Fax

Adempas Approved for Pulmonary Hypertension
On October 8, 2013, Bayer Healthcare received approval from the U.S. Food and Drug
Administration (FDA) for Adempas® (riociguat) for the treatment of adults with
persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group
4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO
functional class. It is also approved for the treatment of adults with pulmonary arterial
hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional
class and delay clinical worsening. In PAH, it can be used alone or in combination with
endothelin receptor antagonists (ERAs) or prostanoids (inhaled, oral or subcutaneous). The
recommended starting dose is 1mg three times daily. A lower starting dose of 0.5mg three
times daily may be considered in patients who may not tolerate the hypotensive (low blood
pressure) effects with Adempas. Treatment can be titrated up to a maximum of 2.5mg three
times daily. The labeling for Adempas contains a boxed warning concerning the risk of embryo-
fetal toxicity. Due to this risk, females are only able to obtain Adempas through a restricted
distribution programs called the Adempas Risk Evaluation and Mitigation Strategy (REMS)
Program. Adempas will be launched this week. It will be available through a very limited
network of specialty pharmacies that includes Accredo. CuraScript will not be dispensing
Adempas. Full prescribing information can be found at:
 At a Glance
 Brand (Generic) Name: Adempas® (riociguat)
 Manufacturer: Bayer HealthCare
 Date Approved: October 8, 2013
 Indication: Treatment of adults with persistent/recurrent chronic thromboembolic
pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. It is also approved for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.  Dosage Forms Available: 0.5mg, 1mg, 1.5mg, 2mg and 2.5mg tablets
 Launch Date: Adempas is expected to be available later this week.
 Estimated Annual Cost: Adempas will cost approximately $90,000 per year.
 Specialty Status: Adempas will be added to Express Scripts’ specialty drug list.
 Pulmonary hypertension is a chronic, progressive disease that is caused by abnormally high blood pressure in the arteries of the lungs. It can cause symptoms such as shortness of breath, tiredness, fainting and swollen ankles and legs. Pulmonary hypertension is a debilitating disease that often leads to death or need for lung transplantation.  Adempas is a soluable guanylate cyclase (sGC) stimulator that causes vasodilation to increase blood flow and decrease blood pressure.  Other drugs to treat pulmonary hypertension include phosphodiesterase 5 (PDE5) inhibitors [e.g., Adcirca® (tadalafil – Lilly), Revatio® (sildenafil – Pfizer, generics)]; ERAs [e.g., Tracleer® (bosentan – Actelion), Letairis® (ambrisentan – Gilead)]; and prostacyclin analogs [e.g., Remodulin® (treprostinil – United Therapeutics), Tyvaso® (treprostinil – United Therapeutics), Flolan® (epoprostenol – GlaxoSmithKline, generics), Ventavis® (iloprost – Actelion)] 2013 Express Scripts Holding Company. All Rights Reserved.

Source: https://www.afspa.org/wp-content/uploads/2013/10/This-is-an-Express-Scripts-Clinical-Flash-11-October-2013.pdf