Radar on Drug Benefits

✦ The FDA on Dec. 18 issued an emergency use authorization for Moderna, Inc.’s vaccine for preventing COVID-19, making it the second vaccine to receive an EUA. The Moderna vaccine’s EUA allows it to be distributed to people 18 and older, while the vaccine from Pfizer Inc. and BioNTech is authorized for people 16 and older. On Dec. 21, The New York Times reported that the first batches of Moderna’s vaccine began to be distributed across the country, with roughly 6 million doses expected to be shipped to 3,700 locations this week. The Moderna vaccine is a particularly welcome sight at rural hospitals, as they generally lack the ultracold equipment and staffing numbers to handle the Pfizer-BioNTech shipments, the Times noted. Both Pfizer and Moderna are testing their vaccines to see whether they work against a mutated version of the coronavirus that is causing concern in the United Kingdom and other countries because it may be more transmissible than other variants, CNN reported. Meanwhile, the European Union on Dec. 21 granted approval to the Pfizer-BioNTech vaccine, raising hopes that countries across the 27-nation bloc can begin administering the first shots to their citizens right after Christmas, according to the Associated Press. Read more at https://bit.ly/3rjlEkL, https://nyti.ms/3aA8Y2Q, https://cnn.it/2WC8EIH and https://bit.ly/2KKK9Xk.

✦ On Dec. 21, CMS finalized a rule that aims to make it easier for payers and drug manufacturers to enter into value-based purchasing (VBP) agreements for costly new therapies. The rule, which the Trump administration first proposed this summer (RDB 6/25/20, p. 1) would update Medicaid’s “best price” rules that determine how rebates are calculated in the Medicaid Drug Rebate Program, allowing drugmakers to report “varying best price points” for certain value-based arrangements and including VBP arrangements under the definition of a “bundled sale,” among other revisions. CMS also kept in a controversial provision requiring that drug manufacturers consider the value of coupon assistance in their determination of best price for Medicaid, unless they could ensure that such financial aid actually helped patients. The agency said it made the change because it is concerned that due to the rising prevalence of copay accumulator programs, the value of copay coupons is not directly benefiting patients but is instead going to health plans and PBMs. While pleased that the final rule gave stakeholders an extra year to comply with the new requirements, the HIV + Hepatitis Policy Institute still criticized the provision. “If this policy were to be implemented, drug manufacturers would be less willing to offer copay assistance to patients in the private market, all due to a Medicaid rule and damaging actions that are being taken by insurers and their PBMs,” said Carl Schmid, executive director of the group. Read the final rule at https://go.cms.gov/2WzOgYV.

In recent weeks, Prime Therapeutics LLC has entered into not one, not two, but three value-based contracts with drug manufacturers for a trio of migraine medicines. The PBM owned by 18 Blue Cross and Blue Shield plans tells AIS Health that it identified migraine treatments as a key target for value-based pacts — which tie reimbursement to outcomes and costs — because of how the market for such drugs is shaping up.

“Prime focused on the migraine class because there were new opportunities to bring value associated with both new chronic and acute migraine [drugs] to the class, more expensive than existing therapeutics,” says Kelly McGrail-Pokuta, vice president of trade relations and strategy and chief trade relations officer at Prime. “With new products there is no real-world evidence, so by implementing value-based contracts, Prime and the manufacturers are given the opportunity to look at data.”

Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders say.

Xcopri (cenobamate tablets) launched in May for the treatment of partial-onset seizures in adults. According to manufacturer SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., clinical trials have shown “significant reductions in seizure frequency compared to placebo at all doses studied, and as many as one in five patients achieved zero seizures during the maintenance phase.”

In 2020, the PBM industry continued to deepen its integration with other industry players, a trend that experts say is likely to continue in coming years. Meanwhile, PBMs faced rising regulatory scrutiny and saw their mail-order business lines experience a boom in consumer demand amid the COVID-19 pandemic.

The PBM space has consolidated to the point that five firms — UnitedHealth Group’s OptumRx, CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, Anthem Inc.’s IngenioRx, Humana Inc.’s Humana Pharmacy Solutions, and the Blue Cross and Blue Shield affiliate-owned Prime Therapeutics LLC — manage the lion’s share of the pharmacy benefits offered to U.S. health plan members. Beyond their deepening integration with the payers that own them, these firms are working to expand their data and direct-to-consumer operations.

In a unanimous, earlier-than-expected decision that surprised some observers, the U.S. Supreme Court on Dec. 10 unanimously rejected a trade group’s challenge to a 2015 Arkansas law regulating PBMs. The rule paves the way for states to continue tightening the reins on the increasingly scrutinized “middlemen” in the prescription drug supply chain, provided that such measures involve rate regulation.

The managed care industry had been closely watching the case, Rutledge v. Pharmaceutical Care Management Association (PCMA). That’s because it has implications for not only Arkansas’ Act 900 — which requires PBMs to reimburse pharmacies at no less than what pharmacies pay to acquire drugs — but also a host of other PBM-targeting measures passed by states across the country.