Aurinia Pharmaceuticals (AUPH) Announces Positive Cost-Effectiveness Assessment of LUPKYNIS in Latest ICER Draft Evidence Report

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today announced a favorable assessment regarding the cost-effectiveness and value of LUPKYNIS™ (voclosporin), based on an independent analysis issued by the Institute for Clinical and Economic Review (ICER) in a revised Evidence Report issued on March 12, 2021. The report finds that LUPKYNIS represents an important new treatment option for patients living with lupus nephritis (LN) and at the estimated net price, determined the therapy to be priced in alignment with ICER’s recommended health-benefit price benchmark ranges.

LN is a serious progression of systemic lupus erythematosus (SLE) that can lead to permanent and irreversible kidney damage, if poorly controlled. Medical expenses are four times higher for people with LN when compared to people with SLE alone and black people with SLE are four times more likely to develop the condition. The ICER report determined LUPKYNIS to be more cost-effective across several sub-groups of LN patient populations, including black patients, compared to the general population, which ICER notes could have the potential to reduce historic disparities.

The ICER report also reiterated that voclosporin added to standard therapy nearly doubled the complete response (CR) and markedly increased the partial response (PR) of patients at one year compared with standard therapy alone. In the AURA-LV Phase 2 and AURORA Phase 3 clinical trials, when added to the standard of Care (SoC), LUPKYNIS nearly doubled the likelihood of achieving CR and reduced the median time to urine protein/creatinine ratio (UPCR) by 50 percent, when compared to treatment with the SoC alone.

“We are encouraged by ICER’s recognition of the burden of lupus nephritis, particularly its impact on the racial disparities that we know exist. ICER’s assessment of LUPKYNIS is consistent with the real-world view of LUPKYNIS’ value we are hearing during our positive interactions with both physicians and payers during the first two months since our launch,” said Peter Greenleaf, Chief Executive Officer of Aurinia Pharmaceuticals. “As we observed in our clinical studies, patients responded to voclosporin nearly two times faster than the current standard of care within one year and we are confident that with this time-to-response and efficacy data, LUPKYNIS provides significant therapeutic and economic value for patients and the healthcare system.”

ICER is an independent non-profit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations. The report will next be evaluated by the ICER Council before the organization issues its final Evidence Report.

About Lupus Nephritis

LN is a serious progression of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

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