Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Amvuttra (vutrisiran) requires prior authorization.

2)    Amvuttra is used in the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

3)    Amvuttra is covered under the medical benefit.

Amvuttra (vutrisiran) requires prior authorization subject to the criteria listed below:

I. Initial Approval Criteria

A. Hereditary Transthyretin-Mediated Amyloidosis (must meet all):

1. Diagnosis of hATTR with polyneuropathy;

2. Prescribed by or in consultation with a neurologist;

3. Age ≥ 18 years;

4. Documentation confirms presence of a transthyretin (TTR) mutation;

5. Biopsy is positive for amyloid deposits or medical justification is provided as to why treatment should be initiated despite a negative biopsy or no biopsy;

6. Member has not had a prior liver transplant;

7. Member has not received prior treatment with Onpattro® or Tegsedi™;

8. Amvuttra is not prescribed concurrently with Onpattro or Tegsedi;

9. Dose does not exceed 25 mg every 3 months.

Approval duration: 6 months

II. Continued Therapy

A. Hereditary Transthyretin-Mediated Amyloidosis (must meet all):

1. Member is currently receiving medication via QualChoice benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: measures of polyneuropathy (e.g., motor strength, sensation, and reflexes), quality of life, motor function, walking ability (e.g., as measured by timed 10-m walk test), and nutritional status (e.g., as evaluated by modified mass index);

3. Member has not had a prior liver transplant;

4. Amvuttra is not prescribed concurrently with Onpattro or Tegsedi;

5. If request is for a dose increase, new dose does not exceed 25 mg every 3 months.

Approval duration: 12 months

Codes Used In This BI:

1)    J0225 – Injectoin, vutrisiran, 1mg

1. Amvuttra Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; June 2022. Available at: https://www.alnylam.com/sites/default/files/pdfs/amvuttra-usprescribing-information.pdf. Accessed June 28, 2022.

2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). NCT03759379: HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis). Updated July 20, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03759379. Accessed July 29, 2021.

3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). NCT04153149: HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy. Updated July 16, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04153149. Accessed July 29, 2021.

4. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet J Rare Dis. 2013 Feb 20;8:31.

5. Magrinelli F, Fabrizi GM, Santoro L, et al. Pharmacological treatment for familial amyloid polyneuropathy. Cochrane Database Syst Rev. 2020 Apr 20;4(4):CD012395.