CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid Fee‑for‑Service Cystic Fibrosis, Oral PA Summary

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This document governs prior authorization (PA) requirements and coverage criteria for oral cystic fibrosis therapies for Georgia Medicaid Fee-for-Service members, including age and genotype-based approval rules. It affects prescribers and pharmacists managing CF medications for Georgia Medicaid members.

Policy Summary

PayerGeorgia Department of Community Health

PolicyGeorgia Medicaid Fee‑for‑Service Cystic Fibrosis, Oral PA Summary

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for all listed oral CF agents and is valid for 1 year; PA requests may be initiated by calling OptumRx at 1-866-525-5827.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearlength of authorization

≥6 yrsAlyftrek min age

≥18 yrsBronchitol min age

≥1 moKalydeco min age

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Drug-specific Coverage Criteria

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)

Approvable when ALL of the following are met:

Alyftrek approval criteria: Member is 6 years of age or older AND has a diagnosis of cystic fibrosis AND has at least one F508del mutation or another CFTR mutation responsive to the product.

Bronchitol (mannitol)

Approvable when ALL of the following are met:

Bronchitol approval criteria: Member is 18 years of age or older AND has a diagnosis of cystic fibrosis AND has an FEV1 % predicted between 40% and 90% AND has passed a Bronchitol Tolerance Test AND has been prescribed a short-acting bronchodilator with inadequate response OR has allergies, contraindications, drug-drug interactions, or intolerable side effects to hypertonic saline and Pulmozyme AND will use Bronchitol as add-on maintenance therapy to improve pulmonary function.

Kalydeco (ivacaftor)

Approvable when ALL of the following are met:

Kalydeco approval criteria: Member is 1 month of age or older AND has a diagnosis of cystic fibrosis AND has at least one CFTR mutation responsive to ivacaftor based on clinical evidence or in vitro assay data.

Orkambi (lumacaftor/ivacaftor)

Approvable when ALL of the following are met:

Orkambi approval criteria: Member is 1 year of age or older AND has a diagnosis of cystic fibrosis AND is homozygous for the F508del mutation in the CFTR gene.

Symdeko (tezacaftor/ivacaftor and ivacaftor)

Approvable when ALL of the following are met:

Symdeko approval criteria: Member is 6 years of age or older AND has a diagnosis of cystic fibrosis AND is homozygous for F508del OR has at least one CFTR mutation responsive to tezacaftor/ivacaftor based on clinical evidence or in vitro assay data.

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

Approvable when ALL of the following are met:

Trikafta approval criteria: Member is 2 years of age or older AND has a diagnosis of cystic fibrosis AND has at least one F508del mutation OR a CFTR mutation responsive based on in vitro data.

There are no automatic exceptions to the coverage criteria in this policy. Any request for an exception must be submitted and reviewed through the prior authorization process for consideration.

Clinical / Measurement Criteria

inv-08: FEV1 % predicted — clinical threshold used in criteria.

FEV1 % predicted range40% to 90%

Context of useRequired for Bronchitol (mannitol) approval in members ≥18 years with cystic fibrosis

MeasurementForced expiratory volume in one second (FEV1) percent of predicted

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for all listed oral cystic fibrosis agents. The length of authorization is 1 year. PA requests may be initiated by calling OptumRx at 1-866-525-5827.

Length of authorization: 1 year
Initiate PA: OptumRx 1-866-525-5827

Step Therapy

Bronchitol step therapy requirements

Before Bronchitol (mannitol) is approvable, the member must have had an inadequate response to a short-acting bronchodilator plus trials of hypertonic saline and Pulmozyme, or have documented allergies, contraindications, drug–drug interactions, or intolerable side effects to hypertonic saline and Pulmozyme.

Member ≥18 years with CF and FEV1 40%–90% and passed Bronchitol Tolerance Test (context for use)
Documentation of inadequate response to hypertonic saline and Pulmozyme, or documented allergies/contraindications/DDIs/intolerance

Clinical Background

Cystic fibrosis management includes genotype-specific CFTR modulator therapy (examples include ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor, and combinations) and adjunct airway therapies. Approval under Georgia Medicaid is based on age and specific genotype or evidence of a CFTR mutation being responsive to the requested modulator, with each product’s criteria specifying the minimum age and the required mutation status or in vitro/clinical responsiveness.

Adjunct therapies such as inhaled agents (for example, mannitol/Bronchitol) have additional clinical-entry requirements (including pulmonary function thresholds and tolerance testing) and may require prior trials or documented contraindications to alternate therapies before approval as add-on maintenance therapy.

Definitions & Testing

inv-14: responsive mutation / responsive based on in vitro data — definition of responsive CFTR gene mutation for modulators.

DefinitionA CFTR gene mutation that is responsive to a specific CFTR modulator (e.g., ivacaftor, tezacaftor, elexacaftor) as demonstrated by clinical evidence or in vitro assay data.

PurposeUsed to determine eligibility for CFTR modulators (examples: ivacaftor, tezacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor) per product-specific approval criteria

Applications in this policyKalydeco, Symdeko, Trikafta, and other modulators require a responsive mutation as specified in each agent's criteria

Evidence acceptedClinical evidence or in vitro assay data demonstrating responsiveness

inv-15: Bronchitol Tolerance Test — definition and requirement for assessing tolerance prior to initiation.

Definition