Tag Archives: Pharmacy Briefing

Pharmacy Briefing: July 2021

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

  • Acting FDA Commissioner calls for investigation into correspondence between FDA and Biogen
  • WellDyne publishes 2021 Drug Trend Report
  • Amazon Pharmacy launches six-month for $6 program for Prime members
  • Walmart launches ReliOn analog insulin, offers cheaper list prices than other currently available branded analog insulins

FDA Approvals and Launches

  • Prevnar 20 (pneumococcal 20-valent conjugate vaccine) is approved to provide immunization against streptococcus pneumoniae.
  • Kerendia (finerenone) is approved to reduce the risk of cardiovascular and kidney disease associated with type 2 diabetes.
  • Astepro (azelastine nasal spray) is approved for over-the-counter (OTC) use as the first OTC antihistamine nasal spray to treat seasonal allergies.
  • Soaanz (torsemide) is approved to treat edema associated with heart failure or kidney disease.
Continue reading

Pharmacy Briefing: June 2021

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

  • Aduhelm (aducanumab) is approved to treat Alzheimer’s disease
  • Wegovy (semaglutide) is approved as a weight-loss agent in patients with or without diabetes
  • Milliman publishes 2021 Milliman Medical Index (MMI)
  • Institute for Clinical and Economic Review (ICER) analysis estimates Aduhelm (aducanumab) cost-effectiveness range between $2,500 to $8,300 per year

FDA Approvals and Launches

  • Aduhelm (aducanumab) is approved to treat Alzheimer’s disease.
    • The drug was approved despite overwhelmingly negative feedback from an FDA advisory committee.
  • Wegovy (semaglutide) is approved as a weight-loss agent in patients with or without diabetes.
  • Farxiga (dapagliflozin) receives additional indication to treat chronic kidney disease in patients with or without diabetes.
  • Zeposia (ozanimod), an oral drug approved for multiple sclerosis, receives additional approval to treat ulcerative colitis.
  • Brexafemme (ibrexafungerp) is approved to treat vaginal yeast infections.
Continue reading

Pharmacy Briefing: May 2021

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 2020 Drug Trend Report
  • Janssen publishes 2020 U.S. Transparency Report
  • American Journal of Health-System Pharmacy (AJHP) trend report describes changes in pharmaceutical expenditures in 2020
  • Oklahoma and Kentucky limit use of copay accumulator policies

FDA Approvals and Launches

  • Praluent (alirocumab) receives additional indication as add-on therapy to treat homozygous familial hypercholesterolemia.
  • Myrbetriq (mirabegron) receives additional indication to treat a pediatric bladder dysfunction.
  • Qelbree (viloxazine) is approved to treat ADHD in patients ages 6 to 17.
  • Farxiga (dapagliflozin) receives additional indication to reduce risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease
Continue reading

Pharmacy Briefing: April 2021

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

  • Evernorth publishes 2020 Drug Trend Report
  • Fierce Pharma reports highlight top 10 drugs losing patent exclusivity and top 10 most anticipated drug launches in 2021
  • Sanofi publishes 2021 Pricing Principles Report
  •  CMS updates Medicare payment rates for COVID-19 vaccine administration

FDA Approvals and Launches

  • Actemra (tocilizumab) receives additional indication to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.
  • Humira (adalimumab) receives additional indication to treat moderate to severe ulcerative colitis in pediatric patients.
  • Ponvory (ponesimod) is approved to treat relapsing forms of multiple sclerosis.
  • Zegalogue (dasiglucagon) is approved to treat severe hypoglycemia in patients with diabetes.
Continue reading

Pharmacy Briefing: March 2021

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 grants Emergency Use Authorization for third COVID-19 vaccine
  • Merck partners with Johnson & Johnson to manufacture COVID-19 vaccines
  • Manufacturers of Plavix (clopidogrel) ordered to pay $834 million to state of Hawaii
  • FiercePharma summarizes the year’s top 10 most anticipated drug launches
  • Semaglutide produces significant weight loss among non-diabetic patients in phase 3 trial

FDA Approvals and Launches

  • Evkeeza (evinacumab-dgnb) is approved to treat a rare form of high cholesterol.
  • Entresto (sacubitril/valsartan) receives additional indication to treat patients with heart failure with either reduced or preserved ejection fraction.
  • Nulibry (fosdenopterin) is approved to treat molybdenum cofactor deficiency, a rare genetic disorder.
  • Amondys 45 (casimersen) is approved to treat Duchenne muscular dystrophy.
  • Azstarys (serdexmethylphenidate/dexmethylphenidate) is approved to treat attention deficit hyperactivity disorder.
Continue reading

Pharmacy Briefing: February 2021

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
  • Consolidated Appropriations Act signed into law
  • CMS Office of the Actuary releases 2019 National Health Expenditures
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • FDA extends review period for investigational Alzheimer’s drug aducanumab
FDA Approvals and Launches
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • Vocabria (cabotegravir) is approved as one component of a precursor to HIV treatment with Cabenuva (cabotegravir/rilpivirine).
  • Generic version of Glucagon Emergency Kit for Low Blood Sugar is approved to treat cases of severe hypoglycemia in diabetics.
  • Lupkynis (voclosporin) is approved for the treatment of lupus nephritis.
  • Verquvo (vericiguat) is approved for the treatment of heart failure.
News

Consolidated Appropriations Act signed into law

  • The act includes a wide range of provisions regarding COVID-19, medical billing, and pricing transparency, among others.
  • Plans will be required to submit specified pharmacy claims metrics to the federal government on an annual basis.
    • This data collection provision will be used by the government to produce drug pricing trend reports.

Read more

CMS Office of the Actuary releases 2019 National Health Expenditures

  • Retail prescription drug spending grew 5.7% in 2019 compared to 3.8% in 2018.
  • The increased growth rate was driven by an increase in utilization rather than price; retail drug prices declined by 0.4%.

Read more

FDA extends review period for investigational Alzheimer’s drug aducanumab

  • The new action date was extended from March 7 to June 7 to allow for additional review of clinical data.

Read more

Senate Finance Committee releases investigative report on insulin prices

  • The report describes how the relationship among list prices, rebates, and formulary placement has led to increased prices for plan sponsors and consumers.
  • Report authors found that manufacturers also employed “shadow pricing,” a tactic that the report describes as “price increases on related brands of aging products from competing companies that often seem to move in synchronized fashion.”

Read more

Department of Health and Human Services funds report comparing drug prices in the United States with those found internationally

  • After adjusting prices to account for rebates, the authors estimated that U.S. prices were 90% higher than prices found in other countries.

Read more

Maryland State Senate rejects governor’s veto of prescription drug affordability board

  • The drug affordability board was created to help the state create regulations that would attempt to make prescription drugs more affordable by using strategies such as setting payment limits for government payers.

Read more

Consulting firm McKinsey reaches $573 million settlement regarding its role in opioid crisis

  • The firm worked closely with Purdue Pharma, the manufacturer of Oxycontin (oxycodone) extended-release tablets.

Read more

Companies pledge to pay employees for getting the COVID-19 vaccine

  • Companies such as Trader Joe’s, Aldi, and Dollar General will pay employees extra hourly wages as an incentive to get vaccinated but will not make the vaccine mandatory.

Read more

Entrepreneur Mark Cuban launches generic drug company

  • The company’s first drug is antiparasitic drug albendazole but plans to offer over 100 additional drugs by the end of 2021.

Read more

Clinical Trials

Skyrizi (risankizumab) outperforms placebo in phase 3 psoriatic arthritis trial

  • The auto-immune drug is currently only indicated for the treatment of plaque psoriasis.
  • Skyrizi (risankizumab) is considered a successor to Humira (adalimumab) and is currently being studied for the treatment of many overlapping indications.

Read more