CurrentCignaPolicy v041526

Crizanlizumab (Adakveo) prior authorization for sickle cell disease

This document is a Cigna prior-authorization form governing requests for coverage of crizanlizumab (Adakveo) for patients (primarily with sickle cell disease). It specifies provider attestation, clinical history, dosing, and site-of-care information required to process a PA request.

Policy Summary

PayerCigna

PolicyCrizanlizumab (Adakveo) prior authorization for sickle cell disease

Policy CodePolicy v041526

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and submit the prior authorization form with documentation of sickle cell diagnosis, at least one crisis in the past 12 months, hydroxyurea history or contraindication, requested dosing, site of care, and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

Up to 5 mg/kgrequested dosing

1 year lookbackprior period crises required

Coverage Criteria for Crizanlizumab (Adakveo)

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Prescriber and patient identifiers: PA form completed with all asterisked patient identifiers, prescriber specialty, DEA/NPI/TIN, and prescriber signature/attestation

Contact information and Cigna ID required

Prescriber specialty and consultation: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (for example, a hematologist)

Indicate specialist status on the form

Diagnosis and clinical history: Patient has a documented diagnosis of sickle cell disease and has had at least one sickle cell-related (vaso-occlusive) crisis in the previous 12 months>=1 crisis in 12 months

Policy Summary

PayerCigna

PolicyCrizanlizumab (Adakveo) prior authorization for sickle cell disease

Policy CodePolicy v041526

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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If patient is already on Adakveo, prescriber must attest to clinical benefit

Hydroxyurea consideration: If the patient is not currently receiving hydroxyurea, documentation that hydroxyurea was tried and had inadequate efficacy or caused significant intolerance, or documentation that the patient is not a candidate for hydroxyurea (examples: pregnancy, planning pregnancy, immunosuppressive condition)

Prescriber must mark applicable box on the form

Dosing and administration: Requested dosing is up to 5 mg/kg intravenous infusion given at Weeks 0 and 2, and then once every 4 weeks thereafterUp to 5 mg/kg; Weeks 0,2 then q4w

Site of care must be indicated; some plans require the least intensive medically appropriate setting

The PA form collects the site of infusion and asks where the drug will be administered (home, physician’s office, hospital outpatient, or other). The form includes a plan-level requirement that, for some Cigna plans, infusion MUST occur in the least intensive, medically appropriate setting. Providers should indicate the proposed site of care and, when appropriate, document medical necessity for a more intensive setting or request redirection assistance from a Specialty Care Options Case Manager.

The form requires documentation of key clinical items (for example, history of at least one sickle cell–related crisis in the prior 12 months and the patient’s hydroxyurea status). If those required clinical fields are not completed or the prescriber does not attest to prior therapy/response where requested, the submission may be denied or delayed because it would lack the documentation the plan uses to determine medical necessity.

Requested Product and Coding Details

Requested productmixed

Adakveo 100mg/10ml vial

Medication requested (crizanlizumab-tmca)

Sickle cell-related crises in prior period — threshold / required count

Required count>= 1 sickle cell-related crisis in the previous 12 months

Lookback period12 months (previous 12-month period)

Documentation sourceProvider attestation on the PA form confirming at least one crisis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — complete and submit the Cigna prior authorization form for coverage requests. The form must include all required patient identifiers and prescriber information and can be faxed or submitted online via CoverMyMeds or SureScripts in your EHR.

Submit via fax or online at www.covermymeds.com/main/prior-authorization-forms/cigna/ or via SureScripts in your EHR
Standard response time: 5 business days; call to expedite for urgent requests

Documentation Required

Required Documentation

Required documentation must accompany the PA request. Include the completed PA form with patient identifiers, prescriber specialty, DEA/NPI/TIN, Cigna ID, date of birth, diagnosis (sickle cell disease), medication requested, ICD-10 code, dosing, quantity, duration, and office contact information.

Patient identifiers: name, Cigna ID, DOB, address, phone
Prescriber info: name, specialty (hematology if applicable), DEA, NPI or TIN, office phone/fax
Medication details: medication requested, dose, directions, quantity, duration, ICD-10

Denial Risk

Documentation-related Denial Risks

Documentation-related denial risks: failure to document at least one sickle cell–related crisis in the prior 12 months (when applicable), missing documentation of hydroxyurea trial/response or justification for not using hydroxyurea, lack of prescriber specialty information, or omission of key patient identifiers may result in denial of the request.

If patient is not currently receiving hydroxyurea, document prior trial and inadequate efficacy or intolerance, or document why patient is not a candidate (for example, pregnancy or immunosuppressive condition)
Document whether patient had ≥1 sickle cell–related crisis in the previous 12 months when required
Confirm requested dosing regimen: up to 5 mg/kg IV at Weeks 0 and 2 and then every 4 weeks

Definitions

Sickle cell-related crisis (vaso-occlusive crisis) — definition and form request for occurrence in prior period

DefinitionAn acute painful episode related to sickle cell disease (vaso-occlusive crisis).

Form questionPA form asks: 'Has the patient had at least one sickle cell-related crisis in the previous 12-month period?' with Yes/No checkboxes.

If already on therapyForm also asks if the patient (if currently receiving Adakveo) is receiving clinical benefit (examples: reduction in number of vaso‑occlusive crises, delay in time to crises, reduction in hospital days).

Related hydroxyurea inquiryForm requests current hydroxyurea use and, if not on hydroxyurea, whether it was tried with inadequate efficacy or intolerance, or whether the patient is not a candidate (examples: pregnancy or immunosuppressive condition).

Background

Crizanlizumab (Adakveo) is indicated to reduce vaso-occlusive (sickle cell–related) crises in patients with sickle cell disease. The PA form captures whether the prescriber is an SCD specialist, whether the patient experienced at least one sickle cell-related crisis in the previous 12 months, current hydroxyurea use or, if not receiving hydroxyurea, whether hydroxyurea was tried and found ineffective or not tolerated, or the patient is not a candidate for hydroxyurea. The form also requests the requested dosing (up to 5 mg/kg IV at Weeks 0 and 2, then every 4 weeks) and the site of administration to support coverage review.