CurrentCentenePolicy CP.PMN.132

Tadalafil (Cialis, Chewtadzy) for BPH and ED

Coverage and prior authorization criteria for tadalafil products for treatment of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) across Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyTadalafil (Cialis, Chewtadzy) for BPH and ED

Policy CodePolicy CP.PMN.132

Change TypeNo material change

Effective DateJun 1, 2018

Next Review Date

Key ActionSubmit prior authorization with clinical documentation demonstrating diagnosis, required prior therapy failures, appropriate age, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 mg/dayMax daily dose (BPH)

20 mg/dayMax daily dose (ED)

12 monthsApproval duration

≥18Min age (BPH)

≥21Min age (ED)

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy - BPH

Covered when ALL of the following are met:

BPH Initial Approval: 1. Diagnosis of benign prostatic hyperplasia (BPH). 2. Age ≥ 18 years. 3. Failure of both of the following, at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects: (a) one alpha blocker (e.g., alfuzosin, doxazosin, prazosin, tamsulosin, or terazosin) AND (b) one 5‑alpha reductase inhibitor (finasteride or dutasteride). 4. If request is for brand Cialis or Chewtadzy, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced. 5. Tadalafil is not prescribed concurrently with nitrates (e.g., Nitrodur, Nitrobid, Nitrostat, Isordil, Ismo). 6. Tadalafil is not prescribed concurrently with guanylate cyclase stimulators (e.g., riociguat/Adempas). 7. Dose does not exceed both: (a) 5 mg per day AND (b) 1 tablet per day.

For Illinois HIM requests, the step therapy requirements do not apply for formulary agents as of 1/1/2026 per IL HB 5395.

Initial Therapy - ED (Commercial only)

Covered for Commercial LOB when ALL of the following are met:

ED Initial Approval (Commercial): 1. Diagnosis of erectile dysfunction (ED). 2. Age ≥ 21 years. 3. Failure of generic sildenafil (Viagra; sildenafil 25 mg, 50 mg, or 100 mg), unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for brand Cialis or Chewtadzy, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced. 5. Tadalafil is not prescribed concurrently with nitrates (e.g., Nitrodur, Nitrobid, Nitrostat, Isordil, Ismo). 6. Tadalafil is not prescribed concurrently with guanylate cyclase stimulators (e.g., riociguat/Adempas). 7. Dose does not exceed both: (a) 20 mg per day AND (b) health plan‑approved quantity limit.

Cialis and Chewtadzy are not covered for ED for HIM and Medicaid.

Continuation Therapy - BPH

Renewal/Continuation covered when ALL of the following are met:

BPH Continuation: 1. Member is currently receiving medication via the 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. 2. Member is responding positively to therapy. 3. If request is for brand Cialis or Chewtadzy, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for a dose increase, new dose does not exceed both: (a) 5 mg per day AND (b) 1 tablet per day.

Continuation Therapy - ED (Commercial only)

Renewal/Continuation covered when ALL of the following are met (Commercial only):

ED Continuation (Commercial): 1. Member is currently receiving medication via the 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. 2. Member is responding positively to therapy. 3. If request is for brand Cialis or Chewtadzy, member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for a dose increase, new dose does not exceed both: (a) 20 mg per day AND (b) health plan‑approved quantity limit.

Cialis is not covered for ED for HIM and Medicaid.

Other/Off-label Indications

For other uses:

Other Indications: 1. If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the referenced formulary/no‑coverage or non‑formulary policies for the relevant line of business (see listed policy numbers). 2. If the requested use (diagnosis, age, dosing regimen) is not specifically 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.

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53.

Indication-specific dosing and safety criteria

Coverage aligns with indication-specific dosing and safety contraindications.

BPH dosing: Member has BPH and the requested tadalafil dosing is 2.5–5 mg PO once daily with maximum 5 mg/day.dose within 2.5-5 mg QD

See product-specific Chewtadzy dosing for BPH (5 mg QD).

ED dosing: Member has ED and the requested tadalafil dosing is either as‑needed 10–20 mg prior to sexual activity (not to exceed 1 dose/24 hours) OR 2.5 mg once daily for daily use. For once‑daily ED use the maximum is 5 mg/day.as-needed max 20 mg per dose and daily use max 5 mg/day

If member has both ED and BPH, daily dose limit is 5 mg/day for combined use.

Contraindications: Tadalafil must not be used with nitric oxide donors (organic nitrates/nitrites) or guanylate cyclase stimulators (e.g., riociguat) and should not be used with other PDE‑5 inhibitors; history of serious hypersensitivity to tadalafil is a contraindication.

Non-FDA approved indications are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies. Refer to CP.CPA.09 for Commercial, HIM.PHAR.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid when requesting coverage for indications not approved by the FDA.

Tadalafil must not be used in patients receiving nitric oxide donors (organic nitrates or nitrites) or guanylate cyclase stimulators (for example, riociguat), as combining these agents can produce significant hypotension. The policy also specifies that tadalafil is not to be prescribed concurrently with nitrates or with GC stimulators. Additionally, tadalafil (Cialis, Chewtadzy) should not be used in conjunction with other PDE‑5 inhibitors such as sildenafil.

Cialis and Chewtadzy are not covered for the diagnosis of erectile dysfunction under the HIM and Medicaid lines of business. For Medicaid and HIM, the policy lists ED coverage as Not covered; commercial coverage is available only when commercial criteria are met.

Requests that would result in use despite the listed contraindications — including concurrent use with nitrates or guanylate cyclase stimulators (e.g., riociguat), or a history of a serious hypersensitivity reaction to tadalafil — are contraindicated and would be considered for denial. Providers should not request tadalafil when these contraindications are present.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet the listed Initial Approval criteria for the applicable indication (BPH or ED) including diagnosis, age thresholds, step therapy failures (where applicable), dosing limits, and contraindication checks. Prior authorization decisions follow the policy criteria and approval durations specified by the plan.

Prior authorization required for both initial and reauthorization requests per plan policies.
Commercial ED: PA required; Cialis/Chewtadzy not covered for ED for HIM and Medicaid.
Illinois HIM: step therapy bypasses and exceptions per IL HB 5395 (effective 1/1/2026 and updates in 2025/2026 may apply).

Prior Authorization

Prior Authorization — Plan-Specific Requirements & History

Prior authorization requirements have changed historically and may vary by line of business. Examples: generic tadalafil requirement was added for initial and reauthorization requests (2022); Commercial ED approval duration revised to 12 months or duration of request; IL-specific step therapy bypasses were added per IL HB 5395 (2024–2025 updates). Check the plan-specific PA rules and any formulary edits (e.g., generic tadalafil, generic sildenafil requirements) when submitting requests.

2022: requirement to try generic tadalafil added for initial and reauthorization requests.
2023: clarified HIM PA requirement for generic sildenafil (Viagra) for ED.
2024–2025: IL-specific step therapy bypass added per IL HB 5395.

Documentation Required

Clinical documentation must be submitted to support that the member meets all approval criteria. Failure to provide adequate documentation may result in denial or delay of the request.

Acceptable documentation: office/chart notes, medication history, prior authorization history for attempted agents, lab results (if relevant), and any documentation of contraindications or adverse reactions.
Document the indication (BPH or ED), dates of therapy trials, doses tried, reasons for discontinuation (adverse effects or contraindications), and current dosing regimen requested.
For ED Commercial requests, document trials of generic sildenafil (25, 50, 100 mg) unless contraindicated; for brand Cialis/Chewtadzy requests, document trial of generic tadalafil unless contraindicated.

Documentation Required

Required Clinical Documentation

Providers must submit specific clinical details when requesting tadalafil for BPH or ED. Requests lacking these required clinical data elements may be denied.

For BPH: diagnosis of BPH, age ≥ 18, documentation of failure of both an alpha blocker and a 5‑alpha reductase inhibitor at maximally indicated doses unless contraindicated or not tolerated; requested dose (2.5–5 mg QD) and rationale if outside limits.
For ED (Commercial only): diagnosis of ED, age ≥ 21, documentation of trial and failure of generic sildenafil (unless contraindicated), documentation of trial of generic tadalafil for brand requests (unless contraindicated), requested dosing regimen and confirmation dose limits (as‑needed 10–20 mg, or daily 2.5–5 mg).
Include dates and dosing for prior therapies, clinical rationale for exceptions, and any relevant adverse effect or allergy documentation.

Step Therapy

Step Therapy Requirements

Step therapy requirements apply and must be documented. Exceptions and bypasses (such as IL HIM exceptions per statute) are recognized when supported by documentation.

BPH step therapy: documented failure of both an alpha blocker (e.g., alfuzosin, doxazosin, prazosin, tamsulosin, terazosin) and a 5‑alpha reductase inhibitor (finasteride or dutasteride) at maximally indicated doses, unless contraindicated or not tolerated.
ED (Commercial): failure of generic sildenafil (25, 50, 100 mg) required prior to tadalafil, unless contraindicated or clinically significant adverse effects.
Policy history: generic tadalafil requirement added in 2022 for initial and reauthorization; IL HB 5395 provides step therapy bypasses for certain HIM requests effective per state guidance (document applicability).

Denial Risk

Contraindications Trigger Denial

Contraindications must be checked and documented; presence of listed contraindications will trigger denial.

Concurrent use of organic nitrates or nitric oxide donors (any form) is contraindicated — tadalafil potentiates hypotensive effects of nitrates.
Concurrent administration with guanylate cyclase stimulators (e.g., riociguat/Adempas) is contraindicated.
History of a serious hypersensitivity reaction to tadalafil is a contraindication.
If a contraindication exists, provide documentation; requests for members with contraindications will be denied.

OpenPayer

Tadalafil (Cialis, Chewtadzy) for BPH and ED

Coverage Criteria

Coding and Dose Limits

Provider Actions & Requirements

Background

Definitions