In this series, we speak with cancer care practitioners about how pathways are being used in their practices, how they are being applied in a particular disease state, and what challenges remain for treatment decision-making.
For this installment, we spoke with Jason N Valent, MD, oncologist and hematologist in the Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute (Cleveland, OH). This interview is part of a larger Cancer Center Spotlight piece on the Taussig Cancer Institute, to be published soon as an online exclusive.
Can you discuss your specific role at Cleveland Clinic? What does a typical day in your shoes look like?
Dr Valent: I am the program director for the plasma cell disorder team. Generally speaking, most of my responsibilities are patient related. I usually start clinic around 8:30 am and end after 5:00 pm.
Our team generally will see between 15 and 20 patients a day with various plasma cell disorders, such as multiple myeloma or amyloidosis. We have a little bit of administrative time, so I benefit from two half-days that allow me to take care of clinical trial management as well as responsibilities related to managing the disease team.
The team has two meetings per month that generally involve research. We tend to go over clinical trials that are proposed, those that are active, and those that are closed to make sure that management is up-to-date. One disease team meeting per month focuses on development and updating care paths.
What are some of the largest challenges to treating patients with multiple myeloma at Cleveland Clinic? What are some of the programs or initiatives that Cleveland Clinic has developed to address these challenges?
Dr Valent: One of the more difficult challenges, in terms of patient management, is obtaining timely insurance authorization for the treatments that are almost always Food and Drug Administration (FDA) approved. Payers have up to 14 days to render a decision regarding payment, or at least planned payment for treatments, even for treatments that are widely accepted as standard of care. In the case of many of our patients (especially those with kidney failure), treatment needs to begin as soon as possible. One of our large, ongoing initiatives is reducing time to the start of treatment, but one of the barriers to that is obtaining insurance authorization in a timely fashion. To address this barrier, the Clinic devotes an entire department within the cancer center to reducing authorization hold-ups with insurance companies.
Another challenge worth noting is many multiple myeloma drugs are now administered orally, and authorization falls under the patient’s prescription coverage portion of their insurance. Copays can be very high because these drugs are quite expensive. We have three care coordinator nurses who spend a lot of time ensuring that our prescription orders travel through proper authorization with insurers, and then copay assistance programs are brought into play when the copays are excessive.
We have also recently added a full-time pharmacist to the multiple myeloma program whose job it is to assist with the insurance authorizations and processing the prescriptions through various specialty pharmacies.
With all of those resources, I think we are truly giving our patients the best possible chance to receive timely care.
Is prior authorization being built into the care path for multiple myeloma to alleviate the
issues of the 14-day insurer window?
Dr Valent: The care path centers around all FDA-authorized treatments. If there is a clinical trial available, eligible patients are offered the trial as part of the care path journey. Currently, we have no mechanism whereby we can say, “What we are requesting is FDA approved and there should be no question about the authorization.” Our leadership works with the insurers on a daily basis to try and make these processes streamlined. Hopefully, with ongoing discussions, it will become less of an issue. Unfortunately, the truth is it seems to be becoming more of an issue.
Can you describe the care path for multiple myeloma at Cleveland Clinic?
Dr Valent: A newly diagnosed multiple myeloma case has recommendations for initial therapy within the care path. These are based on National Comprehensive Cancer Network guidelines or FDA-approved therapies and offer instruction for disease monitoring, response monitoring, and recommendations for bone modifying agents. Our standard for almost all patients, whether they are transplant eligible or ineligible, is a triplet with bortezomib, lenalidomide, and dexamethasone. We participated heavily in the SWOG S0777 study, which demonstrated the benefits of the bortezomib, lenalidomide, and dexamethasone triplet compared with the lenalidomide plus dexamethasone doublet.
After 4 to 6 months of initial therapy, the care path will instruct clinicians to determine whether the patient is transplant eligible. If the patient wishes to receive a transplant, then he or she is offered high-dose melphalan and autologous stem cell transplant. The care path also includes maintenance therapy, which is listed as indefinite until disease progression or intolerance.
A recent update to the care path included data that was presented, published, and now FDA approved for non-transplant eligible patients using daratumumab, lenalidomide, and dexamethasone in the newly-diagnosed setting. It is up to the discretion of the treating physician in the non-transplant eligible setting which regimen option they would prefer.
There is an ongoing study of bortezomib, lenalidomide, and dexamethasone with or without daratumumab in newly-diagnosed patients. This study will likely be the next study to impact the care path. Our preferred initial therapy is bortezomib, lenalidomide, and dexamethasone, but if the addition of daratumumab to that regimen shows benefit, it would probably be our preferred regimen moving forward.
We will have to wait and see what the data indicates from that study. But as of right now, bortezomib, lenalidomide, and dexamethasone is our preferred upfront regimen.
How involved were you in the initial design as well as the continued maintenance of this care path?
Dr Valent: I have been involved since the initial development of our original multiple myeloma care path in 2014. It has been updated on two occasions since then with the most recent update in March 2019. Nowadays, with all of the new data coming out, we have a monthly review. The meeting is very well received by everybody on the team because any and all input is welcomed. Anybody can say, “This is working, but that is not working. We should streamline this or we should expand that.” After deliberation, we come together as a group and make a consensus decision for standardized action moving forward.
It is remarkable how productive and highly scientific the discussions are in these meetings. Our staff generally like them, and we always schedule them in a way that makes it easy for everybody to come. Meetings occur the second Friday of each month from 9 am to10 am. There is no pushback from anybody on the team, and I believe everybody on the team looks forward to them.
At a minimum of once per year, the leadership mandates that we have an update to the multiple myeloma care path and other care paths that we have. All of the physicians, nurses, pharmacists, and research faculty who are part of the multiple myeloma team are required to come to this meeting. Generally speaking, it consists of physicians, nurses, and pharmacy. There are five physicians, one pharmacist, and typically a minimum of five nurses. We examine any new data coming out from the FDA that may change the care path.
Not only have we been able to establish a multiple myeloma care path, but we have established a care path for light-chain amyloidosis as well. Furthermore, we are working on a relapsed/refractory multiple myeloma care path, which is almost complete, as well as a care path for monoclonal gammopathy of undetermined significance, monoclonal gammopathies of renal significance, and POEMS syndrome.
The relapsed/refractory care path will consider patients from their first relapse, what therapy they were previously treated with, and what they may have responded to previously. The care path splits into five different directions based what the previous treatment was and what the response was in order to give a recommendation as to what the next line of therapy should be.
To what degree do practicing physicians interact with these care paths when they are treating patients? In other words, are the care paths open in front of the patients to serve as an interactive experience? Are patients aware that they are being treated “on pathway?”
Dr Valent: The care paths are easily accessible through our intranet on the Cleveland Clinic cancer center intranet. The multiple myeloma care path is no exception.
We do not often show patients directly the contents of our care path. When I talk with patients, I describe my treatment recommendation (as laid out in the care path) as our standard, front-line treatment approach that has been accepted across North America.
I do not tell them specifically that we have a care path and that this is how we treat patients with multiple myeloma at Cleveland Clinic. If they have questions regarding the therapies or why we recommend what we recommend, then I present the data showing a survival advantage for our triplet regimen.
If there is a legitimate reason to deviate from the care path, the care path is designed to allow for this to occur based on patient or physician preference. We generally ask for the physicians to document why they deviate. If a patient has severe comorbidities, it may certainly be justifiable to use a doublet regimen.
