Radar on Drug Benefits

✦ HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

✦ The White House, HHS and the FDA on June 8 released a report containing several policy recommendations to address “vulnerabilities in U.S. pharmaceutical supply chains” that the COVID-19 pandemic revealed. For its part, HHS will make an initial commitment of about $60 million, sourced from the Defense Production Act appropriation in the American Rescue Plan, “to develop novel platform technologies to increase domestic manufacturing capacity for API [active pharmaceutical ingredients].” The report’s overall policy recommendations, meanwhile, are based on four main themes: boosting local production and fostering international cooperation; promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience; creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and leveraging data to improve supply chain resilience.

Spurred by CMS’s decision to cover chimeric antigen receptor T-cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up, experts say.

“Despite the costs of CAR-T, I know many plans were already looking at providing coverage prior to the CMS decision,” which was released in October 2019, says Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue. “CMS’s decision provided confirmation that they were on the right track,” he tells AIS Health, a division of MMIT.

Amazon.com, Inc. launched a long-anticipated expansion of its pharmacy business on June 8, saying it will allow Prime members to purchase up to six-month supplies of generic prescription drugs for $6. Experts say Amazon is well positioned to claim substantial market share in the growing prescription drug delivery market, which incumbent players have already begun to target.

Industry watchers have argued over the notion that the web retailer would make a disruptive move into the pharmacy space ever since Amazon acquired PillPack in 2018. Experts tell AIS Health that Amazon’s well-developed logistics and internet retail abilities mean it will be a formidable player.

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

Alzheimer’s, which affects more than 6 million Americans and tens of millions of people worldwide, is marked by progressive cognitive and functional decline that eventually results in death. It kills more people than breast and prostate cancers combined and, along with other forms of dementia, is expected to cost the U.S. $355 billion this year alone, according to the Alzheimer’s Association.

✦ In a proposed rule issued on May 26, CMS delayed for six months a provision in a Trump administration-era rule that would have required drug manufacturers to report multiple Medicaid “best prices” connected to a value-based purchasing arrangement. The rule, finalized on Dec. 31, 2020, altered 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 models including year-to-year scheduled prices that could change in relation to patient outcomes.

✦ Thousands of health plans that sought to make their lawsuits against Cigna Corp. into a class action were stymied by a federal judge on May 20, according to a Modern Healthcare article. The self-funded health plans alleged that Cigna overcharged their members for prescription drugs by secretly clawing back the difference when a given drug costs less than a patient’s copayment amount and prohibiting pharmacists from telling patients their drugs could cost less without insurance. U.S. District Judge Jeffery Alker Meyer said plan contracts varied too widely for a class-wide ruling.