MMIT Reality Check on Parkinson’s Disease (3Q 2023)

Payer Coverage:

A review of market access for Parkinson’s disease treatments shows that under the pharmacy benefit, about 34% of the lives under commercial formularies are covered with utilization management restrictions. Around 56% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 24% of the lives under commercial policies are covered with utilization management restrictions. Almost 16% of the lives under health exchange policies have access to at least one of the drugs without utilization management restrictions.

For about 72% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 33% of the lives require multiple steps. Around 41% of payer-controlled pharmacy benefit covered lives require prior authorization, with 32% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Kynmobi Is Voluntarily Withdrawn

In June 2023, Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) was voluntarily withdrawn from the U.S. market due to limited utilization. In May 2020, the medication was approved by the FDA for the acute, intermittent treatment of “off” episodes in people with Parkinson’s disease. The dose range is 10 mg to 30 mg administered sublingually, with a maximum of five doses per day. The drug became available in the U.S. on Sept. 29, 2020.

FDA Approves Dhivy

In November 2021, the FDA approved Alora Pharmaceuticals company Avion Pharmaceuticals, LLC’s Dhivy (carbidopa/levodopa) tablets for the treatment of Parkinson’s disease, post-encephalitic parkinsonism and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. The drug launched on Feb. 14, 2022.

FDA Approves Ongentys

In April 2020, the FDA approved Neurocrine Biosciences, Inc.’s Ongentys (opicapone) as an add-on treatment to levodopa/carbidopa in people with Parkinson’s disease experiencing “off” episodes. The recommended dose of the capsule is 50 mg once daily at bedtime. The drug became available in the U.S. on Sept. 14, 2020.

Key Findings:

Market Events Drive Changes

In June 2023, Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) was voluntarily withdrawn from the U.S. market due to limited utilization. In November 2021, the FDA approved Avion Pharmaceuticals, LLC’s Dhivy (carbidopa/levodopa) tablets for the treatment of Parkinson’s disease, post-encephalitic parkinsonism and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Competitive Market Landscape

The Parkinson’s market is continually growing, with many drugs in the pipeline. Contracting may occur with multiple monoamine oxidase-B inhibitors available. This therapeutic class includes many quality options, both generic (the majority) and brand. New players are emerging, but big prescription sales are illusive compared with the oral market of old. Despite advantages to injectables and transdermal patches, physician behavior and coverage are slower compared with oral agents.

Pharmacy, Medical Benefit Implications

Given the number of generic orals, management of the remaining name-brand oral products is restrictive but less so than in other classes. Drugs are covered primarily under the pharmacy benefit. With many strong orals available, understanding how restrictions translate (or don’t) to brand-name products is critical. When prior authorization is defined, diagnosis and clinical documentation are required.

Key Players in Market:

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