Timothy L. Vollmer, MD, Director, Yale Center for Multiple Sclerosis Treatment and Research, Yale University School of Medicine, VA Connecticut Healthcare System, New Haven, CT; Olympia Hadjimichael, MPH, Coordinator, NARCOMS Project, Yale Center for Multiple Sclerosis Treatment and Research, Yale University School of Medicine, VA Connecticut Healthcare System, New Haven, CT

Multiple sclerosis (MS) is a degenerative disease affecting the nervous system. MS symptoms occur because of immune attacks on the central nervous system that destroy a fatty substance called myelin, which enwraps nerve fibers and helps them transmit signals. The cause of MS is unknown, but it is believed that most likely some trigger in the environment leads to the disease in people who have a genetic predisposition. In the United States, 250,000 to 350,000 people have MS.

MS usually begins during young adulthood and affects primarily women. In most cases, MS start s with brief flare-ups of neurological symptoms that are followed by much longer periods of remission, during which symptoms often decrease. This form of MS is called ”relapsing - remitting.” After some years, disabilities incurred during the exacerbations become permanent, and the patient is increasingly disabled. Late in the course of MS, most patients become progressively more disabled even without experiencing relapses; this form of disease is termed “secondary progressive.” A small percentage of patients, mostly men, never experience a relapse, but have steadily increasing neurological symptoms and disability. This is termed “primary progressive” MS.

A number of treatments are available to help control the symptoms of MS, which include difficulty with movement, loss of sensation, muscle spasticity, pain, fatigue, depression, and bladder problems. There is also a small set of therapies that can slow the progression of the disease (National Multiple Sclerosis Society Medical Advisory Board, 2001; Goodin et al., 2002). Known as disease modifying agents for MS (DMAMS), these drugs include the interferons (Betaseron®, Avonex®, and Rebif®), glatiramer acetate (Copaxone®), mitoxantrone (Novantrone®), and a number of other medications that suppress the immune system. In addition to medications, patients with MS often require rehabilitative services and help with activities of daily living. Counting the cost of medications and services, and indirect costs like lost wages for patients and their families, the average health-related costs per patient with MS per year have been estimated at about $35,000. For large health care systems, such as the Veterans Healthcare Administration (VHA), that provide benefits to a great number of patients with MS, the direct health care costs related to caring for these patients alone can be very high. For this reason, there is a lot of motivation to understand what types of services a re needed and what services are being used by patients with MS, so that care can be provided in an efficient and low-cost manner.

For any kind of medical research, it is necessary to study a group of people who are representative of all those who have a particular illness, so that the results are applicable to all. This is especially important for MS because the natural history of the disease is so variable that if the group studied is small, the characteristics of the disease in that group may be very different from the characteristics in the larger patient population. One way to get around this problem is to use information from a very large number of patients, since the larger the group, the more likely it is that it will resemble the universal MS population. The NARCOMS MS Patient Registry, which collects data on over 20,000 patients with MS, is an excellent source for the data needed for research studies. Recently, we used the Registry to investigate the disability levels of and treatment received by U.S. veterans with MS whose health services are provided by the VHA. The VHA resembles nationalized health care systems, like the one in Canada, and offers comprehensive health care and preventive care to eligible veterans. We compared the Information about these veterans with the same data for veterans who receive care from health plans outside the VHA and for non-veterans to see whether MS care differs when it is provided within a comprehensive health care system such as the VHA.

Veterans in the Registry

In 1998, Eastern Paralyzed Veterans Association (EPVA) and Paralyzed Veterans Association (PVA) collaborated with the NARCOMS MS Patient Registry to recruit veterans with MS, leading to the enrollment of more than 4,000 veterans. The total enrollment in NARCOMS currently exceeds 20,000 persons with MS. Hence, the NARCOMS MS database is particularly well suited for studies that compare veterans and non-veterans.

As a first step, we compared veterans and non-veterans in the MS database. The data include demographic information (date of birth, gender, age, where the patient lives, etc.), health care insurance, history of MS, use of DMAMS, treatment for MS symptoms, health care services used, and information on disability and handicap. The information about disability and handicap is based on two scales, the patient-determined disease steps (PDDS) and the Performance Scales. The numbers generated by these scales reflect the ability to function according to eight neurological measurements: mobility, hand function, fatigue, vision, cognition, sensation, bladder function, and spasticity. The PDDS is on an 8-point scale where 0 = no disability and 8 = bedridden. The information in the Registry is updated every 6 months by most participants.

Patients in the Registry were assigned an MS type based on their answers to questions about relapses over the course of the disease in the last year. Patients with relapses but no increase in symptoms, or a drop in disability over the past year, were classified as having “relapsing-stable ” disease. Patients with “relapsing-worsening” disease had worsening symptoms over the past year. These patients have secondary progressive MS, which is often accompanied by relapses, or relapsing-remitting disease with accumulating disability. Finally, patients with primary progressive disease never had a relapse, but had increasingly worsening symptoms.

Of the patients in the database, 4,230 were veterans. Among those, 2,150 veterans received health care from the VHA and 2,107 received health care from other providers. There were 16,119 patients in the Registry who were not veterans.

Overall, the patients in the NARCOMS MS Registry have the expected MS characteristics. For example, 75% are female, 95% a re Caucasian, and 35% are disabled. Many of these characteristics, however, are different in the subset of patients who are veterans. As the numbers show in Table 1, the male veteran population with MS outnumbers the female by three to one. The veterans are typically older than the non-veterans and have had MS for a longer time. Fewer veterans are employed than are non-veterans, and veterans with VHA care are more likely to earn less than $30,000/year than are other veterans or non-veterans.

There are differences in the course of the disease as well. More VHA veterans had relapsing-worsening disease than did other patients. Both veteran groups included a higher percentage of patients with primary progressive MS than is seen among non-veterans. This form of MS is more common in men, and the higher percentile among veterans is probably because there are so many more male than female veterans (Polliack, Barak, Achiron, 2001; Cottrell et al., 1999).

As might be expected from their greater age and length of illness, the VHA veterans were also more disabled than the other veterans or non-veterans. On the PDDS scale, VHA veterans scored an average of 5.0, other veterans scored 4.0, and non-veterans 3.6. Even when the scores were adjusted for age, veterans were still more disabled than were other patients with MS.

Comparing Veterans and Non-Veterans

Matched Groups: Since a straightforward comparison of veterans with non-veterans in the NARCOMS MS Registry showed that there were many differences between the two patient populations, direct comparison of treatment patterns would not be appropriate. In order to compare treatments MS to non-veterans who obtain health care from the private sector, we matched each VHA veteran with a non-veteran according to age, gender, and degree of disability. As a result of this matching strategy, we obtained two groups of 1,704 patients with very similar characteristics. These groups were then used to investigate differences in treatment between VHA veterans and non-veterans.

Clinical Care: First, we examined the kind of clinical care received by each group over the previous year (Figure 1). We found that veterans receiving care from the VHA consulted neurologists, both MS specialists and non-specialists, about as often as non-veterans did, but VHA veterans consulted MS specialists less often than non-veterans did. VHA veterans received care from rehabilitation specialists, such as physical and occupational therapists, much more often than non-veterans did (30% vs. 20%). VHA veterans were more likely to have received care from nurse clinicians and primary care providers than were non-veteran patients with MS. Visiting nurses provided home services equally to both groups.

Medication Use: We compared the non-veteran and VHA veteran groups to determine what medications they used, considering some non-prescription alternative medications, prescription medications for MS symptoms, and DMAMS (Betaseron, Avonex, Copaxone, Novantrone). We found that only a minority of patients in both groups (less than 25%) used alternative therapies such as special MS diets, evening primrose oil, and so forth. Up to 80% of all patients used prescription medications for MS symptoms, although VHA veterans with relapsing disease were more likely than non-veterans to use medications for symptoms.

The largest difference between the groups was in the use of DMAMS (Figure 2). Among the VHA veterans with relapsing-stable MS, 40% used DMAMS, compared to 55% of patients in the private sector. A smaller difference was seen among the relapsing-worsening patients with MS. For primary progressive MS, there was no difference between the groups: 30% of patients in both groups used DMAMS, although there is little evidence to suggest these medications help patients with this form of MS.

Further investigation into differences in DMAMS use showed that among the FDA approved drugs, such as Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer acetate), and Novantrone (mitoxantrone), VHA veterans were much more likely to be treated with Avonex than were non veterans, and less likely to be treated with Copaxone or Novantrone (Table 3). VHA veterans were also less likely to be treated with other DMAMS medications, such as immunosuppressants, than were patients in the private sector.

Conclusions From This Study

This study was a comparison of MS - related disability and treatment among veterans receiving care from the VHA with veterans receiving care in the private sector and with non-veterans. A direct comparison of the characteristics of these groups showed that veterans are more likely to be male, older, and more disabled than are non-veterans with MS. VHA veterans also have a lower income than do other patients with MS. These findings suggest that care of this patient population by the VHA is likely to be costly. The clinical care provided by the VHA proved to be quite similar and in some ways superior to care in the private sector. Although VHA veterans are slightly less likely to see MS specialists, which probably limits their access to experimental therapies, they see neurologists to the same extent as do patients in the private sector, and they receive more primary and rehabilitative care . VHA veterans use slightly more medications to alleviate symptoms than non-veterans. Of concern, however, is the lower use of DMAMS by VHA veterans, because starting treatment with these drugs early in the course of MS is considered to be important for slowing its progression. We see the gap in the use of DMAMS to be narrowing and, therefore, this may not be a serious concern over time.

This study also showed that a larger percentage of VHA veterans than private-sector patients were treated with Avonex. There is some evidence that stronger doses of interferons than are provided by Avonex may work better, so Avonex may not be the optimal treatment for all of these patients. Although the reason for the differences in prescriptions written by neurologists within the VHA and in the private sector is unclear, VHA neurologists may not have the same continuing education opportunities, as do many neurologists in the private sector. We believe it would be worthwhile to investigate this issue further.

In summary, although the care provided by the VHA to veterans with MS is in many ways similar or superior to care that is available in the private sector, one area of concern is the less frequent prescription of DMAMS, which should be investigated further. In addition, this study provides needed information that could be used by the VHA to improve the quality and efficiency of the health care it delivers to patients with MS and, perhaps, to make itself a model for MS health care. Data from the NARCOMS MS Patient Registry allowed us to make a valid comparison of these disparate patient populations. Studies like this are the payoff for the ongoing contributions made by thousands of patients and clinicians, and many other studies will be possible because of the availability of the NARCOMS MS Registry data.

References

Cottrell, D. A., Dremenchutzky, M., Rice, G. P. A., Koopman, W. J., et al. (1999). The natural history of multiple sclerosis: A geographically based study. 5. The clinical features and natural history of primary progressive multiple sclerosis. Brain, 122, 625 - 639.

Goodin, D. S., Frohman, E. M., Garmany, G. P., Halper, J., Likosky, W. H., Lublin, F. D., et al. (2002). Disease-modifying therapies in multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology, 58, 169 - 178 .

National Multiple Sclerosis Society Medical Advisory Board . (2001). Disease management consensus statement. Retrieved January 18, 2002, from http://www.nationalmssociety.org.

Polliack, M. L., Barak, Y., & Achiron, A. (2001). Late onset multiple sclerosis. Journal of the American Geriatric Society, 49, 168 - 171 .

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