COVERED USES:

Treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening.

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

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:

For both drugs: Documentation of optimal therapy with calcium channel blockers, cardiac glycosides, diuretics, and/or supplemental oxygen.

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

Patients receiving Ventavis® should not be candidates for Tracleer® due to above risk factors.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

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