Radar on Drug Benefits

In a development that sparked frustration among some industry stakeholders, an agreement to pass a government spending bill that contained significant PBM reforms collapsed late last week. Congress ultimately passed a pared-down spending bill just in time to avert a government shutdown, but that left PBM critics wondering when reform policies with bipartisan backing will ever make it into law.

“Probably late Wednesday, it looked like it was in and a done deal, and then the entire package…fell apart,” lamented Joe Shields, managing director of Transparency-Rx.

Two House Republicans recently requested documents from CVS Health Corp., saying they are investigating whether the company’s Caremark PBM engaged in anticompetitive practices by barring independent pharmacies from participating in specialty pharmacy hubs, also referred to as pharmaceutical hubs. But some experts question the move, noting there is little indication that CVS is engaging in this practice.

House Judiciary Committee Chair Jim Jordan (R-Ohio) and Rep. Thomas Massie (R-Ky.) on Dec. 12 sent a letter to CVS CEO David Joyner, requesting documents and communications from Caremark to independent or specialty pharmacies related to pharmacy hubs. Jordan’s concern is that Caremark is preventing independent pharmacies from participating in “innovative” arrangements that could save money for customers, by threatening to kick pharmacies out of Caremark’s network if they participate in such an arrangement.

Most major commercial payers provided fair access to a sample of prescription medications, according to a recent review from the Institute for Clinical and Economic Review (ICER). Sarah Emond, ICER’s president and CEO, tells AIS Health that payers “should be given a lot of credit for being in line with a lot of the criteria that we’ve established.” However, she cautions it is difficult to assess how payers implement the written policies in a real-world setting.

ICER’s fourth annual “Barriers to Fair Access” report, published on Dec. 19, assessed coverage policies associated with 11 medications that the nonprofit organization evaluated for cost-effectiveness in 2022. The authors identified the 10 largest commercial payers in the U.S. and selected those insurers’ largest formularies based on the number of covered lives. They obtained the formulary data from MMIT, AIS Health’s parent company, which also provided information on coverage policies if the payer did not share them with ICER.

In its sixth annual Unsupported Price Increases (UPI) report, the Institute for Clinical and Economic Review (ICER) found that five of the top 10 drugs with substantial net price increases in 2023 did not have adequate clinical evidence to support the increases. That was the fewest number of drugs with unsupported price increases in the six years of the report and was down from eight out of 10 in last year’s report.

The other five drugs with substantial net prices did have new clinical evidence last year, which manufacturers could use to justify the net price increases. However, ICER noted it did not conduct a thorough analysis to determine whether the price increases met its strict cost-effectiveness criteria.

The FDA on Dec. 23 approved the first generic GLP-1 once-daily injectable for patients with Type 2 diabetes. The generic for Victoza (liraglutide) is particularly important because Victoza is in shortage, noted the FDA, which also approved the first generic version of twice-daily GLP-1 Byetta (exenatide) last month.  Liraglutide reduces blood sugar in patients ages 10 and older with Type 2 diabetes. On Dec. 20, the FDA also approved a new indication for another GLP-1, Zepbound (tirzepatide), for the treatment of obstructive sleep apnea in adults with obesity.

Johnson & Johnson sued The Cigna Group’s Express Scripts PBM and Accredo specialty pharmacy, accusing them of profiting from J&J’s copay assistance funds, the Wall Street Journal reported. J&J added the Cigna divisions to its original lawsuit against middleman SaveOnSP LLC, accusing all three of working together to drain J&J of $100 million more in assistance funds. According to the suit, SaveOn increased the copay amount on certain drugs, billed J&J’s copay assistance program, and pushed payments to SaveOn’s drug benefit plan, paying itself a commission. The amended lawsuit accuses Express Scripts and Accredo of working with SaveOn in this arrangement. J&J is seeking damages to be specified in court.