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Prior Authorization Protocol

MARINOLR (dronabinol), CESAMETTM (nabilone)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:

    Marinol
    Cesamet
    Controlled Substance Schedule Category
    CIII
    CII
    Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments
    X
    X
    Treatment of anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS)
    X

  2. Health Net Approved Indications and Usage Guidelines:

    Treatment of nausea and vomiting associated with cancer chemotherapy

    • Patient has received highly or moderately emetogenic chemotherapy and was intolerant or refractory to 5-HT3 serotonin antagonist (e.g., ondansetron), in combination with EmendR and dexamethasone
    AND
    • Failure or clinically significant adverse effects to TWO of the following: metoclopramide, prochlorperazine or lorazepam
    Marinol Requests Only: Treatment of anorexia with weight loss in patients with AIDS
    • Use of Marinol is for appetite stimulation for AIDS
    AND
    • Failure or clinically significant adverse effects to megestrol
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Cesamet may be administered for 48 hours after the last dose of each cycle of chemotherapy.
    • Cesamet is not intended for use on an as-needed basis.
    • Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.
    • The following table is National Comprehensive Cancer Network's classification for emetogenic potential of significant chemotherapy and other agents.

    Agents
    Frequency of Emesis
    AC combination defined as either doxorubicin or epirubicin with cyclophosphamide, carmustine > 250 mg/m2, cisplatin, cyclophosphamide > 1,500 mg/m2, dacarbazine, doxorubicin ≥ 60 mg/m2or epirubicin >90 mg/m2, ifosamide ≥ 2gm/m2 per dose, mechlorethamine, streptozocin
    High Emetic Risk
    >90%
    aldesleukin > 12-15 million IU/m2, amifostine > 300 mg/m2, arsenic trioxide, azacitidine, bendamustine, busulfan, carboplatin, carmustine #250 mg/m2, clofarabine, cyclophosphamide #1500 mg/m2, cytarabine > 200 mg/m2, dactinomycin, daunorubicin, doxorubicin<60 mg/ m2, epirubicin #90 mg/m2, idarubicin, ifosfamide <2 gm/m2 per dose, interferon alpha ≥ 10 million IU/m2, irinotecan, melphalan, MTX ≥ 250 mg/m2, oxaliplatin, temozolomide
    Moderate Emetic Risk
    30-90%
    ado-trastuzumab emtansine, amifostine #300 mg, aldesleukin #12 million IU/m2, brentuximab vedotin, cabazitaxol, carfilzomib, cytarabine (low dose) 100 - 200 mg/m2, docetaxel, doxorubicin (liposomal), eribulin, etoposide, 5-fluorouracil, floxuridine, gemcitabine, interferon alpha > 5 <10 million IU/m2, ixabepilone, MTX > 50 mg/m2 < 250 mg/m2, mitomcyin, mitoxantrone, omacetaxine, paclitaxel, paclitaxel-albumin, pemetrexed, pentostatin, pralatrexate, romidepsin, thiotepa, topotecan, ziv-aflibercept
    Low Emetic Risk
    10-30%
    alemtuzumab, asparaginase, bevacizumab, bleomycin, bortezomib, cetuximab, 2-chlorodeoxyadenosine (cladribine), cytarabine < 100 mg/m2, decitabine, denileukin diftitox, dexrazoxane, fludarabine, interferon alpha #5 million IU/m2, ipilimumab, MTX #50 mg/m2, nelarabine, ofatumumab, panitumumab, pegaspargase, peginterferon, pertuzumab, rituximab, temsirolimus, trastuzumab, valrubicin, vinblastine, vincristine, vincristine (liposomal), vinorelbine
    Minimal Emetic Risk
    <10%
    altretamine, busulfan (≥ 4 mg/d), crizotinib, cyclophosphamide (≥ 100 mg/m2/d), estramustine, etoposide, lomustin (single day), mitotane, procarbazine, temozolomide (> 75 mg/m2/d), vismodegib
    Emetogenic potential of oral antineoplastic agents: Moderate to High
    axitinib, bexarotene, bosutinib, busulfan (< 4 mg/d), cabozantinib, capecitabine, chlorambucil, cyclophosphamide (< 100 mg/m2/d), dasatinib,dabrafenib, erlotinib, everolimus, fludarabine, gefitinib, hydroxyurea, imatinib, lapatinib, lenalidomide, melphalan, mercaptopurine, methotrexate, nilotinib, pazopanib, pomalidomide, ponatinib, regorafenib, ruxolitinib, sorafenib, sunitinib, temozolomide (#75 mg/m2/d), thalidomide, thioguanine, topotecan, trametinib, tretinoin, vandetanib, vemurafenib, vorinostat
    Emetogenic potential of oral antineoplastic agents: Minimal to low

  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    5-HT3 Serotonin Antagonists

    ondanestron (ZofranR)*

    Moderately emetogenic chemotherapy (MEC):
    Adults and children 12 years and older: 8 mg PO BID administered 30 minutes before the start of chemotherapy, with a subsequent dose 8 hours after the first dose; continue 8 mg BID for 1 to 2 days after completion of chemotherapy
    Adults: Three 0.15 mg/kg IV doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of chemotherapy. Subsequent doses may be repeated twice, administered 4 and 8 hours after the first dose.

    Highly emetogenic chemotherapy (HEC):
    Adults: 24 mg PO (given as three 8 mg tablets) 30 minutes prior to start of single-day chemotherapy
    Adults: Three 0.15 mg/kg IV doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of chemotherapy. Subsequent doses may be repeated twice, administered 4 and 8 hours after the first dose.

    As specified by length of chemotherapy

    5-HT3 Serotonin Antagonists

    AnzemetR (dolasetron)*

    Moderately emetogenic chemotherapy
    Adults:
    100 mg PO within 1 hour prior to chemotherapy

    As specified by length of chemotherapy

    5-HT3 Serotonin Antagonists

    granisetron*

    Moderately and highly emetogenic chemotherapy
    2 mg PO QD 1 hour prior to chemotherapy OR 1 mg BID 1 hour prior to chemotherapy and then 12 hours later
    As specified by length of chemotherapy
    5-HT3 Serotonin Antagonists

    SancusoR (granisetron)*
    Moderately and highly emetogenic chemotherapy
    Adults:
    Apply a single patch to the upper outer arm from 24 to 48 hours before chemotherapy. Remove the patch a minimum of 24 hours after completion of chemotherapy.
    The patch can be worn for up to 7 days depending on the duration of chemotherapy regimen.
    As specified by length of chemotherapy
    5-HT3 Serotonin Antagonists

    AloxiR (palonosetron)*
    Highly or Moderately emetogenic chemotherapy
    0.25 mg IV infused over 30 seconds beginning 30 minutes prior to chemotherapy

    As specified by length of chemotherapy
    NK1 Receptor Antagonist

    EmendR (aprepitant)*
    Moderately and highly emetogenic chemotherapy
    125 mg PO 1 hour prior to chemotherapy and 80 mg on days 2, 3

    1 x 125 mg and 2 x 80 mg capsules per cycle

    Oral Corticosteroids

    Dexamethasone

    20 mg (12 mg with Emend) PO (pre-chemotherapy) and 8 mg PO daily on Days 2, 3
    Various chemotherapy dosage regimens

    40 mg/day

    Phenothiazines

    Promethazine (Phenergan)
    Oral, Rectal, Intramuscularm, Intravenous: 12.5 mg-25 mg PO/PR/IM/IV q4-6 hours PRN

    100 mg/day

    Phenothiazines

    Prochlorperazine (Compazine)
    Oral: 5-10mg PO q 6-8 hours.
    Rectal: 25 mg PR q12 hours
    Intramuscular/Intravenous: 5-10 mg IM or IV q3-4 hours PRN
    PO/IM: 40 mg/day
    PR: 50 mg/day
    Dopamine Receptor Antagonists

    Metoclopramide (Reglan Metozolv)

    1-2 mg/kg/ dose IV 30 minutes before chemotherapy. May repeat every 2 hours for 2 doses then repeat every 3 hours for 3 doses.

    This field intentionally left blank.
    Benzodiazepines

    Lorazepam (Ativan)
    Oral: 2.5 mg PO the evening prior to and after initiation of chemotherapy
    Instramuscular/Intravenous: 0.025-0.05 mg/kg (maximum 4 mg) IM or IV given slowly (2 mg/min) 30 to 35 minutes prior to chemotherapy. May supplement with 1-2 mg PO every hour PRN

    Various chemotherapy dosage regimens

    10 mg/day

    Miscellaneous

    oxandrolone (OxandrineR)*
    Weight loss due to AIDS wasting
    2.5 - 20 mg/day PO QD in 2 to 4 divided doses for 2 to 4 weeks

    20 mg/day

    Miscellaneous

    megestrol suspension (MegaceR)

    Weight loss due to AIDS wasting
    400-800 mg PO QD

    800 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    MarinolR (dronabinol)

    Nausea & vomiting:
    Initially given as 5 mg/m2 PO per dose.
    1st dose is given 1-3 hours before chemotherapy,
    then every 2-4 hours after chemotherapy for total of 4-6 doses/day.
    This dose may be increased by 2.5mg/m2
    increments to a maximum 15 mg/ m2 per dose.

    Appetite Stimulant:
    Initially, 2.5 mg PO BID before lunch and dinner.
    The dose may be increased to a maximum dose
    20 mg/day administered in divided oral doses.

    Nausea & vomiting:
    As specified by length of chemotherapy

    Appettite Simulant:
    Length of Benefit

    CesametTM (nabilone)

    Nausea & vomiting:
    1 - 2 mg PO BID.
    1st dose is given 1-3 hours before chemotherapy.
    A dose the night before chemotherapy may be useful.
    Dose may be increased as necessary.
    Max dose 6 mg/day in divided doses TID.
    Dosing may continue during entire course
    of each cycle of chemotherapy and, if needed,
    for 48 hours after the last dose of each cycle of chemotherapy.
    As specified by length of chemotherapy
  7. Product Availability:
    Dronabinol (Marinol): 2.5 mg, 5 mg, 10 mg capsules
    Cesamet: 1 mg capsules
  8. References:
    1. Marinol [Prescribing Information] North Chicago, IL: AbbVie, Inc; February 2013.
    2. Cesamet [Prescribing Information] Somerset, NJ: MEDA Pharmaceuticals Inc.; September 2013.
    3. Basch E, Prestrud AA, Hesketh, PJ, et al. Antiemetics: American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Update 2011 J Clin Oncol 29:4189-4198.
    4. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology - Antiemesis V.1.2012. NCCN Web site. Available at http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed July 1, 2014
    5. Clinical Pharmacology Web site, Available at http://clinicalpharmacology-ip.com/default.aspx. Accessed June 24, 2015..
    6. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 24, 2015.
    7. Cesamet. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 24, 2015.
    8. Marinol. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 24, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.