Diabetes Prevention Program (DPP) ROI Abstracts Article 1: DPP Research Group; Costs Associated With the Primary Prevention of Type 2 Diabetes Mellitus in the Diabetes Prevention Program; Diabetes Care; 26:36-47, 2003. 1. What was the intervention/program? Random assignment of participants into 3 groups: 1) Lifestyle Intervention 2) Medication (Metformin) Intervention 3) Placebo The lifestyle intervention consisted of a 16 lesson curriculum including diet, exercise, and behavior modification taught by case managers on a one on one basis for the first 24 week and then monthly individual and group sessions to reinforce behavior change. The goal of the lifestyle intervention was a 7% weight reduction through decreased calories consumption, decreased dietary fat and moderate intensity physical activity. The medication intervention randomized participants to either receive metformin or a placebo at 850 mg/daily for the first month and then twice daily after. Lifestyle recommendations were given via written information and annual 20-30 minute individual sessions in addition to quarterly adherence visits. 2. In what setting? What population? Eligibility was determined by: IGT, 25 years or older, BMI of 24 or higher or BMI of 22 or high or Asian Americans. A total of 3,234 participants enrolled with a mean age of 51 and a mean BMI of 34. Women comprised 68% of participants and 45% were of minority groups. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost-benefit: Describes the costs associated with primary prevention of T2D in the DPP comparing the costs between interventions. 4. From whose perspective? (individual, payer, societal) Cost from a large health system (payer) perspective and societal perspective. 5. What were the cost and types of costs? Costs included direct medical costs, direct non-medical costs, and indirect costs of lifestyle and medication interventions compared to placebo. Large health system costs include only direct medicals coats while societal costs include direct medical and non-medical costs in addition to indirect costs. Direct medical costs include identification of individuals with IGT, implementation and maintenance of interventions, hospitalization, outpatient care, laboratory tests, medications, and costs of medical care outside of the DPP. Direct non-medical costs include the participants time spent traveling for appointments, exercising, purchase of equipment or gym memberships, shopping, and cooking. Indirect costs include loss of work, illness, or disability related to morbidity and lost productivity due to premature death/mortality. 6. What were the benefits? (Results) The direct medical cost of identifying each randomized participant was $139. Placebo Intervention: Year 1 direct medical costs= $43/subject; year 2 and 3= $18/subject Metformin Intervention: Year 1 direct medical costs= $1,019/subject ($671=cost of med.); year 2=$772 ($618=cost of med); year 3= $751 ($595=cost of med) Lifestyle Intervention: Year 1 direct medical costs= $1,399/subject ($750=staff time); year 2= $679/subject ($339=staff time); year 3=$702 ($339=staff time) Over 3 years, direct medical costs per participant for the placebo group, metformin group, and lifestyle intervention were $79, $2,542, and $2,780 respectively. However, when comparing the direct medical costs outside of the DPP, the metformin group was $272 less and the lifestyle group $432 less compared to the placebo group. Over 3 years, direct nonmedical costs were $9 less for the metformin group and $1,445 greater for the lifestyle participants compared to the placebo. Over 3 years, indirect costs were $230 greater for the metformin participants and $174 less for lifestyle participants than for the placebo participants. From the perspective of a large health system, both the metformin and lifestyle intervention cost approximately $750 per participant per year, or $2,250 per participant over 3 years. Costs are likely to decrease with the use of generic formulas of metformin and better efficiency of utilization of staff time by using group visits. 7. What are the key talking points? Article 2: DPP Research Group; Within-Trial Cost-Effectiveness of Lifestyle Intervention or Metformin for the Primary Prevention of Type 2 Diabetes; Diabetes Care; 26:2518-2523, 2003. 1. What was the intervention/program? Random assignment of participants into 3 groups: 1) Lifestyle Intervention 2) Medication (Metformin) Intervention 3) Placebo The lifestyle intervention consisted of a 16 lesson curriculum including diet, exercise, and behavior modification taught by case managers on a one on one basis for the first 24 week and then monthly individual and group sessions to reinforce behavior change. The goal of the lifestyle intervention was a 7% weight reduction through decreased calories consumption, decreased dietary fat and moderate intensity physical activity. The medication intervention randomized participants to either receive metformin or a placebo at 850 mg/daily for the first month and then twice daily after. Lifestyle recommendations were given via written information and annual 20-30 minute individual sessions in addition to quarterly adherence visits. 2. In what setting? What population? Eligibility was determined by: IGT, 25 years or older, BMI of 24 or higher or BMI of 22 or high or Asian Americans. A total of 3,234 participants enrolled with a mean age of 51 and a mean BMI of 34. Women comprised 68% of participants and 45% were of minority groups. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost effectiveness in terms of diabetes prevented; cost utility in terms of measuring qualityadjusted life-years. 4. From whose perspective? (individual, payer, societal) Cost from a health system (payer) perspective and societal perspective. 5. What were the cost and types of costs? Costs included direct medical costs, direct non-medical costs, and indirect costs of lifestyle and medication interventions compared to placebo. Large health system costs include only direct medicals coats while societal costs include direct medical and non-medical costs in addition to indirect costs. Direct medical costs include identification of individuals with IGT, implementation and maintenance of interventions, hospitalization, outpatient care, laboratory tests, medications, and costs of medical care outside of the DPP. Direct non-medical costs include the participants time spent traveling for appointments, exercising, purchase of equipment or gym memberships, shopping, and cooking. Indirect costs include loss of work, illness, or disability related to morbidity and lost productivity due to premature death/mortality. 6. What were the benefits? Increased quality of life (measured by health utility scores) and quality-adjusted life-years (QALYs) over 3 years: For the lifestyle intervention a total of 0.072 in QALY’s were gained and 0.022 for the metformin intervention. Using number need to treat (NNT) calculation, found that 6.9 people with IGT would need to be treated with the lifestyle intervention and 14.3 with the metformin intervention to prevent 1 case of diabetes. 7. What are the key talking points? The intervention was DPP. From a payer perspective, the lifestyle intervention cost $15,700 per case of diabetes prevented or delayed and the metformin intervention cost $31,300; per QALY societal perspective, the lifestyle intervention cost $24,400 per case of diabetes prevented or delayed and the metformin intervention cost $34,500; per QALY gained, the lifestyle intervention cost $51,600 and metformin intervention cost $99,200. Article 3: DPP Research Group; The 10-Year Cost-Effectiveness of Lifestyle Intervention or Metformin for Diabetes Prevention; Diabetes Care, 35:723-730, 2012. 1. What was the intervention/program? The interventions were the DPP and DPPOS. The DPPOS was a follow up study to the DPP. Participants in the DPP were informed of the main results and treatment groups were revealed. Metformin and placebo participants entered a 1-2 week drug washout study. All participants were then offered a 16-session lifestyle curriculum as a bridge protocol. Lifestyle sessions were offered to all participants at 3 month intervals. For the original lifestyle participants only, 2 group classes comprising of 4 sessions per year were offered. The metformin group continued 850mg twice daily unless development of diabetes required further treatment by physician. Outcome assessment examinations continued per DPP protocol yearly and 6 monthly. The primary objectives were to assess long-term effects of DPP intervention on the development of diabetes and the complications. 2. In what setting? What population? 3,150 surviving DPP participants were eligible, irrespective of whether they had developed diabetes. Of those eligible, 2,766 (88%) enrolled in the DPPO study. Demographics did not differ significantly by sex or ethnic origin when compared to the original DPP participants. Enrollment was lower in women with a history of gestational diabetes and was related to greater age, and in women, by lower weight and BMI. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost effectiveness in terms of diabetes prevented; cost utility in terms of measuring qualityadjusted life-years 4. From whose perspective? (individual, payer, societal) Cost from a health system (payer) perspective 5. What were the cost and types of costs? Total direct medical costs associated with the DPP and DPPOS interventions were calculated over each of the 10 years. Cost of lifestyle was estimated if it had been administered in a group format rather than individually as a sensitivity analysis. Direct nonmedical sots were assessed twice, once during the DPP and once during the DPPOS. The cumulative per participant costs of the lifestyle intervention (original one on one format) was $4,601, metformin intervention $2,300, and placebo $769. The cost of the lifestyle intervention dropped to $3,023 when estimating the cost in a group setting. The cumulative direct medical costs for care outside of the interventions were $24,563 for lifestyle, $25,616 for metformin, and $27,468 for place. Cumulative total direct medical costs were $29,164 for lifestyle, $27,915 or metformin, and $28,236 for placebo. The direct medical costs of nonintervention-related medical care were 34%-44% higher among diabetic participants compared to non-diabetic participants. Over 10 years, per capita nonintervention direct medical costs were $1,853 and $2.905 more for the placebo groups compared to both intervention groups. 6. What were the benefits? Each year after randomization, quality of life was better for the lifestyle group when compared to the other two. The lifestyle group had the greater quality of well-being score over 10 years of 6.81 while the metformin group was 6.69 and placebo 6.67. Per QALY gained was $10,037 for the lifestyle group with the metformin group having a slightly lower cost per QALY. 7. Key points? From the perspective of a health system (payer) the lifestyle intervention is cost-effective while the metformin intervention is slightly cost-saving when compared to the placebo. Article 4: Eddy DM, Schlessinger L, Kahn R; Clinical Outcomes and Cost-Effectiveness of Strategies for Managing People at High Risk for Diabetes; Ann Intern Med, 143:251-264, 2005. 1. What was the intervention/program? Using the Archimedes model, the investigators aimed to determine the cost-effectiveness of no prevention, DPP’s lifestyle program, lifestyle modification after developing diabetes, and metformin. 2. In what setting? What population? The population is derived from basic studies, epidemiologic studies, clinical trial, and Kaiser Permanente administrative data. These populations are defined at high risk for diabetes by a BMI greater than 24, fasting glucose levels between 5.3 and 6.9, and a 2-hr glucose tolerance test of 7.77 to 11 mmol/L. Measurements included are diagnosis of diabetes and complications of diabetes. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) A cost-effectiveness analysis is used to determine cost associated between no prevention of diabetes, cost of treatment with diagnosed diabetes, and lifestyle and medication interventions. Cost-utility analysis is used in terms of QALYs. 4. From whose perspective? (individual, payer, societal) The perspective is from the healthcare system or payer. The societal cost is also analyzed for each group. 5. What were the cost and types of costs? Compared to no intervention, per QALY, the DPP lifestyle intervention would be $143000 from the payers perspective and $62,000 from a societal perspective. The use of metformin, per QALY, from the payers perspective would be about $35,000. Delaying intervention until diagnosis would cost $24,500 per QALY. The DPP lifestyle program’s marginal cost-effectiveness compared to delaying lifestyle modification until after diabetes diagnosis is about $201,800. 6. What were the benefits? (Did not show “benefits”) Over a 30 year time period, investigators found that a DPP-like lifestyle change would prevent approximately 11% of cases of diabetes, 22% of serious complications, and about 18% of related deaths for people at high risk. In terms of per person costs to a health plan, for the first 5 years it would cost approximately $60 per month for a high-risk person. For cost-effectiveness, about 100,000 members with a 10% turnover per year, the 30 year cost per QALY of a DPP like program would be about $143,000 from a health plans perspective. From a societal perspective the cost/QALY compared with no program would be about $63,000 over 30 years. 7. Key Points? Compared to no intervention, lifestyle modification could be cost-saving over 30 years if the annual cost of the intervention was reduced to about $100. This study using existing literature found that the DPP may be cost too expensive for health plans to handle. Article 5: Ackermann RT, Marrero DH, Hicks KA, Hoerger TJ, An Evaluation of Cost Sharing to Finance a Diet and Physical Activity Intervention to Prevent Diabetes; Diabetes Care, 29:1237-1241, 2006. 1. What was the intervention/program? Investigators used the DPP lifestyle intervention results to determine if there would be a ROI for private health insurers while still attracting participants, employers and Medicare. A Markov simulation model used DPP data to estimate direct medical costs and direct medical costs not associated with the intervention for individuals that did not develop diabetes within the 3 year period. 2. In what setting? What population? DPP eligibility was determined by: IGT, 25 years or older, BMI of 24 or higher or BMI of 22 or high or Asian Americans. A total of 3,234 participants enrolled with a mean age of 51 and a mean BMI of 34. Women comprised 68% of participants and 45% were of minority groups. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost effectiveness in terms of diabetes prevented; cost utility in terms of measuring qualityadjusted life-years. 4. From whose perspective? (individual, payer, societal) The article is written from a health system (payer) perspective comparing DPP lifestyle and placebo interventions. 5. What were the cost and types of costs? Direct medical costs were looked at while assuming that year 3 costs of the program would be incurred each year until individuals developed diabetes or died. 6. What were the benefits? Lifetime health economic benefits: Compared to the placebo, people starting the program before 50 years of age, diabetes risk was reduced from 87% to 65% and the cost-effectiveness ratio was $1,288 per QALY gained. For Medicare, for every 100 people in the intervention at age 50, there were about 28 fewer people living with diabetes at 65 years old. After age 65, medical costs were $2,136 lower for participants compared to the placebo. For private payers these benefits were associated with a 15-year incremental cost of $2,894 and incremental costeffectiveness of $9,647 per QALY gained. According to the model, if a group intervention were offered with similar results, a private payer contribution would be completely recovered after 3 years. Compared to no intervention, the DPP could prevent 37% of new cases of diabetes before the age of 65 if the program was offered at age 50. This would be at a cost of $1,288 per QALY gained. In addition, the model estimates that a private payer could reimburse up to 24% of intervention costs during the first 3 years of the program and still achieve complete ROI. 7. Key points? Through cost sharing, the DPP intervention would be practical and provide a financial return for private payers and benefits Medicare if offered to people between the age of 50 and 64. Article 6: Herman WH, Hoerger TJ, Brandle M, et al. The Cost-Effectiveness of Lifestyle Modification or Metformin Preventing Type 2 Diabetes in Adults with Impaired Glucose Tolerance; Ann Inn Med, 142:323-332, 2005. 1. What was the intervention/program? DPP lifestyle, metformin and placebo intervention protocol 2. In what setting? What population? DPP participants and use of a Markov simulation model 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost effectiveness in terms of diabetes prevented; cost utility in terms of measuring qualityadjusted life-years 4. From whose perspective? (individual, payer, societal) Health system (payer) and societal 5. What were the cost and types of costs? What was missing? Costs included direct medical costs, direct non-medical costs, and indirect costs of lifestyle and medication interventions compared to placebo. Large health system costs include only direct medicals coats while societal costs include direct medical and non-medical costs in addition to indirect costs. Direct medical costs include identification of individuals with IGT, implementation and maintenance of interventions, hospitalization, outpatient care, laboratory tests, medications, and costs of medical care outside of the DPP. Direct non-medical costs include the participants time spent traveling for appointments, exercising, purchase of equipment or gym memberships, shopping, and cooking. Indirect costs include loss of work, illness, or disability related to morbidity and lost productivity due to premature death/mortality. 6. What were the benefits? What was missing? The cost per QALY was $1100 for the lifestyle intervention and $31,300 for the metformin intervention when compared to the placebo. From a societal perspective the lifestyle intervention costs about $8800 per QALY and $29,900 for the metformin intervention when compared to placebo. The lifestyle intervention was estimated to delay onset of diabetes by about 11 years while metformin delayed onset by about 3 years. Article 7: DPP Research Group; 10-year follow-up diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study; Lancet; 374(9702): 1677-1686, November 2009. 1. What was the intervention/program? The DPPOS was a follow up study to the DPP. Participants in the DPP were informed of the main results and treatment groups were revealed. Metformin and placebo participants entered a 1-2 week drug washout study. All participants were then offered a 16-session lifestyle curriculum as a bridge protocol. Lifestyle sessions were offered to all participants at 3 month intervals. For the original lifestyle participants only, 2 group classes comprising of 4 sessions per year were offered. The metformin group continued 850mg twice daily unless development of diabetes required further treatment by physician. Outcome assessment examinations continued per DPP protocol yearly and 6 monthly. The primary objectives were to assess long-term effects of DPP intervention on the development of diabetes and the complications. 2. In what setting? What population? 3,150 surviving DPP participants were eligible, irrespective of whether they had developed diabetes. Of those eligible, 2,766 (88%) enrolled in the DPPO study. Demographics did not differ significantly by sex or ethnic origin when compared to the original DPP participants. Enrollment was lower in women with a history of gestational diabetes and was related to greater age, and in women, by lower weight and BMI. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Analysis was by intention to treat. The delay of diabetes onset would be cost-utility. 4. From whose perspective? (individual, payer, societal) Cost from a health system (payer) perspective and societal perspective 5. What were the cost and types of costs? What was missing? Costs were not provided in this follow up study. Costs would be similar to the original DPP intervention for cost of medication, staff time, and time requirements for participants. 6. What were the benefits? What was missing? During DPPOS, diabetes incidence rates were stable in the lifestyle group and fell in the placebo and metformin groups. In the combined time period of DPP, bridge, and DPPOS, the incidence rate of the lifestyle group was reduced by 34% and metformin by 18% compared with placebo. The lifestyle group showed the greatest reduction in participants between the ages of 60 and 85 years with a 49% reduction rate. Median delay of onset was estimated from the differences between treatments groups in the time to 40% cumulative incidence of diabetes. This time point was delayed by about 4 years in the lifestyle group and 2 years in the metformin group when compared to the placebo. At the last examination point, normoglycemic ranges were reached by 23% in the lifestyle and 19% in the metformin and placebo groups. Article 8 Ramsey S, Summers KH, Leong SA et al.; Productivity and Medical Costs of Diabetes in a Large Employer Population; Diabetes Care; Volume 25, Number 1; 2002. 1. What was the intervention/program? Using a sample population from a large firm, the mean differences between the costs of diabetes between the diabetes and control population were measured. 2. In what setting? What population? The study population came from a Fortune 100 manufacturing firm with facilities throughout the U.S. and more than 100,000 medical plan beneficiaries. These included industrial, service, and professional employees. All employees were covered by the health insurance program with 90% covered by disability benefits. A sample of 8,170 beneficiaries with diabetes was matched to control subjects. In the diabetes sample, 44% were female, 47% employees, 29% spouses/dependents, with a mean age of 53. The control subjects were 43% female, 48% employees, 39% spouses/dependants, with a mean age of 53. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) 4. From whose perspective? (individual, payer, societal) Employer’s Perspective (large company/payer) 5. What were the cost and types of costs? What was missing? Costs included payments by the employer to health care providers or employees for medically related missed workdays. Direct medical care costs and productivity costs were included. There was a mean annual incremental cost of $4,410 for all beneficiaries with diabetes and $4,413 for employees with diabetes compared with controls. Over 30% of costs associated with diabetic employees were attributable to medically related work absences and disability. Article 9 Zhuo BX, Zhang P, Gregg EW, et al; A Nationwide Community-Based Lifestyle Program Could Delay or Prevent Type 2 Diabetes Cases and Save $5.7 Billion in 25 Years; Health Affairs; 31(1), 2012. 1. What was the intervention/program? This study aimed to project the long-term costs and benefits of a community-based DPP. A hypothetical prevention strategy was used to identify and screen the target population, followed by a program based on the DPP lifestyle intervention. The simulation model compares current screening practices with the intervention and no intervention. The intervention would be provided in a group setting with sixteen intensive core sessions over 5 month to encourage weight loss, followed by six monthly post core sessions to sustain weight loss behaviors. It was then assumed that participants would be offered eight maintenance sessions during the second year and one or two counseling sessions annually after the first two years. 2. In what setting? What population? The population would include adults ages 18-84 at high risk for diabetes. It was assumed that people 65-84 would be contacted by letter to undergo a lab test and those 18-44 would take a pencil and paper diabetes risk test when at their primary care physician’s office. It was estimated that 52% of the younger group would screen positive and 54% of the older group would screen positive. It was then estimated that of those identified, 50% from the younger group and 60% from the older group would participate. The simulation used approximately 100 million potential screening of individuals 18-84 over the next 25 years in the model. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost-effectiveness in terms of diabetes prevented/money saved and cost-utility in terms of QALYs. 4. From whose perspective? (individual, payer, societal) The simulation model assumed the perspective of the health care system (payer) 5. What were the cost and types of costs? What was missing? Costs calculated included the cost of the intervention and direct medical costs associated with diabetes and potential complications. Costs and QALYs were discounted at three percent per year. It was projected that the program would cost $24.1 billion for screening, diagnosis, and life-style interventions over the 25 year period. Estimated net costs of the program are $1.2 billion for the first year for those between the ages of 65 and 84. This cost would increase until year 3 where it would start to decline. It is predicted that at year 13 it would break even and start to reduce costs. Projected cost saving would increase to $2.4 billion in year 25. These predictions were similar for the younger age group. 6. What were the benefits? What was missing? It was projected that the program would prevent or delay 885,000 new cases of type 2 diabetes and result in a gain of 952,000 life years and 669,00 quality-adjusted life-years. This would result in $29.8 billion in downstream savings from treatment costs for people who might have developed diabetes and related complications. This would be a net savings of $5.7 billion over twenty-five years. 7. Key points Over 25 years, a community based lifestyle intervention would prevent about $885,000 cases of diabetes and save $5.7 billion nationwide. If it were restricted to ages 65 to 84, it would take one year less for the program to break even and would result in 596,000 fewer cases of diabetes and decrease health care costs by a net $2.4 billion over 25 years. Article 10 Hoerger JT, Hicks KA, Sorensen SW, et al.; Cost-Effectiveness of Screening for Pre-Diabetes Among Overweight and Obese U.S. Adults; Diabetes Care; Volume 30, Number 11; 2007. 1. What was the intervention/program? Costs and quality of life were estimated using a Markov simulation model. The program considered two different screening/treatment strategies for individuals with pre-diabetes. Strategy 1 would have subjects with both IGT and IFG receive the DPP intervention, while Strategy 2 would have subjects receive the program if diagnosed with either IFG or IGT. 2. In what setting? What population? The study targeted the overweight and obese (BMI great than 25) population between the ages of 45 and 74. The study cohort came from data from the 1999-2000 National Health and Nutrition Examination Survey and the 2000 U.S. Census population estimates. 3. What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) Cost-effectiveness of screening overweight and obese individuals for pre-diabetes and then modifying their lifestyle based on the DPP. Cost-utility analysis was used in terms of QALYs. 4. From whose perspective? (individual, payer, societal) Health-care system perspective (payer) 5. What were the cost and types of costs? What was missing? A CBG screening test added to an already scheduled physician visit incurred a cost of $32.68 per screened patient. If the patient screened positive either a FPG or oral glucose tolerance test would be administered for a diagnostic test. The cost per diagnostic test totaled $42.92, including $11.61 for the test, $3.00 for the blood draw, and an extra 10 minutes of physician time. Under strategy 1, 80% of subjects with IFG and IGT were diagnosed and began treatment, and strategy 2 provided treatment to 53%. 6. What were the benefits? What was missing? Relative to no screening, Strategy 1 decreased the development of diabetes from 76.4% to 58.6% while Strategy 2 decreased incidence from 574% to 45.2%. Strategy 1 had higher total costs and more QALYs than no-screening. The cost-effectiveness ratio for Strategy one was $8.181 per QALY. The cost-effectiveness ratio for strategy 2 was $9,511 per QALY relative to no screening and $10,167 per QALY relative to strategy 1. Article 11 Vojta D, Sa JD, Prospect T, Stevens S; Effective Interventions For Stemming the Growing Crisis of Diabetes and Prediabetes: A Nation Payer’s Perspective; Health Affairs; 31(1), 2012. 1. 2. 3. 4. 5. What was the intervention/program? In what setting? What population? What type of economic analysis? (minimization, cost-benefit, cost-effectiveness, cost-utility) From whose perspective? (individual, payer, societal) What were the cost and types of costs? What was missing?