AMVUTTRA (vutrisiran)

AMVUTTRA (vutrisiran)

Medical Administration – injectable

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of hereditary transthyretin-mediated amyloidosis:

• Dose does not exceed 25 mg injected once every 3 months, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a neurologist, geneticist, or a physician who specializes in the treatment of amyloidosis, AND
• Diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy, AND
• Patient has a transthyretin (TTR) mutation (e.g., V30M), AND
• ONE of the following (A, B, C or D):
  • A. Patient has a baseline polyneuropathy disability (PND) score less than or equal to IIIb 
  • B. Patient has a baseline familial amyloidotic polyneuropathy (FAP) stage of 1 or 2 
  • C. Patient has a baseline neuropathy impairment score (NIS) greater than or equal to 5 and less than or equal to 130 
  • D. 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), AND
• Patient has not had a liver transplant

Reauthorization Criteria:

For diagnosis of hereditary transthyretin-mediated amyloidosis:

• Dose does not exceed 25 mg injected once every 3 months, AND
• Documentation of 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 (A, B, C or D):
  • A. Patient continues to have a polyneuropathy disability (PND) score less than or equal to IIIb 
  • B. Patient continues to have a familial amyloidotic polyneuropathy (FAP) stage of 1 or 2 
  • C. Patient continues to have a neuropathy impairment score (NIS) greater than or equal to 5 and less than or equal to 130 
  • D. Patient continues to have a Karnofsky Performance Status score greater than or equal to 60% 

Coverage Duration: 

•    Initial: 1 year
•    Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

• Amvuttra is for subcutaneous use only and should be administered by a healthcare professional.

Policy Updates:

• 11/15/2022 – New policy approved by P&T.

References:

1.    Amvuttra Prescribing Information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. June 2022. 
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.