Amvuttra™

Drug - Amvuttra™ (vutrisiran) [Alnylam Pharmaceuticals, Inc.]

January 2025

Therapeutic Area - Amyloidosis Agents-Transthyretin (TTR) Suppression

Initial approval criteria

Patient is at least 18 years of age; AND
Vutrisiran must NOT be used in combination with other transthyretin (TTR) reducing agents (e.g., inotersen [Tegsedi®], tafamidis [Vyndamax®, Vyndaqel®], patisiran [Onpattro®]); AND
Patient has a definitive diagnosis of hereditary transthyretin-mediated (hATTR) amyloidosis/FAP (familial amyloidotic polyneuropathy) as documented by amyloid deposition on tissue biopsy and identification of a pathogenic TTR variant using molecular genetic testing; AND
Polyneuropathy is demonstrated by ≥ 2 of the following criteria:
- Subjective patient symptoms are suggestive of neuropathy
- Abnormal nerve conduction studies are consistent with polyneuropathy
- Abnormal neurological examination is suggestive of neuropathy; AND
Patient’s peripheral neuropathy is attributed to hATTR/FAP and other causes of neuropathy have been excluded; AND
Baseline strength/weakness has been documented using an objective clinical measuring tool (e.g., Medical Research Council [MRC] muscle strength); AND
Patient has NOT been the recipient of an orthotopic liver transplant (OLT)
Initial approval is for 6 months

Patient continues to meet the above criteria; AND
Patient is absent of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: ocular symptoms related to hypovitaminosis A, etc.; AND
Patient has experienced disease response compared to pretreatment baseline as evidenced by stabilization or improvement in ≥ 1 of the following: ¬ Signs and symptoms of neuropathy ¬ MRC muscle strength
Renewal approval is for 6 months

Amvuttra must be billed as a medical claim.

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