Subject: Benign Prostatic Hyperplasia (BPH) Agents

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	doxazosin
P	finasteride	X		X
P	prazosin
P	terazosin
P	tamsulosin	X
P	Jalyn™  (dutasteride and tamsulosin)	X
P	Avodart®  (dutasteride)	X
P	Uroxatral®  (alfuzosin)	X
FE	Cardura®					X
FE	Cardura® XL  (doxazosin)					X
FE	Flomax®  (tamsulosin)	X			X	X
FE	Hytrin®  (terazosin)					X
FE	Minipress ®  (prazosin)					X
FE	Proscar®  (finasteride)	X		X		X
FE	Rapaflo™  (silodosin)	X				X

Policy:

1. Precertification Criteria

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

Member is male
A or B – Proscar, finasteride

A. Age > 50 yrs old

OR

B. Member has diagnosis of BPH (Benign Prostatic Hyperplasia)

NOTE: Avodart, Flomax, Jalyn, Rapaflo, tamsulosin and Uroxatral do not require precertification for males; please see below for precertification criteria for females.

Member is female 
A AND (B OR F) – For Proscar, finasteride
A AND F - For Avodart and Jalyn
C OR D OR E OR F– For Flomax, tamsulosin 
F – For Rapaflo, Uroxatral

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. Documented diagnosis of Urethral syndrome (urinary hesitancy, frequency, and dysuria)

OR

D. Documented diagnosis of intractable micturition difficulties (difficulty passing urine)

OR

E. Documented diagnosis of Ureteral calculi

OR

F. Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females.


2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Flomax is subject to step-therapy.  Aetna considers Flomax to be medically necessary for those members who meet the following step-therapy criteria:

For Flomax
A documented trial of one month of the drug’s generic equivalent

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception. (See criteria under section III below.)


 
3. Medical Exception Criteria

Flomax is currently listed on the Aetna Formulary Exclusion and Step Therapy lists. Therefore, Flomax is excluded from coverage for members enrolled in prescription drug benefit plans that used a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers Flomax to be medically necessary for those members who meet the criteria below:

Cardura, Cardura XL, Hytrin, Minipress, Proscar and Rapaflo are currently listed on the Aetna Formulary Exclusions List.* Therefore, Cardura, Cardura XL, Hytrin, Minipress, Proscar and Rapaflo 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, Proscar and Rapaflo to be medically necessary for those members who meet any of the following criteria:

For Flomax

Member is male

A.  Documented

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

OR

Member is female – (A OR B OR C OR D) AND E

A. Documented diagnosis of Urethral syndrome (urinary hesitancy, frequency, and dysuria)
OR
B. Documented diagnosis of intractable micturition difficulties (difficulty passing urine)
OR
C. Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females.
OR
D. Documented diagnosis of Ureteral calculi

AND
E.  Documented

a. Contraindication to the preferred generic equivalent OR,
b. Intolerance to the preferred generic equivalent OR,
c. Allergy to the preferred generic equivalent OR
d. Failure of an adequate trial of one month of the preferred generic equivalent

For  Proscar

Member is male - (A OR B) AND (C OR D)

A.  Age > 50 yrs old

OR

B. Documented diagnosis of BPH (Benign Prostatic Hyperplasia)

AND

C. Documented

• Contraindication to one preferred alternative indicated for the member's condition OR 
• Intolerance to one preferred alternative 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 indicated for the member's condition OR
• Member has a documented diagnosis of hypotension/low blood pressure (Proscar-only )

OR

D. Documentation of a prostate volume > 40 cm3


OR

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


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 (controlled clinical trial) from the peer-reviewed medical literature for medical use in females.

AND

D.  Documented

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

For Rapaflo

Member is male

A.  Documented

• Contraindication to one preferred alternative indicated for the member’s condition OR,
• Intolerance to one preferred alternative 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 indicated for the member’s condition.

Member is female

Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use in females.

AND
A.  Documented

• Contraindication to one preferred alternative indicated for the member’s condition OR,
• Intolerance to one preferred alternative 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 indicated for the member’s condition

For Cardura, Cardura XL, Hytrin and Minipress 

A.  A documented

• Contraindication to one preferred alternative indicated for the member's condition OR
• Intolerance to one preferred alternative 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 indicated for the member's condition.

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. Mehik, Aare. Alfuzosin Treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled, Pilot Study.  Urology 2003; 62 (3): 425-429.
8. Narayan, Perinchery. Long-term Safety and Efficacy of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. The Journal of Urology 2003; 170 (2): 498-502.
9. Vaughan, D. Long Term (7 to 8 year) Experience with Finasteride in Men with Benign Prostatic Hyperplasia. Urology 2002; 60 (6): 1040-1044
10. AUA Practice Guidelines Committee. AUA Guideline Management of Benign Prostatic Hyperplasia: Chapter1: Diagnosis and Treatment Recommendations. The Journal of Urology 2003; 170(2): 530-547
11. Dolder CR. Dutasteride: a dual 5-alpha reductase inhibitor for the treatment of symptomatic benign prostatic hyperplasia. Ann Pharmacother. 2006;40(4):658-65.
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.
13. Kaplan SA, Roehborn CG, ,Chancellor M et al. Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Score. BJU Int 2008;102:1133-9.
14. DeCastro J, Stone B. Improving therapeutic outcomes in BPH through diagnosis, treatment, and patient compliance. Am J Med 2008;121(Suppl 8)S27-33.
15. Neal RH, Keister D. What’s the best for your patient with BPH? J Fam Pract 2009;58:241-7.
16. Chang DF. Floppy iris syndrome: why BPH treatment can complicate cataract surgery. Am Fam Physician 2009;79:1051, 1055-6.
17. Abramowicz M. Silodosin (Rapaflo) for benign prostatic hyperplasia. Medical Letter 2009;51(1303):3-4.
18. Dhaliwal AS, Habib G, Deswal A et al. Impact of alpha-1 adrenergic antagonist use for benign prostatic hypertrophy on outcomes in patients with heart failure. Am J Cardiol 2009;104:270-5.
19. Barkin J, Roehrborn CG, Siami P, et al. Effect of dutasteride, tamsulosin, and the combination on patient reported quality of life and treatment satification in men with moderate-to-severe benign prostatic hyperplasia: 2 year data from the CombAT trial.  BJU International 2009:(103):919-26.

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.

November 01, 2010