The CHEUAL Breast Cancer Model: Interactive Cost-Utility Analysis to Support Decision Making Transforming Health & Economics 8th World Congress on Health Economics Assessing Cancer Treatment Denise Capela dos Santos, PhD Álvaro Lopes Dias, PhD Toronto, 11st July 2011 1
Outline of the Presentation Context Challenge Research Strategy and Methodology CHEUAL BC Model development Model Validation Summary and reflections 2 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Context Breast cancer is associated with substantial prevalence, incidence, morbidity and mortality. 0,08282% of Portuguese female population has BC (INE, 2005). 0,00962% new BC cases per year (European Observatory of Health, 2008). Female BCRMR was 3,1% of all female number of death (INE, 2009) . Huge burden on both individuals and health systems. Oncology represents the greater costs to the country, with a relative weight of 25,2% of total hospital costs. The major impact on expense was found to be attributable to antineoplasic and imunomodulator therapy, with a burden of 14.269.774 € per month (INFARMED, 2009). Ministry of Health leads the spending cuts, with a decrease of 7% of the expense from 2010 to 2011 (Portuguese State Budget, 2011). Multiple alternative approaches to BC treatment. Aggregate treatment costs will rise quickly even if a treatment at the individual level is perceived to be inexpensive (Karnon & Jones, 2003). Mathematical modeling makes inferences about future economics and health outcomes to provide data to aid decision-making. Decisions relating to the allocation of resources in fixed-budget healthcare systems are of extreme importance to cost-containment (ISPOR, 2007). 3 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Challenge Research Gap Closed CHEUAL BC model Cost-utility Analysis: New treatment intervention Long-term outcomes for patients in breast cancer Economic Consequences Hospital drug Comission of formulary decision- Pharmacy and makers Therapy How can oncologists, hospital drug formulary and reimbursement decision-makers do an Clinical therapy economic evaluation of pharmacological Oncologists decision-makers treatment policies or interventions in early stage and metastatic breast cancer, helping them to do their job in a fast, transparent, Reimbursement Health Payer credible and efficient way? decision-makers Organizations 4 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Research Strategy and methodology Development of the CHEUAL model Variable integration and data processor construct Model validation Software Development • Primary data: 200 Prescription Charts (most currently used therapy) • Secondary data: Literature review (costs, consequences, other clinical and demographic data) 5 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model development: CHEUAL BC Model design Input Data Clinical Data Baseline risk factors (New) Personal history of disease(s): Progression risk factors (indicating Treatment Kidney, Liver, Heart, Hematologic BC stage) Patterns to • Tumor type: HER2 +/-; ER+/- Pulmonary, Rheumatic and Intestinal be tested • Tumor size: ≥ 2 cm; 2 -5cm, ≥ 5cm Diseases, Osteoporosis Medicine • Patients Age at Diagnosis • Lymph node involvement +/- Dosage Therapy Study Perspective duration Patient Female Number Ministry of Health , Hospital or Clinical Data Processor Transition probabilities Country specific • Probability of progressing to the next level of disease severity data • Probability of developing a disease complication /adverse effect from therapy • Female • Probability of dying: Mortality rate specific to BC Population Country-specific mortality rate non-related to BC Number Most Common CUA data BC data • Disease stages direct costs Cycle Length Treatment Patterns Incidence and • Disease stages utilities Drug, Dose, Therapy Prevalence • Country specific discount rate Time Horizon duration Output Data Costs Utilities Sensitivity analysis Total costs per patient per therapy QALY per patient per option therapy option Incremental Cost-Utility Analysis 6 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model development: most currently used therapy Early BC First line therapy (Stages 0, I and II) Trastuzumab FEC IV, charge dose of 8mg/kg, HER2 +; ER - 5-Fluorouracil (IV, 500mg/m 2 ) + 6mg/Kg maintenance dose, Cyclophosphamide (IV, 500mg/m 2 ) + 21 day cycle, 1 year Epirubicin (IV, 75mg/m 2 ), Tamoxifen 3 week cycle 6 consecutive times po 20mg/day HER2 - ;ER + 5 years, minimum Early BC Second line therapy/ Metastatic BC First line therapy (Stage III ) Trastuzumab TAC HER2 +; ER - IV, charge dose of 8mg/kg, Docetaxel (IV, 75mg/m2) + 6mg/Kg maintenance dose, Doxorubicin (IV, 50mg/m2) + 21 day cycle during 1 year Cyclophosphamide (IV, 500mg/m2), 3 week cycle 6 consecutive times Letrozole HER2 - ;ER + po 2,5mg/day 5 years, minimum Metastatic BC Second line therapy (Stage IV) 5-Fluorouracilo Bolus IV, 200mg/m 2 /day 7 days, 28 day cycle Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
User sets simulation conditions Model development: Generate baseline population complication sub-models No Any patients to run? Stop! Yes Time horizon reached? Yes No Metastasis Acute Cardio- Arthralgia Acute Acute Acute Osteoporosis Acute incidence renal vascular hepatic pulmonary cytopenia Diarrhea failure toxicity failure injury SM1 SM2 SM3 SM4 SM5 SM6 SM7 SM8 SM9 Specific Specific Specific Specific Specific Specific Mortality Mortality Mortality Mortality Mortality Mortality Overall annual survival Update simulation data 8 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model development: Markov Process Disease Progression Scheme Well Stage 0 Complic ation Open Matrix of Markov ´ s Disabled Decision Process Stage I 5 stages of disease 20 cycles of transition (6 month each) Time horizon of 10 years Disabled Death Stage II 2 age groups (24-64; +65) 2 types of tumor (HER2+/ HER2-) 3 level of history of disease associated with BC treatment Disabled complications (0,1 e 2) Stage III 3 perspectives 720 Sub-Matrices that make up the CHEUAL model Disabled Stage IV 9 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model Validation Internal validity (inference of causality) Univariate sensibility analysis Sensibility Analysis Probabilistic sensibility analysis External validity (generalization) Comparing the results from model simulations with observed outcomes from published epidemiological and clinical studies used and not used to construct the model. 10 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model Validation: One-way senbibility analysis Alternative Breast Cancer Pharmacological Treatment Data Processor Input Data Study Perspective Current treatment patterns (drug/administration costs) Output Data (New) Treatment Pattern to test H1 H6 (drug/administration costs) Global Therapy Cost Cost-Utility Analysis Clinical Data Costs H7 Global Therapy QALY H2 Personal history of disease H8 Country Discount Rate Patients Age at Diagnosis QALYs H3 H9 Time horizon Tumor Stage H4 H10 Incremental cost-utility Tumor type; Tumor size H11 analysis H5 Complications Lymph node involvement H12 Acute Renal Failure H13 Acute Hepatic Failure H14 Acute Pulmonary Disease H15 Cardiovascular Failure H16 Osteoporosis H17 Acute Arthargia H18 Acute Cytopenia H19 Acute Diarrhea 11 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
Model Validation: One-way senbibility analysis results Variation (%) Hypothesis Test 2,46 H1 x Study perspective (NHS, Hospital, Clinical) 13,52 H2 √ New drug costs* ± 25% 14,67 H3 √ Personal history of disease (0, 1 or 2) 42,94 H4 √ Patients age at diagnosis (24-65 or +65) 2636,42 H5 √ Tumor stage (0, I, II, III and IV) 4,34 H6 √ Current treatment drug costs* ± 25% 66,67 H7 √ Global BC costs ± 25% 66,67 H8 √ Global BC QALYs ± 25% 55,13 H9 √ Country discount rate (C/QALY: 5%/0% or 5%/5%) 101,80 H10 √ Study time horizon (5 or 10 years) 11,44 H11 √ Global complication incidence ± 25% 0,75 H12 x ARF ± 25% 6,06 H13 √ AHF ± 25% 0,87 H14 x APD ± 25% 0,45 H15 x ACVD ± 25% 0,01 H16 x Osteoporosis ± 25% 0,22 H17 x AA ± 25% 2,75 H18 √ AC ± 25% 0,18 H19 x AD ± 25% *ambulatory day care visit, drug, and drug Exclusion criteria: Variation ≤ 2,5% preparation and administration costs 12 Toronto, 11st July 2011 The CHEUAL BC Model: Interactive Cost-Utility Analysis to Support Decision-Making
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