Download Pulmonary Arterial Hypertension Oral Agents

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.