Comparative Effectiveness and Cost-Effectiveness of Natalizumab and Fingolimod in Patients with Inadequate Response to Disease-Modifying Therapies in Relapsing-Remitting Multiple Sclerosis in the United Kingdom.

BACKGROUND: Patients with highly active relapsing-remitting multiple sclerosis inadequately responding to first-line therapies (interferon-based therapies, glatiramer acetate, dimethyl fumarate, and teriflunomide, known collectively as "BRACETD") often switch to natalizumab or fingolimod. OBJECTIVE: The aim was to estimate the comparative effectiveness of switching to natalizumab or fingolimod or within BRACETD using real-world data and to evaluate the cost-effectiveness of switching to natalizumab versus fingolimod using a United Kingdom (UK) third-party payer perspective. METHODS: Real-world data were obtained from MSBase for patients relapsing on BRACETD in the year before switching to natalizumab or fingolimod or within BRACETD. Three-way-multinomial-propensity-score-matched cohorts were identified, and comparisons between treatment groups were conducted for annualised relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M). Results were applied in a cost-effectiveness model over a lifetime horizon using a published Markov structure with health states based on the Expanded Disability Status Scale. Other model parameters were obtained from the UK MS Survey 2015, published literature, and publicly available UK sources. RESULTS: The MSBase analysis found a significant reduction in ARR (rate ratio [RR] = 0.64; 95% confidence interval [CI] 0.57-0.72; p < 0.001) and an increase in CDI6M (hazard ratio [HR] = 1.67; 95% CI 1.30-2.15; p < 0.001) for switching to natalizumab compared with BRACETD. For switching to fingolimod, the reduction in ARR (RR = 0.91; 95% CI 0.81-1.03; p = 0.133) and increase in CDI6M (HR = 1.30; 95% CI 0.99-1.72; p = 0.058) compared with BRACETD were not significant. Switching to natalizumab was associated with a significant reduction in ARR (RR = 0.70; 95% CI 0.62-0.79; p < 0.001) and an increase in CDI6M (HR = 1.28; 95% CI 1.01-1.62; p = 0.040) compared to switching to fingolimod. No evidence of difference in CDW6M was found between treatment groups. Natalizumab dominated (higher quality-adjusted life-years [QALYs] and lower costs) fingolimod in the base-case cost-effectiveness analysis (0.453 higher QALYs and £20,843 lower costs per patient). Results were consistent across sensitivity analyses. CONCLUSIONS: This novel real-world analysis suggests a clinical benefit for therapy escalation to natalizumab versus fingolimod based on comparative effectiveness results, translating to higher QALYs and lower costs for UK patients inadequately responding to BRACETD.

Economic burden of multiple sclerosis on Kuwait health care system.

BACKGROUND: Multiple Sclerosis (MS) is a chronic neurological disease with heavy economic and social burdens resulting in significant disability. OBJECTIVE: This study aims to (1) measure the cost of health resources utilization by MS patients and (2) to examine the difference in utilization and its attributed costs amongst patients who may have a different course of MS and expanded disability status scale (EDSS) scores. METHODS: A cross-sectional study using Kuwait National MS registry was conducted to estimate the costs of utilization of resources from 2011 to 2015. RESULTS: Between the period 2011-2015, 1344 MS patients were included in the registry. The average annual cost per MS patient has increased from $10,271 in 2011 to $17,296 in 2015. Utilization of disease-modifying therapies (DMTs) was the main driver of costs reaching 89.9% in 2015. Throughout the five-year period, the occurrence of relapses decreased from 21.8% to 12.2% (p <0.0001). During this same period, ambulatory relapse treatment increased by 5.8% while hospitalizations decreased by 2.6%. Patients with a moderate EDSS score (3.5-6) had the highest average cost (p<0.0001) compared to mild and severe EDSS scores. CONCLUSIONS: Multiple sclerosis has been a significant economic burden on the Kuwait healthcare system. DMTs are the main driver of cost.

Burden of migraine in a Kuwaiti population: a door-to-door survey.

BACKGROUND: Migraine prevalence and disability imprints on Kuwaiti population are underreported. We aimed to measure the prevalence of migraine and to assess its burden in Kuwait. METHODS: A cross-sectional community-based study was conducted which included biologically unrelated Kuwaiti adult population aged 18-65 years. They were randomly recruited from all six governments of Kuwait using stratified multistage cluster sampling. Trained interviewers visited the samples in door-to-door approach. The Headache-Attributed Restriction, Disability, and Social Handicap and Impaired Participation (HARDSHIP) questionnaire was used to collect the data. Demographic enquires were followed by diagnostic and disability questions. RESULTS: A total of 15,523 subjects were identified; of whom 3588 (23%) were diagnosed as episodic migraine and 845 (5.4%) as chronic headache. Prevalence of episodic migraine was 31.71% in female versus 14.88% in males (P < 0.01) with a mean age of 34.56 ± 10.17 years. Most of migraine cohort (64.4%) sought medical advice with respect to their migraine headaches and the majority (62.4%) were seen by general practitioners (GPs) while 17.2% were assessed by neurologists and 3.7% was seen by other specialties. Tension type headache and sinus-related headaches were diagnosed in 8.9% and 2.1% of migraine subjects respectively. The majority (94.6%) of migraine subjects used symptomatic drugs for headache attacks, whereas 39.9% were taking preventive medication. In the preceding 3 months to the survey, subjects with episodic migraine had lost a mean of 1.97 days from their paid work or school attendance compared to 6.62 days in chronic headache sufferers (P < 0.001). Additionally, subjects with episodic migraine lost a mean of 1.40 days from household work compared to 5.35 days in subjects with chronic headache (P < 0.001). Participants with episodic migraine and chronic headache missed a mean of 2.81 and 3.85 days on social occasions, in the preceding 3 months (P < 0.001). CONCLUSIONS: Migraine in Kuwait is highly prevalent and it has a significant impact on activity of daily living, schooling/ employment and social occasions of patients. Accurate diagnosis, effective abortive and preventive treatments of migraine are paramount to improve quality of life and as well as cost saving.

Assessment of plasma biomarkers for their association with Multiple Sclerosis progression.

In a cross-sectional study involving 160 Multiple Sclerosis (MS) patients and 70 healthy controls we set out to determine the association of five blood biomarkers with MS risk and progression scores. High levels of Semaphorin3A (SEMA3A) in females, and low levels of prolactin and estradiol in males associated with MS risk. High MS disability correlated with higher SEMA3A levels in females. Our findings suggest the clinical applicability of SEMA3A, and prolactin as biomarkers for MS progression. However, these biomarkers had sex-specific associations with MS, and any therapeutic approaches utilizing them should take that into consideration.