Quality Initiatives in Managing Multiple Sclerosis

Minneapolis—The US Food and Drug Administration has approved several drugs in recent years to treat multiple sclerosis (MS), including fingolimod, the first oral MS therapy. There are also 5 drugs in phase 3 trials intended to treat MS. However, the disease remains costly, and the cause of MS is unknown. With an increasing emphasis on quality initiatives, though, healthcare professionals are gaining confidence that they can better manage MS, according to presenters who spoke during a satellite symposium at the AMCP meeting titled Quality Improvement Initiatives in Multiple Sclerosis Management. Karen Koi, RPh, pharmacy services manager for Aetna Pharmacy Management in Orlando, Florida, said AMCP is in a good position to represent pharmacists’ interests in the evolving federal quality initiatives. In February, AMCP was appointed to the National Quality Forum’s Measure Applications Partnership Coordinating Committee. The committee provides guidance to the Department of Health and Human Services on public reporting issues and performance-based payment programs. With advanced biopharmaceuticals becoming more popular, Ms. Koi said there are potential concerns regarding monopoly power because only one or very few companies manufacture the drugs, which could lead to high prices. In addition, patients expect they will have the costly drugs covered in their plans, but the effectiveness of the drugs may not be what some believe. Ms. Koi said MS is becoming more expensive because of new diagnostic tools, molecular biology-based drugs, and emerging imaging technologies. She cited a 2006 article from Neurology that found that the total cost of treating MS patients in 2004 was $47,215 per year, which included direct and indirect costs such as early retirement and productivity losses. Ms. Koi also discussed a November 2010 article from The Medical Letter that compared the yearly cost of treatment for several drugs to treat relapsing MS: interferon beta-1a costs between $38,532.00 and $38,654.98; interferon beta-1b costs $35,810.32; fingolimod costs $57,699.20; glatiramer acetate costs $42,939.65; and natalizumab costs $40,426.36. To lower costs associated with MS, Ms. Koi said healthcare professionals must focus on reducing the number of relapses. Although Ms. Koi admitted the cost of treating a relapse is difficult to calculate, she cited a study that estimated the cost between $243 and $12,870 (in 2002 dollars) depending on the intensity of the MS episode. One major problem, Ms. Koi said, is that many MS patients do not adhere to their medications. In some studies, 50% of patients discontinued use of therapies because of an adverse effect or lack of efficacy. Ms. Koi said patient adherence decreases over time because of a loss of motivation or complacency. Disease management programs may be effective at increasing adherence, but only a few managed care organizations have them, according to Ms. Koi. She said also specialty pharmacies are in a position to provide medication therapy management services, but their roles will change with new therapies entering the market. Howard L. Zwibel, MD, founding medical director emeritus of Neuroscience Consultants in Coral Gables, Florida, followed with an overview of MS and treatment options. There are approximately 400,000 cases of MS in the United States and 2.5 million worldwide, and it is the leading cause of neurologic disability in young adults, according to Dr. Zwibel. Approximately 75% of cases are present in people between 15 and 45 years of age. Dr. Zwibel discussed the McDonald criteria for diagnosing MS as well as the Extended Disability Status Score (EDSS) system. EDSS is a scoring system that measures MS disability progression and is “very important” in understanding a patient’s status, according to Dr. Zwibel. MS patients may soon have many more choices for therapy, Dr. Zwibel said, with 5 oral drugs currently in phase 3 trials: cladribine, teriflunomide, laquinimod, dimethyl fumarate, and firategrast. Late-stage trials are also evaluating the safety and effectiveness of monoclonal antibodies such as alemtuzumab, daclizumab, rituximab, ocrelizumab, and ofatumumab. As of now, the following are first-line treatments for relapsing-remitting MS: 20 mg of glatiramer acetate administered subcutaneously once daily; 30 mcg of low-dose interferon beta-1a administered through intramuscular injection once per week; 22 or 44 mcg of high-dose interferon beta-1a administered subcutaneously 3 times per week; 250 mcg of high-dose interferon beta-1b administered subcutaneously every other day; and 0.5 mg of fingolimod administered orally once daily. “[Trials] show these drugs are effective in the long term, and they are safe,” Dr. Zwibel said. With so many MS treatment options and rising costs, healthcare professionals should design programs to help effectively manage the disease, according to Donald Fetterolf, MD, MBA, FACP, principal of Fetterolf Healthcare Consulting in Imperial, Pennsylvania. The program goals may include lowering per member per month costs, improving quality, reducing administrative overhead, increasing revenue, improving relations with physicians and patients, and creating a return on investment. Before designing a program, Dr. Fetterolf said organizations must identify the goals and initiatives. They can then determine outcomes metrics that reflect and examine the development, progression, and treatment of MS. The outcomes measured could include descriptive, demographic, clinical, and utilization statistics as well as financial impact, such as the program’s cost, savings, and return on investment. “There are a lot of strategies, but it’s more than one thing,” Dr. Fetterolf said. “There’s a whole list of procedures and technique designed to address errors in the system.” Dr. Fetterolf said it is important for healthcare professionals to link indicators of MS to metrics that assess MS on an individual and societal level. However, he said the progression has not moved as quickly in other diseases with similar cost profiles, such as diabetes, chronic heart failure, and asthma. “There really aren’t clinical guidelines for MS,” Dr. Fetterolf said. “It would be nice to be able to say ‘do this,’ or even have an algorithm to help us know what to do.” Quality measurements are also crucial to managing MS, according to Dr. Fetterolf. He discussed a 2010 article from Multiple Sclerosis in which the authors identified 25 MS symptom domains and 14 general health domains of MS care and determined 76 MS care indicators that could be used to measure quality. Dr. Fetterolf suggested that in the coming years, healthcare professionals should utilize these and other quality measures to determine if MS patients are receiving appropriate and comprehensive care. In addition, Dr. Fetterolf said there needs to be an increased emphasis on benchmarking, measuring the clinical effectiveness of MS, determining the economic impact of the disease, and implementing cost-effectiveness research.