Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024

Rhea-AI Summary

Aurinia Pharmaceuticals (NASDAQ: AUPH) announced the cost-effectiveness of LUPKYNIS® (voclosporin) for treating lupus nephritis (LN) at the National Kidney Foundation Spring Clinical Meeting 2024. The updated analysis, consistent with a 2021 assessment, utilized the ICER AnalyticsTM LN model and found LUPKYNIS to be below the $150,000 willingness-to-pay threshold, costing $88,076 per QALY and $77,643 per evLYG for adults with active LN. For Black, Hispanic, and Latino patients, costs were $77,436 per QALY and $67,828 per evLYG. Additional data from the AURORA clinical program and the Enlight-LN registry highlighted the drug's sustained efficacy and reduced steroid use over three years. A propensity analysis indicated superior proteinuria reduction and decreased exposure to toxicities versus high-dose glucocorticoid regimens.

Positive

• LUPKYNIS cost per QALY is $88,076, below the $150,000 threshold.
• Cost per evLYG for LUPKYNIS is $77,643, also below the $150,000 threshold.
• LUPKYNIS cost-effectiveness in Black, Hispanic, and Latino patients is $77,436 per QALY and $67,828 per evLYG.
• Sustained complete renal response and reduced steroid use over three years in the AURORA clinical program.
• Superior reductions in proteinuria and decreased exposure to toxicities in comparison to high-dose glucocorticoid regimens.

Negative

• No new clinical data presented that surpasses previous research results.
• Dependence on cost-effectiveness model assumptions, which could change, impacting the analysis validity.
• Potential financial burden for patients if insurance does not cover the cost of LUPKYNIS.

Insights

Financial Analyst

Economic Implications: The updated cost-effectiveness analysis of LUPKYNIS indicates that the drug remains a financially viable treatment for lupus nephritis, with an incremental cost of $88,076 per quality-adjusted life year (QALY). This figure is below the willingness-to-pay threshold of $150,000 set by ICER. For investors, this suggests that LUPKYNIS could become a preferred option among healthcare providers due to its relative affordability.

Market Potential: The analysis showed cost-effectiveness in a subgroup of Black, Hispanic and Latino patients, further broadening its market reach. Considering the high prevalence of lupus nephritis in these demographics, this could positively influence the drug’s adoption and, by extension, Aurinia's revenue streams.

Stock Valuation: Given that economic viability is a significant factor in drug adoption, this positive cost-effectiveness review can boost investor confidence, potentially driving stock prices upward. However, investors should also consider long-term data and market competition before forming an investment strategy.

Medical Research Analyst

Clinical Relevance: The AURORA clinical program data confirming the long-term efficacy of LUPKYNIS is crucial. This evidence supports that the drug provides sustained renal benefits and reduces steroid use over three years. For healthcare providers, these outcomes are significant selling points that can drive prescription rates.

Safety Profile: The propensity analysis demonstrates that LUPKYNIS-based regimens reduce exposure to toxic glucocorticoids, enhancing its appeal as a safer, long-term treatment option. Patients achieving greater than 50% reduction in urine protein creatinine ratio is a compelling efficacy indicator.

Regulatory Considerations: The consistent safety and efficacy data could help in future regulatory submissions or label expansions, potentially extending the drug’s lifecycle and market share.

Market Research Analyst

Market Dynamics: The findings from the Enlight-LN registry, which reflect the larger LN population in the US, provide a real-world insight into the drug's utilizations and effectiveness. This observational data can be a powerful marketing tool, showing potential adopters that LUPKYNIS performs well outside of controlled clinical trials.

Competitive Landscape: In the context of other treatments for chronic conditions like diabetes and hypertension, LUPKYNIS holds up well in cost-effectiveness. This comparative advantage might attract both healthcare providers and insurers, increasing its market penetration.

Long-term Strategy: Aurinia’s strategy to continuously update and present these analyses at high-profile conferences demonstrates a commitment to transparency and scientific rigor. This approach not only builds trust among healthcare providers but also strengthens the company’s competitive position.

• An updated analysis showed that LUPKYNIS is a cost-effective treatment for lupus nephritis, on par with other interventions for diabetes, blood pressure, and hyperlipidemia in adult patients with active lupus nephritis (LN). 
• Additional data on baseline demographics from the Enlight-LN registry and safety and efficacy data of LUPKYNIS will also be presented.

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced the presentation of results from an updated cost-effective analysis of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), at the annual National Kidney Foundation (NKF) Spring Clinical Meeting 2024 taking place in Long Beach, CA, May 14-18. The Company will also share additional data from its AURORA clinical program.

Economic modeling by the Institute for Clinical and Economic Review (ICER) in March 2021 demonstrated the cost-effectiveness of LUPKYNIS in adults with active lupus nephritis (LN). An updated cost-effectiveness analysis demonstrated that LUPKYNIS continues to be a cost-effective treatment for lupus nephritis (LN). Cost-effectiveness was assessed with the ICER Analytics^TM LN model and the majority of model assumptions from the original analysis were consistent with the 2021 analysis. Updated inputs in this new analysis included the 2023 cost of LUPKYNIS, the duration of treatment for people who did not respond to treatment, and the cost of treating LN patients with end-stage kidney disease.

LUPKYNIS is substantially below ICER’s willingness-to-pay threshold of $150,000 in adult patients with active LN. The incremental cost of the treatment was $88,076 per quality adjusted life year (QALY) and $77,643 per equal value of life year gained (evLYG) in patients with active LN.

ICER uses a common set of cost-effectiveness thresholds for all assessments, including those for treatments of ultra-rare disorders, providing a uniform range of results from $50,000 to $200,000 per QALY and per evLYG for all assessments. The QALY is the standard for measuring how well various medical treatments lengthen and/or improve patients’ lives, and therefore the metric has served as a fundamental component of cost-effectiveness analyses. To complement the use of the QALY, ICER’s reports also include a calculation of evLYG, which evenly measures any gains in length of life, regardless of the treatment’s ability to improve patients’ quality of life.

Moreover, in a smaller subgroup analysis of Black, Hispanic, and Latino patients — a population disproportionately affected by LN — cost-effectiveness was on par with other interventions for diabetes, blood pressure, and hyperlipidemia. The incremental cost of the treatment per QALY was $77,436 and was $67,828 per evLYG in Black, Hispanic, and Latino patients.

“People living with lupus nephritis must be able to access clinically meaningful treatment options to manage the severity of the disease. When considering LUPKYNIS for their LN patients, physicians can take this cost-effectiveness analysis into account, along with long-term data from our AURORA clinical program, which showed that LUPKYNIS, in combination with MMF and steroids, provided sustained complete renal response and reductions in steroid use over three years of treatment, compared to MMF and steroids alone,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia.

An interim assessment of baseline demographics and clinical characteristics of patients currently enrolled in the prospective, observational Enlight-LN registry found that this initial cohort of patients is reflective of the larger LN population in the US. The Enlight-LN registry, designed to characterize the real-world effectiveness profile and usage patterns of LUPKYNIS, is enrolling patients in the US.

A propensity analysis of the Aspreva Lupus Management Study (ALMS), AURA-LV, and AURORA 1 studies suggested that LUPKYNIS plus standard of care demonstrated superior reductions in proteinuria and reduced patient exposure to toxicities compared with higher doses of mycophenolate mofetil (MMF) and glucocorticoids or cyclophosphamide and glucocorticoids alone. Safety and efficacy outcomes for propensity-matched patients with active LN from the AURA-LV plus AURORA 1 studies were assessed at three and six months. Patients who received the LUPKYNIS -based regimen experienced reductions in exposure to glucocorticoids and more patients achieved a >50% urine protein creatinine ratio reduction from baseline compared to their propensity-matched counterparts in ALMS.

Following are the titles and authors of Aurinia’s presentations at NKF’s Spring Clinical Meeting 2024:

Title: Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis
Authors: Ernie Lee, Victoria Atencio, Ronald Flauto, Vanessa Birardi, Lisa Kennedy
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center

Title: Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States
Authors: Stephen Myers, Michelle Zubrycki, Lily Cipolla, Ron Flauto
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center

Title: A propensity Analysis of AURA-LV plus AURORA 1 vs ALMS to Compare a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy
Authors: Kenneth Kalunian, Anca Askanase, Maria Dall'Era, Neil Solomons, Matt Truman, Lucy S Hodge, Ernie Yap
Location: Exhibit Hall A, The Long Beach Convention & Entertainment Center

About LUPKYNIS
LUPKYNIS (voclosporin) is the first U.S. Food and Drug Administration and European Commission approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids.

About Lupus Nephritis
Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes.

About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with high unmet medical needs that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. This may lead to serious, even fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased if administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy that may require antihypertensive therapy. Monitor blood pressure regularly.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause neurotoxicities that if severe can include posterior reversible encephalopathy syndrome, delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium periodically.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia have been reported in patients treated with another CNI. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.

SPECIFIC POPULATIONS

Pregnancy: Avoid use of LUPKYNIS.

Lactation: Consider the benefits and risks of LUPKYNIS and possible risks to the fetus when prescribing LUPKYNIS to a lactating woman.

Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.

Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

References

1. Lee E. et al. Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.
2. Myers S. et al. Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.
3. Kalunian K. et al. A propensity Analysis of AURA-LV plus AURORA 1 vs ALMS to Compare a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy. Presented at the National Kidney Foundation’s Spring Clinical Meeting, 2024, Long Beach, CA.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240514274649/en/

Media and Investor Inquiries:

Andrea Christopher

Corporate Communications & Investors Relations

achristopher@auriniapharma.com

ir@auriniapharma.com

Source: Aurinia Pharmaceuticals Inc.

FAQ

What is the cost-effectiveness of LUPKYNIS for treating lupus nephritis?

LUPKYNIS costs $88,076 per QALY and $77,643 per evLYG, below the $150,000 willingness-to-pay threshold.

Is LUPKYNIS cost-effective for Black, Hispanic, and Latino patients?

Yes, LUPKYNIS is cost-effective for Black, Hispanic, and Latino patients, costing $77,436 per QALY and $67,828 per evLYG.

What additional data was presented on LUPKYNIS at the National Kidney Foundation Spring Clinical Meeting 2024?

Additional data included long-term efficacy from the AURORA clinical program and initial findings from the Enlight-LN registry, highlighting the drug's real-world effectiveness and reduced steroid use.

What were the findings from the AURORA clinical program about LUPKYNIS?

The AURORA clinical program showed that LUPKYNIS, combined with MMF and steroids, sustained complete renal response and reduced steroid use over three years.

How does LUPKYNIS compare to high-dose glucocorticoid regimens?

A propensity analysis indicated that LUPKYNIS reduced proteinuria and decreased exposure to toxicities more effectively than high-dose glucocorticoid regimens.