Adcirca vpamcv2.doc

Adcirca™ (tadalafil)

FDA-APPROVED INDICATION
Adcirca™ is indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (World Health
Organization group 1) to improve exercise ability.
COVERAGE POLICY
Adcirca™ is covered for members who meet the following criteria:
A. Patients with PAH diagnosed by a Pulmonologist or Cardiologist, and
B. Belongs to WHO Group I, and
C. Based on acute vasoreactivity testing result:
a. For patients with positive testing result, documentation of a trial and failure with calcium
channel blocker therapy, unless it is contraindicated, such as those with right heart failure or hemodynamic instability. OR
b. For patients with negative testing result, Adcirca is covered as first line therapy.
* Per ACCP guideline, an acute response to acute vasodilator testing is defined as a decrease in mPAP (mean pulmonary artery pressure) by at least 10 mm Hg to an absolute level of less than 40 mg Hg without a decrease in cardiac output.
DOSE
The recommended dose of Adcirca™ is 40 mg per day taken as a one time dose of two 20 mg tablets. This
can be taken with or without food. Dividing the dose throughout the day is not recommended.

Quantity limit: 2 tablets/day

AUTHORIZATION PERIOD
Approval: 3 years
Reason for Non-Coverage:
1. Use not approved by the FDA, and
2. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see
Off-Label Use Policy for determining ‘accepted use’) REFERENCES
1. Adcirca (tadalafil) prescribing information. Eli Lilly and Company., May 2009. 2. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension. J. Am. Coll. Cardiol. 2009 Mar;53 [239 references] 3. Badesch DB, Abman SH, McLaughlin Vv, et. Al. Updated Medical Therapy For Pulmonary Arterial Hypertension: ACCP Evidence-Based Clinical Practice Guidelines. Chest. June 2007; 131: 1917-1928.
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Source: http://chcmedicaid-pennsylvania.coventryhealthcare.com/web/groups/public/documents/webcontent/c051427.pdf