LFA Leads Efforts to Provide Patient Voice for Value Assessment of Lupus Nephritis Treatments
In August of 2020, the Institute for Clinical and Economic Review (ICER) announced plans to assess two U.S. FDA-approved treatments for lupus nephritis (lupus that affects the kidney). Those treatments are voclosporin (Lupkynis, Aurinia Pharmaceuticals, Inc.) and belimumab (Benlysta, GlaxoSmithKline). ICER is a non-profit research organization that evaluates the clinical and economic value of prescription drugs, medical tests and other medical interventions.
ICER Review and Public Meeting
Over the last ten months, the Lupus Foundation of America (LFA) took the lead to engage with ICER throughout the entire process to ensure the voice and experiences of people living with lupus was understood and included in their review. Additionally, the LFA worked to ensure that assessments of the value of new treatments do not simply rely on the clinical and economic value of a drug, but also the value of the drug to people with lupus when it comes to improving and making a difference in their lives.
The LFA led a team of experts made of patients, researchers and physicians, to provide ICER with input and feedback at each stage of the process, including participating in the final public meeting earlier this year in March. Overall, the outcome of the review was very positive for the lupus community, and the voice of people with lupus was heard. Both treatments received ICER’s second highest evidence rating (B+) and ICER specifically highlighted in the report that “Lupus nephritis is a serious chronic disease, one that has a disproportionately large impact on Black, Hispanic, and other communities of color in the US. Both belimumab and voclosporin are important new treatment options.”
Below is a brief Q&A with Toni Grimes, lupus warrior and Dr. Brad Rovin, a nephrologist at Ohio State University Wexner Medical Center, on their experience working on this review with the LFA.
Q1: This was your first experience working on an ICER review. When the LFA asked you to join our team of experts for the review, why did you feel it was important for you to participate?
TONI: I felt it was important because I knew this review could have an impact on these new treatments being accessible for people living with lupus. I know what it feels like to have almost no options for my lupus nephritis and I wanted to ensure that the patient perspective was clearly understood and remained at the center of this conversation. As a black woman who knows all too well the impact lupus nephritis can have, I wanted to make sure that my voice represented women who look like me and are living with lupus. As a LFA support group facilitator I’m in contact with many lupus warriors throughout Arizona and I hear their concerns about access to care and having safe treatments. By working on the ICER review I was able to be the voice of my community.
DR. ROVIN: As you mentioned this was my first time participating in a review like this. I see patients struggling every day because of lupus nephritis (LN). I felt it was important to join LFA’s team of experts to ensure that the work we did as a group informed ICER of the full story and impact of this disease. Participating in this review gave me a chance to continue to support the lupus nephritis community and help ICER understand what these two new treatments can do to help improve the lives of people living with LN and their families. I was concerned that the cost of the medication would disproportionately affect ICER’s recommendations. I wanted to make sure that everyone understood the science behind these two new medications, the benefits the drugs may provide to patients with LN, and how much more significant the cost of LN becomes if we fail to control the disease and the patient then requires kidney replacement therapy like dialysis or a transplant. The long-term view, in my opinion, puts perspective on the up-front cost of medications in terms of what we may save by avoiding kidney replacement therapy in the future, and of course what this means for the individual patient.
Q2: You both were invited to participate and speak at the public meeting in March. How would you describe your role and that experience?
TONI: My role was to provide a clear perspective and experience of the impact of lupus nephritis. This type of review includes a lot of calculations, economic modeling and attempts to quantify into numbers what people living with lupus go through. And as we all know, you simply cannot understand the journey of a person living with lupus through an economic model. So, for my presentation during the public meeting, I shared my journey as someone at the height of my military career as an Army officer, and how lupus then changed my career aspirations and my life. I expressed what these treatments would have meant to me back then and how my life could have been very different. I made sure they knew that the journey of a lupus warrior is like a fingerprint, no two of us are alike. I shared my hope for patients and health care providers to have access to these two new drug options. I really enjoyed this opportunity to share my experiences, but in some ways, I wish there was more time for other patients and caregivers to participate. I was proud to have a voice in this process not just for me but for the estimated 1.5 million lupus warriors across the country.
DR. ROVIN: My role during the public meeting was to provide the expertise of someone who treats lupus nephritis. The panel that votes on the final report is not made up of experts in lupus, so my perspective was to guide them and help them to understand the ins and outs of a complicated disease. I also participated in a policy roundtable where we discussed some of the key issues in lupus nephritis that the economic modeling and analyses could not incorporate. I wanted to make it clear that achieving a kidney response defined clinically in terms of urine protein and kidney function at 12 or 24 months was not the only issue in taking care of patients with LN. I tried to point out that these clinical trials provided data that suggested other benefits for long-term kidney health that would be important to patients.
Q3: The outcome of the ICER review was positive. What are important priorities for us to focus on moving forward, especially as it relates to ensuring access to these treatments?
TONI: The next steps of this process are perhaps the most important. It is great the ICER review was positive and I applaud the LFA and the rest of the team that worked on helping to achieve that. It’s great that we have new treatments, but if the people who needs them the most can’t get access to them what good does it do? So, a major priority for me is to continue working with the LFA on how we can educate insurance companies and the government, especially state Medicaid programs, on why the lupus nephritis community needs access to these two new medications. And what I want to see is those types of decisions influenced by the patient and people like Dr. Rovin, who understand this disease and how to treat it. That is a really important priority to me and one that I think the entire lupus community can support. Disparities in health care are well documented and so is the impact lupus nephritis has on communities of color – so I also think that needs to be a focus of what we do and I know it is something the LFA is committed to working on and improving.
DR. ROVIN: I think Toni said it best. If people can’t access these treatments, the system isn’t working as it should. If a doctor and patient agree that the right step to treat their lupus nephritis is to prescribe one of these medications, then I hope we can work together to ensure that process goes as smoothly as possible. At the panel roundtable I emphasized the difficulty of getting drugs to our patients even after FDA approval because of the roadblocks often put into place by insurance companies. I pointed out that if insurance companies need prior authorization the physician would appreciate actual peer-to-peer calls that can be done quickly, as opposed to languishing paper work. I emphasized that when we prescribe these treatments prompt initiation is often necessary and insurance delays put patients at risk.
What is ICER?
ICER is a non-profit research organization that evaluates the clinical and economic value of prescription drugs. The favorable review recognizes the clinical and economic value of the two drugs, as well as their value to people living with lupus.
Why is ICER important for people living with lupus?
The favorable review recognizes the clinical and economic value of belimumab and voclosporin, as well as their value to people living with lupus. Importantly, the favorable review means that people with lupus are less likely to face barriers in acquiring the medications in the future.