Relyvrio

Indicated For

ALS

About This Medication

# Relyvrio Patient Guide: How to Get Relyvrio at Low or No Cost **Important Update: Relyvrio (sodium phenylbutyrate / taurursodiol) is no longer available for new patients.** As of April 2024, Amylyx Pharmaceuticals voluntarily discontinued marketing authorizations for Relyvrio following disappointing Phase 3 PHOENIX trial results showing no significant benefit in ALS.[1][7][8] However, **current patients who wish to continue therapy, in consultation with their physician, can transition to a free drug program provided by Amylyx.**[1] This guide focuses on that free access program for existing users, drawing from the former Amylyx Care Team (ACT) Support Program structure.[2][6] ## About Relyvrio Relyvrio was an oral, fixed-dose combination therapy (sodium phenylbutyrate and taurursodiol) approved by the FDA in September 2022 for adults with amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease affecting nerve cells in the brain and spinal cord.[2][5][10] It aimed to slow the loss of physical function, based on earlier CENTAUR trial data published in top medical journals.[2] Despite initial promise, the confirmatory PHOENIX trial failed to meet primary and secondary endpoints, leading to its market withdrawal.[1][4][8] It is not known to be safe or effective in children.[5] Always consult your doctor about risks, including potential side effects like diarrhea, nausea, or abdominal pain (detailed in the Medication Guide).[5] ## Who Qualifies for Free Relyvrio? **New patients cannot start Relyvrio.** The drug is off the market, and no new prescriptions are being filled.[1][7] **Eligibility is limited to current patients already on Relyvrio who, with their physician's guidance, choose to continue.**[1] Previously, the ACT program supported prescribed ALS patients navigating insurance and costs, including copay assistance and an Interim Access Program for up to two months of free medication while awaiting coverage.[2][3][6] Now, this has evolved into a **free drug program** for ongoing use, eliminating financial barriers for those patients.[1] No specific income thresholds are detailed, as it's provided free to qualifying current users without mention of financial eligibility.[1][6] ## Income Eligibility Breakdown Since Relyvrio is withdrawn and free for current patients only, traditional income-based patient assistance programs (PAPs) with Federal Poverty Level (FPL) thresholds do not apply. Here's a summary: | Household Size | Income Threshold | Notes | |---------------|------------------|-------| | Individual | Not applicable | Free for current patients only; no income limits specified.[1] | | Couple | Not applicable | Free for current patients only; no income limits specified.[1] | | Family of 3 | Not applicable | Free for current patients only; no income limits specified.[1] | | Family of 4 | Not applicable | Free for current patients only; no income limits specified.[1] | **Key Note:** Unlike standard PAPs (often 400-500% FPL), this is not income-restricted for eligible current patients.[1] Contact Amylyx for confirmation. ## Insurance Requirements Insurance is not required for the free drug program for current patients.[1] Previously, ACT helped with coverage verification for commercial insurance, Medicare, and Medicaid, offering copay programs to reduce out-of-pocket costs to $0 where possible.[2][3][9] Medicare/Medicaid patients received tailored support.[3] Now, with free provision, insurance navigation may still assist transitions but is secondary.[1][6] ## Step-by-Step Application Process for Current Patients 1. **Consult Your Physician:** Discuss continuing Relyvrio. Your doctor must confirm your current use and prescribe via the ACT enrollment process.[1][6] 2. **Contact Amylyx Care Team (ACT):** Call 1-866-318-2989, fax 1-844-283-0375, or email amylyxcareteam@amylyx.com to initiate transition.[6] 3. **Complete Enrollment Form:** Use the RELYVRIO Enrollment Form (2-4 pages). Patient section: Provide info, diagnosis date, treatments, insurance (if any), and sign HIPAA authorization and consent.[3][6] Physician completes prescription (e.g., 56-count carton for 28-day supply) and optional Interim Access if needed.[6] 4. **Submit:** Fax/email form to ACT. They handle processing, including any prior authorizations.[3][6] 5. **Approval and Delivery:** ACT coordinates free shipment via specialty pharmacy.[2][6] ## Timeline and Delivery For current patients transitioning, expect prompt processing similar to prior ACT timelines (4-6 weeks for initial access historically).[3] Free drug program aims for continuity without delays.[1] Medication ships directly from designated pharmacies in 28-day supplies.[6] Track via your ACT single point of contact.[2] ## Alternatives if Denied or Unable to Continue - **If not currently on Relyvrio:** No access; explore other FDA-approved ALS treatments like Riluzole, Edaravone, or Tofersen (for specific genetic cases).[10] - **Denied transition:** Appeal via physician and ACT; reasons may include physician recommendation against continuation.[1] - **Other ALS Support:** NeedyMeds.org, Partnership for Prescription Assistance, or ALS Association for copay cards and state programs. Clinical trials via ClinicalTrials.gov. - **No biosimilars:** None available.[4] ## Disclaimer This guide is for informational purposes only and based on public announcements as of 2024. It is not medical, legal, or financial advice. Program details may change; **verify with Amylyx directly (1-866-318-2989)** and your healthcare provider.[1][6] Eligibility, availability, and terms are at Amylyx's discretion. Free program is for current patients only—new starts are not possible.[1] Word count: 942.

Program information last verified: March 30, 2026