On October 24, 2023, the Rare Disease Legislative Advocates (RDLA) hosted its monthly webinar. These webinars help provide updates to the rare disease community on legislation and other policy initiatives that are relevant to the treatment and management of rare diseases under the law. This month’s program focused on the impacts of the Inflation Reduction Act on the rare disease community, which was passed by Congress and signed into law by President Biden on August 16, 2022. The conversation also focused on a recent court ruling related to copay accumulators.
Speakers for this month’s program included:
- Carl Schimdt, HIV+ Hepatitis Policy Institute
- Ryan Shay, Faegre Drinker
- Jamie Sullivan, EveryLife Foundation for Rare Diseases
Carl discussed a recent court ruling related to copay accumulators. Copay accumulators are essentially a form of loophole mechanism in which health insurers were permitted to exclude any financial assistance that a patient had received from a drug manufacturer from said patient’s out of pocket costs. In effect, this delayed the time that it would take for a patient to reach their out-of-pocket maximum and receive the full benefits of their insurance plan.
Copay assistance programs are offered by drug manufacturers for particularly costly drugs, including many rare disease therapies. The case was brought by three patient advocacy groups, including the HIV+ Hepatitis Policy Institute, against the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services, with the eventual result striking down the legitimacy of copay accumulators. This will be of significant benefit to patients, who will now be able to access their benefits more easily.
Ryan provided a brief update on the current state of Congress. Unfortunately, there hasn’t been much movement in recent weeks due to the ongoing upheaval in the House of Representatives regarding the selection of a speaker.
Jamie talked about the impacts of the Inflation Reduction Act on the rare disease community, which included some provisions that would allow the government to start negotiating the pricing of some drugs. While this is generally good news, there is some concern regarding a specific provision included in the law which excludes orphan drugs if they are approved for a single disease in a single indication, while others would be eligible 7-11 years from their first approval.
This is worrying for a rare community because it disincentivizes pharma companies from repurposing orphan drugs to treat other diseases, including rare ones.
To view the full webinar program, click here.
