Tag Archives: Pharmacy Briefing

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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Pharmacy Briefing: November 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

  • Consumers and third-party payers may be eligible for recent class action lawsuit settlement payments
  • Descovy (emtricitabine/tenofovir alafenamide) is approved for use as HIV pre-exposure prophylaxis (PrEP) therapy
  • Allergan reaches $750 million settlement over antitrust charges
  • California bans “pay for delay” drug manufacturer agreements

FDA Approvals and Launches

  • Descovy (emtricitabine/tenofovir alafenamide) is approved for use as HIV pre-exposure prophylaxis (PrEP) therapy.
    • Prior to this approval, only Truvada (emtricitabine/tenofovir disoproxil) was approved for this indication.
    • Generic versions of Truvada are expected to be available in September 2020.
  • Aklief (trifarotene) cream and Amzeeq (minocycline) foam are approved to treat acne vulgaris.
  • Beovu (brolucizumab-dbll) is approved to treat age-related macular degeneration.
  • Alternative delivery system of Fasenra (benralizumab) is approved to treat eosinophilic asthma. The pen allows patients to self-administer at home.
  • Reyvow (lasmiditan) is approved for the acute treatment of migraine.
  • Stelara (ustekinumab) receives additional approval to treat ulcerative colitis.
  • Vumerity (diroximel fumarate) is approved to treat relapsing forms of multiple sclerosis.

News

Consumers and third-party payers may be eligible for recent class action lawsuit settlement payments

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Pharmacy Briefing: October 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

  • Rybelsus (oral semaglutide) is approved for treatment of type 2 diabetes mellitus
  • Cigna announces Embarc program to help employers pay for expensive gene therapies
  • FDA advisory committee votes in favor of approving peanut allergy drug Palforzia
  • Express Scripts and OptumRx publish formulary changes effective January 2020

FDA Approvals and Launches

  • Rybelsus (oral semaglutide) is approved for the treatment of type 2 diabetes mellitus.
  • Mavyret (glecaprevir/pibrentasvir) receives expanded approval as an eight-week regimen for any treatment-naïve hepatitis C virus (HCV) patient, regardless of cirrhosis status or genotype.
  • Gvoke (glucagon injection) is approved to treat cases of severe hypoglycemia.
  • Rituxan (rituximab) receives additional indications to treat microscopic polyangiitis and granulomatosis with polyangiitis, two rare vascular diseases.
  • Ibsrela (tenapanor) is approved to treat irritable bowel syndrome with constipation.
  • Invokana (canagliflozin) receives additional indications to reduce risk of end-stage kidney disease, cardiovascular death, and hospitalization for heart failure.
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