Emmaus Support Program Gives US Patients Low-cost Access to Endari

Emmaus Life Sciences has launched a program that will allow eligible sickle cell disease patients in the U.S. to access its Endari (L-glutamine) medication at low cost or free of charge.

Patients who currently lack insurance coverage or financial means to afford treatment may reach out to Endari’s support program by phone at 1-855-723-5646, or by visiting its website, to determine their eligibility to enter the program and complete an online application form.

“We are very pleased to launch the Endari Support Program, which will allow us to better serve the sickle cell disease community by providing financial assistance to increase patient access to our treatment,” Yutaka Niihara, MD, chairman and CEO of Emmaus, said in a press release.

“This program follows our existing commercial co-pay assistance program,” he said. “Emmaus is committed to providing Endari to all patients who may benefit from our sickle cell disease treatment, regardless of their means and situation.”

Endari is an oral therapy approved by the U.S. Food and Drug Administration (FDA) in 2017 to treat severe complications associated with SCD in patients, 5 and older. It was the first therapy approved for sickle cell disease (SCD) in nearly 20 years.

The treatment works by increasing the levels of the amino acid L-glutamine, which helps red blood cells avoid the damaging effects of oxidative stress, regain flexibility, and improve their ability to transport oxygen throughout the body. Amino acids are protein building blocks. Oxidative stress is a form of cellular damage caused by high levels of oxidant molecules.

The company has partnered with Lash Group’s TheraCom Specialty Pharmacy, which is part of the AmerisourceBergen Corporation, to launch the support program and fill treatment prescriptions.

“At Lash Group, we are very excited to be partnering with Emmaus to help patients with sickle cell disease access and afford therapy through the Endari Support Program,” said Tommy Bramley, president of the Lash Group.

Emmaus also announced it has recently received a notification from the Michigan Department of Health and Human Services (MDHHS) explaining that Endari’s previous authorization criteria have been altered in the state.

Changes were introduced to eliminate the prior use of hydroxyurea, another approved treatment for SCD, as a mandatory requirement for Endari’s prescribing authorization. With these alterations, MDHHS has now joined the list of other U.S. state health agencies that have eliminated this requirement from Endari’s authorization criteria.

The two changes in Endari’s authorization requirements include the addition of “patient/family refusal” to the list of justifications of intolerance and contraindication for the use of hydroxyurea, and the removal of previous use and adherence or intolerance to hydroxyurea.

Introduced following a review by a Michigan working group, changes will be effective starting Jan. 1, 2021.

“These revisions, based on review and input from the Medicaid Health Plan Common Formulary Workgroup, will allow Endari to be prescribed to more of Michigan’s sickle cell disease patients, more quickly, than under the current prior authorization criteria,” Niihara said in another press release.

“Our goal is to provide Endari to all patients who may benefit from it as promptly as possible,” he added.