Navigating Brand and Generic Therapy Choices

When it comes to choosing a therapy, individuals living with pulmonary arterial hypertension (PAH), and the medical professionals who treat them, face unique challenges. For children and their families, the challenge is that only one of the targeted PAH therapies has been FDA approved for pediatric use. For adults, there are fourteen such therapies including both brand and generic options.

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.

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 to generic without notifying the person who takes the medication or their physician. In other states, notification is required or required in some circumstances but not others. Since the law differs by state, ask your pharmacist or physician if you would like more information.

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 2018, Medicare must provide 60 days’ notice before transitioning someone to a generic drug. However, in 2019, no notice to Medicare beneficiaries will be required.

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 whether you are receiving the brand or generic drug; whether your plan covers both the brand and generic drug; and how your drug is covered. In other words, what your out-of-pocket responsibility is based on the coverage tier in which your drug is placed (see above).

In general, grants from charitable assistance organizations such as the Patient Advocate Foundation and PAN Foundation will cover both brand and generic options. Additional information about financial assistance for PAH therapies is available at www.PHAssociation.org/HELP or by calling 301-565-3004 x749

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?