ModifiedHealth NetPolicy CP PMN.128

Dutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) prior authorization

Defines prior authorization criteria and coverage requirements for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn) for treatment of benign prostatic hyperplasia (BPH) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyDutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) prior authorization

Policy CodePolicy CP PMN.128

Change TypeAdded generic redirectIL step therapy bypassrevised commercial approval duration

Effective Date05.01.16

Next Review Date

Key ActionObtain prior authorization and submit documentation showing diagnosis of BPH, age, trials of two formulary BPH agents, dosing within limits, and use of generic when available.

SourceLink

POLICY UPDATE CHANGES

Added reference to generic dutasteride in the Policy/Criteria description as criteria would apply.

Added step therapy bypass for IL per IL HB 5395.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

Added requirement to redirect to generic Avodart or Jalyn.

0.5 mgdaily dutasteride dose for Avodart

0.5/0.4 mgdaily dutasteride/tamsulosin dose for Jalyn

fail 2 agentsstep therapy requirement

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typical approval duration

2Q 2025most recent annual review

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval for BPH: Member has a diagnosis of benign prostatic hyperplasia (BPH); member is age >= 18 years; failure of 2 formulary agents indicated for BPH (examples: doxazosin, finasteride, prazosin, tamsulosin, terazosin) at up to maximally indicated doses unless contraindicated or intolerant; if request is for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced; requested dose does not exceed the specified dosing limits (Avodart 0.5 mg once daily OR Jalyn 0.5 mg dutasteride / 0.4 mg tamsulosin once daily).N/A

Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Continuation Therapy

Continued therapy is covered when ONE of the following is met:

Continued Therapy: Member is currently receiving the medication via the Centene benefit OR member has previously met initial approval criteria OR member is enrolled in a state/product with continuity of care regulations; member is responding positively to therapy; if request is for a dose increase, the new dose does not exceed the specified maximum doses (Avodart 0.5 mg once daily; Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin once daily); if request is for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced.N/A

Non‑FDA indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety for the off‑label use. Such documentation must comply with the applicable off‑label use policies referenced by this policy (for example, CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or be supported by an applicable evidence of coverage document.

When there is a conflict between this clinical policy and a state Medicaid coverage provision, the state Medicaid coverage provisions take precedence for Medicaid members. Providers should refer to the relevant state Medicaid manual for specific coverage rules that apply.

Use of dutasteride, dutasteride/tamsulosin, or related products for non‑FDA approved indications is prohibited under this policy unless the request is accompanied by appropriate off‑label documentation that meets the referenced off‑label policies or an evidence of coverage document authorizing the indication. Requests lacking such documentation may be denied.

Provider Actions and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn). Approvals are granted only when the member meets the clinical criteria (diagnosis of BPH, age criteria, and step therapy requirements unless bypassed per state law) and dosing limits. Requests for brand products will be redirected to the corresponding generic unless contraindicated or significant adverse effects documented.

Approval conditioned on documented diagnosis of BPH and fulfillment of policy criteria.
Dose must not exceed listed maximums (Avodart 0.5 mg PO QD; Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin PO QD).

Denial Risk

Generic Redirect Requirement

Prescribers must redirect requests for brand Avodart or brand Jalyn to the corresponding generic product (generic dutasteride or generic dutasteride/tamsulosin) unless the member has a documented contraindication or clinically significant adverse reaction to the generic. Failure to redirect to a generic when available may result in non‑coverage or denial.

Definitions

BPH — definition

TermBenign prostatic hyperplasia (BPH)

DefinitionCommon condition in men characterized by prostate enlargement causing lower urinary tract symptoms (listed as abbreviation in Appendix A).

Clinical relevanceIndication for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn) therapy to improve symptoms and reduce risk of acute urinary retention and BPH‑related surgery.

Avodart — definition and prescribing information

Brand / GenericAvodart (dutasteride)

Prescribing informationAvodart Prescribing Information. GlaxoSmithKline; January 2020. (Reference listed in policy References).

Background

Benign prostatic hyperplasia (BPH) is a common condition in men characterized by prostate enlargement that can produce lower urinary tract symptoms. Dutasteride (a 5‑alpha reductase inhibitor; brand name Avodart) and the fixed‑dose combination dutasteride/tamsulosin (brand name Jalyn) are FDA‑approved for treatment of symptomatic BPH in men with an enlarged prostate to improve symptoms and reduce the risk of acute urinary retention and BPH‑related surgery. When used per this policy, dosing should remain within the specified limits and supporting prescribing information should be documented.

Revision History

2025-05-25annual_reviewLatest

2Q 2025 annual review: added reference to generic dutasteride in the policy/criteria description and added a step therapy bypass for Illinois (IL HB 5395); references reviewed and updated.

2024-05-24annual_review

2Q 2024 annual review: no significant clinical changes; references reviewed and updated.

2016-05-01effective_date

Policy effective date established.

Policy Summary

PayerHealth Net

PolicyDutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) prior authorization

Policy CodePolicy CP PMN.128

Change TypeAdded generic redirectIL step therapy bypassrevised commercial approval duration

Effective Date05.01.16

Next Review Date

Key ActionObtain prior authorization and submit documentation showing diagnosis of BPH, age, trials of two formulary BPH agents, dosing within limits, and use of generic when available.

SourceLink

On This Page

Generic redirect requirement added in 2Q 2022 review and reinforced in later reviews.
Exceptions permitted when contraindication or significant adverse effects to the generic are documented.

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation with the prior authorization request — examples include office chart notes, medication history showing trials of prior BPH agents, and relevant lab or diagnostic results. Documentation must support diagnosis, prior trials/exemptions, dosing, and any contraindications to generics if claiming exception.

Acceptable documentation: office notes, lab results, medication trial records, and prescribing information supporting dose.
When requesting brand product, include documentation showing contraindication or adverse reaction to the generic.

Step Therapy

Step Therapy Requirement and IL Bypass

Step therapy requirement: member must have failed trials of two formulary BPH agents (examples include doxazosin, finasteride, prazosin, tamsulosin, terazosin) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, the step therapy requirements do not apply as of 01/01/2026 per IL HB 5395.

Failure = inadequate response or intolerable adverse effects after a therapeutic trial at appropriate dose and duration.
IL statutory bypass: Step therapy does not apply for HIM requests in Illinois effective 01/01/2026 (IL HB 5395).

Typical dosing noted in policyDutasteride 0.5 mg PO once daily (maximum 0.5 mg/day).

Jalyn — definition and prescribing information

Brand / CompositionJalyn — fixed‑dose combination capsule containing dutasteride and tamsulosin

Prescribing informationJalyn Prescribing Information. GlaxoSmithKline; December 2020. (Reference listed in policy References).

Typical dosing noted in policyOne Jalyn capsule daily containing 0.5 mg dutasteride and 0.4 mg tamsulosin (0.5/0.4 mg once daily).