CurrentMass General Brigham Health PlanPolicy N/A

Tadalafil (Adcirca, Alyq, generic) — Pharmacy Prior Authorization for Pulmonary Arterial Hypertension and Secondary Raynaud's Phenomenon

Pharmacy benefit prior authorization policy for tadalafil products used to treat pulmonary arterial hypertension (WHO Group 1) and for compendial use in secondary Raynaud's phenomenon; applies to Commercial/Exchange members and specialty pharmacy dispensing.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTadalafil (Adcirca, Alyq, generic) — PAH & secondary Raynaud's prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date04/01/2023

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming WHO Group 1 PAH with supporting hemodynamic data or evidence of inadequate response for secondary Raynaud's.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

WHO Group 1PAH classification required

mPAP>20; PCWP≤15; PVR≥3Hemodynamic criteria

up to 12 moApproval length

60 tabs/moQuantity limit

Coverage Criteria for Tadalafil

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Pulmonary Arterial Hypertension (PAH)

Covered when ALL of the following are met

PAH treatment criteria: 1. Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix).

Hemodynamic confirmation: 2. PAH was confirmed by ONE of the following:see hemodynamic thresholds

Confirmation options

Right heart catheterization: Pretreatment right heart catheterization with ALL of the following results: i. mPAP > 20 mmHg; ii. PCWP ≤ 15 mmHg; iii. PVR ≥ 3 Wood units.mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units
Infant alternative: For infants <1 year of age, confirmation by Doppler echocardiogram when right heart catheterization cannot be performed.

Secondary Raynaud's Phenomenon

Covered when ALL of the following are met

Secondary Raynaud's: Member has secondary Raynaud's phenomenon and has had an inadequate response to ONE of the following: 1) Calcium channel blockers; 2) Angiotensin II receptor blockers; 3) Selective serotonin reuptake inhibitors; 4) Alpha blockers; 5) Topical nitrates.

Compendial use

Continuation of Therapy

Reauthorization: Physician documentation of benefit from therapy as evidenced by disease stability or disease improvement is required for reauthorization.

Reauthorization interval up to 12 months

This policy applies to tadalafil products (Adcirca, Alyq, and generic tadalafil tablets) under the pharmacy benefit for Commercial/Exchange members and is managed through the plan’s prior authorization process. Specialty designation applies — tadalafil must be dispensed through a contracted specialty pharmacy when required by the plan. Tadalafil prescribed for benign prostatic hyperplasia (BPH) is managed under a separate policy and is not covered by this PAH/Raynaud’s policy.

Authorization requests for members who are new to the plan will be considered when the medication is not obtained solely as samples or through a manufacturer's patient assistance program; products available only through those channels are excluded from authorization as a new-to-plan treatment. Providers should submit documentation consistent with the policy requirements (see clinical documentation and hemodynamic confirmation thresholds) as part of the prior authorization request.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization and specialty dispensing required

Prior authorization is required for tadalafil products under the pharmacy benefit for Commercial/Exchange members. The medication has been designated specialty and must be filled at a contracted specialty pharmacy.

Step Therapy

Step therapy — trial of one listed agent required

For secondary Raynaud's phenomenon, authorization requires documentation that the member had an inadequate response to ONE of the listed agents before tadalafil will be approved.

Calcium channel blockers
Angiotensin II receptor blockers
Selective serotonin reuptake inhibitors
Alpha blockers
Topical nitrates

Documentation Required

Required clinical documentation and hemodynamic values

Provide clinical documentation confirming WHO Group 1 pulmonary arterial hypertension and supporting hemodynamic data from a pretreatment right heart catheterization (mPAP, PCWP, PVR); for infants <1 year, provide Doppler echocardiogram if catheterization cannot be performed. For reauthorization, provide physician documentation of clinical benefit (disease stability or improvement).

Right heart catheterization results: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units
Or Doppler echocardiogram for infants <1 year when catheterization cannot be performed
For reauthorization: physician documentation of disease stability or improvement

Denial Risk

Denial triggers — non-covered sources and unmet criteria

Authorization may be denied when the member is not new to the plan and the product was obtained as samples or via the manufacturer's patient assistance programs, or when approval criteria are not met.

Background

Tadalafil (Adcirca, Alyq, and generic tadalafil) is indicated in this policy as therapy to improve exercise capacity in pulmonary arterial hypertension (WHO Group 1). Clinical trial populations supporting this indication primarily included patients with New York Heart Association (NYHA) Functional Class II–III symptoms and etiologies such as idiopathic/heritable PAH and connective tissue disease–associated PAH.

When used for PAH, disease confirmation requires hemodynamic evidence from pretreatment right heart catheterization showing all of the following: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; and pulmonary vascular resistance (PVR) ≥ 3 Wood units. For infants under 1 year in whom catheterization cannot be performed, confirmation by Doppler echocardiogram is acceptable. Secondary Raynaud's phenomenon is a recognized compendial use and may be authorized only after an inadequate response to one of the listed alternative agents.