RXMP-29 Vutrisiran (Amvutra) Form

vutrisiran (Amvuttra)

Updated on:

Page 1 of 2 Policy Number RXMP-29 Line of Business Medicaid & Medicare Effective Date 8/15/2023 (Medicaid), 1/1/2024 (Medicare) Revision Date 11/3/2025

Products: vutrisiran (Amvuttra)

Override(s)
Approval Duration
Prior Authorization
Initial Request: 3 months; COC/Reauthorization: 12 months

HCPCS Description Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered J0225 Injection vutrisiran 1 mg (Amvuttra 25mg/0.5mL syring) 1 syringe per 3 months

Medicare Criteria
Medicare ST/Part B criteria
Medicare Part B Coverage Criteria
• Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/3/2025. Review using General Coverage Criteria below. Note there is an LCD for: Molecular Testing for identification and management of Hereditary Transthyretin Amylodis LCD - MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis (L39948) Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products vutrisiran (Amvuttra) Line of Business Medicare and Medicaid Approval Length Initial Request: 26 weeks Renewal: 12 months Override Type PA, QL Initial Criteria

1. Diagnosis of hereditary transthyretin (hATTR)-mediated amyloidosis or transthyretin-type familial amyloid polyneuropathy (ATTR-FAP) (ICD-10 E85.1: Neuropathic heredofamilial amyloidosis); AND
2. Documentation of TTR mutation verified by genotyping; AND
3. Documentation of clinical manifestations of ATTR-FAP, including but not limited to amyloid deposition in biopsy specimens, TTR protein variants in serum, progressive peripheral sensory-motor polyneuropathy, autonomic neuropathy, motor disability; AND
4. Prescribed by or in consult with geneticist; AND
5. Documentation that the member has one of the following baseline levels: a. Polyneuropathy disability (PND) score ≤ IIIb b. Familial amyloid polyneuropathy (FAP) Stage 1 or 2 c. Neuropathy impairment score (NIS) ≥ 5 and ≤ 130

vutrisiran (Amvuttra)

Updated on:

Page 2 of 2 d. Karnofsky performance status (KPS) score ≥ 60% Renewal Criteria

1. Documentation of clinically improvement or stabilization in clinical signs and symptoms of disease, including but not limited to improved ambulation, improvement in neurologic symptom burden, improvement in activities of daily living, improvement of neuropathy severity and rate of disease progression, manual grip strength; AND

2. Documentation that the member has one of the following: a. A PND score less than or equal to IIIb b. A FAP stage of 1 or 2 c. A NIS score of between 5 and 130 d. A KPS score ≥ 60%

   Exclusion

3. Member has a history of liver transplantation.
4. Member has severe renal impairment or end-stage renal disease.
5. Member has moderate or severe hepatic impairment.
6. Member has New York Heart Association (NYHA) class III or IV heart failure.
7. Member has sensorimotor or autonomic neuropathy not related to hATTR amyloidosis (including but not limited to, monoclonal gammopathy, autoimmune disease).
8. Member is using in combination with an RNA interference agent (e.g. Onpattro (patisiran), Tegsedi (inotersen)).

9. Member is using in combination with a transthyretin stabilizer (e.g. Vyndaqel (tafamidis meglumine) or Vyndamax (tafamidis)).

   FDA Indications & Dosing Indication Dosing/Administration polyneuropathy of hereditary transthyretin-mediated amyloidosis 25mg SQ Q3 months

   References

10. Amvuttra Prescribing Information. Alnylam Pharmaceuticals. Revised 2/2023.
11. Alnylam Pharmaceuticals. HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis). NLM Identifier: NCT 03759379. Last updated: June 22, 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT03759379.
12. Ando Y, Coelho T, Berk JL, et. al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet J Rare Dis. 2013;8(31).

13. Gertz MA, Benson MD, Dyck PJ, et. al. Diagnosis, Prognosis, and Therapy of Transthyretin Amyloidosis. J Am Coll Cardiol. 2015;66(21):2451-2466.

    Review History 10/4/2023 PH: New