Radar on Drug Benefits

Seven of the 10 drugs with the highest estimated overall cost to the U.S. health care system in 2021 saw price hikes that were unsupported by new clinical evidence, according to the latest edition of the Unsupported Price Increase Report prepared by the Institute for Clinical and Economic Review (ICER). The report may be the one of the last to document business as usual for the pharmaceutical industry: Starting in 2023, as a result of this year’s Inflation Reduction Act (IRA), drug companies will face pressure from Medicare to restrict price hikes. 

The seven drugs introduced $801 million in “incremental added costs to U.S. payers in 2021,” according to the report . ICER also separately identified three Medicare Part B drugs with clinically unsupported price increases. Three of the named drugs also appeared in last year’s report: Salix Pharmaceuticals, Inc.’s Xifaxan (rifaximin); Novartis AG’s Promacta (eltrombopag); and Horizon Pharma plc’s Krystexxa (pegloticase), which was on 2021’s Part B list and 2020’s main list. 

The opioid epidemic — which by one measure peaked in 2017, when the Centers for Disease Control and Prevention (CDC) recorded 17,029 U.S. deaths involving prescription opioids — is far from over. In fact, CDC data show that deaths tied to prescription opioids, after declining in 2018 and 2019, came roaring back with the onset of the COVID-19 pandemic, and totaled 16,416 in 2020.  

As the country continues to grapple with this stubborn issue, health insurers have learned they have a role to play in helping stop would-be opioid use disorder cases where many originate: with well-meaning doctors poised to write out a prescription. One such insurer is Pittsburgh-based Highmark, which is engaged in a multiyear partnership with a company called Wayspring to track providers’ prescribing habits and reach out to educate those who appear to deviate from the CDC’s recently updated clinical practice guidelines for prescribing opioids for pain. 

The FDA on Nov. 22 approved Hemgenix (etranacogene dezaparvovec-drlb), the first gene therapy for adults with hemophilia B, a genetic bleeding disorder. CSL Behring, the medication’s commercial rights holder, set a list price of $3.5 million, making it the most expensive drug in the U.S.

That price exceeds the $2.96 million health benefit price threshold (HBPB) that the nonprofit Institute for Clinical and Economic Review (ICER) determined recently in an evidence report, meaning it is not fairly priced according to the nonprofit’s guidelines.

Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s most powerful lobbying group, has commissioned a major lobbying firm to review its failure to kill Medicare drug price negotiation, among other drug price reforms included in August’s landmark Inflation Reduction Act (IRA), Politico reported. The lobbying firm, BGR Group, will place its chairman and CEO, former HHS aide Bob Wood, in charge of the review. “Like most organizations, it’s our standard operating procedure to do an after-action review following a large-scale, organization-wide advocacy effort,” PhRMA spokesperson Brian Newell told Politico. 

Meanwhile, the Association for Accessible Medicines (AAM), a pharma lobbying group that represents generics manufacturers, is in the middle of leadership turmoil, according to STAT. AAM fired its president, Dan Leonard, and will replace him with the group’s current executive vice president of sciences and regulatory affairs, David Gaugh. Leonard denied he was fired, but anonymous sources told STAT that his ouster was also related to the passage of the IRA. 

The copay accumulator bans passed in 15 states affect about 15 million people, or 11% of U.S. commercial plan members, according to research by consulting firm Avalere Health. Experts say the drug manufacturer-backed bans pick winners between payers and patients, but don't come close to solving the persistent problem of sky-high prices for life-saving drugs. 

Copay accumulators are the practice, implemented by PBMs, of preventing the value of copay assistance programs from counting toward a plan member's deductible and out-of-pocket maximum calculation. A related practice, copay maximizers, spreads out the value of a copay coupon over 12 months while also preventing that coupon from counting toward a patient’s deductible/out-of-pocket maximum. Fifteen states and Puerto Rico have banned these practices in fully funded plans, which states can regulate — self-insured plans, since they are regulated by the Employee Retirement Income Security Act, are not included.