Medical_Policy

Highmark Commercial Medical Policy - Pennsylvania

Medical Policy:	I-193-001
Topic:	Daunorubicin and Cytarabine Liposomal (Vyxeos)
Section:	Injections
Effective Date:	August 20, 2018
Issue Date:	August 20, 2018
Last Reviewed:	July 2018

Daunorubicin and cytarabine (Vyxeos^TM) is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine) in a 1:5 molar ratio. This ratio has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models.

Daunorubicin has antimitotic and cytotoxic activity by forming complexes with DNA, inhibiting topoisomerase II activity. Thus affecting regulation of gene expression, and producing DNA-damaging free radicals. Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. Cytarabine acts primarily through inhibition of DNA polymerase. Animal data shows the liposomes enter and persist in the bone marrow, where they are taken up intact by bone marrow cells. In these studies it has been show that the liposomes are taken up by leukemia cells to a greater extent than by normal bone marrow cells. After cellular internalization, liposomes undergo degradation releasing daunorubicin and cytarabine within the intracellular environment.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

FDA Indications

Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for individuals 18 years and older with ANY ONE of the following:

Therapy-related acute myeloid leukemia (t-AML); or
AML with myelodysplasia-related changes (AML-MRC)

AND ALL of the following:

Inadequate response, intolerance, high risk for intolerance or relapse, or contraindication to the use of daunorubicin and cytarabine separately; and
Clinician agrees NOT to interchange with other daunorubicin and/or cytarabine containing products; and
Clinician provides documentation of ECG and assessment of cardiac function by multi-gated radionuclide angiography (MUGA) scan or echocardiography (ECHO) prior to administration of daunorubicin and cytarabine (Vyxeos); and
Clinician confirms monitoring of complete blood counts and urine copper levels on a regular basis

Daunorubicin and cytarabine (Vyxeos) is considered experimental/investigational for all other indications and therefore, non-covered. Scientific evidence does not support the use for any other indications than those listed above.

Procedure Codes

J9999

NCCN Indications

Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for ANY of the following indications:

Treatment inducation for individuals with cytotoxic therapy-related AML or individuals with antecedent Myelodysplastic Syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or cytogenetic changes that are consistent with MDS:
- In individuals less than 60 years of age without core binding factor (CBF) abnormalities; or
- In individuals 60 years or older for intensive remission induction therapy with unfavorable cytogenetic/molecular markets/antecedent hematologic disorder/therapy-related AML; or
For re-induction after standard-dose cytarabine induction for individuals with cytotoxic therapy-related AML or patients with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS:
- In individuals less than 60 years of age with significant residual disease without a hypocellular marrow and without CBF abnormalities; or
- In individuals 60 years or older with residual disease; or
For post-remission therapy for individuals with cytotoxic therapy-related AML or patients with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS:
- For individuals less than 60 years of age without CBF abnormalities, treatment-related disease and/or poor-risk cytogenetics and/or molecular abnormalities; or
- For individuals 60 years or older with complete response to previous intensive therapy.

Procedure Codes

J9999

NOTE: Dosage recommendations per the FDA label.

Place of Service: Inpatient/Outpatient

The policy position applies to all commercial lines of business

Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Outpatient HCPCS (C Codes)

C9024

Links

Link to Provider Resource Center for the Medical Policy Update

08/2018, Coverage Guidelines Established for Daunorubicin and cytarabine (Vyxeos)

Link to Diagnosis Codes

Link to References

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

Provides free aids and services to people with disabilities to communicate effectively with us, such as:

Qualified sign language interpreters

Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:

Qualified interpreters

Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.