MMIT Reality Check on Kidney Cancer (August 2022)

Payer Coverage:

A review of market access for kidney cancer treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions. Around 25% 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 54% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 13% of the lives require multiple steps. Around 78% 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, including metastatic renal cell carcinoma in combination with interferon alfa. 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.

FDA Grants Keytruda Another Indication

In November 2021, the FDA granted another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The FDA first approved the drug on Sept. 4, 2014. Dosing 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 $10,268.72; for the every-six-weeks dose, it’s $20,537.44.

FDA Approves Lenvima and Keytruda Combination

In August 2021, the FDA approved the combination of Eisai Inc.’s Lenvima (lenvatinib) and Merck and Co., Inc.’s Keytruda (pembrolizumab) for the first-line treatment of adults with advanced renal cell carcinoma. The review used the Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid, a voluntary submission from the applicant to help the FDA’s assessment. The application had priority review and breakthrough therapy designation. Recommended dosing is 20 mg of Lenvima capsules once daily and 200 mg of Keytruda every three weeks via a 30-minute intravenous infusion or 400 mg every six weeks. Drugs.com lists the price of 60 20 mg doses of Lenvima as more than $21,268. Keytruda’s list price for the every-three-weeks dosing is $10,067.36; for every six weeks, it’s $20,134.72.

Key Findings:

Market Events Drive Changes

A higher starting dose of Eisai Inc. and Merck & Co., Inc.’s Lenvima (lenvatinib), compared with a lower starting dose, prolonged the time that patients with renal cell carcinoma (RCC) experience negative effects. Recent study results show that Exelixis, Inc.’s Cabometyx (cabozantinib) should be considered the new standard for systemic therapy in patients with metastatic papillary RCC. In April 2022, the FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions, including metastatic RCC in combination with interferon alfa. In November 2021, the agency granted another indication to Merck’s Keytruda (pembrolizumab) for the treatment of people with RCC at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Competitive Market Landscape

There can never be too many treatment options in a disease like RCC. Most recently, with the combinations with immunotherapy and first-line therapy, there’s been a dramatic benefit to patients. There have also been a number of these different combinations that have been studied and shown to be effective. It has all expanded into more therapeutic options for patients. There is a renewed sense of hope and promise for patients who are diagnosed with this disease that they may have a better outcome because there are so many more options available.

Pharmacy, Medical Benefit Implications

Coverage is strong for all products in the class, with prior authorization required by most payers to ensure standard of care is followed, and products are used according to their FDA-approved label and/or follow national guidelines in cancer treatment. Oral medications are covered under the pharmacy benefit. Intravenous medications are generally covered under the medical benefit with some pharmacy coverage also seen, especially on Medicare Part D.

Key Players in Market:

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