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.
- 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.
Intercept Pharmaceuticals submits NDA for Ocaliva (obeticholic acid) for the treatment of nonalcoholic steatohepatitis (NASH)
- If approved, Ocaliva would be the first FDA-approved treatment for NASH.
- FDA decision is expected in the first quarter of 2020.
Ohio Attorney General files additional charges against OptumRx, alleges breach of contract with Ohio Bureau of Workers’ Compensation
- OptumRx is accused of failing to adhere to contractual pricing provisions, resulting in over $16 million in overcharges between January 1, 2015, and October 27, 2018.
U.S. Department of Health and Human Services (HHS) sues Gilead for patent infringement of HIV pre-exposure prophylaxis (PrEP) therapy
- HHS alleges that Gilead profited from the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) in PrEP regimens that HHS developed and patented.
Novartis acquires The Medicines Company for $9.7 billion, obtaining rights to investigational cholesterol treatment
- The Medicines Company has developed inclisiran, a novel therapy for treating atherosclerotic cardiovascular disease and familial hypercholesterolemia.
- Phase III trials of inclisiran have demonstrated potent LDL reduction and an excellent safety profile.
AARP publishes Rx Price Watch report, spotlights increase in prices for brand name drugs
- Report states that in 2018, “retail prices for 267 widely used brand name prescription drugs increased by 5.8 percent, contrasting with the general inflation rate of 2.4 percent over the same period.”
Senator Cory Booker announces legislation to create the Bureau of Prescription Drug Affordability and Access
- The purpose of the proposed agency would be to conduct reviews of drug prices and determine appropriate list prices.
University of Pittsburgh Medical Center (UPMC) Health Plan and Biogen agree to value-based contract for multiple sclerosis treatments
- Manufacturer reimbursements for Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) will be directly related to patient-reported measures of disability progression rather than indirect indicators such as hospitalizations or medication adherence.
CVS Health and UPS announce first successful drone delivery of prescription medication
- CVS Health continues to explore convenient, alternative delivery options for customers with limited access to brick and mortar stores, such as those with impaired mobility.
Kaiser Health News report highlights wide variations in flu shot pricing
- Price may vary by more than double for the same vaccine, depending on where it is purchased.
- Due to Patient Protection and Affordable Care Act (ACA) regulations, insured patients receive flu vaccines at no charge, shielding them from the actual price associated with the vaccine.
- The full cost of the vaccine is covered by a patient’s health plan and passed back to consumers through their premiums.
Clinical Trials and Research
EMPRISE study suggests that Jardiance (empagliflozin) reduces risk of heart failure hospitalizations when compared to other classes of diabetes treatments
- Results come from an interim analysis of three-year data comparing the treatment to dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists.
FDA advisory committee recommends approval of Vascepa (icosapent ethyl) to reduce risk of cardiovascular events when used as an add-on to statin therapy
- Recommendation targets patients with elevated triglycerides or other risk factors for cardiovascular disease.