Community Corner: Onfi Drug Alert

People using Onfi, the brand name for clobazam, should know that generic forms of this drug may be available in the coming months. Lundbeck received approval of Onfi from the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of seizures associated with Lennox-Gastaut syndrome in people at least 2 years old. At the end of October 2018, the exclusive patent on Onfi will expire – this means that other companies can make generic forms of clobazam. We do not know if or when this will happen, but it’s likely we will see generic clobazam shortly.

What does this mean for people currently taking Onfi?

Having a generic form of clobazam is good news. Using a generic medication can cost less for many people. And it’s the same drug.

According to the FDA, generic medications should be the same as the brand name product. There may be slight differences in how much of the medicine is available in the body and brain between a generic and a brand medicine, or between one generic form and another of the same drug. Usually any difference does not affect how the drug works.

Dr. Barry Gidal, medication editor for epilepsy.com, said, “Well-controlled studies have been conducted that support the FDA position that generic seizure medications can be safely substituted.” Individual issues may arise, and Dr. Gidal explains that “occasionally, it may be prudent for an individual patient to remain on the branded medicine. Similarly, if a patient is taking a generic form of a medication, they should talk to their pharmacist about staying with the same drug manufacturer if at all possible. This is a decision that a patient and their health care providers should make together.”

Is the brand name Onfi still available?

Yes, the brand drug Onfi is still available - the same as it is now. However, once a generic form of a medicine is available, some insurance companies require people to try the generic first. If you can’t take the generic for some reason, the insurance company will want to know why. If you are starting Onfi for the first time, you may be asked to try the generic version first before considering the brand formulation.

Here are a few tips to think through as you consider your medicine and insurance options.

• Check your health insurance coverage. Look for the drug formulary list and see what medicines are covered or if you are required to try a generic medicine first.
  • Look on your health insurer’s website or contact them by phone.
  • Ask your pharmacist to check with your insurance company if you can’t find the information.
• If your insurance coverage allows brand name medicine to be given, call the health care provider who gives it to you. Ask them to make sure and write “brand name medically necessary, dispense as written” each time they refill your medicine or write a new prescription.
• If your insurance company will not cover brand name Onfi and your provider feels that you must take the brand name medicine, call your provider. Ask to speak with a nurse or case manager in the practice if the prescribing provider is not available.
  • Ask if there is any reason why you should not try generic or if you should stay on the brand name Onfi.
  • If you need to stay on the brand name Onfi, you likely will need a letter from your provider or a completed form that states why you need the brand name medicine. This must be completed and sent to the insurance company BEFORE the pharmacy can give you the brand drug.

What if I need the brand name Onfi, but my insurance won’t cover it?

If your insurance company refuses to pay for the brand or the copay cost is too high, file an appeal. An appeal basically asks the insurance company to review your situation and make an exception to their policy.

• Appeals usually need to be started by the person whose name is on the insurance card. If that person cannot file the appeal, a parent, guardian or representative can do it.
• Some plans will allow a health care provider to start the appeal process.
• Contact your insurance plan for instructions on how to file an appeal. Most plans require your provider’s office to send in paperwork about you, why you need the medicine, and why you can’t take a generic form.
• It is helpful to include the risks of not getting the medicine that controls your seizures. For example, if you have had a change in seizures, side effects, or injuries.
• Make sure you and your doctor’s office send in this information well before your medicine runs out.

What if my medicine runs out before I get an answer from my insurance?

In many states, pharmacists can give an emergency supply of medicine to a person whose prescription has run out if they have a life-threatening condition and not taking medication is dangerous. Usually they can give medicine to cover a few days but check with your own pharmacist and state laws. This is true for any medicine, brand or generic.

• Ask for an emergency supply if your provider’s office has not been reached or has not been able to send in the paperwork soon enough. Or if you are waiting for an answer from your insurance company, you should ask for an emergency supply.
• Make sure you tell your pharmacist that your epilepsy is a life-threatening problem. Stopping any medicine suddenly or missing doses can lead to seizure emergencies including death in some people.
• Don’t wait until the last minute to ask for an emergency supply.
• If you cannot get an emergency supply and you start having seizures, go to your nearest emergency room.

Is there other support available to help me get Onfi?

Lundbeck, the maker of Onfi, still has patient support programs available. Patients who have limited resources and who do not have insurance coverage for Onfi may qualify for help through Lundbeck’s patient assistance programs.

• Call ONFI Support Center at 1-855-345-6634 for more information.
  • A free 14-day voucher for eligible patients who have commercial insurance may be available. This can be tried even after a generic clobazam is available.
  • Depending on where you live and your insurance, you may be able to use a copay card that is available from onfi.com.
• Other resources are available for help affording medicines or getting them at low cost. Please call the Epilepsy Foundation 24/7 Helpline for more information at 1-800-332-1000 (en Español 1-866-748-8008).
• You can also try Partnership for Prescription Assistance, pparx.org, to find resources in your area.
• The Assistance Fund helps eligible patients with copayments related to epilepsy and seizure medications. Learn more at tafcares.org/patients.

It can be hard when people are faced with changes in what their pills look like, changes in doses, or changes from one form to another (like brand to generic or generic to brand). Thinking this through now may help make it easier.

Be proactive and talk to your health care team and pharmacist now. Don’t wait for your next appointment.

And please call us if you need any help!

With best wishes,

Patty Osborne Shafer RN, MN
Senior Director and Associate Editor