MMIT Reality Check on Cervical Cancer

Payer Coverage:

A review of market access for cervical cancer treatments shows that under the pharmacy benefit, about 33% of the lives under commercial formularies are covered with utilization management restrictions. Around 39% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 56% of the lives under commercial policies are covered with utilization management restrictions. Almost 68% of the lives under Medicare 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, about 14% require multiple steps. Around 67% of payer-controlled pharmacy benefit covered lives require prior authorization, with 3% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Alymsys

In April 2022, the FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) 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. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.

Regeneron and Sanofi Withdraw Libtayo’s sBLA

Regeneron Pharmaceuticals, Inc. and Sanofi said on Jan. 28, 2022, that they are voluntarily withdrawing Libtayo’s (cemiplimab-rwlc) supplemental Biologics License Application (sBLA) for the second-line treatment of people with advanced cervical cancer. The companies said they “were not able to align on certain post-marketing studies” with the FDA. They also noted that since they submitted the sBLA, “another PD-1 inhibitor was approved as first-line treatment for patients with persistent, recurrent or metastatic cervical tumors that express PD-L1.” The FDA approved Merck & Co., Inc.’s Keytruda (pembrolizumab) for this indication on Oct. 13, 2021.

FDA Gives Keytruda Additional Indication

In October 2021, the FDA gave another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of people with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1) (Combined Positive Score (CPS) > 1) as determined by an FDA-approved test. The agency also converted the June 12, 2018, accelerated approval for the programmed death receptor-1 (PD-1) inhibitor for the treatment of people with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS > 1), as determined by an FDA-approved test, to regular approval. The FDA first approved the drug on Sept. 4, 2014. Dosing for both indications is 200 mg via a 30-minute intravenous infusion every three weeks or 400 mg every six weeks. The price of the every-three-weeks dose is $10,067.36; for the every-six-weeks dose, it’s $20,134.72.

Key Findings:

Market Events Drive Changes

In April 2022, the FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions, including for persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan. In October 2021, the agency gave another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of people with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1) (Combined Positive Score (CPS) > 1) as determined by an FDA-approved test. In September 2021, the FDA gave accelerated approval to Seagen Inc. and Genmab A/S’s Tivdak (tisotumab vedotin-tftv) to treat adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Pharmacy, Medical Benefit Implications

Drugs in the market basket have good coverage across payers and lines of business. The majority of payers have policies in place to ensure standard of care is met and appropriate biomarker testing for targeted therapy is conducted.

Key Players in Market:

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