Asseburg, C.

Soini, E.J.

Taiha, M.

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PMS81 Cost-Effectiveness and Budget Impact of Certolizumab Pegol Against a Mix of Treatments in an Outcomes-Based Risk-Sharing Scheme in Finland 

signed to duloxetine or pregabalin cohorts based on their initiated agent. Patients
who had pill coverage of the agents over 90 days preceding the initiation were
excluded. The two comparative cohorts were constructed using propensity score
greedy match approach. Descriptive analysis and paired-t test were performed to
compare fibromyalgia-related health care utilization rates (inpatient, outpatient,
medication) in the one-year post-initiation period between the two matched
cohorts. RESULTS: Both matched cohorts (n  1,265 pairs) had a similar mean
initiation age (49-50 years), female percentage (87-88%), and baseline co-morbid
conditions (neuropathic pain other than diabetic peripheral neuropathic pain, low
back pain, cardiovascular disease, hypertension, headache or migraine and osteo-
arthritis). In the year preceding the initiation, both cohorts had similar inpatient
utilization rates (15.7-16.1%), outpatient utilization rates (100%) and medication
utilization rates (97.9-98.7%). In the post-initiation year, the utilization rates were
different between the cohorts with the pregabalin cohort using more fibromyalgia
related inpatient care (3.2% vs. 2.2%, p0.05), all inpatient care (19.3% vs. 16.8%,
p0.05), fibromyalgia related outpatient care (62.1% vs. 51.8%, p0.05), selective
serotonin reuptake inhibitors (34.0% vs. 20.1%, p0.05) and other fibromyalgia re-
lated medications, including antidepressants and anticonvulsants other than du-
loxetine or pregabalin. CONCLUSIONS: Compared to fibromyalgia patients who
initiated duloxetine, fibromyalgia patients who initiated pregabalin consumed
more fibromyalgia-related inpatient, outpatient, and medication care in the first
post-initiation year.
PMS78
DEMOGRAPHI˙C AND SOCI˙OECONOMI˙C CHARACTERI˙STI˙CS THAT AFFECT
SELECTI˙ON OF I˙NTRAVENOUS VERSUS SUBCUTANEOUS I˙NJECTI˙ON TUMOR
NECROSIS FACTOR INHI˙BITORS FOR RHEUMATOID ARTHRITIS PATIENTS
Baser O1, Wang L2, Lewis-beck C3, Wang H3, Li L2, Xie L3
1STATinMED Research/The University of Michigan, Ann Arbor, MI, USA, 2STATinMED Research,
Dallas, TX, USA, 3STATinMED Research, Ann Arbor, MI, USA
OBJECTIVES: Identify the demographic and socioeconomic predictors associated
with Rheumatoid Arthritis (RA) patients treated with intravenous (IV) versus in-
jectable tumor necrosis factor inhibitors (TNF-i). METHODS: Patients with at least
two RA diagnoses initiating infliximab, etanercept, adalimumab, and IV abatacept
were selected from Medicare database (January 2006 to December 2009). The index
date was defined as the initial prescription or IV administration date. Logistic re-
gression was used to determine covariates that increased the probability a patient
was treated with an IV form of TNF-i (infliximab or IV abatacept) as opposed to a
subcutaneous injection (etanercept or adalimumab). Medications were also ana-
lyzed separately using a multinomial logistic regression model. Demographic, clin-
ical and socioeconomic status (SES) scores were controlled in the models.
RESULTS: Subcutaneous injections were used as the reference category in the
regression model. Patients between ages 65 and 69 were less likely to use IV treat-
ment compared to patients over age 80 (Odds Ratio [OR]: 0.59; p0.0001]). Females
were also less likely to be prescribed IV treatment (OR: 0.76; p0.0001]). Patients
with medium (OR: 1.46; p0.0001) and high SES scores (OR: 1.51; p0.0001) were
more likely to use IV treatments compared to patients with low socioeconomic
status. For multinomial regression, the reference treatment was etanercept. Fe-
male patients had a lower chance of switching to infliximab (OR: 0.73; p0.0001)
and abatacept (OR: 0.76; p0.0001). Patients with an Elixhauser index score2 were
more likely to be prescribed abatacept (OR: 1.45; p0.0001), but less likely to be
prescribed infliximab (OR: 0.86; p0.0023). Lastly, patients were less likely to switch
to adalimumab from etanercept if they had high SES scores. CONCLUSIONS: RA
medication prescriptions are dependent on patient demographic and clinical char-
acteristics. Gender, socioeconomic status, age, and Elixhauser index are all signif-
icant variables in determining the treatment of choice.
PMS79
EVALUATION OF CURRENT HEALTH TECHNOLOGY ASSESSMENTS FOR
RHEUMATOID ARTHRITIS – AN INSIGHT INTO THE KEY UNCERTAINTIES
GENERATED BY THE AVAILABLE EVIDENCE
Sweeney N1, Heemstra L1, Hansen K2, Adalsteinsson JE2
1Quintiles, Hoofddorp, The Netherlands, 2Novo Nordisk A/S, Søborg, Denmark
OBJECTIVES: To gain insight into the key uncertainties generated from the avail-
able evidence in current health technology assessments (HTAs) for rheumatoid
arthritis. METHODS: Step I: Manual search of 75 health care agencies’ websites for
published anti-rheumatic drug-related assessments (January 2010-May 2012). Step
II: All HTAs that received a negative funding decision were then selected for further
evaluation. Of these, the reasons for rejection were categorized and frequency of
mentioning counted. RESULTS: Step I identified 96 HTAs for rheumatoid arthritis;
79 were relevant single technology assessments (STA), appraising a total of 21
drugs (of which 8 biologics). Step II: A total of 26 assessments received a negative
funding decision by 11 independent HTA bodies, appraising between them 12 drugs
(4 biologics). There were 17 reasons for rejecting drugs discussed; with uncertain-
ties generated by the lack of head-to-head trials reported most frequent; together
with unfavorable cost-effectiveness. Other reasons include but were not limited to;
positioning in treatment pathway, dosing regimen and lack of long term follow up
data. The two most rejected drugs were TNF inhibitors: Certolizumab pegol (7
times rejected) and golimumab (4). Specific reasons for rejecting certolizumab
pegol were concerns around the maintenance of response and high patient with-
drawals in the study. Golimumab was rejected due to uncertainties regarding re-
duction in progression of structural damage (INESSS, Canada) and uncertainties
associated with the indirect comparisons; including the sequence of treatments
chosen for the economic assessment (NCPE, Ireland). NCPE later accepted goli-
mumab for funding following a price reduction. CONCLUSIONS: HTA agencies
report various reasons for rejecting anti-rheumatic drugs. Within the HTA agen-
cies, there is a strong demand for comparative head-to-head studies with current
biologics. Sound health economic evidence is essential for new medicines to in-
crease the chances of approval.
PMS80
BIOLOGIC THERAPIES FOR RHEUMATOID ARTHRITIS – ELIGIBILITY CRITERIA IN
THE UK
Lebmeier M, Righetti C
Bristol-Myers Squibb Company, Uxbridge, Middlesex, UK
OBJECTIVES: The British Society for Rheumatology (BSR) Guidelines recommends
biological therapies for the treatments of patients with RA as measured by Disease
Activity Score (DAS-28) 3.2. Current UK reimbursement Guidance recommends
use for biologics to treat patients with RA who have a DAS-28 of 5.1 only (severe
RA). Our objective is to highlight the need for a review of the eligibility criteria for
use of biologic therapies to treat RA in the UK, and to illustrate the number of
patients with RA who would be eligible to receive biologic therapies if the criteria of
DAS-28 3.2 were to be applied. METHODS: The UK-population estimate was ap-
plied to the NICE costing template for biologics for RA, and the number of RA
patients eligible to receive biological treatment was calculated. Prevalence rates
were based on Symmons. Percentages have been reworked by reference to the
population age and sex profile. Based on the Commissioning Guide for biological
therapies, which incorporates estimates of patients with a DAS-28 5.1 in whom
treatment with disease-modifying anti-rheumatic drugs has failed; 10% patients
with RA are eligible for treatment with biologics. Based on clinical opinion collected
from a number of leading UK rheumatologists the proportion of patients eligible for
treatment with biologics at a DAS-28 score3.2 was estimated to be 50%. RESULTS:
The total estimated prevalence of patients with RA is 421,022. Utilising the restric-
tions outlined in current guidance and applying a DAS-28 score 5.1 results in
42,102 RA patients being eligible to receive treatment with biologics. Whereas
210,511 patients would be treated if a DAS-28 score 3.2 were to be applied.
CONCLUSIONS: Restrictions on UK-guidance leave a significant number patients
untreated compared to international guidance. There is widespread agreement
that there is a need to make these drugs available to those patients most likely to
respond to them.
PMS81
COST-EFFECTIVENESS AND BUDGET IMPACT OF CERTOLIZUMAB PEGOL
AGAINST A MIX OF TREATMENTS IN AN OUTCOMES-BASED RISK-SHARING
SCHEME IN FINLAND
Asseburg C1, Soini EJ1, Taiha M2
1ESiOR Oy, Kuopio, Finland, 2UCB Pharma Oy Finland, Espoo, Finland
OBJECTIVES: Assessment of a risk-sharing scheme (RSS) for certolizumab pegol
(CZP) in terms of per-patient value-for-money and affordability in the Finnish
population.METHODS: Literature search, indirect comparison of American College
of Rheumatology (ACR) responses for biologic treatments for RA in anti-TNF-naïve
patients, and stochastic modelling using a new hybrid approach that combines the
assessments of per-patient cost-effectiveness and per-population budget impact
in one Markov model. Using 12-week cycles, multiple comparators (treatment-mix
modelling, i.e. real-life combination of treatments instead of a single comparator)
and a Finnish societal perspective, effects and costs (administration, drug, in-pa-
tient, monitoring, adverse event, travelling, productivity; 2011 real value) were
evaluated over a five-year horizon. If an ACR20 response was achieved at 12 weeks,
CZP treatment was continued. Otherwise, CZP acquisition costs were refunded
under the RSS, and maintenance treatment was initiated. Quality-adjusted life-
years were estimated based on a relationship between EQ-5D and Health Assess-
ment Questionnaire. The budget impact part assumes a rising incidence of RA
during 2013–2017 in Finland and includes treatment persistence estimates.
RESULTS: Over the five years, introducing the CZP RSS for all starting patients
provided cost savings of €4796 together with 0.04 additional quality-adjusted life-
years per patient (100% cost-effectiveness probability). Approximately 4.7% of CZP
acquisition costs were refunded due to RSS. The correspondent budget per patient-
year was estimated at €27,310 under the current mix of anti-TNFs and subsequent
therapies, which could be reduced to average €26,299 per patient-year if all starting
patients were to receive CZP with RSS. Whereas the magnitude of the budget im-
pact is based on several assumptions, all the sensitivity analysis conducted were
consistent and showed that CZP would reduce costs and improve patient health.
CONCLUSIONS: The current analysis showed that CZP in association with a RSS is
cost-effective and affordable compared to current mix of treatments in Finland.
PMS82
US TREATMENT PATTERNS IN PSORIATIC ARTHRITIS NEWLY INITIATED ON
ETANERCEPT OR ADALIMUMAB
Zhang F1, Li S2, Curtis JR3
1Celgene Corporation, Summit, NJ, USA, 2Celgene Corporation, Warren, NJ, USA, 3The University
of Alabama at Birmingham, Birmingham, AL, USA
OBJECTIVES: Etanercept (ETN) and Adalimumab (ADA) are commonly prescribed
biologic disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis
(PsA) patients. The objective of this study was to describe treatment patterns fol-
lowing the initiation of ETN and ADA in PsA. METHODS: Adult PsA patients were
selected from MarketScan Commercial Claims database (2005-2009) if no index
biologics prescription prior to the index date (first ETN/ADA prescription date);
continuous enrollment 6-month prior and 12-month post index date; 2 PsA diag-
noses in different office visits; no diagnosis of ankylosing spondylitis. Treatment
patterns are defined as: treatment discontinuation--a treatment interruption of
60 consecutive days with no other DMARD use after last prescription; switch--the
A454 V 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


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PMS81 Cost-Effectiveness and Budget Impact of Certolizumab Pegol Against a Mix of Treatments in an Outcomes-Based Risk-Sharing Scheme in Finland

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