Pharmacy Prior Authorization Criteria

Amvuttra (vutrisiran)

Indications for Prior Authorization

Amvuttra (vutrisiran)

• For diagnosis of Hereditary transthyretin-mediated amyloidosis
  Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Criteria

Amvuttra

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy
AND
• Patient has a transthyretin (TTR) mutation (e.g., V30M) [1-3]
AND
• One of the following [1-4, A, B]:
• Patient has a baseline polyneuropathy disability (PND) score less than or equal to IIIb
• Patient has a baseline familial amyloidotic polyneuropathy (FAP) stage of 1 or 2
• Patient has a baseline neuropathy impairment score (NIS) greater than or equal to 5 and less than or equal to 130
• Patient has a baseline Karnofsky Performance Status score greater than or equal to 60%
AND
• Presence of clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy, walking ability, quality of life) [1-3]
AND
• Patient has not had a liver transplant [2-3]
AND
• Requested drug is not used in combination with a TTR silencer (e.g.,Tegsedi) or a TTR stabilizer (e.g., Vyndaqel)
AND
• Prescribed by or in consultation with a neurologist

Amvuttra

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by an improvement in clinical signs and symptoms from baseline (e.g., neuropathy, quality of life, gait speed, nutritional status, decrease in serum TTR level)
AND
• One of the following [1-4, A, B]:
• Patient continues to have a polyneuropathy disability (PND) score less than or equal to IIIb
• Patient continues to have a familial amyloidotic polyneuropathy (FAP) stage of 1 or 2
• Patient continues to have a neuropathy impairment score (NIS) greater than or equal to 5 and less than or equal to 130
• Patient continues to have a Karnofsky Performance Status score greater than or equal to 60%
AND
• Requested drug is not used in combination with a TTR silencer (e.g.,Tegsedi) or a TTR stabilizer (e.g., Vyndaqel)
AND
• Patient has not had a liver transplant [2-3]

P & T Revisions

2024-09-18, 2023-09-29, 2023-08-02, 2022-08-09

References

1. Amvuttra Prescribing Information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. January 2023.
2. Adams D, Tournev IL, Taylor MS, et al. Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial. Amyloid. 2022;1-9. Available at https://www.tandfonline.com/doi/full/10.1080/13506129.2022.2091985. Accessed August 4, 2022.
3. Adams D, Suhr OB, Dyck PJ, et al. Trial design and rationale for APOLLO, a phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017;17:181.
4. Amvuttra. European Medicines Agency Web Site. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/amvuttra. Published July 21, 2022. Accessed August 4, 2022.
5. Velez-Santamaria, V.,Nedkova-Hristova, V., et al. Hereditary Transthyretin Amyloidosis with Polyneuropathy: Monitoring and Management. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9789700/. Accessed August 2, 2023.
6. Carroll, A., Dyck, P., et al. Novel approaches to diagnosis and management of hereditary transthyretin amyloidosis. Available at: https://jnnp.bmj.com/content/93/6/668. Accessed August 2, 2023.

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Revision History

• 2024-09-18: 2024 annual review. Background Updates. Addition of criterion 'patient has not had a liver transplant' to the reauth for consistency throughout PA. Addition of criterion to confirm Amvuttra is not used in combination with a TTR silencer or a TTR stabilizer.
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-08-02: 2023 Annual Review.
• 2022-08-09: 2022 New UM PA Criteria

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