Pharmacy Briefing: February 2021

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
  • Consolidated Appropriations Act signed into law
  • CMS Office of the Actuary releases 2019 National Health Expenditures
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • FDA extends review period for investigational Alzheimer’s drug aducanumab
FDA Approvals and Launches
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • Vocabria (cabotegravir) is approved as one component of a precursor to HIV treatment with Cabenuva (cabotegravir/rilpivirine).
  • Generic version of Glucagon Emergency Kit for Low Blood Sugar is approved to treat cases of severe hypoglycemia in diabetics.
  • Lupkynis (voclosporin) is approved for the treatment of lupus nephritis.
  • Verquvo (vericiguat) is approved for the treatment of heart failure.
News

Consolidated Appropriations Act signed into law

  • The act includes a wide range of provisions regarding COVID-19, medical billing, and pricing transparency, among others.
  • Plans will be required to submit specified pharmacy claims metrics to the federal government on an annual basis.
    • This data collection provision will be used by the government to produce drug pricing trend reports.

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CMS Office of the Actuary releases 2019 National Health Expenditures

  • Retail prescription drug spending grew 5.7% in 2019 compared to 3.8% in 2018.
  • The increased growth rate was driven by an increase in utilization rather than price; retail drug prices declined by 0.4%.

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FDA extends review period for investigational Alzheimer’s drug aducanumab

  • The new action date was extended from March 7 to June 7 to allow for additional review of clinical data.

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Senate Finance Committee releases investigative report on insulin prices

  • The report describes how the relationship among list prices, rebates, and formulary placement has led to increased prices for plan sponsors and consumers.
  • Report authors found that manufacturers also employed “shadow pricing,” a tactic that the report describes as “price increases on related brands of aging products from competing companies that often seem to move in synchronized fashion.”

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Department of Health and Human Services funds report comparing drug prices in the United States with those found internationally

  • After adjusting prices to account for rebates, the authors estimated that U.S. prices were 90% higher than prices found in other countries.

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Maryland State Senate rejects governor’s veto of prescription drug affordability board

  • The drug affordability board was created to help the state create regulations that would attempt to make prescription drugs more affordable by using strategies such as setting payment limits for government payers.

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Consulting firm McKinsey reaches $573 million settlement regarding its role in opioid crisis

  • The firm worked closely with Purdue Pharma, the manufacturer of Oxycontin (oxycodone) extended-release tablets.

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Companies pledge to pay employees for getting the COVID-19 vaccine

  • Companies such as Trader Joe’s, Aldi, and Dollar General will pay employees extra hourly wages as an incentive to get vaccinated but will not make the vaccine mandatory.

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Entrepreneur Mark Cuban launches generic drug company

  • The company’s first drug is antiparasitic drug albendazole but plans to offer over 100 additional drugs by the end of 2021.

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Clinical Trials

Skyrizi (risankizumab) outperforms placebo in phase 3 psoriatic arthritis trial

  • The auto-immune drug is currently only indicated for the treatment of plaque psoriasis.
  • Skyrizi (risankizumab) is considered a successor to Humira (adalimumab) and is currently being studied for the treatment of many overlapping indications.

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