ISPOR Fourth Annual European Congress Contributed Presentation Abstracts Contributed Podium Presentations

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  • Volume 4 Number 6 2001VALUE IN HEALTH

    ISPOR 1098-3015/01/$15.00/401 401420

    401

    ISPOR Fourth Annual European CongressContributed Presentation Abstracts

    Contributed Podium Presentations

    SESSION I

    HEALTH POLICY I

    HP1

    VALIDITY OF THE MINIMUM-DATA-SET-BASED QUALITY INDICATOR FOR DETERMINING THE PREVALENCE OF ANTIPSYCHOTIC MEDICATION USAGE AMONG LOW RISK NURSING HOME RESIDENTS: A STATEWIDE ASSESSMENT

    Monroe DM

    1

    , Cortes LL

    2

    , Fouladi R

    3

    1

    The University of Texas at Austin, Austin, TX, USA;

    2

    Texas Department of Human Services, Austin, TX, USA;

    3

    The University of Texas at MD Anderson Cancer Center, Houston, TX, USA

    OBJECTIVE:

    The Minimum Data Set (MDS) is an inter-national facility-reported database used to standardizethe assessment process and improve the quality of care innursing homes. Specific MDS assessments are used asquality indicators to determine the prevalence of antipsy-chotic prescribing as well as potentially inappropriate anti-psychotic usage. MDS classifies low-risk residents as receiv-ing an antipsychotic medication but having no documentedpsychotic or related condition and no cognitive impairmentwith behavioral symptoms. Without an audit of residentrecords, it is impossible to determine if the MDS accuratelyreports the prevalence of antipsychotic medications andwhether all low-risk residents represent inappropriateprescribing. The purpose of this study was to deter-mine MDS validity for identifying low-risk residents inTexas.

    METHODS:

    Facility-based MDS assessments were com-pared to independent on-site assessments. A team ofpharmacists reviewed the chart records of low risk resi-dents and determined whether a resident received an an-tipsychotic medication and the presence or absence of avalid indication. These findings were compared to thestatewide MDS quality indicator prevalence rate.

    RESULTS:

    Based on MDS assessments, 10,163 residentsfrom 1021 nursing homes were identified as low risk.The chart records revealed that 12.4% of these residentswere not receiving antipsychotic medication. Of the 8904residents who were receiving an antipsychotic, 48.2%had a valid diagnosis or indication and were mistakenlyidentified as low-risk by the MDS database. Of the re-maining 4610 residents, 84.4% were missing a diagnosisand 15.6% had an inappropriate indication.

    CONCLUSION:

    For this population of residents, a lackof accurate essential diagnostic information in MDS as-sessments and a high prevalence of inappropriate antipsy-chotic prescribing was found to be a widespread prob-lem. These findings indicate that nursing facilities wereinaccurate in their responses to MDS assessment itemsand therefore, the MDS had poor validity as a quality in-dicator for antipsychotic use.

    HP2

    TRANSLATING EVIDENCE TO PRACTICE IN BREAST CANCER

    Bloom BS

    1

    , Jayadevappa R

    1

    , de Pouvourville N

    2

    , Chartre S

    1

    1

    University of Pennsylvania, Philadelphia, PA, USA;

    2

    University of Paris Medical School, Paris, France

    OBJECTIVE:

    Practice guidelines are being implementedfor many diseases to improve outcomes, increase use ofevidence-based medicine, and to reduce medical errors.Rarely are these efforts systematically evaluated in clini-cal care. We chose breast cancer in women as one diseasethat has excellent scientific evidence on treatment efficacybut almost no data on actual use in physician practice.

    METHODS:

    We studied use of breast conserving sur-gery, breast reconstruction, adjuvant chemotherapy, radi-ation, taxoids, tamoxifen, and aromatase inhibitors in el-igible women. The population was diagnosed between1995 and 2000 in six surgical oncology practices in theeight counties around Philadelphia with nearly seven mil-lion people. Four thousand three hundred ninety fivewomen were enrolled and followed retrospectively up tofive years after diagnosis. We abstracted each patientscomplete clinical record.

    RESULTS:

    Lumpectomy was provided to 51.0% ofwomen, among whom 2.3% also had reconstruction.Forty nine percent of women (49.0%) had mastectomywith 18.0% having breast reconstruction, 56.8% re-ceived radiation therapy and 32.3% received adjuvantchemotherapy. Among eligible women, 0.6% had aro-matase inhibitors and 12.3% were prescribed taxoids.Among estrogen and/or progesterone-receptor-positivewomen, 72.4% got tamoxifen, while 35.1% with nega-tive estrogen and progesterone receptors got tamoxifen.One woman refused all treatment, one refused any breastsurgery, five refused adjuvant chemotherapy, two refusedradiation. Eight percent of eligible women refused tamox-ifen, mainly because of elevated risk of adverse side effects,and one had an autologous bone marrow transplant. Lo-gistic regression found that breast reconstruction was in-

  • 402

    Abstracts

    versely related to patient age (p

    .0029), tamoxifen var-ied directly with patient age (p

    .0002) but inverselywith physician age (p

    .02), and adjuvant chemotherapyand taxoids varied inversely with patient age (p

    .0001).

    CONCLUSIONS:

    Two decades of multiple randomizedcontrol trials and meta-analyses have led to only modestsuccess in the use of highly beneficial treatments forbreast cancer in these specific oncology practices, al-though non-beneficial treatments are almost never used.

    HP3

    REGIONAL VARIATION IN PRESCRIPTION USE IN THE UNITED STATES

    Motheral BR, Cox ER, Mager D, Henderson R

    Express-Scripts, Maryland Heights, MO, USA

    OBJECTIVE:

    To evaluate the factors influencing the utiliza-tion of prescribed medications across the United States.

    METHODS:

    Prescription claims data for a random sam-ple of commercially insured Express Scripts members, 18to 64 years of age and continuously eligible for at leasttwo months in 1999 (N

    1,467,699), were geo-coded atthe block group level. Key independent variables includedage, gender, family size, median income, education, ur-ban/rural location, client type, and pharmacy benefit de-sign. Outcome measures included any use of prescrip-tions. Hierarchical modeling (HLM) was used to controlfor clustering of patients within health plans.

    RESULTS:

    Results from HLM indicate that after control-ling for demographics, client type, and pharmacy benefitdesign, variation in the probability of using a prescribedmedication was found across regions of the country.Members in the South have a greater likelihood of useand members in the Northeast and West having a lowerprobability of use than members in the Midwest. Agreater probability of use was associated with older age,female gender, higher income, family size

    1, and enroll-ment in a managed care plan. Factors associated withlower probability of prescription use included presence ofa deductible, living in an urban area and having a manda-tory generic policy.

    CONCLUSIONS:

    While patient age and gender remainkey factors driving prescription utilization, socioeconom-ics, pharmacy benefit design, and where a person lives arealso predictors of prescription use. Future research isneeded to better understand the causative roles of diseaseburden, physician practice style, and consumer preferencesin prescription drug use variation across the United States.

    CANCER I

    CN1

    BRIEF ASSESSMENT OF PRIORITY SYMPTOMS IN HORMONE REFRACTORY PROSTATE CANCER (HRPCA)

    Yount SE

    1

    , Banik D

    1

    , Singh A

    2

    , Ashraf T

    2

    , Padley RJ

    2

    , Dalal M

    2

    , Cella D

    1

    1

    Evanston Northwestern Healthcare, Evanston, IL, USA;

    2

    Abbott Laboratories, Abbott Park, IL, USA

    OBJECTIVE:

    The objective of this study was to derive abrief, clinically relevant symptom index for men withHRPCa.

    METHODS:

    An international sample of 44 medical on-cologists, radiation oncologists, and urologists were pre-sented with 29 disease-related symptoms derived fromthe Functional Assessment of Cancer Therapy-Prostate(FACT-P) quality of life (QOL) instrument and asked toselect the five most important symptoms in assessing thetreatment response for men with HRPCa. Symptoms en-dorsed at a frequency greater than chance were retainedfor the index. Retrospective validation of the index wasaccomplished using data from a multi-national, random-ized, double-blind, placebo-controlled clinical trial ofatrasentan, a selective, oral ET-A receptor antagonist.The FACT-P and European Organization for Researchand Treatment of Cancer (EORTC) QLQ-C30 adminis-tered at baseline, six weeks and final visit were used toevaluate QOL responses to treatment of 288 men withHRPCa.

    RESULTS:

    Experts initially selected eight priority symp-toms. Item-Response Theory analysis identified one mis-fitting item (worry), lending support for a seven-item in-dex (FPSI-7). Internal consistency was high for the seven-item index (0.75). Concurrent validity was establishedthrough correlations (

    P

    0.05) between the FPSI-7 andthe FACT-General (FACT-G;

    r

    0.56); FACT-P (

    r

    0.73); FACT Prostate Cancer Subscale (PCS;

    r

    0.88);Trial Outcome Index (TOI;

    r

    0.83); and QLQ-C30global score (

    r

    .56), symptom domain scores (

    r

    0.33 to

    0.76), and generic domain scores (

    r

    0.36 to0.60). The FPSI-7 successfully differentiated patients byfunctional status, measured by the Eastern CooperativeOncology Group (ECOG) performance status rating(PSR,

    p

    .001), and clinical outcome, measured by dis-ease progression status (

    p

    .001). PSR and disease pro-gression are important outcomes for patients and clinicaltrials. The FPSI-7s responsiveness to PSR change com-pared favorably to the FACT-G, PCS, FACT-P and TOI.

    CONCLUSION:

    The FPSI-7 is a valid and responsivesymptom index that can provide efficient, rapid symptomassessment to evaluate treatment outcome in clinical trials.

    CN2

    RESOURCE CONSUMPTION RELATED TO MUCOSITIS IN LYMPHOMA PATIENTS RECEIVING HIGH-DOSE CHEMOTHERAPY WITH AUTOLOGOUS PBPC TRANSPLANTATION

    Chan WW, Lawless G

    Amgen Inc, Thousand Oaks, CA, USA

    OBJECTIVES:

    To evaluate resource consumption relatedto mucositis in lymphoma patients receiving high-dosechemotherapy (HDC) with autologous PBPC transplan-tation.

  • Abstracts

    403

    METHODS:

    Data on mucositis and clinical parametersof hospitalization, IV antibiotic use, fever, analgesic use,and parenteral nutrition were collected as part of a multi-center clinical trial conducted in Europe (n

    234). Pa-tients were quantified as having mucositis if ulcerativelesions were present after receiving BEAM (BCNU, Eto-poside, Ara-C, Melphalan) HDC. Days of usage for clini-cal parameters were quantified as resource consumptionand compared in patients with and without mucositis.

    RESULTS:

    Mucositis showed an association with resourceconsumption. Days of analgesia had the highest correla-tion followed by antibiotic use, fever, hospitalization, andparenteral nutrition (r

    0.4128*, 0.3003*, 0.2634*,0.2558*, 0.0973, respectively, *p

    .0001). Patients withmucositis had two additional days of hospitalization andthree additional days of IV antibiotics. Mean

    s.e. for re-source consumption is listed for patients (with mucositis,without mucositis, p-value), as follows: days of hospital-ization (26.8

    0.4, 24.4

    0.5, p

    .001); days of IV an-tibiotics (12.6

    0.7, 9.5

    0.7, p

    .002); days of anal-gesic use (9.2

    0.7, 4.3

    0.5, p

    .001); days ofparenteral nutrition (1.8

    0.3, 1.6

    0.2, p

    .668);days of fever (2.9

    0.3, 2.0

    0.3, p

    .035).

    CONCLUSIONS:

    Patients with mucositis had signifi-cantly higher resource consumption. Mucositis impactson length of hospitalization, days of fever, IV antibiotic,and analgesic use.

    CN3

    AN ECONOMIC MODEL FOR THE PHARMACOLOGICAL MANAGEMENT OF ADVANCED NON-SMALL CELL LUNG CANCER IN THE US

    Sorensen SV

    1

    , Chambers M

    2

    , Heyes A

    3

    1

    MEDTAP International, Bethesda, MD, USA;

    2

    MEDTAP International UK, London, UK;

    3

    AstraZeneca UK Limited, Macclesfield, UK

    OBJECTIVES:

    The majority of patients with non-smallcell lung cancer (NSCLC) present with advanced disease,for which pharmacological therapy is the primary treat-ment option. Economic models are useful tools to helpdecision-makers determine the cost and health impact ofexisting and new therapies in their practice settings.

    METHODS:

    A decision-analytic model was developed torepresent the progression of advanced (stage IIIB/IV)NSCLC from diagnosis and first-line therapy to subse-quent lines of therapy, best supportive care and death.The model is a semi-Markov process with three-week cy-cles and a two-year time horizon. By selecting differentsets of model parameters, it may be used to estimate cost-of-illness (by pooling cost and health outcomes across arange of therapies), cost-effectiveness (comparison be-tween new or existing therapeutic options) and impact onhealth-care budgets. Data sources include published clini-cal trials, treatment patterns based on published studies,and a panel of US clinicians and US unit costs. In thiscase, the NSCLC model was used to examine the costs

    and outcomes of a distribution of mono and combinationagents most commonly administered as first and second-line therapy in the US.

    RESULTS:

    Over one and two years respectively the aver-age cost of therapy was $42,319 and $48,151 per pa-tient, with an estimated survival of 40.2% and 7.4%.The estimated cost for a health-care purchaser with aprevalence of 100 patients with advanced NSCLC was$4.90 million per year. If all patients used carboplatinand paclitaxel as first-line therapy, this increased to$5.14 million. If a new therapy increased the median timeto progression for patients on first-line therapy by twomonths, the cost increased to $5.0 million per year.

    CONCLUSION:

    This model provides a flexible analyti-cal platform for a range of economic evaluations of alter-native therapeutic strategies in advanced NSCLC. This isvaluable for strategic planning in Phase II/III drug devel-opment.

    CARDIOVASCULAR DISEASE I

    CV1

    ESTIMATING THE IMPACT OF ANTICOAGULATION QUALITYON EVENT RATES

    Matchar DB, Samsa GP

    Duke University, Durham, NC, USA

    OBJECTIVES:

    Warfarin anticoagulation has been shownto effectively decrease the rate of thromboembolism (TE),with an associated increased rate of bleeding. Maximiz-ing the benefit and minimizing the risk depends on main-taining patients in a narrow therapeutic range for pro-thrombin time (measured as INR). An increased percentageof time spent in target range (TTR) is predictive of betterclinical outcomes. However, strategies to increase TTR canbe costly. To allow local clinical policy makers to deter-mine whether these strategies can be justified, we developeda general approach to estimating bleeding and TE rates as-sociated with a given population distribution of INR.

    METHODS:

    We used data from a large cohort (Cannegi-eter, 1995) to derive a logistic equation for baseline abso-lute risk of bleeding as a function of INR. Based on a sep-arate large cohort of patients (Fihn, 1993) with varioustimes since initiation of therapy, we derived a risk ratiothat modifies the above baseline relationship that ac-counts for time since initiation of therapy. A similar strat-egy was used to estimate TE, using INR and indication(mechanical valve versus atrial fibrillation) as predictors.

    RESULTS:

    The model fo...