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The American Journal of Managed Care June 2014
Comparison Between Guideline-Preferred and Nonpreferred First-Line HIV Antiretroviral Therapy
Stephen S. Johnston, MA; Timothy Juday, PhD; Amanda M. Farr, MPH; Bong-Chul Chu, PhD; and Tony Hebden, PhD
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Martin Zalesak, MD, PhD; Joyce S. Greenbaum, BA; Joshua T. Cohen, PhD; Fotios Kokkotos, PhD; Adam Lustig, MS; Peter J. Neumann, ScD; Daryl Pritchard, PhD; Jeffrey Stewart, BA; and Robert W. Dubois, MD
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Ateev Mehrotra, MD; Ruopeng An, PhD; Deepak N. Patel, MBBS; and Roland Sturm, PhD
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Gregory B. Steinberg, MB, BCh; Bruce W. Church, PhD; Carol J. McCall, FSA, MAAA; Adam B. Scott, MBA; and Brian P. Kalis, MBA
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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.
Objectives
Value-based insurance design (V-BID) is an insurance cost-sharing model in which patients pay less for medications deemed to be of higher value. Our objective was to determine the association between V-BID and medication adherence, clinical outcomes, healthcare utilization, and spending in patients with or at risk for cardiovascular chronic diseases, compared with no differential lowering of drug co-payments.

Study Design
Systematic review.

Methods
We searched PubMed, MEDLINE, EMBASE, CINAHL, Cochrane Controlled Trials Register, Current Controlled Trials, and reference lists of included studies and relevant reviews up to September 2012. Two reviewers independently identified primary research studies with the following study designs: randomized controlled trial, interrupted time series, and controlled before-after studies. Two reviewers independently extracted data and assessed quality.

Results
Ten studies were identified: 1 high-quality randomized controlled trial, 1 interrupted time series analysis, and 8 controlled before-and-after studies. Heterogeneity in study populations and interventions, overall low study quality, and lack of standard error reporting precluded meta-analysis. All reported improvement in medication adherence for medications subject to V-BID, of between 2 and 5 percentage points. Impact on clinical outcomes was unclear, with only 1 study reporting on this, noting no difference in the primary outcome, but a reduction in adverse secondary outcomes with V-BID. Of the four studies that examined the impact of VBID on healthcare expenditures, V-BID tended to increase overall prescription drug spending, though three of the four studies reported similar overall healthcare costs due to decreased non drug medical spending.

Conclusions
V-BID is associated with improved medication adherence but its effects on clinical outcomes, healthcare utilization, and spending remain uncertain.

Am J Manag Care. 2014;20(6):e229-e241
  • Value based insurance design for prescription drug coverage improves medication adherence by about 2-5 percentage points for patients with chronic cardiovascular disease.
  • The impact of VBID on clinical outcomes and health care expenditures is uncertain due to smaller numbers of studies examining these outcomes, and conflicting results across studies.
  • Existing VBID studies are limited by moderate to high risk of bias. There is a need for high quality studies that examine impact of BID not only for medication adherence, but also for clinical outcomes and healthcare expenditures, before widespread implementation of VBID can be recommended.
Prescription drug costs comprise 10% of all healthcare expenditures in the United States,1 reaching $263 billion in 2011, and they are projected to rise to nearly $500 billion annually over the next 10 years.2 Patient co-payments and/or deductibles were established in part to lower costs to the insurer and to reduce inappropriate overconsumption. The amount of cost sharing has traditionally been based on drug acquisition cost, where expensive brand name medications have higher levels of co-payments than less expensive generic drugs.3 Past studies have shown that patients may reduce drug use in response to cost sharing, but tend to reduce both appropriate and inappropriate therapy,4,5 indicating that they may not be able to differentiate high- from low-value therapies.6 This leads to increased medical complications and healthcare utilization4,7 and higher overall healthcare costs.

Fendrick and colleagues introduced a novel cost sharing design in 2001, initially termed “benefit-based co-pay,”8 and subsequently renamed “value-based insurance design” (VBID). 3 The underlying premise is that a drug co-payment is based on the clinical benefit, or value, of that drug rather than its acquisition cost. More specifically, Fendrick and colleagues define V-BID as “decreasing cost sharing for interventions that are known to be effective and increasing cost sharing for those that are not.”9 The goal of the V-BID system is to encourage the use of the most effective drugs, while constraining costs by keeping cost sharing intact for drugs deemed to be of lower value.6

Since 2001, numerous private insurers have implemented V-BID for prescription drug coverage. We conducted a systematic review to determine the impact of V-BID on medication adherence, clinical outcomes, and health-system costs in patients with cardiovascular-related chronic diseases, compared with those with usual drug coverage. We defined V-BID as the selective lowering or waiving of drug co-payments for medications that were deemed to be of high value in the treatment of chronic diseases. Our search focused on cardiovascular (CV)-related chronic diseases, given that long-term medication use (in addition to lifestyle changes) is the mainstay of treatment for these conditions, and that a large body of evidence shows that selected medications are effective in reducing morbidity and mortality. For example, treatment of hypertension reduces the risk of major CV events, with similar benefit seen across many antihypertensive drug classes used.10 Similarly, intensive glycemic control in diabetes with oral hypoglycemic agents or insulin reduces complications of retinopathy and nephropathy.11 V-BID is one method by which evidence-based appropriate treatment can be promoted for these diseases.

METHODS

Data Sources and Searches

A study protocol was created that outlined the objectives,eligibility criteria for study inclusion in the systematic review, and plan for data abstraction, synthesis, and quality assessment. We searched the following databases from inception to September 12, 2012: PubMed, MEDLINE, EMBASE, CINAHL, Cochrane Controlled Trials Register, and Current Controlled Trials. Key terms included hypertension, cardiovascular diseases, stroke, diabetes mellitus, dyslipidemia, cost sharing, deductibles and coinsurance, co-pay, and value-based pricing or plan. The search strategy can be found in the eAppendix. The search was limited to English and French language studies, and no limitations were placed on patient characteristics, study duration, or outcome. Reference lists of all included studies and relevant narrative reviews were manually searched.

Study Selection

Using a 2-step process, 2 reviewers (KLT and LB) first independently reviewed all identified abstracts for eligibility, then extracted and reviewed the full-text articles for the abstracts that were thought to meet eligibility criteria, or where there was any uncertainty. Studies published exclusively as abstracts without accompanying full-text articles were not considered. Disagreements were resolved by consensus or with the aid of a third party (BJM). Eligibility criteria were the implementation of V-BID as described above, inclusion of at least a proportion of adults with 1 or more CV-related chronic disease (hypertension, dyslipidemia, diabetes, coronary artery disease, heart failure, or stroke), and 1 or more outcome of interest (medication adherence, clinical outcomes, healthcare utilization, or costs). We included randomized controlled trials (RCTs), nonrandomized controlled trials, interrupted time series (ITS) analyses, and controlled before-and-after studies, based on the Cochrane Effective Practice and Organization of Care Group [EPOC] taxonomy of healthcare policy studies.12 Studies were excluded if the patient populations were exclusively children or adolescents.

Data Extraction and Quality Assessment

Data were extracted on study characteristics (including funding, inclusion/exclusion criteria, design, and methods), baseline characteristics of the intervention and comparator groups, and primary and secondary outcomes for each study. Two reviewers independently extracted data from all studies fulfilling eligibility criteria; disagreements were resolved by consensus. The quality of included studies was assessed using the Cochrane Collaboration risk of bias tools.12

Data Synthesis and Analysis

The significant heterogeneity in study populations and interventions across studies, the overall low quality of the studies, and lack of reported standard error or standard deviation for outcome measurements precluded pooling of results in a meta-analysis. Furthermore, though adherence was reported for all studies, definitions varied slightly among them. Results for each study are summarized individually.

RESULTS

Our search identified 2186 citations, of which 43, along with an additional 4 identified through manual review of reference lists, were included for full-text review (Figure). Of those, 10 studies evaluating 9 V-BID interventions met inclusion criteria: 1 randomized controlled trial,13 1 interrupted time series study,14 and 8 controlled before-and-after studies15-22 (Table 1). All studies were completed in the United States. Of the 10 studies, 2 studies13,14 selectively lowered or waived co-payments for CV medications only (antihypertensives and statins); 3 studies15,19,22 waived co-payments for diabetic medications only, and 5 studies16-18,20,21 waived co-payments for a combination of both CV and diabetic medications. Two studies19,22 waived copayments for brand name drugs only, while the other 8 studies reduced cost-sharing for both generic and brand name drugs.

Six studies14,16,17,19-21 included disease management cointerventions. Five of these14,16,17,19,20 introduced V-BID alongside a separate voluntary disease management programa while 1 study21 tied the V-BID intervention to the disease management program; refusal to participate in disease management in this study also precluded patients from participating in V-BID, making it impossible to distinguish whether outcomes could be attributed to V-BID or the disease management intervention in this study. In 3 of the 6 studies14,16,17,20 with disease management co-interventions, both the intervention and comparison groups could voluntarily participate in disease management programs. Therefore, disease management participation is expected to influence outcomes only if participation rates differed between these 2 groups. Two of these 3 studies16,17 reported similar disease management participation rates in the V-BID and comparison groups, while the third study14 did not report participation rates at all. Four of the 6 studies14,16,17,20 with disease management co-interventions reported only overall results and did not report separate outcomes for participants of disease management programs. A total of 2 studies15,22 ensured that participating insurance plans in the intervention and control groups did not administer disease management programs simultaneously; and 2 studies13,18 did not mention the presence or absence of concurrent disease management programs at all.

Quality of Studies

The only randomized controlled trial13 was rated high quality and the interrupted time series study14 was rated moderate quality. The remainder of the studies, all controlled before-and-after studies, were considered poor quality (Table 2) primarily because of their study designs and their risk of confounding due to concurrent disease management programs for which outcomes were not adjusted.14,16,21

Five studies14,16-18,20 reported significant differences in baseline characteristics (such as age, gender, and baseline medication co-payments) between the intervention and control groups, which were partly addressed in 3 of the 5 studies17,18,20 through propensity score matching, though this did not entirely eliminate differences across groups in all studies.18,20 In another study,21 though the baseline characteristics were similar among groups, the control group was comprised of patients who declined to participate in disease management programs (and therefore were ineligible for V-BID), while the intervention group included patients who agreed to participate in (and therefore also received) V-BID. Five studies15,16,19-21 also reported statistically significant differences in baseline medication adherence between the intervention and control groups.

Impact on Medication Adherence

All 10 studies reported the impact of V-BID implementation on medication adherence, either on its own (n = 4) or when given in conjunction with disease management (n = 6) (Table 3). Baseline adherence (ie, medication possession ratios) across studies was generally in the range of 60% to 80%, though 2 studies13,19 reported much lower baseline adherence rates of between 30% and 40%. Overall, V-BID was associated with an increase in medication adherence, as measured by medication possession ratio or proportion of days covered, of approximately 2 to 5 percentage points compared with the control group for medications subject to V-BID. In the randomized controlled trial,13 the increase was 4.4 to 6.2 percentage points across the medications subject to V-BID. Similar outcomes were seen across all studies, with follow-up periods ranging from 3 months13 to 3 years post V-BID implementation.19,20 Choudhry and colleagues’ interrupted time series study14 showed that following an immediate improvement in medication adherence in the V-BID group, the rate of decline in adherence was similar between the 2 groups over time.

Absolute increases in medication adherence were also similar between studies that evaluated V-BID only and those that also implemented voluntary disease management programs (Table 3). In the 2 studies19,21 that reported on the combined effect of disease management and V-BID, medication adherence improved by 2.7 to 6.5 percentage points in patients who received both V-BID and disease management programs. Kim and colleagues21 added that improvement was seen only if the disease management program was intensive in nature, such as with telephone counseling with a nurse to set goals and care plans, but not when the program consisted only of health education mailings.

 
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