Pharmacy Briefing: August 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

  • President Trump signs Executive Orders addressing drug pricing
  • Supreme Court decision allows employers to opt out of contraceptive coverage mandated by the Patient Protection and Affordable Care Act (ACA)
  • EvaluatePharma publishes annual World Preview report with insights into the pharmaceutical industry
  • Novartis to pay over $642 million to settle investigations into kickback payments
  • Ohio sues Express Scripts for contract breaches with Ohio Highway Patrol Retirement System

FDA Approvals and Launches

  • Rukobia (fostemsavir) is approved to treat multi-drug resistant forms of HIV.
  • Tremfya (guselkumab), currently approved to treat plaque psoriasis, receives additional indication to treat active psoriatic arthritis.
  • Xywav (calcium, magnesium, potassium, and sodium oxybates) is approved to treat symptoms of narcolepsy.
    • The drug is a low-sodium version of Xyrem (sodium oxybate).
  • Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is approved to treat chronic obstructive pulmonary disease (COPD).

News

President Trump signs Executive Orders addressing drug pricing

  • The orders cover 340B discounts for insulin and epinephrine auto-injectors, an importation plan for drugs, “most favored nation” pricing, and pharmacy benefit manager (PBM) rebates under Medicare Part D programs.

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Supreme Court decision allows employers to opt out of ACA-mandated contraceptive coverage

  • The ruling clears the way for employers to opt out of the ACA mandate under religious or moral objections. However, future challenges to the ruling are expected.

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EvaluatePharma publishes annual World Preview report with insights into the pharmaceutical industry

  • Tirzepatide, a diabetes therapy, was considered the investigational drug with the most financial potential for its manufacturer.
  • Keytruda (pembrolizumab), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), and Eliquis (apixaban) are projected to be the three top selling products in the United States in 2026.
    • These products treat cancer, HIV, and blood clotting disorders, respectively.

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Novartis to pay over $642 million to settle investigations into kickback payments

  • Drugs identified in the lawsuits include Gilenya (fingolimod), Afinitor (everolimus), Lotrel (amlodipines/benazepril), Tekturna (aliskiren), Diovan (valsartan), and Exforge (amlodipine/valsartan).

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Ohio Attorney General files lawsuit suing Express Scripts for contract breaches with Ohio Highway Patrol Retirement System

  • The state alleges a failure to adhere to pricing guarantees and misclassification of brand and generic drug types.

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Taro Pharmaceuticals to pay over $400 million to settle antitrust investigation

  • The drug manufacturer was charged with fixing prices for generic drugs in cooperation with other manufacturers in deals dating back to at least as early as May 2013.

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Two sentenced in $21 million compound prescription fraud case

  • A pharmacist and his wife were convicted of billing the U.S. Department of Labor for medically unnecessary compounds and creams.

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Manufacturer of highly anticipated hemophilia drug valoctocogene roxaparvovec receives FDA complete response letter

  • The drug is expected to go through further efficacy review, with a potential expected approval date of November 2021.

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Dexamethasone demand increases more than 600%, strains supply chains

  • Recent clinical trial data has shown improved clinical outcomes associated with the drug’s use as treatment for COVID-19.

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Medscape article discusses the utilization and costs of medical foods

  • An increasing number of medical foods are being developed and marketed.
  • Because medical foods are not FDA-approved products, the authors suggest that physicians evaluate supporting data to understand safety and efficacy of these products in relation to costs.

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GoodRx tracks midyear manufacturer price increases

  • Price increases reflect list prices rather than net prices after rebates.
  • Manufacturers traditionally introduce list price increases in January and July.

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CVS Health expands hyperinflation strategy to include a CVS Outlier Pharmacy program

  • The program monitors dispensing habits of pharmacies to identify unusual dispensing practices associated with high-cost, low-value drugs.

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Clinical Trials and Research

Phase 3 trial demonstrates efficacy of Brilinta (ticagrelor) in preventing stroke

  • Brilinta (ticagrelor) was used in combination with aspirin as a prophylactic treatment in patients with a previous history of acute ischemic stroke or transient ischemic attacks.

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Rinvoq (upadacitinib) achieves all endpoints in atopic dermatitis trial

  • The drug, currently approved for rheumatoid arthritis, produced significant improvement in skin clearance and symptomatic itching compared to patients receiving placebo.

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