Arrighi, H.M.

Diels, J.

Gaudig, M.

Spencer, M.

Thompson, G.

van Sanden, S.

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tions. Extrapolating to national data, it is estimated that more than €14 billion were
paid for AEDs in off-label use (more than €13 billion paid by the NHS).
PND8
PREVALENCE AND INCIDENCE RATES OF MULTIPLE SCLEROSIS IN THE UNITED
STATES
Baser O1, Wang L2, Li T3, Shu Z3, Xie L4
1STATinMED Research/The University of Michigan, Ann Arbor, MI, USA, 2STATinMED Research,
Dallas, TX, USA, 3STATinMED (BeiJing) International Healthcare Technology Assessment Co.,
Ltd., BeiJing, China, 4STATinMED Research, Ann Arbor, MI, USA
OBJECTIVES: Multiple sclerosis (MS) is a chronic inflammatory disease with 12,000
new diagnoses per year in the United States. Higher latitude is associated with
higher MS prevalence rates, and the female-to-male ratio in MS incidence has been
estimated at 2:3 in 2000. This study aims to estimate the prevalence and incidence
rate of MS in the United States. METHODS: Patients with an MS diagnosis (Inter-
national Classification of Diseases Ninth Revision Clinical Modification [ICD-9-CM]
code: 340.XX) between January 2006 and December 2010 were identified from a
large U.S. claims database. Prevalence rates from 2006 to 2010 were calculated by
dividing the number of MS patients by the total number of health plan enrollees in
each year. The 2010 incidence rate was calculated by dividing the number of pa-
tients with a new MS diagnosis in 2010 by the total number of enrollees in 2010.
RESULTS: The prevalence rate remained stable at 0.16% from 2006 to 2008, and
then increased in 2009 (0.17%) and again in 2010 (0.19%). In 2010, MS prevalence in
women (0.26%) was more than twice the rate than that of the male population
(0.09%). To examine regional differences, prevalence rate was also calculated for
each U.S. state. Regional prevalence rates ranged from 0.11% (Arkansas) to 0.29%
(Rhode Island). The estimated incidence rate for 2010 was 0.03% for the overall
population, 0.05% for female, and 0.02% for male patients. Incident cases had an
average age of 49 years, and were more likely to suffer from comorbid conditions,
such as disturbance of skin sensation, fatigue, and hypertension. Incidence rates
by state ranged from 0.01% (Maine) to 0.08% (Michigan). CONCLUSIONS: This study
confirms that MS prevalence and incidence rates are higher in female patients, and
in regions farther away from the equator.
PND9
FREQUENCY AND IMPACT OF RELAPSES IN GERMAN PATIENTS WITH
MULTIPLE SCLEROSIS BASED ON A LONGITUDINAL POPULATION-BASED
STUDY
Schmidt J1, Dippel FW2, Kuehne S3, Holz B4, Larisch K5
1TU München, Garching, Germany, 2Sanofi Deutschland GmbH, Berlin, Germany, 3Sanofi-Aventis
Deutschland GmbH, Berlin, Germany, 4Genzyme GmbH, Neu Isenburg, Germany,
5Gesundheitsforen Leipzig GmbH, Büro München, München, Germany
OBJECTIVES: One important aspect for patients suffering from multiple sclerosis
(MS) is the frequency and severity of relapses that lead to a significant increase in
symptoms and an aggravation of health related quality of life. In this study, data of
about 3,000 MS patients have been analysed over a five year period in order to
identify the number of relapses and the events that may follow a relapse.
METHODS: Information was taken from 2006 to 2010 German claims data. To iden-
tify a relapse, several indicators such as hospitalisations, specific relapse medica-
tion and outpatient consultations have been investigated. RESULTS: The results
show that the identification of relapses can be achieved by including inpatient,
outpatient and relapse medication data. Relapses were found for 47% of all MS
patients. Among those receiving MS medication, 67% suffered from relapses while
only 32% of the patients without medication were affected. This may indicate that
the proportion of patients having a higher risk of relapses is usually under MS-
treatment. Most patients with relapses (64%) did not show more than three re-
lapses within five years. The events following a relapse were classified by the
number of hospitalisations (14% within one month after the relapse), transitions
from basic to escalating MS medication (3% within one quarter after the relapse) or
changes of disease modifying drug (3% within one quarter after the relapse).
Changes of basic MS medication are not necessarily related to relapses, while
changes from basic to escalating MS medication are often observed after such an
event. CONCLUSIONS: Patients with high frequencies of relapses are treated with
disease modifying drugs more often than other patients. Most of the MS patients do
not suffer from relapses within the observation period of five years, with a small
group of patients suffering from numerous relapses.
PND10
FASTER COGNITIVE DECLINE IS ASSOCIATED WITH DECREASING SURVIVAL IN
PATIENTS WITH ALZHEIMER’S DISEASE
van Sanden S1, Diels J2, Gaudig M3, Spencer M4, Thompson G5, Arrighi HM6
1EMEA HEMAR Analytics, Janssen EMEA, Beerse, Belgium, 2Janssen Pharmaceutica, Beerse,
Belgium, 3Janssen Alzheimer Immunotherapy, Dublin, Ireland, 4Janssen-Cilag Limited, High
Wycombe, Bucks, UK, 5Janssen-Cilag Ltd., High Wycombe, UK, 6Janssen Alzheimer
Immunotherapy, San Francisco, CA, USA
OBJECTIVES: To explore the impact of severity and rate of decline of cognitive
impairment on mortality within Alzheimer’s disease (AD) patients. METHODS:
Data on AD patients were from CERAD (Consortium to Establish a Registry for
Alzheimer’s Disease), a US multicenter, longitudinal study. Patient demographics,
cardiovascular and other co-morbidities, activities of daily living (ADL), cognitive
impairment measured by the Mini-Mental State Examination (MMSE) and Clinical
Dementia Rating (CDR), and survival status were obtained at study entry (baseline),
and at annual follow-up visits. Study survival time was modelled as a function of
patient baseline demographics, cognitive impairment at entry and its decline over
time using parametric survival models and semi-parametric Cox proportional haz-
ard model (PH), with decline of cognitive impairment as a time-dependent
covariate. RESULTS: 1010 patients with non-missing survival data were included in
the analysis. At baseline, men, age and cognitive impairment significantly in-
creased the mortality risk (p0.001 for all). Additionally, patients progressing to a
more severe stage of cognition over time had significantly higher mortality risk
(p0.001), with a hazard ratio for CDR change over time versus baseline as a time
dependent covariate of 1.35 [95% CI: 1.21-1.51]. CDR and MMSE scores were highly
correlated; results based on models using either CDR or MMSE were mostly consis-
tent. Results were confirmed by sensitivity analyses with varying modelling
assumptions. CONCLUSIONS: Severity and rate of decline of cognitive impairment
are both strong predictors of survival in AD, additional to the usual demographic
and clinical patient characteristics. These findings suggest that treatments delay-
ing the progression of AD patients to more severe stages of cognitive impairment
might positively impact overall survival.
PND11
ESTIMATING SURVIVAL-BENEFIT OF NEW THERAPEUTIC INTERVENTIONS IN
CYSTIC FIBROSIS PATIENTS IN GERMANY, FRANCE, UK AND IRELAND
Becker CC, Kim M, Johnson C
Vertex Pharmaceuticals, Cambridge, MA, USA
OBJECTIVES: Cystic fibrosis (CF), the most common lethal genetic disease in Cau-
casians, causes a high burden of disease. Median age at death is in the late 20s with
the most common mode of death being respiratory failure. Treatment with iva-
caftor, a CF transmembrane conductance regulator (CFTR) protein potentiator, was
generally safe and improved risk-factors for mortality in CF, including pulmonary
function, weight and pulmonary exacerbations. Since controlled clinical trials can-
not directly demonstrate survival benefits, we estimated the potential for survival
benefit from drug therapies based on similar, observed short-term changes to risk
factors known to impact survival in CF. METHODS: Survival information for CF
patients in Germany, France, the UK, and Ireland was obtained from national reg-
istries and individually fitted to a Weibull function. From these survival curves the
hazard function for an average CF patient was calculated as a function of age. The
impact to the hazard function from improvements in risk factors (FEV1, weight-
for-age z-score, pancreatic sufficiency, diabetes, Staphylococcus aureus, Burkholderia
cepacia, and annual number of pulmonary exacerbations) was estimated using pre-
viously published Cox proportional hazards model for CF mortality. RESULTS: For
each country, a survival function was developed taking into account current aver-
age mortality rates and estimated long-term changes to risk factors. Sensitivity
analysis suggest that it is possible for drugs that improve clinical outcomes in CF,
including pulmonary function, weight and pulmonary exacerbations, to add a de-
cade to the median life expectancy CF patients. CONCLUSIONS:Modeling suggests
that therapies that improve clinical risk factors for mortality in CF, including pul-
monary function, weight and pulmonary exacerbations, may extend the lives of CF
patients.
NEUROLOGICAL DISORDERS - Cost Studies
PND12
BUDGET IMPACT ANALYSIS OF ROUTINE TESTING FOR GENETICALLY BASED
CARDIOPATHIES ASSOCIATED WITH HIGH RISK OF SUDDEN DEATH IN SPAIN:
PRELIMINARY RESULTS
Fernández I1, García-Pavía P1, Ripoll T2, Boldeanu A3, Gracia A4, Ramírez de Arellano A4,
Aceituno S5, Lizán L5, Puig-Gilberte J6, Salas E6
1Hospital Universitario Puerta del Hierro, Madrid, Spain, 2Hospital Son Llàtzer, Palma de
Mallorca, Spain, 3FERRER-inCode, Barcelona, Spain, 4Ferrer Grupo, Barcelona, Spain, 5Outcomes
10, Castellón, Spain, 6GENDIAG, Barcelona, Spain
OBJECTIVES: To estimate the economic impact of introducing the test for diagnos-
ing the five cardiopathies associated to SCD related to the currently best known
genes in Spain: 1.Hypertrophic Cardiomyopathy (HCM); 2.Arrhythmogenic Right
Ventricular Cardiomyopathy (ARVC); 3.Long-QT Syndrome (LQTS); 4.Brugada Syn-
drome (BrS), and 5.Catecholaminergic Polymorphic Ventricular Tachycardia
(CPVT). METHODS: A 3-year budget impact analysis was carried out based on in-
ternational sources of epidemiological and health care resource utilization data;
local input costs and market share, and expert opinion. Two scenarios were com-
pared: current clinical practice (with no genetic testing) vs. alternative practice
(with genetic testing). The perspective adopted was that of the Spanish National
Healthcare System (NHS). All costs referred to €, 2012. RESULTS: The target popu-
lation at risk of SCD was estimated on 25,220 patients for year 1; 26,352 for year 2,
and 26,340 for year 3. Genetic testing would be conducted in 350, 550 and 700
patients in 2012, 2013 and 2014, respectively. The budget impact of introducing the
genetic testing would imply an additional cost of € 309,187, € 532,311, and € 724,404,
respectively. Genetic testing compared to current practice would imply cost sav-
ings of € 10,152 and of € 41,062, in the first year; of € 30,327 and € 84,026, in the
second, and of € 57,269 and € 126,660 in the third year derived from two reasons:
preventing new events in patients at risk and from averting follow-up in patients at
no risk, respectively. CONCLUSIONS: Potential cost savings derived from prevent-
ing new events and unnecessary follow-up may overcome the costs of introducing
the genetic testing for HCM, ARVC, LQTS, BrS and CPVT in the Spanish NHS.
PND13
BUDGET IMPACT ANALYSIS AND UPDATE OF A COST EFFECTIVENESS
EVALUATION FOR ALPHA () POLYMORPH RIFAXIMIN FOR THE TREATMENT OF
ACUTE HEPATIC ENCEPHALOPATHY
Cardona DP1, Zapata L2, Ceballos M1, Diez F3, Rico I2, Zavala A3
1Universidad De Antioquia- Facultad De Quimica Farmaceutica, MEDELLIN, ANTIOQUIA,
Colombia, 2Guia Mark, Mexico, DF, Mexico, 3Guia Mark, México, DF, Mexico
OBJECTIVES: Cirrhosis and its complications, such as hepatic encephalopathy (HE)
are the sixth cause of general mortality in Mexico. The objective is to update costs,
A547V A L U E I N H E A L T H 1 5 ( 2 0 1 2 ) A 2 7 7 – A 5 7 5


PND10 Faster Cognitive Decline is Associated With Decreasing Survival in Patients With Alzheimer'S Disease 

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PND10 Faster Cognitive Decline is Associated With Decreasing Survival in Patients With Alzheimer'S Disease

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