How to Get Rezdiffra (Resmetirom) in North Dakota

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

Rezdiffra (resmetirom) is the first FDA-approved medication specifically targeting metabolic dysfunction-associated steatohepatitis (MASH), formerly called non-alcoholic steatohepatitis (NASH). The FDA granted accelerated approval in March 2024 based on surrogate endpoints of NASH resolution and fibrosis improvement [1]. Before this approval, no pharmacotherapy existed for MASH. Patients relied entirely on weight loss, dietary changes, and management of comorbidities.

Resmetirom works as a selective thyroid hormone receptor beta (THR-β) agonist. It activates hepatic THR-β to reduce liver fat, lower atherogenic lipoproteins, and decrease markers of hepatic inflammation without the cardiac side effects associated with systemic thyroid hormone activation [2]. In the MAESTRO-NASH trial (N=966), 25.9% of patients receiving the 100 mg dose achieved NASH resolution with no worsening of fibrosis at 52 weeks, compared to 9.7% on placebo (P<0.001) [1]. A separate co-primary endpoint showed that 24.2% of the 100 mg group achieved at least one stage of fibrosis improvement with no worsening of NASH, versus 14.2% for placebo [1].

The drug also produced meaningful metabolic effects. LDL cholesterol dropped by approximately 13 to 16% from baseline, and hepatic fat fraction measured by MRI-PDFF decreased by roughly 45 to 53% relative to placebo [2]. These results gave the FDA sufficient evidence for accelerated approval while Madrigal continues the confirmatory phase of the MAESTRO-NASH trial.

For the estimated 1.5, 2 million Americans with MASH-related F2, F3 fibrosis, Rezdiffra represents a first-in-class treatment option. North Dakota patients with confirmed MASH now have a defined pathway to access it.

Who Can Prescribe Rezdiffra in North Dakota?

Any licensed prescriber in North Dakota with the appropriate scope of practice can write a Rezdiffra prescription. This includes MDs, DOs, nurse practitioners (NPs), and physician assistants (PAs).

In practice, Rezdiffra prescriptions most commonly originate from hepatologists and gastroenterologists because MASH diagnosis requires fibrosis staging through FibroScan (vibration-controlled transient elastography) or liver biopsy [3]. North Dakota's prescriber pool for liver-specific conditions is concentrated in Fargo, Bismarck, and Grand Forks. Sanford Health and CHI St. Alexius maintain gastroenterology divisions in these cities. Rural patients often face 90-minute or longer drives to see a specialist in person.

Primary care physicians can also prescribe Rezdiffra if they have confirmed the MASH diagnosis and fibrosis stage. The AASLD practice guidance on MASLD/MASH supports primary care involvement in MASH management, particularly when specialist access is limited [3]. North Dakota's rural geography makes this relevant: 27 of the state's 53 counties have no gastroenterologist.

NPs in North Dakota have full practice authority under NDCC 43-12.1, meaning they do not need a collaborative physician agreement to prescribe. PAs practice under physician supervision but retain prescriptive authority for scheduled and non-scheduled medications. Both can initiate Rezdiffra provided the diagnostic criteria are documented.

Telehealth Prescribing: How It Works in North Dakota

North Dakota permits telehealth prescribing of Rezdiffra, opening access for patients who cannot easily reach a hepatologist. The state's telehealth laws, codified under NDCC 43-17-01 and expanded during the post-2020 legislative updates, allow out-of-state physicians to treat North Dakota patients if they hold an active North Dakota medical license or a valid interstate compact license.

The telehealth workflow for Rezdiffra typically follows a defined sequence. First, the patient completes an intake that includes medical history, current medications, and recent lab results. The provider then reviews FibroScan or biopsy data confirming F2, F3 fibrosis. If no FibroScan has been performed, some telehealth platforms coordinate with local imaging centers in Fargo, Bismarck, or Minot to schedule one before the clinical visit. After diagnostic review, the provider can issue an electronic prescription to the patient's preferred pharmacy.

A telehealth consultation for Rezdiffra typically costs between $150 and $350 without insurance, depending on the platform and whether it includes lab review. Some platforms bundle FibroScan coordination and prior authorization support into their fees.

One practical consideration: the prescribing provider needs to review a thyroid function panel (TSH and free T4) before starting resmetirom, since the drug acts on thyroid hormone receptors [4]. Patients with uncontrolled thyroid disease or TSH outside the normal range may not be candidates. Most telehealth providers will order these labs through Quest, Labcorp, or a local hospital system before finalizing the prescription.

Patients in western North Dakota towns like Williston, Dickinson, or Watford City, where specialist access is limited, benefit the most from telehealth pathways. The prescription is sent electronically to a participating pharmacy and can be shipped directly to the patient's address.

Required Labs and Diagnostic Workup Before Starting Rezdiffra

The FDA label for Rezdiffra specifies that the drug is indicated for adults with MASH and moderate-to-advanced hepatic fibrosis (consistent with stages F2 to F3), confirmed by liver biopsy or noninvasive testing [4]. This means several diagnostic steps must be completed before a prescription can be written.

Liver fibrosis staging is the most important requirement. FibroScan (VCTE) is the standard noninvasive method: a liver stiffness measurement (LSM) of 8.0, 13.9 kPa generally corresponds to F2, F3 fibrosis, though cutoffs vary slightly by clinical context [5]. Liver biopsy remains the gold standard but is invasive, costly (typically $3,000, $6,000 out of pocket), and carries procedural risk. Most insurers accept FibroScan for prior authorization purposes.

Baseline laboratory tests required or recommended before initiation include:

• Comprehensive metabolic panel (CMP) with ALT, AST, and alkaline phosphatase
• TSH and free T4 (thyroid function)
• Lipid panel (LDL, HDL, triglycerides)
• HbA1c if the patient has diabetes or prediabetes
• Hepatitis B and C serologies (to rule out viral causes)
• Complete blood count (CBC)

The Rezdiffra prescribing information notes that liver enzyme elevations can occur during treatment, so monitoring ALT, AST, and bilirubin is recommended at baseline, during dose titration, and periodically thereafter [4]. Specifically, the label advises checking liver tests prior to initiation, during the titration from 80 mg to 100 mg (which occurs at month 3), and as clinically indicated after that.

Thyroid monitoring deserves special attention. Resmetirom's mechanism involves THR-β agonism, and while it is selective for the beta receptor (avoiding the cardiac effects mediated by THR-α), prescribers should verify normal thyroid function at baseline [4]. Patients already on levothyroxine or other thyroid medications need TSH rechecked 4 to 8 weeks after starting Rezdiffra.

In North Dakota, FibroScan is available at Sanford Health facilities in Fargo and Bismarck, Altru Health System in Grand Forks, and select CHI St. Alexius locations. Patients in rural areas may need to travel for the scan, though some mobile FibroScan services have begun operating in the upper Midwest.

Pharmacy Access and 503A Compounding in North Dakota

Once prescribed, Rezdiffra can be dispensed through specialty pharmacies or traditional retail pharmacies that stock the medication. Madrigal Pharmaceuticals distributes Rezdiffra through a specialty pharmacy network. The three largest specialty pharmacy channels serving North Dakota are Optum Specialty, CVS Specialty, and Accredo (Express Scripts).

North Dakota also permits dispensing through 503A compounding pharmacies licensed by the North Dakota Board of Pharmacy. A 503A pharmacy compounds medications pursuant to individual patient prescriptions under Section 503A of the Federal Food, Drug, and Cosmetic Act [6]. These pharmacies can ship within North Dakota and, depending on licensure, across state lines.

The distinction matters for cost. Branded Rezdiffra from Madrigal carries a list price of approximately $47,400 per year. A 503A pharmacy compounding resmetirom (if the API is available and the pharmacy has a valid prescription) may offer a lower price point, though availability of the active pharmaceutical ingredient through 503A channels varies.

Shipping timelines within North Dakota typically run 2, 5 business days for specialty pharmacy orders. Patients in Fargo or Bismarck may have same-day or next-day pickup options at local specialty pharmacy locations. Rural addresses in western North Dakota should expect the longer end of that range.

Patients should confirm with their pharmacy whether the medication will be shipped as a standard or cold-chain package. Rezdiffra tablets are stored at room temperature (68, 77°F), so cold-chain shipping is not required [4].

Insurance, Prior Authorization, and Cost in North Dakota

North Dakota Medicaid does not currently cover Rezdiffra for MASH. This affects approximately 90,000 North Dakotans enrolled in Medicaid as of 2025 [7]. Patients on Medicaid who need Rezdiffra may pursue appeals or exception requests, but approval is unlikely without a formulary change.

Commercial insurers operating in North Dakota, including Blue Cross Blue Shield of North Dakota, Sanford Health Plan, and Medica, generally require prior authorization before covering Rezdiffra. The prior authorization process typically demands:

• Confirmed MASH diagnosis via biopsy or FibroScan (F2, F3 fibrosis documented)
• Evidence that lifestyle modifications were attempted for at least 6 months
• Baseline liver enzyme values (ALT, AST)
• Prescriber attestation that the patient does not have decompensated cirrhosis (Child-Pugh B or C)
• Documentation that the patient is not pregnant or planning pregnancy

Prior authorization decisions in North Dakota typically take 5, 15 business days. Denials can be appealed, and the North Dakota Insurance Department provides a formal external review process if internal appeals fail.

For patients without insurance coverage, Madrigal Pharmaceuticals offers the Rezdiffra patient assistance program and a copay assistance card. The copay card can reduce out-of-pocket costs to as low as $0 per month for commercially insured patients, with a maximum annual benefit cap [8]. Uninsured patients may qualify for the free drug program based on income thresholds.

The MAESTRO-NASH trial data strengthens appeal arguments. Citing the trial's statistically significant results on both co-primary endpoints, specifically the 25.9% NASH resolution rate versus 9.7% placebo and the 24.2% fibrosis improvement rate versus 14.2% placebo, gives appeals committees quantifiable evidence of clinical benefit [1].

Dosing, Titration, and What to Expect After Starting Rezdiffra

Rezdiffra is initiated at 80 mg once daily for the first three months, then increased to the target dose of 100 mg once daily [4]. Both doses are taken orally with or without food. The titration schedule is fixed; the prescribing information does not recommend dose adjustments based on weight or hepatic function for patients with compensated liver disease.

Common side effects reported in MAESTRO-NASH include diarrhea (28.7% vs. 16.3% placebo), nausea (22.2% vs. 12.6%), and abdominal pain [1]. Most gastrointestinal symptoms were mild to moderate and occurred during the first 4 to 12 weeks of treatment. The diarrhea rate decreased substantially after the initial months.

Patients should expect the following monitoring schedule after initiation:

• Month 1, 3 (80 mg phase): Check ALT, AST, and bilirubin at least once. Report any signs of hepatotoxicity (jaundice, dark urine, right upper quadrant pain).
• Month 3 (dose escalation): Repeat liver tests before increasing to 100 mg. Recheck TSH if the patient has thyroid disease.
• Month 6: Repeat lipid panel and liver enzymes. Consider repeat FibroScan at 12 months to assess treatment response.
• Month 12 and beyond: Annual FibroScan, ongoing liver enzyme monitoring, and lipid assessment.

The MAESTRO-NASH trial measured outcomes at 52 weeks, so clinicians should set expectations that meaningful fibrosis improvement takes roughly a year to assess [1]. Liver fat reduction, measured by MRI-PDFF, occurs earlier and may be evident by 12 to 24 weeks. LDL reductions are typically seen within the first 8 weeks.

Patients who experience persistent diarrhea beyond the first 8 weeks should notify their prescriber. Dose reduction back to 80 mg is not recommended in the label; the prescriber will assess whether the benefit-risk ratio supports continuation.

North Dakota-Specific Considerations for Rural Patients

North Dakota's population density (11.5 people per square mile, the fourth lowest in the United States) creates access challenges that differ from most other states. Roughly 44% of the state's population lives in rural areas, and hepatology specialists are concentrated in three cities.

For rural patients, a practical access pathway looks like this:

1. Initial screening: Primary care provider orders FIB-4 index (calculated from age, ALT, AST, and platelet count). FIB-4 above 1.3 warrants further evaluation [5].
2. Diagnostic confirmation: Referral for FibroScan at the nearest Sanford or Altru facility, or telehealth consultation with a hepatologist who can order the scan.
3. Prescription: Telehealth or in-person visit with a qualifying prescriber. Electronic prescription sent to a specialty pharmacy.
4. Delivery: Medication shipped to the patient's home address. No in-person pharmacy visit required.
5. Monitoring: Follow-up labs drawn at a local clinic or through a mobile phlebotomy service. Results reviewed via telehealth.

This model eliminates the need for repeated long-distance trips. Patients in Williston (330 miles from Fargo) or Bowman (290 miles from Bismarck) can complete the entire process with a single trip for the FibroScan and handle everything else remotely.

North Dakota's critical access hospitals, of which there are 36, can perform the required baseline labs. They cannot perform FibroScan, but the FIB-4 and NAFLD fibrosis score can guide whether the FibroScan trip is warranted [5].