✦ 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.