CurrentCentenePolicy CP.PHAR.213

Clinical Policy: Lumacaftor/Ivacaftor (Orkambi)

Defines medical necessity guidance and coverage criteria for use of lumacaftor/ivacaftor (a CFTR modulator) for members; applies to providers and claims administrators for the Health Plan.

Policy Summary

PayerCentene

PolicyLumacaftor/Ivacaftor (Orkambi) clinical policy

Policy CodePolicy CP.PHAR.213

Change TypeRemoved LCIadded Alyftrek to concurrent exclusionsclarified continued therapy response

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation and follow the Health Plan's authorization process reflecting removal of LCI and inclusion of Alyftrek in concurrent exclusions.

SourceLink

POLICY UPDATE CHANGES

Removed lung clearance index from criteria to align with competitor analysis and standard of care.

For continued therapy, clarified positive response as an 'improvement' (e.g., decrease) of LCL and improvement of ppFEV1 as an 'increase from baseline'.

Added Alyftrek to list of CFTR modulator concurrent exclusion criteria.

3explicit recent content changes noted

1state-specific override reminder (Medicaid precedence)

P&Tpolicy review/approval referenced

Coverage Criteria for Lumacaftor/Ivacaftor

Updated Initial and Continued Therapy Criteria (summaries)

Covered when ALL of the following summary criteria are met:

Initial Therapy Criteria (summary): Documentation no longer requires ppFEV1 between 40–90% for initiation; initial therapy must otherwise meet the full policy’s initial-therapy requirements (see full criteria sections).

Full initial therapy criteria located in other policy sections; this policy update removed the 'ppFEV1 between 40 - 90%' requirement to align with other CFTR modulator criteria.

Continued Therapy Criteria (summary): Member must demonstrate a positive clinical response as defined by the policy: an improvement in lung clearance measures and an increase from baseline in ppFEV1. Note that lung clearance index (LCI) has been removed from required criteria and appendices per recent updates; continued therapy decisions should rely on the remaining documented measures of clinical benefit in the full policy.

'Improvement' clarified as a decrease for LCI measures and 'increase from baseline' for ppFEV1 in prior language; LCI subsequently removed from required metrics—see exclusions and full continued-therapy criteria.

Concurrent use of lumacaftor/ivacaftor with Alyftrek is excluded; Alyftrek has been added to the policy's list of CFTR modulator concurrent exclusion criteria.

Policy Summary

PayerCentene

PolicyLumacaftor/Ivacaftor (Orkambi) clinical policy

Policy CodePolicy CP.PHAR.213

Change TypeRemoved LCIadded Alyftrek to concurrent exclusionsclarified continued therapy response

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation and follow the Health Plan's authorization process reflecting removal of LCI and inclusion of Alyftrek in concurrent exclusions.

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.

The policy no longer requires Lung Clearance Index (LCI) as a metric for coverage decisions. LCI has been removed from the criteria and appendices and is not a required measure for initial or continued therapy determinations.

This document does not include explicit "not medically necessary" determinations in the provided sections. Coverage determinations remain subject to the applicable Health Plan evidence of coverage, contract terms, and administrative policies and procedures; providers should follow plan-specific coverage documents when interpreting coverage scope.

Coding and Billing References

Affected codes (referenced)mixed

affected codes

placeholder — document references prior authorization and coverage but specific CPT/HCPCS/ICD-10 codes are in other sections not present in this chunk.

Provider Requirements and Administrative Actions

Prior Authorization

Coverage conditional on benefit documents

Prior authorization is required for CFTR modulator therapies per Health Plan medical policy and benefits. Note: coverage is conditional on the member's benefit document (contract, certificate, summary plan description) — the Health Plan will apply any applicable terms, conditions, exclusions, and limitations of those benefit documents when making coverage decisions.

Coverage decisions are subject to the member's specific benefit terms and may vary by product or contract.
Providers should verify member eligibility and benefit limitations (medical necessity, quantity limits, prior authorization requirements) before initiating therapy.

Step Therapy

Concurrent-modulator exclusions (Alyftrek added)

Alyftrek (bivacaftor/ivacaftor) has been added to the list of CFTR modulators that cannot be used concurrently with other CFTR modulators where the policy prohibits concurrent use. Providers must follow step-therapy and concurrent-modulator rules: do not initiate or continue overlapping CFTR modulator regimens that are listed as mutually exclusive by the Health Plan.

Effective 3Q 2025: Alyftrek added to concurrent-modulator exclusion list.
Do not submit claims for concurrent administration of Alyftrek with other excluded CFTR modulators; requests for such combinations will be subject to denial unless an approved exception exists.
If transitioning therapies, request prior authorization for the new agent and include documentation of rationale and any required washout or monitoring per Health Plan guidance.

Documentation Required

Documentation and compliance

Providers must comply with Health Plan administrative policies and maintain documentation supporting the medical necessity and authorization of CFTR modulator therapy. Documentation should be retained consistent with contract and legal/regulatory requirements and must be available upon request.

Include relevant clinical data in prior authorization requests (diagnosis, genotype, baseline clinical measures, prior treatments, and response when applicable).
Maintain records of authorizations, monitoring, and clinical response for audits and appeals.

Background

This clinical policy governs use of the CFTR modulator lumacaftor/ivacaftor for members with cystic fibrosis and defines the criteria used by the Health Plan to authorize therapy. Recent updates removed LCI from the required metrics and clarified measures of response for continued therapy (for example, an improvement such as a decrease in LCI and an increase from baseline in ppFEV1 were previously referenced). The policy also added Alyftrek to the CFTR modulator concurrent exclusion list. Coverage determinations are administered in accordance with Health Plan-level administrative policies, evidence of coverage, and applicable law.

Key Definitions

LCI — Lung Clearance Index

TermLung Clearance Index (LCI)

DefinitionAn index derived from multiple-breath washout testing that measures ventilation inhomogeneity (lung clearance).

Policy statusRemoved from coverage criteria and appendices; LCI is no longer a required metric for coverage decisions.

ContextPreviously referenced as a measure of positive response (improvement/decrease) for continued therapy but subsequently removed to align with standard of care.

ppFEV1 — Percent predicted FEV1

TermppFEV1 (Percent predicted FEV1)

DefinitionPercent predicted forced expiratory volume in 1 second — a spirometric measure expressed as a percentage of the predicted normal value for age, sex, height, and race.

Use in policyUsed as a measure of positive response for continued therapy; response described as an 'increase from baseline'.

Change noteRequirement specifying ppFEV1 between 40–90% for initial therapy was removed to align with other CFTR modulator criteria.

Policy Revision History

2025-04-14material_changeLatest

Added Alyftrek to the list of CFTR modulator concurrent exclusion criteria (3Q 2025 annual review).

2024-12-31material_change

Removed Lung Clearance Index (LCI) from criteria to align with competitor analysis and standard of care.

2024-08-24clarification

Clarified continued therapy positive response wording: 'improvement' (e.g., decrease) of LCI and 'increase from baseline' for ppFEV1; also removed ppFEV1 40–90% initial therapy criterion to align with other CFTR modulators (P&T approval).

2025-08-25administrative_review

P&T approval recorded for 3Q 2025 annual review updates including Alyftrek addition and reference updates.