Health Plans Are Hesitant to Add New Narcolepsy Drugs to Formularies

by Jane Anderson

Two newly approved narcolepsy medications offer novel, possibly more effective options to people for whom older medications aren't working well, but most health plans are requiring patients and providers to try generic alternatives first.

The FDA approved Jazz Pharmaceuticals' Sunosi (solriamfetol) for adults with narcolepsy or obstructive sleep apnea in March and Harmony Biosciences, LLC's Wakix (pitolisant) in August. Sunosi was launched in July, and Wakix is expected to be launched later this year.

Some researchers say Sunosi and Wakix may have advantages over older treatments. Still, plans have been reluctant so far to add Sunosi to their preferred drug lists, and they seem likely to take the same cautious approach with Wakix.

First-line treatment for narcolepsy generally involves stimulant medications such as methylphenidate, amphetamines or modafinil/armodafinil, says Mesfin Tegenu, R.Ph., president of PerformRx. "Efficacy of the agents rarely exceeds around 70% to 80% of the normal ability to stay awake," Tegenu tells AIS Health.

Some stimulants, including modafinil and some forms of methylphenidates and amphetamines, are available in generic form, Tegenu says. "Many plans may require trial(s) of an available generic product prior to payment of a brand-only formulation, or trial of less costly alternatives to higher-priced generic items if there’s a significant price difference," he says.

It's not clear whether either Sunosi or Wakix provide substantially better outcomes than the therapies currently in use, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.

Tegenu says that both Sunosi and Wakix are non-formulary products for now for PerformRx, since it's not possible to know whether they're equally or more effective than older treatments. They will be "handled the same as all newly available drugs: considered non-formulary until enough clinical data is made available to add them to the covered medications class of drugs."

From RADAR on Drug Benefits