Cardiovascular Disease Prevention and Control: Reducing Out-of-Pocket Costs for Cardiovascular Disease Preventive Services for Patients with High Blood Pressure and High Cholesterol

Task Force Finding & Rationale Statement

Definition

Reducing out-of-pocket costs (ROPC) for patients with high blood pressure and high cholesterol involves program and policy changes that make cardiovascular disease preventive services more affordable. These services include medications, behavioral counseling (e.g., nutrition counseling), and behavioral support (e.g., community-based weight management programs, gym membership). Costs for these services can be reduced by providing new or expanded treatment coverage and lowering or eliminating patient out-of-pocket expenses (e.g., copayments, coinsurances, deductibles).

ROPC is coordinated through the health care system and preventive services may be delivered in clinical or non-clinical settings (e.g., worksite, community). ROPC is often implemented with additional interventions intended to improve patient–provider interaction and patient knowledge such as team-based care with medication counseling, and patient education. ROPC programs or policy changes may be communicated to patients and providers to increase awareness and use of covered services.

Task Force Finding

The Community Preventive Services Task Force recommends reducing patient out-of-pocket costs (ROPC) for medications to control high blood pressure and high cholesterol when combined with additional interventions aimed at improving patient–provider interaction and patient knowledge, such as team-based care with medication counseling, and patient education. This recommendation is based on strong evidence of effectiveness in improving (1) medication adherence and (2) blood pressure and cholesterol outcomes. Limited evidence was available to assess the effectiveness of reducing patient out-of-pocket costs for behavioral counseling or behavioral support services independent of reducing patient costs for medications

Rationale

Basis of Finding

The Task Force finding is based on evidence from 14 studies that assessed effectiveness of reducing out-of-pocket costs for one or more cardiovascular disease preventive services for patients with high blood pressure, high cholesterol, or both (search period January 1980-June 2012). Table 1 summarizes review results by outcome.

Table 1. Summary Results from Review

Review Outcome	Effectiveness Measurements	Summary Estimates
Medication adherence	Absolute percentage point change in patient adherence rates for blood pressure and cholesterol medications	Median: increase of 3.2 pct. pts. (IQI: 2.0 pct. pts. to 4.6 pct. pts.) 3 studies with 10 study arms
Medication adherence	Absolute percentage point change in proportion of patients achieving 80% adherence	Increase of 5.1 pct. pts. 1 study
Medication adherence	Absolute percentage point change in patient adherence by baseline adherence rate	Patients with low adherence (≤55%): increase of 21.5 pct. pts. Patients with high adherence (>55%): reduction of 2.2 pct. pts. 1 study
Blood pressure	Absolute percentage point change in proportion of patients achieving blood pressure goal (<140 mmHg/90 mmHg)	Median: increase of 18.0 pct. pts. (IQI: 6.0 pct. pts. to 33.0 pct. pts.) 7 studies
Blood pressure	Change in mean systolic blood pressure (mmHg)	Median: reduction of 8.7 mmHg (IQI: -10.9 mmHg to -1.9 mmHg) 10 studies
Blood pressure	Change in mean diastolic blood pressure (mmHg)	Median: reduction of 4.5 mmHg (IQI: -6.1 mmHg to -3.0 mmHg) 10 studies
Low density lipoprotein (LDL) cholesterol	Change in mean LDL (mg/dl)	Median: reduction of 14.0 mg/dl (IQI: -16.7 mg/dl to -9.9 mg/dl) 6 studies
Low density lipoprotein (LDL) cholesterol	Absolute percentage point change in proportion of patients achieving LDL goal	Increase of 13.0 pct. pts. (Min: 10.0, Max: 24.7 pct. pts.) 3 studies
Triglycerides (TG)	Change in mean TG (mg/dl)	Median: reduction of 29.0 mg/dl (IQI: -34.7 mg/dl to -10.1 mg/dl) 5 studies
Total cholesterol (TC)	Change in mean TC (mg/dl)	Median: reduction of 20.0 mg/dl (Max: -26.6 mg/dl, Min -12.0 mg/dl) 4 studies
Total cholesterol (TC)	Absolute percentage point change in proportion of patients achieving cholesterol goal	Increase of 7.0 pct. pts. 1 study
High density lipoprotein (HDL) cholesterol	Change in mean HDL (mg/dl)	Median decrease of 0.8 mg/dl (Min: -2.2 mg/dl, Max: +4.0 mg/dl) 5 studies
High density lipoprotein (HDL) cholesterol	Absolute percentage point change in proportion of patients achieving HDL goal	Decrease of 1.30 pct. pts. 1 study

IQI=interquartile interval (calculated for ≥5 study arms); pct. pts. = percentage points

 

All 14 studies evaluated programs or policies that reduced patient out-of-pocket costs for medications to treat high blood pressure or high cholesterol. Ten studies combined ROPC for medications with one or more additional interventions. These interventions included team-based care with medication counseling (seven studies), pro-active follow-up (five studies), linkages to other resources and services (four studies), disease management (three studies), and patient education (four studies). Six studies were policy-based; four of these evaluated value-based insurance design (VBID). Ten of 14 studies assessed the impact of ROPC for medications on blood pressure and cholesterol outcomes. Five studies assessed the impact of ROPC on adherence to blood pressure- and cholesterol-lowering medications. Only one of 14 studies evaluated the impact of both medication adherence and blood pressure and cholesterol outcomes.

The Task Force finding reflects (1) the focus of available studies on reducing patient out-of-pocket costs for medications, (2) modest improvements in medication adherence in studies with ROPC policy changes, (3) meaningful improvements in blood pressure and cholesterol outcomes in patients from studies in which most ROPC efforts were combined with additional interventions such as team-based care with medication counseling, and (4) the lack of studies including or evaluating ROPC for behavioral counseling or behavioral support services for patients with high blood pressure or high cholesterol, independent of ROPC for medications.

Applicability and Generalizability Issues

Twelve of 14 included studies were conducted in the United States with study populations that were balanced by gender and included working-age adults. Studies examined outcomes in different racial and ethnic groups (i.e. Hispanic, white, and African-American) with similar results. Six studies found effectiveness of ROPC in improving treatment outcomes for low-income patients. Overall, results indicate that evidence of effectiveness is broadly applicable to patients with high blood pressure and high cholesterol in the U.S. health care system.

Included studies evaluated different types of implementers with evidence of effectiveness suggesting applicability to employers, health plans and insurers, and government agencies. Four studies examined VBIDs in which patient out-of-pocket costs for medications for high blood pressure and high cholesterol were reduced or eliminated based on assessments of importance of the clinical benefit (high-value service). All four studies assessed medication adherence and reported modest, but favorable results.

Eight of 14 studies eliminated copayments for medications (100% cost reduction), and were found to be effective in improving outcomes. Five studies both eliminated and reduced costs with favorable results, but did not report outcomes by level of reduction (i.e., improvements among those prescribed free versus reduced-cost medications) or by drug patent type (i.e., generic versus brand-name drugs). Few studies reported the actual dollar amount of cost reductions.

Five studies evaluated the effectiveness of ROPC policy changes on medication adherence in large patient populations. Although improvements in adherence were modest, adherence rates were relatively high (53% to 83%) at baseline in these populations. Improvements in adherence were larger among the patients with low adherence prior to the policy change (Table 1).

Data Quality

Eight included studies had a comparison group and the other six measured before-after changes without a comparison group. The most common limitations of included studies were incomplete descriptions of study population and lack of detailed information about the ROPC program or policy.

Other Benefits and Harms

Included studies did not describe or evaluate additional benefits of ROPC. The coordination of ROPC with additional interventions (such as team-based care with medication counseling) may increase opportunities for patient–provider interaction on treatment issues such as dealing with medication side effects. Neither the included studies nor the broader literature identified any harms to patients from these interventions.

Considerations for Implementation

The Task Force finding supports incorporation of policies or programs to reduce or eliminate out-of-pocket costs for medications to treat patients with high blood pressure or high cholesterol as one part of a cardiovascular disease prevention effort. Although team-based care and disease management programs were common additional interventions evaluated in the included studies, broader health system efforts such as Patient-Centered Medical Homes could also provide a useful infrastructure for coordination of prevention activities. In addition, partnerships with employers, providers, and community-based organizations may provide resources and settings that enhance access and use of preventive services.

Potential implementers include healthcare providers and plans, government agencies, and self-insured and fully-insured employers. The results of this review suggest opportunities for innovative application of ROPC policies, coordination of programs, and partnerships for delivery of services. Linking medical and pharmacy claims data and other information systems across settings may enhance coordinated service delivery, monitoring of service use, and assessment of program effectiveness for multiple outcomes of interest.

To increase awareness and use of ROPC covered services, it is critical to promote ROPC benefits to patients and providers. Only three of the 14 included studies described communicating ROPC for medications benefits to patients. Benefits were communicated to patients via letter, newsletter, and company intranet. None of the studies evaluated or reported changes in awareness as a result of activities related to communicating ROPC benefits.

The evidence indicates that a combination of interventions including ROPC for medications is effective in improving blood pressure and cholesterol outcomes for low-income patients. Innovative, culturally appropriate, and targeted promotion strategies to increase awareness among low-income groups with low medication adherence should be considered. Partnering with community organizations may also provide opportunities to increase awareness and use of ROPC benefits among underserved populations.

Reducing out-of-pocket costs for patients with high blood pressure and high cholesterol could be implemented as part of a broader effort to increase use of effective cardiovascular disease preventive services. A comprehensive approach would coordinate these policies with ROPC for evidence-based tobacco cessation treatments, and coverage to improve management of patients with diabetes. Evidence in this review, including studies evaluating VBID, indicates that ROPC interventions are effective in increasing adherence to medications in patients with different cardiovascular risk conditions.

Evidence Gaps

Although the evidence indicates that reducing patient out-of-pocket costs for medications to control high blood pressure and high cholesterol is effective, evidence is limited for assessing effectiveness of ROPC for behavioral counseling and behavioral support services. Additional studies could examine ROPC programs and policies to evaluate these cardiovascular disease preventive services, especially when coordinated with ROPC for medications. Future studies should include and describe efforts to effectively communicate the presence and availability of covered ROPC benefits, and evaluate both the reach and effectiveness of different communication techniques.

Although eliminating patient out-of-pocket costs for cardiovascular disease preventive services is likely to maximize patient uptake, additional research could examine relationships between cost reduction and patient use, providing evidence on thresholds and differential effectiveness.

Additional research could also describe and examine effectiveness of ROPC by total medication cost, proportional cost-reduction, patient income, or drug patent type. In general, policy studies included in this review examined the impact of adding ROPC for medications for an entire patient population, but only evaluated changes in medication adherence. Conversely, the studies evaluating multicomponent programs that include ROPC for medications examined clinical outcomes for patients in the program, but did not report on changes in medication adherence. Both outcomes provide useful information to potential implementers and should be reported.

Review Completed: December 2012