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Pulmonary Arterial Hypertension Oral Agents Covered Medications Phosphodiesterase Inhibitors Revatio® (sildenafil citrate tablets) ® Adcirca (tadalafil tablets) Endothelin antagonists Tracleer® (bosentan tablets) Letairis™ (ambrisentan tablets) Prostanoids Tyvaso® (treprostinil inhalation solution) ® Ventavis (Iloprost inhalation solution) What they do and how they are used ¾ ¾ ¾ ¾ ¾ ¾ ¾ Pulmonary Arterial Hypertension (PAH) is a condition characterized by unusually high pressure in the vessels carrying blood between the heart and the lungs. Patients initially experience respiratory symptoms such as shortness of breath (dyspnea). They may also experience tiredness (fatigue), and fainting (syncope). As the disease progresses, symptoms become more acute and patients may develop bluish lips and skin (cyanosis), swelling of the legs and ankles (edema), and chest pain (angina). The disease is progressive and eventually leads to right-sided heart failure and death. Approximately 100,000 individuals are affected by this rare but severe lung disease. According to a 4-year study (1981-1985) done by the National Institutes of Health (NIH), the median survival of patients with idiopathic PAH was 2.8 years. Actual survival rates differ between patients and range from months to years after diagnosis. Treatment options focus on relieving respiratory symptoms and increasing exercise ability. These include drugs to lessen the constriction of pulmonary vessels such as calcium channel blockers and nitrates. Adjunctive treatments consist of anticoagulants (i.e., blood thinners), inotropic agents (i.e., digoxin), diuretics (i.e., water pills), and oxygen. Several agents have been developed in recent years to specifically target the mechanisms involved in PAH. High pressures within the lungs from pulmonary vascular resistance are in part due to the effects of phosphodiesterase, an enzyme whose actions result in constriction of the pulmonary vessels. Revatio® and Adcirca® work by inhibiting a specific phosphodiesterase enzyme found in the smooth muscle of the pulmonary vasculature, thus resulting in a relaxation of pulmonary smooth muscles and ultimately, a decrease in resistance. Prostacyclin is a naturally occurring prostaglandin that has been found to have vasodilatory effects as well as antiplatelet effects and is known to be produced by the vascular epithelium. Tyvaso®, and Ventavis® are analogs of prostacyclin, and decrease pulmonary vascular resistance by taking advantage of the vasodilatory effects of this prostaglandin. Tyvaso® and Ventavis® are inhaled. Endothelin, a potent blood vessel constrictor, is present in higher amounts in the blood and lungs of patients with pulmonary hypertension. Tracleer® and Letairis™ work by blocking endothelin’s ability to bind to receptors on lung blood vessels thus preventing constriction of these vessels. What they cost Product Revatio® 20 mg tablets Adcirca® Ventavis® Tyvaso® Tracleer® Letairis™ Dose 20 mg orally three times per day 40 mg orally once daily 2.5 mcg inhalation initially, followed by an increase to 5 mcg inhaled 6-9 times per day (max every 2 hours) only during waking hours, max daily dose of 45mcg (3 of the 20mcg/mL ampules or 5 of the 10mcg/mL ampules) 18mcg inhalation initially, followed by an additional increase of 18mcg at approximately 1-2 week intervals to 54mcg inhalation four times per day (4 hours apart) only during waking hours, Starting dose 125 mg twice daily titrated up to a maximum of 250 mg twice daily Initial dose 5 mg daily and if tolerated, increase to 10 mg once daily Cost per day (AWP/max dose) $52 Cost per year (AWP) $38 $372 (10 mcg/mL) OR $223.20 (20 mcg/mL) ~$447.33 (price based on 1 refill kit) $13,870 $135,780 (10 mcg/mL) OR $81,504.50 (20 mcg/mL) $162,670 (includes 1 starter & 11 refill kits) $400 $146,000 $200 $73,000 $18,980 Rationale for coverage authorization To provide coverage for use in the treatment of PAH in situations where treatment is likely to provide benefit and to provide coverage for a quantity sufficient for treating PAH. Benefit design ¾ Coverage is determined through prior authorization for every claim. Coverage authorization criteria Coverage for PAH agents is provided in accord with the following: ¾ Coverage is provided for the treatment of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization demonstrating a mean PAP of more than 25 mm Hg at rest Medco Health Solutions, Inc. ¾ ¾ The patient must be under the care or referral of a pulmonologist or cardiologist Coverage is provided for combination use of two or more drugs with different pharmacology in patients who have not adequately responded to monotherapy For Revatio® and Adcirca®: ¾ Coverage is not provided in situations where patients are receiving nitrate therapy. Coverage duration: 12 months. Coverage may be renewed. ¾ ¾ ¾ ¾ ¾ ¾ ¾ ¾ ¾ References Adcirca® (tadalafil). Prescribing information. Eli Lilly and Company. Indianapolis, IN: May 2009 Badesch DB, Abman SH, Ahearn GS, et al. Medical therapy for pulmonary arterial hypertension: Updated ACCP evidence-based clinical practice guidelines. Chest 2007; 131; 1917-1928. Gaine SP, Rubin LJ. Primary pulmonary hypertension. Lancet 1998; 352:719–725. Letairis™ (ambrisentan). Prescribing information. Gilead Sciences, Inc. Foster City, CA: June 2007. McLaughlin VV, Presberg KW, Doyle RL, Abman SH, McCrory DC, Fortin T, Ahearn G. Prognosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest 2004 Jul;126:78S-92S. Revatio® (sildenafil) tablets, injection. Prescribing information. Pfizer. New York: November 2009. Tracleer® (bosentan). Prescribing information. Actelion Pharmaceuticals. South San Francisco, CA: February 2007. Tyvaso® (treprostinil). Prescribing information. United Therapeutics Corp. Research Triangle Park, NC: July 2009. Ventavis® (iloprost). Prescribing information. Actelion Pharmaceuticals US, Inc. South San Francisco, CA: August 2009. Medco Health Solutions, Inc.