Medical Necessity Criteria for Rapaflo (silodosin) Background

Alpha blockers for the treatment of benign prostatic hypertrophy (BPH). This class includes two non-selective agents (doxazosin and terazosin) and three uroselective agents (Uroxatral, Flomax and Rapaflo). This drug class was initially reviewed by the DoD P&T Committee in August 2005 and designated as non-formulary on 15 Feb 2006. The class was re-reviewed by the DoD P&T Committee in November 2007 and again in May, 2010. These recommendations have been approved by the Director, TMA.

Effective Date: 4 August 2010 (medical necessity, step therapy / prior authorization requirements updated August 2010)

Patients currently using a nonformulary alpha blocker for BPH may wish to ask their doctor to consider a formulary alternative.

Special Notes:

1. Active duty cost share always $0 in all points of service for all three tiers; Active duty cost share always $0 in all points of service for all three tiers; TRICARE does not cover non-formulary medications for active duty service members unless they are determined to be medically necessary. 2. MTFs will be able to fill non-formulary requests for non-formulary medications only if both of the following conditions are met: 1) a MTF provider writes the prescription, and 2) medical necessity is established for the non-formulary medication. MTFs may (but are not required to) fill a prescription for a non-formulary medication written by a non-MTF provider to whom the patient was referred, as long as medical necessity has been established. 3. Patients are not required to try a non-selective alpha blocker (doxazosin or terazosin), but must try the formulary uroselective alpha blockers generic tamsulosin and Uroxatral (alfuzosin) before medical necessity will be approved for Rapaflo (silodosin).

Medical Necessity Criteria for Rapaflo (silodosin)

All current and new users of Rapaflo (silodosin) must meet one of the following criteria in order for medical necessity to be approved:

1. Use of generic tamsulosin and Uroxatral is contraindicated (e.g., hypersensitivity; moderate to severe hepatic insufficiency).

2. The patient has experienced significant adverse effects from generic tamsulosin and Uroxatral.

3. Use of generic flomax and Uroxatral has resulted in therapeutic failure (no improvement in BPH symptoms).

4. The patient requires a drug that can be crushed or sprinkled on food.

Medical necessity Criteria recommended by the DoD Pharmacy & Therapeutics Committee at the November 2007 meeting & approved by the Director, TMA on 12 February 2008. For more information, please see the DoD P&T Committee minutes..

www.tricare.mil is the official Web site of the TRICARE Management Activity, a component of the Military Health System Skyline 5, Suite 810, 5111 Leesburg Pike, Falls Church, VA 22041-3206

US Family Health Plan Pharmacy Program Medical Necessity Form for Rapaflo (silodosin)

This form applies to the US Family Health Plan Mail Order Pharmacy and the US Family Health Plan Retail Pharmacy programs. This form must be completed and signed by the prescriber.

. Doxazosin, terazosin, tamsulosin (Flomax) and Uroxatral (alfuzosin) are the formulary alpha blockers on the DoD Uniform Formulary for the treatment of symptoms of benign prostatic hypertrophy (BPH). Tamsulosin is available at the formulary generic cost share and Uroxatral at the formulary brand cost share. Rapaflo (silodosin) is non-formulary, but available to many beneficiaries at the non-formulary cost share. Please note that step therapy/prior authorization (PA) requirements apply to patients newly starting on Rapaflo. PA forms are available on the TRICARE Pharmacy website at http://pec.ha.osd.mil/forms_criteria.php. This form may NOT be used to meet step therapy/PA requirements. . You do NOT need to complete this form in order for non-active duty beneficiaries (spouses, dependents, and retirees) to obtain non-formulary medications at the non-formulary cost share. The purpose of this form is to provide information that will be used to determine if the use of a non- formulary medication instead of a formulary medication is medically necessary. If a non-formulary medication is determined to be medically necessary AND a non-Active duty beneficiary has met step therapy/PA requirements, non-active duty beneficiaries may obtain it at the formulary cost share.

• The provider may call: 1-877-880-7007

or the completed form may be faxed to:1-617-562-5296

and • The patient may attach the completed form to the prescription and mail it to: ATTN: Pharmacy, 77 Warren St, Brighton, MA 02135 RETAIL

MAIL ORDER

Step Please complete patient and physician information (Please print) Patient Name: Physician Name: 1 Address: Address:

Sponsor ID # Phone #: Date of Birth: Secure Fax #: Step Please explain why the patient cannot be treated with the formulary uroselective alpha blockers tamsulosin (Flomax) and Uroxatral (alfuzosin). NOTE: Doxazosin and terazosin are also on formulary at the generic (Tier 1 copay); however, patients are not 2 required to try a non-selective alpha blocker before medical necessity will be approved for Rapaflo. Please indicate which of the reasons below (1-4) applies. You MUST circle a reason AND supply a specific written clinical explanation. Formulary Medication Reason Clinical Explanation

Tamsulosin (Flomax) 1 2 3 4

Uroxatral (alfuzosin) 1 2 3 4

1. Use of the formulary medication is contraindicated (e.g., due to hypersensitivity or moderate to severe hepatic insufficiency). 2. The patient has experienced significant adverse effects from the formulary medication. 3. Use of the formulary medication has resulted in therapeutic failure. 4. The patient requires a drug that can be crushed or sprinkled on food. Step I certify the above is true to the best of my knowledge. Please sign and date:

3 Prescriber Signature Date Latest revision: September 28, 2011