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 medication
adherence and outcomes for high blood pressure and cholesterol. 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. A summary of the Task Force finding and rationale is at www.thecommunityguide.org/cvd/ROPC.html.
Definition
Reducing out-of-pocket costs (ROPC) for patients with high blood pressure and high
cholesterol involves program and policy changes that make medications for cardiovascular
disease (CVD) prevention more affordable. Costs for treatment medications can be reduced
by providing new or expanded treatment coverage and lowering or eliminating patient
out-of-pocket expenses (eg, copayments, coinsurances, deductibles).
Reducing out-of-pocket costs is coordinated through the health care system, and preventive
services may be delivered in clinical or nonclinical settings (eg, worksite, community).
ROPC can be implemented alone or in combination with additional interventions to enhance
patient–provider interaction such as team-based care, medication counseling, and patient
education. Program and policy changes may be communicated to patients and providers
using targeted messages to increase awareness and use of covered services.
Basis of Finding
The Task Force finding is based on evidence from 18 studies (published from January
1980 to July 2015) that assessed the effectiveness of reducing out-of-pocket costs
for medications to treat high blood pressure, high cholesterol, or both (1). All 18
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
including team-based care with medication counseling (7 studies), proactive follow-up
(5 studies), linkages to other resources and services (4 studies), disease management
(3 studies), and patient education (4 studies). Nine of 18 studies assessed the impact
of ROPC for medications on blood pressure and cholesterol outcomes. Six studies assessed
the impact of ROPC on adherence to blood pressure- and cholesterol-lowering medications.
Only one of 18 studies evaluated the impact of both medication adherence and blood
pressure and cholesterol outcomes. Twelve studies were policy-based; 7 of these evaluated
value-based insurance design (VBID).
The Task Force finding reflects 1) the focus of available studies on ROPC for medications,
2) meaningful improvements in blood pressure and cholesterol outcomes (median decrease
of 5.9 and 3.75 mm Hg in systolic and diastolic blood pressure, respectively, in 4
studies and a reduction of 15 mg/dL in 1 study) in patients from studies in which
most ROPC efforts were combined with additional interventions such as team-based care
with medication counseling, 3) modest improvements in medication adherence (median
adherence for all 15 blood pressure and lipid-lowering medications increased 3.0 percentage
points in 6 studies) in studies with ROPC policy changes, 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
Fifteen of the 18 studies were conducted in the United States with study populations
that included working-age adults balanced by sex. Studies examined outcomes in different
racial and ethnic groups (ie, 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 ROPC is effective in a wide range
of patients with high blood pressure and high cholesterol in the US health care system.
Evidence also shows applicability to diverse policy and program implementers, such
as employers and government agencies.
ROPC can be coordinated with other interventions (eg, medication counseling) with
the goal of increasing opportunities for patient–provider interaction on treatment
issues such as medication side effects. No harms to patients from these interventions
were identified in the included studies or the broader literature.
Economic Evidence
The systematic economic review of the intervention included 9 studies that evaluated
ROPC for medications to treat high blood pressure or high cholesterol. Seven of these
were for reductions in medication costs as part of VBID plans. Two of the 9 studies
combined reduced cost for medications with team-based care and 3 studies combined
reduced medication cost with coaching for lifestyle or disease management. However,
only one of the studies of these combined interventions provided the cost to implement
both the ROPC and the added component.
Five of the 7 studies that estimated the effect of the intervention on nonpharmacy
health care cost indicated these costs were reduced. The time frame of these analyses
ranged from 5 years of follow-up to 1 year, with most in the 1- to 2-year range. Three
studies that assessed net benefit of change in health care cost minus intervention
cost indicated mixed results, one showing the intervention was cost-neutral and 2
indicating they were cost-increasing. No studies reported cost-effectiveness outcomes.
An overall economic conclusion about the intervention cannot be drawn from this small
and inconsistent body of cost-benefit evidence.
Considerations for Implementation
This 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 an effort to prevent cardiovascular disease. Team-based
care and disease management programs were common additional interventions evaluated
in the reviewed studies; broader health system efforts such as Patient-Centered Medical
Homes could also provide a useful infrastructure to coordinate prevention activities.
In addition, partnerships with employers, providers, and community-based organizations
may provide resources and settings that enhance access to and use of preventive services.
Potential implementers include health care providers and plans, government agencies,
and self-insured and fully insured employers. Review results 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 3 of 18 included studies described communicating
available benefits for reducing out-of-pocket medication costs to patients via letter,
newsletter, or company intranet. No reviewed studies evaluated or reported changes
in awareness resulting from activities to communicate ROPC benefits.
Low-income patients experienced improved blood pressure and cholesterol outcomes after
being treated with a combination of interventions including ROPC for medications.
Implementers should consider promotion strategies that are innovative, culturally
appropriate, and targeted to increase awareness among low-income groups with low medication
adherence. Partnering with community organizations can also provide opportunities
to increase awareness and use of ROPC benefits among underserved populations.
One ROPC policy approach is to reduce or eliminate copayments for generic medications.
Providers may need to discuss appropriate generic medications with their patients.
Prescribing providers can be important advocates for patients unaware of ROPC benefits.
Providers can 1) ask patients about their ability to pay for medications and 2) be
familiar with medications covered by patients’ health insurance plans and the costs
to patients.
Reducing out-of-pocket costs for patients with high blood pressure and high cholesterol
can be implemented as part of a broader effort to increase use of effective cardiovascular
disease preventive services. Evidence in the review, including studies evaluating
VBID, indicates ROPC interventions are effective in increasing adherence to medications
in patients with different cardiovascular risk conditions. A comprehensive approach,
for example, could coordinate ROPC for medications to improve blood pressure and cholesterol
outcomes with evidence-based tobacco cessation treatments, coverage to improve management
of patients with diabetes, or both. The Affordable Care Act, recognizing the potential
of VBID plans to improve patient receipt of preventive health services without cost-sharing
(2), provides opportunities to reduce patients’ out-of-pocket costs and assist in
preventing cardiovascular disease through a section of the law featuring VBID and
calling for health plan coverage of preventive health services (3).
Evidence Gaps
Although evidence indicates effectiveness of ROPC for medications to control high
blood pressure and high cholesterol, additional research should take into account
the assessment of ROPC in other areas of cardiovascular disease preventive services
(eg, behavioral counseling), especially when coordinated with ROPC for medications.
Future studies should also describe efforts to effectively communicate the presence
and availability of covered ROPC benefits and evaluate both the reach and effectiveness
of different communication techniques. Relationships between cost reduction and patient
use must be examined, providing evidence on thresholds and differential effectiveness.
In addition, research could 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 evaluated only 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 together.
There are very few complete economic evaluations of ROPC interventions for cardiovascular
disease prevention services. Less than half of the interventions evaluated for effectiveness
included any assessment of economic costs or benefits. Cost-effectiveness could not
be calculated for VBID plans because their evaluations did not report clinical outcomes
such as changes in blood pressure. The cost of communicating the ROPC benefits to
providers and patients was not discussed or estimated in any of the economic studies.
Research efforts in these areas can improve understanding of the ways in which ROPC
for medications to treat high blood pressure, high cholesterol, or both can help improve
patient health.