FORT LAUDERDALE, FLA. – When the Food and Drug Administration in 2017 approved L-glutamine (Endari) to treat the symptoms of sickle cell disease (SCD), it was the first new drug indicated for the condition in nearly two decades. But a small study of sickle cell patients in New York has found that patients are having difficulty obtaining the drug and sticking to the regimen.
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“We found out that there are multiple barriers, mostly insurance related, and that after 10 months only one-fifth of the patients were still actively taking this medication,” said Ugochi Ogu, MD, assistant director of the Sickle Cell Center for Adults at Montefiore Medical Center in New York. She presented preliminary study results at the annual meeting of the Foundation for Sickle Cell Disease Research.
L-glutamine oral powder is taken twice a day to treat the symptoms of SCD. GoodRx reports that the average cash price for a 60-day supply of L-glutamine is $2,773.
The study followed 101 patients prescribed L-glutamine at the Montefiore Medical Center. When they returned to the clinic, patients were asked about barriers to obtaining the medication and adherence to the twice-a-day dosing. The center used a nearby local specialty pharmacy to fill the prescriptions.
The study also evaluated adherence by calculating the mean possession ratio (MPR) utilizing pharmacy records. The average age of the patient population was 36 years, and 56% were women.
It’s the first study of L-glutamine barriers and adherence in SCD patients in the real-world setting, Dr. Ogu said.
At the end of the 10-month study period, 21% of the patients were actively taking the medication, she said. “Forty-three percent had discontinued the medication, and 33% never filled the prescriptions; 4% had received but never started Endari,” Dr. Ogu said.
Of the patients who never filled the prescriptions, Dr. Ogu reported that 27% said their insurer denied prior authorization, 19% said their deductible was too high, and 16% cited other insurance issues.
“So we can see that insurance alone accounted for over 60% of why patients did not receive or could not start the medication,” she said.
Most patients – 94% – either had Medicare or Medicaid; the remainder had private insurance.
Among the 43% of all study patients who stopped taking the medication, reasons given include poor adherence (47%), side effects (9%), pregnancy and breast feeding (5%), and no perceived benefit (5%), Dr. Ogu said. At the outset, pharmacy records estimated adherence at 74% by using the average MPR, a rate similar to the phase 3 trial adherence rate of 77.4%.
Patient education is important to eliminate these barriers to treatment for SCD, Dr. Ogu said. “The patients need to understand why they’re taking whatever medication you prescribe. We need to educate them about the side effects, and we need to make them understand why it’s important to take certain medications or how they’re going to help them,” she said.
But even more important, she added, is a systems-based method to deal with insurance barriers. “If 62% of the patients did not get the medication due to insurance issues, I don’t think we’re doing a good job of making it accessible to them.”
Dr. Ogu reported a financial relationship with Vertex.
SOURCE: Ogu U et al. FSCDR 2019, Abstract JSCDH-D-19-00041.