Subject: Diuretics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	amiloride
C	bumetanide
C	chlorothiazide
C	chlorthalidone
C	eplerenone
C	furosemide
C	hydrochlorothiazide (HCTZ)
C	indapamide
C	mannitol	X
C	methyclothiazide
C	metolazone
C	spironolactone
C	spironolactone/HCTZ
C	torsemide
C	amilodride/HCTZ
C	triamterene/HCTZ
NC	Aldactazide®  (spironolactone and HCTZ)						X
NC	Aldactone®  (spironolactone)						X
NC	Bumex®  (bumetanide)						X
NC	Demadex®  (torsemide)						X
NC	Dyrenium®  (triamterene)						X
NC	Dyazide®  (triamterene/HCTZ)						X
NC	Edecrin®  (ethacrynic acid)						X
NC	Enduron®  (methyclothiazide)						X
NC	Inspra®  (eplerenone)						X
NC	Lasix®  (furosemide)						X
NC	Maxzide®  (triamterene/HCTZ)						X
NC	Osmitrol®  (mannitol)	X					X
NC	Zaroxolyn®  (metolazone)						X

Policy:

1. Precertification Criteria

Under Medicare prescription drug benefit plans, including plans that use an open or closed formulary, mannitol and Osmitrol are subject to review because they may be considered to be either a Medicare Part B drug or a Medicare Part D drug.  

Medicare Part B Criteria:

Mannitol and Osmitrol will be considered to be Medicare Part B drugs and medically necessary for those members who meet the following precertification criteria:

A. The indication for which the drug is being prescribed is covered under Part B as determined by the physician's local carrier

OR

B. Drug is being administered via an infusion pump in the beneficiary's home


Medicare Part D Criteria:

Mannitol and Osmitrol will be considered to be Medicare Part D drugs and medically necessary for those members who meet the following precertification criteria:

A.  The indication for which the drug is being prescribed is an approved indication in the drug 
      labeling or CMS approved compendia and is not being covered by the physician's local
      carrier.

       AND

B.    Drug is being administered via an infusion pump in a setting other than the beneficiary's
       home, such as a long term care facility


            

2. Medical Exception Criteria

For Part D drugs only; Part D criteria above also met

Aldactazide, Aldactone, Bumex, Demadex, Dyrenium, Dyazide, Edecrin, Enduron, Inspra, Lasix, Maxzide, Osmitrol and Zaroxolyn 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 benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Aldactazide, Aldactone, Bumex, Demadex, Dyrenium, Dyazide, Edecrin, Enduron, Inspra, Lasix, Maxzide, Osmitrol and Zaroxolyn to be medically necessary for those members who meet the criteria as specified below:

For Aldactazide 25/25, Aldactone, Bumex, Demadex, Dyazide, Enduron, Inspra, Lasix, Maxzide, and Zaroxolyn

A.   A documented:

• Intolerance to the equivalent preferred generic diuretic OR
• Contraindication to the equivalent preferred generic diuretic OR
• Allergy to the equivalent preferred generic diuretic OR
• Failure of an adequate trial of one month of the equivalent preferred generic diuretic

For Dyrenium and Edecrin

A.    A documented:

• Intolerance to two preferred diuretics indicated for the member's condition OR
• Contraindication to two preferred diuretics indicated for the member's condition OR
• Allergy to two preferred diuretics indicated for the member's condition OR
• Failure of an adequate trial of one month each of two preferred diuretics indicated for the member's condition

For Aldactazide 50/50

A. A documented:

• Intolerance to one of the following preferred generic diuretics: spironolactone or HCTZ OR
• Contraindication to one of the following preferred generic diuretics: spironolactone or HCTZ OR
• Allergy to one of the following preferred generic diuretics: spironolactone or HCTZ OR
• Failure of an adequate trial of one of the following preferred generic diuretics: spironolactone or HCTZ

For Osmitrol

A. A documented:

• Contraindication to the preferred generic alternative mannitol OR
• Intolerance to the preferred generic alternative mannitol OR
• Allergy to the preferred generic alternative mannitol OR
• Failure of an adequate trial of two (2) days of the preferred generic alternative mannitol
  

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.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

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.

January 01, 2009