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Where can you get Rezdiffra™ (resmetirom)? A Guide to Accessing This Specialty Medication

3 min read

Following its FDA accelerated approval in March 2024, Rezdiffra™ (resmetirom) became the first and only medication specifically approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH). As a specialized treatment, Rezdiffra™ is not available at standard retail pharmacies, and obtaining it requires a specific process involving a prescription and a network of specialty pharmacies.

Quick Summary

Accessing Rezdiffra™ involves a multi-step process, beginning with a valid prescription. The medication is distributed exclusively through a limited network of specialty pharmacies. Patients and healthcare providers can also work with the manufacturer's patient support program to navigate insurance, understand costs, and coordinate medication delivery.

Key Points

  • Specialty Distribution: Rezdiffra™ is a specialty medication, only available through a limited, authorized network of specialty pharmacies, not standard retail drugstores.

  • Prescription Required: A valid prescription from a qualified healthcare provider, typically a liver specialist, is necessary to initiate the process.

  • Patient Support Program: Madrigal Patient Support can help coordinate the process, verify insurance coverage, and identify financial assistance options.

  • Direct Delivery: The specialty pharmacy will ship the medication directly to the patient's home, with delivery details coordinated in advance.

  • Insurance Prior Authorization: Many insurance plans will require prior authorization before covering the cost of Rezdiffra™.

  • Financial Assistance: Eligible commercially insured patients may access a copay savings card, while assistance is also available for uninsured patients.

In This Article

The Rezdiffra™ Access Process: From Prescription to Delivery

Obtaining Rezdiffra™, a specialty medication, differs from the process for typical retail prescriptions. Patients must follow a specific pathway to ensure proper access, which is managed by the drug's manufacturer, Madrigal Pharmaceuticals, and its network of partners. The journey begins with a clinical evaluation and ends with the medication being delivered directly to your home.

Step 1: Getting a Prescription from a Qualified Healthcare Provider

The first and most crucial step is to receive a valid prescription. Rezdiffra™ is prescribed for adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 and F3 fibrosis). Due to the specialized nature of the condition, the prescription is typically written by or in consultation with a liver specialist, such as a gastroenterologist or hepatologist. The doctor will evaluate your condition, determine if Rezdiffra™ is the appropriate treatment, and write the prescription.

Step 2: Engaging the Madrigal Patient Support Program

After receiving a prescription, many patients and their doctors will engage with the Madrigal Patient Support program. A dedicated case manager from this program can assist with several aspects of the access process, including:

  • Insurance Verification: Helping to determine your specific insurance coverage for the medication and confirming if prior authorization is required.
  • Financial Assistance: Explaining financial assistance options, such as the copay savings card for commercially insured patients or a patient assistance program for those who are uninsured.
  • Specialty Pharmacy Coordination: Acting as a liaison between the doctor, the patient, and the specialty pharmacy to ensure a smooth transition.

Step 3: Distribution Through a Specialty Pharmacy Network

Rezdiffra™ is a Limited Distribution Drug (LDD), meaning it is only available through a select group of authorized specialty pharmacies. These pharmacies handle medications that require special handling, are high-cost, or involve complex administration, which is why they differ from a standard retail pharmacy. A doctor or the Madrigal Patient Support program will send the prescription to one of these authorized pharmacies within the network. The medication is then shipped directly to the patient's home, often with a dedicated point of contact at the specialty pharmacy for ongoing support.

Specialty Pharmacy Network for Rezdiffra™ AcariaHealth Accredo Amber Centerwell CVS Specialty Optum Walgreens Specialty

Step 4: Confirming Costs and Scheduling Delivery

Before the first shipment, the specialty pharmacy or a Madrigal Patient Support representative will contact you to confirm insurance coverage, discuss your potential out-of-pocket costs, and walk you through any available financial assistance. They will also schedule a delivery time to ensure someone is available to receive the medication. For refills, the process is streamlined, with the specialty pharmacy or a case manager reaching out to you to arrange the next delivery.

Comparison of Specialty Pharmacy and Retail Pharmacy Access

Feature Specialty Pharmacy for Rezdiffra™ Standard Retail Pharmacy
Drug Availability Exclusively available through a limited, authorized network Stocks general, high-volume medications
Medication Type Handles high-cost, high-touch, and complex medications like Rezdiffra™ Focuses on common, traditional prescriptions
Logistics Often involves direct home delivery with coordinated delivery schedules Requires in-person pickup at a physical store location
Patient Support Provides dedicated case managers, financial assistance programs, and ongoing support Offers general pharmacist consultations and limited assistance
Insurance Processing Often handles complex prior authorization requirements and appeals May require patient to navigate complex insurance processes directly

Conclusion: Navigating the Pathway to Rezdiffra™

Accessing a specialized medication like Rezdiffra™ requires navigating a system that goes beyond a simple trip to a local drugstore. The process, which involves a specific prescription from a liver specialist, distribution through a limited specialty pharmacy network, and potential support from the manufacturer's patient program, is designed to ensure patients with noncirrhotic NASH receive this unique treatment effectively and safely. For patients, understanding these steps is crucial to successfully start and maintain their therapy. The key is working closely with your healthcare provider and leveraging the resources provided by Madrigal Patient Support and the specialty pharmacies to streamline the entire process.

For more information on the manufacturer's patient support services, visit the official Madrigal Patient Support website.

Frequently Asked Questions

No, Rezdiffra™ is a specialty medication and is not available at typical retail pharmacies. It must be obtained through a limited network of authorized specialty pharmacies.

A specialty pharmacy handles high-cost, high-touch, or complex medications that often require special handling and administration. They provide specialized services, such as home delivery and ongoing support.

Yes, you must have a valid prescription from a healthcare provider. Given the nature of NASH, this is often a liver specialist like a gastroenterologist or hepatologist.

Coverage depends on your specific insurance plan. Many plans require prior authorization before approving coverage. The Madrigal Patient Support program can help you understand your plan's specific requirements.

If you are uninsured or face high costs, financial assistance is available. Madrigal offers a patient assistance program, and other resources like the Rezdiffra™ Copay Savings Card may help eligible patients.

Once your prescription is processed and confirmed, a specialty pharmacy will arrange to ship the medication directly to your home. You will be contacted to schedule the delivery.

For refills, the specialty pharmacy or your case manager from Madrigal Patient Support will contact you proactively to coordinate the next shipment. This ensures a seamless continuation of your treatment.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.