Maximizing Value and Equity: CMS Must Prioritize Value, Equity, and Patient Engagement in Drug Price Negotiation Program Implementation

In March, the Centers for Medicare and Medicaid Services (CMS) released draft guidance for its implementation of the Drug Price Negotiation Program (DPNP), a key component of the Inflation Reduction Act (IRA). This release and its associated comment period sparked far-ranging debate and a stream of news articles, conference panels, and position statements on how the agency can improve its process and implementation. Perspectives on these issues are as diverse as the voices weighing in. The one matter they all seem to assume is that CMS is interested in?value, defined as the improvement of health outcomes per the costs needed to do so, both for their beneficiaries and the other stakeholders involved.?This thinking has not changed with the release of the revised guidance in June.

Having engaged with CMS on a variety of issues over the last 20 years, I am not sure this assumption is correct. While value is an important component of their work—including development of innovative models for value-based care—when it comes to the IRA, the prevailing emphasis seems to be only on drug prices and their cost to Medicare.?

Along with many other colleagues, I strongly believe that CMS should focus on maximizing value instead of simply minimizing drug prices. The IRA presents a tremendous opportunity for CMS to establish an inclusive and forward-thinking approach that emphasizes negotiations and decision-making based on maximizing value to Medicare enrollees, the Medicare system, and American society. If CMS does not take full advantage of this opportunity, they should, at a minimum, integrate two major components into the DPNP implementation process: equity and patient engagement.

First, CMS should consider health equity in the DPNP, and more importantly, incorporate strategies supporting equity into all aspects of its activities. From reading the guidance, one would have no idea that?advancing health equity?is the first pillar of CMS’s Strategic Plan.?In fact, there is no mention or insinuation of “equity” in the initial DPNP guidance at all. As a highly visible and novel program within Medicare, it is imperative that the DPNP be consistent with and reflect the objectives and practices outlined in the CMS Strategic plan.?

Specific actions that CMS can take to ensure there is focus on health equity in the implementation of the DPNP include:

1)????Developing a process for evaluating potential bias and equity implications of evidence.

2)????Creating enrollee advisory groups composed of patients from diverse communities with relevant lived experience who can contribute at specified stages of negotiations.?

3)????Requiring and incentivizing evidence generation and data collection with underrepresented populations.

Second, CMS should include better patient engagement throughout the DPNP implementation by systematically elevating the patient voice. Beneficiaries, their families and caregivers, and organizations that represent them should have a voice in decision making and be involved in DPNP processes. By including specific measures in its evaluation of candidate drugs, CMS puts the patient experience first. While some steps have provided opportunities to support the negotiations, the guidance fails to include mechanisms for patient engagement beyond evidence submissions and the incorporation of patient experience data with clinical trial data. Even the addition of "patient-focused listening sessions" are not a systematic approach to patient engagement. However, patient advisory groups are a better alternative that can provide essential guidance and context from lived experience and advance health equity.

Engaging patients in dialogue and soliciting input from patients and other affected populations is necessary, but not sufficient. It is critical that CMS explicitly include measures throughout the process to ensure patients have equal standing as stakeholders and participants in decision making. Guidance should be provided for patient advisory boards to outline the topics within the group’s scope, including how input and recommendations will be documented. Most importantly, this guidance should identify specific points in the process and provide a detailed outline where advisory groups have complete or partial decision-making authority.

Similar steps are required to make certain that evidence submitted on patient experience, patient preferences, and similar topics is included in negotiations. This is especially important in the context of determining unmet needs, degree of therapeutic advance, and comparison to alternative therapies. Such evidence is frequently dismissed or discounted in similar contexts due to perceived lack of rigor relative to other evidence or lack of experience incorporating qualitative data. DPNP implementation should specify measures to evaluate the?consistent inclusion of patient experience data, such as incorporating patient researchers in CMS evaluation teams, developing frameworks for the evaluation of evidence and weighting in reviews, and providing guidelines for mixed-method approaches designed to account for qualitative evidence.?

The IRA has significant implications for the future of drug pricing, access, and development. In its implementation of the Medicare DPNP, CMS has a unique opportunity to push for a more patient-centric, value-driven healthcare system. This opportunity is only possible with the collaboration, inclusion, and investment of all stakeholders. Even if CMS does not embrace this opportunity and focus on value, it can still move this vision forward by creating strategies to support and promote health equity and true patient engagement, thus enhancing value. This is only consequential if the goal is high-quality, efficient, innovative, and equitable care for all people and communities. The stakes are too high for anything less.?

For two decades, Dr. Spangler, IVI’s Chief Executive Officer, has worked in the professional health policy and public health sector with pharmaceutical and non-profit organizations.

About IVI

The Innovation and Value Initiative (IVI) is a 501(c)(3) tax-exempt, non-profit research organization dedicated to advancing the science and improving the practice of health technology assessment through development of novel methods and the creation and application of enhanced health technology assessment models to support local decision-making needs in healthcare.