January, 2017 - SUPPORT Summary of a systematic review | print this article |

What are the impacts of policies regarding direct patient payments for medicines?

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

 

  • Restrictive caps may decrease use of medicines for symptomatic conditions and overall use of medicines and insurers' expenditures on medicines; and have uncertain effects on health service utilisation.
  • A combination of a cap, co-insurance, and a ceiling may increase the use of medicines overall and for symptomatic and asymptomatic conditions, and decrease the cost of medicines for both patients and insurers.
  • A combination of a cap and fixed co-payments may increase the use of medicines for symptomatic conditions; and has uncertain effects on the insurer’s cost of medicines.
  • Fixed co-payments may decrease the use of medicines for symptomatic and asymptomatic conditions and the insurer’s expenditures on medicines.
  • Fixed and tier co-payments have uncertain effects on the use of medicines and the insurer’s expenditures on medicines.
  • A combination of a ceiling and fixed co-payments may slightly decrease the use of medicines and lead to little or no difference in health service utilisation.
  • A combination of a ceiling and co-insurance probably slightly decreases the overall use of medicines, may decrease the use of medicines for symptomatic conditions, may slightly decrease the insurer’s short-term expenditures on medicines, and may increase health service utilisation.

None of the included studies were conducted in a low-income country or reported health outcomes.

 

Background

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:

  • decrease unnecessary use of medicines.
  • shift to cheaper medicines.
  • pay more out of pocket, thus shifting costs from the insurer to patients.
Although medicine use and costs can be reduced, an overly restrictive policy may have unintended consequences, particularly for low income or other vulnerable populations, even when there are exemptions.The discontinuation of essential medicines (medicines that are life sustaining or that are important for managing chronic conditions) or medicines for relieving symptoms may lead to a deterioration in health and increase health service utilisation and expenditures for patients and insurers.The extent to which prescribers and patients are informed about the price of medicines, medicine substitution possibilities, and the patient's ability to pay can affect the impact of direct payment policies.


About the systematic review underlying this summary

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:

  1. Medicine use.
  2. Health service utilisation.
  3. Health outcomes.
  4. Costs (medicine expenditures and other healthcare and policy administration expenditures)

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.

Date of most recent search: February 2013

Limitations: This is a well conducted systematic review with only minor limitations.

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.

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.

Summary of findings

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.

1) Restrictive cap

Four cap policies were evaluated in four studies. 

 

  • Introducing a more restrictive cap

· 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.


More restrictive caps versus no restrictions or less restrictive caps  

People

Vulnerable and general populations

Settings

High-income countries (USA and Australia)

Intervention

More restrictive caps in terms of time of coverage or number of prescriptions

Comparison

No restrictions or less restrictive caps

Outcomes Impact Certainty
of the evidence
(GRADE)
Comments

Overall use of medicines

Moderate decrease

Low

 

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.

Outpatient care

Moderate increase

Very low

GRADE: GRADE Working Group grades of evidence (see above and last page)

(Use the top rows for dichotomous outcomes when there is a meta-analysis. Use the bottom row for other outcomes.)


2) Combination of a cap, co-insurance, and a ceiling

One intervention was evaluated in seven studies.

 

  • Introducing a combination of a cap, co-insurance, and a ceiling

· 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.

Cap, co-insurance, and a ceiling versus limited medicines coverage  

People

Vulnerable population: Senior 65 years old or more

Settings

USA

Intervention

Implementation of Medicare part D (a cap combined with co-insurance and a ceiling)

Comparison

Heterogeneous but limited medicines coverage

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.

Use of medicines for symptomatic conditions

Moderate increase

Low

Use of medicines for asymptomatic conditions

Small increase

Low

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.

Health service utilisation

   

No studies reported on health service utilisation.

GRADE: GRADE Working Group grades of evidence (see above and last page)


3) Combination of a cap and fixed co-payments

Two interventions were evaluated in two studies.

 

  • Introducing a combination of a cap and 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 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.

Cap and fixed co-payment versus a cap alone or a lower cap and fixed co-payment  

People

Swedish population

Settings

Sweden

Intervention

Implementation of fixed co-payment or its implementation in association with a cap

Comparison

Cap alone or a lower cap and fixed co-payment

Outcomes Impact Certainty
of the evidence
(GRADE)
Comments

Overall use of medicines

Small decrease

Very low

 

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.

GRADE: GRADE Working Group grades of evidence (see above and last page)


4) Tier with fixed co-payments

Two interventions were evaluated in two studies.

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.

5) Fixed co-payments

Four interventions were evaluated in five studies.

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

People

Seniors and general population

Settings

USA and Canada

Intervention

Implementation or increase of fixed co-payments

Comparison

Lower fixed co-payments or full coverage

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%).

Use of medicines for symptomatic conditions

Small decrease

Low

Use of medicines for asymptomatic conditions

Small decrease

Low

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.

Health service utilisation

See comments

-

No studies reported on health service utilisation.

GRADE: GRADE Working Group grades of evidence (see above and last page)


6) A ceiling with fixed co-payments

Five interventions were evaluated in nine studies.

 

  • Introducing a combination of a ceiling with fixed co-payments

· 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.

Ceiling + Fixed co-payment vs. lower value of fixed co-payment or full medicines coverage

People

Low income and general population

Settings

Australia and Canada

Intervention

Implementation or increase of a ceiling combined with fixed co-payments

Comparison

Full medicines coverage or lower fixed co-payments

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.

Use of medicines for symptomatic conditions

Small decrease

Low

Use of medicines for asymptomatic conditions

Small decrease

Low

 

Insurers’ expenditures on medicines

Small decrease

Very low

No studies reported patient expenditures.

Emergency department visits and hospitalisations

No increase

Low

 

Outpatient care

No increase

Low

 

GRADE: GRADE Working Group grades of evidence (see above and last page)

 

7) A ceiling with co-insurance

Five interventions were evaluated in nine studies.

 

  • Introducing a combination of a ceiling with co-insurance

· probably slightly decreases the overall use of medicines. The certainty of this evidence is moderate.

  • may decrease the use of medicines for symptomatic conditions . The certainty of this evidence is low.

· 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.

  • has uncertain effects on outpatient care. The certainty of this evidence is very low.

A ceiling with co-insurance versus lower fixed co-payments or full coverage

People

General population

Settings

Canada, USA and Sweden

Intervention

Implementation or increase of a ceiling combined with fixed co-insurance

Comparison

Full coverage or fixed co-payments and lower co-insurance

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%).

Use of medicines for symptomatic conditions

Medium decrease

Low

Use of medicines for asymptomatic conditions

Small decrease

Very low

 

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

 

Outpatient care

Small increase

Very low

 

GRADE: GRADE Working Group grades of evidence (see above and last page)

Relevance of the review for low-income countries

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:

 

  • Low income populations may be particularly disadvantaged, depending on where the ‘cut point’ for direct payments is set.
  • Low income populations may be particularly vulnerable if they are also more likely to be sick.
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.


*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

 

Additional information

Related literature

Selection and Rational Use of Medicines. World Health Organization.

 

http://www.who.int/medicines/areas/rational_use/en/index.html 


Ryan R, Santesso N, Hill S, Lowe D, Kaufman C, Grimshaw J. Consumer oriented interventions for evidence based prescribing and medicines use: an overview of systematic reviews. Cochrane Database Syst Rev 2011; 5:CD007768.

 

Acosta A, Ciapponi A, Aaserud M, et al. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database Syst Rev 2014; 10:CD005979.

 

Sturm H, Austvoll Dahlgren A, Aaserud M, et al. Pharmaceutical policies: effects of financial incentives for prescribers. Cochrane Database Syst Rev 2007; 3:CD006731

 

Green CJ, Maclure M, Fortin PM, et al. Pharmaceutical policies: effects of restrictions on reimbursement. Cochrane Database Syst Rev 2010; 8:CD008654.

 

Gemmill MC, Thomson S, Mossialos E. What impact do prescription drug charges have on efficiency and equity? Evidence from high income countries. Int J Equity Health 2008, 7:12. http://www.equityhealthj.com/content/7/1/12

 

Polinski JM, Donohue JM, Kilabuk E, Shrank WH. Medicare Part D's effect on the under and overuse of medications: a systematic review. J Am Geriatr Soc 2011; 59:1922-33.

 

Polinski JM, Kilabuk E, Schneeweiss S, Brennan T, Shrank WH. Changes in drug use and out of pocket costs associated with Medicare Part D implementation: a systematic review. J Am Geriatr Soc 2010; 58:1764-79.

This summary was prepared by

Agustín Ciapponi, Argentine Cochrane Centre IECS Institute for Clinical Effectiveness and Health Policy Iberoamerican Cochrane Network, Argentina

 Conflict of interest

None declared. For details, see: www.supportsummaries.org/coi

Acknowledgements

This summary has been peer reviewed by: Vera Lucia Luiza and Tamara Kredo.

This review should be cited as

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.

The summary should be cited as

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

Keywords

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

 

 



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