Radar on Drug Benefits

Editor’s Note: A quotation from Philip Ball has been updated to clarify that he was describing drug manufacturers’ criticisms of ICER, not his own.

As states continue their quest to lower prescription drug prices for the benefit of their budgets and residents, a small but growing number are considering legislation that would levy an 80% tax on drug price increases that the Institute for Clinical Effectiveness Research (ICER) deems “unsupported” by clinical evidence.

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders say.

In fact, a newly approved expanded indication for Entresto, plus more products recently approved and in the pipeline, could shift the balance more toward brand-name drugs in heart failure treatment, the insiders say.

Hospital groups are lobbying regulators at the federal and state levels to restrict the practice of “white bagging” in physician-administered specialty pharmacy dispensing. Practitioners and pharmacists argue that the practice, which is driven by vertically integrated insurer-PBM-specialty pharmacy combinations like UnitedHealth Group’s Optum and Anthem, Inc.’s IngenioRx, is a danger to patients with severe conditions, but it’s not clear whether regulators have the ability to block the practice.

The American Hospital Association (AHA) on Feb. 4 sent a letter to CMS asking the agency to review UnitedHealth’s “specialty pharmacy coverage policies” and specifically called out “certain white bagging,” arguing that the practice degrades quality of care, disrupts the 340B Drug Pricing Program and could even be a danger to patients. Meanwhile, in connection with a Feb. 18 meeting of the California State Board of Pharmacy, several provider groups called for the board to stop white bagging. The meeting was billed as “informational” on the board’s website, so it is unlikely to result in immediate action.

✦ Humana Inc. and its PBM and pharmacy subsidiaries, alongside Roche Diagnostics Corp. and Roche Diabetes Care, Inc., agreed to pay $12.5 million to settle a lawsuit that claimed they engaged in fraud and illegal kickbacks. The settlement, unveiled on Feb. 8, resolves a whistleblower’s allegations that Roche forgave millions of dollars’ worth of debt from Humana in exchange for the insurer purchasing Roche’s diabetes testing supplies and favoring them in its Medicare Advantage plan formularies. Read more at https://bit.ly/3jBVTIU.

✦ Included in House Democrats’ evolving budget-reconciliation bill for COVID-19 relief is a provision that would lift the cap on rebates in the Medicaid Drug Rebate Program. Currently, that cap is set at 100% of a drug’s Average Manufacturer Price, and proposals to increase or eliminate the cap would “generate savings for the program and lower revenues for drug manufacturers,” according to a Kaiser Family Foundation issue brief. The provision in House Democrats’ COVID-relief bill is slated to go into effect in 2023 if it makes it into the final version of the legislation. View the provision at https://bit.ly/3a8tmrb.

Humana Inc. entered an agreement with Cigna Corp. to join a group purchasing organization (GPO) for prescription drugs called Ascent Health Services, a Switzerland-based subsidiary of Cigna’s Express Scripts PBM. Humana representatives said the move would give the insurer more clout in negotiations with pharmaceutical manufacturers, but critics of the accelerating GPO trend (RDB 8/13/20, p. 1) say that the agreements are a way for carriers and PBMs to capture rebate revenue that should flow to plan sponsors by increasing pricing opacity and complexity.

“This arrangement will help us leverage scale and buying power to extract deeper price discounts from drug manufacturers and advance affordability for our customers while at the same time preserve our ability to address their specific clinical needs,” a Humana spokesperson told AIS Health via email. The agreement only applies to Humana’s commercial group plan members, which comprise a small percentage of the Medicare-focused insurer’s total covered lives.