CurrentCareSourcePolicy N/A

Tegsedi (inotersen) — Coverage Criteria for hATTR Polyneuropathy

This policy governs prior authorization and medical necessity criteria for coverage of Tegsedi (inotersen) for adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) under CareSource; it applies to prescribers and payers managing requests for Tegsedi.

Policy Summary

PayerCareSource

PolicyTegsedi (inotersen) — Coverage Criteria for hATTR Polyneuropathy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization and provide documentation of genetic confirmation of a transthyretin pathogenic variant, symptomatic polyneuropathy evidence, age ≥18, and specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard initial approval duration

284 mg weeklystandard dosing

<100 x10^9/Lcontraindicated platelet threshold

REMS requiredREMS

Adults ≥18age requirement

Coverage Criteria for Tegsedi (inotersen)

FDA-Approved Indication (Polyneuropathy of hATTR)

Covered when ALL of the following are met:

Initial approval criteria for Tegsedi: A) Patient is ≥ 18 years of age; B) Patient has a transthyretin pathogenic variant confirmed by genetic testing; C) Patient has symptomatic polyneuropathy (examples include reduced motor strength/coordination and impaired sensation such as pain, temperature, vibration, or touch; assessments may include history and clinical exam, electromyography, or nerve conduction studies); D) Patient does not have a history of liver transplantation; E) Medication is prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in amyloidosis.duration=1 year; dosing=284 mg subcutaneous once weekly

All conditions A–E required for approval.

Requests for Tegsedi used concurrently with other therapies indicated for hereditary transthyretin-mediated amyloidosis are not recommended for approval. Specifically, concurrent use with vutrisiran, acoramidis, patisiran, eplontersen, or tafamidis products is excluded because combination therapy is not supported by controlled clinical trial data and the medication should not be administered in combination with other agents for hATTR polyneuropathy or transthyretin-mediated amyloid cardiomyopathy.

Coverage of Tegsedi is not recommended for indications or circumstances that are not listed in the Recommended Authorization Criteria. The policy will be updated if new published data support additional indications or uses.

Policy Summary

PayerCareSource

PolicyTegsedi (inotersen) — Coverage Criteria for hATTR Polyneuropathy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Requirements, Documentation, and Exclusions

Prior Authorization

Prior Authorization Required

Prior Authorization is required. Approvals are provided for the duration noted in the policy (typically 1 year for FDA‑approved indication) and are contingent on meeting the documented clinical criteria and dosing. Because of the specialized evaluation and monitoring required for Tegsedi, therapy must be prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in amyloidosis. Requests for doses outside the established dosing in this policy will be reviewed on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist).

Approval duration: 1 year for FDA‑approved indication when criteria met
Prescriber requirement: neurologist, geneticist, or amyloidosis specialist
Non‑standard dosing: case‑by‑case review by Medical Director or Pharmacist

Step Therapy

Step Therapy / Automation

There is no automation for step therapy. Standardized step edits do not apply. Requests for doses or regimens outside the policy (including non‑standard dosing) will be evaluated individually.

Automation: None
Step therapy: Not automated; case‑by‑case review for non‑standard dosing

Documentation Required

Required Documentation

Documentation must include objective evidence of the diagnosis and supporting test results. Submit the following with the prior authorization request:

Genetic testing confirming a pathogenic transthyretin (TTR) variant
Clinical documentation of symptomatic polyneuropathy (examples: clinical history and exam findings, electromyography, nerve conduction studies)
Documentation that the patient is ≥ 18 years of age
Confirmation that the medication is prescribed by or in consultation with an appropriate specialist (neurologist, geneticist, or amyloidosis specialist)
Clinical justification if prior liver transplant history is present (policy excludes patients with history of liver transplantation)

Denial Risk

Safety, Population Exclusions, and Concurrent Use

Tegsedi has important safety exclusions and monitoring requirements. Review these before initiating therapy and include relevant laboratory and clinical data in the request.

Contraindication / exclusion: platelet count < 100 x 10^9/L — do not approve
History of liver transplantation: excluded from approval
REMS requirement: patient must be enrolled in the Tegsedi REMS program due to risks of severe thrombocytopenia and glomerulonephritis
Safety monitoring documentation: provide recent platelet count and renal evaluation (e.g., serum creatinine, urinalysis) and evidence of ongoing monitoring plan
Concurrent use exclusion: do not approve requests for Tegsedi used concurrently with other therapies indicated for hATTR polyneuropathy or TTR‑mediated cardiomyopathy (examples: vutrisiran/Amvuttra, acoramidis/ATTRUBY, patisiran/Onpattro, eplontersen/Wainua, tafamidis products)

Definitions and Program Requirements

hATTR — definition

DefinitionHereditary transthyretin-mediated amyloidosis (hATTR) is a progressive disease caused by pathogenic variants in the transthyretin (TTR) gene leading to multisystem organ dysfunction, commonly presenting with sensorimotor and autonomic polyneuropathy.

Typical manifestationsCommon neurologic manifestations include sensorimotor polyneuropathy, autonomic neuropathy, small-fiber polyneuropathy, and carpal tunnel syndrome.

Affected populationIndication and treatments described apply to adult patients (≥18 years).

REMS — restricted distribution requirement for Tegsedi

REMS requirementTegsedi is available only through a restricted distribution program under the Tegsedi REMS (Risk Evaluation and Mitigation Strategy) due to risks of severe thrombocytopenia and glomerulonephritis.

PurposeREMS exists because of the need for frequent monitoring for life‑threatening thrombocytopenia and for glomerulonephritis that may require immunosuppressive treatment.

Implication for authorizationDocumentation of enrollment or compliance with the Tegsedi REMS program is required as part of safety monitoring and prior authorization processes.

OpenPayer

Tegsedi (inotersen) — Coverage Criteria for hATTR Polyneuropathy

Coverage Criteria for Tegsedi (inotersen)

Coding and Laboratory Thresholds

Provider Requirements, Documentation, and Exclusions

Definitions and Program Requirements

Background