The Pulmonary Hypertension Association (PHA) recently learned that the Food and Drug Administration (FDA) has approved a generic version of tadalafil, the pulmonary arterial hypertension (PAH)-targeted therapy sold as Adcirca®. Availability of the generic therapy for patients remains to-be-determined. PHA also has been advised that generic versions of other PAH-targeted therapies may become available soon.

During the upcoming months, PAH care teams will continue to gather information about these generic therapies. Although a care team might not be able to answer all questions right away, patients and caregivers may wish to initiate a conversation with them about a potential transition to generic therapy from Adcirca® (tadalafil) or two other medications that soon could have generic options, Letairis® (ambrisentan) and Tracleer® (bosentan). In addition, the FDA offers a generic drug questions and answers page on its website.

Together with their care teams, patients may consider questions such as:

  • How would my current out-of-pocket cost for this medication compare to my out-of-pocket responsibility for the generic equivalent?
  • Will my eligibility for co-pay assistance change when transitioning from brand to generic therapy?
  • If I currently benefit from support services such as a nursing hotline provided by a specialty pharmacy, will the same services be available after a transition to generic therapy?
  • What is the difference between “Dispense as Written” and “Generic Substitution Permitted” prescriptions? If my insurance company requires transition to the generic therapy, is my prescription written in a way that will allow me to do so without a disruption in my treatment?

PHA will continue to provide additional information about generic therapy as it becomes available. For more information about PHA’s treatment access program, visit https://PHAssociation.org/Patients/Insurance/ or contact Insurance@PHAssociation.org.