Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 1 | Issue 1
February 1, 2019
Contributors:
Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD
Clinical Update
The American Diabetes Association (ADA) has released its 2019 Standards of Medical Care in Diabetes
The new Standards of Medical Care in Diabetes guidelines include several important updates including recommendations for greater personalization of care, expanded treatment recommendations for children with type 2 diabetes, use of technology (i.e. telemedicine), and information on medical nutrition, among others. Most notably, the recommendations pertaining to cardiovascular disease are aligned with the American College of Cardiology (ACC) for the first time ever.
Effective management of diabetes is becoming increasingly important as the prevalence of diabetes is rising and becoming more expensive to treat. The American Diabetes Association released new research in March, that estimates the total costs of diabetes have risen to $327B in 2017 from $245B in 2012. This represents a 26 percent increase over a five-year period. Anti-diabetic medications and diabetic supplies made up 45 percent of total medical expenditures.
Safety First
FDA warns about increased risk of aorta ruptures or tears with fluoroquinolone antibiotics
A review conducted by the FDA found that fluoroquinolone antibiotics (i.e. ciprofloxacin, levofloxacin) can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. Evaluated evidence suggests the estimated risk of occurrence is between 9-300 events per 100,000 people per year. They recommended that fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. Prescribing reference information and patient medication guides will now be required to include a warning about this risk.
From the Industry
The year of digital therapeutics
As patients continue to take a more active role in their healthcare, the pharmaceutical industry’s interest in technology- based medical assistance is taking off. 2018 was the year of the first-ever digital pills and connected smart medical devices (i.e. Abilify MyCite®). The number of people using digital therapeutics will increase from an estimated 4.5 million in 2018 to 130 million by 2023, according to Juniper Research, with estimated sales ranging from $6B to $9B.
FDA Approvals
Recent FDA Approvals
3 new medications to treat blood related conditions
Ultomiris™ (ravulizumab-cwvz)
Treatment of adult patients with a rare blood disorder that causes blood clots, red blood cell destruction, and impaired bone marrow function known as paroxysmal nocturnal hemoglobinuria (PNH), [12/21/18 – BLA; Orphan Drug; Priority Review – Alexion Pharmaceuticals]
Elzonris™ (tagraxofusp-erzs)
Treatment for patients > 2 years old for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood and bone marrow disorder that often presents as leukemia or evolves into acute leukemia [12/21/18 – BLA; Orphan Drug; Priority Review; Breakthrough Therapy – Stemline Therapeutics]
Asparlas™ (calaspargase pegol-mknl)
Treatment for patients aged 1 month to 21 years old with acute lymphoblastic leukemia (ALL), a type of blood cancer that effects white blood cells [12/20/18 – BLA; Orphan Drug – Servier Pharmaceuticals]
New Generics
New Generics Entering the Marketplace
pimecrolimus (Elidel®)
Dosage Form/Strength: 1% cream
Average Wholesale Price (AWP): Generic = $1,014/tube | Brand = $1,129/tube
mesalamine (Canasa®)
Dosage Form/Strength: 1,000 mg suppository
Average Wholesale Price (AWP): Generic = $1,210/30 units | Brand: $1,273/30 units