Tag Archives: Rebekah Bayram

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 health care 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 1st

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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Pharmacy Briefing: May 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 issues emergency use authorization for remdesivir for the treatment of COVID-19
  • National Council for Prescription Drug Programs (NCPDP) issues guidance for pharmacy-led COVID-19 testing
  • Eli Lilly introduces Lilly Insulin Value Program allowing those with commercial insurance or without any insurance to fill monthly insulin prescriptions for $35
  • Express Scripts publishes “America’s State of Mind Report” examining recent utilization of mental health medications

FDA Approvals and Launches

  • Generic version of Proventil HFA (albuterol sulfate) is approved to prevent and treat bronchospasms.
  • Koselugo (selumetinib) is approved to treat neurofibromatosis type 1 (NF1), a rare genetic disorder.
  • Ontruzant (trastuzumab-dttb) is launched, the fifth biosimilar to Herceptin (trastuzumab).
  • Ongentys (opicapone) is approved as an add-on therapy to treat Parkinson’s disease.
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Pharmacy Briefing: April 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

  • PBMs introduce new policies in response to COVID-19 pandemic (Milliman article)
  • Cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost
  • FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list
  • Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy

FDA Approvals and Launches

  • Generic version of Daraprim (pyrimethamine) is approved to treat toxoplasmosis and malaria
  • Isturisa (osilodrostat) is approved to treat Cushing’s disease
  • Ofev (nintedanib) receives additional approval to treat chronic fibrosing interstitial lung diseases.
  • ArmonAir Digihaler (fluticasone propionate) Inhalation Powder is approved to treat asthma.
  • Zeposia (ozanimod) is approved to treat relapsing forms of multiple sclerosis.
    • The manufacturer announced that the drug’s launch will be delayed indefinitely due to the pandemic.

News

Pharmacy benefit managers (PBMs) introduce new policies in response to COVID-19 pandemic

(Milliman article authored by Andrew Jackson, Brian Anderson, and Marc Guieb)

  • Utilization management changes include automatic extension of prior authorizations, refill-too-soon overrides, and imposing quantity limits on certain drugs.
  • Many health plan members are transitioning to mail-order services to fill prescriptions.

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Yale School of Public Health and Massachusetts General Hospital cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost

  • Descovy and Truvada (emtricitabine/tenofovir disoproxil fumarate) are the only approved medications for use in HIV pre-exposure prophylaxis (PrEP) therapy.

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FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list

  • Truvada (emtricitabine/tenofovir disoproxil fumarate), with $2.64 billion in 2019 sales, tops the list.
    • A generic version of Truvada is expected to be released in September 2020.

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Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy

  • The manufacturer was charged for conspiring with four generic drug companies to fix the price of several drug products.

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Sanofi publishes “Prescription Medicine Pricing: Our Principles and Perspectives” annual pricing report

  • In 2019, the average aggregate list price of Sanofi products increased 2.9% whereas the average aggregate net price of these same products decreased 11.1%.

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FDA adds Black Box Warning for Singulair and generic montelukast equivalents

  • Serious side effects found during an observational study include suicidal thought and actions.

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Costco purchases equity interest in Navitus Health

  • Equity interest includes a stake in Lumicera Health Services, Navitus’s specialty pharmacy.

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Health insurers and drug manufacturers spar over 2021 CMS manufacturer coupon proposal

  • The Centers for Medicare and Medicaid Services (CMS) proposal would allow insurance providers to determine whether manufacturer coupons apply to patient cost-sharing accumulator programs.

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Brand and authorized generic EpiPen (epinephrine auto-injector) may contain manufacturing defects 

  • Patients and pharmacists should inspect their products and contact the manufacturer if defects are discovered.

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