CurrentMass General Brigham Health PlanPolicy N/A

Adakveo (crizanlizumab-tcma) coverage for sickle cell vaso-occlusive crises

Defines prior authorization, eligibility, and continuation criteria for coverage of Adakveo (crizanlizumab-tcma) for members with sickle cell disease to reduce vaso-occlusive crises; applies to Mass General Brigham Health Plan covered members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdakveo (crizanlizumab-tcma) coverage for sickle cell vaso-occlusive crises

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document criteria including age ≥16, ≥2 VOCs in prior 12 months, hematology prescriber involvement, and trial/intolerance to hydroxyurea.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2crises required

≥16 yearsmin age

6 moinitial approval

12 moreauthorization

Coverage Criteria for Adakveo (crizanlizumab-tcma)

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial coverage criteria: Member is using Adakveo to reduce the frequency of vaso-occlusive crises (VOC) associated with sickle cell disease.

Age requirement: Member age is ≥ 16 years.

Crisis frequency: Member has experienced ≥2 sickle cell crises in the previous 12 months.

Prescriber specialty: Prescriber is a hematologist or the medication is being used in consultation with a hematologist.

Hydroxyurea trial or contraindication: Member has had inadequate response to hydroxyurea at maximally tolerated dose for ≥ 3 months OR has had an adverse reaction or has a contraindication to hydroxyurea.

Currently receiving treatment exception: Authorization may be granted for members new to the plan who are currently receiving treatment with Adakveo, excluding when the product was obtained only as samples or via the manufacturer's patient assistance programs.

Continuation of Therapy — Reauthorization criteria

Reauthorization criteria

Continuation criteria: Member previously met initial coverage criteria and the prescribing physician has submitted clinical documentation of treatment response (e.g., decreased VOCs, reduced need for pain management, decreased hospitalizations).

Initial approvals are for 6 months; reauthorization may be granted for 12 months.

Provider Actions, Requirements, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adakveo under the pharmacy benefit; authorization may be granted for members already receiving treatment (excluding product obtained as samples or via manufacturer's patient assistance programs).

Prior authorization required under the pharmacy benefit
Authorization may be granted for members already receiving Adakveo (not if obtained as samples or via manufacturer assistance)

Documentation Required

Reauthorization Documentation

Clinical documentation must be submitted to support reauthorization. Examples of acceptable documentation include evidence of clinical response such as a decrease in vaso-occlusive crises (VOCs), reduction in need for pain management, decreased hospitalizations, or other objective notes from the treating physician demonstrating benefit.

Documented decrease in VOC frequency
Reduced need for pain management or opioid use
Fewer hospitalizations or emergency visits related to sickle cell crises
Physician progress notes documenting clinical improvement

Denial Risk

Triggers for Denial

Authorization will be denied if required documentation or criteria are not met. Common triggers for denial include failure to document that the member is age ≥16 years, has experienced two or more sickle cell crises in the previous 12 months, or has inadequate documentation of prior hydroxyurea trial/contraindication. Also denied when member is not using Adakveo to reduce the frequency of VOCs for sickle cell disease or when initial eligibility requirements are not demonstrated.

Member age < 16 years documented
Fewer than two sickle cell crises in the prior 12 months
No documentation of use to reduce VOC frequency
No documentation of inadequate response to hydroxyurea at maximally tolerated dose for ≥3 months, or no documented intolerance/contraindication to hydroxyurea
Lack of prescriber specialty (no hematologist or no hematology consultation)

Definitions

Vaso-occlusive crisis — definition of VOC as acute painful episodes in sickle cell disease

TermVaso-occlusive crisis (VOC)

DefinitionAcute painful episodes in sickle cell disease resulting from vascular occlusion due to sickled erythrocyte adhesion and vaso-occlusion.

PathophysiologyVascular occlusion occurs when P-selectin–mediated adhesion of sickled erythrocytes, platelets, leukocytes, and endothelial cells impairs blood flow.

Clinical significanceVOC events are the target of therapies (e.g., crizanlizumab) that block P-selectin to reduce vaso-occlusive episodes and related pain crises.

Background

Crizanlizumab (Adakveo) is a humanized monoclonal antibody that binds to P‑selectin and blocks its interaction with ligands on blood cells and the endothelium. By inhibiting P‑selectin–mediated adhesion among endothelial cells, platelets, leukocytes, and sickled red blood cells, crizanlizumab is intended to reduce the cellular interactions that contribute to vascular occlusion and thereby decrease the frequency of vaso‑occlusive crises (VOCs) in patients with sickle cell disease.