BEHAVIORAL HEALTH CORNER

Shortages of stimulants for ADHD are currently being reported by the FDA. This includes generic methylphenidate extended-release (ER) tablets as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate immediate release (IR) tablets also continue to be reported from select manufacturers.

WEIGHT MANAGEMENT CORNER

Recently, the Congressional Budget Office (CBO) had issued a question and answer summary following a hearing on the oversight of the CBO. Questions have arisen regarding Medicare’s potential coverage of obesity medications. Specifically, CBO had stated that if the FDA approves glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) for CV indications, it is expected Medicare will provide coverage for these indications in patients with obesity. Currently, the CBO is researching the number of individuals receiving treatment with anti-obesity medications and recognizes that ongoing use of these medications is generally required as discontinuation can result in regained weight and associated adverse health outcomes. The CBO’s evaluation of proposals to expand Medicare coverage of GLP-1 RAs takes into consideration the chronicity of use of these medications by the patient as well as the importance of continued medication coverage for those patients who transition from commercial insurance to Medicare. Semaglutide (Wegovy®) is FDA-approved for secondary prevention of cardiovascular disease (CVD) in adults with obesity or overweight.

CLINICAL CORNER

The FDA has approved the Dexcom Stelo Glucose Biosensor System as the first OTC continuous glucose monitor (CGM). The device is intended for use in adults who do not use insulin. This includes individuals with diabetes mellitus (DM) managed with oral medications as well as individuals without DM who want to monitor the impact of diet and exercise on their blood glucose levels. The system does not alert users to hypoglycemic episodes and therefore is not intended for those with problematic hypoglycemia. Dexcom Stelo Glucose Biosensor System includes a wearable sensor that pairs with an application (app) on a smartphone or other smart device and provides continuous data on the individual’s blood glucose measurements every 15 minutes. Sensors can be worn for up to 15 days. A clinical study demonstrated the system was comparable in performance to other integrated CGMs. The OTC CGM is expected to be available in summer 2024.

The FDA is reporting limited availability of dulaglutide (Trulicity®) 1.5 mg/0.5 mL and 4.5 mg/0.5 mL injection through April 2024 due to increased demand. The 0.75 mg/0.5 mL and 3 mg/0.5 mL strengths remain available. Trulicity is a GLP-1 RA indicated (1) as an adjunct to diet and exercise to improve glycemic control in patients ≥ 10 years of age with type 2 DM (T2DM) and (2) to reduce the risk of major adverse cardiovascular events (MACE) in adults with T2DM who have established CVD or multiple CV risk factors.

COVID-19: NOTABLE DEVELOPMENTS

The FDA has announced that only NDA-labeled nirmatrelvir tablets/ritonavir tablets (Paxlovid™) can now be dispensed for both NDA-approved and EUA-authorized uses. As EUA-labeled product is no longer authorized for emergency use, regardless of the labeled or extended expiration date, it should be disposed of or returned to manufacturer. This revision to the EUA marks the completion of the transition from EUA-labeled Paxlovid to FDA-approved Paxlovid.

The CDC published an MMWR on interim effectiveness of the updated 2023–2024 COVID-19 vaccines (monovalent XBB.1.5) against COVID-19-associated emergency department visits, urgent care encounters, and hospitalizations in immunocompetent adults. During the first 7 to 59 days following receipt of an updated dose, interim vaccine effectiveness (VE) against COVID-19-associated emergency department/urgent care encounters was 51% (95% confidence interval [CI], 47 to 54). During days 60 to 119 following an updated dose, interim VE was 39% (95% CI, 33 to 45). For protection against COVID-19-associated hospitalization, data from two CDC networks demonstrated VE estimates were 52% (95% CI, 47 to 57) and 43% (95% CI, 27 to 56); the median interval from an updated dose was 42 days and 47 days, respectively.

An upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is planned for May 16, 2024. Recommendations on strain(s) for inclusion in the 2024–2025 formula for COVID-19 vaccines are expected.

INFLUENZA UPDATES

The CDC is reporting influenza-like illness (ILI) for the week ending March 16, 2024. Seasonal influenza activity remains elevated in the U.S. but is decreasing or stable in some regions; a slight increase is being reported in the Pacific Northwest. The most frequently reported viruses this week were influenza A (H3N2). As of March 4, 2024, the FDA is reporting available product from all manufacturers of antiviral influenza medications.

The CDC published an MMWR on interim estimates of the 2023–2024 seasonal influenza VE across the country. In pediatric individuals 6 months to 17 years of age, interim VE against outpatient visits was 59% to 67% and protection against hospitalization was 52% to 61%. In adults, interim VE against outpatient visits was 33% to 49% and protection against hospitalization was 41% to 44%.

The FDA’s VRBPAC convened on March 5, 2024 to determine the composition of the influenza vaccinations for the 2024–2025 influenza season. The committee recommended a trivalent vaccine composition for the upcoming influenza season. Trivalent vaccines will include two influenza A viruses (H1N1 and H3N2) and one influenza B virus. The change from quadrivalent influenza vaccines to trivalent influenza vaccines is based on removal of the influenza B/Yamagata lineage due to lack of confirmed detections of circulating B/Yamagata lineage viruses worldwide after March 2020.