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.

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. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd

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

The Inflation Reduction Act (IRA) of 2022 established a Drug Price Negotiation (DPN) Program for Medicare. The program requires the U.S. Department of Health and Human Services (HHS) to negotiate prices with drug manufacturers for some single-source medications covered under Medicare Part B and Part D. HHS is scheduled to release, on September 1, 2023, the first list of selected, qualifying medications, and to begin negotiations on October 1, 2023. In June 2023, Merck & Co. filed the first lawsuit against HHS challenging the constitutionality of the DPN program. The Ohio Chamber of Commerce, Bristol Myers Squibb, and Pharmaceutical Research and Manufacturers of America have also filed lawsuits challenging the constitutionality of the DPN program. The impact the DPN program will have in the commercial space is still unknown as prices on the selected single-source medications could remained unchanged or even possibly increase as drug manufacturers look to offset losses in revenue. For more information, visit: https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation and https://jamanetwork.com/journals/jama-health-forum/fullarticle/2787467