CurrentMass General Brigham Health PlanPolicy N/A

Ambrisentan (generic) prior authorization for pulmonary arterial hypertension

Defines prior authorization requirements for ambrisentan (generic) under Mass General Brigham Health Plan's pharmacy benefit for commercial/exchange members, including specialty pharmacy dispensing and medical criteria for PAH (WHO Group 1).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAmbrisentan (generic) prior authorization for pulmonary arterial hypertension

Policy CodePolicy N/A

Change TypeRevised criteria and operational update

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and submit right heart catheterization results (or echocardiogram for infants) to document WHO Group 1 PAH.

SourceLink

POLICY UPDATE CHANGES

Switched from CVS Standard to custom criteria

12 monthsInitial and reauthorization approval duration

Commercial/ExchangePlan applicability

Prior AuthorizationProgram type

Specialty pharmacyDispensing requirement

Coverage Criteria for Ambrisentan

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Initial therapy for PAH (WHO Group 1)

Authorization may be granted when ALL of the following are met:

PAH diagnosis: Member has PAH defined as WHO Group 1 class of pulmonary hypertension (Refer to Appendix)

See Appendix WHO classification

Diagnostic confirmation

RHC criteria: Right heart catheterization with mPAP > 20 mmHg AND PCWP ≤ 15 mmHg AND PVR ≥ 3 Wood unitsmPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units
Infant alternative: For infants less than one year of age, PAH confirmed by Doppler echocardiogram if right heart catheterization cannot be performed

Continuation of therapy / Reauthorization

Authorization of 12 months may be granted for members with a covered indication who are currently receiving the requested medication and who are experiencing benefit from therapy as evidenced by:

Current therapy: Member is currently receiving the requested medication

Clinical benefit: Evidence of disease stability or disease improvement

Duration of authorization is 12 months

Authorization may not be granted for members new to the plan who are not currently receiving the requested medication unless they meet the documented medical criteria. Members transferring coverage who are already receiving the medication may be authorized provided their therapy is not exclusively from samples or manufacturer patient assistance programs.

Provider Requirements and Operational Notes

Prior Authorization

Prior authorization and specialty dispensing

Prior authorization is required for ambrisentan under the pharmacy benefit for Commercial/Exchange members; this medication is designated specialty and must be dispensed through a contracted specialty pharmacy.

Step Therapy

Step therapy status

No step therapy requirement is specified for ambrisentan in this policy.

Documentation Required

Required clinical documentation

Provide documentation that the member has pulmonary arterial hypertension defined as WHO Group 1 and submit results of the confirming test: right heart catheterization pretreatment values (mPAP, PCWP, PVR) or Doppler echocardiogram for infants <1 year when catheterization cannot be performed. For continuation requests, include evidence of clinical benefit (disease stability or improvement).

Right heart catheterization pretreatment values: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units
Doppler echocardiogram acceptable only for infants <1 year if catheterization cannot be done
For reauthorization, documentation of clinical benefit or stability (authorization may be granted for 12 months)

Denial Risk

Insufficient diagnostic confirmation

If documentation does not confirm WHO Group 1 PAH with objective hemodynamic criteria (right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, PVR ≥ 3 Wood units) — or, for infants <1 year when catheterization is not possible, an appropriate Doppler echocardiogram — the authorization may be denied for insufficient diagnostic confirmation.

Definitions and Diagnostic Criteria

PAH (WHO Group 1) — Definition and subtypes

DefinitionPulmonary arterial hypertension (PAH) is WHO Group 1 pulmonary hypertension, including idiopathic, heritable, drug- and toxin-induced, and PAH associated with conditions such as connective tissue disease, HIV, portal hypertension, congenital heart disease, and schistosomiasis.

Common subtypes listedIdiopathic PAH; Heritable PAH; Drug- and toxin-induced PAH; PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis.

Other categoriesPAH long-term responders to calcium channel blockers; PAH with overt venous/capillary (PVOD/PCH) involvement; Persistent pulmonary hypertension of the newborn syndrome.

Hemodynamic confirmation of PAH — Right heart catheterization criteria

Required confirmation testRight heart catheterization (RHC)

RHC pretreatment mPAP thresholdmPAP > 20 mmHg

RHC pretreatment PCWP thresholdPCWP ≤ 15 mmHg

RHC pretreatment PVR thresholdPVR ≥ 3 Wood units

Background

Ambrisentan is an endothelin receptor antagonist approved for the treatment of pulmonary arterial hypertension (WHO Group 1). It is used with the clinical intent to improve exercise capacity and delay disease progression; it may be used in combination with other PAH therapies where clinically indicated. Diagnosis of PAH requires hemodynamic confirmation, typically by right heart catheterization.

Revision History and Policy Changes

2023-07-12policy review

Reviewed at July P&T; decision made to switch from CVS Standard to custom criteria, effective 2023-09-01.

2023-09-01operational changeLatest

Operational change: policy switched from CVS Standard criteria to custom criteria, as implemented effective 09/01/2023.