EAL

MNT: Cost Effectiveness, Cost-benefit, or Economic Savings of MNT (2009)

Citation:

Eddy DM, Schlessinger L, Kahn R. Clinical outcomes and cost-effectivenss of strategies for managing people at high risk for diabetes. Ann Intern Med. 2006; 143: 251-264.

PubMed ID: 16103469

Study Design:

Cost-Effectiveness Analysis

Class:

M - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To estimate the effects of the lifestyle modification program used in the Diabetes Prevention Program (DPP) on health and economic outcomes.

Inclusion Criteria:

Not described in this publication.

Exclusion Criteria:

Not described in this publication.

Description of Study Protocol:

Recruitment

Data sources included published basic and epidemiologic studies, clinical trials, and Kaiser Permanente administrative data. Specific sources were identified by searching Medline from 1970 to February 2005 and by consulting textbooks and clinical experts.

Design

Cost-effectiveness analysis using Archimedes model (simulation for 10,000 people).

Intervention

Lifestyle modification program used in Diabetes Prevention Program (DPP)
Lifestyle modification begun after a person develops diabetes
Metformin
No prevention.

Statistical Analysis

Comparison of DPP lifestyle program to Baseline program relevant to QALY, incremental cost-effectiveness.

Data Collection Summary:

Timing of Measurements

Data used to build model were derived from basic physiological studies, surveys, epidemiologic studies, clinical trials (methods described in technical report).

Models tested for internal consistency by variety of methods, including face validity, use of inputs with known outputs, independent duplicate programming of parts, stimulation of studies and trials that have empirically known results.

Each equation in model estimated by fitting functions to data; fits confirmed by comparing resulting function with data from which they were fitted.

Dependent Variables

Direct medical cost of delivering lifestyle and metformin interventions
Quality of life (QALY).

Independent Variables

Lifestyle vs. metformin intervention.

Description of Actual Data Sample:

Initial N: Not described
Age: Not reported
Ethnicity: Not reported
Location: Worldwide studies.

Summary of Results:

Effect of lifestyle program on expected costs in a health plan with 100,000 members for four time periods.

Variable	Cost Without Lifestyle Program Baseline ($)				Cost Difference Made by Lifestyle Program ($)
Variable	Five years	10 years	20 years	30 years	Five years	10 years	20 years	30 years
Hospital Admissions	10.03	23.11	57.66	96.12	0.83	0.67	1.53	2.23
Office Visits	8.26	16.14	33.00	47.78	-0.36	-1.01	-1.66	-2.02
Procedures	7.40	15.93	37.63	57.07	-0.82	-2.03	-4.21	-5.46
Medications and Programs	3.38	6.64	15.61	26.14	14.09	26.36	48.18	64.13
Total	29.07	61.82	143.90	227.11	13.73	24.00	43.84	58.88
Increase in per Member per Month for High-Risk Patients					57.22	49.99	45.67	40.89
Increase in per Member per Month for Entire Membership					2.29	2.00	1.83	1.64

30-year costs, QALY, and incremental cost/QALY for four programs (societal perspective).

Program	Cost Per Person	QALY Per Person (y)	Cost Per QALY ($)	Incremental Increase In Cost	Incremental Increase In QALY (Nine Years)	Cost Per QALY ($)
Baseline	37,171	11.319
Lifestyle when FPG >125mg/dl	40,237	11.444	24,523	3,066	0.125	24,523
DPP Lifestyle	47,140	11.478	62,602	6,903	0.034	201,818
Metformin	41,189	11.432	35,523	dominated	dominated	dominated

Other Findings

Compared with no prevention program, the DPP lifestyle program would reduce a high-risk person's 30-year chances of getting diabetes from about 72% to 61%, the chances of a serious complication from about 38% to 30% and the chances of dying of a complication of diabetes from about 13.5% to 11.2%
Metformin would deliver about one third the long-term health benefits achievable by immediate lifestyle modification
Compared with not implementing any prevention program, the expected 30-year cost/quality-adjusted life-year (QALY) of the DPP lifestyle intervention from the health plan's perspective would be about $143,000
From a societal perspective, the cost/QALY of the lifestyle intervention compared with doing nothing would be about $62,600. It would be cost saving if the annual cost of the intervention decreased from $672 to $100.
Either using metformin or delaying the lifestyle intervention until after a person develops diabetes would be more cost-effective, costing about $35,400 or $24,500 per QALY gained, respectively, compared with no program
Compared with delaying the lifestyle program until after diabetes is diagnosed, the marginal cost-effectiveness of beginning the DPP lifestyle immediately would be about $201,800.

Author Conclusion:

Lifestyle modification is likely to have important effects on the morbidity and mortality of diabetes and should be recommended to all high-risk people. The program used in the DPP study may be too expensive for health plans or a national program to implement. Less expensive methods are needed to achieve the degree of weight loss seen in the DPP.

Funding Source:

Industry:

kaiser permanente, Bristol Myers-Squibb

Pharmaceutical/Dietary Supplement Company:

Other:

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

See Supporting Material (appendix) included with paper for explanation of Archimedes Model, as well as an application example.

Authors note the following limitations:

There may be other populations for whom the natural history or response to lifestyle modification is substantially different from that seen in the DPP study or UKPDS
Clinical trials and actual practice may be different
Costing based on true resource costs, which may not apply to other settings
No way to ensure that the Archimedes model is perfectly accurate for predicting events that have never been studied empirically with trials.

Quality Criteria Checklist: Review Articles
Relevance Questions
	1.	Will the answer if true, have a direct bearing on the health of patients?	Yes
	1.	Will the answer if true, have a direct bearing on the health of patients?	Yes
	2.	Is the outcome or topic something that patients/clients/population groups would care about?	Yes
	2.	Is the outcome or topic something that patients/clients/population groups would care about?	Yes
	3.	Is the problem addressed in the review one that is relevant to dietetics practice?	Yes
	3.	Is the problem addressed in the review one that is relevant to dietetics practice?	Yes
	4.	Will the information, if true, require a change in practice?	Yes
	4.	Will the information, if true, require a change in practice?	Yes

Validity Questions
	1.	Was the question for the review clearly focused and appropriate?	Yes
	1.	Was the question for the review clearly focused and appropriate?	Yes
	2.	Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described?	Yes
	2.	Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described?	Yes
	3.	Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased?	???
	3.	Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased?	???
	4.	Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible?	???
	4.	Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible?	???
	5.	Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined?	Yes
	5.	Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined?	Yes
	6.	Was the outcome of interest clearly indicated? Were other potential harms and benefits considered?	Yes
	6.	Was the outcome of interest clearly indicated? Were other potential harms and benefits considered?	Yes
	7.	Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described?	Yes
	7.	Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described?	Yes
	8.	Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included?	Yes
	8.	Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included?	Yes
	9.	Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed?	Yes
	9.	Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed?	Yes
	10.	Was bias due to the review's funding or sponsorship unlikely?	Yes
	10.	Was bias due to the review's funding or sponsorship unlikely?	Yes