Dear PH Community,

The past year has seen rapid expansion in the availability of generic therapy options for individuals with pulmonary arterial hypertension (PAH.) Four branded PAH therapies now have generic versions available on the market. Generic versions of a fifth, bosentan (Tracleer®), were approved by the Food and Drug Administration in April but are not yet available to the public.

In addition to the number of PH therapies approved and either available or becoming available in the future, states are beginning to pass generic drug-related laws and private insurers as well as government payors Medicaid and Medicare are still adapting their coverage policies to reflect this changing environment.  As a result, there is growing confusion and concern among patients and health care professionals about access to these lifesaving therapies. PHA has been and will continue to play a leading role in providing critical and timely information about these changes so that patients and their health care providers can make the best decisions regarding their care.

As PHA helps our community navigate today’s rapidly changing PH healthcare environment, one of our core principles is that medical care should be driven by clinician judgment and the patient-clinician relationship.  Together with their care teams, patients may wish to consider questions like these when choosing between brand and generic therapy:

  • 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 copay 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, drug manufacturer or other source, 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 believes that an informed patient is an empowered patient and that is why PHA’s online generics resource provides information about what you need to consider when navigating between brand and generic therapies, including emerging state laws.

In addition to receiving the therapy you and your health care team determine is best for you, it is important to know the potential annual financial impact and available financial resources to help with copayments and deductibles for both branded and generic drugs. PHA’s online financial assistance resource can provide you with important information about charitable assistance foundations, industry patient assistance programs, government assistance programs and other important information.  For those with Medicare Part D coverage, we also provide an out-of-pocket expense infographic from the National Council on Aging to help explain how these expenses might change for you throughout the year.

As the pace of change in the PH environment increases and open enrollment begins later this year, we encourage you to explore these and other PHA resources at PHAssociation.org and bookmark them so you can refer back to them easily and often to learn what has changed.  As always, PHA will continue to monitor and evaluate any changes taking place with regards to generics entering the market and keep the PHA community informed.  If you need additional information about generics or access to therapies, please call 301-565-3004 x749 or email Insurance@PHAssociation.org.

Please share your thoughts on this topic with me at BradWongPHA@PHAssociation.org. I look forward to hearing from you.

Best wishes,

Brad A. Wong
PHA President & CEO