Following an Oct. 6 Supreme Court hearing, legal experts tell AIS Health that PBMs appear to have a good shot at prevailing in their challenge of a 2015 Arkansas law, which has major implications for how both health and drug benefits are regulated.
The case, Rutledge v. Pharmaceutical Care Management Association (PCMA), centers on a law known as Act 900 that aimed to protect independent pharmacies from what Arkansas Attorney General Leslie Rutledge calls the “abusive payment practices” of PBMs. Chiefly at issue is whether Arkansas can force PBMs to reimburse pharmacies for the price of any given drug set by the pharmacy’s wholesaler, even if that amount is higher than the maximum allowable cost (MAC) set by a PBM.
✦ Highmark Inc. said on Sept. 21 that it entered into an outcomes-based payment agreement with AstraZeneca PLC for Fasenra (benralizumab), which is an add-on treatment for patients age 12 and older with severe asthma. The agreement will hold AstraZeneca accountable for the clinical effectiveness of Fasenra when used by Highmark’s commercial and Medicare members. Previously, the insurer and drugmaker collaborated on an outcomes-based agreement for the asthma and chronic obstructive pulmonary disease drug Symbicort (budesonide/formoterol fumarate dihydrate), “one of the first outcomes-based agreements in the U.S. for the treatment of those chronic respiratory conditions.” Read more at https://bit.ly/2ROxyCA.
✦ Cigna Corp. on Sept. 16 said that it is rebranding its health services portfolio — which includes its PBM and specialty pharmacy businesses — as Evernorth. Tim Wentworth, who was the CEO of Express Scripts before Cigna acquired it, will be the CEO of the rebranded division. Cigna also unveiled new products that Evernorth will offer, including a “comprehensive fertility solution” called FamilyPath and Healthy Ways to Work, a suite of solutions that aims to help health plans and employees address challenges tied to COVID-19. Read more at https://bit.ly/3ks2vZD.
Over the past six months, the pharmaceutical industry spent more than $156 million on lobbying even as drugmakers have been racing to produce coronavirus vaccines and treatments. The Pharmaceutical Research and Manufacturers of America (PhRMA) spent $14.43 million in the first half of 2020, according to the U.S. Senate Lobbying Disclosure Act Database. Lobbying expenditures from Gilead Sciences jumped by 26%, going from $2.94 million in the first half of 2019 to $3.71 million over the same period in 2020. Meanwhile, drugmakers have distributed thousands of checks to lawmakers ahead of this year’s election, according to a recent Stat analysis. The industry has traditionally supported Republican candidates, and it donated nearly $200,000 to Senate Majority Leader Mitch McConnell (R-Ky.) this year. Among the 14 lawmakers who’ve received more than $100,000 from the industry in 2020, 11 are Republican lawmakers and six are senators up for reelection.
During a Sept. 17 virtual session of the America’s Health Insurance Plans (AHIP) National Conference on Medicare, Medicaid & Dual Eligibles, health insurance industry leaders were cautiously optimistic about the impact of CMS’s recent proposed rule seeking to promote value-based purchasing (VBP) for prescription drugs, despite mixed reviews from some industry stakeholders (RDB 7/9/20, p. 1).
In the regulation, which was proposed this summer, CMS outlined an updated interpretation of Medicaid “best price” rules — which dictate how rebates are calculated in the Medicaid Drug Rebate Program — by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes (RDB 6/5/20 p. 1).
This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments.
Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.
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