FDA Approves Generic Abilify: Potential Impact on Medicare Set-Asides

By Angela Wolfe June 22, 2015

On April 25, 2015, the FDA issued approval for multiple manufacturers to market generic aripiprazole (Abilify). Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

It is the policy of the Centers for Medicare and Medicaid Services (CMS) to price the generic form of a medication in a Workers' Compensation Medicare Set-Aside (WCMSA) if the treatment records or prescription refill history demonstrates current refills of the generic form. If the claimant continues to fill the brand version, as evidenced by the records, CMS will recommend the brand price. Therefore, to see a reduction in the cost of the medication in the WCMSA, the claimant must fill the medication as the generic form.

CMS will price all injury-related medications in the WCMSA if the medication meets an FDA-approved use or an off-label use that is supported by the CMS-approved compendium. FDA-approved uses of Abilify (aripiprazole) include schizophrenia, bipolar disorder, and adjunctive therapy in major depression. Abilify (aripiprazole) is not FDA-approved as a first-line drug for major depression. In addition, the CMS-approved compendium does not support off-label use of the drug as a first-line treatment for major depression. Therefore, Abilify (aripiprazole) is approved as an add-on drug in major depression only when other antidepressants alone are not effective.

CMS continues to calculate injury-related prescription medications based on the lowest average wholesale price (AWP). Currently, the lowest AWP for generic Abilify (aripiprazole) is approximately three dollars less per unit/pill than brand Abilify for each dosage form. That can have a significant pricing impact over life expectancy in the WCMSA. AWP pricing is regularly updated, and the savings may be even greater with later AWP pricing updates.

ISO Claims Partners will continue to work with our partners to identify issues that affect WCMSAs. Our team routinely reviews treatment records and prescription refill records to price the appropriate form of medication consistent with CMS policy. We also review records to identify off-label uses that do not meet CMS-approved off-label use for exclusion from the WCMSA.


Angela Wolfe

Angela Wolfe is medical director of MSP compliance at ISO Claims Partners. Angela concentrates on all facets of the claims arena, specializing in the MSP medical and legal aspects of MSP compliance. As an attorney, registered nurse, Advanced Certified Registered Nurse Practitioner, and Certified Lifecare Planner, she is a valuable asset to our best-in-class team of legal and medical MSP compliance experts. Angela can be reached at awolfe@iso.com or 978-825-8353.