Tag Archives: Rebekah Bayram

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
  • 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
  • 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 10mg/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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Pharmacy Briefing: July 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

  • The United States sends withdrawal notice to the World Health Organization (WHO)
  • Several Blue Cross Blue Shield (BCBS) insurers sue CVS Health over its Health Savings Pass drug discount program
  • Employer and Patient Protection and Affordable Care Act (ACA) health plans required to cover the cost of HIV PrEP
  • Remdesivir list price set to be $3,120 for a five-day course of therapy

FDA Approvals and Launches

  • Lyumjev (insulin lispro-aabc) is approved as an ultra-rapid acting insulin for the treatment of both type 1 and type 2 diabetes.
  • Phexxi (lactic acid/citric acid/potassium bitartrate) is approved for use as an on-demand contraceptive applied before sexual intercourse.
  • Amivas (artesunate) is approved to treat malaria.
  • Taltz (ixekizumab) and Cosentyx (secukinumab) receive additional approval to treat spondyloarthritis.
  • Oncology drug Nyvepria (pegfilgrastim-apgf) is approved as the fourth biosimilar to Neulasta (pegfilgrastim).
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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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