CurrentCignaPolicy IP0101

Tadalafil (Cialis) for Individual and Family Plans

Defines medical necessity, reauthorization, quantity limits, and non-covered conditions for tadalafil (Cialis) for Individual and Family Plans administered by Cigna; includes criteria for erectile dysfunction, benign prostatic hyperplasia, Raynaud's phenomenon, prophylaxis after radical prostatectomy, and high-altitude pulmonary edema.

Policy Summary

PayerCigna

PolicyTadalafil (Cialis) for Individual and Family Plans

Policy CodePolicy IP0101

Change TypeAnnual Revision — no criteria changes

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain medical necessity review and document prior failures/contraindications and the chosen tadalafil dosage per policy requirements.

SourceLink

POLICY UPDATE CHANGES

Annual Revision dated 2/1/2025 with no criteria changes.

5Covered Indications (listed)

2Not eligible for continuation beyond 12 months

8Max tablets per 30 days (as-needed ED)

Coverage Summary

Scope: Defines medical necessity, reauthorization, quantity limits, and non-covered conditions for tadalafil (Cialis) for Individual and Family Plans administered by Cigna; includes criteria for erectile dysfunction, benign prostatic hyperplasia, Raynaud's phenomenon, prophylaxis after radical prostatectomy, and high-altitude pulmonary edema. Coverage Policy Number: IP0101 (effective 2/1/2025).

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Coverage stance: Covered with criteria — tadalafil (Cialis) is covered when the medical necessity criteria are met, subject to plan terms and medical necessity review. Benefit availability and any exclusions are determined by the applicable benefit plan document.

Covered indications count: 5 listed indications (erectile dysfunction, benign prostatic hyperplasia, Raynaud's phenomenon, prophylaxis after radical prostatectomy, and prevention/treatment of HAPE).

Quantity limits highlights: as-needed erectile dysfunction — ≤ 8 tablets per 30 days (tadalafil 5 mg, 10 mg, 20 mg); once-daily use for ED or BPH — ≤ 30 tablets per 30 days (tadalafil 2.5 mg or 5 mg). Note that quantity limits and step therapy may vary by individual benefit plan and plan documents govern final coverage terms.

Key Limits / Thresholds

Quantity limit - as-needed ED<= 8 tablets per 30 days (tadalafil 5 mg, 10 mg, or 20 mg)

Quantity limit - once-daily ED or BPH<= 30 tablets per 30 days (tadalafil 2.5 mg or 5 mg)

Renal impairment dosing concern exampleCreatinine clearance 30-50 ml/min cited as example justification to use 2.5 mg once daily instead of 5 mg

Initial Therapy Criteria (Medical Necessity)

Medical Necessity Criteria

Tadalafil (Cialis) is considered medically necessary when the individual meets ONE of the following:

ANY of the following

Treatment of Erectile Dysfunction
- ED - benefit plan exclusion and quantity limits: Erectile dysfunction therapy may be excluded under many benefit plans; refer to applicable benefit plan document to determine benefit availability and terms (for example, quantity limitations).
- ED - as-needed quantity limit: Where covered, as-needed use: maximum quantity up to 8 tablets per 30 days for tadalafil 5 mg, 10 mg, or 20 mg.<= 8 tablets per 30 days (5, 10, or 20 mg)
- ED - once-daily quantity limit: Where covered, once-daily use: maximum quantity of 30 tablets per 30 days for tadalafil 2.5 mg or 5 mg.<= 30 tablets per 30 days (2.5 or 5 mg)
Treatment of Benign Prostatic Hyperplasia (BPH)
- BPH - dosage documentation
  - BPH dosage 5 mg: Dosage of tadalafil used will be 5 mg once daily
  - BPH dosage 2.5 mg: Dosage of tadalafil used will be 2.5 mg once daily if significant clinical concern prevents use of 5 mg daily (e.g., creatinine clearance 30-50 ml/min or concomitant potent CYP3A4 inhibitors such as ketoconazole or ritonavir)
- BPH - prior therapy
  - Alpha1-blocker
  - 5-alpha-reductase inhibitor: 5 alpha-reductase inhibitor
Treatment of Raynaud's Phenomenon
- Raynaud's - prior therapy: Documentation of failure, contraindication, or intolerance to ONE calcium channel blocker
- Raynaud's - non-covered product criteria: Non-Covered Product Criteria is met (see Non-Covered Products table)
Prophylaxis after Radical Prostatectomy (Early Penile Rehabilitation)
- Post-prostatectomy - timing: Documentation of radical prostatectomy within the previous 12 months
- Post-prostatectomy - specialist involvement: Medication is prescribed by, or in consultation with, a urologist
- Post-prostatectomy - non-covered product criteria: Non-Covered Product Criteria is met (see Non-Covered Products table)
Prevention or Treatment of High-Altitude Pulmonary Edema (HAPE)
- HAPE - diagnosis or history: Documentation of diagnosis of HAPE or history of HAPE
- HAPE - prior therapy: Documented failure, contraindication, or intolerance to ONE other pharmacologic therapy for treatment or prevention of HAPE
- HAPE - non-covered product criteria: Non-Covered Product Criteria is met (see Non-Covered Products table)

Erectile dysfunction plan-specific note: Erectile dysfunction therapy is specifically excluded under many benefit plans; refer to the applicable benefit plan document to determine benefit availability and terms (for example, quantity limitations).

When covered, quantity limits differ by dosing strategy: for as-needed use of tadalafil 5 mg, 10 mg, or 20 mg the maximum is 8 tablets per 30 days; for once-daily use of tadalafil 2.5 mg or 5 mg the maximum is 30 tablets per 30 days.

Benefit plan documents determine benefit availability and may require step therapy or medical necessity review; in the event of conflict the customer’s benefit plan document supersedes the Coverage Policy.

Continuation / Reauthorization Criteria

Reauthorization Criteria

Continuation is medically necessary when original criteria are met AND there is documentation of beneficial response.

Reauthorization

Original criteria: Original medical necessity criteria continue to be met
Beneficial response: Documentation of beneficial response to tadalafil

Non-Covered Products & Product Criteria

Non-Covered Product Criteria definition: Coverage of brand Cialis requires a trial of the bioequivalent generic tadalafil and documentation that the individual cannot take the generic because of a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction.

This Non-Covered Product Criteria is applied as specified in the Individual and Family Plan Non-Covered Products table and referenced in the medical necessity criteria for applicable indications.

Provider Actions & Prior Authorization

Prior Authorization

Medical necessity review required

Coverage requires medical necessity review; for plans that exclude sexual dysfunction, additional medical necessity review may be required and step therapy may apply per benefit plan document.

Sexual dysfunction exclusions and step therapy may apply per the applicable benefit plan document.

Documentation Required

Document prior therapy failures or contraindications

Providers must document prior failure, contraindication, or intolerance to required comparator therapies.

For BPH: alpha1-blocker and 5-alpha-reductase inhibitor
For Raynaud's phenomenon: one calcium channel blocker
For HAPE: one alternative pharmacologic therapy for treatment or prevention

Documentation Required

Dosage documentation for BPH

Providers must document chosen tadalafil dosage (5 mg once daily or 2.5 mg once daily with clinical justification).

5 mg once daily
2.5 mg once daily — justify for clinical concerns such as creatinine clearance 30-50 ml/min or concomitant potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)

Prior Authorization

Specialist involvement for post-prostatectomy prophylaxis

Medication for prophylaxis after radical prostatectomy must be prescribed by or in consultation with a urologist.

Billing Rule

Sample products do not satisfy criteria

Receipt of sample product does not satisfy any criteria requirements for coverage.

Applicable Codes & Identifiers

Policy identifiers / metadatamixed

IP0101

Coverage Policy Number (Cigna)

Clinical Evidence & Guideline References

Background evidence summary: Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor with labeled indications including erectile dysfunction and benign prostatic hyperplasia. Adcirca (tadalafil) for pulmonary arterial hypertension is addressed in a separate coverage policy. Quantity limits and step therapy requirements vary by benefit plan and coverage may be restricted or excluded for sexual dysfunction under some plans.

Selected Guideline References

Wilderness Medical Society 2019 (HAPE)Guidelines recommend nifedipine as the preferred pharmacologic option for prevention/treatment of high-altitude pulmonary edema

EULAR 2023 (Raynaud's phenomenon)Recommends dihydropyridine calcium channel blockers (eg, oral nifedipine) as first-line; PDE5 inhibitors should be considered in specific scenarios

Background

Background: Tadalafil is a PDE5 inhibitor indicated for erectile dysfunction and benign prostatic hyperplasia and has been studied for other uses including high-altitude pulmonary edema, prophylaxis after radical prostatectomy, Raynaud's phenomenon, and pulmonary arterial hypertension. Adcirca (tadalafil) for pulmonary arterial hypertension is addressed separately in a distinct coverage policy, and plan-level quantity limits and step therapy vary by benefit plan.

Revision History

2025-02-01Annual RevisionLatest