MMIT Reality Check on Parkinson’s Disease (August 2022)
A review of market access for Parkinson’s disease treatments shows that under the pharmacy benefit, about 37% of the lives under commercial formularies are covered with utilization management restrictions. Around 40% 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 15% of the lives under health exchange policies have access to at least one of the drugs without utilization management restrictions.
For about 71% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 45% of the lives require multiple steps. Around 47% of payer-controlled pharmacy benefit covered lives require prior authorization, with 40% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
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 Kynmobi
In May 2020, the FDA approved Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) 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 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.
Market Events Drive Changes
In November 2021, the FDA approved Avion Pharmaceuticals’ 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. In May 2020, the agency approved Sunovion Pharmaceuticals Inc.’s Kynmobi (apomorphine) for the acute, intermittent treatment of “off” episodes in people with Parkinson’s disease.
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: