Pharmacist Champion Role Improves Access to Resmetirom for MASH

In recent study results, a pharmacist champion promoted access to resmetirom, a drug for metabolic dysfunction-associated steatohepatitis (MASH). The results highlight the value of including a pharmacist champion in coordinating access to medications in specialty care.¹

Resmetirom (Rezdiffra; Madrigal Pharmaceuticals) is a selective agonist of the thyroid hormone receptor b, which is predominantly found in the liver. Activating this receptor decreases inflammation and fibrosis in patients with MASH.^2,3

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MASH is a chronic liver disease characterized by inflammation and damage due to the buildup of excess fat in individuals who drink little to no alcohol. However, resmetirom has improved steatosis, steatohepatitis, and fibrosis in clinical trials.^2,3 In the Phase 3 MAESTRO NASH trial, resmetirom was significantly associated with greater MASH resolution without worsening fibrosis.³

The FDA granted resmetirom conditional approval on March 14, 2024.⁴ However, the drug is available only through a handful of specialty pharmacies in the United States, and providers must complete preauthorization procedures to obtain it.⁴

The study, published in Hepatology Communications, examined the use of a pharmacist champion to obtain access to resmetirom. The pharmacist worked for a university health system-based hepatology clinic, and patients were prescribed resmetirom for treating MASH with stage 2 or 3 fibrosis.¹

After receiving the prescription, the pharmacist champion initiated prior authorization procedures with the payors, who then determined approval and any co-pay. Once approved, payors selected a specialty pharmacy for dispensing. The pharmacist also submitted appeals on prior authorization denials. In the event of continued denials, the pharmacist guided patients to the Madrigal patient assistance program. The pharmacist also coordinated communication with the prescribers and the clinical nursing staff during the approval process.¹

The pharmacist champion intervention led to the medication's approval in 110 of the 113 prescriptions (102 payor, 8 patient assistance program). The payor initially denied 10 prescriptions; 8 required a single appeal, and 2 needed 2 appeals before approval. Eighty-three patients (75%) started the medication a mean of 30 days after the date of prescribing.¹

The authors concluded that the clinic’s prescribing process, led by a pharmacist champion, successfully dispensed resmetirom to almost all patients who were prescribed it.

REFERENCES

1. Ravela N, Shackelford P, Blessing N, Yoder L, Chalasani N, Samala N. Early experience with resmetirom to treat metabolic dysfunction-associated steatohepatitis with fibrosis in a real-world setting. Hepatol Commun. 2025;9(4):e0670. doi:10.1097/HC9.0000000000670

2. Harrison SA, Bashir MR, Guy CD, et al. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019;394(10213):2012-2024. doi:10.1016/S0140-6736(19)32517-6

3. Harrison SA, Bedossa P, Guy CD, et al. A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. N Engl J Med. 2024;390;497-509. doi:10.1056/NEJMoa2309000

4. FDA Approves First Treatment for Patients With Liver Scarring Due to Fatty Liver Disease. News release. FDA. Updated March 14, 2024. Accessed May 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease