MMIT Reality Check on Ovarian Cancer (4Q2023)
Payer Coverage:
A review of market access for ovarian cancer treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 19% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 48% of the lives under commercial policies are covered with utilization management restrictions. Almost 71% 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 11% require multiple steps. Around 71% of payer-controlled pharmacy benefit covered lives require prior authorization.
Trends:
FDA Approved Bio-Thera’s Avzivi
In December 2023, the FDA approved Bio-Thera Solutions, Ltd.’s biosimilar Avzivi (bevacizumab-tnjn) for seven of its reference drug’s, Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab), indications, including 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 who received no more than two prior chemotherapy regimens. The vascular endothelial growth factor (VEGF) inhibitor is the fifth FDA-approved Avastin biosimilar. Sandoz will commercialize the agent.
FDA Approved New Formulation for Zejula
In April 2023, the FDA approved a new tablet formulation of GSK plc’s Zejula (niraparib) 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 first-line platinum-based chemotherapy and for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, with appropriate patients selected based on an FDA-approved companion diagnostic. The tablets are available in 100 mg, 200 mg and 300 mg strengths. The poly (ADP-ribose) polymerase (PARP) inhibitor initially was approved on March 27, 2017, as a 100 mg capsule. For advanced ovarian cancer, dosing in people weighing less than 77 kg or with a platelet count less than 150,000/mcL, the recommended dose is 200 mg once daily; for patients weighing more and who have a platelet count of at least 150,000/mcL, dosing is 300 mg once daily. For recurrent germline BRCA-mutated ovarian cancer, the recommended dose is 300 mg once daily. Drugs.com lists the price of 30 100 mg capsules as more than $9,112.
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.
Key Findings:
Market Events Drive Changes
In December 2023, the FDA approved Bio-Thera Solutions, Ltd.’s biosimilar Avzivi (bevacizumab-tnjn) for seven of its reference drug’s, Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab), indications, including 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 who received no more than two prior chemotherapy regimens. In April 2023, the FDA approved a new tablet formulation of GSK plc’s Zejula (niraparib) 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 first-line platinum-based chemotherapy and for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, with appropriate patients selected based on an FDA-approved companion diagnostic. In November 2022, the agency 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.
Competitive Market Landscape
There are several branded products currently FDA approved to treat varying stages of ovarian cancer, including five biosimilars of Avastin. There are more than 10 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:
