— DRUG UPDATE —
NEW & NOTABLE
NOVEL MEDICATIONS WORTH KNOWING BY FARAH JALLOUL,
director of professional development, Michigan Pharmacists Association; JACKSON MAURER, P4 student pharmacist, Ferris State University; and JASON CORMIER, P4 student pharmacist, Wayne State University
“When a new brand of medication enters the market, one of the first questions asked, by both healthcare professionals and patients alike, is what the cost will be, especially on the patient end?”
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MichiganPharmacists.org
Novel Medications for Type 2 Diabetes Just as Michigan was starting to warm up for summer this year, a novel injectable medication by Eli Lilly and Company, Mounjaro™ (tirzepatide) entered the world of medicine. Mounjaro™ received approval from the U.S. Food & Drug Administration (FDA) for adjunct treatment of patients with type 2 diabetes with concurrent diet and exercise, becoming the first and only medication of its kind in regard to its mechanism of action. Unlike all previous diabetic injection therapies, Mounjaro™ has a dual mechanism of action acting on both glucosedependent insulinotropic polypeptide (GIP) and glucagonlike peptide-1 (GLP-1) receptor agonism. Once-weekly injections, established auto-injector pens and a pre-attached hidden needle device are a few of the advantages of this dual-acting agent. Mounjaro™ markets therapeutic maintenance doses of 5 mg, 10 mg and 15 mg with 2.5 mg increments available for titration purposes. In a study, patients in the approval-based SURPASS program had a decrease in A1C of 1.8 percent to 2.1 percent with the 5 mg dose and 1.8 percent to 2.4 percent with both 10 mg and 15 mg maintenance doses. These were superior to all comparators in the trials including weekly semaglutide. Mounjaro™ is not currently indicated for weight loss; however, it was an endpoint throughout the SURPASS program with patients receiving treatment losing between 12 to 25 pounds on average. Weight loss is significant for this patient population, as 90 percent of patients are overweight and 60 percent are obese. This weight loss is one of the benefits leading to proposed healthcare savings for patients, as well as the theorized possibility of improving other concurrent disease states. The side effect profile of Mounjaro™ mirrors that of its GLP-1 injection counterparts, being low incidents of hypoglycemia. The highest reported side effects were nausea, diarrhea and other gastrointestinal distress. Mounjaro™ is not indicated for use in patients with type 1 diabetes, history of pancreatitis, and it does carry a black box warning of thyroid C-cell tumors. When a new brand of medication enters the market, one of the first questions asked, by both healthcare professionals and patients alike, is what the cost will be, especially on the patient end? The manufacturer of the medication is providing patient assistance; for those who qualify, patients will have a $25 copay, lasting for the first year of treatment using Mounjaro™. For more information on cost savings options please visit www.Mounjaro.com. Further information on coverage and accepted plans will come with time.
A New Addition to Weight Loss Therapy In June 2021, Wegovy® (semaglutide) became the first drug in over a decade to receive an FDA approval for chronic weight loss management. Wegovy® is now one of only five medications approved for this indication. This approval comes in the midst of the ongoing COVID-19 epidemic, with studies tying obesity to overall worse health outcomes in COVID-19 patients, including higher rates of hospitalization, higher risk of being placed on ventilation and increased mortality. The Semaglutide Treatment Effect in People with Obesity (STEP) program, a 68-week trial, showed a 14.9 percent decrease in patient mean body weight on Wegovy® – a marked improvement over a shorter 56-week trial (SCALE 2015) that itself showed an 8 percent decrease in mean body weight. Wegovy® boasts a weekly injection schedule, as compared to the daily administration of similar product Saxenda®; both have similar common side effects and titration schedules that mirror one another in purpose and duration. Weekly dosing of Wegovy® for this indication, 2.4 mg, exceeds the maximum recommended dose for semaglutide’s other indication, treatment of type-2 diabetes mellitus (2.0 mg). Following this data, Wegovy® appears to be a good option for the patient populations included in the study, with fewer injections, similar side effects, and greater efficacy than Saxenda.® The downside to new medications is always cost, and Wegovy® is no exception. However, patient assistance programs exist from the manufacturer for those who qualify.
NEW with Norliqva® Norliqva® 1 mg/mL is the first FDA-approved liquid solution of amlodipine indicated for the treatment of hypertension and coronary artery disease in adults. It is indicated for the treatment of hypertension in children 6 years of age and older to lower blood pressure; it is kidfriendly, with a mild peppermint flavor. Adult recommended starting dose: 5 mg orally once daily with a maximum of 10 mg orally once daily. Small, fragile or elderly patients, or patients with hepatic insufficiency, may be started on 2.5 mg orally once daily. Pediatric starting dose: 2.5 mg to 5 mg orally once daily. To learn more about Norliqva, visit: www.Norliqva.com. Patients may qualify for the EasyPay Copay program, visit: www.CMPPharma.com/EasyPay for more information.
