CurrentmhnPolicy CP.PMN.128

Dutasteride (Avodart) and Dutasteride/Tamsulosin (Jalyn) Prior Authorization

Defines prior authorization requirements, coverage criteria, dosing limits, and approval durations for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn) for the treatment of benign prostatic hyperplasia (BPH) for the payer's lines of business.

Policy Summary

Payermhn

PolicyDutasteride (Avodart) and Dutasteride/Tamsulosin (Jalyn) Prior Authorization

Policy CodePolicy CP.PMN.128

Change TypeNo material changes

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of BPH, age ≥18, failure of 2 formulary BPH agents, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2products requiring prior authorization

≥18minimum age (years)

2required failed agents

0.5 mgmax dutasteride dose

12 mostandard approval duration

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Initial Therapy

Covered when ALL of the following are met for Benign Prostatic Hyperplasia (BPH):

BPH Initial Therapy Criteria: 1) Diagnosis of BPH;

BPH Initial Therapy Criteria: 2) Age ≥ 18 years;

BPH Initial Therapy Criteria: 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; (Illinois HIM: step therapy does not apply as of 1/1/2026 per IL HB 5395).

BPH Initial Therapy Criteria: 4) If request is for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced;

BPH Initial Therapy Criteria: 5) Dose does not exceed one of the following: a) Avodart 0.5 mg per day (1 capsule per day); or b) Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin per day (1 capsule per day).

Continuation Therapy

Continuation therapy covered when ALL of the following are met:

BPH Continued Therapy Criteria: 1) Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity of care regulations;

BPH Continued Therapy Criteria: 2) Member is responding positively to therapy;

BPH Continued Therapy Criteria: 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;

BPH Continued Therapy Criteria: 4) If request is for a dose increase, new dose does not exceed one of the following: a) Avodart 0.5 mg per day (1 capsule per day); or b) Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin per day (1 capsule per day).

Other Indications / Off-label

Other indications and off‑label uses:

Other Indications: 1) 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, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business as specified in the policy;

Other Indications: 2) If the requested use (diagnosis, age, dosing regimen) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 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 HIM, CP.PMN.53 for Medicaid).

Other Indications: Note: Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the referenced off-label use policies; see section III for exclusions (includes contraindication in pregnancy/women of childbearing potential).

Uses for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or unless the indication is otherwise supported by the member’s evidence of coverage.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for any specific coverage rules that apply.

Requests for therapy for non‑FDA approved indications that lack sufficient supporting evidence per the off‑label use policies referenced in this document are not authorized.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn). Approval requires meeting the specified clinical criteria.

Affected agents: dutasteride (Avodart), dutasteride/tamsulosin (Jalyn)
Prior authorization required before coverage

Documentation Required

Required Documentation and Denial Risk

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests lacking sufficient documentation that the member meets all approval criteria will be denied or returned for more information.

Examples of acceptable documentation: office visit notes, relevant lab results, medication history showing trials of prior agents, documentation of contraindications or adverse effects
Incomplete requests without supporting documentation will be denied or returned

Step Therapy

Step Therapy Requirement

Step therapy requirement: Failure of 2 formulary agents indicated for BPH at up to maximally indicated doses is required prior to approval, unless clinically significant adverse effects are experienced or all are contraindicated. For Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Required step therapy: failure of 2 formulary agents (examples: doxazosin, finasteride, prazosin, tamsulosin, terazosin)
IL HIM exception: step therapy bypassed per IL HB 5395 effective 01/01/2026

Note

Policy as Medical Necessity Guide

This clinical policy is a guide to medical necessity and coverage decisions are subject to plan terms, exclusions, limitations, and applicable state Medicaid provisions. When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence.

Follow state rules for Medicaid members where conflicts exist

OpenPayer

Dutasteride (Avodart) and Dutasteride/Tamsulosin (Jalyn) Prior Authorization

Coverage Criteria for Dutasteride and Dutasteride/Tamsulosin

Provider Actions, Prior Authorization, and Documentation

Background

Definitions