MMIT Reality Check on Ovarian Cancer (4Q2022)

Payer Coverage:

A review of market access for ovarian cancer treatments shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 20% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 57% of the lives under commercial policies are covered with utilization management restrictions. Almost 64% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 93% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, only 9% require multiple steps. Around 71% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Gives Elahere Accelerated Approval

In November 2022, the FDA gave accelerated approval to ImmunoGen Inc.’s Elahere (mirvetuximab soravtansine-gynx) for the treatment of adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. The agent is a first-in-class antibody-drug conjugate directed against FRα, as well as the first FDA-approved antibody-drug conjugate for platinum-resistant ovarian cancer. Dosing is 6 mg/kg of adjusted ideal body weight via intravenous infusion every three weeks. The price of a 100 mg dose is $6,220. The FDA also approved Roche’s VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to aid in identifying people with epithelial ovarian cancer who are eligible for treatment with Elahere by detecting folate receptor 1 protein (FOLR1 or FRα). It is the first immunohistochemistry (IHC) companion diagnostic approved for this use.

PARP Inhibitors’ Data on Later Line Use in Ovarian Cancer Prompts Indication Withdrawals

Since June 2022, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.

GSK Limits Indication for Zejula

GSK plc will limit the second-line maintenance indication for Zejula (niraparib) in patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy to those patients who have deleterious or suspected deleterious germline BRCA mutations, the company revealed Nov. 11. The drug launched after the FDA first approved it for use in the second-line setting on March 27, 2017. The company says that the drug’s first-line indication for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy remains unchanged. The move comes amid multiple withdrawals for poly (ADP-ribose) polymerase (PARP) inhibitor ovarian cancer late-line indications in 2022. It also occurred less than two weeks before a scheduled Nov. 22 FDA Oncologic Drugs Advisory Committee (ODAC) meeting to discuss Zejula’s second-line use and whether it should remain on the drug’s label. ODAC canceled the meeting in late October.

Key Findings:

Market Events Drive Changes

In November 2022, the FDA gave accelerated approval to ImmunoGen Inc.’s Elahere (mirvetuximab soravtansine-gynx) for the treatment of adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. In September, the agency approved Celltrion USA’s Vegzelma (bevacizumab-adcd) for the treatment of multiple indications, including epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and paclitaxel, followed by Vegzelma as a single agent, for stage III or IV disease following initial surgical resection or in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens or in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Vegzelma as a single agent, for platinum-sensitive recurrent disease. In April, the FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. Alymsys and Vegzelma are the third and fourth FDA-approved biosimilars of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group.

Competitive Market Landscape

There are several branded products currently FDA approved to treat varying stages of ovarian cancer. More than 10 pipeline agents are 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:

0

0

0 Comments

0

0

• Reality Check