CurrentUnitedHealthcarePolicy 2024 P 1265-6

Tegsedi (inotersen) prior authorization

UnitedHealthcare prior authorization program for Tegsedi (inotersen) covering initial and reauthorization criteria for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy in adults, plus additional clinical rules and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyTegsedi (inotersen) prior authorization

Policy CodePolicy 2024 P 1265-6

Change TypeAnnual reviewclarifications

Effective DateFeb 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required; approval will be granted only if initial or reauthorization criteria are met.

SourceLink

POLICY UPDATE CHANGES

Annual reviews (2018-2024) documented; 11/2024 annual review noted no change to coverage criteria.

Added Amvuttra (vutrisiran) as an example of oligonucleotide agent not to be used in combination with Tegsedi (not a change in clinical intent).

12 monthsAuthorization Duration

1Required Genetic Confirmation

1Required Clinical Response for Reauthorization

2Combination Contraindications Listed

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Coverage Summary

Tegsedi (inotersen) is covered with prior authorization for treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Policy number: 2024 P 1265-6. Status: CURRENT. Effective date: 2025-02-01. Last review: 2024-11-01. Program summary: UnitedHealthcare prior authorization program for Tegsedi (inotersen) covering initial and reauthorization criteria for treatment of hATTR amyloidosis with polyneuropathy in adults, plus additional clinical rules and a 12-month authorization duration.

Key Policy Facts

Authorization Duration12 months

Combination Contraindications Listed2

Required Genetic Confirmation1

Required Clinical Response for Reauthorization1

Effective Date2025-02-01

Last Review2024-11-01

Policy Number2024 P 1265-6

Initial Therapy Criteria

Continuation Therapy Criteria

Reauthorization

Tegsedi will be approved based on all of the following criteria:

ALL of the following

Diagnosis of hATTR amyloidosis with polyneuropathy
Patient has a pathogenic TTR mutation (e.g., V30M)
ALL of the following
- NONE of the following
  - Oligonucleotide agents (e.g., Onpattro (patisiran), Amvuttra (vutrisiran))

Provider Actions & Operational Rules

Prior Authorization

Prior authorization required (automated approval may occur via claim/medication history or diagnosis codes)

Prior authorization/notification is required; approval will be granted only if initial or reauthorization criteria are met. UnitedHealthcare may also approve based solely on claim/medication history or diagnosis codes via automated processes.

Documentation Required

Documentation of pathogenic TTR mutation

Provider must document that the patient has a pathogenic TTR mutation (example given: V30M).

Documentation Required

Documentation of clinical response for reauthorization

For reauthorization, the provider must document a positive clinical response to Tegsedi therapy.

Applicable Codes

ICD-10 Diagnosis Codes (permitted to support automated approval/claim logic)ICD-10

No codes listed

Clinical Evidence & Definitions

Evidence: Tegsedi [package insert], Akcea Therapeutics, Inc.; January 2024. Background: Tegsedi (inotersen) is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. UnitedHealthcare's program establishes prior authorization criteria for initial and continuation therapy and may use automated approval processes based on claims/diagnosis history.

Definitions: hATTR = Hereditary transthyretin-mediated amyloidosis.

Revision History

2024-11annual_reviewLatest

11/2024 annual review documented; no change to coverage criteria.

2022-11annual_review

11/2022 annual review documented; added Amvuttra (vutrisiran) as an example of an oligonucleotide agent not to be used in combination with Tegsedi (no change in clinical intent).