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Prior Authorization Protocol
RELISTORR (methylnaltrexone bromide)


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:
    • Treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient
    • Treatment of opioid-induced constipation in adult patients with chronic non-cancer pain
  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to TWO of the following:
      • Over the counter (OTC) laxatives (e.g., docusate, bisacodyl, polyethylene glycol)
      • Amitiza
      • Movantik

    AND

    • Treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient
    OR
    • Treatment of opioid-induced constipation in adult patients with chronic non-cancer pain
  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.
    • Patients with known or suspected mechanical gastrointestinal obstruction
  4. General Information:
    • Advanced illness is defined as life-ending or terminal disease. In Relistor clinical trials, opioid-induced constipation was defined as less than three bowel movements in the preceding week or no bowel movement for 2 days.
    • The use of Relistor beyond four months has not been studied.
    • Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
    • Therapeutic Alternatives:
      Drug Dosing Regimen Dose Limit/ Maximum Dose

      lactulose

      10-20 gm PO QD

      40 gm/day

      OTC Agents Not Covered by majority of plans

      methylcellulose



      1 tbsp in 8 oz of water PO QD-TID prn or 2 caplets with 8 oz of water up to 6 times/day


      3 tbsp/day (powder) or 12 caplets/day
      docusate sodium

      100 mg PO QD-BID

      300 mg/day
      bisacodyl

      5-15 mg PO QD

      30 mg/day

      polyethylene glycol 3350

      17 gm PO QD

      17 gm/day

      psyllium

      1-2 tsp PO QD-TID

      6 tsp/day

      senna
      1-2 tablets PO BID; 10-15 mL PO BID
      8 tablets/day; 30 mLs/day

      Amitiza

      24 mcg PO BID

      48 mcg/day

      Movantik

      25 mg PO QD

      25 mg/day

      * Requires Prior Authorization
    • Recommended Dosing Regimen and Authorization Limit:
      Drug Dosing Regimen Authorization Limit

      Relistor

      Opioid-induced constipation in adult patients with advanced illness:

      Weight lb/kgDose SC QOD up to QD
      < 84 lb (38 kg)0.15 mg/kg*
      84 lb to <136 lb (38 kg to < 62 kg)0.4 mL = 8 mg
      136 lb to 251 lb (62 kg to 114 kg)0.6 mL = 12 mg
      >251 lb (114 kg)0.15 mg/kg*
      *Calculate the injection volume using one of the following:
      Multiply weight in lb by 0.0034, round up to nearest 0.1 mL
      Multiply weight in kg by 0.0075, round up to nearest 0.1 mL

      Opioid-induced constipation in adult patients with chronic non-cancer pain:
      12 mg SC QD

      4 months

    • Product Availability:

      Single use vial: 12 mg/0.6 mL for subcutaneous injection
      Pre-filled syringes: 8 mg/0.4 mL, 12 mg/0.6 ml for subcutaneous injection

    • References:
      1. Relistor [package insert]. Raleigh,NC:Salix Pharmaceuticals, Inc; Ocober 2014.
      2. Shaiova L, Rim F, Friedman D, et al: A review of methylnaltrexone, a peripheral opioid receptor antagonist, and its role in opioid-induced constipation. Palliat Support Care. 2007;5(2):161-166.
      3. Yuan CS, Foss JF, O'Connor M, et al: Methylnaltrexone for reversal of constipation due to chronic methadone use: a randomized controlled trial. JAMA. 2000;283(3):367-372.
      4. Yuan CS: Methylnaltrexone mechanisms of action and effects on opioid bowel dysfunction and other opioid adverse effects. Ann Pharmacother. 2007;41(6):984-993.
      5. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 10, 2015.
      6. Relistor. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 2015.
      7. Clinical Pharmacology Web site. Available at http://clinicalpharmacology-ip.com/. Accessed July 10, 2015.
      8. Michna E, Blonsky ER, Schulman S, et al: Subcutaneous Methylnaltrexone for Treatment of Opioid-Induced Constipation in Patients With Chronic, Nonmalignant Pain: A Randomized Controlled Study. The Journal of Pain. 2011: pp 1-9
    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.