CurrentCignaPolicy N/A

Cystic Fibrosis - Trikafta Drug Quantity Management Policy - Per Rx

Defines retail and home delivery quantity limits and exception criteria for Trikafta (elexacaftor/tezacaftor/ivacaftor) products for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Trikafta Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeAdded oral granules limits; clarified tablet limits

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionIf quantity management rule is not met at point of service, submit a clinical criteria-based exception request; approvals are valid for 1 year.

SourceLink

POLICY UPDATE CHANGES

This policy creates new quantity limits for the Trikafta oral granules with overrides provided.

Quantity limits with no overrides were previously approved for Trikafta tablets.

84retail tablets per Rx

252home delivery tablets per Rx

56retail granules packets per Rx

168home delivery granules packets per Rx

112override retail packets

336override home delivery packets

Quantity Limit Exceptions and Approval Criteria

Quantity limit exceptions and criteria

Exceptions to standard quantity limits are allowed only as specified below; approvals are valid for 1 year.

Trikafta Oral Granules (elexacaftor 80 mg, tezacaftor 40 mg, ivacaftor 60 mg packets co-packaged with ivacaftor 59.5 mg packets): No overrides recommended (standard retail max 56 packets; home delivery max 168 packets).

Overrides allowed for specific granules strength

If the patient is 6 to 11 years of age AND weighs ≥ 30 kg: approve the requested quantity, not to exceed 112 packets per dispensing at retail or 336 packets per home delivery.
If the patient is ≥ 12 years of age: approve the requested quantity, not to exceed 112 packets per dispensing at retail or 336 packets per home delivery.

Trikafta Tablets (elexacaftor 100 mg, tezacaftor 50 mg, ivacaftor 75 mg tablets co-packaged with ivacaftor 75 mg tablets): No overrides recommended (standard retail max 84 tablets; home delivery max 252 tablets).

Policy Summary

PayerCigna

PolicyCystic Fibrosis - Trikafta Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeAdded oral granules limits; clarified tablet limits

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionIf quantity management rule is not met at point of service, submit a clinical criteria-based exception request; approvals are valid for 1 year.

SourceLink

On This Page

Quantity Limits and Packaging Thresholds

Tablets (co-packaged strengths 50/25/37.5 mg + 75 mg; 100/50/75 mg + 150 mg)mixed

Trikafta tablets (elexacaftor/tezacaftor/ivacaftor; ivacaftor tablets, co-packaged) - Elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg co-packaged with ivacaftor 75 mg	Each carton contains 84 tablets (56 combination tablets and 28 single tablets). Retail maximum quantity per Rx = 84 tablets; Home Delivery maximum quantity per Rx = 252 tablets.
Trikafta tablets (elexacaftor/tezacaftor/ivacaftor; ivacaftor tablets, co-packaged) - Elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg co-packaged with ivacaftor 150 mg	Each carton contains 84 tablets (56 combination tablets and 28 single tablets). Retail maximum quantity per Rx = 84 tablets; Home Delivery maximum quantity per Rx = 252 tablets.

Oral granules (co-packaged packets)mixed

Trikafta oral granules - Elexacaftor 80 mg / Tezacaftor 40 mg / Ivacaftor 60 mg packets co-packaged with Ivacaftor 59.5 mg packets	Each carton contains 56 packets (28 combination packets and 28 single packets). Retail maximum quantity per Rx = 56 packets; Home Delivery maximum quantity per Rx = 168 packets. Exceptions to the quantity limits are covered as medically necessary when criteria are met.
Trikafta oral granules - Elexacaftor 100 mg / Tezacaftor 50 mg / Ivacaftor 75 mg packets co-packaged with Ivacaftor 75 mg packets	Each carton contains 56 packets (28 combination packets and 28 single packets). Retail maximum quantity per Rx = 56 packets; Home Delivery maximum quantity per Rx = 168 packets. Exceptions to the quantity limits are covered as medically necessary when criteria are met.

Retail and Home Delivery quantity thresholds

Retail — tablets (per retail Rx)84 tablets (per carton contains 84 tablets)

Home delivery — tablets (per Rx)252 tablets

Retail — oral granules (per retail Rx)56 packets

Home delivery — oral granules (per Rx)168 packets

Overrides for eligible patientsApprove up to 112 packets per retail dispensing or 336 packets per home delivery for patients 6–11 years and ≥30 kg, or for patients ≥12 years

Authorization, Approvals, and Exceptions

Prior Authorization

Authorization and approvals — coverage determined by criteria; 1-year approvals

If the Drug Quantity Management rule is not met at the point of service, coverage for the requested medication will be determined by the specified Criteria. All approvals are provided for a duration of 1 year.

Denial Risk

Exceptions to quantity limits — covered only when criteria met

Exceptions to the listed quantity limits are covered as medically necessary only when the specified criteria are met; any other exception is considered not medically necessary.

Key Terms

Definition: Trikafta (elexacaftor/tezacaftor/ivacaftor)

Generic nameElexacaftor/tezacaftor/ivacaftor (co-packaged with ivacaftor)

Brand name (per source)Trikafta

Indication summaryTreatment of cystic fibrosis in patients ≥2 years with at least one F508del mutation or a responsive CFTR mutation

Drug Quantity Management program

Program nameDrug Quantity Management program

PurposeTo promote the safe, effective, and economic use of Trikafta and to set per‑prescription quantity limits

Coverage when rule not metIf the Drug Quantity Management rule is not met at point of service, coverage is determined by the stated Criteria; all approvals are provided for 1 year

ExceptionsExceptions to quantity limits are covered as medically necessary only when the specified criteria are met; other exceptions are not medically necessary