Pharmacy Prior Authorization Criteria

Adakveo (crizanlizumab-tmca)

For diagnosis of Sickle Cell Disease
Indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

AND

Documentation of 2 vaso-occlusive events that required medical facility visits and treatments in the past 12 months (e.g., sickle cell crisis, acute pain episodes, acute chest syndrome, hepatic sequestration, splenic sequestration, priapism) [1, 2]

AND

Trial and failure or inadequate response, contraindication, or intolerance to one of the following: [3, 4, 5, 6]

AND

Hematologist/Oncologist
Specialist with expertise in the diagnosis and management of sickle cell disease

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

Patient demonstrates positive clinical response to therapy (e.g., reduction in annual rate of vaso-occlusive events, increased time between each vaso-occlusive event)

1970-01-01, 2023-09-05, 2023-01-04, 2021-12-16, 2021-09-27, 2021-05-18, 2020-12-30, 2020-02-13, 2019-12-19

Adakveo (crizanlizumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2022.
Ataga K, Kutlar A, Kanter J et al. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. New England Journal of Medicine. 2017;376(5):429-439. doi:10.1056/nejmoa1611770.
Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014. Nhlbi.nih.gov. https://www.nhlbi.nih.gov/sites/default/files/media/docs/sickle-cell-disease-report%20020816_0.pdf. Published 2014. Accessed December 6, 2021.
Brawley O, Cornelius L, Edwards L et al. National Institutes of Health Consensus Development Conference Statement: Hydroxyurea Treatment for Sickle Cell Disease. Ann Intern Med. 2008;148(12):932. doi:10.7326/0003-4819-148-12-200806170-00220.
Niihara Y, Miller S, Kanter J et al. A Phase 3 Trial of l-Glutamine in Sickle Cell Disease. New England Journal of Medicine. 2018;379(3):226-235. doi:10.1056/nejmoa1715971.
Brandow A, Carroll C, Creary S et al. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020;4(12):2656-2701. doi:10.1182/bloodadvances.2020001851.

2023-09-05: Program update to standard reauthorization language. No changes to clinical intent.
2023-01-04: 2023 UM Annual Review. Updated references
2021-12-16: Added age criterion in initial authorization to align with prescribing information. Updated references.
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-18: Addition of EHB formulary to guideline, no changes to criteria
2020-12-30: 2021 UM Annual Review.
2020-02-13: Positive change made to criteria. Added option for "inadequate response" in the trial and failure verbiage per Feb P&T feedback.
2019-12-19: New Program. Pending Jan 2020 P&T Decision.