Performance Improvement Strategies in Multiple Sclerosis. Community of Practice Audioconference Recorded December 7, 2010

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1 Performance Improvement Strategies in Multiple Sclerosis Community of Practice Audioconference Recorded December 7, 2010 Audioconference faculty: Bruce A. Cohen, MD Director, Multiple Sclerosis Program Professor, Davee Department of Neurology Feinberg School of Medicine, Northwestern University Attending Neurologist: Northwestern Memorial Hospital Consultant Neurologist: Rehabilitation Institute of Chicago Chicago, IL

2 MODERATOR: Welcome to the Multiple Sclerosis Community of Practice audioconference with expert faculty, Dr. Bruce Cohen. I m Olivia, your moderator for today s discussion. This audioconference is being recorded; however, use of the content is prohibited. During this evening s call you will have an opportunity to discuss strategies for overcoming barriers in multiple sclerosis (MS) patient care. We will review the current evidence and consensus opinion for the management of MS to discover processes for enhancing practice performance and improving patient care. You are invited to voice questions or comments during this live discussion for immediate faculty feedback. This activity has been developed as part of the American Medical Association (AMA)-standardized CME initiative, Performance Improvement Strategies in Multiple Sclerosis, for which Dr. Cohen has served as faculty chair. This performance improvement series is sponsored by Med- IQ. Additional details about this initiative will be discussed during this evening s audioconference. I am pleased to now introduce Dr. Cohen. Dr. Cohen is an attending neurologist at Northwestern Memorial Hospital in Chicago, Illinois, and a consultant neurologist with the Rehabilitation Institute of Chicago. He also serves as Professor of Neurology in the Davee Department of Neurology at the Feinberg School of Medicine at Northwestern University. Dr. Cohen. BRUCE COHEN, MD: Good evening. Thank you, Olivia. Welcome to this Community of Practice Audioconference for Multiple Sclerosis. The goal of this call is to bring together specialists interested in the care of patients with MS to discuss current challenges and advances in care of these patients. Before we get to the questions, I first wanted to share some of the reasons why programs such as this performance improvement initiative are so important and also provide you with a bit of insight about the current state of MS care. For those of you who may not be familiar with performance improvement, or PI, programs, this is an AMA-approved CME format in which clinicians work on improving individual performance by completing two stages of retrospective patient data collection and implementing a plan for improving care in their practice. There s an increasing acceptance that improving care will require us as healthcare professionals to measure and monitor indicators of quality with the goal of identifying areas where current practice falls below established standards and where opportunities for improvement are present. PI CME is one way of doing this. To our knowledge, this program is the only PI initiative focused solely on the care of patients with MS. There s three phases in this process, and five CME credits are available for each step, with an additional five credits available to those who complete the entire activity, for a total of 20. In Stage A, the first step, participants perform a retrospective analysis of five patient charts by completing a standardized data form. The data can be either entered online directly by the participant or their designee, or faxed into Med- IQ and one of their staff will enter the data for you. Once the chart review has

3 been completed, participants receive a summary of their practice patterns relative to those of their peers also enrolled in the program and any peerbased or national standards where available. In the next step, Stage B, participants review these results and design a process-based improvement strategy specific to the needs of their practice. To help develop a plan, clinicians may read a complimentary, certified CME implementation guide that outlines the current evidence base and treatment guidelines and provides some practical tools and resources. We recommend that participants implement their improvement plans for at least 30 days before returning to review an additional five patient charts in the final step, Stage C. Charts selected for this stage of this program should be for patients who are seen after the clinician started the program and ideally would include patients who were initially diagnosed after the clinician put his or her improvement strategy into place. At the conclusion of Stage C, participants receive a summary of their current practice patterns relative to their earlier practice patterns as well as those of their peers and any national standards that apply. They can then assess whether there s been any change in their practice. The American Board of Psychiatry and Neurology has reviewed this PI program and accepted it as meeting the maintenance of certification requirements for the performance in practice, or PIP, and lifelong learning programs. Now that we ve discussed the framework of PI CME, I d like to take a few minutes to highlight the key challenges we face in managing patients with MS and some of the early data we gathered through this particular PI program. When we started to develop the PI program, we had to identify quality of care indicators that could be used to assess the management of MS. This proved difficult due to the complexity of managing MS in the individual patient. Although significant advances in the recognition and management of MS have provided us with more understanding of the disease and more therapeutic options, this has also increased the complexity of optimizing treatment at the individual patient level. In the end, we developed this program to focus on three general areas of care for patients with MS: the assessment and management of MS-related symptoms, patient education, and the initiation and monitoring of diseasemodifying treatments. This PI program launched about 5 months ago. To date, approximately 400 clinicians have registered for the program, about 55 have started or completed Stage A, and 11 have completed the entire program. We currently have baseline data from about 300 patient charts. Although it s still very early in the data collection process, for the most part, the baseline data is refreshing in that, for most of the measures, there is a pretty high level of performance among participating neurologists and other clinicians. But there s still some room for improvement in some of these areas. Let s start with the symptomatic assessment and management. Symptomatic

4 issues such as fatigue, cognitive impairment, depression, bladder dysfunction, and gait impairments are quite common in MS and occur in all phases of the disease. The symptoms may be disproportionately severe in comparison with physical disability and may significantly impair quality of life. Patients may not always raise some of these symptomatic issues themselves for a variety of reasons. Therefore, an active approach to assessing patients for MS symptoms, as well as effective symptomatic treatment, is an essential component for managing MS. Looking at some of the early baseline data in the Med-IQ program, clinicians appear to be assessing patients for symptomatic complaints in the majority of cases. The highest rate of assessment has been 90% for pain and other sensory complications. The lowest rate for bowel and general urinary complications report has a participant reporting assessment in about 82%, which is still fairly high. This is not at all surprising since complications such as sexual dysfunction may be more difficult to discuss. Checklists and flow sheets may help with remembering to ask patients about possible symptoms. Once a symptom has been identified, it s important to try to determine the cause and to recommend strategies, which may be pharmacologic, nonpharmacologic, or both, to help treat or manage the symptoms and prevent subsequent complications. Switching gears to disease-modifying treatments, we know there are many complicated decisions. There s a general consensus that disease-modifying treatments are useful in all relapsing forms of MS to reduce the frequency and severity of relapses and reduce disease activity, resulting in improved quality of life. Current data suggest that early intervention with diseasemodifying treatment in high-risk clinically isolated syndrome and early diagnosed relapsed remitting MS is critical because of the early and ongoing central nervous system damage. Factors entering into a decision to initiate treatment are complex, however, and potential adverse effects and patient adherence have to be taken into account. Available guidelines don t emphasize selection of one agent over another based on comparative efficacy or risk benefit. The approval 2 months ago of the first oral treatment, fingolimod, is additional news that has been long awaited in that we finally have an alternative to the currently available injectable agents. However, this may add to the complexity of treatment decisions as we now have to determine how this agent and future oral drugs, which are close behind, will fit into our therapeutic regimen and how their side effect profiles, which differ from those of the injectables in some cases, will be evaluated for use in individual patients. Looking at participants in this program, clinicians reported considering disease-modifying treatment in 91% of patients with relapsing forms of MS and actually initiating it in 83%. This was much higher than what was found in a National MS Society study, which reported only 57% of patients with relapsing-remitting MS were receiving disease-modifying therapy. When it comes to monitoring for adverse effects, almost all patient charts had a

5 record of monitoring for different laboratory tests suggested or required based on the prescribing information. One area that was noted to be in need of improvement is monitoring patients for potential skin reactions, which were not assessed in approximately 25% of patients. As I m sure all of you are well aware, MS is a highly variable and individual disease, and it s difficult to anticipate the response to a particular therapy that an individual patient will have. Therefore, monitoring disease activity and assessment of treatment response are important components in identifying those patients who are having suboptimal responses to therapy. This evaluation is hindered in some ways because there is no universally accepted or validated definition of what constitutes a suboptimal response. Thus, it may be difficult to determine when a change in therapy is needed. We asked participants in this program to report how they monitored disease status and response to therapy. The most frequent method was to read subjective reports of function in 88%. Relapses and changes on MRI were reported for 79% of patients each, while only 46% of patients were monitored through changes on neurologic examination or formal EDSS scores. Five percent of patients had no monitoring reported. In 35% of these patients, the clinicians believed the patient had worsening disease, but a treatment change was recommended only in two-thirds of these patients. So, in conclusion, I ve just touched on a few of the many challenges we encounter in managing MS. We re entering a very exciting time where we have emerging oral agents to add to our therapeutic options, and the complexity of selecting treatment for individual patients and monitoring response to it is only increasing. At this point, I d like to open things up to comments and questions about challenges that you may face in managing your MS patients and strategies for improving their management. So, let me turn it over now to Olivia to begin the instructions for asking these questions. MODERATOR: Thank you, doctor. At this time, we will begin the question and answer session. To ask a question, please press 0, followed by 1 on your touch tone phone. Questions will be answered in the order they are received. Again, if you would like to ask a live question, please press 0, followed by a 1 now. Please pause to assess whether we receive live questions in queue. While we pause, Med-IQ received several questions in advance for this teleconference. At this time, Dr. Cohen will share a question that was submitted by one of your colleagues. Dr. Cohen. DR. COHEN: Thank you, Olivia. So, one of the questions we received was, How will fingolimod, the newly approved oral agent, fit into the current MS treatment algorithm? In particular, what are the major precautions and side effects of this agent that people should be aware of? First, let me just comment that fingolimod is an oral agent that is taken once daily in a dosage of 0.5 mg. The drug has been shown to be beneficial in two large clinical trials, which were published in the New England Journal of Medicine in February of this year. There is a third large phase 3 clinical trial that is

6 currently close to completion with results expected early next year. Fingolimod is indicated for patients with relapsing forms of MS. It is not restricted in that indication, therefore it is potentially available to both patients with newly diagnosed relapsing forms of MS as well as those who may have been on some other therapy and who are being switched to an alternate agent. Among the side effects of fingolimod are an initial drop in blood pressure and pulse rate, which occur on administration of the first dose. This requires observation during that administration for a period of about 6 hours. Most patients don t experience any symptoms in spite of drops in blood pressure and heart rate; however, some do. Some individuals will experience changes in cardiac conduction resulting in irregular heartbeats. Again, most of these individuals are asymptomatic, but some are not; therefore, observation is required. This effect seems to dissipate once an individual has been given this first dose, and further observation of dosing is not required unless the individual has to discontinue medication for a period of 2 weeks or longer, at which time the initiation process has to be repeated. Monitoring for elevation of liver enzymes is required for this agent, similar to other drugs. It is also recommended that individuals be tested for antibodies to varicella zoster virus before administering this agent. The agent is not recommended for individuals who don t have immunity to varicella zoster. It is possible to immunize those individuals, but it s recommended to wait at least 2 months and that immunity be confirmed before the agent is administered. It s not recommended that this agent be given in conjunction with any other immunesuppressive or immune-modulating agents, as it has not been tested in conjunction with any of these agents. There is an increased risk of infections, primarily respiratory tract infections such as bronchitis and herpetic infections, including an increased risk of herpes varicella zoster mostly in the form of shingles in patients receiving fingolimod compared to controls receiving either interferon or placebo. There is also a small risk of macular edema, or swelling in the back of the eye, which requires ophthalmologic monitoring prior to administration of the agent and after 4 months of exposure. Some clinicians will recommend periodic reassessment. Individuals who have diabetes or who have had uveitis may be at increased risk independently of macular edema and should be monitored more frequently. So, to get to the question of where this drug fits in, I think this is an agent to be considered for individuals who are currently on a disease-modifying therapy, but who are not responding as well as either their physician or they would like or who are not tolerating their current disease-modifying therapy well. It is also an option for those individuals who wish to switch from an injectable to an oral agent and do not have any contraindications such as pre-existing cardiac disease, hepatic disease, or other potential contraindications. So, let me stop at this point and see whether there are any questions from folks who are listening.

7 MODERATOR: Thank you, Dr. Cohen. At this time, there are no questions in queue. But as a reminder to our participants, if you would like to ask a live question, you may press 0, followed by a 1 now. And, Dr. Cohen, we do have a live question at this time. And that question comes from Merrillville, Indiana. Please go ahead with your question. PARTICIPANT: Hi, Dr. Cohen. DR. COHEN: How are you? PARTICIPANT: I m glad you re giving this presentation. I m fine, thank you. I have a question regarding patients who have diabetes who may be considering treatment with fingolimod. How much data do we have regarding the risk in those patients and how serious is the risk? DR. COHEN: So, the major issue with respect to patients with diabetes would be the increased risk of macular edema. Those individuals were not included. They were excluded from the clinical trial, so there are no data specifically on that. It is, however, recommended that you should go through not only the baseline screening and the 4 months of screening with those individuals, but also that periodic screening be conducted in individuals who have increased risks, such as those with diabetes. PARTICIPANT: Okay. Thank you. MODERATOR: Thank you for your question. And at this time, Dr. Cohen, would you please proceed with another presubmitted question? DR. COHEN: All right. So, I have two questions related to natalizumab. One is regarding the optimal treatment of individuals who may be found to be seropositive for the JC virus and the questioner is asking whether these patients always have to come off natalizumab. The second question, which is similar, has to do with how to manage individuals who have been on natalizumab treatment for 2 years, whether they should come off the drug, take a drug holiday, continue treatment, or switch to another agent? So, I think the first thing to say in addressing this is that the current study that is ongoing, known as STRATIFY-2, in which individuals are taking the serologic test for JC virus, is still determining the significance of a positive serology and the ability of a positive test to predict future outcomes and risks. So that is not yet determined but is, in fact, one of the goals of this study. Having said that, the latest information that s been reported from cross sectional data from cohorts that have been sampled using this particular assay have suggested that the seropositive rate is about 54%, and that the seronegative rate in individuals who are excreting the virus in their urine, so therefore the false-negative rate, is about 3.5%. It is intuitive and logical that those who are positive and have the virus would have an increased risk of having the disease associated with the virus, but it s also quite clear that not all of these individuals will develop PML. The latest statistics that we have available would suggest that at about the 2-year point, the risk of PML in all

8 individuals receiving natalizumab for at least 2 years is about one per thousand. It may be that the risk will be higher in those individuals who are positive, but that hasn t yet been determined. Having said that, the decision about whether to continue or to discontinue therapy in an individual who is known to be JC positive once they reach the 2-year point would depend on an assessment of how well that individual is doing on the drug, compared to what alternatives might be available to them in the way of alternative disease-modifying therapies, and that to some degree is an individual decision. Some of these individuals may have gone through other alternatives, and, therefore, this may be the best option for them. Other individuals may have such concerns and discomfort regarding continued treatment that an alternative option would be preferable. It isn t known, at this time, what interval would be required in switching from treatment with natalizumab to treatment with other agents. No such studies have been formally conducted. In the clinical trials with fingolimod, a 6-month interval was required between individuals who had been previously exposed to natalizumab and entry into the clinical trials. However, there are no good data that tell us when the effect of natalizumab is completely gone in an individual patient. There are some data that suggest that the beneficial effects of the drug subside within 3 months, but some spinal fluid data suggest that the impact on immune cells in the central nervous system may be more prolonged, perhaps 6 months or longer. Unfortunately, there is no way of assessing this at the individual level currently. So, to some degree, the issue of what other options are available and how well the individual is doing are probably the major issues regarding the decision whether to continue or discontinue natalizumab. With respect to drug holidays, it is unknown at this time whether taking somebody off natalizumab for a period of time and then restarting the drug changes the risk pattern or simply delays it such that the individual then reaccumulates risk at the same rate as they were before stopping. Furthermore, there obviously would be a risk of disease breakthrough when the individual stopped treatment, and the alternative treatment that might be pursued would have to be considered as well. Thirdly, we don t know what the ideal drug holiday interval would be, if there is one whether it should be 6 months, whether it should be 3 months, whether it should be a year. So, it s difficult to know at this point in the absence of any formal data whether drug holidays are of any value whatsoever. Nonetheless, some individuals do opt to discontinue medication after 2 years exposure and, in those instances, certainly a switch to some other disease-modifying agent is indicated at least for the interval when they re off natalizumab. MODERATOR: Thank you. And, Dr. Cohen, we have time to take one final question. We do have a live question in queue, and that question comes from Bay Harbor, Florida. Please go ahead with your question. PARTICIPANT: Hello. Please tell me the final target the final target point is the T

9 line, T cell line or the B cell line or both concerning the inhibition or reduction of the specific or non specific immunologic? Is the new drug fingolimod trying to reduce the B line of response to an unknown antigen or is it the T line or a combination of B and T? DR. COHEN: Okay. It s an important question, but one for which the evidence is still evolving. There is strong evidence for B cell activity in MS. The strongest of which is the effectiveness of pure B cell monoclonal antibodies such as rituximab. In those situations, the activity of the B cell is not likely due to production of immunoglobulin since immunoglobulin levels in those studies didn t drop all that much, probably because rituximab doesn t affect plasma cells. On the other hand, there was a significant effect on the disease process, which probably reflected the role of the B cells as both antigenpresenting cells and as regulatory cells. So, to address your question, I think that there is both T and B cell components in the inflammatory process in MS. PARTICIPANT: Because I think the regulatory is more in the T line, T1 or T2. DR. COHEN: Well, there are clearly T cell regulatory cells. Yes, CD4, CD25, and FOX P3 cells are clearly regulatory. PARTICIPANT: So, it s totally different for rituximab, right? It s mainly on plasma cells. Rituximab works mainly with plasma cells, so it s definitely Bs? DR. COHEN: No, it works on B cells and pre-b cells, but specifically not plasma cells. Plasma cells are spared. PARTICIPANT: Thank you very much. DR. COHEN: You re welcome. MODERATOR: Thank you for your question. Thank you, Dr. Cohen. And thank you all for your attention. This concludes this evening s Multiple Sclerosis Community of Practice Audioconference, which has been sponsored by Med- IQ and supported by an educational grant from Teva Neuroscience. This activity is part of the AMA-standardized, certified, three-stage PI CME series, Performance Improvement Strategies in Multiple Sclerosis. More than 350 specialists have enrolled in this PI initiative to self assess their current MS practice patterns and improve their processes of care. To learn more about this complimentary CME series, or to start today, please visit Thank you for your time and commitment to improving MS patient care.

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