ModifiedmhnPolicy N/A

Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) — coverage for cystic fibrosis mutations and dosing

Policy covers Trikafta indications, mutation-specific responsiveness, pediatric dosing/formulations, and revised documentation and prior authorization criteria affecting prescribers and medical/pharmacy reviewers.

Policy Summary

Payermhn

PolicyElexacaftor/Tezacaftor/Ivacaftor (Trikafta) — coverage for cystic fibrosis mutations and dosing

Policy CodePolicy N/A

Change TypeCriteria revisedexclusions added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of one of the accepted pulmonary function tests (e.g., ppFEV1 or other listed tests) to support prior authorization per revised criteria.

SourceLink

POLICY UPDATE CHANGES

Revised initial approval criteria: removed age restriction and ppFEV1 40-90% limitation; replaced 'chart notes that indicate pulmonary function tests' with 'documentation of one of the following pulmonary function tests'.

Revised continuation criteria to 'stabilization or improvement in ppFEV1' and 'stabilization or decrease in LCI from baseline'; later clarified 'improvement' language and updated LCI info.

RT4: revised criteria to include pediatric expansion and new granule formulation; added age-specific ppFEV1/LCI options and updated Appendix D.

Removed lung clearance index from criteria to align with competitor and standard of care (LCI removed).

Added Alyftrek to list of CFTR modulator concurrent exclusion criteria.

6 monthsinitial approval duration (updated)

removedLCI status

3formulations (co-packets)

Policy Summary

Payermhn

PolicyElexacaftor/Tezacaftor/Ivacaftor (Trikafta) — coverage for cystic fibrosis mutations and dosing

Policy CodePolicy N/A

Change TypeCriteria revisedexclusions added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of one of the accepted pulmonary function tests (e.g., ppFEV1 or other listed tests) to support prior authorization per revised criteria.

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.

2formulations (granules)

numerousmutation listings

Alyftrekconcurrent exclusion

Coverage Criteria and Policy Scope

Coverage criteria (summary)

Covered when meeting revised clinical and documentation criteria as specified in the policy (summarized below).

Initial Approval: Initial approvals require documentation of an acceptable pulmonary function test (documentation of one of the following pulmonary function tests per policy) and meet age/formulation-specific eligibility; initial approval duration is 6 months.6 months

Includes pediatric expansion and new granule formulation eligibility; initial approval duration standardized to 6 months across updates.

Continued Therapy: Continued therapy requires demonstration of stabilization or improvement in ppFEV1. (LCI stabilization/decrease was previously part of continuation criteria but LCI was removed from criteria in later revisions.)

Positive response language clarified as increase in ppFEV1; historical continuation language included stabilization or decrease in LCI from baseline when applicable.

Mutation-specific Indication: Indication includes members with specified CFTR gene mutations shown to be responsive to elexacaftor/tezacaftor/ivacaftor (Trikafta) per prescriber information and clinical data; Appendix E lists responsive mutations.

RT4 added non-F508del responsive mutation indications based on clinical data and updated Appendix E.

Concurrent Exclusions: Concurrent use of specified CFTR modulators is excluded (policy updates add Alyftrek to the concurrent exclusion list).

Concurrent exclusion of Alyftrek added in 3Q 2025 annual review.

The policy language was updated to remove the use of lung clearance index (LCI) from the coverage criteria. This change was made to align the criteria with competitor policies and was recorded in the 3Q 2024 revisions, which explicitly state that LCI was removed from the criteria.

The policy now specifies that concurrent use of certain CFTR modulators is an exclusion. The 3Q 2025 annual review added Alyftrek to the list of CFTR modulators excluded from concurrent use with Trikafta.

Use of LCI as an approval criterion has been removed and is no longer used for medical necessity determinations. The revisions note removal of LCI from criteria to align with competitor analysis and standard of care across the 2024–2025 updates.

Dosing and Maximum Daily Dose

Maximum daily dose — elexacaftor/tezacaftor/ivacaftor by age/weight group

Maximum daily dose (adults and older pediatric group)elexacaftor 200 mg / tezacaftor 100 mg / ivacaftor 300 mg per day (Adults, pediatric patients age ≥12 years, or pediatric patients age 6–<12 years weighing ≥30 kg).

Maximum daily dose (pediatric 6–<12 yrs, <30 kg)elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 150 mg per day (Pediatric patients age 6 to <12 years weighing <30 kg).

Maximum daily dose (pediatric 2–<6 yrs, ≥14 kg)elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 150 mg per day (Pediatric patients age 2 to <6 years weighing ≥14 kg).

Maximum daily dose (granule packet single-packet content example)Morning packet for adults/tablet-equivalent regimens contains elexacaftor 80 mg / tezacaftor 40 mg / ivacaftor 119.5 mg (per chunk dosing table); dosing regimens vary by formulation as described.

Prior Authorization, Documentation, and Concurrent Therapy Rules

Prior Authorization

Prior Authorization Required and Approval Durations

Prior authorization is required for initiation and continuation per the revised criteria. Initial approval durations have been updated over time (legacy Wellcare: initial approval changed from 12 months to 6 months; later updates changed initial approval from 4 months to 6 months) — current standard initial approval duration is 6 months. Documentation must include mutation-specific indication and required supporting clinical data per the policy.

Initial approval duration: 6 months (current standard).
Prior authorization must document mutation-specific indication (see Appendix E updates).
Continuation approvals require documentation of clinical response as specified in continuation criteria.

Denial Risk

Legacy Wellcare: Initial Approval Changes and Impact

Legacy Wellcare changes reduced the initial approval duration from 12 months to 6 months to align with standard Medicaid practice; template and appendix updates were applied and may affect authorization length and required documentation. Providers should be aware that requests based on older durations or legacy criteria may be denied if current documentation does not meet the revised thresholds.

Definitions and Mutation Listings

CFTR gene mutations listed as 'responsive to Trikafta'

Responsive CFTR mutations (representative list)Document lists numerous specific CFTR gene mutations considered responsive to Trikafta based on in vitro data and prescriber information (examples include: N1303K; D1152H; L206W; R1066H; S945L; 1507_1515del9; 2183A→G; 3141del9; 546insCTA; A1006E and many others as enumerated in the policy appendix).

Source of responsiveness determinationResponsiveness is based on in vitro data and prescriber information as cited in the policy mutation list.

Appendix referenceAppendix E (prescriber information) updated to list non‑F508del mutations responsive to Trikafta per 3Q2025 annual review.

Percent predicted FEV1 (ppFEV1) — definition and threshold references

DefinitionPercent predicted forced expiratory volume in one second (ppFEV1) — a pulmonary function test metric used to document baseline and treatment response in cystic fibrosis patients.

Drug and Indication Background

Trikafta (elexacaftor/tezacaftor/ivacaftor with ivacaftor) is a CFTR modulator indicated for treatment of cystic fibrosis in people with specific CFTR mutations identified as responsive to this regimen. The policy materials list numerous responsive CFTR gene mutations and provide dosing guidance by age and formulation, including standard adult/pediatric maximums (for example, the maximum daily combined dose for older children and adults is listed as elexacaftor 200 mg / tezacaftor 100 mg / ivacaftor 300 mg per day).

Legacy Wellcare initial approval duration changed from 12 months -> 6 months.
Template changes applied to continued therapy sections and appendices; references updated.

Documentation Required

Pulmonary Function Test Documentation Required

Required pulmonary function documentation must include one of the following specified tests rather than general chart notes. Revisions over time removed age-specific phrasing and narrowed acceptable documentation to discrete pulmonary function test results. For pediatric patients alternative metrics were previously allowed (e.g., LCI ≥ 7.4 for age < 6 years) but LCI has since been removed from criteria — confirm current acceptable tests in the policy appendix.

Provide documentation of one of the following pulmonary function tests as specified in policy (ppFEV1 or other enumerated tests).
Removed wording: avoid submitting vague 'chart notes' without specified test results.
Note: LCI was previously an alternative for certain pediatric ages but has been removed from criteria — use current Appendix guidance.

Note

Legacy Step/Failure Requirements Removed

Earlier criteria that required demonstration of lack of responsiveness to other CFTR modulators (legacy step/coverage requirements) were removed. Providers should not rely on prior requirements that a member fail other modulators — verify current indication-specific criteria and mutation responsiveness instead.

Legacy requirement: lack of responsiveness to other CFTR modulators (WCG) removed.
Current policy uses mutation-specific responsiveness (see Appendix E) rather than documented failure of other modulators.

Billing Rule

Concurrent Therapy Exclusions

Concurrent therapy exclusions apply: certain CFTR modulators (for example, Alyftrek) are listed as concurrent exclusions and cannot be used simultaneously with policies' covered modulators. Ensure treatment selection and prior authorization requests reflect these exclusions.

Alyftrek added to concurrent CFTR modulator exclusion list (3Q 2025 update).
Do not request concurrent coverage for excluded CFTR modulators; selection must comply with policy exclusions.

Role in initial approvalInitial approval criteria require documentation of an acceptable pulmonary function test including ppFEV1 (policy language revised to require 'documentation of one of the following pulmonary function tests').

Role in continued therapyContinued therapy requires demonstration of 'stabilization or improvement in ppFEV1' compared with baseline (policy clarified positive response as an increase in ppFEV1).

Lung clearance index (LCI) — prior use and removal

Definition and historical useLung clearance index (LCI) was previously listed as an alternative pulmonary function metric for younger children (e.g., allowed option for age <6 years when baseline LCI ≥ 7.4) and as a continuation criterion (stabilization or decrease from baseline).

Policy changeLCI was later removed from the coverage criteria to align with competitor policies (policy explicitly states 'Removed lung clearance index from criteria').

Continuing-therapy language (historical)Earlier continuation language included 'stabilization or decrease in LCI from baseline' when baseline was elevated; this was clarified in 2024 updates prior to removal.