On October 2nd, the U.S. District Court for the District of Columbia struck down a Department of Health and Human Services (HHS) rule that allows certain commercial plans to not count the amount of assistance provided by manufacturer copay assistance programs toward a patient’s deductible and out-of-pocket maximum.
These so-called “copay accumulators” programs basically increase patient out-of-pocket costs – often surprisingly when a patient’s financial assistance has run out and they learn they have not met their deductible. They may be faced with a bill of thousands of dollars. This has spurred the All Copays Count coalition and led to 16 states to date to ban such programs.
This ban at a federal level is a major win for manufacturers over insurers and PBMs.
The decision is perceived as a major victory by nearly thirty patient groups which argued that the rule, first enacted under the Trump administration, restricted access to the most promising therapies and contradicted the cost-sharing principles that are central to the Affordable Care Act. As a result of the ruling:
- Insurers will have to adhere to an earlier federal rule (2020) whereby copay accumulators are only allowable for brand-named therapies with a generic equivalent – if permitted by state law.
- HHS will be permitted to make any needed adjustments to the statutory language.
Increased attention on value and affordability
While the federal ruling presents an immediate defeat for insurers and PBMs, manufacturers will need to carefully consider upcoming pricing and access decisions.
- For manufacturers with commercialized therapies, adjustments in financial assistance programs and near-term price increases can quickly be perceived as profit-driven.
- Manufacturers preparing for regulatory approval should anticipate increased attention on patient discount programs and value discussions with stakeholders.
- Manufacturers should also be prepared to speak about cost-sharing arrangements more broadly, and how much economics should or does factor into prescribing in their specific disease state.