CurrentCareSourcePolicy N/A

Tegsedi (inotersen) — Pharmacy Coverage Criteria

Defines pharmacy benefit coverage, prior authorization, quantity limits, allowed site of service, and clinical criteria for Tegsedi (inotersen) for members with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy in the listed jurisdiction.

Policy Summary

PayerCareSource

PolicyTegsedi (inotersen) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeRemoved site-of-service officedocumentation and prescriber updates

Effective Date01/01/2022

Next Review DateN/A

Key ActionObtain prior authorization and provide chart documentation confirming hATTR diagnosis, TTR genetic testing, FAP stage, and baseline platelet counts (>=100 x 10^9/L).

SourceLink

POLICY UPDATE CHANGES

Removed 'office' from site of service allowed; expanded prescriber scope; separated genetic testing and FAP staging into mandatory requirements; removed several exclusions.

Removed prescriber specialty requirement.

New policy for Tegsedi created.

4monthly limit

284 mg/wkdose

6 moinitial approval

12 moreauthorization

>=18min age

Coverage Criteria for Tegsedi (inotersen)

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization Requirements: Member is 18 years old or older; Member has diagnosis of hATTR amyloidosis with polyneuropathy confirmed by chart notes; Member has documented transthyretin (TTR) gene mutation as confirmed through genetic testing (documentation required); Member has documentation of familial amyloid polyneuropathy (FAP) stage 1 (unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs) or stage 2 (assistance with ambulation required; mostly moderate impairment progressing to upper limbs and trunk); Member does not have prior liver transplant; Member does not have known primary or leptomeningeal amyloidosis; Platelet count >= 100 x 10^9/L; Member is not using Tegsedi concomitantly with Onpattro, Vyndaqel, or Vyndamax; Dosage: 284 mg subcutaneous once weekly.

If all requirements met, approve for 6 months.

Continuation/Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization Requirements: Member continues to have FAP stage 1 or stage 2; Chart notes show positive response to Tegsedi (e.g., improved quality of life or motor function, slowed disease progression, or reduced serum TTR levels); Member did not have acute glomerulonephritis caused by Tegsedi; Platelet count remains >= 100 x 10^9/L; Member is not using Tegsedi concomitantly with Onpattro, Vyndaqel, or Vyndamax.

Policy Summary

PayerCareSource

PolicyTegsedi (inotersen) — Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeRemoved site-of-service officedocumentation and prescriber updates

Effective Date01/01/2022

Next Review DateN/A

Key ActionObtain prior authorization and provide chart documentation confirming hATTR diagnosis, TTR genetic testing, FAP stage, and baseline platelet counts (>=100 x 10^9/L).

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.

If met, approve for additional 12 months.

Tegsedi (inotersen) is not medically necessary for indications that are not expressly listed in this policy. The policy explicitly states that coverage is limited to the disease states and criteria contained herein, and conditions not listed should be considered excluded from coverage. Earlier policy versions contained specific exclusion examples (e.g., certain comorbid conditions) that were later removed, but the current policy maintains that non-listed indications remain not medically necessary.

Treatment of diseases not enumerated in this document is considered not medically necessary. Providers requesting Tegsedi must document that the member’s condition matches one of the covered indications and meets all listed clinical criteria; requests for unlisted diagnoses should be denied as not medically necessary.

Initial Therapy Requirements

Initial Therapy

Initial: Age >= 18; Confirmed diagnosis of hATTR amyloidosis with polyneuropathy by chart notes; Documented TTR gene mutation confirmed by genetic testing; Documented FAP stage 1 or 2; Platelet count >= 100 x 10^9/L; No prior liver transplant; No known primary or leptomeningeal amyloidosis; Not used concomitantly with Onpattro, Vyndaqel, or Vyndamax; Dosage 284 mg subcutaneous once weekly.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: Continued FAP stage 1 or 2; Documented positive clinical response to Tegsedi (e.g., QoL or motor improvement, slowed progression, or reduced serum TTR); No history of Tegsedi-induced acute glomerulonephritis; Platelet count >= 100 x 10^9/L; No concomitant use with Onpattro, Vyndaqel, or Vyndamax.

Billing and Coding

Billing requirementsNDC

NDC required

Must use valid NDC code when billing Tegsedi

inv-06: Platelet count requirement — >= 100 x 10^9/L

Platelet count requirement>= 100 x 10^9/L

Context in initial authorizationPlatelet count >= 100 x 10^9/L is required for initial approval

Context in reauthorizationPlatelet count must remain >= 100 x 10^9/L for reauthorization

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tegsedi (inotersen) when billed under the pharmacy benefit as a non-preferred product. Approval for initial requests is contingent on meeting the listed clinical criteria (age ≥ 18, diagnosis of hATTR amyloidosis with polyneuropathy, documented TTR gene mutation, documented FAP stage, baseline labs, and other required documentation). If initial criteria are met, approval is for 6 months; reauthorization requires documentation of clinical benefit and lab monitoring and, if met, may be approved for 12 months.

Benefit type: Pharmacy
Quantity limit: 4 prefilled syringes per month
Dosage allowed: 284 mg SQ once weekly
Approval length: Initial = 6 months; Reauthorization = 12 months (if criteria met)

Denial Risk

Concomitant Therapy Restriction

Concomitant use of Tegsedi with any of the following products is not permitted: Onpattro, Vyndaqel, or Vyndamax. Requests that indicate concurrent therapy with these agents will be denied.

Not allowed concomitant therapies: Onpattro (patisiran), Vyndaqel (tafamidis meglumine), Vyndamax (tafamidis)
Reauthorization also requires documentation that the member is not using Tegsedi concomitantly with these agents

Documentation Required

Required Documentation

Documentation must be submitted with the PA request and retained in the medical record. Required documentation includes clinical chart notes, genetic testing confirming a pathogenic TTR gene mutation, documentation of FAP stage (stage 1 or 2), baseline and ongoing laboratory results (including platelet counts and renal function), and evidence of prior transplant or other exclusions where applicable.

Diagnosis confirmation: chart notes documenting hATTR amyloidosis with polyneuropathy
Genetic testing: documented TTR gene mutation (test report required)
FAP stage: documentation of stage 1 (unimpaired ambulation or mostly mild neuropathy) or stage 2 (assistance with ambulation required)
Baseline labs: platelet count, renal function tests; platelet count must be ≥ 100 x 10^9/L for initiation and remain ≥ 100 x 10^9/L for continuation
Other documentation: prior liver transplant status, documentation of contraindications (e.g., primary or leptomeningeal amyloidosis), and for reauthorization — chart notes demonstrating clinical benefit (improved QoL/motor function, slowed disease progression, reduced serum TTR)

Denial Risk

Denial Triggers

Requests may be denied for failure to obtain prior authorization or for incomplete/missing required documentation. Common denial triggers include: patient age <18, lack of confirmed hATTR diagnosis, absence of documented TTR mutation, missing FAP stage, platelet count <100 x 10^9/L, evidence of disallowed concomitant therapy, or prior liver transplant when listed as an exclusion.

Denial triggers: no PA on file; missing genetic test proof; missing chart notes confirming hATTR with polyneuropathy; absent FAP stage documentation
Lab-related denials: platelet count < 100 x 10^9/L or missing baseline/ongoing platelet and renal function tests
Therapy-related denials: concomitant use with Onpattro, Vyndaqel, or Vyndamax

Step Therapy / Concomitant Therapy Rules

Step	Requirement	Coverage status
1	Do not initiate Tegsedi (inotersen) concomitantly with Onpattro (patisiran), Vyndaqel (tafamidis meglumine), or Vyndamax (tafamidis).	Member must not be using Tegsedi with these agents for approval (see initial and reauthorization criteria).

Quantity Limits

inv-16: Tegsedi (inotersen) — 4 prefilled syringes per month limit

Monthly quantity limit4 prefilled syringes per month

ProductTegsedi (inotersen)

Billing noteQuantity limit applies under the pharmacy benefit

Allowed Site of Service

Note

Home is the allowed site of service

Tegsedi may be administered in the member's home; the policy removed 'office' as an allowed site of service in the 07/06/2020 revision.

Key Definitions

inv-12: FAP staging — definitions for FAP stage 1 and stage 2

FAP stage 1Unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs.

FAP stage 2Assistance with ambulation required; mostly moderate impairment progressing to upper limbs and trunk.

Use in criteriaDocumentation of FAP stage 1 or 2 is required for initial authorization and must persist for reauthorization.

Background

Hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy is a genetic disorder caused by mutations in the transthyretin (TTR) gene that leads to progressive peripheral nerve degeneration. The policy covers Tegsedi (inotersen), an antisense oligonucleotide disease-modifying therapy, when the member has a documented diagnosis of hATTR amyloidosis with polyneuropathy confirmed in chart notes, a documented TTR gene mutation by genetic testing, and documentation of familial amyloid polyneuropathy (FAP) stage 1 or 2. Approved dosing under the policy is 284 mg subcutaneous once weekly, with initial approval typically for 6 months and reauthorization contingent on documented clinical benefit.