Subject: Benign Prostatic Hyperplasia (BPH) agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	doxazosin
C	finasteride		X
C	prazosin
C	terazosin
C	Avodart®  (dutasteride)		X
C	Flomax®  (tamsulosin)
C	Rapaflo™  (silodosin)		X
C	Uroxatral®  (alfuzosin)
NC	Cardura®  (doxazosin)						X
NC	Cardura XL®  (doxazosin SR)						X
NC	Hytrin®  (terazosin)						X
NC	Minipress®  (prazosin)						X
NC	Proscar®  (finasteride)		X				X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Avodart, finasteride, Proscar and Rapaflo are subject to precertification for members who are female.   If precertification requirements apply Aetna considers Avodart, finasteride, Proscar and Rapaflo to be medically necessary for those members who meet the following precertification criteria:

For Avodart
Member is male

OR

Member is female - A AND B

A. Member is NOT pregnant
AND
B. Member's physician provides documentation from the drug labeling OR CMS approved compendia for medical use in females.

For finasteride and Proscar
Member is male

OR

Member is female - A AND (B OR C)

A.   Member is NOT pregnant

AND

B.   Documented diagnosis of hirsutism secondary to ovarian or adrenal dysfunction (for example, polycystic ovary syndrome, adrenal or ovarian tumor)

OR

C. Member's physician provides documentation from the drug labeling OR CMS approved compendia for medical use in females.

For Rapaflo
A.  Member is male

OR

B.  If member is female, physician provides documentation from the drug labeling OR CMS approved compendia for medical use in females.

2. Medical Exception Criteria

Cardura, Cardura XL, Hytrin,  Minipress and Proscar 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 Cardura, Cardura XL, Hytrin, Minipress and Proscar to be medically necessary for those members who meet any of the following criteria:

For Cardura, Cardura XL, Hytrin and Minipress

A.  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 month of one preferred alternative agent indicated for the member's condition

For Proscar

Member is female - A AND (B OR C) AND D;

Member is male- D ONLY

A.   Member is NOT pregnant
AND
B.   Documented diagnosis of hirsutism secondary to ovarian or adrenal dysfunction (for example,   
polycystic ovary syndrome, adrenal or ovarian tumor)
OR
C.   Member's physician provides documentation from the drug labeling OR CMS approved compendia for medical use in females

AND

D.   A documented:

• Contraindication to the corresponding generic alternative OR
• Intolerance to the corresponding generic alternative OR
• Allergy to the corresponding generic alternative OR
• Failure of an adequate trial of one month of the corresponding generic alternative
  

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. American Urological Association, Inc. The management of benign prostatic hyperplasia. Baltimore (MD): American Urological Association, Inc.; (2003/Updated '06).
8. Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2006 Sep 18.
9. Debruyne F, Barkin J, van Erps P, et al. Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol 2004;46(4):488-94.
10. Gittelman M, Ramsdell J, Young J, McNicholas T. Dutasteride improves objective and subjective disease measures in men with benign prostatic hyperplasia and modest or severe prostate enlargement. J Urol 2006;176:1045-1050.
11. Nordling J, et al. Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once-daily for treating symptomatic benign prostatic hyperplasia. BJU International 2005;(95):1006-1012.
12. De Reijke, Klarskov P. Comparative efficacy of two alpha1-adrenoreceptor antagonists, doxazosin and alfuzosin, in patients with lower urinary tract symptoms from benign prostatic enlargement. BJU International 2004;(93):757-762.

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.

October 23, 2009