Tag Archives: Pharmacy Briefing

Pharmacy Briefing: January 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

  • The U.S. Supreme Court upholds Arkansas Act 900 regulating pharmacy benefit manager (PBM) practices
  • Drug manufacturers implement annual price increases
  • Highly publicized joint venture Haven Healthcare disbands
  • CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption

FDA Approvals and Launches

  • Ebanga (ansuvimab-zykl) is approved to treat the ebolavirus.
  • Imcivree  (setmelanotide) is approved for weight management in three rare genetic disorders.
  • Klisyri (tirbanibulin) is approved to treat actinic keratosis.
  • Gemtesa (vibegron) is approved to treat symptoms of an overactive bladder.

News

The U.S. Supreme Court upholds Arkansas Act 900 regulating PBM practices

  • The act mainly regulates PBM reimbursement to pharmacies, ensuring rates higher than the pharmacies’ acquisition costs.
  • The ruling may encourage other states to pass similar laws regulating PBM practices.

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Drug manufacturers implement annual price increases

  • List prices, which don’t reflect net prices paid after rebates, increased by an average of 3.3%.

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Highly publicized joint venture Haven Healthcare disbands

  • In 2018, Amazon, Berkshire Hathaway, and JPMorgan Chase founded Haven Healthcare with a goal of addressing issues in the employer healthcare market.

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CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption

  • 28% of people surveyed were interested in receiving a vaccine as soon as possible whereas 17% did not plan to receive the vaccine at all.

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Employers consider whether to mandate COVID-19 vaccinations

  • Employers may consider public safety, the benefits of a safer work environment, and the concerns of those who worry about the safety of the vaccine before exercising the legal right to mandate vaccination.

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Centene acquires Magellan Health and specialty pharmacy PANTHERx

  • Centene will acquire 5.5 million members on government-sponsored plans, 2 million PBM members, and 16 million medical pharmacy members
  • PANTHERx specializes in providing care to patients with rare conditions and will work under the umbrella of Centene’s Evolve Pharmacy Solutions program.

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Federal Trade Commission (FTC) issues report describing Hatch-Waxman patent settlements

  • The report describes patent settlements occurring in 2017 between brand and generic manufacturers.
    • The total amount of final settlements remained close to the record high set in 2016.
    • The number of reverse-payment agreements, otherwise known as “pay-for-delay” agreements, remains low compared to previous years.

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Amgen releases 2020 Biosimilars Trends Report

  • The report describes trends among the 28 FDA-approved and 18 market-launched biosimilar products.
    • The report includes comparisons between biosimilar and reference product prices, market share trends, and class-specific trends.

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Elixir drug pipeline report highlights six developments to watch in 2021

  • Developments include increases in the orphan drug and gene therapy markets, an investigational type 1 diabetes drug, and commentary on the COVID-19 vaccine.

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Clinical Trials

Long-acting injectable HIV drug combination produces positive results in phase 3b study

  • The combination of cabotegravir and rilpivirine given intramuscularly every eight weeks was found to be non-inferior to dosing given every four weeks.
    • This investigational treatment has the potential to increase adherence over standard treatments that must be dosed daily.

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Pharmacy Briefing: December 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
  • FDA grants Emergency Use Authorization for Pfizer/BioNTech COVID-19 vaccine
  • Amazon enters retail pharmacy sector, launches Amazon Pharmacy
  • United Kingdom approves Pfizer/BioNTech COVID-19 vaccine
  • Kaiser Family Foundation report describes COVID-19’s effect on national health spending and utilization
FDA Approvals and Launches
  • Sesquient (fosphenytoin injection) is approved to treat status epilepticus.
  • Flu treatment Xofluza (baloxavir marboxil) receives additional indication for use in flu prevention (post-exposure prophylaxis).
  • Oxlumo (lumasiran) is approved to treat primary hyperoxaluria type 1, a rare genetic disorder.
  • Orladeyo (berotralstat) is approved to treat hereditary angioedema.
News

FDA grants Emergency Use Authorization for Pfizer/BioNTech COVID-19 vaccine

  • The decision follows a recommendation from the agency’s Vaccines and Related Biological Products Advisory Committee.

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Amazon enters retail pharmacy sector, launches Amazon Pharmacy

  • The online pharmacy can service patients with or without insurance and provides free two-day delivery for Prime members.
  • The service currently comes with some limitations.
    • No option of 90-day fills or automatic refills.
    • Examples of unavailable products include diabetic testing supplies, schedule II-controlled substances, specialty medications, and liquid suspensions.

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Kaiser Family Foundation report describes COVID-19’s effect on national health spending and utilization

  • As of the third quarter (Q3) 2020, authors found a decrease of 2.4% in non-pharmaceutical health spending relative to the same period in 2019.
  • As of October 2020, pharmaceutical spending increased 6.3%.

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HHS and FDA under legal pressure against drug importation final rule

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FDA advisory committee rejects endorsement of investigational Alzheimer’s drug aducanumab

  • The drug, if approved, would be the first Alzheimer’s treatment approved in over 17 years.

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U.S. Department of Health and Human Services (HHS) Special Fraud Alert warns against prescription kickback loophole

  • The alert highlights the practice of drug manufacturers awarding high-prescribing healthcare providers with speaking deals worth potentially hundreds of thousands of dollars.
  • HHS cautions that this practice violates federal anti-kickback statutes.

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OptumRx publishes Q4 Drug Pipeline Insights Report

  • The report highlights five drugs with FDA decisions in the near future, including novel cholesterol drug inclisiran.

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United Healthcare delays implementation of Accumulator Adjustment – Medical Benefit program

  • The program faced public backlash from several groups including the American Academy of Family Physicians and American Medical Association.

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Clinical Trials and Research

Pfizer/BioNTech and Moderna produce positive COVID-19 vaccine trial results

  • As a result of the clinical trial data, the manufacturers of the two vaccines have submitted requests for Emergency Use Authorization to the FDA.
  • The vaccines require two separate doses to achieve full efficacy.

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United Kingdom becomes first country to approve a COVID-19 vaccine

  • The country approved the vaccine developed by manufacturers Pfizer and BioNTech.
  • As of December 9, Bahrain and Canada have also approved the same product.

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Investigational long-acting HIV drug, cabotegravir, achieves endpoints in superiority trial

  • The injectable drug is dosed once every two months and was found to be more effective than daily Truvada (emtricitabine/tenofovir disoproxil fumarate) at preventing HIV transmission in women.

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Pharmacy Briefing: November 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
  • Kaiser Family Foundation releases 2020 Employer Health Benefits Survey
  • Price and cost-sharing rules are finalized requiring insurers to disclose negotiated prices and cost-sharing information
  • Most-favored nation and point-of-sale rebate regulations finalized
  • Federal government partners with retail pharmacies to promote access to future COVID-19 vaccines
  • Veklury (remdesivir) is FDA-approved to treat COVID-19 in patients requiring hospitalization
  • World Health Organization (WHO) study finds no reduction in mortality rates associated with COVID-19 patients treated with remdesivir
FDA Approvals and Launches
  • Veklury (remdesivir) is approved to treat COVID-19 in patients requiring hospitalization.
  • Ultomiris (ravulizumab-cwvz) 100 mg/mL is approved to treat certain blood disorders.
    • The formulation improves upon the 10 mg/mL formulation by allowing for reduced infusion times.
  • Eysuvis (loteprednol etabonate) ophthalmic suspension is approved to treat dry eye disease.
  • Inmazeb (atoltivimab/maftivimab/odesivimab-ebgn) is approved to treat the Ebola virus.
  • Bronchitol (mannitol) inhalation powder is approved to treat symptoms of cystic fibrosis.
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Pharmacy Briefing: October 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 order on “most-favored-nation” drug prices
  • U.S. Department of Health and Human Services (HHS) issues final rule on plan for Canadian drug importation
  • OptumRx announces annual formulary updates
  • CVS Health announces annual formulary updates
  • Generic versions of HIV drugs Truvada (emtricitabine/tenofovir disoproxil) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil) are launched
  • Meta-analysis finds decreased COVID-19 mortality rate associated with corticosteroid treatment
FDA Approvals and Launches
  • Generic versions of HIV drugs Truvada (emtricitabine/tenofovir disoproxil) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil) are launched.
  • Generic versions of multiple sclerosis drug Tecfidera (dimethyl fumarate) are launched.
  • Mylan launches long-acting insulin Semglee (insulin glargine) as an alternative to Lantus (insulin glargine).
    • The two products are not currently interchangeable.
  • Winlevi (clascoterone cream), a first in-class androgen inhibitor, is approved to treat acne.
  • Trelegy (fluticasone furoate/umeclidinium/vilanterol) receives additional approval as a maintenance treatment for asthma.
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Pharmacy Briefing: September 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

  • Teladoc and Livongo merge to create $37 billion dollar healthcare enterprise
  • President Trump signs executive order for essential drugs and medical supplies
  • Express Scripts makes changes to 2021 national formulary
  • UnitedHealthcare to stop covering Descovy (emtricitabine/tenofovir alafenamide) starting September 1

FDA Approvals and Launches

  • Spravato (esketamine) receives new indication to treat certain patients with major depressive disorder.
  • Evrysdi (risdiplam) is approved as the first oral therapy to treat spinal muscular atrophy.
  • Enspryng (satralizumab) is approved to treat neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease.
  • Generic version of Tecfidera (dimethyl fumarate), used to treat multiple sclerosis, launches.
  • Kesimpta (ofatumumab) is approved to treat multiple sclerosis.
  • Winlevi (clascoterone) cream is approved to treat acne vulgaris.
  • FDA removes amputation risk boxed warning from Invokana (canagliflozin) labeling.
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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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