CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Xalkori (crizotinib) Coverage Criteria for Inflammatory Myofibroblastic Tumor

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Georgia Medicaid pharmacy prior authorization coverage for Xalkori (crizotinib), primarily for members age 1 year and older with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumor; includes authorization criteria, reauthorization, dosage and quantity limits, and cancer request routing.

Policy Summary

PayerCareSource Georgia

PolicyXalkori (crizotinib) Coverage Criteria for Inflammatory Myofibroblastic Tumor

Policy CodePolicy GA-MED-P-366579

Change TypeNew policyno material clinical or coverage changes identified

Effective DateApr 1, 2024

Next Review DateN/A

Key ActionSubmit cancer requests through the NantHealth/Eviti portal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 1+Minimum member age

3 monthsInitial approval

12 monthsReauthorization approval

120/30 daysCapsule limit

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CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Xalkori (crizotinib) Coverage Criteria for Inflammatory Myofibroblastic Tumor

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Policy Summary

PayerCareSource Georgia

PolicyXalkori (crizotinib) Coverage Criteria for Inflammatory Myofibroblastic Tumor

Policy CodePolicy GA-MED-P-366579

Change TypeNew policyno material clinical or coverage changes identified

Effective DateApr 1, 2024

Next Review DateN/A

Key ActionSubmit cancer requests through the NantHealth/Eviti portal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 1+Minimum member age

3 monthsInitial approval

12 monthsReauthorization approval

120/30 daysCapsule limit

ALK-positive IMTCovered condition

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following are met:

Initial authorization criteria

Member age: Member is at least 1 year of age.>= 1 year
Prescriber specialty: Medication is prescribed by or in consultation with a hematologist/oncologist.
Diagnosis: Member has a documented diagnosis of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT).
Tumor biomarker: Test results show the member's tumor is ALK-positive.ALK-positive

Continuation Therapy

Covered for reauthorization when the following requirement is met:

Reauthorization criterion: Chart notes show a positive clinical response to treatment, such as tumor shrinkage and/or symptomatic improvement.

If the requirement is met, approval is for an additional 12 months.

Conditions or indications not listed in this policy are excluded from medical necessity under this policy. Other indications should be referred to the Off-Label policy for review.

Xalkori (crizotinib) is not medically necessary for the treatment of conditions that are not listed in this document.

Provider Actions and Submission Requirements

Prior Authorization

Pharmacy Prior Authorization Required

Prior authorization is required for Xalkori (crizotinib). Initial authorization requires the member to meet the age, prescriber, diagnosis, and ALK-positive tumor criteria; approval is for 3 months when all requirements are satisfied.

Member is at least 1 year of age.
Xalkori is prescribed by or in consultation with a hematologist/oncologist.
Member has unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT).
Test results document that the tumor is ALK-positive.

Billing Rule

Submit Cancer Requests Through NantHealth/Eviti

Clinical Background

Inflammatory myofibroblastic tumors (IMTs) are rare mesenchymal neoplasms that often occur in children or young adults, although they may occur at any age. These tumors can arise in multiple anatomic locations throughout the body.

Definitions

Inflammatory Myofibroblastic Tumor (IMT)

DefinitionA rare but usually benign mesenchymal neoplasm.

Age groupMay occur at any age, but most often develops in children or young adults.

Anatomic distributionTypically affects the abdominal cavity, although any area of the body can be affected.

Clinical courseSurgery is the initial standard-of-care treatment when feasible; tumors may recur after surgery.

Tyrosine Kinase Inhibitor (TKI)

DefinitionA small-molecule inhibitor of tyrosine kinase activity.

Targeted pathway

Initial Authorization

Initial authorization requires ALL of the following clinical criteria:

Initial authorization criteria

Member age: Member is at least 1 year of age.>= 1 year
Prescriber specialty: Medication is prescribed by or in consultation with a hematologist/oncologist.
Diagnosis: Member has a documented diagnosis of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT).

Reauthorization

Reauthorization requires documented positive clinical response:

Continuation criterion: Chart notes must show a positive clinical response to treatment, such as tumor shrinkage and/or symptomatic improvement.

Additional authorization is for 12 months when the requirement is met.

Dosage and Quantity Limits

Capsule Quantity Limit

MedicationXalkori (crizotinib) capsules

Quantity limit120 capsules per 30 days

Pellet Quantity Limit

MedicationXalkori (crizotinib) pellets

Quantity limit240 pellets per 30 days

Policy Summary

PayerCareSource Georgia

PolicyXalkori (crizotinib) Coverage Criteria for Inflammatory Myofibroblastic Tumor

Policy CodePolicy GA-MED-P-366579

Change TypeNew policyno material clinical or coverage changes identified

Effective DateApr 1, 2024

Next Review DateN/A

Key ActionSubmit cancer requests through the NantHealth/Eviti portal.

SourceLink

On This Page

Cancer-related Xalkori requests must be submitted through the NantHealth/Eviti portal.

Applies to requests for lung cancer or lymphoma.

Documentation Required

Initial Authorization Documentation

Include complete initial-authorization documentation with the request. Documentation must establish the member’s age, prescribing-provider qualifications, diagnosis, and ALK-positive tumor status.

Document that the member is at least 1 year of age.
Provide the diagnosis of unresectable, recurrent, or refractory IMT.
Submit test results showing the tumor is ALK-positive.
Identify the hematologist/oncologist who prescribed or was consulted regarding therapy.
When applicable, document the prescribed regimen and quantity: adults 250 mg orally twice daily; pediatric patients 280 mg/m² orally twice daily, with capsule quantity limited to 120 per 30 days and pellet quantity limited to 240 per 30 days.

Documentation Required

Document Clinical Response for Reauthorization

For reauthorization, submit chart notes documenting a positive clinical response to treatment.

Examples include tumor shrinkage and/or symptomatic improvement.
When criteria are met, reauthorization is approved for an additional 12 months.

Prior Authorization

Cancer Request Submission Requirement

Route every Xalkori request for cancer treatment through the NantHealth/Eviti portal before submission for review.

Cancer requests include lung cancer and lymphoma indications.

Denial Risk

Failure to Meet Initial Authorization Criteria

Authorization may be denied when the initial clinical requirements are not met. The request must satisfy the minimum age, specialist-prescriber, diagnosis, and ALK-positive testing requirements.

Member must be at least 1 year of age.
The medication must be prescribed by or in consultation with a hematologist/oncologist.
The diagnosis must be unresectable, recurrent, or refractory IMT.
Testing must confirm an ALK-positive tumor.
If all requirements are not met, the initial 3-month approval will not be authorized.

Denial Risk

Unlisted Indication

Xalkori is not medically necessary for conditions not listed in this policy. For another indication, refer the request to the applicable Off-Label policy.

Do not submit unlisted indications as covered Xalkori requests under this policy.
Route other indications according to the Off-Label policy.

Targets ALK-driven oncogenic signaling.

ALK biologyALK rearrangements can give rise to oncogenic fusion proteins that contribute to cell proliferation and tumor survival.

Therapeutic roleCrizotinib is an ALK-directed TKI used for systemic therapy of ALK-positive inflammatory myofibroblastic tumor.

Test results show the member's tumor is ALK-positive.