Radar on Drug Benefits

COVID-19 presented the health care system with many challenges in 2020, but one of the most sobering was the impact on opioid misuse.

The Centers for Disease Control and Prevention (CDC) said earlier this month that more than 93,000 Americans died from a drug overdose in 2020. This represents a 29% increase compared to 2019. Only two states, New Hampshire and South Dakota, reported a decrease in drug overdose deaths.

Medicare spent $2.6 billion more on 184 most common generic drugs compared with Costco member prices for the same prescriptions in 2018, according to a recent research letter published in JAMA Internal Medicine. By analyzing more than 1.4 billion Part D claims, researchers estimated that Medicare spent 13.2% more in 2017 and 20.6% more in 2018 than Costco members paid for 30-day and 90-day prescription fills. In 2018, Medicare spending exceeded the Costco member price on 43.2% of all 30-day and 90-day fills of the generic drugs studied.

Even as Congress inches closer to passing the largest individual spending bill in U.S. history through budget reconciliation, health care insiders are still uncertain what drug pricing measures could make their way through both chambers. However, D.C. insiders say that some combination of Medicare Part D out-of-pocket spending caps, Medicare drug price negotiation, caps on launch prices and/or price growth, and PBM reform are all possible — though policies will have to make their way through the twin gauntlets of the preferences of Senate committees and the rules requirements of budget reconciliation.

Consideration of drug pricing measures has moved to the Senate. Insiders expect H.R. 3, the law introduced by Speaker Nancy Pelosi (D-Calif.), has the votes to make it out of the lower chamber. However, few expect that the bill would make it through the Senate intact. H.R. 3, titled the Lower Drug Costs Now Act, caps Part D out-of-pocket costs, allows Medicare to negotiate drug prices and bans the price of drugs from increasing faster than the annual rate of inflation. Some — but not all — of those provisions could clear the Senate.

Aduhelm (aducanumab), the Biogen Inc. Alzheimer’s drug recently approved by the FDA, seems less and less likely to be dispensed to patients, as prominent providers, practitioner groups and experts have all publicly argued against doing so. Several health insurers have said they will not pay for the drug unless patients pass strict prior authorization standards — and the FDA approval itself could be in jeopardy as the agency’s acting commissioner has called for the HHS Office of Inspector General (OIG) to investigate the process that led to the approval.

FDA Acting Commissioner Janet Woodcock, M.D., on July 9 asked the OIG to investigate the approval process for Aduhelm. (Woodcock was not involved in the decision to approve the drug.)

✦ Eli Lilly & Co. is making a direct equity investment in MiNA Therapeutics Limited, a company that describes itself as “the pioneer in small activating RNA therapeutics.” Lilly’s investment of $15 million comes roughly two months after the companies agreed to work together on developing novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform. The smaller firm said it will use the proceeds from Lilly’s investment to advance and expand its internal pipeline of saRNA therapeutics, “which is initially focused on immuno-oncology and genetic diseases.”

✦ CureVac N.V. revealed the results of a Phase 2b/3 study of its coronavirus vaccine candidate, saying it demonstrated an overall efficacy of 48% against COVID-19 of any severity. That falls short of the 50% efficacy threshold set by the World Health Organization “to ensure that a widely deployed COVID-19 vaccine is effective,” although the German biopharmaceutical firm emphasized that the vaccine was 53% effective in the 18 to 60 age group against disease of any severity and across all 15 identified strains. The vaccine was 77% effective against moderate to severe disease for that age group and provided 100% protection against hospitalization and death in that cohort.