Drug Alerts: Changes in Access to Vigabatrin (Sabril) and Clobazam (Onfi)

Getting access to seizure medications can be a difficult process for many reasons.

• A specific medication may not be covered at all by an insurance company.
• Even if a drug is prescribed by a health care professional, it may not be covered if the person’s seizure type or diagnosis is different from the indication approved by the U.S. Food and Drug Administration (FDA).
• A medication may be in a category requiring a high copay.
• Patient assistance programs may not be available for a specific drug or not cover some age groups or situations.
• Release of a generic version of a drug may alter availability or coverage of a brand name drug.

For a variety of reasons, getting or affording Sabril and Onfi have been a problem for some people. Here is the latest information we have about their availability and where to get more information.

SABRIL (generic name is vigabatrin)

What is Sabril/vigabatrin used for?

The brand name drug Sabril is made by Lundbeck. It is approved by the FDA for the treatment of

• People with refractory focal or partial seizures from 10 years of age and older
• Babies with infantile spasms from age 1 month to 2 years

Is it covered by insurance companies for other types of epilepsy or in different age groups?

Many seizure medicines are prescribed for a wide variety of seizure types. Based on how a drug works, a medicine initially approved for focal seizures may be very helpful in treating generalized seizures. Or the reverse may be true.

However, some insurance companies provide coverage only for the use approved by the FDA. Thus, the insurance company can refuse to cover it if prescribed for another seizure type or reason. Or an insurer may require a high copay for its use. Check your insurance policy to find out the rules for your health coverage plan.

What can I do if my insurance company won’t pay for it?

• First, talk to your prescribing health care provider and ask them to request prior authorization for you to obtain this medication. Be specific in your ask – do you need it covered fully by the insurance company or provided with a copay that is affordable?
• Contact the manufacturer (Lundbeck) for assistance (see below).
• Contact your state Medicaid services to see if you are eligible for any assistance.
• Contact your local health departments and non-profit agencies to see if assistance for medications are available.
• Visit www.pparx.org (Partnership for Prescription Assistance) to learn about other prescription assistance programs that may help.

What patient assistance programs are available from Lundbeck for help with Sabril?

• Contact the Sabril SharePlus program at 888-457-4273 on Mondays through Fridays from 8 a.m. to 8 p.m. ET to learn how they can help you. Or visit https://www.sabril.net.
• Starter Rx is a one-time, 30-day supply of Sabril available to babies who have infantile spasms and are being started on Sabril.
  • People must first contact the Sabril SharePlus program and complete the Sabril Prescription Form and Vigabatrin REMS Program form.
• After this initial Sabril assistance, people with a commercial insurance plan who fit other eligibility criteria may be able to get copay assistance.
  • The individual pays a minimum $10 copay for each 30-day supply of Sabril, while Lundbeck helps with the additional amount. However, there may be a limit as to how much copay can be covered. The SharePlus program can provide details about this.
  • Your pharmacist may be able to tell you what your copay would be and how this copay assistance may help.

Can people with focal or partial epilepsy get help from these assistance programs?

• Contact the general Lundbeck Patient Assistance Program at 1-833-800-0119 for more information.
• Also, don’t forget to contact our 24/7 Helpline at 1-800-332-1000 and visit www.pparx.org.

Is a generic version of vigabatrin available?

• Yes, a generic vigabatrin is available from Par Pharmaceutical in an oral solution.
• Par Pharmaceutical can help with insurance authorizations, REMS enrollment, copay assistance, and other questions. Call 1-833-727-4357.
• According to current FDA policies, most generic seizure medications can be used interchangeably with brand name seizure medications.
• The way vigabatrin works in the brain suggests that no differences would be noted for people using a generic form.
  • Yet changing from one generic to another generic or from brand to generic has caused changes in seizures or side effects in some people.
  • It is usually best for people to avoid frequent switching from one product to another.
• Each person using Sabril/vigabatrin should talk first with their prescribing health care provider about whether the brand or generic form of this (or any) medication is best for them.

What pharmacies provide brand Sabril?

• Sabril is dispensed to people through specialty pharmacies and mailed to you. This means that you first must contact Sabril SharePlus or the Par Pharmaceutical's Assistance program. The prescription is then sent to a specialty pharmacy and shipped to you. If you are already working with a specialty pharmacy for other reasons, ask them if they can manage the Sabril/vigabatrin prescriptions for you.
• When using specialty mail-order pharmacies, allow at least 1 week to have the medicine shipped to you.

ONFI (generic name is clobazam)

What is Onfi/clobazam used for?

The brand name drug Onfi is made by Lundbeck. It is approved by the FDA

• For the treatment of people 2 years of age and older who have seizures associated with Lennox-Gastaut syndrome (LGS)
• As an add-on therapy, which means it is given in addition to another seizure therapy

Is it covered by insurance companies for other types of epilepsy or in different age groups?

Onfi may be helpful for many different types of seizures that are commonly seen in LGS, but the person may not have a diagnosis of LGS. Some insurance companies provide coverage only for the use approved by the FDA. Thus, the insurance company can refuse to cover it if a person does not have the specific diagnosis of LGS. Or an insurer may require a high copay for its use. Check your insurance policy to find out the rules for your health coverage plan.

What can I do if my insurance company won’t pay for it?

• First, talk to your prescribing health care provider and ask them to request prior authorization for you to obtain this medication. Be specific in your ask – do you need it covered fully by the insurance company or provided with a copay that is affordable?
• Contact the manufacturer (Lundbeck) for assistance (see below).
• Contact your state Medicaid services to see if you are eligible for any assistance.
• Contact your local health departments and non-profit agencies to see if assistance for medications are available.
• Visit www.pparx.org (Partnership for Prescription Assistance) to learn about other prescription assistance programs that may help.

What patient assistance programs are available from Lundbeck for help with Onfi?

• Contact the Onfi Support Center at 1-855-345-6634 from 8 a.m. to 8 p.m. ET or visit www.onfi.com.
  • The support center can confirm your eligibility for help and what programs may be available.
• For people who are just starting Onfi, are 2 years of age and older, and have a commercial insurance plan, they may obtain a one-time, 14-day supply of Onfi. This can help while insurance coverage is being obtained.
• Copay assistance may also be available for people with a commercial insurance plan.
  • The individual pays a minimum of $25 out of pocket for each 30-day supply of Onfi. Lundbeck can help with the additional copay, although a maximum limit may apply.
  • To obtain a copay card, visit www.onfi.com or call the Onfi Support Center.
  • Your pharmacist may be able to tell you what your copay would be and how this copay assistance may help.

Can people with focal or partial epilepsy get help from these assistance programs?

• Currently, people who have focal or partial epilepsy are not covered under the Onfi support programs unless they also have a diagnosis of Lennox-Gastaut syndrome.
• Contact the general Lundbeck Patient Assistance Program at 1-833-800-0119 for more information.
• Also, don’t forget to contact the Epilepsy Foundation 24/7 Helpline at 1-800-332-1000 and visit www.pparx.org.

Is a generic version of Onfi available?

Sometime after October 21, 2018, a generic form of Onfi, called clobazam, may be available. It is not available right now.

What pharmacies provide brand Onfi?

Onfi can be obtained from any pharmacy. A specialty pharmacy is not needed. While some people prefer to use mail-order pharmacies, people who are having their dose of medicine just started or changed frequently, should consider a local pharmacy so they do not run out of medicine too soon.

 

Please let us know if you have problems obtaining any seizure medicine or health care for epilepsy.