CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines medical-benefit coverage and prior authorization criteria for Adakveo (crizanlizumab-tmca) for members aged 16 and older with sickle cell disease under the Arkansas PASSE pharmacy policy. Specifies initial and reauthorization requirements, dosing, duration, concomitant therapy exclusion, and not medically necessary statement for other indications.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeClinical criteria revised (hydroxyurea trial length increased); prescriber requirement updated

Effective DateJul 1, 2024

Next Review Date

Key ActionPrior authorization is required; document age ≥16, hematologist prescriber or consultation, ≥6 months hydroxyurea trial (ineffective or not tolerated), ≥2 VOCs in prior 12 months, exclusion of concurrent voxelotor, and dosing to support initial 6-month approval.

SourceLink

POLICY UPDATE CHANGES

Increased hydroxyurea trial length from 3 months to 6 months

Removed prescriber specialty of a physician who has experience in treating sickle cell

Policy placed on current template and diagnosis language aligned to Oxbryta policy (02/21/2022 historical change)

>=2Required VOCs in past 12 months

16+Minimum member age (years)

5 mg/kgDose per administration

Coverage Summary

Covered with criteria for Adakveo (crizanlizumab-tmca) for sickle cell disease in members 16 years of age or older; medical benefit; prior authorization required. Effective date: 07/01/2024; last review: 01/23/2024. Coverage requires prescription by or in consultation with a hematologist, a trial of hydroxyurea for at least 6 months (ineffective or not tolerated), documented diagnosis with ≥ 2 vaso-occlusive pain crises in the past 12 months, dosing of 5 mg/kg IV at week 0, week 2, then every 4 weeks, and excludes concurrent use with voxelotor. Initial approval duration: 6 months; reauthorization requires documentation of reduced VOC frequency and allows an additional 12 months if met.

Key thresholds and durations for Adakveo (crizanlizumab-tmca)

Minimum member age16+ years

Required VOCs (past 12 months)>= 2 vaso-occlusive pain crises

Hydroxyurea trial duration>= 6 months (ineffective or not tolerated)

Dose per administration5 mg/kg intravenously

Initial approval duration6 months

Reauthorization approval duration12 months

Initial Therapy Criteria

Initial Authorization Duration

Initial authorization duration: If all initial criteria are met, approve medication for 6 months6 months

Initial approval duration per policy

Continuation / Reauthorization Criteria

Not Medically Necessary / Exclusions

Applicable Codes & Billing

Benefit type / Billing statusmixed

Adakveo (crizanlizumab-tmca) = Medical benefit; Prior Authorization Required

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. For initial approval, submit documentation showing: member is ≥16 years old; medication prescribed by or in consultation with a hematologist; member trialed hydroxyurea for at least 6 months and it was ineffective or not tolerated; member has a documented diagnosis of sickle cell disease with ≥2 vaso-occlusive pain crises in the prior 12 months; therapy will not be used concurrently with Oxbryta (voxelotor); and dosing per policy is 5 mg/kg IV at week 0, week 2, then every 4 weeks. If all initial criteria are met, approve for 6 months.

Documentation Required

Reauthorization documentation

For reauthorization, provide chart notes demonstrating the member has experienced a reduction in frequency of vaso-occlusive crises since starting Adakveo. If this documentation is provided, approve for an additional 12 months.

Clinical Evidence & References

Evidence includes FDA approval of Adakveo in 2019 with the package insert referenced (Novartis, 2022). An ICER evidence report evaluating crizanlizumab, voxelotor, and L-glutamine for sickle cell disease was published on January 23, 2020. Background sources describe the mechanism of action: Adakveo is a P-selectin blocker that reduces vaso-occlusive crises by blocking P-selectin–mediated cellular interactions implicated in VOCs.

Background

Indication: Adakveo (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in patients aged 16 years and older with sickle cell disease. Mechanism: the drug binds P-selectin, blocking interactions between endothelial cells, platelets, red blood cells, and leukocytes (including P-selectin glycoprotein ligand 1/PSGL-1) and can dissociate preformed P-selectin/PSGL-1 complexes, thereby reducing VOCs. Hydroxyurea is the first-line therapy for sickle cell disease and must be tried for at least 6 months (unless ineffective or not tolerated) prior to authorization.

VOC: Vaso-occlusive crisis (pain crisis).

Revision History

01/23/2024materialLatest

Initial authorization criteria updated: hydroxyurea trial length increased from 3 months to 6 months; prescriber requirement changed to prescription by or in consultation with a hematologist (removed prior language requiring a physician with experience treating sickle cell).

02/21/2022non-material

Policy transferred to current template and diagnosis language aligned to Oxbryta (voxelotor) policy.