Market access

COVID-19 vaccines are likely to cost payers billions on an annual basis, according to a new analysis based on publicly disclosed vaccine price projections by executives from Pfizer Inc. and Moderna Inc. Despite criticism from some progressive members of Congress, who say the vaccines will be priced too high, one vaccine expert tells AIS Health, a division of MMIT, that per-dose costs aren’t out of line with typical vaccine prices for adults.

The federal government initially bought COVID vaccines, using its purchasing power to accelerate research and development. COVID vaccines were developed in record time, and federal purchasing helped manufacturers hit remarkable earnings figures. However, despite requests from the Biden administration for more funds to purchase future COVID vaccines, Congress seems unlikely to pay for more. Federal vaccination funds and vaccine stockpiles are likely to run out sometime in 2023.

AbbVie Inc. is leaving several lobbying organizations, including the Pharmaceutical Research and Manufacturers of America (PhRMA), widely regarded as the most powerful drug industry trade group, according to Politico. PhRMA has had a tough year. In August, the trade group faced its most notable political failure in a generation when Democrats passed Medicare drug price negotiation as part of the Inflation Reduction Act. In the months since, PhRMA has launched an internal review of that episode and has dismissed several of its most prominent executives.

Amgen Inc. plans to acquire Horizon Therapeutics plc. for $27.8 billion, or $116.50 per share, according to regulatory filings; the deal is the largest health care merger of the year, per the Wall Street Journal. Horizon develops specialty drugs for autoimmune and inflammatory diseases. The firm’s best-seller is Tepezza (teprotumumab-trbw), a treatment for thyroid eye disease. If, as expected, Tepezza earns approval in the European Union and Japan, Horizon projects $4 billion in global annual revenue from the drug.

A review of market access for nonmetastatic prostate cancer treatments shows that under the pharmacy benefit, about 51% of the lives under commercial formularies are covered with utilization management restrictions. Around 36% of the lives under Medicare formularies are not covered for at least one of the drugs.

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.

As multiple biosimilars to AbbVie’s Humira (adalimumab) are set to hit the market in 2023, two of the largest pharmacy benefit managers (PBMs) in recent weeks made favorable coverage decisions for the soon-to-debut drugs. The FDA has approved seven Humira biosimilars so far, with Amgen’s Amjevita set to launch first, in January 2023. Bloomberg on Nov. 15 reported Optum Rx will cover up to three of the new biosimilars on the same tier as Humira on its 2023 formularies, while Cigna Corp.’s Express Scripts on Dec. 5 said it will cover the biosimilars as preferred products on its “largest formularies.” The PBM said it will “continue to evaluate all biosimilar products to Humira….and will provide updates related to specific changes as available.” Combined, the two PBMs and their corresponding payer units cover nearly 15 million people on their Medicare formularies, according to data from MMIT Analytics (MMIT is the parent company of AIS Health). Most people (86%) covered under Medicare formularies have access to Humira on the specialty tier, with utilization management restrictions such as step therapy and prior authorization.

A review of market access for ovarian cancer treatments shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 20% of the lives under Medicare formularies are not covered for at least one of the drugs.

Seven of the 10 drugs with the highest estimated overall cost to the U.S. health care system in 2021 saw price hikes that were unsupported by new clinical evidence, according to the latest edition of the Unsupported Price Increase Report prepared by the Institute for Clinical and Economic Review (ICER). The report may be the one of the last to document business as usual for the pharmaceutical industry: Starting in 2023, as a result of this year’s Inflation Reduction Act (IRA), drug companies will face pressure from Medicare to restrict price hikes.

The seven drugs introduced $801 million in “incremental added costs to U.S. payers in 2021,” according to the report . ICER also separately identified three Medicare Part B drugs with clinically unsupported price increases. Three of the named drugs also appeared in last year’s report: Salix Pharmaceuticals, Inc.’s Xifaxan (rifaximin); Novartis AG’s Promacta (eltrombopag); and Horizon Pharma plc’s Krystexxa (pegloticase), which was on 2021’s Part B list and 2020’s main list.

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.

Two newcomers in the pharmacy space are teaming up to offer what they describe as a “first-of-its-kind supplemental drug discount product” aimed at helping self-funded employers winnow down their drug costs. The product — EmsanaRx Plus — is the result of a collaboration between the Mark Cuban Cost Plus Drugs Company and EmsanaRx, a not-for-profit PBM owned by the Purchaser Business Group on Health (PBGH). Yet industry observers tell AIS Health, a division of MMIT, that they’re skeptical about how disruptive the new product will truly be.

“Whether EmsanaRx Plus, integrating Cost Plus Drugs, fills an unmet need in the market will depend on how Cost Plus Drugs is integrated into the self-insured employer's benefit design,” suggests Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.

A review of market access for follicular lymphoma treatments shows that under the pharmacy benefit, about 44% of the lives under commercial formularies are covered with utilization management restrictions. Around 37% of the lives under Medicare formularies are not covered for at least one of the drugs.