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A Systematic Review of Value-Based Insurance Design in Chronic Diseases
Karen L. Tang, MD; Lianne Barnieh, PhD; Bikaramjit Mann, MD; Fiona Clement, PhD; David J.T. Campbell, MD, MSc; Brenda R. Hemmelgarn, MD, PhD; Marcello Tonelli, MD, SM; Diane Lorenzetti, MLS; and Braden J. Manns, MD, MSc

A Systematic Review of Value-Based Insurance Design in Chronic Diseases

Karen L. Tang, MD; Lianne Barnieh, PhD; Bikaramjit Mann, MD; Fiona Clement, PhD; David J.T. Campbell, MD, MSc; Brenda R. Hemmelgarn, MD, PhD; Marcello Tonelli, MD, SM; Diane Lorenzetti, MLS; and Braden J. Manns, MD, MSc
Value-based insurance design for prescription drug coverage increases drug adherence in patients with chronic disease, though their effect on clinical outcomes and health spending remain uncertain.
Impact on Clinical Outcomes

Only the 1 randomized controlled trial13 examined the impact of essential drug coverage on clinical outcomes. The trial showed that in patients discharged from the hospital after a myocardial infarction, the rate of first major vascular event or revascularization was similar between those with full drug coverage for essential CV medications (angiotensin converting enzyme inhibitors, beta-blockers, and statins) and those with “usual drug coverage” (mean co-payments for the medications of interest ranging between $12.83 and $24.92 depending on the class). However, rates of total major vascular events or revascularization (hazard ratio [HR] 0.89; 95% CI, 0.80-0.99), and first major vascular event (HR 0.86, 95% CI, 0.74-0.99) were significantly lower in the full drug coverage group compared with the usual coverage group.

Impact on Health Utilization and Expenditures

One controlled before-and-after study21 examined changes to healthcare utilization before and after implementation of V-BID, but showed conflicting results, with a reduction in hospitalizations in the high-risk group who participated in V-BID and an intensive disease management program, but an increase in hospitalizations in the low-risk group participating in V-BID and a less intensive disease management program when compared with controls who chose not to participate in either program.

Three of the 4 studies13,19,21 that examined the impact of V-BID on healthcare expenditures found an increase in prescription drug expenditures overall (Table 4), while the fourth study found no statistically significant difference. 20 As expected, patient-borne prescription drug costs decreased (relative spending 0.70, 95% CI, 0.65-0.75) with V-BID implementation in the randomized trial.13 Total healthcare spending, including both drug and non-drug expenditures, was similar in the V-BID group compared with the usual care group in 3 studies,13,19,20 including the randomized trial.13 In the fourth study,21 total healthcare spending was lower in those patients who participated in V-BID and intensive disease management, but higher in the V-BID and less intensive disease management group compared with those who did not participate in either the V-BID or disease management programs.

DISCUSSION

To our knowledge, this is the first systematic review to examine V-BID. We found 10 studies that evaluated 9 interventions which compared V-BID with no differential lowering of drug co-payments in patients with CV-related chronic diseases. Although V-BID was consistently associated with an increase in medication adherence of 2 to 5 percentage points across all studies, including the sole randomized trial, the evidence of impact of V-BID on clinical outcomes was far more limited, with only 1 study13 evaluating this. Though this study showed no difference in the primary clinical outcome, there was a decrease in adverse clinical secondary outcomes. Furthermore, the combined role of disease management and V-BID is unclear. Only 2 low-quality studies, at high risk of residual confounding21 and selection bias,19,21 reported outcomes separately for patients participating in V-BID and disease management compared with those who chose not to participate in either, allowing assessment of the impact of combining these programs.

Our review reveals a substantial evidence gap on the impact of V-BID on clinical outcomes, health utilization, and healthcare spending, consistent with prior narrative reviews by Choudhry and colleagues23 and Fairman and Curtiss.24 One possible reason that V-BID has not resulted in overall cost savings is that an increase in co-payments for low-value medications has not yet been applied together with a decrease in co-payments for high-value medications, as described in the original V-BID model.8 As a result, any cost savings with V-BID interventions depend on improved medication adherence leading to improved clinical outcomes and resulting in decreased healthcare utilization and medical spending. Melnick and Motheral,25 using a plausibility calculation method, argued that net cost savings with V-BID is highly unlikely, as large reductions in drug co-payments result only in small increases in medication use (low price elasticity), and that avoidable adverse events due to improved medication adherence are rare.

Despite the limited evidence, approximately 20% of private insurance plans offered by large American employers include V-BID.24 Moreover, in 2007, 80% of large employers indicated an interest in implementing V-BID over the ensuing 5 years.23 There has also been substantial US governmental interest and political activity regarding V-BID, and in 2009, the Seniors’ Medication Copayment Reduction Act was created, requesting a demonstration program to test V-BID in Medicare beneficiaries.26 Most recently, the Patient Protection and Affordable Care Act, under Section 2713(a), specifically addresses V-BID, stating “The Secretary may develop guidelines to permit a group health plan and a health insurance issuer offering group or individual health insurance coverage to utilize value-based insurance designs.”27 V-BID need not be limited to drug insurance alone, and could potentially be applied to other health services. In 2010, new regulations in the US required private health insurance plans to cover high-value preventive services that were given a rating of grade A or B by the United States Preventive Services Task Force. This includes breast and colon cancer screening, diabetes screening, and routine vaccinations.28 There has also been interest in applying VBID to the areas of diagnostic imaging,29 gastroenterologic procedures such as endoscopy,30 and oncology.31 However, actual implementation and subsequent evaluation of VBID has yet to extend beyond prescription medications. The limitations in evidence do not seem to substantiate the widespread interest and implementation of V-BID and should be considered experimental.

There were limitations to our review. First, our review evaluated only the impact of V-BID and not whether medications that had their co-payments reduced were correctly classified as “high value” in their respective V-BID programs. As with any systematic review, our study was limited by the quality of the underlying studies. Except for the 1 randomized trial, the literature base in V-BID at the time of our study had a moderate to high risk of bias, specifically in study design (in particular with selection bias) and reporting.24,32,33 Our focus on CV-related chronic diseases may limit generalizability to other conditions, though medications for these diseases constitute a large proportion of the medications funded by outpatient prescription drug benefit plans. In addition, private insurers implemented V-BID in 9 of the 10 studies, potentially also limiting generalizability of the findings, especially with respect to public drug insurers. Lastly, current studies in V-BID target populations that already have good medication adherence, and this may limit the ability of V-BID to increase compliance.25 A notable exception was the randomized trial, 13 with a baseline adherence of about 44%, likely because a variety of insurance plan sponsors were included—employer, union, and government insurers—thereby better representing the general population. Further research on the impact of V-BID on clinical and economic outcomes is required, particularly in populations that might benefit most,23 such as those at highest risk for clinical adverse events, those with low baseline compliance, and those facing financial barriers to drug adherence.

If V-BID is expected to lower costs, consideration must be given to increasing cost sharing for low-value medications. The major challenge is in classifying and defining a medication as low value, given that the evidence for services or medications being of low value is far less established than for high-value medications.34,35 Additional research into this, as well as the most appropriate patient populations to target, is required to inform further use of V-BID,36 particularly within publicly funded drug formularies.

Value-based insurance design is a novel approach to encourage adherence to high-value medications. Though it appears to be associated with improved medication adherence, the effects on clinical outcomes and overall health utilization and expenditures remain uncertain. Further high-quality research is required before more widespread implementation of V-BID can be encouraged.

Acknowledgments

Dr Campbell was supported by an Alberta Innovates-Health Solutions (AI-HS) Clinician Fellowship award. Dr Barnieh was supported by an Alberta Innovates-Health Solutions Trainee award. Drs Manns and Hemmelgarn were supported by career salary support awards from Alberta Innovates-Health Solutions. Dr Hemmelgarn was also supported by the Roy and Vi Baay Chair in Kidney Research. Dr Tonelli was supported by a Government of Canada Research Chair. Drs Manns, Hemmelgarn, and Tonelli were also supported by an alternative funding plan from the Government of Alberta and the Universities of Calgary and Alberta.

aDisease management programs consisting of targeted health education mailing, disease workbooks, telephone outreach, and counseling with a nurse to set care plans, periodic monitoring, or any combination of the above.

Author Affiliations: Department of Medicine, University of Calgary, Alberta, Canada (KLT, LB, BM, DJTC, BRH, BJM); Department of Community Health Sciences, University of Calgary, Alberta, Canada (LB, FC, DJTC, BRH, DL, BJM); Interdisciplinary Chronic Disease Collaboration, Calgary, Alberta, Canada (LB, FC, DJTC, BRH, MT, BJM); Institute of Public Health, University of Calgary, Alberta, Canada (FC, BRH, BJM); The Libin Cardiovascular Institute, University of Calgary, Alberta, Canada (BRH, BJM); Department of Medicine, University of Alberta, Edmonton, Alberta, Canada (MT).

Source of Funding: This research was supported by an interdisciplinary team grant from Alberta Innovates-Health Solutions, the Interdisciplinary Chronic Disease Collaboration.

Author Disclosures: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Authorship Information: Concept and design (KLT, LB, BM, FC, DJTC, BRH, MT, DL, BJM); acquisition of data (KLT, LB, BM, FC, DJTC, BRH, MT, DL, BJM); analysis and interpretation of data (KLT, LB, BM, FC, DJTC, BJM); drafting of the manuscript (KLT); critical revision of the manuscript for important intellectual content (KLT, LB, BM, FC, DJTC, BRH, MT, DL, BJM).

Address correspondence to: Braden J. Manns, MD, MSc, Foothills Medical Centre, 1403 29th St NW, Calgary, AB T2N 2T9. E-mail: braden.manns@albertahealthservices.ca.
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