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Radar On Market Access: Despite New Approvals, Plans Still Favor Generics for Epilepsy

Posted by Jane Anderson on Jan 5, 2021

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Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders tell AIS Health.

Xcopri (cenobamate tablets), manufactured by SK Biopharmaceuticals Co., Ltd.'s subsidiary SK Life Science, Inc., launched in May for the treatment of partial-onset seizures. However, many plans haven't jumped to add Xcopri to their formularies, says Mesfin Tegenu, R.Ph., president of PerformRx.

"Some plans have opted to take a cautious approach and leave the medication as non-formulary to start," Tegenu says. "It is difficult to tell the impact of this new drug launch on the treatment of epilepsy. However, Xcopri trials demonstrated high efficacy in partial onset seizures and refractory epilepsy, lending it a strong clinical profile. One could reasonably suspect a high impact on the epilepsy treatment paradigm."

In most cases, though, generics are the first-line treatments for many forms of the disorder, according to Tegenu. Many of the drugs used to treat epilepsy are covered without restriction by plans.

Prime Therapeutics LLC treats Xcopri as a non-preferred brand, says April Kunze, senior director of clinical formulary development and trend management strategy for the PBM. Premera Blue Cross' Medicare Advantage formularies, Cigna Corp.'s national preferred formulary and HealthPartners' commercial formularies impose quantity limits on Xcopri, according to their plan documents.

"Treatment is based on the type of epilepsy diagnosed, and labeled and off-label indications of the individual products. There is a fair amount of overlap as many drugs share multiple indications. However, many newer agents are narrowly indicated," Tegenu says.

In November 2018, GW Pharmaceuticals launched its product Epidiolex (cannabidiol), a much-anticipated new drug for two rare forms of childhood epilepsy. In August, the FDA expanded indications for Epidiolex to include seizures associated with tuberous sclerosis complex in patients age 1 or older.

"Based on previous positive trial results in TSC patients, Epidiolex may become an important treatment option for patients," Elizabeth Thiele, M.D., Ph.D., director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, said in a statement when the FDA widened Epidiolex indications.

For his part, Tegenu expresses some skepticism about the drug. "Epidiolex represents another option for treatment of Lennox-Gastaut and Dravet syndrome," Tegenu says. "However, its efficacy hasn't shown significant improvement relative to existing treatments."


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Topics: Industry Trends, Market Access, Product Release