MMIT Reality Check on Chemotherapy-Induced Nausea and Vomiting (June 2022)

Payer Coverage:

A review of market access for treatments of chemotherapy-induced nausea and vomiting shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 58% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 21% of the lives under commercial policies are covered with utilization management restrictions. Almost 87% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 85% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 50% require multiple steps. Around 41% of payer-controlled pharmacy benefit covered lives require prior authorization, with 14% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Multiple Companies Launch Emend Generics

In September 2019, Apotex, Dr. Reddy’s and Novadoz were among companies launching the first AP-rated generic versions of Merck & Co., Inc.’s Emend (fosaprepitant) 150 mg injection. Emend is approved in combination with other antiemetics in people at least 6 years old for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, as well as to prevent delayed nausea and vomiting associated with moderately emetogenic chemotherapy.

FDA Approves Generic Palonosetron

In March 2018, the FDA approved Teva Pharmaceutical Industries Ltd.’s 0.25 mg/5 mL generic palonosetron to prevent nausea and vomiting in adults that may occur after chemotherapy, as well as to prevent nausea and vomiting up to 24 hours after surgery. Its launch made it the first generic version of Eisai Inc.’s and Helsinn Healthcare SA’s injectable Aloxi on the market.

FDA Approves Cinvanti

In November 2017, the FDA approved Heron Therapeutics, Inc.’s Cinvanti (aprepitant) injectable emulsion for intravenous infusion. The medication is a substance P/neurokinin-1 (NK1) receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Key Findings:

Market Events Drive Changes

In September 2019, multiple companies launched the first AP-rated generic versions of Merck & Co., Inc.’s Emend (fosaprepitant) 150 mg injection, which is approved in combination with other antiemetics in people at least 6 years old for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, as well as to prevent delayed nausea and vomiting associated with moderately emetogenic chemotherapy. In March 2018, the FDA approved Teva Pharmaceutical Industries Ltd.’s 0.25 mg/5 mL generic palonosetron to prevent nausea and vomiting in adults that may occur after chemotherapy, as well as to prevent nausea and vomiting up to 24 hours after surgery. Its launch made it the first generic version of Eisai Inc.’s and Helsinn Healthcare SA’s injectable Aloxi (palonosetron hydrochloride) on the market.

Competitive Market Landscape

New entrants to this market have benefited from rapid uptake, driven both by clinical advantages and by favorable reimbursement dynamics. Emend and Aloxi have the most favorable coverage compared with other brand name antiemetics.

Pharmacy, Medical Benefit Implications

Coverage is under both the pharmacy and medical benefits. Most policies will require documented use of a generic 5-HT3 antagonist such as ondansetron or granisetron. When prior authorization is defined, diagnosis will be required along with whether nausea and vomiting are associated with initial and repeat courses of highly and/or moderately emetogenic chemotherapy. Oral or injectable generic 5-HT3 antagonists are the most common preferred agents. Medicare Part B covers oral antiemetics if they are initiated within two hours of a chemotherapy agent.

Key Players in Market:

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