A review of market access for hepatocellular carcinoma treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions. About 46% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 63% 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 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 23% 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 October 2022, the FDA approved AstraZeneca Pharmaceuticals’ Imjudo (tremelimumab) in combination with the company’s Imfinzi (durvalumab) for adults with unresectable hepatocellular carcinoma. Dosing for people weighing at least 30 kg is 300 mg of Imjudo, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, via intravenous infusion plus 1,500 mg of Imfinzi, a programmed death-ligand 1 (PD-L1) inhibitor, also via intravenous infusion at cycle one/day one and then Imfinzi as a single agent every four weeks. For those weighing less than 30 kg, dosing is 4 mg/kg of Imjudo plus 20 mg/kg of Imfinzi at cycle one/day one and then Imfinzi every four weeks.
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.
Market Events Drive Changes
In October 2022, the FDA approved AstraZeneca Pharmaceuticals’ Imjudo (tremelimumab) in combination with the company’s Imfinzi (durvalumab) for adults with unresectable hepatocellular carcinoma. In August 2021, Bristol Myers Squibb said it would voluntarily withdraw the U.S. indication for Opdivo (nivolumab) as a monotherapy for people with hepatocellular carcinoma who previously were treated with sorafenib.
Competitive Market Landscape
This will be a very crowded class in the coming years. More bevacizumab biosimilars and several programmed death-ligand 1 (PD-L1) therapies are in line for approval.
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: