CurrentCignaPolicy IP0097

Tadalafil (Cialis) Coverage Policy

Defines medical necessity, quantity limits, authorization durations, and covered indications for tadalafil (Cialis) across Cigna-administered plans; applies to providers requesting coverage decisions. Coverage may vary by specific benefit plan.

Policy Summary

PayerCigna

PolicyTadalafil (Cialis) Coverage Policy

Policy CodePolicy IP0097

Change TypeNo material change

Effective DateFeb 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain and document required clinical information including dosage and prior trial/failure/contraindication/intolerance to required alternate therapies per indication when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial approval duration

30/30QD ED/BPH limit

8/30As-needed ED limit

5Covered indications

Coverage Criteria for Tadalafil (Cialis)

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Overall: Select one indication below to meet medical necessity

Erectile Dysfunction (ED): ED therapy: covered only where the member's benefit plan includes coverage for sexual dysfunction. Where covered, quantity limits apply: as-needed up to 8 tablets/30 days (5,10,20 mg) or once-daily up to 30 tablets/30 days (2.5 or 5 mg).

Refer to the applicable benefit plan document to determine benefit availability and terms and conditions of coverage; many plans exclude ED therapy.

Benign Prostatic Hyperplasia (BPH): Individual must meet ALL: A) Documentation of ONE of: i) dosage of tadalafil 5 mg once daily OR ii) dosage of tadalafil 2.5 mg once daily when significant clinical concern prevents use of 5 mg (for example, creatinine clearance 30-50 mL/min or concomitant potent CYP3A4 inhibitors such as ketoconazole or ritonavir); AND B) Documentation of failure, contraindication, or intolerance to ONE of: i) an alpha1-blocker, ii) a 5-alpha-reductase inhibitor, or iii) a combination 5-alpha-reductase inhibitor/alpha1-blocker.

Quantity limit when covered: up to 30 tablets/30 days (2.5 or 5 mg).

Raynaud's Phenomenon: Documentation of failure, contraindication, or intolerance to ONE calcium channel blocker.

Covered when above is met.

Prophylaxis after Radical Prostatectomy (Early Penile Rehabilitation): Individual must meet ALL: A) documentation of radical prostatectomy within the previous 12 months; AND B) medication prescribed by, or in consultation with, a urologist.

Intended as early penile rehabilitation; continuation beyond the initial 12 months is not applicable per criteria.

Prevention or Treatment of High-Altitude Pulmonary Edema (HAPE): Individual must meet ALL: A) documented diagnosis of HAPE or history of HAPE; AND B) documentation of failure, contraindication, or intolerance to ONE other pharmacologic therapy for the treatment or prevention of HAPE.

Continuation beyond the initial 12 months is not applicable per criteria.

Erectile dysfunction therapy is specifically excluded under many benefit plans (both Employer Groups and Individual and Family Plans); providers must refer to the member's applicable benefit plan document to confirm whether ED treatment is a covered benefit and to determine any plan-specific terms such as quantity limits. Other indications listed in this policy are subject to the clinical criteria and quantity limits specified for each indication.

Dosage Strengths and Quantity Limits

Covered dosage strengths referencedmixed

2.5 mg	Tadalafil tablet strength (dosage form referenced for QD use)
5 mg	Tadalafil tablet strength (dosage form referenced for QD and as-needed use)
10 mg	Tadalafil tablet strength (as-needed ED)
20 mg	Tadalafil tablet strength (as-needed ED; Adcirca marketed as 20 mg for PAH)

Quantity limits — per 30 days

As‑needed erectile dysfunction (5, 10, 20 mg)Maximum 8 tablets per 30 days

Once‑daily erectile dysfunction (2.5 or 5 mg)Maximum 30 tablets per 30 days

Once‑daily benign prostatic hyperplasia (2.5 or 5 mg)Maximum 30 tablets per 30 days

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Plan-Specific Exclusions

Prior authorization or medical necessity review may be required and coverage varies by benefit plan. Erectile dysfunction (ED) uses of tadalafil are excluded under many employer and individual plans; confirm benefit availability and any quantity limits in the member's specific plan document. Step therapy requirements may apply for brand Cialis and plan-specific exclusions may limit coverage for sexual dysfunction indications.

Prior authorization may be required per the member's benefit plan.
ED indication is commonly excluded — verify plan coverage and deny/redirect claims as appropriate.
Step therapy: many plans require trial of the generic bioequivalent tadalafil before brand Cialis will be covered; coverage exceptions limited to documented formulation-related allergy or serious adverse reaction.

Step Therapy

Step Therapy / Product Trial Requirements

Some plans require trial of alternative products before covering brand Cialis. Be prepared to document prior trials, failures, contraindications, or intolerances to meet step-therapy or plan trial requirements.

Employer group non-covered criteria: trial of generic tadalafil required unless the member cannot take the generic due to an inactive-ingredient-related allergy or serious adverse reaction.
If plan uses step therapy, document dates and outcomes of prior medication trials.
Quantity limits (e.g., maximum 30 tablets per 30 days for once-daily BPH dosing) may apply per plan benefits.

Documentation Required

Required Clinical Documentation

Provide clear clinical documentation to support medical necessity for the requested indication and to satisfy plan and PA requirements.

Diagnosis and indication being treated (e.g., BPH, Raynaud's phenomenon, HAPE, post-radical prostatectomy prophylaxis).
Recommended dose, frequency, and duration (for BPH, document intent to use 5 mg once daily or 2.5 mg once daily with clinical rationale).
Documentation of prior trial and failure, contraindication, or intolerance to required alternatives per indication (e.g., alpha1-blocker, 5-alpha-reductase inhibitor, calcium channel blocker, other pharmacologic therapy for HAPE).
If claiming an exception to generic trial, documentation that the member cannot take the generic due to a formulation-related allergy or serious adverse reaction.
For post-prostatectomy prophylaxis: documentation of radical prostatectomy within the previous 12 months and that the medication is prescribed by or in consultation with a urologist.
Any relevant lab values or clinical notes (for example, creatinine clearance if using 2.5 mg daily instead of 5 mg due to renal impairment).
Note that receipt of sample product does not satisfy prior trial or criteria requirements.

Denial Risk

Other Uses Considered Experimental/Investigational

Use for any indication not specifically listed in the coverage criteria is considered experimental, investigational, or unproven and may be denied.

Any other use beyond listed indications (ED, BPH, Raynaud's phenomenon, HAPE, post-radical prostatectomy prophylaxis) is considered experimental/investigational.
Criteria will be updated as new published data become available — deny when no established clinical criteria exist for the requested use.

Background and Clinical Context

Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor with approved indications that include erectile dysfunction and benign prostatic hyperplasia (BPH). It has also been studied for other conditions such as Raynaud’s phenomenon, prophylaxis after radical prostatectomy (early penile rehabilitation), high-altitude pulmonary edema (HAPE), and pulmonary arterial hypertension (marketed as Adcirca). Guideline-preferred first-line therapies exist for some of these other conditions (for example, calcium channel blockers for Raynaud’s and nifedipine for HAPE), and those alternatives should be considered per the indication-specific criteria in this policy.

Definitions

Adcirca — brand formulation and relation to tadalafil/Cialis

Adcirca formulationAdcirca tablets contain the same active ingredient (tadalafil) as Cialis but are marketed separately for pulmonary arterial hypertension; Adcirca is available as a 20 mg tablet.

Cialis / generic strengthsTadalafil (Cialis, generic) is available in 2.5 mg, 5 mg, 10 mg, and 20 mg tablets.

Indication distinctionAdcirca is indicated for pulmonary arterial hypertension, while Cialis (tadalafil) is indicated for erectile dysfunction and benign prostatic hyperplasia; the same active ingredient does not imply identical labeled indications.