Amvuttra (vutrisiran) Injectable Medication Precertification Request - Coverage Criteria
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Precertification documentation and requirements for Aetna members requesting coverage for Amvuttra (vutrisiran), including initial and continuation therapy information to be completed by the provider and dispensing/administration details.
No material clinical or coverage changes in this revision.
Coverage Criteria for Amvuttra (vutrisiran)
Initial and continuation therapy criteria
Coverage consideration requires completion of clinical fields demonstrating diagnosis and, for continuation, clinical benefit.
Form solicits whether diagnosis was confirmed by TTR gene mutation, presence of amyloid deposition or TTR protein variants, and captures site-of-care, adverse event history, liver transplant status, and whether prescriber is a specialist.
Each item on the form must be completed for precertification review.
Responses inform coverage decision-making but are collected as part of the clinical record.
Continuation checkbox and supporting clinical documentation are required on page 2.
The precertification form includes specific clinical fields assessing the proposed outpatient infusion setting and potential risks that could affect site-of-care decisions. The form asks whether the infusion will occur in an outpatient hospital setting and whether the patient has experienced an adverse event with the requested product that did not respond to conventional interventions or a severe adverse event (examples listed include anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures) occurring during or immediately after administration. It also solicits whether the patient has significant behavioral, physical, or cognitive impairments that would impact infusion safety in the absence of a caregiver, and whether the patient is medically unstable (with respiratory, cardiovascular, or renal conditions) that could limit tolerance of large volumes or predispose to severe events requiring an alternate setting with appropriate medical personnel and equipment.
The form does not include explicit language declaring therapies not medically necessary. However, it states that required clinical information must be completed in its entirety for all precertification requests, and missing or incomplete clinical documentation (including the adverse event, stability, and diagnostic confirmation fields) can prevent a request from meeting precertification review requirements and thus impede authorization.
Billing and Diagnosis Codes
| Administration code(s) (CPT) | Field for provider to list CPT codes for administration |
| Primary ICD Code | Primary diagnosis ICD code field |
| Secondary ICD Code | Secondary diagnosis ICD code field |
| Other ICD Code | Other diagnosis ICD code field |
Provider Steps, Submission, and Documentation Requirements
Prior/Combination Therapy and Specialist Involvement
Prior/combination therapy and specialist involvement: Indicate if the requested medication will be used in combination with any other FDA‑approved therapy for hereditary transthyretin-mediated amyloidosis (for example, Onpattro, Tegsedi, Vyndamax, Vyndaqel, Wainua). Also indicate whether the medication will be prescribed by or in consultation with an appropriate specialist (Neurologist, Geneticist, or a physician specializing in the treatment of amyloidosis).
- Will the requested medication be used in combination with any other approved medication for hereditary transthyretin-mediated amyloidosis? (Yes/No). If Yes, list agent(s).
- Will the requested medication be prescribed by or in consultation with one of the following specialists: Neurologist, Geneticist, or a physician who specializes in amyloidosis? (Yes/No). If Yes, provide specialist name, specialty, NPI, and documentation of consultation if applicable.
- Document prior therapy response/intolerance/contraindication to Onpattro (patisiran) where applicable: ineffective response, intolerance, or contraindication (Yes/No with supporting details).
Background
This precertification request form is specific to treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR-FAP). It requests confirmation of the diagnosis, including whether the diagnosis was confirmed by detection of a TTR gene mutation, and whether the patient exhibits clinical manifestations of ATTR-FAP (for example, amyloid deposition on biopsy, TTR protein variants in serum, or progressive peripheral sensory-motor polyneuropathy).
Definitions
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