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Advanced Therapies for Pharmacologic Treatment of Pulmonary Hypertension

Pulmonary Arterial Hypertension (PAH)Combination therapy for the treatment of PAH (World Health Organization [WHO] Group I) may be considered medically necessary when all of the following conditions are met (see Policy Guidelines section):

Patients have failed to demonstrate an adequate response to a single medication;

Medications are from different therapeutic classes;

Each medication may be considered medically necessary for the treatment of PAH (see above statement).

Combination therapy with tadalafil and ambrisentan as first-line treatment may be considered medically necessary in the treatment of treatment naive PAH patients who have WHO Functional Class Groups II and III disease.

Use of other advanced therapies for the pharmacologic treatment of PAH (WHO group 1) that are not approved by the U.S. Food and Drug Administration for this indication, including but not limited to imatinib, simvastatin, and atorvastatin, is considered investigational.

Pulmonary Hypertension
The use of epoprostenol, treprostinil, iloprost, bosentan, ambrisentan, macitentan, sildenafil, tadalafil, or vardenafil is considered investigational for the treatment of pulmonary hypertension (PH; WHO Groups 2-5), including but not limited to:

PH associated with left heart diseases;

PH associated with lung diseases and/or hypoxemia (including chronic obstructive pulmonary disease);

PH due to chronic thrombotic and/or embolic disease;

Miscellaneous group (ie, sarcoidosis, histiocytosis X, lymphangiomatosis).

Chronic Thromboembolic Pulmonary Hypertension
The use of riociguat (Adempas) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH; WHO group 4) may be considered medically necessary in the following conditions:

Persistent PH after surgical thrombectomy, or

Inoperable CTEPH.

The use of riociguat or medications specific to PAH to reduce pulmonary vascular resistance before surgery in patients with CTEPH who are considered candidates for pulmonary endarterectomy is considered investigational.

The use of riociguat is considered investigational for the treatment of PH (WHO groups 2, 3, and 5), including but not limited to:

PH associated with left heart diseases;

PH associated with lung diseases and/or hypoxemia (including chronic obstructive pulmonary disease);

Miscellaneous group (ie, sarcoidosis, histiocytosis X, lymphangiomatosis).

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