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Supplements Improving the Quality of Life in Patients With Multiple Sclerosis: New Strategies and Opportunities

Improving Quality of Life in Multiple Sclerosis: An Unmet Need

Howard L. Zwibel, MD and Jennifer Smrtka, MSN, ANP-BC, MSCN

Multiple sclerosis (MS) affects approximately 400,000 people in the United States and 2.1 million people worldwide. It is the most common chronic, non-traumatic neurological disorder afflicting young people during their peak productive ages. MS can diminish quality of life (QOL) by interfering with the ability to work, pursue leisure activities, and carry on usual life roles. Symptoms that affect QOL may include impaired mobility, fatigue, depression, pain, spasticity, cognitive impairment, sexual dysfunction, bowel and bladder dysfunction, vision and hearing problems, seizures, and sDwallowing and breathing difficulties. Direct medical costs of MS in the United States are estimated in excess of $10 billion per year. Indirect costs of MS include costs of reduced employment or unemployment, assistive equipment, disability related home modifications, and paid and unpaid personal care. Although direct medical costs predominate in the earlier stages of MS, indirect costs of productivity loss are responsible for higher costs later. Disease-modifying therapies (DMTs) lessen symptoms, reduce relapses, and delay disability progression. Unfortunately, many DMTs might produce only modest improvements in QOL. Although symptom-specific therapies do not delay disease progression, they may delay unemployment and dependency, thereby reducing indirect costs.
(Am J Manag Care. 2011;17:S139-S145)

Multiple Sclerosis and Its Cost Burden

Multiple sclerosis (MS) is a disorder in which inflammation and damage to the insulation surrounding nerve fibers (demyelination) impairs nerve signaling.1,2 MS afflicts approximately 400,000 people in the United States3,4—twice as many women as men2,5 and 2.1 million people worldwide.4 Although most patients with MS are treated at community physician practices, more than 200 centers in the United States, Canada, and Europe are affiliated with the Consortium of Multiple Sclerosis Centers (CMSC), and serve more than 150,000 patients in a specialized setting.6

MS is the most common chronic, non-traumatic neurological disorder among young people.7 Onset usually occurs during the peak productive ages of 20 to 50 years.1,2,7,8,9 MS severely impacts the labor force with both direct and indirect costs (Table 1).9,10,11 Direct medical costs in the United States may exceed $10 billion per year.2 Annual direct costs are estimated to average $47,000 per patient,10 with treatment for a single average MS episode estimated at $12,879.11 In a retrospective claims database analysis, compared with healthy comparison subjects, patients with MS had significantly higher annual total costs and costs for inpatient services, radiology, office visits, and therapies (P <.001).3 MS drugs were $4436 per patient per year.3

Indirect costs include those of reduced employment or unemployment, assistive equipment, disability-related home modifications, and paid or unpaid personal care.11 Depending on the locations of damaged myelin, MS affects sensation, cognition, and motor function,1 all potentially essential to productivity. Fatigue, one of the most common MS symptoms, can be a critical reason for poor job performance and attendance. A 1994 estimate of total lifetime costs per patient ($2.2 million) attributed 57% to non-healthcare costs of lost earnings, home and workplace alterations, equipment, and formal and informal care.12 Although lost income has greatest impact on the patient and family, companies also bear tangible costs (eg, sick days, private insurance disability benefits), as does society as a whole (eg, social security disability benefits). Productivity loss may constitute the largest societal cost burden of MS, with absenteeism or reduced work hours plus early retirement equaling 44% of total costs (Table 1).10 A claims database study found employees with MS had 29.8 disability days per year versus 4.5 days for control employees (P <.0001) and significantly higher annual disability costs ($3868 versus $414, P <.0001), absenteeism costs ($1901 versus $1003, P <.0001), and total indirect costs ($5769 versus $1417, P <.0001).13 Using quality-adjusted life-years valued at $60,000, reduced QOL has been estimated to add $15,315 to annual costs per patient.10

Furthermore, as disease severity increases, costs also increase.14 Direct medical costs predominate in earlier stages, but indirect costs of productivity loss lead the cost distribution later, suggesting that early interventions to delay disease progression may help reduce the cost burden. Disease severity and type of immunomodulatory treatment affect lost work hours.15 Therefore, early treatment that impedes disease progression and delays productivity loss could potentially be cost-effective. However, none of the current disease-modifying treatments cure the disease, stop progression completely, or improve all effects of MS in individual patients, especially reduced QOL.

Disability: Affected by Phenotype and Relapses

MS has 4 main phenotypes which affect progression and influence disability over time. Of all patients with MS, 85% have the relapsing-remitting type (RRMS),16 with symptoms for at least 24 hours followed by remission for at least 1 month.16,17 In many patients, RRMS evolves to secondary progressive MS (SPMS),16 with steady neurologic and functional deterioration independent of relapses, which also may occur.2,5,17 Progressive relapsing MS (PRMS) is continuously progressive from onset, but includes superimposed relapses.2,17,18 Primary progressive MS (PPMS) progresses from onset without relapses and remissions.2,5,17,18,19

MS-related disability, commonly measured with the Kurtzke Expanded Disability Status Scale (EDSS) (Figure),20 accumulates from incomplete recovery after a relapse or deterioration independent of relapse in progressive types.16 In a study of patients given placebo in several clinical trials, at 64 days post relapse, 28% had residual deficit of at least 1.0 EDSS point and 42% had residual deficit of at least 0.5 point.21

In a retrospective review of patients with PRMS, time to EDSS 6.0 (assistive device required to walk ~100 meters) was associated with time to first relapse (r = .80, P = .0004).18 In another study, early relapse in relapsing-onset patients increased immediate risk of reaching EDSS 6.0 and reaching SPMS by 48% and 29%, respectively.16 Once SPMS was reached, relapses had no discernible effect on further progression, suggesting an early window of opportunity for treatments that reduce relapses.16 RRMS may become SPMS when accumulating damage reaches a threshold after which functional deterioration becomes irreversible.2 This would also imply that disease-modifying treatments (DMTs) should be started early during RRMS because they would have reduced effect in SPMS.2 No DMT has received Food and Drug Administration (FDA) approval for PPMS,22 which is more resistant to DMT treatment.2

The actions of DMTs to reduce relapses and delay disability progression (which may lessen symptoms)22 are critical to employment and activities of daily living (ADLs). However, none of the DMTs have data to suggest they are effective to completely arrest disease progression. Additionally, adherence can be problematic regardless of the route of administration. In a retrospective study of pharmacy claims data (injectable medication), the mean medication possession ratio over 24 months was 68.0% and decreased with increasing drug copayments.23 Within 14 months, 43% of patients were non-compliant with their DMT.23 Hospital admissions were higher in patients who were non-adherent (24.7%) than adherent patients (17.7%),23 suggesting that efforts to increase adherence might help control hospital costs.

QOL Burdens on MS Patients and Families

QOL is a subjective measure of a patient’s life satisfaction that is affected by mood, coping mechanisms, life experiences, and emotional support as well as disease state.24 Clinicians cannot appreciate any of these factors without information from the patient. Initial and ongoing MS management should include QOL assessment with structured interviews or formal instruments (eg, MSQOL-54) and additional patient-specific, open-ended questions. Patient feelings about autonomy, empowerment, and QOL can significantly impact adherence to medications and affect physical rehabilitation. Therefore, the CMSC recommends interdisciplinary team care that provides emotional support and promotes self-efficacy as well as skill development.25

According to the National Multiple Sclerosis Society (NMSS), MS diminishes QOL by interfering with ability to work, pursue leisure activities, and carry on usual life roles.26 QOL domains include physical and occupational function, psychological state, and social interaction,27 all of which may be affected in MS. Physical composite QOL scores on the MSQOL-54 are inversely related to disability.28 QOL scores in Physical Functioning and Role-Physical Functioning on the Short Form-36 (SF-36) predict change in EDSS.29 A study found that patients with MS had poorer QOL than other disabled persons and that poor QOL was associated with fatigue, unemployment, and mobility limitations on stairs.30 Thus, QOL is a practical concern related not just to satisfaction or happiness, but to function and productivity in society.

Currently, no cure for MS exists, so it is imperative that decision makers and clinicians consider QOL and the patient’s ongoing experience of MS. Compared with clinicians, patients with MS show less concern about physical role limitations and more concern about mental health and emotional role limitations.31 Psychosocial factors sometimes affect QOL more than physical symptoms,24 and in MS, psychosocial impairments may be independent of disease severity.32 One study found the strongest correlation with poor QOL was the interference of MS with social activities,30 a question clinicians might not ask when assessing disability and progression. Unfortunately, by not asking about QOL, an important need is being overlooked. When clinicians do investigate QOL with patients and caregivers, they may discover issues affecting adherence and gain insight into more effective treatment individualization. Formal assessment instruments include the Multiple Sclerosis Quality of Life-54 (MSQOL-54),33 the Multiple Sclerosis Quality of Life Inventory,34 the Beck Depression Inventory,28 and the Multiple Sclerosis Modified Fatigue Impact Scale.35

In addition to optimizing symptom management and delaying disability progression, assessing and promoting QOL should be a principal goal of treatment. For many MS patients, this remains an unmet need. Ideally, patients diagnosed with MS should be evaluated in MS specialty centers with multidisciplinary teams, such as those in the CMSC, to identify individual needs and design therapy to minimize progression and maximize QOL. Although DMTs may reduce symptoms and relapses and delay progression,1,2,8 many DMTs produce little improvement in QOL.32 Other treatments, which do not impede the underlying disease process, improve specific symptoms and function, which may positively impact QOL.

Symptoms That Worsen QOL

 
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