Pharmacy Briefing: June 2020

Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.

Highlights

  • CVS Health publishes 2019 Drug Trend Report
  • Navitus publishes 2019 Drug Trend Report
  • IQVIA publishes weekly report describing the impact of COVID-19 on the pharmaceutical market

FDA Approvals and Launches

  • Darzalex FasPro is approved as a subcutaneous version of Darzalex (daratumumab), a drug used to treat multiple myeloma.
  • Farxiga (dapagliflozin) receives additional indication to treat patients with certain types of heart failure.
  • A generic version of cholesterol drug Vascepa (icosapent ethyl) receives FDA approval.
  • Vesicare LS (solifenacin) is approved to treat bladder dysfunction in patients as young as 2 years of age.
  • Oriahnn (elagolix/estradiol/norethindrone acetate) is approved to treat heavy menstrual bleeding associated with uterine fibroids.

News

CVS Health publishes 2019 Drug Trend Report

  • The PBM reported, net of rebates, a 1.4% overall trend in 2019, despite a specialty trend of 9.3%.

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Navitus publishes 2019 Drug Trend Report

  • The PBM reported a “net cost per member per month (PMPM) of $78.12 in 2019, which is 16% lower than the forecasted industry average of $93.11 PMPM.”
  • Specialty trend increased 13.1%, with the highest proportion of spend being attributed to analgesic and anti-inflammatory specialty drugs.

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IQVIA publishes weekly report describing the impact of COVID-19 on the pharmaceutical market

  • The report provides timelines of major events and government actions, retail pharmacy initiatives, summaries of commercial payer policies, prescription trends, and many other data points.

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FDA discovers carcinogen impurities in some versions of extended-release metformin, a widely-used diabetes drug

  • The agency has recommended voluntary recalls of the products from five manufacturers.

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AmerisourceBergen publishes Biosimilars Pipeline Report

  • The report summarizes currently available, approved, and in-development biosimilar products, grouped by therapeutic class.

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The Coronavirus Aid, Relief, and Economic Security (CARES) Act temporarily suspends sequestration for Retiree Drug Subsidy Program (RDS)

  • Between May 1, 2020, and December 31, 2020, the 2% mandatory payment reduction in the calculated Subsidy Amount will be suspended.

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CMS finalizing policy permitting manufacturer discount programs to contribute toward annual cost-sharing limits for Patient Protection and Affordable Care Act (ACA) plans

  • Discount programs are permitted, by not required, to be counted toward these limits.

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Generic manufacturer Apotex admits to price fixing, pays penalty of $24.1 million

  • Price fixing occurred from May 2013 to at least December 2015 and involved the sale of the cholesterol drug pravastatin.

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Clinical Trials and Research

Mavacamten achieves all primary and secondary endpoints in phase 3 EXPLORER trial

  • The drug is being studied as a treatment for obstructive hypertrophic cardiomyopathy, a genetic heart condition.
  • A New Drug Application is expected to be submitted to the FDA in the first quarter of 2021.

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Ozempic (semaglutide) demonstrates sustained weight loss compared to placebo in phase 3 trial

  • The drug is currently approved for the treatment of type 2 diabetes and may also provide benefits in preventing and mitigating the health consequences associated with obesity.

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Retrospective study links poorly controlled blood glucose with increased COVID-19 mortality

  • Researchers observed a 10 times greater chance of death among type 2 diabetes patients with COVID-19 and poorly controlled blood glucose. 

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