WEIGHT MANAGEMENT CORNER

The FDA has approved 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg single-dose vials of tirzepatide (Zepbound), a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. The agent is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥ 30 kg/m² or of ≥ 27 kg/m² in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus [T2DM], obstructive sleep apnea, cardiovascular disease). Zepbound was already approved in 0.5 mL single-dose pens in all strengths.

The FDA is currently reporting shortages of GLP-1 agonists that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management. This includes liraglutide (Saxenda), which has limited availability due to increased demand. The 2.5 mg/0.5 mL strength of tirzepatide (Zepbound) is currently available, all other strengths have limited availability through Q2 2024 due to increased demand for the drug.

Shortages are also being reported for GLP-1 agonists that are indicated for select patients with T2DM. Liraglutide (Victoza) has limited availability through June 2024 due to delays in shipping. Additionally, tirzepatide (Mounjaro) in the 2.5 mg/0.5 mL is currently available, all other strengths have limited availability through Q2 2024 due to increased demand.

BEHAVIORAL HEALTH CORNER

Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) are currently being reported. These include generic methylphenidate HCl extended-release (ER) tablets, as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate immediate release (IR) tablets also continue from select manufacturers.

BIOSIMILAR CORNER

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized contract year 2025 changes enhancing the flexibility of Medicare Part D plans to substitute lower cost biosimilars for their reference products. Specifically, the final rule allows for all biosimilars to be substituted as formulary maintenance changes that would not require explicit prior approval from CMS. Previously, only interchangeable biosimilars were eligible for substitution as a “maintenance change.” Allowing for all biosimilar substitutions to be treated as maintenance changes ensures that midyear formulary substitution of biosimilars for their reference products applies to all enrollees (following a 30-day advance notice), including patients who are already receiving a reference product before the effective date of change. Prior to this change, Part D sponsors were required to obtain approval before substituting a biosimilar for a reference product if the biosimilar was not an interchangeable biosimilar. As a result, these substitutions were only applicable to enrollees who initiated therapy after the effective date of change. Furthermore, the contract year 2025 final rule allows for new interchangeable biological products to be immediately substituted on the formulary. This would apply to interchangeable biosimilars not commercially available at the time of initial formulary submission for CMS approval. Sponsors who have met certain requirements will have the option to immediately substitute new interchangeable biosimilars for a reference product, with impacted enrollees notified of the change after it has been enacted.