CurrentUCarePolicy N/A

Sickle Cell Disease - Adakveo Utilization Management Medical Policy

This policy governs prior authorization and medical benefit coverage criteria for Adakveo (crizanlizumab-tmca) to reduce vasoocclusive crises in patients with sickle cell disease age ≥16 across all UCare plans.

Policy Summary

PayerUCare

PolicySickle Cell Disease - Adakveo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the coverage criteria (age ≥16, crisis history or current benefit, hydroxyurea status when applicable) with prescribing by or consultation with a sickle cell specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum age

5 mg/kgdose

W0,W2,q4wschedule

1 yrauth period

~60%trial on hydroxyurea

Recommended Authorization Criteria

Policy Summary

PayerUCare

PolicySickle Cell Disease - Adakveo Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2020

Next Review DateN/A

SourceLink

On This Page

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Initial Therapy and Continuation Therapy

Approve for 1 year if the patient meets ONE of the following (A or B):

Root: One of the following groups (A or B) must be satisfied

A) Initial Therapy: All of the following must be met for Initial Therapy

A.i Age: Patient is ≥ 16 years of age≥16 years

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A.ii Crisis history: Patient has had at least one sickle cell-related crisis in the previous 12-month period≥1 crisis in prior 12 months

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A.iii Hydroxyurea status: Patient meets one of: (a) currently receiving a hydroxyurea product; (b) has tried hydroxyurea and experienced inadequate efficacy or significant intolerance per prescriber; or (c) per prescriber is not a candidate for hydroxyurea therapy (examples: pregnancy, planning pregnancy, or immunosuppressive condition)

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A.iv Specialist: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., hematologist)

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B) Currently Receiving Adakveo: All of the following must be met for continuation therapy

B.i Age: Patient is ≥ 16 years of age≥16 years

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B.ii Clinical benefit: Per prescriber, patient is receiving clinical benefit from Adakveo therapy (examples: reduction in number of vasoocclusive crises, delay in time to crises, reduction in hospital days)

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B.iii Specialist: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., hematologist)

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Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adakveo. Approvals are provided for up to 1 year when the patient meets either the Initial Therapy or Currently Receiving Adakveo criteria. Requests for doses outside the dosing documented in the policy will be reviewed case-by-case by a clinician. Because evaluation and monitoring require specialty expertise, Adakveo must be prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist).

Approve for 1 year when criteria met
Specialist prescribing or consultation required

Step Therapy

Hydroxyurea Requirement for Initial Approval

For initial approval, patients must meet the policy's hydroxyurea requirement: the patient is ≥16 years and has had ≥1 sickle cell–related crisis in the prior 12 months, and the patient must meet ONE of the following regarding hydroxyurea: currently receiving a hydroxyurea product; OR tried hydroxyurea with inadequate efficacy or significant intolerance per the prescriber; OR not a candidate for hydroxyurea therapy (examples: pregnancy/planning pregnancy, immunosuppressive condition such as cancer). The medication must be prescribed by or in consultation with a sickle cell specialist.

Hydroxyurea: current use, prior trial with inadequate efficacy/intolerance, or documented not a candidate
Age and crisis history requirements for initial approval

Documentation Required

Prior Authorization Documentation

Approval requires documentation that the patient meets the specified criteria: age (≥16 years), history of sickle cell disease with at least one sickle cell–related crisis in the prior 12 months for initial therapy, hydroxyurea status per above, or documentation of clinical benefit for continuing Adakveo. Documentation must also show that the medication is prescribed by or in consultation with a physician who specializes in sickle cell disease. Requests for non-standard dosing should include supporting clinical rationale for review.

Document age and crisis history for initial therapy
Document hydroxyurea status (current use, prior failure/intolerance, or not a candidate)
For continuation, document clinical benefit from Adakveo (e.g., reduced vasoocclusive crises, delayed time to crisis, fewer hospital days)
Include specialist prescribing/consultation and rationale for non-standard dosing

Key Definitions

Adakveo — definition and indication

DrugAdakveo (crizanlizumab-tmca)

Drug classMonoclonal antibody

IndicationReduce the frequency of vasoocclusive crises due to sickle cell disease

Minimum patient age for coverage≥16 years

Prior authorization stanceMedical benefit prior authorization required; approve for 1 year if criteria met

Vasoocclusive crisis / sickle cell‑related crisis

DefinitionVasoocclusive crises: episodes of pain and complications related to sickling of red blood cells as measured in clinical studies

Pivotal study entry historyPatients had 2–10 vasoocclusive crises in the 12 months prior to enrollment in the 52‑week SUSTAIN study

Concomitant therapy in studyApproximately 60% of patients were on concomitant hydroxyurea during the SUSTAIN study

Clinical outcomes observedAdakveo reduced annual crisis rate, delayed time to first and second crises, and decreased annual hospitalized days versus placebo

Background and Clinical Context

Adakveo (crizanlizumab‑tmca) is a monoclonal antibody indicated to reduce the frequency of vasoocclusive crises in patients with sickle cell disease aged ≥16 years. In the pivotal 52‑week SUSTAIN trial, eligible patients had a history of 2–10 vasoocclusive crises in the prior 12 months, and about 60% of participants were receiving concomitant hydroxyurea. The trial demonstrated a significant reduction in annual crisis rates, delayed time to first and second crises, and fewer hospitalized days versus placebo, supporting the use of Adakveo to reduce vasoocclusive events.

Per this policy, dosing follows the trial and product guidance: 5 mg/kg IV at Week 0 and Week 2, then every 4 weeks, and authorization decisions consider age, prior crisis history, hydroxyurea status, and prescriber specialty.