Tag Archives: Pharmacy Briefing

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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Pharmacy Briefing: September 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

  • AbbVie’s next generation treatment for rheumatoid arthritis, Rinvoq (upadicitinib), is approved for the treatment of moderate to severe rheumatoid arthritis.
  • AveXis notifies FDA of Zolgensma (onasemnogene abeparvovec-xioi) data manipulation.
  • 2019 Milliman Medical Index (MMI) is released, reports relatively modest prescription drug cost growth.
  • Oklahoma court holds Johnson and Johnson liable for $572 million in damages in opioid lawsuit.

FDA Approvals and Launches

  • Rinvoq (upadicitinib), an orally administered drug, is approved to treat moderate to severe rheumatoid arthritis.
  • Taltz (ixekizumab) receives third indication, can be used to treat ankylosing spondylitis in addition to plaque psoriasis and psoriatic arthritis.
  • Wakix (pitolisant) is approved to treat excessive daytime sleepiness in adults with narcolepsy.
  • Nourianz (istadefylline) is approved as an add-on treatment in Parkinson’s disease.
  • Inrebic (fedratinib) is approved to treat certain forms of myelofibrosis, a rare bone marrow cancer.

News

AveXis notifies FDA of Zolgensma (onasemnogene abeparvovec-xioi) data manipulation

  • AveXis may face penalties because the company was aware of the data manipulation issue before FDA approval and failed to report it.
  •  FDA still considers the drug to have a favorable benefit-risk profile and remains confident the treatment should remain on the market.

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2019 Milliman Medical Index (MMI) is released, reports relatively modest prescription drug cost growth

  • Drug costs for a hypothetical family of four are estimated to have increased by 4.5% from 2017 to 2018 and then by 2.1% from 2018 to 2019.

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Oklahoma court holds Johnson and Johnson liable for $572 million in damages in opioid lawsuit

  • Judge’s ruling found that the company’s “misleading marketing and promotion of opioids created a nuisance.”

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CVS Health formularies target drugs that have hyperinflated prices and cheap alternatives

  • The CVS hyperinflation strategy is projected to save clients $0.38 per member per month by removing targeted drugs from template formularies.
  • The five drugs spotlighted in the report are chlorzoxazone, metformin ER, fenoprofen, lidocaine/tetracaine, and Ortho DF.

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Pharmacy Briefing: August 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

  • The U.S. Department of Health and Human Services (HHS) officially withdraws proposal to remove anti-kickback statute safe harbor protections for drug manufacturer rebates
  • Washington Post releases comprehensive report detailing the distribution of opioids between 2006 and 2012
  • Reckitt Benckiser Group settles for $1.4 billion with the U.S. Department of Justice to resolve investigation into its role in the marketing of opioid addiction treatment Suboxone (buprenorphine/naloxone)

FDA approvals and launches

  • FDA approves first generic formulations of Lyrica (pregabalin), a drug that produced $3.6 billion in U.S. revenue in 2018
  • Amgen and Allergan launch biosimilar versions of Herceptin (trastuzumab) and Avastin (bevacizumab)
  • Sandoz announces retail launch of Symjepi (epinephrine) auto-injector
  • Accrufer (ferric maltol) is approved to treat iron deficiency
  • Baqsimi (glucagon) nasal spray is approved to treat episodes of severe hypoglycemia.
  • Nubeqa (darolutamide) is approved for the treatment of certain types of prostate cancer.

News

HHS officially withdraws proposal to remove safe harbor protections for drug manufacturer rebates

  • The Congressional Budget Office estimated that the proposed rule would increase federal spending by about $177 billion over the 2020-2029 period.

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Washington Post releases comprehensive report detailing the distribution of opioids between 2006 and 2012

  • The report sources data from a Drug Enforcement Administration (DEA) database that tracks the path of every controlled substance from manufacturer to point of sale or distribution.
  • The report found that “[t]he states that received the highest concentration of [opioid] pills per person per year were: West Virginia with 66.5, Kentucky with 63.3, South Carolina with 58…”
  • During this time period, “the companies distributed enough pills to supply every adult and child in the country with 36 [pills] each year.”

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Reckitt Benckiser Group settles for $1.4 billion with Department of Justice to resolve investigation into its role in the marketing of opioid addiction treatment Suboxone (buprenorphine/naloxone)

  • The settlement addresses claims that the group improperly promoted the sale and use of the drug and falsely claimed that the product was less susceptible to diversion and abuse.

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HHS publishes “Safe Importation Action Plan”

  • The plan outlines pathways for the importation of drugs originally intended for distribution in foreign markets, with a goal of providing “safe, lower cost drugs to consumers.”

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Trump administration working on a “favored nations” approach to drug pricing

  • President Trump says the law will ensure Americans “pay whatever the lowest nation’s price is.”

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Court of Appeals for Federal Circuit upholds ruling allowing the sale of generic versions of Suboxone (buprenorphine/naloxone) film

  • Alvogen and Dr. Reddy’s launched “at-risk” generic versions of the drug in February 2019.

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Oregon institutes new pharmacy benefit manager (PBM) regulations, signs HB 2185 into law

  • Examples of items addressed in the bill include retroactive “clawback” fees, pharmacy “gag clauses,” mandatory use of mail-order pharmacies, and the definition of “specialty drug.”

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Internal Revenue Service (IRS) issues notice expanding list of preventive care benefits provided by high-deductible health plans

  • Expands list of preventive benefits to include low-cost care that maintains health status for patients with chronic conditions. Examples include:
    • Angiotensin-converting enzyme (ACE) inhibitors for congestive heart failure, diabetes, and/or coronary artery disease
    • Inhaled corticosteroids for asthma
    • Insulin and other glucose-lowering agents for diabetes

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FDA limits approved uses of 10mg Xeljanz (tofacitinib), adds Black Box Warning about increased risk of blood clots and mortality

  • 10mg Xeljanz (tofacitinib) is indicated for the treatment of ulcerative colitis.
  • Across all strengths, the drug produced $1.4 billion in U.S. revenue in 2018.

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Mylan and Upjohn, a division of Pfizer, merge to create a new company

  • The combined portfolio of the two businesses will include EpiPen (epinephrine) and several off-patent brand drugs such as Lipitor (atorvastatin) and Lyrica (pregabalin).

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Pharmacy Briefing: July 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

  • AbbVie acquires Allergan in $63 billion deal
  • Navitus releases 2018 Drug Trend Report, touts “industry-leading” cost savings, 0.3% drug trend
  • Senate Health Committee approves Lower Health Care Costs Act targeting surprise medical bills and PBMs
  • JAMA study links long-term anticholinergic drug use to an increased risk of dementia

FDA Approvals and Launches

  • Emgality (galcanezumab-gnlm) receives new indication approval for the treatment of episodic cluster headaches.
    • Drug was first FDA-approved in September 2018 for the preventive treatment of migraines.
  • Two new methods for administering asthma drug Nucala (mepolizumab) are approved, now allowing patients to self-administer treatment with an auto-injector or a prefilled syringe.
  • Vyleesi (bremelanotide) is approved to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women.
  • Jazz Pharmaceuticals announces July launch of excessive daytime sleepiness drug Sunosi (solriamfetol) after Schedule IV controlled substance designation.

Teva and Analog Pharma launch generic versions of Diclegis (doxylamine/pyridoxine), a drug used to treat morning sickness.

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Pharmacy Briefing: June 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

  • Congressional Budget Office (CBO) projects that the proposed change to pharmaceutical rebate legislation would increase federal spending by $177 billion over a period of 10 years
  • Connecticut Attorney General files multistate antitrust lawsuit against nation’s largest generic manufacturers and industry executives
  • New York State Senate releases investigative report detailing pharmacy benefit manager (PBM) practices
  • Zolgensma (onasemnogene abeparvovec-xioi) is approved, carries a $2.125 million price tag
  • Eli Lilly launches Insulin Lispro Injection as a cheaper, generic alternative to Humalog (insulin lispro)

FDA approvals and launches

  • Zolgensma (onasemnogene abeparvovec-xioi) is approved for the treatment of spinal muscular atrophy.
    • Novartis quotes a list price of $2.125 million for the one-time treatment.
  • Eli Lilly launches Insulin Lispro Injection as a cheaper, generic alternative to Humalog (insulin lispro).
  • Vyndaquel (tafamidis meglumine) and Vyndamax (tafamidis) are approved for the treatment of transthyretin amyloid cardiomyopathy, a rare heart disease.
  • Ruzurgi (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients between the ages of 6 and 17.
    • Ruzurgi (amifampridine) may compete with Firdapse (amifampridine), an expensive drug with an annual list price of $375,000.
  • Nayzilam (midazolam) nasal spray is approved for the treatment of certain types of seizures.
  • Solirux (calcipotriene) foam is approved for the treatment of plaque psoriasis.
  • Piqray (alpelisib) is approved to treat certain forms of breast cancer.
  • Triple-therapy Qternmet XR (dapagliflozin/saxagliptin/metformin) is approved for use in patients with type 2 diabetes mellitus.
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