MMIT Reality Check on Ovarian Cancer

Payer Coverage:

A review of market access for ovarian cancer treatments shows that under the pharmacy benefit, about half of the lives under commercial formularies are covered with utilization management restrictions. Around 13% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 65% of the lives under commercial policies are covered with utilization management restrictions. Almost 66% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, only 2% require multiple steps. Around 71% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Expands FoundationOne Liquid CDx Label

In October 2020, the FDA expanded the label of Foundation Medicine’s FoundationOne Liquid CDx to include its use as a companion diagnostic for Clovis Oncology’s Rubraca (rucaparib), for use in adults with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube or primary peritoneal cancer who have been treated with at least two chemotherapies.

FDA Expands Lynparza’s Label

In May 2020, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability based on an FDA-approved test.

FDA Expands Zejula’s Label

In April 2020, the FDA expanded the label for GlaxoSmithKline plc’s Zejula (niraparib) to include its use as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. The agency initially approved the drug in March 2017. Dosing for the newest use is either 200 mg or 300 mg once daily based on weight and platelet count. Drugs.com lists the price of 30 100 mg capsules as $7,587.75.

Key Findings:

Market Events Drive Changes

In May 2020, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability based on an FDA-approved test. In April 2020, the agency expanded the label for GlaxoSmithKline plc’s Zejula (niraparib) to include its use as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

Competitive Market Landscape

There are 12 branded products currently FDA approved to treat varying stages of ovarian cancer. Of those, two are bevacizumab biosimilars. There are more than seven pipeline agents in Phase III trials. Ovarian cancer is and will continue to be a crowded market as, according to the American Cancer Society, it is responsible for more deaths than any other cancer in the female reproductive system.

Pharmacy, Medical Benefit Implications

Coverage of ovarian cancer medications falls under both the pharmacy and medical benefits and remains very strong for all of the products in this class. Most products are limited by their policies for treatment at specific stages of ovarian cancer. This may not remain true as we see clinical trials proving that targeted therapies can provide improvement earlier in the disease cycle and during the maintenance phase.

Key Players in Market:

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• Reality Check