Coverage Policies

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Current policies effective through April 30, 2024.

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 03/01/2023 Title: Amvuttra (vurtisiran)
Revision Date: Document: BI711:00
CPT Code(s): J0225
Public Statement

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.


Medical Statement

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


Reference

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.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.