A large life sciences manufacturer anticipated that some of its products may be selected for drug price negotiations under the Inflation Reduction Act (IRA). It sought to create an evidence strategy to articulate the value of its products during negotiations and thus needed to predict how CMS might weigh evidence and evaluate results. We helped the client anticipate CMS’s approach to evaluating evidence packages for products during the negotiation process, and develop strategies to strengthen those packages, to ensure that negotiated maximum fair prices (MFPs) accurately reflect the value of the client’s products.
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We partner closely with clients to ensure their IRA strategy is tailored to their industry position, needs, and goals, helping clients make informed decisions and achieve long-term success.
Planning for Life Sciences
The Inflation Reduction Act brings some of the biggest changes affecting the pharmaceutical industry in the last decade. Megan West discusses how these shifts will impact pharmaceutical organizations and how Avalere can help develop strategies to mitigate risk and identify opportunities throughout the product lifecycle.
Manufacturers should reevaluate CMS engagement strategies as soon as possible to maximize the opportunity to influence the IPAY 2026 Medicare price-setting process.
The IRA’s Part D redesign could lower out-of-pocket costs for people with HIV; providers can help make sure their patients are aware of these changes.
CMS selected 10 Part D drugs for the first year of negotiation. Stakeholders should consider engagement opportunities and evaluate broader therapeutic dynamics.
IRA policies and growing enrollment in Medicare Advantage could begin to destabilize the standalone PDP and LIS benchmark plan market.
Multiple Inflation Reduction Act provisions impact biologics and biosimilars, but the net impact and potential consequences will vary across products.
Comments on initial negotiation guidance significantly shaped the revised guidance, underscoring the importance of stakeholder engagement in IRA implementation.
Manufacturers should adjust commercial and evidence generation strategies in response to the shifted incentives under the IRA and Enhancing Oncology Model.
Recently released guidance and a second draft Negotiation Data Elements ICR introduce several opportunities for patients and caregivers to shape negotiation.
The revised guidance contains significant changes to the initial guidance released in March, but important outstanding questions remain.
The IRA will increase health plans’ financial risk, elevating the importance of Medicare Part D risk adjustment.