BRAND AND GENERIC 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.

Differences Between Brand and Generic Therapy

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

The company that developed the drug has exclusive rights to sell the drug for months or years depending on several 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 it would with a drug for a more common condition.

Once the period of exclusivity ends, other companies can develop and market 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.

What To Expect If a Generic Version of My PAH Therapy Becomes Available

Your availability to get a 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 consulting you or your physicians. Some states require notification in all instances, and others required it in some circumstances but not others. Note: If you are on Medicare, pharmacies aren’t required to notify 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. Commercial plans tend to make them available more quickly than public programs like Medicaid.

In addition, generic specialty drugs are a relatively new phenomenon, and health insurance plans are still sorting out how to pay for them. For example, some plans may place a generic pulmonary arterial hypertension (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 plan administrators 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 if an issue arises.

Cost and Financial Assistance Considerations

What you pay for a brand PAH therapy versus its generic counterpart depends on the price of the medication and how much your health insurance plan will pay.

Grants From Nonprofits

In general, grants from charitable assistance organizations will cover brand and generic medications. Grants often are available if you have 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

If you have commercial insurance, you are most likely to receive financial assistance in the form of a copay card from the company that manufactures its PH therapy. Both brand and generic manufacturers can provide copay cards, but not all manufacturers 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.

Choosing Between a Brand and Generic Therapy

PHA believes that patients’ needs and clinicians’ judgment should drive medical care. With your medical care teams, you 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 from 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 a 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 offers information to assist you or your health care professional as you navigate insurance obstacles.