Lifetime Benefits and Costs of DCCT Intensive Therapy References: Diabetes Care, 1995 18:1468-78. JAMA, 1996 276: 1409-15. DCCT.
Download ReportTranscript Lifetime Benefits and Costs of DCCT Intensive Therapy References: Diabetes Care, 1995 18:1468-78. JAMA, 1996 276: 1409-15. DCCT.
Lifetime Benefits and Costs of DCCT Intensive Therapy References: Diabetes Care, 1995 18:1468-78. JAMA, 1996 276: 1409-15. DCCT The DCCT Study Group Study Chair: Oscar Crofford The DCCT Coordinating Center (GWU BSC): John Lachin, Patricia Cleary, and many others The NIDDK, NIH: Richard Eastman, Carolyn Siebert 29 Clinical Centers in the US and Canada 7 Central Laboratories, Reading Units DCCT The DCCT Economic Evaluation Study Group Study Chair: Oscar Crofford The DCCT Coordinating Center (GWU BSC): John Lachin, Patricia Cleary, Desmond Thompson The NIDDK, NIH: Richard Eastman, Carolyn Siebert The CDC, Collaborators William Herman, Erik Dasbach, Jonathon Javitt, Thomas Songer DCCT Objectives • Assess the benefits over a lifetime of intensive versus conventional therapy complications and mortality years and quality adjusted years saved • Assess the costs of therapy and the costs of treatment of complications and adverse effects DCCT Objectives (cont.) • Assess whether intensive therapy is preferable from the perspective of the health care system DCCT Costs • the annual cost of treatment - intensive treatment - conventional treatment • the annual cost of treating side effects (e.g. hypoglycemia) • the annual cost of treating diabetic complications DCCT Costs • Health care system perspective only Direct medical costs only (not indirect) • 1994 USD • Discounted at 3%/year for the costs of: therapy complications (benefits) adverse effects (hypoglycemia) DCCT Approaches to Identifying Direct Costs • Hospital – gather billing records from acct. dept. • Physician Services – salary information or prevailing fees • Laboratory Tests – identify govt. reimbursement fees • Drugs, Supplies – identify wholesale costs DCCT Benefits • Years free from complications • Years of life • Quality of life • Quality-adjusted life years (QALYs) DCCT Quality-Adjusted Life Years (QALYs) Reduce the value of a year of life associated with concurrent illness 1.0 When free of major illness 0.69 for blindness 0.61 for End Stage Renal Disease (ESRD) 0.80 for lower extremity amputation (LEA) 0.0 for death DCCT What are the Costs of DCCT Therapy? DCCT Increased Use of Primary Diabetes Care Physician Time Nurse/Educator Time Dietician Time Behavioral Scientist Time Self Blood Glucose Monitoring Insulin Injections Laboratory Tests Telephone Follow-up DCCT The Treatment Team & Outpatient Visits Annual minutes per patient Intensive Conventional 700 600 500 400 300 200 100 0 Doctor Nurse Ed Dietician Behav Sci DCCT The Costs of Annual Therapy Dollars 8000 6000 4000 2000 0 CSII MDI Conventional DCCT Costs Used In Simulation Model Conventional Intensive Initiation of therapy Annual Therapy -- 2848 1666/y 4545/y Photocoagulation 948 Renal evaluation 1080 Neurologic evaluation 124 ACE Inhibition therapy 725/y Blindness 1911/y End-stage renal disease Lower extremity amputation Added years of life 46,207/y 31,225 1855 DCCT Research Question Given that intensive therapy uses more resources than conventional therapy, is intensive therapy costeffective? DCCT Costs and Effects of Intensive Therapy Costs Effects Increased use of primary diabetes care Lower incidence of microvascular complications Increased hypoglycemia Health care savings when complications are delayed or prevented Increased weight gain DCCT Methods Determine the costs associated with diabetes treatment Model the long-term impact of diabetes treatment DCCT Monte Carlo Simulation Model cohort microvascular disease model mortality model End of Simulation DCCT Monte Carlo Simulation Model cohort select patient microvascular disease model mortality model End of Simulation DCCT Cohort of Patients in the Model • 120,000 individuals with IDDM in the USA who have clinical and demographic characteristics which meet the eligibility criteria for enrollment in the DCCT • 17% of the US IDDM population 37% of these Primary patients 73% Secondary DCCT Monte Carlo Simulation Model cohort microvascular advance disease model disease mortality model End of Simulation DCCT Microvascular Disease Model retinopath y model nephropathy mode l neuropath y mode l DCCT Assessment of Disease Status Dependent upon.… • Type of Treatment • Previous stage of disease • Duration of IDDM Early Stages: DCCT based Weibull hazard rates Advanced Stages: Clinical trial & epidemiologic data DCCT Nephropathy Model Health states include ... • Urinary albumin excretion rates less than or equal to 40 mg/24 hours • microalbuminuria • clinical nephropathy (albuminuria) • End Stage Renal Disease (ESRD) DCCT Transitions between Disease Stages Diabetic Nephropathy Epidemiologic data Normal microalbuminuria DCCT data clinical nephropathy ESRD Nephropathy Transition Probabilities Conventional Intensive = 1.512 = 0.014 = 1.123 = 0.018 = 1.260 = 0.036 = 1.093 = 0.030 Nephropathy Primary 0.06/y 0.02/y Secondary 0.03/y 0.03/y 0.05/y 0.05/y Microabluminuria Primary Secondary ESRD DCCT Diabetic Nephropathy .94 .98 0.06 conventional 0.02 intensive Normal 0.95 microalbuminuria Primary: =1.5, =0.014 conv. =1.1, =0.018 int. clinical nephropathy 0.05 ESRD Retinopathy Model Health states include ... • • • • • no retinopathy background retinopathy proliferative retinopathy (PDR) with HRC clinically significant macular edema (CSME) visual acuity worse than 20/200 (better eye) DCCT Retinopathy Transition Probabilities Conventional Intensive Background Retinopathy (PDR) = 2.486 = 0.008 = 1.487 = 0.018 Proliferative Retinopathy = 1.898 = 0.004 = 1.165 = 0.007 0.03/y 0.02/y 0.01/y 0.01/y 0.03/y 0.03/y Macular Edema (CSME) Blindness From PDR From CSME DCCT Neuropathy Model Health states include ... • No neuropathy • Clinically significant neuropathy • Lower extremity amputation (LEA) DCCT Monte Carlo Simulation Model cohort microvascular disease model mortality model DCCT End of Simulation determine mortality status Mortality Model • Risk dependent upon age and severity of nephropathy • normal albumin: 1.2x US age-specific mortality • microalbuminuria: 1.4x US age-specific mortality • Clinical nephropathy (albuminuria): 1.7x US age-specific mortality DCCT Cumulative Incidence of Complications At Age 70 Proliferative Retinopathy Macular Edema Blindness Microalbuminuria Albuminuria End-stage renal disease Neuropathy Lower extremity amputation Conventional 70 56 34 86 46 24 57 7 Intensive 30 35 20 64 15 7 31 4 DCCT Cumulative Incidence of Proliferative Retinopathy by Treatment Group 100 Percent 80 60 Conventional 40 20 Intensive 0 19 29 39 49 59 Age 69 79 89 99 Cumulative Incidence of Clinical Nephropathy (Albuminuria) by Treatment Group 100 Percent 80 Conventional 60 40 Intensive 20 0 19 29 39 49 Age (years) 59 69 DCCT Life-Expectancy by Treatment Group Percent surviving 100 80 Intensive 60 40 Conventional 20 0 12 22 32 42 52 62 72 82 92 100 Age (years) DCCT Average Number of Years Living Without ... Conventional Proliferative Retin. Macular Edema Visual Acuity Loss Overt Nephrop. ESRD LE Amputation 1st major comp. 39.1 44.7 49.1 49.7 55.6 55.2 37.0 Intensive Difference 53.9 52.9 56.8 59.5 61.3 60.9 52.2 14.8 8.2 7.7 9.8 5.8 5.7 15.2 DCCT Benefit Implications of DCCT For the 120,000 persons in the United States who meet the DCCT eligibility criteria: Intensive therapy will provide – 920,000 more years free from blindness – 691,000 more years free from ESRD – 678,000 more years free from LE Amputation – 611,000 additional years of life DCCT Annual Cost of Therapy • Conventional - $1,666 per year - includes side effects • Intensive - $4,545 per year - includes MDI/CSII patients and side effects DCCT Cost of End-Stage Complications • ESRD - $46,207 per year • Blindness - $1,911 per year • Lower Extremity Amputation - $31,225 DCCT Type of Health Care Costs by Treatment Group Intensive Conventional DCCT Treatment Side Effects Complications Cumulative Actual Cost of Conventional vs. Intensive Therapy by Treatment Duration Not Discounted $300000 Conventional U.S. Dollars 250000 200000 150000 Intensive 100000 50000 0 1 5 10 15 20 25 30 35 Treatment Duration 40 45 50 DCCT Discounted Average Lifetime Costs Annual costs of therapy + costs of complications $66,076 Conventional $99,822 Intensive $0 $20,000 $40,000 $60,000 U.S. Dollars $80,000 $100,000 DCCT Cost Implications of DCCT For the 120,000 persons in the United States who meet the DCCT eligibility criteria: Intensive therapy will cost about $4 billion more than standard therapy over a lifetime DCCT Mortality Cost-Benefit of Intensive Therapy • Intensive therapy yields 5.1 additional years of life at a cost of $28,661 per year of life gained. • Intensive therapy markedly improves the quality of life at a cost of $19,987 per quality adjusted life year gained. DCCT Sensitivity Analysis • • • • • • Incidence of Complications Annual Cost of Therapy Discount Rate Health State Utilities Compliance to Intensive Therapy Mortality rate DCCT Sensitivity Analysis Assumption Cost per life year gained Best Estimate $28,661 Incidence of microalbuminuria $79,883 50% lower in conventional group 5% Discount Rate $50,925 Intensive Treatment Cost 50% Lower Cost savings Mortality hazard (50%) higher $30,973 DCCT Remaining Issues • • • • Health Policy Decisions Generalizability of the Models Availability to Treatment Extensions to Patients with NIDDM DCCT Costs of Therapy in the DCCT Annual Therapy MDI CSII Conventional Inpatient Outpatient Case-management Self-care Side-effects of therapy TOTAL 127 1,243 548 1,866 210 155 1,244 554 3,621 210 58 513 116 909 70 $4,014 $5,784 $1,666 DCCT Costs of Complications of Type 1 Diabetes laser therapy ACE inhibitor blindness renal failure amputation $948 / episode $725 / yr $1,911 / yr $46,207 / yr $31,225 / episode DCCT Discounting • Even in a world of zero inflation, there are advantages to receiving benefits earlier and incurring costs later. • Discounting adjusts future costs and benefits to current value. DCCT Cost Saving Health Care Interventions (Cost < 0$ per life-year saved) • • • • • prenatal care PKU screening in newborns thyroid screening in newborns childhood immunizations heparin and stockings to prevent venous thrombosis • smoking cessation advice DCCT Cost per Life-year Saved Estimates for Health Care Interventions ($1993) Intervention prenatal care -blockers following MI anti hypertensive rx cronary bypass surgery DCCT Intensive therapy hormone replacement renal dialysis cholesterol lowering therapy n 12 4 6 8 1 13 20 19 median cost / life-year <$0 $2,000 $15,000 $26,000 $28,661 $42,000 $46,000 $154,000 DCCT Intensive therapy represents good value for money DCCT Impact of The DCCT and UKPDS • UKPDS (1998) shows equivalent benefits in type II diabetes (NIDDM) • Intensive therapy is not universally accepted by the health care system • Intensive therapy is not available to the majority of patients with diabetes mellitus, either type I or II DCCT