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 review; clarifications

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.

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

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

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))
  - Tafamidis (e.g., Vyndaqel, Vyndamax)

ref": "b1_0

title": "Initial Authorization

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.

Billing Rule

Authorization duration

Authorization will be issued for 12 months. State mandates, federal regulatory requirements, and member-specific benefit plans may affect coverage.

Denial Risk

Contraindicated combinations

Claims may be denied if Tegsedi is used in combination with oligonucleotide agents (e.g., Onpattro/patisiran, Amvuttra/vutrisiran) or tafamidis (e.g., Vyndaqel, Vyndamax).

Billing Rule

Supply limits

Supply limits may be in place.

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).