On August 25, 2023, several generic drug manufacturers received U.S. Food and Drug Administration (FDA) approval for A-rated generics to Vyvanse® (lisdexamfetamine – Takeda Pharmaceuticals). Lisdexamfetamine is taken once each morning to treat attention deficit hyperactivity disorder (ADHD) for patients at least six years old and binge eating disorder (BED) for adults. A boxed warning cautions that lisdexamfetamine is a Class II controlled (CII) central nervous system (CNS) stimulant with increased potential for abuse and/or dependence. Brand Vyvanse® typically costs about $370 per month while generic lisdexamfetamine is expected to cost approximately $160 per month.
The increased awareness and discussion around more effective weight management medications has resulted in obesity medication pipeline growth. Research and development is focusing on new dosage forms, oral versus injectable, and combinations with glucagon-like peptide-1 receptor agonists. Currently, Eli Lilly and Company (Lilly) and Novo Nordisk dominate the pipeline for weight management medications.
|Product||Manufacturer||Route||Frequency||Class||Maximum Average Weight Loss (Timeframe)||Expected Approval|
|tirzepatide||Lilly||SC||Once weekly||GLP-1 receptor agonist||13.4%
|Late 2023 -
|semaglutide||Novo Nordisk||Oral||Once daily||GLP-1 receptor agonist||15.1%
|CagriSema (cagrilintide/semaglutide)||Novo Nordisk||SC||Once weekly||Amylin analog/GLP-1 receptor agonist||15.6%
|danuglipron||Pfizer||Oral||Twice daily||GLP-1 receptor agonist||-5.4kg
|retatrutide||Lilly||SC||Once weekly||GIP/GLP-1/Glucagon receptor agonist||
|orforglipron||Lilly||Oral||Once daily||GLP-1 receptor agonist||14.7%
Reference source: https://www.clinicaltrialsarena.com/features/obesity-trials-to-watch/
On July 31, 2023, Viatris and Kindeva launched Breyna™, an AB-rated generic version of AstraZeneca’s Symbicort® (budesonide/formoterol) metered-dose inhaler. This generic medication was approved by the FDA on March 15, 2022 and is used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Breyna’s™ wholesale acquisition cost (WAC) is approximately a 39% discount off Symbicort®. ProAct will work with our members taking Symbicort® to transition from the brand name medication to the lower cost generic alternative.
ProAct understands that managing costs and driving out waste are critical concerns for plan sponsors. Our Wipe Out Waste (WOW) Program detects high-cost/low-value products and generates a list of wasteful items that you, as a plan sponsor, may choose to exclude from your pharmacy benefit. Wasteful products may include high-cost unique dosage forms, new non-FDA approved drugs, high-cost topical pain management therapies not aligned to FDA-approved prescribing guidance, unnecessarily combined products often marketed in a higher cost package or kit, or select 510K products (medical devices that do not alter body chemistry and that follow an approval process separate from standard FDA-approved drugs).
On July 13, 2023, the Food and Drug Administration (FDA) approved the first oral contraceptive available over-the-counter (OTC) to prevent pregnancy without age restrictions. Opill (norgestrel 0.075 mg tablets), a progestin-only contraceptive, is the first daily, oral contraceptive approved in the United States for use without a prescription. Opill's OTC approval will allow for consumer purchase at a variety of retail outlets, including drug stores, grocery stores, convenience stores, and online. Opill will be available in stores and online in the first quarter of 2024. Pricing information for Opill has not yet been released.
For more information, visit: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information