Provider Briefing: Rezdiffra Access in 2026

Since its FDA approval in March 2024, Rezdiffra (Resmetirom) has become the standard pharmacological treatment for noncirrhotic MASH with moderate to advanced fibrosis. As the first and only FDA-approved therapy for this indication, it represents a significant advance for the estimated 6–8 million Americans with clinically significant MASH fibrosis.

However, the post-launch reality has been marked by access challenges that directly affect prescribing workflows and patient outcomes. This article provides a comprehensive overview of Rezdiffra availability, prescribing considerations, and practical strategies for helping your patients access this medication in 2026.

Timeline: From Approval to Current State

Here's a brief history of Rezdiffra's journey:

• March 14, 2024: FDA grants accelerated approval to Rezdiffra (Resmetirom) for noncirrhotic NASH with moderate to advanced fibrosis (F2–F3), based on the Phase 3 MAESTRO-NASH trial
• April 2024: Commercial launch begins through specialty pharmacy distribution
• 2024–2025: Payer coverage policies established; prior authorization criteria developed by major insurers including UnitedHealthcare, Cigna, and Aetna
• 2025–2026: Prescriber adoption continues to grow, particularly among hepatologists and gastroenterologists; access barriers remain the primary patient complaint

Notably, Rezdiffra has not appeared on FDA or ASHP drug shortage lists at any point since approval. The access challenges are distribution- and coverage-related rather than supply-related.

Prescribing Implications

Dosing

Rezdiffra is dosed based on actual body weight:

• <100 kg: 80 mg once daily
• ≥100 kg: 100 mg once daily

Dose reductions are required with concomitant use of certain CYP2C8 and OATP1B1/OATP1B3 inhibitors:

• Moderate CYP2C8 inhibitors (e.g., Clopidogrel): reduce by one dose level
• Strong CYP2C8 inhibitors (e.g., Gemfibrozil): not recommended
• OATP1B1/OATP1B3 inhibitors (e.g., Cyclosporine): reduce to 60 mg

Statin Interactions

Rezdiffra increases exposure to commonly co-prescribed statins. Dosage limits when used concurrently:

• Rosuvastatin: ≤20 mg/day
• Simvastatin: ≤20 mg/day
• Atorvastatin: ≤40 mg/day
• Pravastatin: ≤40 mg/day

Monitor for statin-related adverse events including elevated liver enzymes, myopathy, and rhabdomyolysis. Given that MASH patients frequently require statin therapy for comorbid dyslipidemia, this interaction warrants careful attention.

For complete interaction details, see our clinical reference on Rezdiffra drug interactions.

Monitoring Requirements

• Baseline liver function tests (ALT, AST) before initiating therapy
• Monitor liver tests periodically; transient elevations in ALT/AST are expected in the first 4 weeks
• Watch for signs of hepatotoxicity: fatigue, nausea, vomiting, RUQ pain, jaundice, fever, rash, eosinophilia
• Gallbladder-related adverse reactions: cholelithiasis, acute cholecystitis, obstructive pancreatitis

The Availability Picture

The primary access barriers your patients face are:

1. Specialty Pharmacy–Only Distribution

Rezdiffra cannot be filled at retail pharmacies. Patients must be enrolled with an authorized specialty pharmacy, which handles dispensing, shipping, and refill coordination. This creates friction for patients accustomed to picking up prescriptions locally.

2. Prior Authorization

All major commercial insurers and Medicare Part D plans require PA for Rezdiffra. Typical PA criteria include:

• Confirmed diagnosis of MASH/NASH
• Liver biopsy or validated non-invasive testing showing F2–F3 fibrosis
• No decompensated cirrhosis
• Prescribed by or in consultation with a hepatologist or gastroenterologist

PA approval rates vary, and denials are not uncommon — particularly when documentation is incomplete or when patients have not undergone liver biopsy.

3. Cost

At a WAC of approximately $47,400/year, Rezdiffra is priced as a specialty medication. For uninsured or underinsured patients, cost is often prohibitive. Even insured patients may face high specialty-tier copays.

Cost and Access Support

Several programs exist to mitigate cost barriers:

• Madrigal Copay Savings Card: Eligible commercially insured patients may pay as little as $0 per fill. Not available for government-insured patients (Medicare, Medicaid, Tricare).
• Madrigal Patient Support: Comprehensive hub services including benefits investigation, PA support, appeals assistance, and connection to patient assistance programs. Contact: 1-877-219-7770 (M–F, 8 AM–8 PM ET) or madrigalpatientsupport.com
• Independent foundations: Organizations like NeedyMeds and the Medicine Assistance Tool may offer additional resources

For patient-facing cost guidance, refer patients to our article on how to save money on Rezdiffra.

Tools and Resources for Providers

Medfinder for Providers

Medfinder offers provider-specific tools to help you check Rezdiffra availability and guide patients to pharmacies that have it in stock. This can be integrated into your practice workflow to reduce the back-and-forth of pharmacy calls.

Madrigal HCP Resources

Madrigal provides prescriber-facing resources at rezdiffrahcp.com, including:

• Coverage and access support guides
• PA forms and templates
• Dosing and administration information
• Clinical trial data from MAESTRO-NASH

Streamlining PA Workflows

To improve PA success rates and reduce turnaround times:

1. Submit PA with complete documentation upfront (diagnosis, fibrosis staging method and results, medication list)
2. Use electronic PA platforms when available
3. Designate a staff member to track PA status and follow up proactively
4. Be prepared for peer-to-peer reviews
5. Document medical necessity thoroughly in the patient's chart

For a detailed workflow guide, see our article on how to help your patients find Rezdiffra in stock.

Looking Ahead

The MASH treatment landscape is expected to evolve significantly over the next few years:

• Confirmatory trial data: Rezdiffra was approved under accelerated approval; ongoing studies will provide additional long-term efficacy and safety data
• Pipeline competition: Several MASH drugs are in Phase 3 trials, including Efruxifermin, Pegozafermin, Lanifibranor, and Semaglutide. Approvals could provide additional treatment options and increase competitive pricing pressure
• Expanding payer coverage: As more data accumulates and clinical guidelines evolve, PA criteria may become more standardized and approval rates may improve

Final Thoughts

Rezdiffra represents a genuine therapeutic advance for MASH, but access remains a significant clinical challenge in 2026. Providers play a critical role in navigating insurance barriers, educating patients about support programs, and ensuring that the patients who need this medication can actually receive it.

Use Medfinder for Providers to streamline your workflow and help patients find Rezdiffra in stock. For provider-specific cost strategies, see our guide on how to help patients save money on Rezdiffra.