CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tadalafil products for pulmonary arterial hypertension and secondary Raynaud's phenomenon — Coverage Criteria

Covers authorization criteria for tadalafil products when used to treat pulmonary arterial hypertension (WHO Group 1) and for compendial use in secondary Raynaud's phenomenon; applies to members receiving therapy under the payer's pharmacy or medical benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTadalafil products for pulmonary arterial hypertension and secondary Raynaud's phenomenon — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with right heart catheterization results confirming PAH hemodynamics (mPAP > 20 mmHg; PCWP < 15 mmHg; PVR ≥ 3 WU) for 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

WHO Group 1PAH classification eligible for coverage

mPAP > 20hemodynamic threshold for PAH confirmation

PCWP < 15pre-treatment wedge pressure requirement

Coverage Criteria for Tadalafil Products

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Initial therapy for PAH

Covered when ALL of the following are met

PAH indication and prescriber: Member has pulmonary arterial hypertension (WHO Group 1).

Supported by chunks 1 and 4

Hemodynamic confirmation: PAH confirmed by either: (i) mean pulmonary arterial pressure (mPAP) > 20 mmHg with pretreatment right heart catheterization showing pulmonary capillary wedge pressure (PCWP) < 15 mmHg and pulmonary vascular resistance (PVR) >= 3 Wood units in adults; or (ii) for infants <1 year, confirmation by Doppler echocardiogram if right heart catheterization cannot be performed; for pediatrics PVRI >= 3 Wood units·m2.mPAP > 20 mmHg; PCWP < 15 mmHg; PVR >= 3 WU (adults); PVRI >= 3 WU·m2 (pediatrics)

Exact hemodynamic values from chunk 4

Intent and expected benefit: Therapy is prescribed to improve exercise ability in PAH (consistent with populations studied, e.g., NYHA Functional Class II–III and idiopathic/heritable or connective tissue disease–associated PAH).

Supported by chunk 1

Compendial use — Secondary Raynaud's phenomenon

Covered when ALL of the following are met

Secondary Raynaud's step therapy: Member has secondary Raynaud's phenomenon and has had an inadequate response to at least one of the following alternatives: a calcium channel blocker, an angiotensin II receptor blocker, an alpha blocker, a selective serotonin reuptake inhibitor, or topical nitrates.

Step-therapy requirement from chunk 6

Continuation therapy

Continuation of therapy

Continuation criteria: Member is currently receiving a tadalafil product through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or disease improvement; authorization may be renewed for 12 months.

From chunks 7 and 4 (authorization duration)

All other indications not listed (outside FDA‑approved indications and the compendial use for secondary Raynaud's phenomenon) are considered experimental/investigational and not medically necessary.

Use for indications other than the listed FDA‑approved indications and the compendial use for secondary Raynaud's phenomenon is considered not medically necessary and will be denied.

Product and Clinical Threshold Codes / Values

Tadalafil products referencedmixed

Adcirca	tadalafil tablet (brand)
Alyq	tadalafil tablet (brand)
Tadliq	tadalafil oral suspension (brand)
tadalafil	tadalafil tablet (generic)

inv-07: Mean pulmonary arterial pressure — > 20 mmHg

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

ContextRequired as part of confirmatory hemodynamics for PAH diagnosis via right heart catheterization

Use in criteriaOne of the hemodynamic thresholds that must be met for authorization of tadalafil for PAH

inv-08: Pulmonary capillary wedge pressure — < 15 mmHg

Pulmonary capillary wedge pressure (PCWP)< 15 mmHg

Measurement methodDetermined on pretreatment right heart catheterization

Role in diagnosisPart of required hemodynamic profile to confirm WHO Group 1 PAH for coverage

inv-09: Pulmonary vascular resistance (adults) — >= 3 Wood units

Pulmonary vascular resistance (PVR) — adults>= 3 Wood units

ApplicationRequired elevated PVR on right heart catheterization to confirm PAH in adults

Authorization relevanceIncluded in hemodynamic criteria that must be met for 12‑month authorization

inv-10: Pulmonary vascular resistance index (pediatrics) — >= 3 Wood units·m2

Pulmonary vascular resistance index (PVRI) — pediatrics>= 3 Wood units·m2

Pediatric alternativeUsed as the indexed equivalent of PVR for pediatric patients when confirming PAH

Exception for infantsFor infants <1 year, Doppler echocardiogram may be acceptable if catheterization cannot be performed

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months.

Authorization duration: 12 months

Step Therapy

Step Therapy for Secondary Raynaud's Phenomenon

Step therapy applies for Secondary Raynaud's phenomenon. Authorization may be granted only after inadequate response to one of the listed alternative therapies.

Required trial: inadequate response to one of the following — calcium channel blockers, angiotensin II receptor blockers, alpha blockers, selective serotonin reuptake inhibitors, or topical nitrates

Documentation Required

Documentation of PAH Diagnosis with Confirmatory Hemodynamics

Documentation of PAH diagnosis must be provided with confirmatory hemodynamics. PAH (WHO Group 1) must be confirmed by either (i) or (ii) below.

Mean pulmonary arterial pressure (mPAP) > 20 mmHg
Pretreatment right heart catheterization demonstrating pulmonary capillary wedge pressure (PCWP) < 15 mmHg
Pulmonary vascular resistance (PVR) ≥ 3 Wood units in adults or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m2 in pediatric patients
For infants < 1 year of age, confirmation by Doppler echocardiogram is acceptable if right heart catheterization cannot be performed

Denial Risk

Use Outside Approved/Compendial Indications

Use for indications other than the listed FDA-approved or compendial indications (PAH WHO Group 1 and secondary Raynaud's phenomenon) is considered experimental/investigational and not medically necessary.

Definitions

inv-16: Pulmonary arterial hypertension (PAH) — WHO Group 1 definition and scope

WHO Group 1 definitionGroup 1 pulmonary hypertension including idiopathic, heritable, drug- and toxin-induced, and PAH associated with conditions such as connective tissue diseases; see WHO classification for subgroups

Scope of coveragePAH (WHO Group 1) is the indication eligible for tadalafil coverage to improve exercise capacity

Confirmation requiredDiagnosis must be confirmed by right heart catheterization hemodynamics (mPAP > 20 mmHg, PCWP < 15 mmHg, and elevated PVR/PVRI)

Included etiologiesIdiopathic, heritable, drug- and toxin-induced, and PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis, and other WHO Group 1 subtypes