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Mandatory Patient-Focused Listening Sessions with CMS: What Manufacturers Need to Know

The Inflation Reduction Act (IRA) mandates that the Centers for Medicaid & Medicare Services (CMS) negotiate prices for a subset of Part B and Part D drugs. Which drugs will be selected and how negotiations will be handled is coming into focus. CMS has released several draft guidance documents this year. In late June, CMS released updated guidance on the implementation of the Medicare Drug Price Negotiation Program for the first ten Part D drugs. The guidance included new mandatory patient-focused listening sessions for each drug selected for price negotiation.

To learn more about the patient-focused listening sessions, their potential impact, and how manufacturers can prepare, we spoke with Alira Health’s Brad Ship, Partner, and Jennifer Lannon, Director of Patient Engagement and Advocacy. The list of the first 10 Part D drugs selected for price negotiation was released on August 29th, 2023.

Articles
Published on:
August 28, 2023
As a community, we’re all very glad that CMS added the listening sessions to the Negotiation Program. It’s so important to hear from the patients directly.
Jennifer Lannon Director of Patient Engagement and Advocacy
What are the patient-focused listening sessions?

Jennifer: CMS just announced the list of the first ten high expenditure drugs that are selected for the Negotiation Program. For each chosen drug, CMS will hold an in-person meeting, open to the public. These patient-focused listening sessions are an opportunity for patients, patient advocacy groups (PAGs), caregivers, and others to provide feedback on the value of the drug.

Specifically, CMS is looking for “input on therapeutic alternative(s) to the selected drugs, how the selected drugs address unmet medical need, and the impact of selected drugs on specific populations” (Fact Sheet: Medicare Drug Price Negotiation Program Revised Guidance, June 2023). Patient input will provide CMS with a more complete understanding of each drug’s value that they can consider when reviewing how much they should be paying. CMS will share details about the listening sessions at a future date.

Brad: For manufacturers, these listening sessions are important because patient voices are essential and they can’t, and don’t want to, speak on behalf of patients. Patients and their loved ones must live day-to-day with the conditions.

Jennifer: As a community, we’re all very glad that CMS added the listening sessions to the Negotiation Program. It’s so important to hear from the patients directly. And I’ll add that we expect to hear a variety of responses from patients, including some unexpected input. For example, a patient or PAG representative could say that a competitive drug offers a greater improvement on their quality of life. And a few stories like that could have a major impact on the discussion.

Brad: Right. Also, some patients may say, “This drug is so valuable to me, it has changed my life.” But other patients may say, “This drug has changed my life, but I can’t afford it.” Both of those statements show positive belief in the product but would have entirely different implications for pricing.

Jennifer: Exactly. The worst-case scenario for a manufacturer is that the patients say a particular drug is not valuable to them, or that a competitive drug is much more valuable. On the other hand, the best outcome is that the PAGs and/or patients say that a drug that has changed their lives is worth the price.

Manufacturers that have been engaging with advocacy groups, building relationships, and truly taking a patient-centric approach to their business are most likely to see a benefit.
Brad Ship Partner
What role will the patient-focused listening sessions play in the price negotiations?

Brad: What we’ve seen in the FDA’s patient listening sessions is that the needle moves in certain circumstances. We see this when the patient community in question lacks other options, has a significant course of disease, and is well-organized. We might expect a similar situation with the CMS patient listening sessions.

We don’t yet know how influential the listening sessions will be on CMS’s negotiating position. We know they are one data point that CMS will have. And we don’t know what new information patients will bring to the table. Out of the ten drugs under negotiation, it is possible that there may be one or two where the patient input changes the course of what CMS is thinking.

What should manufacturers do to prepare?

Brad: This is where your patient and PAG engagement efforts come to fruition. Manufacturers that have been engaging with advocacy groups, building relationships, and truly taking a patient-centric approach to their business are most likely to see a benefit (although we would not recommend that your patient engagement is done with the expectation of support in the CMS negotiation).

Jennifer: These patient-focused listening sessions are one more reminder that patient engagement is critical. Invest in building great relationships with PAGs because they are major stakeholders in this process. And be sure to engage with PAGs on why drug pricing is the way that it is, and how price cuts could affect R&D for further innovation.

Brad: Yes, exactly. If you haven’t taken patient advocacy and community engagement seriously yet, you should start. Demonstrate to patients and PAGs that patients are a top priority for your company.

How can Alira Health help?

Jennifer Lannon

Jennifer Lannon, Director of Patient Engagement and Advocacy

Jennifer: If you want to revisit your patient engagement strategy in light of the IRA provisions, our market access team knows these regulations well and our patient engagement team are expert in assessing the PAG landscape, selecting the right organizations, and crafting a plan for developing long-term advocacy relationships. We can develop a full picture of how your strategy should change in preparation for possible participation in the Negotiation Program, even if it could be years away.

Bradford-Ship

Brad Ship, Partner

More Resources on the Impact of the IRA

To learn more about the potential significance of the IRA for EU pharmaceutical and biotech companies, we spoke with Alira Health’s Brad Ship, Partner, and Hannah Buser, Engagement Manager. Start reading, “What EU Companies Need to Know about the U.S. Inflation Reduction Act.”

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