Tag Archives: Pharmacy Briefing

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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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.
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Pharmacy Briefing: February 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

  • Allergan reaches $300 million settlement in pay-for-delay lawsuit
  • California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause 
  • Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
  • Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
  • Pfizer announces introduction of three new biosimilars
  • Coronavirus outbreak may affect the U.S. drug supply chain

FDA Approvals and Launches

  • Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) is approved for the mitigation of allergic reactions due to peanut exposure in children.
  • Reyvow (lasmiditan), a novel treatment for patients with acute migraines, launches at a list price of $640 per eight pills.
  • Trijardy XR (empagliflozin/linagliptin/metformin) is approved to treat patients with type 2 diabetes.  
  • Ozempic (semaglutide) receives additional indication to reduce risk of major cardiovascular events in patients with type 2 diabetes and heart disease.
  • Valtoco (diazepam) nasal spray is approved as an acute treatment for epilepsy.
  • Ajovy (fremanezumab-vfrm) receives approval for administration through an auto-injector dose delivery system.
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Pharmacy Briefing: January 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 and Prime Therapeutics announce three-year collaboration
  • Department of Justice files lawsuit against Omnicare, alleges fraudulent billing practices using invalid prescriptions
  • OptumRx acquires specialty pharmacy Diplomat for $300 million
  • Louisiana Department of Health reports positive results from “Netflix model” pricing of Hepatitis C drugs

FDA Approvals and Launches

  • Vascepa (icosapent ethyl) receives additional indication to reduce risk of cardiovascular (CV) events in people with elevated triglyceride levels and either established CV disease or type 2 diabetes and two or more CV risk factors.
  • Mylan launches Ogivri (trastuzumab-dkst), the second available biosimilar to Herceptin (trastuzumab).
  • Toujeo (insulin glargine) receives expanded approval to treat children as young as 6 years of age with Type 1 diabetes.
  • Xeljanz XR (tofacitinib) is approved as a once-daily treatment for ulcerative colitis. 
  • PADCEV (enfortumab vedotin-efjv) is approved for the treatment of locally advanced or metastatic urothelial cancer.
  • Arazlo (tazarotene) lotion is approved to treat acne vulgaris.
  • Ubrelvy (ubrogepant) is approved for the acute treatment of migraine.
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Pharmacy Briefing: December 2019

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

  • Teva and Celltrion launch Truxima (rituximab-abbs), the first approved biosimilar to Rituxan (rituximab)
  • Intercept Pharmaceuticals submits new drug application (NDA) for Ocaliva (obeticholic acid) for the treatment of nonalcoholic steatohepatitis (NASH)
  • Ohio Attorney General files additional charges against OptumRx, alleges breach of contract resulting in over $16 million in overcharges

FDA Approvals and Launches

  • Teva and Celltrion launch Truxima (rituximab-abbs), the first approved biosimilar to Rituxan (rituximab).
    • Rituxan, used to treat certain types of lymphoma and leukemia, generated over $4 billion in U.S. sales for Roche in 2018.
  • Talicia (omeprazole/amoxicillin/rifabutin) is approved for the treatment of Helicobacter pylori infections.
  • Ziextenzo (pegfilgrastim-bmez), a biosimilar to Neulasta (pegfilgrastim), is approved to treat febrile neutropenia.
  • Reblozyl (luspatercept) is approved to treat anemia in patients with beta thalassemia.
  • Oxbryta (voxelotor) and Adakveo (crizanlizumab) are approved to treat patients with sickle cell disease.
  • Givlaari (givosiran) is approved to treat acute hepatic porphyria, a rare inherited disease.
    • The drug’s manufacturer has cited a list price of $575,000 per year of treatment.
  • Xcopri (cenobamate) is approved for the treatment of partial-onset seizures in patients with epilepsy.
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