SUPPORT Summaries
Evidence of the effects of health system interventions
for low- and middle-income countries
Evidence of the effects of health system interventions
for low- and middle-income countries
January, 2017 - SUPPORT Summary of a systematic review | print this article | download PDF
Policies in which consumers pay directly for their medicines when they fill a prescription include caps (a maximum number of prescriptions or medicines that are reimbursed, fixed co-payments (patients pay a fixed amount per prescription or medicine), tier co-payments (the amount payed depends on whether the prescription is for a brand (patented) medicine or a generic medicine), co-insurance (patients pay part of the price of the medicine), and ceilings (patients pay the full price or part of the cost up to a ceiling, after which medicines are free or are available at reduced cost).
Key messages
None of the included studies were conducted in a low-income country or reported health outcomes.
Luiza VL, Chaves LA, Silva RM, et al. Pharmaceutical policies: effects of cap and copayment on rational use of medicines. Cochrane Database Syst Rev 2015; 5:CD007017.
A summary of studies addressing a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise the relevant research, and to collect and analyse data from the included studies.
SUPPORT – was an international project to support the use of policy relevant reviews and trials to inform decisions about maternal and child health in low- and middle-income countries, funded by the European Commission (FP6) and the Canadian Institutes of Health Research.
Substantial and increasing healthcare funds are spent on medicines, posing a challenge to decision makers. It is necessary to optimise the use of medicines and to control medicine costs, without decreasing health benefits.Potential aims of introducing or increasing direct patient payments for medicines can be for patients to:
| Review objectives: To determine the effects of cap and co payment policies on rational use of medicines. | ||
| Type of | What the review authors searched for | What the review authors found |
|---|---|---|
| Study designs & interventions |
Randomised trials, non-randomised trials, repeated measures studies, interrupted time series studies, and controlled before after studies of policies that regulate out of pocket paymentsfor medicines by patients, including changes in the amount paid directly by patients or limits on the amount reimbursed, including caps,fixed copayments, co insurance, maximum copayment ceilings and tier copayments |
32 studies reporting on 39 interventions, including: 1 randomised trial, 8 repeated measures studies,21 interrupted time series studies, and 2 controlled before after studies. Pharmaceutical policies included cappolicies (5 studies); cap with coinsurance and a ceiling policy (6); fixed copayments policies (6); tier copayment with fixed copayment policies(2); fixed copayment with ceiling policies (10); and coinsurance with ceiling policies (10). |
| Participants |
Healthcare consumers and providers within a regional, national or international jurisdiction or system of care, and organisations,such as multisite health maintenance organisations, serving a large population |
Australia: pharmaceutical benefits scheme (PBM) (4); Canada: British Columbia PharmaCare Program (4), Cana-da, Ontario/Quebec medicine/health insurance program (4),Vancouver Residents of British Colum-bia (1); Swedish population (2); USA: Medicare (6), Medicaid (7) a large PBM (1), six cities (1), three nation wide pharmacy chains (1) |
| Settings |
Any |
USA (18), Canada (9), Australia (4), and Sweden (2) |
| Outcomes |
Objectively measured outcomes:
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The studies provided data on medicine use (19 studies), costs (17) and health service utilisation (6). The data on costs were reported as medicine expenditures from the insurer’s perspective (10),medicine expenditures from the patient’s perspective (6), healthcare expenditures (1 study), and intervention costs (1). None of the included studies reported health outcomes. |
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Date of most recent search: February 2013 |
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Limitations: This is a well conducted systematic review with only minor limitations. |
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Luiza VL, Chaves LA, Silva RM, et al. Pharmaceutical policies: effects of cap and copayment on rational use of medicines. Cochrane Database Syst Rev 2015; 5:CD007017.
High: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different† is low.
Moderate: This research provides a good indication of the likely effect. The likelihood that effect will be substantially different† is moderate.
Low: This research provides some indication of the likely effect. Howevver, the likelihood that it will be substantially different† is high.
Very low: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different† is very high.
* This is sometimes referred to as 'quality of evidence' or 'confidence in the estimate'.
† Substantially different = a large enough difference that it might affect a decision.
See last page for more information.
The review included 32 studies reporting on 39 interventions. In this summary we present results on medicine use, costs and health service utilisation. None of the included studies reported health outcomes.
· may decrease use of medicines for symptomatic conditions and overall use of medicines. The certainty of this evidence is low.
· may decrease insurers' expenditures on medicines. The certainty of this evidence is low.
· has uncertain effects on emergency department use, hospitalisations or use of outpatient care. The certainty of this evidence is very low.
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More restrictive caps versus no restrictions or less restrictive caps |
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|
People |
Vulnerable and general populations |
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Settings |
High-income countries (USA and Australia) |
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Intervention |
More restrictive caps in terms of time of coverage or number of prescriptions |
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Comparison |
No restrictions or less restrictive caps |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Moderate decrease |
Low |
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|
Use of medicines for symptomatic conditions |
Moderate decrease |
Low |
The impact on use of medicines for asymptomatic conditions was not reported. |
|
|
Insurers’ expenditures on medicines |
Moderate decrease |
Low |
Introduction of a cap policy reduced Medicaid expenditures for medicines for vulnerable populations in the USA. No studies reported patient expenditures. |
|
|
Emergency department visits and hospitalisations |
Small increase |
Very low |
Introduction of a cap policy in vulnerable populations in the USA led to a small increase in emergency department visits and hospitals and a moderate increase in outpatient care. |
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Outpatient care |
Moderate increase |
Very low |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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(Use the top rows for dichotomous outcomes when there is a meta-analysis. Use the bottom row for other outcomes.)
· may increase the use of medicines overall and for symptomatic and asymptomatic conditions. The certainty of this evidence is low.
· may decrease the cost of medicines for both patients and insurers. The certainty of this evidence is low.
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Cap, co-insurance, and a ceiling versus limited medicines coverage |
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People |
Vulnerable population: Senior 65 years old or more |
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Settings |
USA |
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Intervention |
Implementation of Medicare part D (a cap combined with co-insurance and a ceiling) |
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Comparison |
Heterogeneous but limited medicines coverage |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Uncertain |
Low |
The impact of the intervention varied according to the previous medicines coverage. When the pre-policy medicines coverage was more restrictive, the impact was larger. |
|
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Use of medicines for symptomatic conditions |
Moderate increase |
Low |
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Use of medicines for asymptomatic conditions |
Small increase |
Low |
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Patients’ expenditures on medicines |
Moderate decrease |
Low |
Introduction of a cap policy reduced Medicaid expenditures for medicines for vulnerable populations in the USA. No studies reported patient expenditures. |
|
|
Insurers’ expenditures on medicines |
Large decrease |
Low |
Introduction of a cap policy reduced Medicaid expenditures for medicines for vulnerable populations in the USA. No studies reported patient expenditures. |
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Health service utilisation |
No studies reported on health service utilisation. |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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· has uncertain effects on the overall use of medicines. The certainty of this evidence is very low.
· may decrease the use of medicines for symptomatic conditions. The certainty of this evidence is low.
· has uncertain effects on the cost of medicines for insurers. The certainty of this evidence is very low.
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Cap and fixed co-payment versus a cap alone or a lower cap and fixed co-payment |
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|
People |
Swedish population |
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Settings |
Sweden |
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Intervention |
Implementation of fixed co-payment or its implementation in association with a cap |
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Comparison |
Cap alone or a lower cap and fixed co-payment |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Small decrease |
Very low |
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|
Use of medicines for symptomatic conditions |
Decrease |
Low |
The impact on use of medicines for asymptomatic conditions was not reported. |
|
|
Insurers’ expenditures on medicines |
Small decrease |
Very low |
No studies reported patient expenditures. |
|
|
Health service utilisation |
See comments |
- |
No studies reported on health service utilisation. |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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The implementation or increase of tier combined with fixed co-payments showed inconsistent or potentially biased results. However, all the studies found very small differences (either increases or decreases). No studies reported the effects of this intervention on the cost of medicines or health service utilisation.
è Tier with fixed co-payments has uncertain effects on the overall use of medicines, medicines for symptomatic and asymptomatic conditions, hospitalisation and outpatient care. The certainty of this evidence is very low.
è Introducing fixed co-payments
· has uncertain effects on the overall use of medicines. The certainty of this evidence is very low.
· may decrease the use of medicines for symptomatic and asymptomatic conditions. The certainty of this evidence is low.
· may slightly decrease the insurer’s expenditures on medicines. The certainty of this evidence is low.
|
Fixed co-payments versus lower fixed co-payments or full coverage |
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|
People |
Seniors and general population |
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Settings |
USA and Canada |
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Intervention |
Implementation or increase of fixed co-payments |
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Comparison |
Lower fixed co-payments or full coverage |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Small decrease |
Very low |
The decreased use of medicine was directly related to the increase of cost sharing for patients. Only the use of oral hypoglycaemic medicines increased (by approximately 2%). |
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Use of medicines for symptomatic conditions |
Small decrease |
Low |
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Use of medicines for asymptomatic conditions |
Small decrease |
Low |
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Insurers’ expenditures on medicines |
Small decrease |
Low |
The decrease in the insurer's expenditures on medicines ranged from -16.9% to 0.1%. No studies reported patient expenditures. |
|
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Health service utilisation |
See comments |
- |
No studies reported on health service utilisation. |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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· may slightly decrease the overall use of medicines, medicines for symptomatic and asymptomatic conditions. The certainty of this evidence is low.
· has uncertain effects on insurer expenditure on medicines. The certainty of this evidence is very low.
· may lead to little or no difference in emergency department visits, hospitalisations and outpatient care. The certainty of this evidence is low.
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Ceiling + Fixed co-payment vs. lower value of fixed co-payment or full medicines coverage |
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|
People |
Low income and general population |
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Settings |
Australia and Canada |
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Intervention |
Implementation or increase of a ceiling combined with fixed co-payments |
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Comparison |
Full medicines coverage or lower fixed co-payments |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Small decrease |
Low |
The effect varied according to pharmaceutical groups of medicines, ranging from no effect to a reduction of approximately 25%. The reduction in the use of medicines was higher for symptomatic conditions. |
|
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Use of medicines for symptomatic conditions |
Small decrease |
Low |
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Use of medicines for asymptomatic conditions |
Small decrease |
Low |
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Insurers’ expenditures on medicines |
Small decrease |
Very low |
No studies reported patient expenditures. |
|
|
Emergency department visits and hospitalisations |
No increase |
Low |
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Outpatient care |
No increase |
Low |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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· probably slightly decreases the overall use of medicines. The certainty of this evidence is moderate.
· has uncertain effects on the use of medicines for asymptomatic conditions. The certainty of this evidence is very low.
· may slightly decrease the insurer’s short-term expenditure on medicines . The certainty of this evidence is low.
· may lead to an increase in emergency department visits and hospitalisations. The certainty of this evidence is low.
|
A ceiling with co-insurance versus lower fixed co-payments or full coverage |
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|
People |
General population |
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Settings |
Canada, USA and Sweden |
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Intervention |
Implementation or increase of a ceiling combined with fixed co-insurance |
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Comparison |
Full coverage or fixed co-payments and lower co-insurance |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
Comments | |
|
Overall use of medicines |
Small decrease |
Moderate |
There was a larger reduction in the use of medicines for symptomatic conditions, with the exception of asthma inhalers, for which there was only a slight increase (around 3%). |
|
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Use of medicines for symptomatic conditions |
Medium decrease |
Low |
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Use of medicines for asymptomatic conditions |
Small decrease |
Very low |
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|
Insurers’ expenditures on medicines |
Small decrease |
Low |
There was an initial small decrease in the insurer’s expenditures on medicines, but at the end of the first year there was a small increase. No studies reported patient expenditures. |
|
|
Emergency department and hospitalisation |
Medium increase |
Low |
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Outpatient care |
Small increase |
Very low |
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GRADE: GRADE Working Group grades of evidence (see above and last page) |
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| Findings | Interpretation* |
|---|---|
| APPLICABILITY | |
| All the included studies were conducted in high income countries. Some were targeted at poor or vulnerable populations. |
Factors that need to be considered in assessing whether the intervention effects are likely to be transferable to other settings where health subsidies are competitive to food and other essentials include: -The extent to which increased cost sharing for medicines may present a financial barrier to poor households or to patients with chronic conditions who need a high volume of pharmaceuticals; -The extent to which any deterioration of health in these vulnerable populations may result in increased use of healthcare services and increased overall healthcare expenditures. |
| EQUITY | |
| Introducing a restrictive cap, a fixed copayment, or a combination of a ceiling with fixed copayments or coinsurance may have the unintended effect of reducing the use of necessary medicines for symptomatic conditions. Moreover, a ceiling with fixed coinsurance may lead to an increase in emergency department visits and hospitalisations. These effects could place an extra strain on already vulnerable populations, such as the elderly and those on welfare. |
Policies that increase direct payments for medicines may increase health inequities because:
Direct payments are less likely to cause harm if only non necessary medicines are included or if exemptions are built in to ensure that patients receive needed medical care.
|
| ECONOMIC CONSIDERATIONS | |
| The findings are largely based on observational studies from high income countries. None of the included studies reported the effects of direct patient payments for medicines on health outcomes and few reported effects on health service utilisation. |
It is difficult to extrapolate findings for medicine expenditures from high to low income countries because of differences in prices and conditions. Although direct patient payments can reduce medicine use and insurers’ expenditures, substantial reductions in the use of necessary medicines may have adverse effects on health. This may result in increases in the use of health services and in overall expenditures. |
| MONITORING & EVALUATION | |
| Poor reporting of the intensity of interventions and differences in the size of caps or copayments, pharmaceutical groups of medicines included in the policy, incentives to comply with the policy, information provided to patientsand providers, exemptions, settings and populations make comparisons across studies difficult. |
The impact of changes in direct payments for medicines should be monitored, including impacts on health and health service utilisation and the factors that might modify the effects of policies. Information requirements to monitor some of theconsequences of these policies, especially out of pocket payments by patients could be difficult. Other interventions, such as education or prior authorisation, might be better suited to address inappropriate use of medicines. Impact evaluations should be undertaken prior to taking changes to scale or making them permanent, particularly when vulnerable populations may be affected. Randomised designs should be used when possible and interrupted time series studies when a randomised impact evaluation is not feasible to assess effects on health, overall expenditures, and cost effectiveness. |
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*Judgements made by the authors of this summary, not necessarily those of the review authors, based on the findings of the review and consultation with researchers and policymakers in low-income countries. For additional details about how these judgements were made see: http://www.support-collaboration.org/summaries/methods.htm |
|
Selection and Rational Use of Medicines. World Health Organization.
http://www.who.int/medicines/areas/rational_use/en/index.html
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Agustín Ciapponi, Argentine Cochrane Centre IECS Institute for Clinical Effectiveness and Health Policy Iberoamerican Cochrane Network, Argentina
None declared. For details, see: www.supportsummaries.org/coi
This summary has been peer reviewed by: Vera Lucia Luiza and Tamara Kredo.
Luiza VL, Chaves LA, Silva RM, et al. Pharmaceutical policies: effects of cap and copayment on rational use of medicines. Cochrane Database Syst Rev 2015; 5:CD007017.
Ciapponi A. What are the impacts of policies regarding direct patient payments for medicines? A SUPPORT Summary of a systematic review. January 2017. www.supportsummaries.org
evidence informed health policy, evidence based, systematic review, health systems research, health service, low and middle income countries, developing countries, primary health service, pharmaceutical policies, caps, copayment, coinsurance, ceilings
