Mitoxantrone (Brand Name: Novantrone)

Mitoxantrone is a chemotherapy drug approved for the treatment of certain types of multiple sclerosis, advanced prostate cancer, and acute nonlymphocytic leukemia (ANLL). There is also supporting evidence for its use in certain types of cancer or conditions. Mitoxantrone hydrochloride is given by intravenous (IV) infusion, and should not be used via subcutaneous, intramuscular, intra-arterial, or intrathecal injection. The manufacturer states that mitoxantrone hydrochloride for injection concentrate must be diluted prior to IV infusion.

Definitions

are summaries of drug information and medical evidence to support decision-making about the appropriate use of drugs and medical procedures. Examples include, but are not limited to:

1. American Hospital Formulary Service Drug Information
2. Clinical pharmacology
3. National Comprehensive Cancer Network Drugs and Biologics Compendium
4. Thomson Micromedex DrugDex
5. United States Pharmacopeia-National Formulary (USP-NF)

refers to the federal Food and Drug Administration.

refers to the list of medications and products available to members with or without Prior Authorization.

refers to an attack or exacerbation of MS (also known as a flare-up) resulting in the occurrence of new symptoms or the worsening of old symptoms.

or "relapsing-remitting MS" refers to the most common type of MS in which there are clearly defined attacks or relapses of increasing neurologic symptoms followed by periods of partial or complete recovery or remissions.

or "secondary progressive MS" refers to a version of disease progression that can follow an initial relapsing-remitting course in which there is a worsening of neurologic function and increased disability over time.

Medical Necessity Criteria for Initial Authorization

The Plan considers mitoxantrone medically necessary when ALL the following criteria are met for the applicable indication listed below:

For Cancer:

1. The requested medication is prescribed by or in consultation with a hematology and/or oncology specialist; AND
2. The member has ONE of the following:
   • a. acute nonlymphocytic leukemia (ANLL) [includes myelogenous, promyelocytic, monocytic and erythroid leukemias]); orb.
   • b. advanced hormone-refractory prostate cancer; orc.
   • c. autologous stem cell transplant preparation in patients with relapsed/refractory lymphoma (i.e., in combination with melphalan as a myeloablative conditioning regimen during the transplant phase in patients with relapsed/refractory Hodgkin and non- Hodgkin lymphomas); ord.
   • d. chronic lymphocytic leukemia; ore.
   • e. metastatic hepatocellular cancer; or
   • f. previously treated metastatic breast cancer; org.
   • g. relapsed or refractory acute lymphoblastic leukemia; orh.
   • h. relapsed or refractory Hodgkin and non-Hodgkin lymphomas; ori.
   • i. relapsed, refractory, or poor-risk B-cell lymphomas; orj.
   • j. T-cell prolymphocytic leukemia (T-PLL)
3. The member has documentation of quantitative evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (e.g., echocardiogram, multigated radionuclide angiography (MUGA), or magnetic resonance imagery (MRI)) AND does not have a LVEF less than (<) 50%.

If the above prior authorization criteria are met, mitoxantrone will be approved for 6-months.

For Multiple Sclerosis:

1. The requested medication is prescribed by or in consultation with a neurologist; AND
2. The member has ONE of the following forms of multiple sclerosis:
   • a. secondary (chronic) progressive; orb.
   • b. progressive-relapsing; orc.
   • c. worsening or relapsing-remitting multiple sclerosis (RRMS); AND
3. The member has documentation of quantitative evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (e.g., echocardiogram, multigated radionuclide angiography (MUGA), or magnetic resonance imagery (MRI)) AND does not have a LVEF less than (<) 50%; AND
4. The member is unable to use or has tried and failed ALL appropriate formulary alternative (e.g., Aubagio, Betaseron, Copaxone, dimethyl fumarate, Gilenya, Mayzent, Rebif, Vumerity, Zeposia,Tysabri) for the given diagnosis; AND
5. The member has not received a cumulative lifetime dose of ≥140 mg/m2; AND
6. The requesting provider has submitted the necessary clinical documentation (e.g., chart notes, laboratory reports, disease progression, previous medications tried and failed, etc) for review.

If the above prior authorization criteria are met, mitoxantrone will be approved for 3-months.

Medical Necessity Criteria for Reauthorization

For Cancer:

Reauthorization for six (6) months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. recent chart documentation within the last three (3) months shows ONE of the following:
   • a. the member has NOT developed severe or life-threatening toxicity; orb.
   • b. the member has experienced severe or life-threatening toxicity AND the toxicity has been fully resolved

For Multiple Sclerosis:

Reauthorization for three (3) months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. recent chart documentation within the last three (3) months shows ONE of the following:
   • a. The member has shown a clinical improvement (e.g., reduction in neurologic disability and/or the frequency of clinical relapses) in symptoms since starting the requested medication; orb.
   • b. The member has experienced disease stability since starting the requested medication.