J0225, Injection, vutrisiran, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Diagnosis documentation: wild-type or hereditary ATTR-mediated amyloidosis with cardiomyopathy (ATTR-CM) for Amvuttra cardiomyopathy indication; hATTR amyloidosis with polyneuropathy for polyneuropathy indication.
- Documentation of pathogenic TTR mutation (e.g., V30M) OR cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of ATTR amyloid deposits OR imaging criteria (echocardiogram or cardiac MRI suggestive of amyloidosis plus radionuclide imaging 99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP showing grade 2 or 3 cardiac uptake) and absence of light chain amyloidosis (for ATTR-CM indication).
- Physician attestation that the patient's NT-proBNP level, when combined with signs and symptoms, is considered definitive for a diagnosis of ATTR-CM (cardiomyopathy indication).
Key Coverage Criteria
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Amvuttra (vutrisiran) is medically necessary for the treatment of cardiomyopathy of wild-type (wtATTR) or hereditary transthyretin-mediated (hATTR) amyloidosis (ATTR-CM) in patients who meet all of the following criteria: Diagnosis of wild-type or hereditary ATTR-mediated amyloidosis with cardiomyopathy (ATTR-CM); documentation of one of the following: (a) The patient has a pathogenic TTR mutation (e.g., V30M); or (b) Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of A [...]
- Amvuttra (vutrisiran) — Continuation of therapy for ATTR-CM: Patient has previously received treatment with Amvuttra for wtATTR or hATTR amyloidosis; documentation that the patient has experienced a positive clinical response to Amvuttra (e.g., improved symptoms, quality of life, slowing of disease progression, decreased hospitalizations, etc.); documentation that the patient continues to have NYHA Functional Class I, II, or III heart failure; patient is not receiving Amvuttra in combination wit [...]
- Amvuttra (vutrisiran) and Onpattro (patisiran) are medically necessary for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in patients who meet all of the following criteria (Initial Therapy): Diagnosis of hATTR amyloidosis with polyneuropathy; documentation that the patient has a pathogenic TTR mutation (e.g., V30M); documentation of one of the following baseline measures: polyneuropathy disability (PND) score ≤ IIIb, familial amyloid polyneuropathy [...]
- Amvuttra (vutrisiran) and Onpattro (patisiran) — Continuation of therapy for polyneuropathy of hATTR: Patient has previously received treatment with Amvuttra or Onpattro; documentation that patient continues to meet at least one of: PND score ≤ IIIb, FAP stage 1 or 2, NIS score ≥ 5 and ≤ 130, KPS score ≥ 60%; documentation that the patient has experienced a positive clinical response to therapy (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression [...]
- This policy addresses only the determination of medical necessity for the hospital outpatient setting for infusion and injectable therapy; the medical necessity of the pharmacologic or biologic medication itself may be reviewed separately.
9 Active Policies
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
UHC-POL-rna-targeted-therapies, RNA-Targeted Therapies (Amvuttra and Onpattro)
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
BCBSMT-ADM1001.034, Specialty Medication Administration Site of Care
BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care
Related Codes
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