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.
- Allergan reaches $300 million settlement in pay-for-delay lawsuit
- California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause
- Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
- Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
- Pfizer announces introduction of three new biosimilars
- Coronavirus outbreak may affect the U.S. drug supply chain
FDA Approvals and Launches
- Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) is approved for the mitigation of allergic reactions due to peanut exposure in children.
- Reyvow (lasmiditan), a novel treatment for patients with acute migraines, launches at a list price of $640 per eight pills.
- Trijardy XR (empagliflozin/linagliptin/metformin) is approved to treat patients with type 2 diabetes.
- Ozempic (semaglutide) receives additional indication to reduce risk of major cardiovascular events in patients with type 2 diabetes and heart disease.
- Valtoco (diazepam) nasal spray is approved as an acute treatment for epilepsy.
- Ajovy (fremanezumab-vfrm) receives approval for administration through an auto-injector dose delivery system.
Allergan reaches $300 million settlement in pay-for-delay lawsuit
- Two subsidiaries of Allergan are alleged to have paid drug manufacturers to delay the release of generic versions of Loestrin 24 Fe and Minastrin 24 Fe.
California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause
- California has proposed contracting with generic drug manufacturers to establish the state’s own drug label.
- The budget proposal includes the concept of a “Golden State Pricing Schedule,” where drug manufacturers must bid to sell their products in California while offering prices at or below the price offered to any other entity.
Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
- Class-action lawsuit alleges that Celgene participated in an anticompetitive scheme to delay release of generic versions of each drug.
Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
- Rybelsus (semaglutide) is the only orally dosed glucagon-like peptide-1 (GLP-1) agonist, a class that includes injectable drugs such as Victoza (liraglutide), Ozempic (semaglutide), and Trulicity (dulaglutide).
Eli Lilly announces release of lower-priced versions of Humalog Mix75/25 KwikPen (insulin lispro protamine/insulin lispro) and Humalog Junior KwikPen (insulin lispro)
- Both products will be available by mid-April at a 50% lower list price compared to their branded counterparts.
Pfizer announces introduction of three new biosimilars, Zirabev (bevacizumab-bvzr), Ruxience (rituximab-pvvr), and Trazimera (trastuzumab-qyyp)
- Each product will be priced at the lowest Wholesale Acquisition Cost (WAC) available on the market.
CVS Health introduces RxZERO plan design that eliminates member out-of-pocket costs for diabetes drugs
- According to CVS Health research, RxZERO demonstrates improved medication adherence and reduction in overall medical costs.
- CVS Health also calculates that the plan design can lower overall costs for payers if the CVS Value Formulary is adopted in conjunction with the program.
ICER analysis finds that new sickle cell therapies Adakveo (crizanlizumab), Oxbryta (voxelotor), and Endari (L-glutamine) fail to meet cost-effectiveness threshold
- Each drug has a list price significantly higher than the price needed to achieve ICER’s cost-effectiveness threshold of $150,000 per quality-adjusted life year (QALY).
A group of Blue Cross Blue Shield (BCBS) insurers pledge $55 million in collaboration with Civica Rx to offer cheaper generic drugs
- The BCBS plans and Civica Rx plan to target expensive generic drugs that have little to no competition.
Coronavirus outbreak may affect the U.S. drug supply chain
- China, the epicenter of the COVID-19 outbreak, is facing travel and trade restrictions as it struggles to contain the spread of the disease.
- The U.S. imports large quantities of active pharmaceutical ingredients (APIs) from China.
Clinical Trials and Research
Skyrizi (risankizumab) demonstrates superiority over Cosentyx (secukinumab) in head-to-head study
- Phase 3 trial evaluated treatment in patients with moderate to severe plaque psoriasis, measuring rates of skin clearance between the two drugs.