CurrentmhnPolicy CP.PMN.128

Dutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) - Prior Authorization and Medical Necessity

This policy governs prior authorization and medical necessity requirements for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn) for treatment of benign prostatic hyperplasia (BPH) for Centene-affiliated health plans, affecting providers submitting PA requests.

Policy Summary

Payermhn

PolicyDutasteride (Avodart), Dutasteride/Tamsulosin (Jalyn) - Prior Authorization and Medical Necessity

Policy CodePolicy CP.PMN.128

Change TypeAdded IL step therapy bypassminor administrative updates

Effective DateMay 1, 2016

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: no significant changes; added reference to generic dutasteride in the Policy/Criteria description as criteria would apply; references reviewed and updated.

Added step therapy bypass for IL HIM per IL HB 5395.

Added ICHRA line of business.

2products requiring prior authorization

≥18minimum age (years)

2formulary failures required

0.5 mg/daymax dutasteride dose

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Coverage Criteria for Dutasteride and Dutasteride/Tamsulosin

Initial Therapy for Benign Prostatic Hyperplasia

Covered when ALL of the following are met:

Diagnosis of benign prostatic hyperplasia (BPH)

Age ≥ 18 years

Step therapy: Failure of 2 formulary agents indicated for BPH at up to maximally indicated doses unless clinically significant adverse effects are experienced or all agents are contraindicated2 agents

Examples include doxazosin, finasteride, prazosin, tamsulosin, terazosin. For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 as of 1/1/2026.

Generic requirement: If request is for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced

Dose limit: Dose does not exceed one of the following: Avodart 0.5 mg per day (1 capsule/day) OR Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin per day (1 capsule/day)see dose

Refer to dosing table for maximum daily doses.

Continued Therapy for Benign Prostatic Hyperplasia

Covered when ALL of the following are met:

Ongoing treatment or prior approval: Member meets one of the following: currently receiving medication via Centene benefit or previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (see state addendums CC.PHARM.03A and CC.PHARM.03B)

Clinical response: Member is responding positively to therapy

Generic requirement: If request is for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced

Dose increase: If request is for a dose increase, the new dose does not exceed Avodart 0.5 mg per day or Jalyn 0.5 mg dutasteride/0.4 mg tamsulosin per daysee dose

Non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies and evidence of coverage documents.

When there is a conflict between state Medicaid coverage provisions and the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements.

Use of dutasteride‑containing products for the prevention of prostate cancer is not an FDA‑approved indication. Such use is therefore not covered under this policy unless there is adequate off‑label evidence and documentation consistent with the plan's off‑label use policies.

Product Codes, Dosing, and Billing

Product availability / NDCsNDC

NDC (not specified)

Product availability: Dutasteride (Avodart) capsule 0.5 mg; Dutasteride/tamsulosin (Jalyn) capsule 0.5/0.4 mg

Referenced billing impactmixed

affected codes

Policy notes reference redirecting to generic Avodart or Jalyn and prior authorization/step therapy affected codes (specific codes not listed in this document)

Maximum daily dutasteride dose

Maximum daily dutasteride doseAvodart (dutasteride) maximum dose: 0.5 mg per day (1 capsule per day)

Jalyn dose equivalenceJalyn (dutasteride 0.5 mg / tamsulosin 0.4 mg) 1 capsule per day — dutasteride component = 0.5 mg/day

Dose statement sourceDose limits are specified in the Dosage and Administration and Dose section of the policy

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn). Provider must document diagnosis of benign prostatic hyperplasia (BPH), age ≥ 18 years, prior therapy attempts, and supporting clinical information. Step therapy requires failure of two formulary agents indicated for BPH at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur. For requests for brand Avodart or Jalyn, member must use the corresponding generic product unless contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (a step therapy bypass has been added for IL HIM). Coverage decisions are subject to the terms, exclusions, and limitations of the member's benefit documents and applicable state and federal requirements. Requests lacking documentation that the member meets all approval criteria may be denied or deferred.

Prior authorization required for dutasteride (Avodart) and dutasteride/tamsulosin (Jalyn)
Must document BPH diagnosis and age ≥ 18 years
Step therapy: failure of 2 formulary BPH agents at maximally indicated doses unless contraindicated or adverse effects
Redirect to generic Avodart/Jalyn unless contraindicated
Illinois HIM: step therapy bypass per IL HB 5395 effective 1/1/2026
Provider must submit supporting documentation (office notes, labs, other clinical information)

Background on Dutasteride and Combination Therapy

Dutasteride and the fixed combination dutasteride/tamsulosin are therapies indicated for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve lower urinary tract symptoms. Dutasteride products are available as Avodart 0.5 mg and the combination product as Jalyn 0.5/0.4 mg per prescribing information and product availability references.

Definitions and Clinical References

BPH — Definition

Definition of BPHBPH: benign prostatic hyperplasia

ContextListed in the policy appendices as the abbreviation for benign prostatic hyperplasia

Clinical scopePolicy addresses use of dutasteride-containing products for treatment of symptomatic BPH in men

BPH management references

Primary prescribing referencesAvodart Prescribing Information (Waylis Therapeutics LLC; October 2023) and Jalyn Prescribing Information (Waylis Therapeutics LLC; April 2024)

Clinical guideline referenceAmerican Urological Association guideline: management of benign prostatic hyperplasia (BPH) — AUA guidelines and later updates (2010, 2014 validity confirmation; 2021 and 2023 updates cited)