Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Final Rule Regarding Copay Accumulator Programs May Increase Patients’ Out-of-Pocket Costs for Oral Cancer Drugs

Web Exclusives - Ovarian Cancer

Copay accumulator programs are a new utilization management tool being implemented by private health plans that exclude copay assistance from counting toward the accumulated total costs being applied to a patient’s deductible and out-of-pocket maximum.

These programs, which typically monitor the use of oral therapies dispensed by specialty pharmacies, have been quietly implemented by several private health insurers and pharmacy benefit managers. Patient advocacy groups and other organizations have voiced opposition to copay accumulator programs, pointing out that they unfairly negate the support provided by copay assistance programs and add to patients’ out-of-pocket cost burdens.

Nevertheless, in April 2019, the US Department of Health and Human Services (HHS) finalized a proposal allowing private insurance plans to exclude the value of certain direct manufacturer cost-sharing support (eg, copay coupons) from a patient’s annual cost-sharing limit. However, it also ruled that copay accumulator programs are permitted only for drugs for which there is a generic equivalent.

The HHS’s Final Rule is unclear regarding biologic therapies, which are frequently used to treat patients with cancer. Although biologics are drugs in the technical sense, the FDA evaluates them differently from other agents. Pharmaceuticals are evaluated by the agency’s Center for Drug Evaluation and Research, whereas biologics are reviewed by its Center for Biologics Evaluation and Research.

Although the HHS has not clarified its position regarding biologics, many legal experts agree with the interpretation that the federal ruling does not apply to these products because they are different from pharmaceuticals.

The ruling will affect patients who may not understand how copay coupons are now applied and may ultimately affect prescription compliance because of the adjustment in out-of-pocket expenses. According to the National Community Oncology Dispensing Association, “The impact is significant for cancer patients needing assistance to pay for pharmaceutical therapies.”

Importantly, the Final Rule does not preempt actions taken by individual states. Currently, legislation in several states curbs or prohibits the use of copay accumulator programs. In March 2019, Virginia and West Virginia banned the use of these programs, and California and Massachusetts have limited their use when generic equivalents are available. Arizona has also passed its own legislation that aligns with HHS provisions on generic equivalents. Advocacy groups are continuing to focus efforts on abolishing copay accumulator programs at the state and federal levels.

Related Items
Phase 2 OVARIO Update: Promising Survival Rates in Patients with Advanced Ovarian Cancer Treated with Niraparib plus Bevacizumab Maintenance
Web Exclusives published on September 15, 2020 in Ovarian Cancer
No Difference in PFS Between Platinum-Based Chemotherapy and Olaparib in Women with Platinum-Sensitive Ovarian Cancer
Web Exclusives published on September 15, 2020 in Ovarian Cancer
PARP Inhibitors Do Not Significantly Increase Risk for Secondary Hematologic Malignancy
Web Exclusives published on September 15, 2020 in Ovarian Cancer
Safety of Approved Rucaparib Starting Dose Confirmed from Pooled Analysis
Web Exclusives published on September 15, 2020 in Ovarian Cancer
Phase 3 Study to Investigate Anti–PD-1 Antibody in the Treatment of High-Grade Ovarian Cancer
Web Exclusives published on September 15, 2020 in Ovarian Cancer
Chemotherapy-Free PARP Inhibitor Combination Improves Outcomes versus Single-Agent PARP Inhibitor in Recurrent Ovarian Cancer
Web Exclusives published on July 28, 2020 in Ovarian Cancer
Olaparib Extends Survival by >1 Year in Women with Relapsed Ovarian Cancer and BRCA Mutation
Web Exclusives published on July 28, 2020 in Ovarian Cancer
Individualized Starting Dose of Niraparib Is Recommended in First-Line Maintenance Setting in Recurrent Ovarian Cancer
Web Exclusives published on July 28, 2020 in Ovarian Cancer
Long-Term Responders to Rucaparib More Likely to Have Deleterious BRCA Mutations
Web Exclusives published on July 28, 2020 in Ovarian Cancer
Finding a Pathogenic Mutation on Genetic Testing Does Not Add to Stress or Anxiety in Women with Newly Diagnosed Ovarian Cancer
Web Exclusives published on July 28, 2020 in Ovarian Cancer
Last modified: April 27, 2020