A review of market access for hepatocellular carcinoma treatments shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions. About 13% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 78% of the lives under commercial policies are covered with utilization management restrictions. Almost 68% of the lives under Medicare Part B 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, 28% require multiple steps. Around 80% of payer-controlled pharmacy benefit covered lives require prior authorization, with only 1% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In March 2021, the FDA approved Boston Scientific Corp.’s TheraSphere Y-90 Glass Microspheres for local tumor control of solitary tumors (1-8 cm in diameter), in patients with unresectable hepatocellular carcinoma, Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion and good performance status. The selective internal radiation therapy previously was available via a humanitarian device exemption.
In August 2021, Bristol Myers Squibb said it will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. The move follows an April meeting of the agency’s Oncologic Drugs Advisory Committee to discuss whether to keep certain indications for a handful of checkpoint inhibitors that target programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) and received accelerated approval but had not met post-marketing requirements demonstrating confirmatory benefit. Opdivo received a negative vote for this indication, as did Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy. Merck said recently that it would voluntarily withdraw that indication in the U.S.
The FDA’s Oncologic Drugs Advisory Committee voted to keep most indications for a handful of immune checkpoint inhibitors that target programmed death-1/programmed death ligand-1 (PD-1/PD-L1) and received accelerated approval pending further clinical trial data (RSP 4/21, p. 1). Receiving “yes” votes were Tecentriq (atezolizumab) from Roche subsidiary Genentech USA, Inc. for certain triple-negative breast cancers and urothelial carcinomas and Merck & Co., Inc.’s Keytruda (pembrolizumab) for certain urothelial carcinomas and hepatocellular carcinomas. Keytruda received a negative vote for certain gastric cancers and Bristol Myers Squibb’s Opdivo (nivolumab) did also for certain hepatocellular carcinomas.
Market Events Drive Changes
In August 2021, Bristol Myers Squibb said it will voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib. In May 2020, the FDA expanded the indication for Roche Group unit Genentech USA, Inc.’s Tecentriq (atezolizumab) in combination with bevacizumab for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Pharmacy, Medical Benefit Implications
Coverage is good for products indicated for hepatocellular carcinoma. Exelixis, Inc.’s Cabometyx (cabozantinib), Bayer’s Nexavar (sorafenib) and Stivarga (regorafenib), and Eisai Inc.’s Lenvima (lenvatinib) are covered under the pharmacy benefit only. Most payers have written policies for these products for both approved and off-label indications. Policies are generally written to label or to National Comprehensive Cancer Network (NCCN) guidelines.
Key Players in Market: