CurrentAetnaPolicy N/A

ADAKVEO (crizanlizumab) precertification request form — coverage criteria

Precertification and clinical documentation requirements for ADAKVEO (crizanlizumab) infusions for Aetna members, including initial and continuation therapy details and site-of-care considerations. Affects prescribers, infusion providers, and prior authorization staff processing Aetna member requests.

Policy Summary

PayerAetna

PolicyADAKVEO (crizanlizumab) precertification request form — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete all required clinical and administrative fields on the precertification form for ADAKVEO and submit for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

Requiredclinical information

Initial & continuationrequest types

Aetnapayer contact

Coverage Criteria for ADAKVEO (crizanlizumab)

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Continuation Therapy — Continuation therapy requires demonstration of clinical benefit

Continuation therapy requires demonstration of clinical benefit

Continuation Therapy: Documentation that the patient has experienced a reduction in the frequency of vaso-occlusive crises (VOCs), or has maintained a reduction in VOC frequency, since initiating therapy with ADAKVEOall

From continuation request fields

Site-of-Care Justification — Site-of-care and safety considerations

Site-of-care and safety considerations

Outpatient hospital administration: If infusion is requested in an outpatient hospital setting, provide justification such as: severe adverse event history unresponsive to conventional interventions or a severe adverse event (e.g., anaphylaxis, myocardial infarction, thromboembolism, seizures) during or immediately after an infusion; severe venous access issues requiring special interventions available only in outpatient hospital; significant behavioral, physical, or cognitive impairment that impacts safety of infusion and patient lacks a caregiver; or medical instability (respiratory, cardiovascular, or renal) requiring hospital personnel/equipmentany

From site-of-care questions

All required clinical information on the precertification form must be completed and legible. The form states that required clinical information must be completed in its entirety for all precertification requests and notes that incomplete or missing required clinical documentation may lead to requests being not approvable or delayed.

Coding — Diagnosis and Procedure Codes, Patient Measurements

Diagnosis Codes (ICD-10 placeholders)ICD-10

Primary ICD Code	Primary diagnosis code — specified on form
Secondary ICD Code	Secondary diagnosis code — specified on form

Procedure/Administration CodesCPT

Administration code(s) (CPT)

Place to list CPT administration codes on form

Patient weight/height

Required fieldsPatient current weight and patient height must be provided on the form (lbs or kgs; inches or cms) for dosing calculations

Units acceptedWeight: lbs or kgs; Height: inches or cms

Location on formSection A. Patient Information includes 'Patient Current Weight' and 'Patient Height' fields

Provider Actions and Documentation Requirements

Documentation Required

Required form fields and clinical documentation

Precertification is required for ADAKVEO (crizanlizumab). All required clinical information and form fields must be completed and legible for precertification review. Aetna may request additional information or clarification; incomplete, illegible, or missing required clinical documentation may delay or result in denial of the precertification request.

Complete patient identification: name, DOB, contact information, weight, height, allergies
Complete insurance/payer and precertification requester contact information (phone/fax)
Complete prescriber information: name, license type, address, phone, fax, state license #, NPI, DEA, specialty
Complete dispensing/provider or administration information: place of administration, provider/pharmacy selection, address, phone, TIN/PIN, administration CPT codes if applicable
Complete product information: ADAKVEO (crizanlizumab) — dose and frequency
Complete diagnosis information: primary and any secondary ICD-10 codes
Attach clinical documentation required for all requests (see clinical checklist) and for initial vs continuation requests as applicable

Prior Authorization

Hydroxyurea trial documentation (Initial requests)

For initial precertification requests, document sickle cell genotype and prior hydroxyurea history. The form must indicate whether the patient had an inadequate response or intolerance to hydroxyurea, or has a contraindication to hydroxyurea. If hydroxyurea was tried, specify whether the patient had inadequate response or intolerance. State whether the requested drug will be used concurrently with hydroxyurea.

Sickle cell genotype (select HbSS, HbSbeta0, HbSC, HbSbeta+, other, or unknown)
Hydroxyurea trial documentation: inadequate response, intolerance, or contraindication (must be clearly indicated for initial requests)
Documentation of VOCs in past 12 months (yes/no) where applicable

Denial Risk

Incomplete documentation risk

Incomplete or illegible forms and missing clinical details increase the risk of delayed review or denial. The plan may request additional information or clarification to evaluate requests. Signature and date are required on the acknowledgement; knowingly providing false information is fraud and may result in criminal and civil penalties.

Ensure the acknowledgement section is signed and dated
Be prepared to supply supporting medical records demonstrating prior therapies, adverse events, VOC history, and rationale for site of care if outpatient hospital setting requested
Aetna Precertification Notification: Phone: 1-866-752-7021 (TTY: 711); FAX: 1-888-267-3277
For Medicare Advantage Part B: Use Medicare Request Form

Background

ADAKVEO (crizanlizumab) is used to reduce the frequency of vaso‑occlusive crises (VOCs) in patients with sickle cell disease. The precertification form collects genotype, prior hydroxyurea response or intolerance, VOC history, and site‑of‑care and safety information to document medical necessity for initiation or continuation of therapy; required clinical information must be completed in its entirety for all requests.

Definitions and Form Options

Sickle cell genotypes

Checkbox optionsHomozygous hemoglobin S (HbSS); Sickle beta0-thalassemia (HbSbeta0); Sickle hemoglobin C (HbSC); Sickle beta+-thalassemia (HbSbeta+); Other; Unknown

PurposeIdentify the patient’s sickle cell genotype to support medical necessity and appropriateness of ADAKVEO therapy

Form sectionListed under 'For Initial Requests (clinical documentation required)'

Vaso-occlusive crisis (VOC)

VOC documentationForm asks whether the patient has experienced a vaso-occlusive crisis (VOC) in the past 12 months (Yes/No) and whether therapy has reduced or maintained a reduction in VOC frequency for continuation requests

When requiredCaptured on initial request (history of VOCs in past 12 months) and continuation request (documented reduction or maintenance of reduced VOC frequency)

PurposeUsed to document clinical benefit and support initiation or continuation of ADAKVEO therapy

Continuation Criteria

Continuation — Requirements to continue ADAKVEO

Requirements to continue ADAKVEO

Continuation Criteria: Has the patient experienced a reduction in the frequency of vaso-occlusive crises (VOCs), or maintained a reduction in VOC frequency, since initiating ADAKVEO? Required documentation of clinical benefit must be provided to support continuation.all

Continuation request section

Step Therapy Requirements

Requirement	Documentation required
Hydroxyurea trial or contraindication (step 1)	Indicate whether the patient had an inadequate response or intolerance to a trial of hydroxyurea OR document a contraindication to hydroxyurea. Form fields include: 'Has the patient experienced, at any time in the past, an inadequate response or intolerance to a trial of hydroxyurea?' (Yes/No) with options to specify 'inadequate response' or 'intolerance'; and 'Does the patient have a contraindication to hydroxyurea?' (Yes/No).
Concurrent hydroxyurea use	Indicate if the requested drug will be used with concurrent hydroxyurea therapy (Yes/No).

Requirement

Documentation required

Hydroxyurea trial or contraindication (step 1)

Indicate whether the patient had an inadequate response or intolerance to a trial of hydroxyurea OR document a contraindication to hydroxyurea. Form fields include: 'Has the patient experienced, at any time in the past, an inadequate response or intolerance to a trial of hydroxyurea?' (Yes/No) with options to specify 'inadequate response' or 'intolerance'; and 'Does the patient have a contraindication to hydroxyurea?' (Yes/No).

Concurrent hydroxyurea use

Indicate if the requested drug will be used with concurrent hydroxyurea therapy (Yes/No).

Place of Administration and Justification

Note

Document place of administration and justify outpatient hospital setting

Indicate the place of administration (office, infusion center, outpatient hospital, or home) and provide justification when selecting outpatient hospital—e.g., severe infusion-related adverse events, severe venous access issues, significant behavioral/physical/cognitive impairment without a caregiver, or medical instability.

Select one place of administration on the form
If 'Outpatient hospital' is selected, provide clinical justification such as severe prior adverse events, venous access problems, lack of caregiver with behavioral/physical/cognitive impairment, or medical instability requiring hospital personnel/equipment