A review of market access for kidney cancer treatments shows that under the pharmacy benefit, about 50% of the lives under commercial formularies are covered with utilization management restrictions. Around 35% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 67% 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 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 12% 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.
Celltrion Healthcare Co. launched Vegzelma (bevacizumab-adcd), the company said on April 17, 2023. The FDA approved the injectable last September for multiple types of cancer, including metastatic renal cell carcinoma in combination with interferon alfa. It is the fourth FDA-approved biosimilar of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group, to launch in the U.S. While the company has partnered with other companies in marketing biosimilars in the U.S., its Celltrion USA unit is taking full responsibility for this launch.
Amneal Pharmaceuticals, Inc. launched Alymsys (bevacizumab-maly), the company said Oct. 3, 2003. The FDA approved the biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) on April 13 for multiple indications, including metastatic renal cell carcinoma in combination with interferon alfa. It is the third biosimilar of the vascular endothelial growth factor to launch onto the U.S. market.
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.
Market Events Drive Changes
In 2022, the FDA approved the third and fourth biosimilars of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group. In September, the agency approved Celltrion USA’s Vegzelma (bevacizumab-adcd) for the treatment of multiple indications, including metastatic renal cell carcinoma (RCC) in combination with interferon alfa. And in April, 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 & Co., Inc.’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: