How to Get Rezdiffra (Resmetirom) in Maryland

What Is Rezdiffra and Why Does It Matter for Maryland Patients?

Rezdiffra (resmetirom) is the first FDA-approved oral medication specifically targeting metabolic dysfunction-associated steatohepatitis (MASH), previously called non-alcoholic steatohepatitis (NASH). The drug received accelerated approval in March 2024 based on surrogate histological endpoints from the MAESTRO-NASH trial.

Maryland has one of the higher rates of liver disease in the mid-Atlantic region. The CDC estimates that chronic liver disease and cirrhosis rank among the top 12 causes of death nationally, and MASH is now the fastest-growing indication for liver transplant in the United States. Before resmetirom, Maryland clinicians had no FDA-approved pharmacotherapy for MASH. They relied on weight loss counseling, vitamin E in select non-diabetic patients, and off-label pioglitazone. Rezdiffra changes that equation directly.

Resmetirom works as a thyroid hormone receptor-beta (THR-beta) selective agonist. It activates hepatic THR-beta to reduce liver fat, lower atherogenic lipoproteins, and decrease hepatic inflammation without the cardiac side effects of non-selective thyroid hormone analogs. In the MAESTRO-NASH phase 3 trial (N=966), the 100 mg dose achieved NASH resolution without worsening fibrosis in 25.9% of patients at 52 weeks, compared to 9.7% on placebo (P<0.001) [1]. The drug is dosed as an 80 mg or 100 mg oral tablet once daily, selected based on body weight.

Maryland Telehealth Prescribing Rules for Rezdiffra

Maryland permits telehealth prescribing of Rezdiffra. No in-person visit is required to initiate or continue the prescription, provided the prescriber holds an active Maryland medical license.

Maryland's telehealth statute (Md. Code, Health-General §19-319) was permanently expanded after COVID-era emergency orders. Physicians, nurse practitioners (NPs with independent practice authority gained under Maryland's 2024 NP modernization law), and physician assistants with a collaborative agreement can all prescribe Rezdiffra via synchronous audio-video visits. The Maryland Board of Physicians requires that the provider establish a bona fide provider-patient relationship during the initial telehealth encounter, document a clinical assessment, and maintain records accessible within the state.

For Rezdiffra specifically, telehealth visits must include review of qualifying imaging or biopsy results. The AASLD practice guidance on MASLD/MASH recommends that clinicians confirm fibrosis stage before initiating therapy [2]. A provider conducting a telehealth visit can review uploaded FibroScan, MRE, or liver biopsy reports shared through a patient portal. There is no Maryland-specific requirement that these tests be performed within the state. Results from out-of-state facilities are accepted.

The practical advantage for Maryland patients is significant. Baltimore, the state's largest city, has multiple hepatology centers. But patients in Western Maryland, the Eastern Shore, and Southern Maryland often face 60- to 90-minute drives to see a liver specialist. Telehealth removes that barrier entirely.

Who Can Prescribe Rezdiffra in Maryland?

Three provider types hold prescriptive authority for Rezdiffra in Maryland: MDs/DOs, nurse practitioners, and physician assistants. Each has different scope conditions.

Physicians (MD/DO): Any Maryland-licensed physician can prescribe resmetirom. Hepatologists and gastroenterologists are the most common prescribers given the MASH indication, but endocrinologists, obesity medicine specialists, and primary care physicians with liver disease experience can also write the prescription. No specialty restriction exists in the FDA-approved labeling [3].

Nurse practitioners: Maryland granted NPs full practice authority effective July 2024. NPs no longer require a collaborative agreement with a physician after completing the required supervised practice period. An NP specializing in hepatology or primary care can independently prescribe Rezdiffra and sign prior authorization forms.

Physician assistants: PAs in Maryland must practice under a written delegation agreement with a supervising physician. A PA can prescribe Rezdiffra if their delegation agreement includes authority to prescribe Schedule VI (non-controlled legend drugs) and the supervising physician's practice scope covers the indication.

Required Labs Before Starting Rezdiffra in Maryland

A specific set of laboratory and imaging studies must be completed before any Maryland provider will prescribe resmetirom. These labs serve two purposes: confirming the MASH diagnosis with fibrosis staging and establishing baseline safety monitoring.

Diagnostic confirmation labs:

• FIB-4 index: Calculated from age, AST, ALT, and platelet count. A FIB-4 score ≥1.3 triggers further workup. The American Gastroenterological Association's clinical care pathway recommends FIB-4 as the first-line non-invasive screening tool [4].
• Vibration-controlled transient elastography (FibroScan) or MR elastography: Used to stage fibrosis. The FDA indication covers F1b through F3 fibrosis. FibroScan values between 8.0 and 13.9 kPa generally correspond to this range, though the correlation depends on BMI and etiology [5].
• Liver biopsy (if non-invasive tests are indeterminate): While not universally required, some insurers in Maryland request biopsy confirmation for prior authorization. The MAESTRO-NASH trial used biopsy-confirmed NASH with NAS ≥4 as an entry criterion [1].

Baseline safety labs:

• Comprehensive metabolic panel (CMP): Includes ALT, AST, alkaline phosphatase, albumin, and bilirubin. The FDA label recommends checking hepatic function before initiation.
• TSH and free T4: Resmetirom is a THR-beta agonist. While it is designed to spare THR-alpha (cardiac receptor), baseline thyroid function must be documented. Patients with uncontrolled hypothyroidism or TSH <0.5 mIU/L were excluded from MAESTRO-NASH.
• Lipid panel: Resmetirom significantly lowers LDL-C and triglycerides. In MAESTRO-NASH, the 100 mg dose reduced LDL-C by approximately 14% from baseline at week 24 [1]. Baseline lipid values help track therapeutic response.
• CBC with differential: Needed for FIB-4 calculation and to rule out concurrent hematologic conditions.

Most Maryland labs (Quest, LabCorp, and hospital-affiliated draw stations) can process this full panel within 24 to 48 hours. Telehealth providers typically order labs through a nationwide network and receive results electronically.

Maryland Medicaid and Commercial Insurance Coverage

Maryland Medicaid covers Rezdiffra with prior authorization. Commercial plans vary. Here is what the approval process looks like in practice.

Maryland Medicaid: The Maryland Department of Health Pharmacy Program lists Rezdiffra on its preferred drug list with step therapy and PA requirements. The PA form requires documentation of MASH diagnosis (ICD-10 code K75.81), fibrosis stage (F1b, F2, or F3 confirmed by biopsy or validated non-invasive test), evidence that lifestyle modifications were attempted, and prescriber attestation that the patient does not have decompensated cirrhosis (Child-Pugh B or C). The FDA label explicitly warns against use in decompensated cirrhosis [3]. Initial authorization is typically granted for 12 months, with renewal contingent on documented adherence and follow-up labs.

Commercial insurers in Maryland: CareFirst BlueCross BlueShield, Kaiser Permanente Mid-Atlantic, and UnitedHealthcare, the three largest commercial carriers in the state, have each published medical policies for resmetirom coverage. Common requirements across these plans include:

• MASH diagnosis confirmed by a hepatologist or gastroenterologist
• Fibrosis staging documentation (FibroScan, MRE, or biopsy)
• Failure or contraindication to lifestyle intervention for at least 6 months
• Prescriber specialty verification (some plans restrict to hepatology/GI)

Prior authorization timelines: Maryland law (Insurance Article §15-1003) requires health insurers to respond to non-urgent PA requests within 2 business days. Most PA decisions for Rezdiffra are returned within that window. If denied, patients can file an expedited appeal, which must be resolved within 24 hours for urgent cases and 30 days for standard appeals.

The Endocrine Society's clinical practice guidelines on NAFLD management note that access barriers to newer MASH therapies remain significant, and PA requirements may delay treatment initiation by 2 to 4 weeks in some cases [6].

Pharmacy Access and 503A Compounding in Maryland

Rezdiffra is available through retail specialty pharmacies and 503A compounding pharmacies in Maryland. The dispensing pathway depends on insurance status and prescriber preference.

Specialty pharmacy distribution: Madrigal Pharmaceuticals distributes Rezdiffra through a limited specialty pharmacy network. In Maryland, accredited specialty pharmacies including CVS Specialty, Optum Specialty Pharmacy, and Biologics by McKesson can fill prescriptions. These pharmacies handle PA coordination, copay assistance enrollment, and direct-to-patient shipping. Most patients in Maryland receive home delivery within 3 to 5 business days after PA approval.

503A compounding pharmacies: Maryland licenses 503A compounding pharmacies under COMAR 10.34.19. These pharmacies can compound patient-specific prescriptions, including resmetirom formulations, when prescribed by a licensed provider for an individual patient. This route may be relevant for patients who need dose adjustments outside standard tablet strengths or who face insurance access barriers. A 503A pharmacy must compound from bulk drug substances that meet USP standards and must ship only within states where they hold licensure.

Cost considerations: Without insurance, Rezdiffra carries a list price of approximately $47,400 per year. Madrigal's patient assistance program, Rezdiffra Complete, offers copay support that can reduce out-of-pocket costs to $0 for eligible commercially insured patients. For uninsured patients, the program provides medication at no cost for qualifying individuals below 400% of the federal poverty level. Information is available through Madrigal's prescribing portal [3].

Step-by-Step Process to Get Rezdiffra in Maryland

The path from initial evaluation to first dose follows a predictable sequence. Here is the timeline most Maryland patients experience.

Week 1: Clinical evaluation. Schedule an appointment (in-person or telehealth) with a hepatologist, gastroenterologist, or qualified primary care provider. Bring any existing liver imaging, lab results, and a list of current medications. The provider will assess MASH diagnosis and fibrosis stage. If a FibroScan or MRE has not been performed within the past 12 months, the provider will order one.

Week 1 to 2: Lab work. Complete the required baseline labs (CMP, lipid panel, TSH, CBC). If FibroScan is needed, scheduling at Maryland imaging centers typically takes 3 to 7 days. Johns Hopkins, University of Maryland Medical Center, and several private GI practices across the Baltimore-Washington corridor offer FibroScan.

Week 2 to 3: Prescription and PA submission. Once fibrosis stage is confirmed (F1b to F3) and labs are reviewed, the provider writes the Rezdiffra prescription. Dosing follows body weight: 80 mg once daily for patients weighing <100 kg, and 100 mg once daily for those ≥100 kg [3]. The provider's office or specialty pharmacy submits the PA to the patient's insurer.

Week 3 to 4: PA decision and pharmacy fill. Maryland insurers must respond within 2 business days. After approval, the specialty pharmacy ships medication. Most patients receive their first 30-day supply within 3 to 5 business days of PA approval.

Week 4 onward: Treatment initiation and monitoring. The provider schedules follow-up labs (liver panel at 12 weeks, then every 3 to 6 months) and a clinical reassessment at 6 months to evaluate response. The MAESTRO-NASH protocol used 52-week histological endpoints, but clinical labs and imaging can track interim progress [1].

Transferring a Rezdiffra Prescription to Maryland

Patients relocating to Maryland or receiving care across state lines can transfer an existing Rezdiffra prescription. The process requires a few specific steps.

Maryland accepts prescription transfers from any U.S. state for non-controlled medications. The receiving pharmacy in Maryland contacts the originating pharmacy to verify the prescription, remaining refills, and prescriber information. If the original prescriber is not licensed in Maryland, a new prescription from a Maryland-licensed provider is required. This is where telehealth becomes especially useful: a single video visit with a Maryland-licensed hepatologist can generate a new prescription without requiring transfer of the original.

For patients using specialty pharmacy home delivery, a simpler option exists. National specialty pharmacies (CVS Specialty, Optum) that already fill the patient's prescription can ship to a Maryland address without a formal transfer, provided the prescriber holds a Maryland license or the pharmacy is licensed in both states. Patients should verify their specialty pharmacy's Maryland licensure before assuming smooth delivery.

Monitoring and Long-Term Follow-Up in Maryland

Resmetirom treatment requires ongoing clinical monitoring. The drug's safety profile in MAESTRO-NASH was generally favorable, with the most common adverse events being diarrhea (26.6% vs. 16.8% placebo) and nausea (18.2% vs. 14.5% placebo) at the 100 mg dose [1]. Serious hepatotoxicity was not observed in the trial, but the FDA label recommends periodic liver function monitoring [3].

Maryland providers typically follow this monitoring schedule:

• Week 12: Repeat CMP (ALT, AST focus), lipid panel, and TSH
• Month 6: Clinical reassessment, repeat FibroScan or MRE if baseline was abnormal, evaluate symptom response and tolerability
• Month 12: Full reassessment including all baseline labs, imaging, and consideration of continued therapy vs. dose adjustment
• Annually thereafter: Liver function, lipid panel, thyroid function, and fibrosis staging by non-invasive testing

The AASLD guidance recommends that patients on any MASH pharmacotherapy receive structured follow-up at least every 6 months to assess disease trajectory [2]. Maryland's telehealth infrastructure makes this follow-up accessible even for patients in rural parts of the state.

One critical long-term consideration: Rezdiffra's accelerated approval is contingent on the confirmatory portion of the MAESTRO-NASH trial demonstrating clinical outcome benefit. Data is expected by 2028. If the confirmatory data does not support sustained benefit, the FDA could withdraw approval, which would affect ongoing prescriptions in Maryland and all other states.

Clinical Efficacy Data Supporting Rezdiffra Use

The evidence base for resmetirom centers on the MAESTRO-NASH trial, published in the New England Journal of Medicine in February 2024 [1]. This was a phase 3, randomized, double-blind, placebo-controlled trial enrolling 966 patients with biopsy-confirmed NASH and fibrosis stages F1b through F3.

Two co-primary endpoints were evaluated at 52 weeks: NASH resolution with no worsening of fibrosis, and fibrosis improvement by at least one stage with no worsening of NAS. At the 100 mg dose, 25.9% of patients achieved NASH resolution compared to 9.7% on placebo. Fibrosis improvement occurred in 24.2% on 100 mg versus 14.2% on placebo [1].

Secondary endpoints showed meaningful metabolic benefits. LDL-C decreased by approximately 14%, and triglycerides dropped by roughly 20% from baseline at the 100 mg dose. These lipid effects are clinically relevant because MASH patients carry disproportionate cardiovascular risk. The American Heart Association's 2023 scientific statement on NAFLD and cardiovascular disease reported that cardiovascular events are the leading cause of death in MASH patients, exceeding liver-related mortality [7].

The safety profile showed no signal for thyrotoxicosis, atrial fibrillation, or bone density loss, which were theoretical concerns given the drug's thyroid hormone receptor mechanism. This selectivity for THR-beta over THR-alpha distinguishes resmetirom from older thyroid analogs that caused cardiac adverse events.