CurrentAvMedPolicy N/A

Pharmacy prior authorization for GVHD drugs (ruxolitinib, ibrutinib)

Form and clinical criteria governing prior authorization for Jakafi (ruxolitinib) and Imbruvica (ibrutinib) when used to treat acute or chronic graft-versus-host disease (GVHD); applies to prescribers requesting pharmacy benefit coverage through AvMed.

Policy Summary

PayerAvMed

PolicyPharmacy prior authorization for GVHD drugs (ruxolitinib, ibrutinib)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign the prior authorization form and submit complete member/prescriber/drug information and supporting clinical documentation (progress notes, lab results, staging scores) to avoid delays or denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6initial authorization length

6reauthorization length

>=12min age — ruxolitinib (initial a/cGVHD)

>=1min age — ibrutinib (cGVHD)

20 mgmax daily dose — ruxolitinib

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Authorization Criteria for Ruxolitinib and Ibrutinib

General administrative requirements

All of the following must be provided for approval:

ALL of the following

Completed prior authorization/step-edit request form with prescriber signature (hand-signed; preprinted stamps not valid).
Complete member and prescriber information including phone, fax, DEA or NPI.
Drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code (if applicable), weight, and date supplied on the form.
Documentation to support each checked clinical criterion (lab results, diagnostics, chart notes) must be submitted or request may be denied.

Initial authorization — acute graft-versus-host disease (aGVHD) for ruxolitinib (Jakafi)

All of the following must be met for initial ruxolitinib approval for aGVHD:

ALL of the following

Medication will be used for disease related to allogeneic hematopoietic stem cell transplantation.
Member is at least 12 years of age or older.
Member has acute graft-versus-host disease (aGVHD) that is refractory to treatment with corticosteroids.
Provider has submitted recent progress notes and/or clinical assessment recording symptomology and staging/grading of acute GVHD organ involvement.
Initial authorization duration: 6 months.

Initial authorization — chronic GVHD (cGVHD) for ruxolitinib (Jakafi)

All of the following must be met for initial ruxolitinib approval for cGVHD:

ALL of the following

Medication will be used for disease related to allogeneic hematopoietic stem cell transplantation.
Member is at least 12 years of age or older.
Member has chronic graft-versus-host disease (cGVHD) that is refractory to treatment with corticosteroids.
Member has failed one or two lines of systemic therapy (e.g., mycophenolate, methotrexate) for cGVHD AND ruxolitinib will be used in combination with systemic corticosteroids.
Provider has submitted recent progress notes and/or clinical assessment documenting symptomology and staging/severity of chronic GVHD (e.g., NIH Global Severity Score, NIH organ-specific score).

Initial authorization — chronic GVHD (cGVHD) for ibrutinib (Imbruvica)

All of the following must be met for initial ibrutinib approval for cGVHD:

ALL of the following

Medication will be used for disease related to allogeneic hematopoietic stem cell transplantation.
Member is at least 1 year of age or older.
Medication may be used as a single agent or in conjunction with systemic steroids.
Member has failed one or more previous lines of systemic therapy for cGVHD (e.g., corticosteroids or immunosuppressants such as cyclosporine).
Provider has submitted recent progress notes and/or clinical assessment documenting symptomology and staging/severity of chronic GVHD (e.g., NIH Global Severity Score or NIH organ-specific score).

Reauthorization criteria — general

All reauthorization requests require documentation of treatment response and one of the listed conditions:

ALL of the following

Member has experienced treatment response as evidenced by stabilization or improvement in disease (submit recent progress notes and/or clinical assessments).
One of the following must be met
- Member has been able to discontinue therapeutic doses of corticosteroids, AND additional therapy authorization will be utilized for tapering ruxolitinib. Note: Taper by one dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily).
- Member requires re-treatment because GVHD signs/symptoms recurred during or after tapering of ruxolitinib (submit notes documenting changes/worsening of GVHD organ involvement).
Reauthorization duration: 6 months.

Additional clinical documentation requirements

Specific documentation items that must be submitted with requests:

ALL of the following

For aGVHD: documentation of staging/grading of acute GVHD organ involvement and refractory status to corticosteroids.
For cGVHD: documentation of NIH Global Severity Score and/or NIH organ-specific score and prior systemic therapies tried/failed.
For reauthorization: documentation of stabilization or improvement in GVHD and steroid taper history or recurrence history as applicable.

Approved Dosages and Code Guidance

Maximum allowable daily dosagesmixedCovered

Ruxolitinib	Maximum allowable daily dose: 20 mg per day (acute & chronic GVHD)
Ibrutinib	Maximum allowable daily dose: 420 mg per day (chronic GVHD)

Maximum allowable daily dosagesmixedCovered

Ruxolitinib	Maximum allowable daily dose: 20 mg per day (acute & chronic GVHD)
Ibrutinib	Maximum allowable daily dose: 420 mg per day (chronic GVHD)

Thresholds — age and maximum doses

Minimum age — ruxolitinib (initial requests for aGVHD/cGVHD)12 years

Minimum age — ibrutinib (initial requests for cGVHD)1 year

Ruxolitinib maximum daily dose20 mg/day

Ibrutinib maximum daily dose420 mg/day

What Providers Must Do

Prior Authorization

Submit completed signed PA form

Prescriber must hand-sign the prior authorization form and include complete member, prescriber, and drug information plus supporting clinical documentation to avoid delays or denial.

Hand-signed prescriber signature required (preprinted stamps not valid).
Include complete member and prescriber contact info (phone, fax, DEA or NPI).
Provide drug form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight, and date on the form.
Attach supporting clinical documentation (progress notes, lab results, staging scores).

Documentation Required

Provide disease staging and prior therapy history

Submit recent progress notes and clinical assessments documenting symptomology and disease staging for GVHD and a history of prior systemic therapies and steroid response/tapering.

Clinical Background

Ruxolitinib and ibrutinib are oral therapies indicated for treatment-refractory graft-versus-host disease (GVHD) following allogeneic hematopoietic stem cell transplantation. Ruxolitinib (Jakafi) may be requested for both acute GVHD (aGVHD) and chronic GVHD (cGVHD) that is refractory to corticosteroids; ibrutinib (Imbruvica) is requested for cGVHD after failure of prior systemic therapy. For ruxolitinib, initial approvals require that the disease is related to allogeneic hematopoietic stem cell transplantation and that the member is at least 12 years of age; for ibrutinib the member must be at least 1 year of age. Maximum allowable daily doses are 20 mg/day for ruxolitinib and 420 mg/day for ibrutinib per the authorization form.

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Defined Terms

Definitions

aGVHDAcute graft-versus-host disease occurring after allogeneic hematopoietic stem cell transplantation; must be corticosteroid-refractory for ruxolitinib initial approval.

cGVHDChronic graft-versus-host disease; ruxolitinib and ibrutinib approvals require prior lines of systemic therapy and documentation of NIH severity scores.