FDA approves changes to SABRIL REMS Program

Streamlining of the REMS process is not due to any change in the risk of Sabril-induced permanent vision loss.

The Sabril REMS program, formerly known as SHARE, has been changed after the FDA determined that some of the program’s requirements are no longer necessary to ensure that the benefits of Sabril outweigh the risks.

The new Sabril REMS program will be effective on July 21, 2016.

Sabril is indicated as adjunctive therapy for patients 10 years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for CPS.

Sabril is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.

"When Sabril was approved by the FDA in 2009, Lundbeck worked with the FDA to launch the therapy along with an extensive REMS program to monitor the risk of vision loss," said Alina M Fernández, MD, MPH, MBA, VP, Global Pharmacovigilance-US, Lundbeck.

"The modifications announced today are the result of many meetings between the FDA and Lundbeck, healthcare professionals and the patient community. We’re pleased with the reduced burden associated with prescribing Sabril."

About the Modified REMS

The Sabril REMS Program (formerly known as SHARE) will administer the REMS process, and Sabril will continue to only be available through select specialty and inpatient pharmacies. Lundbeck will continue to provide support through SHAREPlus, including dedicated customer support, benefits investigation, a free starter prescription while benefits investigation is underway, co-pay assistance and a patient assistance program for patients who qualify.

The modified REMS program will alleviate some of the burden associated with prescribing Sabril, as physicians will have fewer forms to submit. Previously, physicians were required to document completion of five forms in order to prescribe Sabril.

Under the new modified Sabril REMS Program, only two forms must be completed and submitted to the Sabril REMS Program. An optional Sabril Prescription Form is available for physicians who choose to submit a prescription through Lundbeck’s SHAREPlus Program. Alternatively, physicians may submit a prescription directly to a pharmacy certified to dispense SABRIL.

Completing the optional Sabril Prescription Form on www.Sabril.net will allow healthcare providers and patients/caregivers access to Lundbeck’s SHAREPlus support program, which includes: dedicated customer support, benefits investigation, a starter prescription while benefits investigation is underway, co-pay assistance, and a patient assistance program for those who qualify.

Healthcare providers must complete an enrollment form to become certified with the new Sabril REMS Program and begin prescribing Sabril for their patients.

Currently enrolled prescribers have 90 days from approval of REMS modification, starting June 21, 2016, within which to complete their new enrollment in order to maintain their ability to prescribe Sabril.

Currently enrolled patients do not need to re-enroll or complete any new forms in order to continue receiving Sabril as prescribed by their healthcare provider.

Healthcare providers will no longer need to complete the treatment initiation form, treatment maintenance form or ophthalmologic assessment form as part of the Sabril REMS program (formerly known as SHARE).

Although the treatment maintenance form has been removed, a benefit risk assessment still needs to be performed as outlined in the prescribing information. Although faxing the ophthalmologic assessment form has been removed as a REMS requirement, vision testing is still recommended, as outlined in the Sabril prescribing information: within 4 weeks of treatment initiation, every 3 months during therapy, and 3-6 months after treatment discontinuation.

The risk of vision loss with Sabril still remains the same, and changes to the REMS process are not due to any change in the risk of Sabril-induced permanent vision loss. Physicians and patients should report any adverse event suggestive of vision loss to the Sabril REMS Program at 1-888-457-4273.

Since the ophthalmologic assessment form will no longer need to be sent to the Sabril REMS Program, drug shipment will no longer be contingent upon completion of this testing and reminder letters will no longer be sent to physicians and patients.