CurrentAvMedPolicy Pub. 100-2

Tegsedi (inotersen) prior authorization — medical necessity criteria

Authorization form and medical necessity criteria for coverage of Tegsedi (inotersen) subcutaneous injection for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis polyneuropathy (FAP) for AvMed members.

Policy Summary

PayerAvMed

PolicyTegsedi (inotersen) prior authorization — medical necessity criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed, signed prior authorization form with required clinical and laboratory documentation including genetic test, biopsy, baseline PND or FAP staging, platelet count, UPCR, eGFR, and REMS enrollment attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

284 mgdosing

6 moinitial approval

6 morenewal

>100platelets threshold

>45eGFR threshold

Coverage Criteria for Tegsedi (inotersen)

Initial Therapy

Covered when ALL of the following are met

Prescriber: Medication must be prescribed by or in consultation with a neurologist

Age: Member must be 18 years of age or older

Genetic confirmation: Documented genetic mutation of a pathogenic TTR variant

Pathology confirmation: Confirmation of amyloid deposits on tissue biopsy

Policy Summary

PayerAvMed

PolicyTegsedi (inotersen) prior authorization — medical necessity criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Reauthorization

Reauthorization covered when ALL of the following are met

Prior treatment: Member has previously received treatment with Tegsedi

Prescriber: Prescribed by or in consultation with a neurologist

Disability threshold continues: Member continues to have a PND score <= IIIb OR continues to have a FAP Stage 1 or 2

Clinical response: Documentation that member has experienced a positive clinical response to Tegsedi (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression)

Toxicity: Absence of drug toxicity

Coverage will not be approved for members with any of the exclusionary conditions listed on the authorization form. These include a documented history of liver transplant, a history of acute glomerulonephritis caused by Tegsedi (inotersen), severe renal impairment or end-stage renal disease, moderate or severe hepatic impairment, or New York Heart Association (NYHA) class III or IV heart failure. Therapy is also excluded when the neuropathy is sensorimotor or autonomic but not related to hATTR amyloidosis (for example, due to monoclonal gammopathy or autoimmune disease), or when the member is receiving concurrent therapy with Onpattro (patisiran), tafamidis, or diflunisal.

Coding and Laboratory Thresholds

Covered HCPCS/Medical administration codeHCPCSCovered

J3490

Unclassified drugs (used here for Tegsedi - inotersen) (Medical)

inv-06: Platelet count — threshold for approval

Platelet count thresholdPlatelet count is above 100 x 10^9/L

Action if below thresholdDo not approve if platelet count is ≤ 100 x 10^9/L

Documentation requiredProvide recent laboratory report showing platelet count prior to initiation

inv-07: UPCR (urinary protein to creatinine ratio) — threshold

UPCR thresholdUrinary protein to creatinine ratio (UPCR) is below 1000 mg/g

Action if above thresholdDo not approve if UPCR ≥ 1000 mg/g

Documentation requiredProvide recent UPCR laboratory result prior to initiation

inv-08: eGFR — renal function threshold

eGFR thresholdEstimated glomerular filtration rate (eGFR) above 45 mL/min/1.73 m^2

Action if at or below thresholdDo not approve if eGFR ≤ 45 mL/min/1.73 m^2

Documentation requiredProvide recent eGFR (or creatinine-based) laboratory report prior to initiation

Provider Requirements and Submission Instructions

Prior Authorization

Prior authorization required — submit signed form with complete Member/Prescriber/Drug information

Submit a completed, signed prior authorization request form for Tegsedi (inotersen) (J3490) with the prescriber’s handwritten signature and all Member, Prescriber, and Drug information filled in; incomplete forms may delay authorization.

Drug requested listed as Tegsedi (inotersen) (J3490) (Medical)
Prescribing physician must sign and clearly print name (preprinted stamps not valid)
Include Member Name, AvMed ID, DOB, Prescriber name, DEA or NPI, phone/fax, drug form/strength, dosing schedule, length of therapy, and diagnosis

Step Therapy

Samples and prior therapy verification — samples do not satisfy PA

Do not rely on free samples to start therapy — use of samples does not meet prior authorization or step-edit criteria; provide evidence of prior therapies when requested as AvMed will verify previous treatments through pharmacy paid claims or chart notes.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Documentation Required

Required clinical and laboratory documentation — genetic test, biopsy, baseline labs, REMS

Provide supporting clinical and laboratory documentation with the request: genetic test confirming a pathogenic TTR variant, tissue biopsy showing amyloid deposits, baseline clinical signs/symptoms and disability (PND score or FAP stage), baseline laboratory results (platelet count, UPCR, eGFR), and attestation of REMS enrollment; these are required to support each checked criterion.

Documented genetic mutation of a pathogenic TTR variant
Confirmation of amyloid deposits on tissue biopsy
Attestation that member is enrolled in the Tegsedi REMS program
Baseline clinical signs/symptoms and baseline PND score ≤ IIIb or baseline FAP Stage 1 or 2
Baseline labs: platelet count (>100 x 10^9/L), UPCR (<1000 mg/g), eGFR (>45 mL/min/1.73 m^2)
For reauthorization, documentation of prior Tegsedi treatment, continued disability threshold, evidence of positive clinical response, and absence of drug toxicity

Denial Risk

Incomplete or illegible submission may delay or deny authorization

An authorization request that is incomplete, incorrect, or illegible — including missing lab results, diagnostics, or chart notes — may be delayed or denied; ensure all requested documentation is legible and attached to avoid denial.

If information provided is not complete, correct, or legible, authorization can be delayed
To support each line checked, all documentation (lab results, diagnostics, and/or chart notes) must be provided or request may be denied

OpenPayer

Tegsedi (inotersen) prior authorization — medical necessity criteria

Coverage Criteria for Tegsedi (inotersen)

Coding and Laboratory Thresholds

Provider Requirements and Submission Instructions

Background

Definitions and Staging