CurrentmhnPolicy CP.PMN.132

CIALIS (PDF)

Clinical policy defining medical necessity criteria, prior authorization requirements, dosing limits, covered indications (BPH and ED), line-of-business differences (Commercial, HIM, Medicaid), contraindications, and approval durations for tadalafil products including brand Cialis and Chewtadzy.

Policy Summary

Payermhn

PolicyCIALIS (PDF)

Policy CodePolicy CP.PMN.132

Change TypeMultiple updates (additions and revisions)

Effective DateJun 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria when requesting tadalafil.

SourceLink

POLICY UPDATE CHANGES

Added Chewtadzy to policy.

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

Added requirement for generic tadalafil use for both initial and reauthorization requests.

Revised ED age limit to 21 years for alignment with Commercial age edit.

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

2FDA‑approved indications covered

2Formulations listed

CP.PMN.132Policy ref

This clinical policy covers tadalafil products (brand Cialis and Chewtadzy, and generic tadalafil) for the FDA‑approved indications of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). The policy defines medical necessity criteria, prior authorization requirements, dosing and quantity limits, contraindications, and approval durations for these products. Line‑of‑business specific rules apply: Commercial, Health Insurance Marketplace (HIM), and Medicaid each have distinct coverage rules (for example, Cialis and Chewtadzy are not covered for ED for HIM and Medicaid and certain HIM strengths are non‑formulary).

The policy requires adherence to formulary/non‑formulary and off‑label use policies for any uses not specified within the document. It also specifies brand versus generic requirements: if the request is for brand Cialis or Chewtadzy, the member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced. Dosing limits and contraindication checks (e.g., concurrent nitrates or guanylate cyclase stimulators) are enforced per indication.

Quick facts & key thresholds

Policy numberCP.PMN.132

StatusCURRENT

Effective date06.01.18

Last review date08.25

BPH - minimum age>= 18 years

ED (Commercial) - minimum age>= 21 years

BPH - maximum daily dose<= 5 mg/day

BPH - max tablets per day<= 1 tablet/day

ED (as-needed) - max dose per administration<= 20 mg per dose; not to exceed 1 dose/24 hours

Initial Therapy Criteria

Initial Approval Criteria - Benign Prostatic Hyperplasia (BPH)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of BPH
Age ≥ 18 years>= 18 years
Failure of both
- Failure of one alpha blocker (e.g., alfuzosin, doxazosin, prazosin, tamsulosin or terazosin) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects experienced
- Failure of one 5-alpha reductase inhibitor (finasteride or dutasteride) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects experienced
If request is for brand Cialis or Chewtadzy, member must use generic tadalafil, unless contraindicated or clinically significant adverse effects are experienced
Tadalafil is not prescribed concurrently with nitrates (e.g., Nitrodur, Nitrobid, Nitrostat, Isordil, Ismo)
Tadalafil is not prescribed concurrently with guanylate cyclase stimulators (e.g., riociguat/Adempas)
Dose limits (both required)
- Dose does not exceed 5 mg per day<= 5 mg/day
- Dose does not exceed 1 tablet per day<= 1 tablet/day

Initial Approval Criteria - Erectile Dysfunction (ED) (Commercial only)

Covered for Commercial line of business when ALL of the following are met:

ALL of the following

Diagnosis of ED
Age ≥ 21 years>= 21 years
Failure of generic sildenafil (Viagra 25 mg, 50 mg, 100 mg), unless contraindicated or clinically significant adverse effects are experienced
If request is for brand Cialis or Chewtadzy, member must use generic tadalafil, unless contraindicated or clinically significant adverse effects are experienced
Tadalafil is not prescribed concurrently with nitrates (e.g., Nitrodur, Nitrobid, Nitrostat, Isordil, Ismo)

Initial Approval Criteria - Other diagnoses/indications

If requested use is not covered above:

ANY of the following

If drug recently (within last 6 months) underwent label change not yet in policy, follow formulary/no-coverage or non-formulary policies depending on status (references: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is not listed in section III and above does not apply, refer to off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Continuation / Reauthorization Criteria

Reauthorization / Continued Therapy - Benign Prostatic Hyperplasia (BPH)

Covered when ALL of the following are met:

ALL of the following

Member status
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for brand Cialis or Chewtadzy, member must use generic tadalafil, unless contraindicated or clinically significant adverse effects are experienced
Dose increase limits (both required)
- New dose does not exceed 5 mg per day<= 5 mg/day
- New dose does not exceed 1 tablet per day<= 1 tablet/day

Reauthorization / Continued Therapy - Erectile Dysfunction (Commercial only)

Covered for Commercial line of business when ALL of the following are met:

ALL of the following

Member status
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for brand Cialis or Chewtadzy, member must use generic tadalafil, unless contraindicated or clinically significant adverse effects are experienced
Dose increase limits (both required)

Provider Actions / Prior Authorization

Documentation Required

Documentation required for PA

Providers must submit documentation such as office chart notes, lab results, or other clinical information demonstrating that the member meets all approval criteria when requesting tadalafil (Cialis, Chewtadzy, or generic tadalafil).

Prior Authorization

Line-of-business restrictions

Cialis and Chewtadzy are not covered for erectile dysfunction for HIM and Medicaid. For HIM, generic sildenafil prior authorization is required per policy language. Coverage and formulary status differ by line of business; verify HIM/Medicaid noncoverage for brand products and follow formulary/PA processes for generics.

Billing Rule

Dose and quantity limits enforced

Dose and quantity limits per indication are enforced. For BPH, dose must not exceed 5 mg per day and no more than 1 tablet per day. For ED (as-needed), dose must not exceed 20 mg per day per dose and must comply with the health plan‑approved quantity limit.

Step Therapy

Step therapy for BPH

Step therapy is required for BPH: member must fail one alpha blocker (e.g., alfuzosin, doxazosin, prazosin, tamsulosin, terazosin) and one 5‑alpha reductase inhibitor (finasteride or dutasteride) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects occur. Note: For Illinois HIM requests, the step therapy requirements do not apply for formulary agents effective 1/1/2026 per IL HB 5395.

Denial Risk

Contraindication checks

Requests should be denied if tadalafil is prescribed concurrently with nitrates (organic nitrates/NO donors) or with guanylate cyclase stimulators (e.g., riociguat/Adempas), or if the patient has a history of known serious hypersensitivity to tadalafil.

Background

Background: Tadalafil is a phosphodiesterase‑5 (PDE‑5) inhibitor indicated for ED, BPH, and ED with BPH. This policy applies to Cialis, Chewtadzy, and generic tadalafil, and includes line‑of‑business specific coverage rules and dose limits. Providers requesting authorization must follow applicable formulary/non‑formulary and off‑label use policies when the requested use is not specified in this policy. The policy also details dosing regimens and maximums (e.g., BPH ≤ 5 mg/day; ED as‑needed up to 20 mg per dose not to exceed one dose per 24 hours) and identifies contraindications such as concurrent use of nitrates or guanylate cyclase stimulators.

Definitions

BPHbenign prostatic hyperplasia

EDerectile dysfunction

HIMHealth Insurance Marketplace

Revision History

08.24added

RT4: Chewtadzy added to policy (P&T Approval Date = 08.24).

3Q 2025 (P&T 08.25)addedLatest

3Q 2025 annual review: step therapy bypass for Illinois HIM added per IL HB 5395; also added reference that criteria apply for generic requests.

3Q 2023 (P&T 08.23)revised

3Q 2023 annual review: revised Erectile Dysfunction (ED) age limit to 21 years to align with Commercial age edit.

3Q 2022 (P&T 08.22)revised

3Q 2022 annual review: requirement added that brand requests must try generic tadalafil for initial and reauthorization requests (member must use generic tadalafil unless contraindicated).

3Q 2022 (P&T 08.22)note

3Q 2022 annual review: non-material note that Commercial approval duration revised from length of benefit to 12 months or duration of request, whichever is less.

Policy Summary

Payermhn

PolicyCIALIS (PDF)

Policy CodePolicy CP.PMN.132

Change TypeMultiple updates (additions and revisions)

Effective DateJun 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria when requesting tadalafil.

SourceLink

On This Page

Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg	Tadalafil (Cialis) strengths
Chewable tablets: 5 mg, 10 mg, 20 mg	Chewtadzy strengths

OpenPayer

CIALIS (PDF)

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Unproven / Not Authorized Indications

Provider Actions / Prior Authorization

Applicable Codes / Formulations

Clinical Evidence & References

Background

Revision History