Pharmacy Briefing: March 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

  • Express Scripts publishes “2019 Drug Trend Report”
  • FDA issues 2019 Novel Coronavirus (COVID-19) statement, warns of potential supply chain disruptions
  • Clarivate identifies 11 potential blockbuster drugs in 2020 edition of “Drugs to Watch” list 
  • OptumRx publishes “Drug Pipeline Insights Report”
  • Four indicted in prescription scam involving compounding pharmacy and physicians

FDA Approvals and Launches

  • A generic version of ProAir HFA (albuterol sulfate), one of the most commonly prescribed asthma inhalers, is approved.
  • Nexletol (bempedoic acid), a once-daily oral medication, is approved to treat high cholesterol as a secondary option to statin therapy.
  • Voltaren (diclofenac gel) and Pataday (olopatadine ophthalmic solution) are approved for over-the-counter (OTC) use for pain/inflammation and allergic conjunctivitis, respectively.
  • Pizensy (lactitol) is approved for the treatment of chronic idiopathic constipation.
  • Twirla (levonorgestrel/ethinyl estradiol) transdermal patch is approved for use as once-weekly contraceptive.
  • Trulicity (dulaglutide) receives additional indication to reduce cardiovascular events in patients with type 2 diabetes with or without established cardiovascular disease.
  • Nurtec ODT (rimegepant) orally disintegrating tablets are approved for the acute treatment of migraines.

News

Express Scripts (ESI) publishes 2019 Drug Trend Report

  • ESI reports a 2.3% drug trend across its commercial line of business, driven by a 1.4% increase in utilization and a 0.9% rise in unit cost.

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FDA issues 2019 Novel Coronavirus (COVID-19) statement, warns of potential supply chain disruptions

  • The statement notes that “…the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.”

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Clarivate identifies 11 potential blockbuster drugs in 2020 edition of Cortellis “Drugs to Watch” list 

  • The 11 drugs identified in the report are predicted to reach $1 billion in sales by 2024.
  • Drugs on the list include Rybelsus (oral semaglutide), investigational cholesterol drug inclisiran, and Valrox (valoctocogene roxaparvovec), a drug expected to launch with a $2 million to $3 million list price.

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OptumRx publishes “Drug Pipeline Insights Report”

  • Highlights from the report include:
    • Nexletol (bempedoic acid), a novel first in-class drug for treating high cholesterol, may be favored over PCSK9 inhibitors due to its patient-friendly oral dosage form.
    • Palforzia (referenced by its investigational drug name AR-101) is the first oral immunotherapy approved to reduce allergic reactions caused by peanut exposure.
    • Obeticholic acid is poised to be the first treatment for nonalcoholic steatohepatitis (NASH), an increasingly common liver condition.

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OptumRx analysis explores the future implications of nonalcoholic steatohepatitis (NASH) treatment

  • Projections of drug sales associated with NASH treatment vary widely due to difficulties in estimating the potential market.
  • FDA approval of obeticholic acid may occur as early as Q2 2020.

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Four indicted in prescription scam involving compounding pharmacy and physicians

  • Millions of dollars were allegedly generated through fraudulent prescriptions for medically unnecessary compound cream medications.
  • The scheme is estimated to have cost the government’s TRICARE program and a labor union health plan over $22 million.

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Treatment Guidelines

JAMA study suggests that switching from extended-release drug formulations to immediate-release drug formulations can be an option that reduces healthcare spending

  • The study authors noted that most extended-release drugs have not consistently shown therapeutic or adherence superiority.
  • The study identified 67 drugs with extended-release formulations that had generic, immediate-release counterparts.

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