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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Laxatives-Cathartics

Status Drug PR PR-QL PR-AL ST M EX‡
P lactulose          
P PEG          
P PEG/electrolyte solution          
FE Amitiza®  (lubiprostone) X       X
FE Colyte®  (PEG/electrolyte soln)         X
FE Golytely®  (PEG/electrolyte soln)         X
FE Halflytely®  (PEG/electrolyte soln/bisacodyl)         X
FE Kristalose®  (lactulose)         X
FE Nulytely®  (PEG/electrolyte soln)         X
FE Osmoprep®  (sod phos mono sod phos di tabs)         X
FE Visicol®  ((sodium phosphate mono/sodium phosphate di)         X
FE Moviprep®  (3350-KCl-NaCl-Na Sulfate-Na Acorbate-C For Soln 100 GM)         X
Non-prescription (OTC) products available (NOT covered under standard benefit plans)
OTC Miralax®  (polyethylene glycol 3350 oral pwd)          


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Amitiza  is subject to precertification.   If precertification requirements apply Aetna considers Amitiza to be medically necessary for those members who meet  the following precertification criteria: 

     

    (A OR B) AND C

     

    A. A documented diagnosis of chronic constipation

    OR

    B. IBS (Irritable Bowel Syndrome) associated with constipation 

              AND

    C. A documented

    • Contraindication to nonprescription Miralax OR
    • Intolerance to nonprescription Miralax OR
    • Allergy to nonprescription Miralax OR
    • Failure of an adequate trial of one treatment of nonprescription Miralax

     

  3. Medical Exception Criteria
  4. Colyte, Halflytely, Golytely, Kristalose, MoviPrep, Osmoprep, Nulytely, and Visicol are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Colyte, Halflytely, Golytely, Kristalose, MoviPrep, Nulytely, Osmoprep, Visicol, and Amitiza to be medically necessary for those members who meet any of the following criteria:

     

    For Colyte, Golytely, Halflytely, Kristalose, Nulytely, Osmoprep, Visicol, Moviprep

         A.  A documented:

     

    [(A OR B) AND C] AND D -For Amitiza

                A. A documented diagnosis of chronic constipation

               

       OR

      B. IBS (Irritable Bowel Syndrome) associated with constipation 

     

                AND

      C. A documented

    • Contraindication to nonprescription Miralax OR
    • Intolerance to nonprescription Miralax OR
    • Allergy to nonprescription Miralax OR
    • Failure of an adequate trial of one treatment of nonprescription Miralax

                 AND

                  D. A documented

    • Contraindication to one preferred alternative agent indicated for the member’s condition OR
    • Intolerance to one preferred alternative agent indicated for the member’s condition OR
    • Allergy to one preferred alternative agent indicated for the member’s condition OR
    • Failure of an adequate trial of one course of one preferred alternative agent indicated for the member’s condition OR
    • Patient needs to prepare for colonoscopy procedure and cannot tolerate large volumes of liquids (Visicol- only)

     


Place of Service:

Outpatient

The above policy is based on the following references:
  1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically. 
  2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD.  Updated periodically. 
  3. DRUGDEX® System [Internet database]. Greenwood Village , Colo: Thomson Micromedex. Updated periodically. 
  4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
  5. PDR® Electronic Library™ [Internet database]. Greenwood Village , Colo: Thomson Micromedex. Updated periodically DiPalma JA and Brady III CE.  Colon cleansing for diagnostic and surgical procedures:  polyethylene glycol-electrolyte lavage solution.  Am J Gastroenterol 1989;84:1008-16.
  6. Davis GR, Santa Ana CA, Morawski SG, Fordtran JS.  Development of a lavage solution associated with minimal water and electrolyte absorption or secretion.  Gastroenterology 1980;78:991-5.
  7. Fordtran JS, Santa Ana CA, Cleveland M.  A low-sodium solution for gastrointestinal lavage.  Gastroenterology 1990;98:11-6.
  8. DiPalma JA and Marshall JB.  Comparison of a new sulfate-free polyethylene glycol electrolyte lavage solution versus a standard solution for colonoscopy cleansing.  Gastrointest Endosc 1990;36:285-9.
  9. Le TH, Timmcke AE, Gathright Jr JB, Hicks TC, Opelka FG, Beck DE.  Outpatient bowel preparation for elective colon resection.  South Med J 1997; 90:526-30.
  10. Oliveira L, Wexner SD, Daniel N, DeMarta D, Weiss EG, Nogueras JJ, Bernstein M.  Mechanical bowel preparation for elective colorectal surgery.  Dis Colon Rectum 1997;40:585-91.
  11. Golub RW, Kerner BA, Wise Jr WE, Meesig DM, Hartmann RF, Khanduja KS, Aguilar PS. Colonoscopic bowel Preparations—Which one?  Dis Colon Rectum 1995;38:594-9.
  12. Aronchick CA, Lipshutz WH, Wright SH, et al. A novel tablet purgative for colonoscopic preparation: Efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc 2000;52:346-52.
  13. Product information for Amitiza. Takeda Pharmaceuticals America, Inc. Lincolnshire, IL 60069. 2006.
  14. Sucampo Pharmaceuticals, Inc. Press release (January 31, 2006): Sucampo obtains FDA approval for Amitiza capsules as treatment for chronic idiopathic constipation in adults. http://www.sucampo.com/article_62.shtml. (Accessed 2006).
  15. MoviPrep Package Insert. Salix Pharmaceuticals, Morrisville NC. August 2006.
  16. Amitiza product information accessed 5-2-08 at: http://www.amitiza.com/hcp/splash.aspx

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 23, 2009
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