CurrentNeighborhood Health Plan of Rhode IslandPolicy 865-C

Cialis (tadalafil) 2.5 mg, 5 mg — daily for symptomatic BPH / ED (prior authorization with quantity limits)

Defines prior authorization and quantity limits for daily-use low-dose Cialis (tadalafil 2.5 mg and 5 mg) for symptomatic benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) for members of Neighborhood Health Plan of Rhode Island under CVS Caremark management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCialis (tadalafil) 2.5 mg, 5 mg — daily for symptomatic BPH / ED

Policy CodePolicy 865-C

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document indication (BPH, ED, or ED+BPH) and symptomatic BPH signs/symptoms; quantity limits and a 36-month duration of approval apply.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2formulations covered

3030-day limit

9090-day limit

36duration (months)

Coverage Criteria for Daily-Use Tadalafil

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Coverage criteria for daily-use tadalafil

Covered when ALL of the following are met:

Indication and dosing: Requested drug is prescribed for daily use for symptomatic benign prostatic hyperplasia (BPH).

Examples of signs and symptoms of BPH include incomplete emptying, weak stream, straining, urinary frequency, intermittency, or urgency.

Therapy status: Request may be for initial therapy or continuation of therapy; for continuation requests the patient must have achieved or maintained a positive clinical response.

Document distinguishes initial versus continuation pathways; continuation requires evidence of positive clinical response.

When tadalafil (Cialis) is prescribed in combination with finasteride to initiate treatment for benign prostatic hyperplasia (BPH), combination therapy should be limited to a maximum of 26 weeks. This limitation reflects evidence that the incremental benefit of tadalafil decreases through 26 weeks and is unknown beyond 26 weeks, so continuation of combination therapy past 26 weeks is not routinely supported.

Product Strengths and Quantity Limits

Covered product strengthsmixedCovered

CIALIS 2.5 mg	tadalafil 2.5 mg daily formulation
CIALIS 5 mg	tadalafil 5 mg daily formulation

Quantity limits — tadalafil daily formulations

Quantity limit (30-day supply)30 tablets per 25 days

Quantity limit (90-day supply)90 tablets per 75 days

Purpose of extended days25 days used for a 30-day fill period and 75 days used for a 90-day fill period to allow time for refill processing

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for daily-use Cialis 2.5 mg and 5 mg when prescribed for the treatment of symptomatic benign prostatic hyperplasia (BPH). Quantity limits apply: 30 tablets per 25 days (30-day fill) or 90 tablets per 75 days (90-day fill).

Prior authorization required for daily-use Cialis 2.5 mg and 5 mg for symptomatic BPH
Quantity limits: 30 tablets per 25 days or 90 tablets per 75 days

Documentation Required

Indication and Symptom Documentation Required

Prescriber must document the indication for use (BPH, ED, or combined ED+BPH) and provide documentation of symptomatic BPH signs or symptoms when the request is for BPH (examples include incomplete emptying, weak stream, straining, urinary frequency, intermittency, or urgency).

Document the prescribing indication: BPH, ED, or ED+BPH
Provide evidence of symptomatic BPH signs/symptoms when applicable

Note

Combination Use with Finasteride — Time Limitation

When initiating BPH treatment in combination with finasteride, combination use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases through 26 weeks and benefit beyond 26 weeks is unknown.

Limit combination tadalafil + finasteride therapy to a maximum of 26 weeks when used to initiate BPH treatment

Denial Risk

Denial Risk for Non‑Daily Use or Non‑BPH Indication

Requests will be denied if the drug is not prescribed for daily use for symptomatic BPH or if the request does not meet the listed coverage criteria (including lack of documented indication or symptomatic BPH).

Denial risk if not prescribed for daily use for symptomatic BPH
Denial risk if required documentation of indication or BPH symptoms is not provided

Background

Cialis (tadalafil) is indicated for the treatment of erectile dysfunction (ED) and for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It may be used in patients who have both ED and BPH, and documentation of symptomatic BPH (for example: incomplete emptying, weak stream, straining, urinary frequency, intermittency, or urgency) is required to support prior authorization when prescribed for BPH.

Definitions

Symptomatic BPH — definition and relevance

DefinitionPresence of lower urinary tract symptoms attributable to benign prostatic hyperplasia such as incomplete emptying, weak stream, straining, urinary frequency, intermittency, or urgency.

Context of useRequested drug must be prescribed for daily use for symptomatic BPH to meet coverage criteria.

Related indicationsCialis is indicated for treatment of erectile dysfunction (ED) and for the signs and symptoms of BPH; may be used for patients with both ED and BPH.