Radar on Drug Benefits

  • Aduhelm Approval Prompts Backlash, Could Bring Investigation

    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.)

  • News Briefs

     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.

  • Generic Drug Prices Vary Significantly Across Hospitals

    In an effort to increase transparency, CMS now requires hospitals to provide pricing information for all medications and services. A recent GoodRx analysis of 12 common generic medications in 16 hospitals found that hospital chargemaster prices of generic drugs are higher than the average retail price at pharmacies and vary markedly from hospital to hospital. For instance, one 50 mg tablet of sertraline (generic for depression and anxiety drug Zoloft) costs $57 a pill at Sunrise Hospital in Las Vegas but just 50 cents a pill in Camden Clark Memorial Hospital in West Virginia. In addition, among the 16 hospitals GoodRx analyzed, only six fully complied with CMS price transparency mandates.
  • Prime Therapeutics Rolls Out New Medical Benefit Offering

    An earlier version of this story incorrectly said that per Prime Therapeutics LLC’s recommendation, one health plan shifted to oncology biosimilars from the reference drugs and realized hundreds of millions of dollars in savings. The plan realized millions in savings. This version has been corrected.

    As payers continue to look for ways to tackle the rising spending on specialty drugs, Prime Therapeutics LLC is launching a medical drug management program. Known as MedDrive, the offering will be rolled out in phases, with the initial one focused on increasing the use of biosimilars.

  • Cell/Gene Therapy Pay Models Face Reporting, Policy Barriers

    Emerging cell and gene therapy oncology treatments are well suited to value-based payment arrangements, but new contracting models must be able to contend with a complex regulatory and financial environment, experts say.

    A new generation of oncology treatments that can cure specific cancers offer a potential breakthrough. Patients who would have had to struggle through chemotherapy and still faced long odds now have the chance to make a significant recovery with one or two rounds of treatment. However, these treatments are extraordinarily expensive — some can cost tens of thousands of dollars for a single course of treatment.

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