Subject: GI - Laxatives-Cathartics-Non-Laxatives

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	diphenoxylate w/ atropine				X
C	lactulose
C	lonox (diphenoxylate w/atropine)				X
C	loperamide
C	paregoric
C	Peg 3350
NC	Amitiza® 24 mcg  (lubiprostone)						X
NC	Amitiza® 8 mcg  (lubiprostone)		X		X		X
NC	Colyte®  (peg 3350-KCl-sod bicarb-sod chloride-sod sulfate)						X
NC	Golytely®  (peg 3350-KCl-sod bicarb-sod chloride-sod sulfate)						X
NC	Halflytely®  (bisacodyl-peg 3350-pot chloride-sod bicarb-sod chloride)						X
NC	Kristalose®  (lactulose)						X
NC	Lomotil®  (diphenoxylate w/ atropine)				X		X
NC	Motofen®  (difenoxin w/ atropine)				X		X
NC	Moviprep®  (peg 3350-sod sulfate-sod chloride-potassium chloride-sod ascorbate-ascorbic acid for oral solution)						X
NC	Nulytely®  (peg 3350-potassium chloride-sod bicarbonate-sod chloride)						X
NC	Osmoprep®  (sodium phosphate monobasic-sodium phosphate dibasic)						X
NC	Visicol®  (sodium phosphate monobasic-sodium phosphate dibasic)						X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, diphenoxylate w/ atropine, Lomotil, lonox and Motofen are subject to precertification for members equal to or greater than 65 years of age.  Aetna considers diphenoxylate w/ atropine, Lomotil, lonox and Motofen to be medically necessary for those members who meet the following precertification criteria: 

A.  A documented:

      A.  Member has tried and failed alternative drugs that are appropriate in the elderly     
            to treat the condition. OR
      B.  Member has been stabilized on the drug for an extended period of time OR
      C.  Discontinuation of the drug or change in drug therapy might result in physical and/or mental  impairment OR
      D.  Member is in a critical or terminal state and disruption of therapy would be inappropriate OR
      E.  It is medically necessary that the member receive the drug AND Member is being  monitored   AND Member has no known history of emergency department visits and/or hospital admissions from use of the drug OR
      F.  Member received a prescription for the drug from an emergency room physician or from a physician in an acute care setting and will only be using the drug for a short duration of time.

Under some plans, including plans that use an open or closed formulary Amitza 8 mcg is subject to precertification for members less than 18 years old. Aetna considers Amitza 8 mcg to be medically necessary for those members who meet the following precertification criteria:

A.  Documented diagnosis of Irritable bowel syndrome (IBS) with constipation AND
                 
B.  Female gender AND

C.  Member's physician provides documentation from the peer-reviewed from the CMS-approved Compendia (AHFS Drug Information®, DRUGDEX® System, or Drug Points®) for medical use in members less than 18 years old.


Under some plans, including plans that use an open or closed formulary, Amitiza 8 mcg is subject to precertification for members who are male.   If precertification requirements apply Aetna considers Amitiza to be medically necessary for those members who meet the following precertification criteria:

A. Member's physician provides documentation from the CMS-approved Compendia (AHFS Drug Information®, DRUGDEX® System, or Drug Points®)for medical use in males..


2. Medical Exception Criteria

Amitiza, Colyte, Golytely, Halflytely, Kristalose, Lomotil, Motofen, Moviprep, Nulytely, Osmoprep and Visicol are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*   Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Amitiza, Colyte, Golytely, Halflytely, Kristalose, Lomotil, Motofen, Moviprep, Nulytely, Osmoprep and Visicol to be medically necessary for those members who meet the following criteria:

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

A. A documented

• Contraindication to Peg 3350 OR
• Intolerance to one Peg 3350 OR
• Allergy to Peg 3350 OR
• Failure of an adequate trial of one course of Peg 3350 OR
• Member has a medical condition that requires a lower electrolyte concentration (Halflytely ONLY)

For Kristalose, Lomotil and Motofen

A.  A documented

• Contraindication to diphenoxylate w/ atropine OR
• Intolerance to diphenoxylate w/ atropine OR
• Allergy to diphenoxylate w/ atropine OR
• Failure of diphenxylate w/atropine

For Amitiza

A OR B

A. A documented diagnosis of chronic constipation

OR

B. IBS (Irritable Bowel Syndrome) associated with constipation, female, and 18 years
     of age and older 

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.
   

ARCHIVE VERSION

Property of 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.

August 06, 2009