical benefit for patients and caregivers that can be used throughout engagement with the Centers for Medicare & Medicaid Services (CMS) as the agency continues to implement the MDPNP.

Patient-centered Principles:
 

Engage patient advocacy organizations, patients, and caregivers in structured, meaningful ways throughout the MDPNP process.

Define clinical benefit to prioritize evaluations around endpoints, patient reported outcomes, patient experience data including impact on quality of life, and preferences that matter most to patients living with cancer and other complex conditions. This includes both qualitative and quantitative measures such as clinical endpoints, patient preference data/models, patient reported outcomes, and social impacts.

Develop critical infrastructure necessary to educate the patient community and facilitate meaningful feedback that prioritizes patient definitions of value, including feedback on the evidence being considered by CMS and whether it reflects patient experiences and preferred outcomes.

Refer to patient navigators to provide information to patients about the impact of these policies and to receive feedback from patients, with an explicit goal to identify any changes in utilization management practices as a result of IRA implementation.

Develop a monitoring and evaluation platform and reporting framework surrounding the MDPNP and its impacts on patients to support continuous improvement in ongoing implementation.

Collect and report specifically on access challenges facing patients as a result of the IRA to allow for continuous improvement of the MDPNP process and lessen the unintended consequences of this process on patients.

Collect and incorporate meaningful data and real-world evidence that amplifies patient values and input within the MDPNP implementation process, including patient reported outcomes, patient experience data, impact to quality of life, and models that capture the dynamic and varied preferences of patients.

Prioritize outreach to patients, people with disabilities, and people living in rural communities to ensure that the MDPNP supports all patient populations and does not threaten health care access.

Consider the groups and populations that have not already engaged in defining patient-focused clinical benefit and impact of the MDPNP process and determine how best to activate those individuals.