How to Get Rezdiffra (Resmetirom) in Maryland

Resmetirom (Rezdiffra, manufactured by Madrigal Pharmaceuticals) works as an oral, once-daily selective agonist of thyroid hormone receptor-beta (THR-beta). In March 2024, the FDA granted accelerated approval for resmetirom in adults with noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis, previously known as NASH) and moderate to advanced fibrosis, intended as an adjunct to diet and exercise modifications. Resmetirom is not indicated for isolated hepatic steatosis in the absence of steatohepatitis or for use in patients with decompensated cirrhosis. For precise language regarding fibrosis staging and current approved indications, consult the FDA label, as accelerated approvals may undergo revision.

The direct answer: a Maryland resident can obtain Rezdiffra from any Maryland-licensed prescriber, in person or by telehealth, once biopsy- or imaging-confirmed MASH with qualifying fibrosis is documented; nothing in Maryland law requires an in-state biopsy or an in-state specialist. What actually controls the timeline and out-of-pocket cost is not state law but the specific insurer's prior authorization policy and the manufacturer's patient assistance program rules at the time of the request, both of which change and must be verified directly rather than assumed from a general guide.

What this page can and cannot tell you

This is general educational information, not a substitute for a conversation with a licensed clinician or a call to your specific insurance plan. Maryland does not have a Rezdiffra-specific state statute; the relevant rules are (1) the FDA-approved label and general prescribing scope law, which are stable, and (2) individual insurer medical policies, pharmacy network contracts, and manufacturer program terms, which are date-sensitive and plan-specific. Where the source material for this article did not include a verifiable Maryland-specific rule, that has been flagged below rather than presented as fact.

Who is a candidate for Rezdiffra

Resmetirom's approval rests on histologic (biopsy-based) surrogate endpoints from a phase 3 trial program, reviewed by the FDA as part of accelerated approval; the confirmatory outcome data required to convert this to full approval was not yet complete at launch. That means resmetirom's benefit on hard clinical outcomes (cirrhosis progression, liver-related death, transplant) is not yet established the way it would be after a full-approval outcomes trial; it is established that the drug reduces liver fat and improves histologic markers of steatohepatitis in the trial population, and it is plausible but not proven that this translates into fewer long-term liver complications. A 2025 review of MASH drug candidates in late-phase development situates resmetirom among the first agents to reach approval, while noting that several other mechanisms remain in trial and that head-to-head data are limited (Therapeutic Strategies for MASH: An Update on Drug Candidates Under Investigation in Late-Phase Clinical Trials, 2025).

Candidacy generally requires:

• A confirmed diagnosis of MASH, typically established by liver biopsy or a combination of noninvasive tests (FIB-4, elastography, or MR elastography)
• Fibrosis staging consistent with the FDA-approved population (moderate to advanced fibrosis, excluding decompensated cirrhosis)
• Baseline metabolic and thyroid labs, since the drug's mechanism and known side-effect profile involve lipid and thyroid-axis effects

A 2025 letter responding to AASLD's October 2024 practice guidance update specifically discusses how clinicians should apply resmetirom criteria in practice, including points of ambiguity in staging and patient selection that clinicians are still working through (Letter to the Editor: Resmetirom therapy for MASLD, AASLD update, 2025). This is a useful signal that even hepatology specialty guidance is still being refined, not a finished, settled protocol.

Can a Maryland telehealth visit start this prescription?

In general, states that broadened telehealth prescribing during and after the COVID-19 public health emergency continue to allow synchronous audio-video visits for non-controlled prescription medications, provided the prescriber holds an active license in the patient's state and establishes a documented clinician-patient relationship. Resmetirom is not a controlled substance, so this general framework is plausible for Maryland. However, this article's underlying source material did not include a verifiable citation to a specific current Maryland statute or Board of Physicians rule, and telehealth scope-of-practice rules for physicians, nurse practitioners, and physician assistants are updated periodically. Anyone relying on telehealth to obtain Rezdiffra in Maryland should confirm directly with the prescribing practice and, if needed, the Maryland Board of Physicians that:

• The prescriber is currently licensed in Maryland
• The visit format satisfies Maryland's bona fide provider-patient relationship requirement
• Imaging or biopsy reports from out-of-state facilities will be accepted as part of the record

A telehealth visit does not remove the need for objective fibrosis-stage documentation; a clinician still needs FibroScan, MR elastography, or biopsy results, and a video visit alone cannot establish fibrosis stage.

Labs and imaging typically requested before prescribing

These are general clinical practice patterns, not a fixed Maryland requirement:

• FIB-4 index (age, AST, ALT, platelet count) as an initial non-invasive fibrosis screen
• Elastography (FibroScan or MR elastography) or liver biopsy to confirm fibrosis stage within the FDA-approved range, since not everyone with a FIB-4 above a screening threshold has fibrosis in the treatable range
• Comprehensive metabolic panel, including liver enzymes, to establish a hepatic baseline
• TSH and free T4, because resmetirom acts on thyroid hormone receptors, and baseline thyroid status should be documented even though the drug is designed to be beta-selective
• Lipid panel, since resmetirom lowers LDL-C and triglycerides in trial populations and a baseline value is needed to interpret change
• CBC, partly to support the FIB-4 calculation

Exact turnaround times for labs and imaging in the Baltimore-Washington corridor versus the Eastern Shore or Western Maryland will vary by facility and should be confirmed with the ordering clinic, not assumed from a general timeline.

Who can prescribe it

Physicians (MD/DO), and in many states nurse practitioners and physician assistants operating within their licensed scope, can prescribe non-controlled medications like resmetirom. Maryland's specific scope-of-practice rules for NPs and PAs, including whether a collaborative or delegation agreement is required, have changed in recent years in many states and should be verified against the current Maryland Board of Nursing and Board of Physicians rules rather than treated as fixed. In practice, most resmetirom prescriptions are written by hepatologists, gastroenterologists, or primary care and endocrinology clinicians experienced in liver disease, because the diagnostic workup (fibrosis staging) usually originates in that setting.

Insurance, prior authorization, and cost: what is verifiable and what is not

Prior authorization is a near-universal feature of coverage for high-cost brand specialty drugs, and Rezdiffra is very likely to require it under Maryland Medicaid and commercial plans. That general pattern is well established. What is not something this article can state reliably is:

• The exact PA turnaround time required by Maryland law for a given plan type
• Which specific commercial insurers in Maryland require hepatology-specialist prescribing versus allow primary care
• The current list price or the current terms of any manufacturer patient assistance program

Manufacturer list prices for newly approved specialty drugs are set at launch and can change; published estimates for Rezdiffra at its 2024 launch were in the tens of thousands of dollars per year, but a reader should confirm the current list price and any assistance program eligibility rules directly with the manufacturer's patient support program and with their own insurer, dated to the day of the check, rather than rely on a number printed in an article. The same applies to whether Maryland Medicaid's preferred drug list currently includes resmetirom and under what step-therapy conditions, since state Medicaid formularies are revised periodically.

Pharmacy access, including a caution about compounding

Rezdiffra is distributed through a limited specialty pharmacy network rather than typical retail pharmacy stock, which is common for new specialty drugs with manufacturer-managed distribution. Confirm with your prescriber's office which specialty pharmacies are in-network for your specific plan.

One caution: 503A compounding pharmacies are generally permitted to compound patient-specific formulations of an FDA-approved drug only under specific circumstances, most commonly when a commercially available product cannot meet an individual patient's documented clinical need (for example, an allergy to an inactive ingredient) or when the drug is on an FDA drug shortage list. Rezdiffra is a recently approved, patent-protected brand product; nothing in the available source material for this article establishes that it is on an FDA shortage list or that Maryland-licensed 503A pharmacies are routinely compounding resmetirom. That claim should not be treated as accurate without direct verification from a licensed compounding pharmacy and confirmation of the clinical justification required for compounding a non-shortage branded drug. Readers should not assume this is a standard access route.

Practical sequence most patients experience

The order of steps below is a general clinical pattern, not a Maryland-specific guarantee, and the time each step takes will vary by clinic, insurer, and pharmacy:

1. Clinical evaluation (in person or telehealth) to assess MASH diagnosis and review or order fibrosis staging
2. Baseline labs: metabolic panel, lipid panel, TSH/free T4, CBC, FIB-4
3. Fibrosis confirmation by elastography or biopsy if not already documented
4. Prescription written with weight-based dosing per the current FDA label, and prior authorization submitted to the insurer
5. Insurer PA decision, followed by specialty pharmacy dispensing once approved
6. Follow-up labs and clinical reassessment, generally at 3 months and then periodically, to monitor liver enzymes, lipids, thyroid function, and tolerability

Monitoring and known risks

In the pivotal trial program that supported approval, diarrhea and nausea were the most commonly reported adverse effects, generally described as mild to moderate. The FDA label carries warnings related to hepatic effects and specifies that resmetirom should not be used in patients with decompensated cirrhosis. Because resmetirom affects lipid levels and acts on a thyroid hormone receptor, ongoing monitoring of liver enzymes, lipid panel, and thyroid function is standard practice, alongside periodic reassessment of fibrosis stage. Confirm current monitoring intervals against the FDA label and your prescriber's protocol rather than a fixed schedule, since practice patterns are still evolving as more clinicians gain experience with the drug.

A material long-term uncertainty: because this is an accelerated approval, continued marketing depends on confirmatory trial data demonstrating clinical outcome benefit. If that confirmatory evidence does not support the drug, the FDA could act to withdraw or modify the approval, which would affect prescriptions nationwide, including in Maryland. This is not a reason to avoid the drug if a clinician recommends it, but it is a reason patients should understand that resmetirom's evidence base is still maturing.

When to seek urgent care instead of waiting on this process: new jaundice, severe abdominal pain, confusion, or signs of decompensated liver disease (swelling, bleeding, significant fatigue with jaundice) warrant immediate medical evaluation rather than continuing through a routine prior authorization or telehealth scheduling process.

Verification checklist: what is stable versus what you must recheck by date

Use this to separate facts that rarely change from facts that must be reconfirmed at the time of your appointment or pharmacy fill. Do not treat anything in the right-hand column as accurate without a same-day check.

Frequently asked questions

References

1. U.S. Food and Drug Administration. Rezdiffra (resmetirom) prescribing information, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217785s000lbl.pdf
2. Centers for Disease Control and Prevention. Liver disease fast facts. https://www.cdc.gov/nchs/fastats/liver-disease.htm
3. Therapeutic Strategies for MASH: An Update on Drug Candidates Under Investigation in Late-Phase Clinical Trials (2025). https://pubmed.ncbi.nlm.nih.gov/41586160/
4. Letter to the Editor: Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease, AASLD October 2024 practice guidance update (2025). https://pubmed.ncbi.nlm.nih.gov/39960317/

This article is a draft prepared for editorial and qualified medical review. It has not yet received clinical sign-off. Maryland-specific insurance, pharmacy, and cost details should be independently verified before publication and before a reader relies on them.