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.
- 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.
Novo Nordisk reveals Rybelsus list price and $10 per month copay coupon program
- List price will be $772 per 30 tablets, similar to the monthly list price of other in-class options.
- Rybelsus is the orally dosed version of blockbuster drug Ozempic (semaglutide injection) and shares the same drug class as injectables Victoza (liraglutide) and Trulicity (dulaglutide).
Cigna announces Embarc program to help employers pay for expensive gene therapies
- Program charges a fixed per member per month payment in exchange for no member cost sharing and no additional plan costs for drugs covered on the Embarc list.
- Program currently covers Luxturna (voretigene neparvovec-rzyl) and Zolgensma (onasemnogene abeparvovec-xioi) and will evaluate the inclusion of future gene therapies as they are launched.
FDA advisory committee votes in favor of approving peanut allergy drug Palforzia
- Drug increases a patient’s ability to tolerate peanuts, reducing frequency and severity of allergic reactions.
- FDA review action due date is late January 2020.
Express Scripts and OptumRx publish formulary changes effective January 2020
- Express Scripts Basic Formulary
- Express Scripts National Preferred Formulary and Formulary Exclusions
- OptumRx Formulary Update
Blue Cross and Blue Shield (BCBS) of Minnesota to offer insulin with no member cost sharing
- Starting in January 2020, the insulin benefit change will be implemented for all commercial, fully insured plans.
- $0 copay applies to insulins in Tiers 1 and 2 on the BCBS formulary.
Federal judge reaffirms legality of 2018 CVS Health-Aetna merger
- Merger was under review by a U.S. District Court judge to ensure compliance with antitrust laws.
Novo Nordisk announces January 2020 launch of NovoLog (insulin aspart) authorized generics
- Authorized generics will launch with a list price that is 50% lower than the current list price of the branded drug.
- Announcement follows March 2019 Eli Lilly announcement introducing Humalog (insulin lispro) authorized generics.
Ways and Means Committee releases report comparing U.S. drug prices to international prices in 11 similar countries
- On average, U.S. drug prices were 3.7 times higher than the combined average of other countries.
- When comparing specific drugs, prices in the United States were up to 67 times higher than prices in other countries.
Clinical Trials and Research
Diabetes drug Farxiga (dapagliflozin) reduces risk of cardiovascular death and worsening heart failure in phase 3 DAPA-HF trial
- Primary endpoint was also achieved in patients diagnosed with heart failure without type 2 diabetes.
JAMA study highlights the rising cost of multiple sclerosis drugs
- Between 2006 and 2016, pharmaceutical spend per 1,000 Medicare Part D beneficiaries increased 10.2-fold and patient out-of-pocket costs increased 7.2-fold.
Tremfya (guselkumab) achieves statistically significant results over Cosentyx (secukinumab) in phase 3 head-to-head study
- Primary endpoint of the study was 90% reduction or more from baseline of Psoriasis Area and Severity Index (PASI 90) response at week 48 in patients with moderate-to-severe psoriasis.