Pharmacy Prior Authorization Criteria

Relyvrio (sodium phenylbutyrate and taurursodiol)

Indications for Prior Authorization

Relyvrio (sodium phenylbutyrate and taurursodiol)

• For diagnosis of Amyotrophic lateral sclerosis
  Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

Criteria

Relyvrio

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis amyotrophic lateral sclerosis (ALS)
AND
• Diagnosis of ALS is further supported by neurogenic changes in electromyography (EMG) [2]
AND
• Patient has had ALS symptoms for less than or equal to 18 months
AND
• Patient has a percent (%) forced vital capacity (%FVC) or slow vital capacity (%SVC) greater than or equal to 60% at the start of treatment
AND
• Patient does not require permanent noninvasive ventilation or invasive ventilation
AND
• Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS

Relyvrio

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., slowed disease progression)
AND
• Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS

P & T Revisions

2023-12-13, 2022-11-30

References

1. Paganoni S, Macklin EA, Hendrix S, et al. Trial of Sodium Phenylbutyrate–Taurursodiol for Amyotrophic Lateral Sclerosis. New England Journal of Medicine. 2020;383(10):919-930.
2. Andersen PM, Abrahams S, Borasio GD, et al. EFNS guidelines on the Clinical Management of Amyotrophic Lateral Sclerosis (MALS) - revised report of an EFNS task force. European Journal of Neurology.
3. Paganoni S, Hendrix S, Dickson SP, et al. Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis. Muscle & Nerve. 2021;63(1):31-39.
4. ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/study/NCT03127514. Accessed May 26, 2022.
5. Galvez-Jimenez N, Goyal NA. Disease-modifying treatment of amyotrophic lateral sclerosis. UpToDate Web site. http://www.uptodate.com. Accessed May 26, 2022.
6. Elman LB, McCluskey, L. Diagnosis of amyotrophic lateral sclerosis and other forms of motor neuron disease. UpToDate Web site. http://www.uptodate.com. Accessed May 26, 2022.
7. Relyvrio Prescribing Information. Amylyx Pharmaceuticals, Inc. Cambridge, MA. September 2022.

---

End Notes

1. Great care should be taken to rule out diseases that can masquerade as ALS. An evolution of atypical symptoms and a lack of progression of typical symptoms are the most important "red flags" suggesting an alternative diagnosis. [2]

---

Revision History

• 2023-12-13: 2023 Annual Review - update to reauth language, no other criteria changes.
• 2022-11-30: New Program

---