UPTRAVI (selexipag)

UPTRAVI (selexipag)

Self-Administration - Oral

Office-Administration - intravenous

Indication for Prior Authorization:

• Indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Coverage Criteria:

For diagnosis of pulmonary arterial hypertension (PAH):

• Dose does not exceed 3200 mcg per day (oral) or 3600 mcg per day (IV), AND
• Prescribed by or in consultation with a Pulmonologist or Cardiologist, AND
• One of the following:
  • Diagnosis of PAH WHO Group I confirmed by right heart catheterization and documented in chart notes, OR
  • Patient is currently on any therapy for a diagnosis of PAH, AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to oral therapies for PAH from at least 2 different categories, each for at least 60 days:
    • PDE-5 inhibitor (i.e., Adcirca, Revatio)
    • Endothelin receptor antagonist [e.g., Letairis (ambrisentan), Opsumit (macitentan), Tracleer (bosentan)]
    • Guanylate cyclase stimulator [e.g., Adempas (riociguat)], OR
  • Patient is receiving, or has received in the past, one of the following prostacyclin therapies for PAH:
    • Treprostinil [e.g., Orenitram oral tablets, Tyvaso for inhalation, Remodulin for injection (IV or SC)]
    • Iloprost (e.g., Ventavis for inhalation)
    • Epoprostenol [e.g., Flolan, Veletri for injection (IV)], OR
  • Continuation of previous Uptravi therapy, AND
• Will not be taken in combination with a prostanoid/prostacyclin analogue (e.g., epoprostenol, Iloprost, treprostinil)

 Reauthorization Criteria:

For diagnosis of pulmonary arterial hypertension (PAH):

• Dose does not exceed 3200 mcg per day (oral) or 3600 mcg per day (IV), AND
• Documentation of positive clinical response to therapy, AND
• Not taken in combination with a prostanoid/prostacyclin analogue (e.g., epoprostenol, Iloprost, treprostinil)

Coverage Duration:

• Initial: 6 months
• Reauthorization: 1 year

Dosing:

• Oral
  • Initial: 200 mcg oral tablets given by mouth twice daily.  Increase the dose by 200 mcg twice daily at weekly intervals to the highest tolerated dose (maximum dose: 1600 mcg tablets twice daily)
• IV
  • Uptravi for injection dose is determined by the patient’s current dose of Uptravi tablets
  • Administered by intravenous infusion, twice daily
  • Uptravi dosing table based on Uptravi current dose

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Use Uptravi for injection in patients who are temporarily unable to take oral therapy
• Warnings and precautions
  • Pulmonary edema in patients with pulmonary veno-occlusive disease.  If confirmed, discontinue treatment
• Contraindications
  • Concomitant use with strong CYP2C8 inhibitors
• Drug interactions
  • Moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox, and teriflunomide).  Reduce the dosing of Uptravi to once daily.
  • CYP2C8 inducers (e.g., rifampin).  Increase up to twice the dose of Uptravi
• Uptravi is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and has not been studied in dialysis patients (or with eGFR < 15 mL/min/1.73m2).

Policy Updates:

• 11/16/2021 – Update to Uptravi policy.  Including IV formulation.
• 10/13/2020 - Format updated; criteria reformatted
• 02/24/2020 - Annual review
• 12/21/2015 - FDA approval

References:

• Uptravi Prescribing Information. Actelion Pharmaceuticals US, Inc. South San Francisco, CA. September 2019.
• Klinger JR, Elliott CG, Levine DJ, Bossone E, Duvall L, Fagan K, Frantsve-Hawley J, Kawut SM, Ryan JJ, Rosenzweig EB, Sederstrom N. Therapy for pulmonary arterial hypertension in adults: update of the CHEST guideline and expert panel report. Chest. 2019 Mar 1;155(3):565-86.
• Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Sanchez MA, Kumar RK, Landzberg M, Machado RF, Olschewski H. Updated clinical classification of pulmonary hypertension. Journal of the American College of Cardiology. 2013 Dec 24;62(25 Supplement):D34-41.