MMIT Reality Check on Narcolepsy

Payer Coverage:

A review of market access for treatments for adults with narcolepsy shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions. Around 38% of the lives under Medicare formularies are not covered for at least one of the drugs.

For about 69% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 67% of the lives require a single step. Around 73% of payer-controlled pharmacy benefit covered lives require prior authorization, with 16% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Gave Wakix Additional Approval

In October 2020, the FDA gave another approval to Harmony Biosciences Holdings, Inc.’s Wakix (pitolisant) for the treatment of cataplexy in adults with narcolepsy. The agency initially approved the selective histamine 3 (H3) receptor antagonist/inverse agonist on Aug. 15, 2019. Website GoodRx lists the price of 60 17.8 mg tablets as more than $11,223.

FDA Approved Xywav

In July 2020, the FDA approved Jazz Pharmaceuticals plc’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The manufacturer said the medication is the first FDA-approved new treatment option indicated for both cataplexy and EDS in people living with narcolepsy in more than 15 years.

Key Findings:

Market Events Drive Changes

In October 2020, the FDA gave another approval to Harmony Biosciences Holdings, Inc.’s Wakix (pitolisant) for the treatment of cataplexy in adults with narcolepsy. The agency initially approved the selective histamine 3 (H3) receptor antagonist/inverse agonist on Aug. 15, 2019. In July 2020, the FDA approved Jazz Pharmaceuticals plc’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. In March 2019, the agency approved Jazz’s Sunosi (solriamfetol), the first dual-acting dopamine and norepinephrine reuptake inhibitor, for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Competitive Market Landscape

Generics are preferred over brands. Analeptics — Teva Pharmaceutical’s Nuvigil (armodafinil) and Provigil (modafinil) — are first line in the treatment pathway, as they are available generically. Following that, generic immediate-release central nervous system stimulants are often second line, with Jazz’s Xyrem (sodium oxybate) reserved for third line due to costs and safety. Pipeline drug FT 218 is an extended-release oral suspension of sodium oxybate under development by Avadel Pharmaceuticals plc (which merged with Flamel Technologies SA on Jan. 1, 2017) using its proprietary micropump technology, for the treatment of narcolepsy and cataplexy. It is being developed to eliminate the second nighttime dose for patients suffering from narcolepsy.

Pharmacy, Medical Benefit Implications

Nearly all products are covered but almost exclusively restricted by prior-authorization policies. The pharmacy benefit is dominant. Xyrem and Xywav provide the largest coverage variance with their Risk Evaluation and Mitigation Strategies programs.

Key Players in Market:

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