CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Pharmacy benefit policy for coverage of Trikafta (elexacaftor/tezacaftor/ivacaftor tablets and ivacaftor tablets) for Arkansas PASSE members, specifying prior authorization, age, genetic mutation and dosing criteria, quantity limit, and reauthorization requirements.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeRevised (12/22/2021); Effective 01/01/2022

Effective DateJan 1, 2022

Next Review Date

Key ActionPrior authorization required under the pharmacy benefit (Preferred Product).

SourceLink

POLICY UPDATE CHANGES

New policy for Trikafta created on 2019-11-12.

Criteria updated on 2020-12-31.

Policy revised on 2021-12-22 (revised date).

1Covered Indication (Cystic Fibrosis)

84-countQuantity limit (per 28 days)

>=12Age threshold

Coverage Summary

Scope: Pharmacy benefit policy for coverage of Trikafta (elexacaftor/tezacaftor/ivacaftor tablets and ivacaftor tablets) for Arkansas PASSE members, specifying prior authorization, age, genetic mutation and dosing criteria, quantity limit, and reauthorization requirements. Coverage stance: covered_with_criteria. Eligible members are those covered under the pharmacy benefit (Arkansas PASSE) who meet the clinical criteria: age >= 12 years, diagnosis of cystic fibrosis and documentation of at least one CFTR mutation (including at least one F508del where indicated) or presence of an allowed CFTR mutation in chart notes, and who meet prior authorization requirements. High-level restrictions include the age threshold (>=12 years), genetic/mutation documentation requirement, prior authorization under the pharmacy benefit, and a quantity limit of an 84-count tablet carton per 28 days.

Initial Therapy Criteria (Cystic Fibrosis)

Initial Authorization (Cystic Fibrosis)

Trikafta will be considered for coverage under the pharmacy benefit when ALL of the following are met:

ALL of the following

Member is 12 years old or older
Diagnosis or genetic testing
- Member has a diagnosis of cystic fibrosis
- Member has had genetic testing documented in chart notes with at least one F508del mutation in the CFTR gene
ALL of the following
- 3141del9
- E822K
- G1069R
- F31Idel
- G1249R
- L1077P
- R170H
- S977F
- A120T
- F311L
- G1349D
- L1324P
- R258G
- S1159F
- A234D
- F508C
- H139R
- L1335P
- R334L
- S1159P
- V456A
- D443Y
- R751L
- V456F
- V1153E
- D836Y
- G194R
- I807M
- Q237H
- R1070Q
- R1162L
- W361R
- D1152H
- G463V
- I1139V
- R74Q
- R1283S
- W1282R
- E56K
- G551D
- I1366N
- R284W
- S13F
- Y10GN
- S549N
- Y101AC
- E403D
- G628R
- L320V
- R117C
- S549R
- Y1032C
- E474K
- G970D
- L346P
- R117G
- S589N
- E588V
- G1061R
- L453S
- R117H
- S737F
ALL of the following
- Morning dose: two elexacaftor 100 mg; tezacaftor 50 mg and ivacaftor 75 mg tablets
- Evening dose: one ivacaftor 150 mg tablet
- Morning and evening doses should be taken approximately 12 hours apart

Initial Approval Duration

If member meets all initial requirements, medication will be approved for 3 months

Continuation / Reauthorization Criteria

Reauthorization Criteria

For reauthorization, ALL of the following must be met:

ALL of the following

Member must be in compliance with all other initial criteria
Member's adherence to medication is confirmed by claims history
ALL of the following
- Improvement in sweat chloride
- Improved FEV1 and/or other lung function tests
- Decrease in pulmonary exacerbations
- Decrease in pulmonary infections
- Decrease in hospitalizations
- Increase in weight/gain

Provider Actions & Billing Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit (Preferred Product).

Documentation Required

Genetic testing documentation

Chart notes must document genetic testing with at least one F508del mutation OR document a diagnosis of cystic fibrosis plus presence of an allowed CFTR mutation; the list of allowed CFTR mutations must be present in the chart notes.

Documentation Required

Reauthorization clinical documentation

For reauthorization, submit chart notes showing the member is adherent to therapy (confirmed by claims history) and documentation of at least one clinical improvement such as improvement in sweat chloride, improved FEV1 or other lung function tests, decreased pulmonary exacerbations, decreased pulmonary infections, decreased hospitalizations, or weight gain.

Billing Rule

NDC billing requirement

Must bill using a valid NDC for the product.

Clinical Evidence & References

Evidence and background: Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor tablets) is a CFTR modulator indicated for treatment of cystic fibrosis in eligible patients (see prescribing information). This policy restricts coverage to members who meet genetic/mutation, age, and clinical response criteria. Key supporting reference: Trikafta [prescribing information], Vertex Pharmaceuticals Inc; December 2020. The policy requires members be >=12 years old, have a diagnosis of cystic fibrosis and documented genetic testing with at least one F508del mutation or presence of an allowed CFTR mutation in chart notes, and follow the specified dosing (morning: two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg tablets; evening: one ivacaftor 150 mg tablet) with approval initially for 3 months and reauthorization contingent on adherence and clinical improvement for an additional 12 months.

Definitions & Background

Definitions:

F508del: A specific deletion mutation in the CFTR gene (commonly written F508del) referenced in genetic testing requirement.

Background: Trikafta is a CFTR modulator indicated for cystic fibrosis; this policy intends to cover Trikafta under the pharmacy benefit for Arkansas PASSE members only when members meet the specified genetic/mutation, age (>=12 years), dosing, prior authorization, and reauthorization clinical-response requirements.