By Haley Willett, PharmD, Associate Director, Strategic Planning, Mosaic
In recent years, health plans have increasingly adopted copay adjustment programs in an effort to mitigate the cost offsets provided by manufacturer copay program support. These copay adjustment strategies include copay accumulator programs, copay maximizer programs, and alternative funding programs. Below we have summarized a September 29, 2023 conclusion by the US District Court for the District of Columbia, and the subsequent appeal, that continue to drive debate and confusion around how copay accumulator programs might be implemented moving forward.1
Copay accumulators 2,3
Copay support does not count toward patient deductible or out-of-pocket (OOP) maximum. Once copay support is exhausted, then patient cost share will count toward the deductible and OOP maximum.
Copay maximizers 2
Copay support does not count toward patient deductible or OOP maximum. The total value of copay support is applied evenly throughout the benefit year, with the patient responsible for the remaining cost-share balance.
Alternative funding programs 4
Specialty carve-out programs that exclude coverage of certain specialty drugs and force patients to apply for manufacturer or other patient assistance programs to obtain treatment coverage.
September 2023 court decision and subsequent appeal
Plaintiffs consisting of 3 patient advocacy groups and 3 individual patients won a lawsuit brought against the 2021 Notice of Benefit and Payment Parameters (NBPP) ruling, whereby the judge struck down the rule that allowed health plans to exclude copay assistance from counting toward patient deductibles under copy accumulator programs.1 If upheld, this decision would mean that insurers must comply with the 2020 NBPP rule, whereby only copay support for branded drugs with available generic equivalents may be excluded from cost-sharing caps.1 The administration was allowed 60 days to appeal the decision.
On November 27, 2023, US Department of Health and Human Services (HHS) filed a motion to clarify the court decision, stating they will not take action to enforce how plans operate such programs.5 This motion was followed by an appeal of the court decision, which was filed by HHS on November 28, 2023.6 The appeal process is ongoing and the outcome is yet to be determined.
History of copay accumulator programs
Before the most recent court decision, there was a 2021 NBPP federal rule* from the HHS.3 This rule allowed insurers to exclude manufacturer copay support from applying toward a patient's annual deductible and OOP maximum through the use of copay accumulator programs.3 Once the patient has reached the maximum copay support dollar amount, patient OOP costs will begin counting toward their deductible (if not already reached) and OOP maximum.3 While the intent of manufacturer copay support is to lessen patient OOP costs, these copay accumulator programs effectively mitigate potential savings and make patients responsible for all cost-sharing up to the OOP maximum.3 While 19 states have already banned copay accumulators, citing increased patient financial burden, they continue to affect patient access and affordability broadly.3
Stakeholder implications if September 2023 decision stands
- Patients prescribed branded drugs without a generic equivalent may experience reduced financial burden due to the September 2023 court decision
- Patients prescribed branded drugs with a generic equivalent may continue to be financially impacted if their health plan utilizes a copay accumulator program in states where allowed
- Patient access and affordability of drugs may continue to be impacted by copay maximizer programs and alternative funding programs
- Manufacturers of branded drugs with a generic equivalent may still need to address the impact of copay accumulator programs on patients in states where they are are allowed
- Given that the September 2023 ruling only applies to copay accumulator programs, manufacturers will still need to consider how copay maximizer and alternative funding programs impact patient access and affordability
- Potential strategies to address the impact include increased patient/provider education and innovative patient support programs
While the September 2023 decision may at some point provide relief for patients and manufacturers of branded drugs without a generic equivalent, including many high-cost drugs in complex therapeutic areas such as immunology, oncology, and rare disease, the results of the appeal and state legislation related to these programs will continue to unfold.
*The 2020 NBPP rule allowed insurers to exclude manufacturer assistance from OOP maximums for brand drugs with an available and appropriate generic equivalent. The 2021 NBPP rule intended to clarify confusion around unclear language in the 2020 rule.