MMIT Reality Check on Narcolepsy (2Q2023)

Payer Coverage:

A review of market access for treatments for adults with narcolepsy shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions. Around 11% 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 62% of the lives require a single step. Around 74% of payer-controlled pharmacy benefit covered lives require prior authorization, with 23% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Gives Lumryz Final Approval

In May 2023, the FDA granted final approval to Avadel Pharmaceuticals plc’s Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. The agency gave the drug tentative approval rather than full approval on July 19, 2022, while Avadel was embroiled in a patent battle with Jazz Pharmaceuticals plc over the latter’s Xyrem (sodium oxybate), of which Lumryz is an extended-release version, taken once a day at bedtime as opposed to Xyrem’s twice-daily dosing: first at bedtime and then again two-and-a-half to four hours later. The U.S. Court of Appeals for the Federal Circuit ruled in February that Jazz must delist its so-called “REMS patent” from the FDA’s Orange Book, a move that cleared the way for the FDA approval. The agency gave the drug orphan drug designation. The recommended starting dose is 4.5 g of the oral suspension once at night, with titration in increments of 1.5 g per week, with a maintenance dose of 6 g to 9 g. The drug is priced at $64.67 per gram or about $177,034 per year.

Hikma Launches Authorized Generic of Xyrem

In January 2023, Hikma Pharmaceuticals PLC said that it had launched an authorized generic of Jazz Pharmaceuticals, Inc.’s Xyrem (sodium oxybate). The company has 180 days of marketing exclusivity for the drug, which is approved for the treatment of cataplexy or excessive daytime sleepiness in people at least 7 years old with narcolepsy. Three other authorized generics have been cleared to launch once Hikma’s exclusivity period expires, and additional multisource generics are expected at the end of 2025.

FDA Grants Tentative Approval to Extended-Release Narcolepsy Agent

A new formulation of a narcolepsy drug may get uptake among providers, according to Zitter Insights research. But payers indicate that they are likely to require patients to fail at least one generic drug before getting access to the new agent and other branded medications. Still, the agent’s less onerous dosing may allow it to pull market share from similar medications within the class.

In July 2022, Avadel Pharmaceuticals plc said that the FDA had granted tentative approval to its Lumryz (sodium oxybate) for the treatment of excessive daytime sleepiness or cataplexy — an abrupt loss of muscle tone that can be triggered by strong emotion — in adults with narcolepsy. The drug — which is also known as FT218 — is a once-at-bedtime extended-release version of Jazz Pharmaceuticals plc’s Xyrem, a drug that requires one dose at bedtime and then another dose between two-and-a-half to four hours later.

Key Findings:

Market Events Drive Changes

In May 2023, the FDA granted final approval to Avadel Pharmaceuticals plc’s Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. In January 2023, Hikma Pharmaceuticals PLC said that it had launched an authorized generic of Jazz Pharmaceuticals, Inc.’s Xyrem (sodium oxybate). The company has 180 days of marketing exclusivity for the drug, which is approved for the treatment of cataplexy or excessive daytime sleepiness in people at least 7 years old with narcolepsy.

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. Avadel’s Lumryz, an extended-release oral suspension of sodium oxybate, has been developed to eliminate the second night-time dose for patients suffering from narcolepsy. This agent will compete directly with Xyrem or Jazz’s Xywav (calcium, magnesium, potassium & sodium oxybates) and may have an edge due to the elimination of the second nighttime dose.

Pharmacy Benefit Implications

Nearly all products are covered but almost exclusively restricted by prior-authorization policies. The pharmacy benefit is dominant. Generics are preferred over brands. In policies, steps through generics are commonly seen with analeptics (modafinil/armodafinil) generally being the first step. Some policies require a trial and failure of central nervous system stimulants.

Key Players in Market:

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