UnitedHealthcare CFTR Modulator Prior Auth Coverage | OpenPayer

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UnitedHealthcare CFTR Modulator Prior Auth Coverage | OpenPayer

Initial Therapy: Kalydeco

Covered when ALL of the following are met:

Kalydeco initiation criteria: 1) Diagnosis of cystic fibrosis; 2) Age >= 1 month; 3) Documented CFTR mutation responsive to ivacaftor (or FDA-cleared CF mutation test used with confirmatory sequencing when recommended); 4) Total daily dose prescribed is 300 mg/day or less; 5) Baseline ALT and AST assessed prior to beginning therapy; 6) Prescriber information and signature provided

From Kalydeco checklist

Initial Therapy: Orkambi

Covered when ALL of the following are met:

Orkambi initiation criteria: 1) Diagnosis of cystic fibrosis; 2) Age >= 1 year; 3) Documented homozygous F508del mutation on both alleles (or FDA-cleared CF mutation test used if genotype unknown); 4) Dosing no greater than two tablets (lumacaftor 200 mg/ivacaftor 125 mg per tablet) taken every 12 hours with fat-containing food; 5) Baseline ALT and AST assessed prior to beginning therapy; 6) Prescriber information and signature provided

From Orkambi checklist

Initial Therapy: Symdeko

Covered when ALL of the following are met:

Symdeko initiation criteria: 1) Diagnosis of cystic fibrosis; 2) Age >= 6 years; 3) Documented homozygous F508del OR one CFTR mutation responsive to tezacaftor/ivacaftor (or FDA-cleared testing if genotype unknown); 4) Dosing of 1 tablet in the morning and 1 tablet in the evening; 5) Baseline ALT and AST assessed prior to beginning therapy; 6) Prescriber information and signature provided

From Symdeko checklist

Initial Therapy: Trikafta

Covered when ALL of the following are met:

Trikafta initiation criteria: 1) Diagnosis of cystic fibrosis; 2) Age >= 2 years; 3) If genotype unknown, confirm at least one F508del or document a CFTR mutation responsive to Trikafta (or use FDA-cleared test); 4) Dosing: one tablet in the morning (tezacaftor 100 mg/ivacaftor 150 mg) and one tablet in the evening (ivacaftor 150 mg); 5) Baseline ALT, AST, and bilirubin assessed prior to beginning therapy; 6) Baseline ophthalmic examination performed if beneficiary is < 18 years of age; 7) Prescriber information and signature provided

From Trikafta checklist

Initial Therapy: Alyftrek

Covered when ALL of the following are met:

Alyftrek initiation criteria: 1) Diagnosis of cystic fibrosis; 2) Age >= 6 years; 3) Documented at least one copy of F508del or a CFTR mutation responsive to vanzacaftor/tezacaftor/deutivacaftor (or FDA-cleared testing if genotype unknown); 4) Dosing does not exceed the specified tablet options (either two tablets: vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg OR three tablets daily: vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg); 5) Baseline ALT, AST, and bilirubin assessed prior to beginning therapy; 6) Baseline ophthalmic examination performed if beneficiary is < 18 years of age; 7) Prescriber information and signature provided

From Alyftrek checklist

Renewal Therapy

Covered when ALL of the following are met:

Renewal criteria: 1) Product-specific questions on the form for the selected medication are completed; 2) Beneficiary is receiving ongoing liver function testing and results are provided; 3) Prescriber signature and date provided

From Renewal Criteria section

The prior authorization form does not list any blanket non-covered diagnoses or categorical exclusions. Instead, coverage is tied to product-specific eligibility fields on the form: the request must document a diagnosis of cystic fibrosis and the applicable CFTR genotype or mutation testing information for the named therapy (or confirmatory FDA‑cleared testing when genotype is unknown). The form therefore relies on verification of diagnosis and mutation responsiveness to each CFTR modulator rather than enumerating separate excluded conditions.

Use of the listed CFTR modulators may be considered not medically necessary when the beneficiary fails to meet the product‑specific criteria captured on the form. Examples include absence of a documented cystic fibrosis diagnosis, age below the product minimum, lack of a CFTR mutation responsive to the requested modulator (or absence of required genotype testing), dosing that exceeds the specified limits, or missing required baseline laboratory/ophthalmic assessments or prescriber signature.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit a completed, signed prior authorization form including beneficiary and prescriber details, drug name/strength/quantity, requested length of therapy, and product-specific questions (diagnosis, age, CFTR genotype/mutation testing details, dosing). Include prescriber contact name and phone, prescriber NPI, and requester contact information.

Beneficiary information: name, date of birth, gender, member ID.
Prescriber information: prescribing provider NPI, prescriber signature (required), requester contact name and phone.
Drug details: drug name, strength, quantity per 30 days, length of therapy (select or specify).
Product-specific completion: answer all medication-specific checklist items (e.g., diagnosis of cystic fibrosis, age eligibility, genotype/mutation testing details, prescribed dose and dosing frequency).

Documentation Required

Required Documentation

Provide documentation that meets renewal and initial review requirements. For initiation and renewals, include results of required baseline and ongoing monitoring tests and documentation that the product-specific criteria are met.

Baseline and ongoing labs/exams as indicated by product: ALT, AST (Kalydeco, Orkambi, Symdeko), ALT, AST, bilirubin (Trikafta, Alyftrek). Include test results and dates.
If beneficiary is <18 years for agents requiring ophthalmic evaluation, include baseline ophthalmic exam date and findings.
Documentation of dosing consistent with product labeling (e.g., maximum total daily dose limits, tablet counts/frequency).
For unknown genotype cases, include results of an FDA-cleared CF mutation test and verification sequencing when recommended by the test instructions.

Denial Risk

Triggers for Denial

Applications may be denied if required elements are missing or eligibility criteria are not met. Ensure all diagnosis, age, genotype, dosing, and baseline test documentation is present and complete before submission.

Missing or undocumented diagnosis of cystic fibrosis.
Age outside the product-specific approved range (e.g., Kalydeco, Orkambi, Symdeko, Trikafta, Alyftrek age limits).
No documentation of a CFTR genotype responsive to the requested modulator, or absence of required mutation testing when genotype unknown.
Failure to provide required baseline labs/exams (ALT, AST, bilirubin, ophthalmic exam when indicated) with results and dates.
Prescriber signature not present on the completed form.