Dutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) Form

The following are benign prostatic hyperplasia (BPH) agents requiring prior authorization: dutasteride (Avodart®) and dutasteride/tamsulosin (Jalyn®). FDA Approved Indication(s) Avodart is indicated:
• For the treatment of symptomatic BPH in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery In combination with the alpha-adrenergic antagonist, tamsulosin, for the treatment of symptomatic BPH in men with an enlarged prostate. • Jalyn is indicated: • For the treatment of symptomatic BPH in men with an enlarged prostate.
Limitation(s) of use: Dutasteride-containing products, including Avodart and Jalyn, are not approved for the prevention of prostate cancer. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Avodart and Jalyn are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Benign Prostatic Hyperplasia (must meet all):

1. Diagnosis of BPH;
   2. Age ≥ 18 years;
   3. Failure of 2 formulary agents indicated for BPH (e.g., doxazosin, finasteride, prazosin, tamsulosin, terazosin) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;

2. If request is for brand Avodart or Jalyn, member must use the corresponding generic product, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 6

   CLINICAL POLICY Dutasteride, Dutasteride/Tamsulosin

3. Dose does not exceed one of the following (a or b): a. Avodart: 0.5 mg per day (1 capsule per day); b. Jalyn: 0.5 mg dutasteride/0.4 mg tamsulosin (1 capsule per day). Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Benign Prostatic Hyperplasia (must meet all):
   
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for brand Avodart or Jalyn, member must use the corresponding generic product, unless contraindicated or clinically significant adverse effects are experienced;

6. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. Avodart: 0.5 mg per day (1 capsule per day); b. Jalyn: 0.5 mg dutasteride/0.4 mg tamsulosin (1 capsule per day). Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less
   Page 2 of 6

   CLINICAL POLICY Dutasteride, Dutasteride/Tamsulosin B. Other diagnoses/indications (must meet 1 or 2):

7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BPH: benign prostatic hyperplasia FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen doxazosin (Cardura) finasteride (Proscar) prazosin (Minipress) tamsulosin (Flomax)
   terazosin (Hytrin) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 1 to 8 mg PO once daily 5 mg PO once daily 2 mg PO twice daily 0.4 mg PO once daily 5 – 10 mg PO once daily Dose Limit/ Maximum Dose 8 mg/day 5 mg/day 9 mg/day 0.8 mg/day 20 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): pregnancy or women of childbearing potential and clinically significant hypersensitivity Page 3 of 6

   CLINICAL POLICY Dutasteride, Dutasteride/Tamsulosin • Boxed warning(s): none reported V. Dosage and Administration
   Dosing Regimen Maximum Dose Drug Name Dutasteride (Avodart) 0.5 mg PO QD Dutasteride/tamsulosin (Jalyn) 1 capsule PO QD 0.5 mg dutasteride and 0.4 mg 0.5 mg/day tamsulosin/day VI. Product Availability
   Drug Name Dutasteride (Avodart) Dutasteride/tamsulosin (Jalyn) Capsule: 0.5/0.4 mg Availability Capsule: 0.5 mg VII.