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Enrollment and Drug Access
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Simplified enrollment for expedited drug access
At PAH Pathways, our goal is to provide a one point of access for your patients taking Tracleer. Our team helps your patients get Tracleer quickly and provides them with answers regarding their shipment status.
Actelion has updated the way patients are enrolled and maintained on Tracleer therapy. Because of the risks of liver injury and serious birth defects associated with Tracleer, the use of Tracleer requires participation in the Tracleer Access Program (T.A.P.®), a restricted distribution program. In order to receive Tracleer, prescribers and patients must enroll in T.A.P. and agree to comply with the requirements of this program. Enrollment in T.A.P. is accomplished by completing and submitting the Tracleer Enrollment and Renewal form to PAH Pathways, which administers T.A.P. You can reach PAH Pathways by calling toll-free at 1-866-ACTELION (1-866-228-3546).
What You Need to Prescribe Tracleer:
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Tracleer Enrollment and Renewal form and HIPAA form |
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Here's how it all comes together:
1. Enroll your patient in the Tracleer Access Program (T.A.P.): In order to receive Tracleer, prescribers and patients must enroll in T.A.P. and agree to comply with the requirements of this program. Enrollment in T.A.P. is accomplished by completing and submitting the Tracleer Enrollment and Renewal form. Call 1-866-ACTELION (1-866-228-3546) or click here to download the Tracleer Access Program prescribing materials.
2. PAH Pathways contacts your patient: Once we receive the Tracleer Enrollment and Renewal form, PAH Pathways will:
- Call your patient to discuss insurance coverage and out-of-pocket costs for Tracleer
- Forward your patient's information to a specialty pharmacy, which will then deliver Tracleer directly and conveniently either to your patient's home or to your office each month
- Mail your patient a Tracleer Getting Started Kit
- Help your patient get started in Sure Steps™, a voluntary patient education program. Patients who enroll in Sure Steps are sent a Welcome Packet along with scheduled mailings and emails to offer continued support and encouragement on their journey.
3. Tracleer is delivered to patient: Tracleer is not dispensed through retail pharmacies; rather, it is dispensed through a restricted network of specialty pharmacies that are certified by Actelion to dispense Tracleer. Specialty pharmacies help to ensure that required monthly liver function and pregnancy testing has occurred.
Specialty pharmacies also arrange for Tracleer to be delivered conveniently and directly to patients each month. If a patient does not confirm having the monthly tests or becomes pregnant, the pharmacy will contact you.
4. Laboratory test reminders and follow-up: Safe use of Tracleer requires that you obtain and review monthly liver function and, if applicable, pregnancy tests. You must counsel your patients about the importance of monthly testing and ensure that test results are obtained and reviewed by your office.
The specialty pharmacy will confirm with your patients that monthly tests have been obtained. If a patient does not confirm having the monthly tests or becomes pregnant, the specialty pharmacy will contact you. Your patients will receive a Medication Guide, which they should read each time because there may be new information. At any time after a patient has started on therapy, they can contact a PAH Pathways counselor with questions or concerns about the delivery of medicine, insurance coverage, or financial assistance programs.
5. Renew Tracleer Enrollment annually: In order to continue your patients on Tracleer, you must return to the start of the process (step 1) annually. The Prescriber Essentials Guide will serve as your guide for the essential steps to enrollment and renewal in T.A.P.
Call 1-866-ACTELION (1-866-228-3546) or click here to download the Tracleer Access Program prescribing materials
Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these potential benefits are sufficient to offset the risk of liver injury in WHO Class II patients, which may preclude future use as their disease progresses.
Tracleer Important Safety Information
Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program. Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) – Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. High potential for major birth defects – Pregnancy must be excluded and prevented through the use of reliable forms of birth control; monthly pregnancy tests should be obtained.
Contraindicated for use with cyclosporine A and glyburide.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Ventavis
For full Prescribing Information for Ventavis, click here.