ModifiedHealth NetPolicy CP.PHAR.440

Elexacaftor/Ivacaftor/Tezacaftor (Trikafta) coverage

Policy governs medical necessity criteria, dosing, and authorization requirements for Trikafta (elexacaftor/tezacaftor/ivacaftor) for Health Net lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyElexacaftor/Ivacaftor/Tezacaftor (Trikafta) coverage

Policy CodePolicy CP.PHAR.440

Change TypeMaterial revisions — pediatric expansion, formulation and exclusion updates

Effective DateDec 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of CF diagnosis, responsive CFTR mutation(s), and required pulmonary function or chart notes to support approval.

SourceLink

POLICY UPDATE CHANGES

Added pediatric expansion and new granule formulation to criteria and Appendix updates.

Removed lung clearance index from criteria and changed initial approval duration from 4 months to 6 months.

Added Alyftrek to list of CFTR modulator concurrent exclusion criteria.

Clarified continued therapy positive response definition for LCI and ppFEV1 as improvement from baseline.

6 monthsInitial approval duration

12 monthsContinued therapy duration

>=2 yrsMin FDA age

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within 90dBaseline ppFEV1 req

AlyftrekConcurrent exclusion

Coverage Criteria for Trikafta (elexacaftor/tezacaftor/ivacaftor)

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: 1) Diagnosis of cystic fibrosis confirmed by meeting all diagnostic elements: clinical symptoms consistent with CF in at least one organ system or positive newborn screen or genetic testing for siblings; evidence of CFTR dysfunction confirmed by either elevated sweat chloride >= 60 mmol/L or genetic testing confirming two disease‑causing CFTR mutations (one from each parental allele); 2) Member has at least one F508del mutation OR a CFTR mutation responsive to Trikafta based on clinical and/or in vitro data (see Appendix E); 3) Prescribed by or in consultation with a pulmonologist; 4) Age >= 2 years; 5) For age >= 6 years: documentation of baseline percent predicted FEV1 (ppFEV1) performed within the last 90 days; 6) Dose does not exceed the specified age/weight‑based dosing in the policy dosing table; 7) Trikafta is not prescribed concurrently with other CFTR modulators (e.g., Alyftrek, Orkambi).

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met for continued therapy

Continued Therapy Criteria: 1) Member is currently receiving the medication via the benefit or previously met initial approval criteria, or member is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy: for age >= 6 years, stabilization or improvement (e.g., increase) in ppFEV1 from baseline; for age < 6 years, evidence of response may include decreased pulmonary exacerbations, increased BMI, or improved respiratory symptoms; 3) Trikafta is not prescribed concurrently with other CFTR modulators (e.g., Alyftrek, Orkambi, Kalydeco, Symdeko); 4) If the request is for a dose increase, the new dose does not exceed the age/weight‑based dosing specified in the policy dosing table.

Approval duration: 12 months

Coverage criteria

Covered when criteria are met for initiation or continuation per policy revisions

Initial approval criteria (high-level): Member has cystic fibrosis with CFTR mutation(s) responsive to Trikafta (see Appendix E); appropriate documentation of diagnosis and pulmonary function testing or chart notes as required by policy; dosing appropriate for age/weight per dosing table; not concurrently using excluded CFTR modulators (for example, Alyftrek).see dosing and mutation list

Policy revisions removed prior requirements for in vitro testing and for demonstrating lack of responsiveness to other CFTR modulators; initial approval duration updated to 6 months.

Continuation criteria (high-level): Documentation of positive response defined as improvement from baseline (for example, increase in ppFEV1 or decrease in LCI) or stabilization per the revised policy; chart notes or pulmonary function documentation required for renewal; approval durations follow policy (initial commonly 6 months, continuation commonly 12 months).improvement or stabilization metrics as defined in policy

LCI was previously used and later removed from criteria; positive response definitions clarified to indicate improvement (e.g., decrease in LCI).

Non-FDA approved indications are not authorized under this policy unless there is sufficient documentation supporting efficacy and safety per the applicable off-label use policies. Providers should refer to the off-label use policies for the relevant line of business — CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid) — when requesting coverage for indications not addressed by this policy.

Concurrent use of certain CFTR modulators with Trikafta is excluded. Per the 3Q 2025 annual review, Alyftrek was added to the list of CFTR modulators that cannot be used concurrently with Trikafta; requests for overlapping therapy with excluded modulators may be denied.

All coverage decisions under this policy are subject to the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies. The policy is a guide to medical necessity and does not guarantee payment.

Uses not listed on the formulary or preferred drug list may be processed under the relevant formulary/non‑formulary or off‑label policies. For formulary routing and required approvals, refer to the no‑coverage and off‑label policies specific to the member's line of business (for example, CP.CPA.190 and CP.CPA.09 for commercial).

Requests that do not meet the documented initiation or continuation criteria — for example, missing required mutation documentation or lacking required pulmonary function evidence (such as baseline ppFEV1 when applicable) — may be denied or routed according to the plan's prior authorization and documentation requirements. Providers must supply supporting chart notes, lab results, or pulmonary function testing as required for review.

No specific conditions labeled 'not medically necessary' are enumerated in the cited policy chunks; instead, non‑authorization is determined when requests fail to meet the policy's initiation or continuation criteria or when coverage is prohibited by the member's coverage documents.

Clinical Thresholds and Definitions

inv-10: Sweat chloride — >= 60 mmol/L

Sweat chloride threshold>= 60 mmol/L

Role in diagnosisOne of the criteria used to confirm CFTR dysfunction when clinical symptoms or genetic testing support CF

Reference guidelineCystic Fibrosis Foundation notes elevated sweat chloride ≥ 60 mmol/L as confirmation of CFTR dysfunction

inv-11: Baseline spirometry (ppFEV1) — Performed within the last 90 days for age >= 6 years

RequirementBaseline spirometry (ppFEV1) performed within the last 90 days for members age >= 6 years

PurposeDocumentation of stabilization or improvement in ppFEV1 is required for continued therapy in age >= 6

Prior Authorization, Documentation, and Routing

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Trikafta (elexacaftor/tezacaftor/ivacaftor) and related CFTR modulators. Providers must submit a completed prior authorization request demonstrating that the member meets all initial approval criteria, including documented CF diagnosis and any age- or weight-specific dosing criteria.

Submit clinical documentation showing cystic fibrosis diagnosis and that the member meets the specific initial therapy criteria in this policy.
Approval duration for initial approvals is 6 months unless otherwise specified in the policy updates.

Prior Authorization

Prior Authorization (operational)

Prior authorization — no additional procedural specifics are provided in this section. Follow standard Health Net/Health Plan prior authorization submission processes and portals for PA form submission and any required fields.

Use the Health Plan’s established PA submission channels and include all requested clinical attachments (office notes, labs, PFTs).

Background and Drug Information

Trikafta is a triple‑combination CFTR modulator (elexacaftor/tezacaftor/ivacaftor) that improves the processing, trafficking, and gating of specific mutant CFTR proteins, resulting in increased CFTR function and reduced sweat chloride. It is indicated for patients aged >= 2 years with at least one F508del mutation or other CFTR mutations identified as responsive to Trikafta per prescriber information and clinical/in vitro data.

Key Definitions and Abbreviations

inv-26: Elevated sweat chloride >= 60 mmol/L or genetic testing confirming disease-causing mutations — CFTR dysfunction confirmed

DefinitionCFTR dysfunction confirmed by elevated sweat chloride >= 60 mmol/L OR genetic testing confirming two disease‑causing CFTR mutations (one from each parental allele)

Clinical contextApplied when clinical symptoms consistent with CF or positive newborn screen exist

Use in criteriaRequired as part of initial approval criteria for Trikafta coverage

inv-27: Percent predicted forced expiratory volume in 1 second — ppFEV1 definition reference

TermppFEV1 = percent predicted forced expiratory volume in 1 second

UseMetric used to document stabilization or improvement for continued therapy in patients aged >= 6 years

Policy Summary

PayerHealth Net

PolicyElexacaftor/Ivacaftor/Tezacaftor (Trikafta) coverage

Policy CodePolicy CP.PHAR.440

Change TypeMaterial revisions — pediatric expansion, formulation and exclusion updates

Effective DateDec 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of CF diagnosis, responsive CFTR mutation(s), and required pulmonary function or chart notes to support approval.

SourceLink

On This Page

Feasibility noteMost children can perform spirometry by age 6; some younger children may be able to perform the test

inv-12: Sweat chloride threshold — >= 60 mmol/L

Defined threshold>= 60 mmol/L

Clinical useUsed to confirm CFTR dysfunction as part of diagnostic criteria for cystic fibrosis

Supporting sourceCystic Fibrosis Foundation guidance referenced in policy

inv-29: CFTR gene mutations listed in Appendix E that are predicted or shown responsive to Trikafta (per prescriber information and in vitro assays)

DefinitionCFTR gene mutations listed in Appendix E that are predicted or shown responsive to Trikafta per prescriber information and in vitro assays

LocationSee Appendix E of the policy for the full list of responsive CFTR mutations

RelevanceMember must have at least one F508del mutation OR a CFTR mutation responsive to Trikafta listed in Appendix E for initiation criteria

Documentation Required

Required Documentation

Required Documentation: Providers must supply supporting clinical documentation with the prior authorization request. This includes office chart notes, laboratory results, and pulmonary function testing as applicable to the member’s age and clinical status.

Pulmonary function documentation options per policy: ppFEV1 where applicable; for certain pediatric ages other specified tests or chart notes may be allowed (see policy criteria).
For initiation and continuation, include relevant PFT results or chart notes documenting ppFEV1 or other accepted testing; include prior medication history when relevant.

Step Therapy

Formulary / Step Routing

Formulary / Step Routing: If the requested drug is on-formulary follow the applicable no-coverage criteria policy for the line of business; if not on-formulary follow the non-formulary policy. If the requested use is not listed in the policy and the drug is not covered under the listed indications, refer to the off-label use policy for the relevant line of business.

Commercial formulary/no-coverage: CP.CPA.190 (or applicable commercial policy).
Health insurance marketplace: HIM.PA.103 / HIM.PA.154 per scenario. Medicaid: CP.PMN.255 / CP.PMN.53 or CP.PMN.16 as applicable.

Denial Risk

Denial Triggers / Provider Responsibility

Denial Triggers and Provider Responsibility: Requests may be denied if documentation does not demonstrate that the member meets initial or continuation criteria (including required mutation responsiveness documentation or pulmonary function testing), or for non–FDA‑approved indications lacking sufficient supporting evidence per off‑label policies. Providers are responsible for exercising professional medical judgment and for submitting complete documentation to support medical necessity.

Denial may result if mutation documentation or required pulmonary function tests (ppFEV1 or other specified tests) are missing or do not meet policy thresholds.
Non‑FDA approved indications will be denied unless sufficient evidence per off‑label policy and the member’s coverage document supports coverage.
Providers must document medical necessity in the chart and include all supporting records with the PA request.

Appendix referenceDefined in Appendix D (general information) of the policy

inv-28: Sweat chloride 2 60 mmol/L — elevated sweat chloride definition

RoleConsidered ‘elevated’ and used to confirm CFTR dysfunction per policy and CFF guidance

ApplicationOne of the diagnostic criteria required for initial Trikafta approval when paired with clinical symptoms or genetic findings