Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) Coverage Criteria
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Defines medical necessity and prior authorization criteria for Trikafta for Peach State Health Plan Medicaid members with cystic fibrosis, including initial and continued therapy requirements, dosing limits, and documentation expectations.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met
inv-02: Continuation Therapy
Covered when ALL of the following are met
Requests for uses that are non‑FDA approved indications not addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the plan's off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.
Trikafta must not be prescribed concurrently with other CFTR modulators. The policy explicitly lists concurrent use exclusions and was updated to include Alyftrek among CFTR modulators that cannot be used together with Trikafta.
Appendix updates in the policy include an expanded and updated list of CFTR gene mutations identified as responsive to Trikafta (see Appendix E). The review history also documents that Alyftrek was added to the CFTR modulator concurrent exclusion criteria.
Use of Trikafta for indications that are not FDA‑approved and not addressed by this policy is considered not authorized unless the provider supplies adequate supporting evidence per the plan's off‑label and no‑coverage policies; absent that documentation, requests may be denied.
Initial Therapy
inv-24: Initial therapy
Initial therapy coverage requirements
inv-25: Initial therapy duration note
Initial approval duration and criteria notes found in review history
This is a review history note documenting intended change to initial approval duration.
Continued Therapy
inv-26: Continued therapy
Continued therapy coverage requirements
See Appendix D for details on ppFEV1 and LCI measurement guidance and the dosing tables for age/weight limits.
inv-27: Continued therapy definitions / clarifications
Continued therapy notes from review history
These entries reflect changes in how response is defined across reviews; check current policy version for operative definitions.
Provider Actions & Requirements
Prior authorization required; submit supporting documentation
Prior authorization is required. Provider must demonstrate the member meets all approval criteria in the policy and submit supporting documentation (such as office chart notes, lab results, or other clinical information) with the request.
- Requests must show member meets initial or continued therapy criteria described in the policy.
PA determinations governed by this clinical policy
This clinical policy governs medical necessity determinations for Trikafta and related products for Peach State Health Plan; prior authorization decisions should follow the criteria and requirements set forth in this policy.
Prior authorization guidance and scope
This document serves as the clinical policy guiding medical necessity determinations for Trikafta; it describes the criteria that must be met for authorization and references affected diagnoses, dosing limits, and continuity guidance.
- Specific prior authorization procedures and affected billing codes are referenced in the policy text and appendices.
Do not prescribe concurrently with other CFTR modulators
Trikafta must not be prescribed concurrently with other CFTR modulators (examples listed include Alyftrek, Orkambi, Kalydeco, Symdeko); concurrent use is an exclusion in both initial and continued therapy criteria.
- Initial therapy criterion 4: 'Trikafta is not prescribed concurrently with other CFTR modulators (e.g., Alyftrek®, Orkambi®, Kalydeco®, Symdeko®)'.
- Continued therapy criterion 3: same concurrent-modulator prohibition.
Concurrent use with Alyftrek excluded
Alyftrek was added to the policy's list of CFTR modulator concurrent exclusion criteria; requests for treatment that involve concurrent use with Alyftrek are excluded.
- Review history and revisions note: 'Added Alyftrek to list of CFTR modulator concurrent exclusion criteria.'
No step therapy requirements specified
No step therapy operational requirements or sequencing steps are specified in the available text; the policy only states that Trikafta should not be used concurrently with other CFTR modulators.
- Policy step_therapy entries: 'No step therapy operational requirements are provided in the available text.'
Required supporting documentation for PA
Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) that demonstrates the member has met all applicable approval criteria when requesting authorization.
- Documentation should directly support diagnosis, CFTR dysfunction confirmation, genotype, age, prescribing clinician, and dosing as applicable.
Document age, weight, and indication for pediatric dosing
For pediatric dosing, prescribers should document patient age and weight and the clinical indication to support the selected dosing regimen (policy specifies age and weight tiers for dosing).
- Examples: age 2 to <6 years with weight <14 kg versus ≥14 kg, and age/weight tiers for older pediatric groups as listed in dosing tables.
Provider obligations and policy terms
Providers are independent contractors and are bound by the terms and conditions of this clinical policy when providing services or submitting claims; unauthorized use or distribution of the policy is prohibited.
Non‑FDA indications may be denied without off‑label evidence
Requests for non–FDA approved indications that are not addressed by this policy may be denied unless sufficient evidence is provided per the applicable off-label or no-coverage policies (see referenced off-label/no-coverage policies).
- Refer to CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid) for off-label documentation requirements.
Review-history notes (no new denial triggers in extract)
Review history notes changes to criteria (for example, planned removal of LCI from continued therapy criteria and updates to approval durations), but no additional explicit denial triggers are provided in this extract.
- 4Q 2024: clarified 'positive response' definitions; 4Q 2025: planned removal of LCI and change to initial approval duration.
Coverage subject to member documents; Medicaid precedence
Coverage decisions are subject to the member's coverage documents, and if state Medicaid provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence.
- Providers should consult the state Medicaid manual for state-specific coverage provisions.
Coding & Diagnostic Criteria
Step Therapy / Sequencing
| Step | Requirement |
|---|---|
| 1 | Do not prescribe concurrently with other CFTR modulators (e.g., Alyftrek®, Orkambi®, Kalydeco®, Symdeko®). |
| Step | Requirement |
|---|---|
| 1 | Concurrent use of certain CFTR modulators is excluded; Alyftrek® was added to the policy’s list of CFTR modulator concurrent exclusion criteria (concurrent use with Trikafta is not allowed). |
Background
Trikafta is a triple‑combination CFTR modulator containing elexacaftor, tezacaftor, and ivacaftor. Elexacaftor and tezacaftor act as correctors to improve trafficking of certain mutant CFTR proteins (including F508del), while ivacaftor potentiates channel gating; together they increase CFTR quantity and function at the cell surface and enhance CFTR‑mediated chloride transport.
Definitions
Revision History
Policy created (initial publication).
4Q 2022 annual review: no clinical changes; references reviewed and updated.
Template changes applied including pediatric expansion and new granule formulation; Appendix D updated.
4Q 2023 annual review: no changes made.
Revised Appendix D to remove information on advanced cystic fibrosis disease.
4Q 2024 annual review: clarified continued therapy 'positive response' language for LCI and ppFEV1; Appendix D LCI supplemental information and references updated.
4Q 2025 annual review: removed lung clearance index (LCI) from criteria and updated initial approval duration from 4 months to 6 months.
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