Navigating Brand and Generic Therapy Choices

Choosing a therapy can be challenging for individuals with pulmonary arterial hypertension (PAH), and the medical professionals who treat them. The information below is intended as a starting point for adult PAH patients seeking to understand how choices between brand and generic therapy may impact them.

What is the Difference Between Brand and Generic Therapy?

When a drug manufacturer develops a new product and it is approved by the Food and Drug Administration (FDA), the product is protected by a patent. This first-of-its-kind medication is often called a brand drug.

The company that developed the drug has exclusive rights to sell the drug for a period of months or years depending on a variety of factors. A company that develops a drug for a rare disease typically keeps an exclusive right to sell the rare disease therapy for longer than they would with a drug for a more common condition.

Once the period of exclusivity ends, other companies can develop and market their own versions of the same medication. This is called a generic. FDA has strict criteria for the “equivalence” of brand and generic medications. FDA offers a generic drug questions and answers page on its website.

chemical/generic name brand name generic(s) available?
ambrisentan Letairis Yes
bosentan Tracleer Yes
epoprostenol (room temperature stable) Veletri No
epoprostinol Flolan No
iloprost Ventavis No
macitentan Opsumit No
riociguat Adempas No
selexipag Uptravi No
sildenafil Revatio Yes
tadalafil Adcirca Yes
treprostinil (inhaled) Tyvaso No
treprostinil (intravenous/subcutaneous) Remodulin generic available for IV administration only
treprostinil (oral) Orenitram No

If a Generic Version of my PAH Therapy Becomes Available, What Should I Expect?

How you are affected by the availability of generic PAH therapy may depend on several things.

Your state of residence
The law in some states allows pharmacies to transition a prescription from a brand therapy to a generic without notifying the persons taking the medication or their physicians. In other states, notification is required or required in some circumstances but not others. Medicare is not required to give notice to beneficiaries when transitioning them from a brand drug to a generic.

Your health insurance plan
Some health insurance plans update their formularies more quickly than others. For example, many commercial plans make generics available quickly while Medicaid plans may take several months to begin offering coverage.

In addition, generic specialty drugs are a relatively new phenomenon and health insurance plans are still sorting out how to pay for them. Some plans may place generic PAH therapy in the same cost-bracket or tier as the brand counterpart, rather than in a lower-cost generic tier. Patients’ out-of-pocket responsibilities could shift as these plans’ administrators begin to better understand the price difference between the two drugs and adjust the tier into which they categorize generics.

Your PH care team, specialty pharmacy or drug manufacturer may be able to help you advocate for yourself with your insurance plan for appropriate coverage of the drug you need.

Cost and financial assistance considerations
What you pay for a brand PAH therapy versus its generic counterpart will depend on the actual price of the medication, how much of the price your health insurance plan will pay and whether you are eligible for financial assistance.

Grants from non-profits: In general, grants from charitable assistance organizations will cover both brand and generic medications. Grants are most often available to individuals with Medicare or Medicaid. Additional information about financial assistance for PAH therapies is available at www.PHAssociation.org/HELP or by calling 301-565-3004 x749.

Commercial insurance: Individuals with commercial insurance are most likely to receive financial assistance in the form of a copay card from the company that manufacturers their PH therapy. Both brand and generic manufacturers can provide copay cards but not all manufactures choose to provide the same amount of assistance. Some states have laws limiting the use of brand copay cards when a generic is available.

Medicare Part D: If your PH therapy is covered under Medicare Part D, what you pay out of pocket each month will vary over the course of the year. The National Council on Aging provides an illustration of 2019 Medicare Part D coverage phases at https://www.ncoa.org/wp-content/uploads/Donut-Hole-2019.pdf

State Laws Impacting Access to Copay Cards for Generics

Patients prescribed either brand or generic PH therapy can continue to receive grants from nonprofit organizations as available. Copay assistance provided by the therapy manufacturer may vary by product and by state. Visit PHAssociation.org/Help for more information.

Massachusetts law states that individuals taking a branded medication may not be provided with a manufacturer copay card if the drug has an FDA-approved generic equivalent.

California law states that individuals taking a branded medication may not be provided with a manufacturer copay card if a generic equivalent of the medication is covered by their health insurance plan in a lower-cost tier. There is an exception to this law that allows brand companies to continue to provide assistance for REMS products that require regular safety testing for some patients such as Letairis® and Tracleer®.

If I Have a Choice Between Brand and Generic Therapy, Which Should I Choose?

PHA believes that patients’ needs and clinicians’ judgement should drive medical care. 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 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, 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?

Insurance Appeal Sample Letters

PHA offers sample letters on a variety of topics to assist you or your health care professional as you navigate insurance obstacles. PHAssociation.org/Patients/Insurance/How-to-file-an-insurance-claim/template-letters/