COVERED USES:

All FDA-approved indications not otherwise excluded from Part D.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

The following criteria must be documented:

1. Catheterization-proven diagnosis of Pulmonary Arterial Hypertension as defined by:
   1. Mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, AND
   2. Pulmonary capillary wedge pressure (PCWP) less than 15 mmHg
AND
2. Patient has WHO classification of Functional Status of Patients with Pulmonary Hypertension OR New York Heart Association (NYHA) Functional Class III or IV
AND
3. Completion of an acute vasoreactivity test (administration of a short-acting vasodilator (i.e. epoprostenol, adenosine, or inhaled nitric oxide) and measurement of hemodynamic response with right heart catheterization:
   1. If positive (defined as mPAP decrease of at least 10 mmHg and to a value of less than 40 mmHg, with an increased or unchanged cardiac output, and minimally reduced or unchanged systemic blood pressure) - must have a trial and failure of or contraindication to a Calcium Channel Blocker (CCB)
   2. If negative, no trial of CCB is necessary

In addition, for Tracleer® the following must be met:

• Patients must be enrolled in the TAP post-marketing program
• Tracleer® needs to be used with caution in patients with moderate or severe hepatic impairment and/or in the presence of elevated aminotransferases (greater than 3 times the upper limit of normal).

EXCLUSION CRITERIA:

Tracleer® is contraindicated during pregnancy and it should not be used concomitantly with Flolan® or Remodulin®.

COVERAGE DURATION:

Initial authorization will be approved for up to six months. Reauthorization will be approved for up to one year.