August, 2016 - SUPPORT Summary of a systematic review | print this article |

How do pharmaceutical policies that restrict reimbursement for selected medications effect health outcomes, drug use and expenditures, and healthcare utilization?

Restrictions on reimbursement are defined as insurance policies that restrict reimbursement for selected drugs or drug classes, often using additional patient specific information related to health status or need.


Key messages

  • Restrictions on reimbursement in health insurance systems with substantial coverage for medicines probably decreases targeted drug use and expenditures on targeted drugs or drug classes.
  • The effects of restriction on reimbursement vary by drug and drug class, and by how the restrictions are implemented and enforced.
  • The impacts of restrictions on health outcomes and health service utilisation are uncertain.
  • All the studies were done in high-income countries and participants were mainly senior citizens or low-income adult populations whose medications were being paid for in whole or part through publicly funded drug benefit plans.
  • The effect of restrictions on reimbursement on equity has not been studied.

Background

Pharmaceutical expenditures are a large component of health expenditures, accounting for an average of 17% of total health spending in Organization of Economic Cooperation and Devel-opment (OECD) countries in 2007 and exceeding 20% of health spending in eight countries. Restrictions on reimbursement are defined as the sets of insurance policies that restrict reimbursement for selected drugs or drug classes, often using additional patient specific information related to health status or need. Approval may be automatic (but subject to audit) if a reason is supplied. Included in this category are policies that are labelled as special authorization, special authority, special consideration, prior authorization, prior approval, pre-authorisation, restricted access, exemptions and for limited use.


About the systematic review underlying this summary

Review objectivesTo determine the effects of a pharmaceutical policy restricting the reimbursement of selected medications on drug use, healthcare utilization, health outcomes and costs (expenditures).
Type of What the review authors searched for What the review authors found
Study designs & interventions Randomized and non-randomized trials, interrupted time series studies including repeated measures studies, and controlled before-after studies assessing prescribing policies - introduction of restriction to reimbursement, relaxation of previously instituted restrictions to reimbursement, or exemption from restrictive policies for targeted cost-effective drugs.
24 studies evaluating restrictions to reimbursement policies. The majority of interventions were prior authorization.  5 studies evaluated policies of releasing or relaxing past restrictions to reimbursement.  All of the studies were interrupted time series. 
Participants Healthcare consumers and providers within a large jurisdiction or system of care (regional, national or international)

Participants were predominantly the beneficiaries of publically subsidized or administered pharmaceutical insurance plans – most often senior citizens aged 65 years or over and low-income adult populations.

Settings

All settings

Health insurance systems with substantial coverage of medicines in the USA (14), Canada (11), Norway (2) and Denmark (2)

Outcomes

Primary outcomes: drug use (prescribed, dispensed or actually used), healthcare utilisation, health outcomes, costs (expenditures). 

Secondary outcomes: changes in equity of access to drugs, changes in access to medically necessary drugs by disadvantaged groups, changes in the distribution of financial burden

Drug use and drug expenditures (24 studies), health outcome data (2 studies), healthcare utilization (9 studies)

Date of most recent searchMEDLINE (2005 to January 2009) and other databases (2005 to October 2008).

LimitationsThis is a well-conducted systematic review with only minor limitations; however the most recent. searches were in January 2009.

Green CJ, Maclure M, Fortin PM, et al. Pharmaceutical policies: effects of restrictions on reimbursement. Cochrane Da-tabase of Systematic Reviews 2010, Issue 8. Art. No.: CD008654.

Summary of findings

Twenty-four studies evaluated restrictions on reimbursement. The majority of interventions were prior authorization policies where drug benefit plans required physicians to apply for exemptions from restrictions before permission was granted to have all or part of the cost of the targeted drug paid for by the insurance plan.


Restrictions to reimbursement

  •  Restrictions on reimbursement probably decrease targeted drug use in the short and long term, and reduce expenditures on target drug or drug class. The certainty of  this evidence is moderate.
  •  The effects of restrictions on reimbursement vary by drug and drug class and by how the restrictions are implemented and enforced.
  •  The impacts of restrictions on reimbursements on health service utilisation and health outcomes are uncertain because the certainty of this evidence is very low.
Outcomes

Impact

Number of participants (studies) Certainty of the evidence (GRADE)

Target drug use, immediately after introduction

Median relative effect (range) -26% (-.04 to -92%)

7 studies

Moderate

Target drug use, at 2 years after introduction

Median relative effect (range) -17% (-9% to -70%)

4 studies

Moderate

Expenditures on target drug or drug class at 6 months after introduction

Median relative effect (range) - 57% (-36% to -85%)

3 studies

Moderate

Expenditures on target drug at 2 years after introduction

Median relative effect (range) - 49% (-18% to -79%)

2 studies

Moderate

Health outcomes

One study found little or no difference in blood pressure control. The results of the other study were confounded.

2 studies

Very Low

Health service utilization

Reported impacts on health service utilization varied.

9 studies

Very Low

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

Relevance of the review for low-income countries

Findings Interpretation*
APPLICABILITY
  • All of the included studies were conducted in high-income countries. Thus there is uncertainty regarding the transferability of the results to low-income country settings.
  • Participants were mainly senior citizens or low-income adult populations in publicly subsidized or administered pharmaceutical benefit plans.
  • Only two of the studies included in this review reported health outcome data.
  • Applicability of these interventions to low-income countries de-pends on there being a:

-Regulatory framework

-Administrative and managerial system which support the implemen-tation of the policy

-Insurance system with relatively broad coverage of medicines

-Efficient, timely access to patient-specific information

-Availability of preferred products that are incentivized by the re-imbursement policy

-Product quality assessments and prescriber and patient trust in the quality of preferred products.

EQUITY
  • Overall, the targeted population was mainly senior citizens or low-income adult populations in publicly subsidized or administered pharmaceutical benefit plans. The included studies provided little data regarding differential effects of the interventions for disadvantaged populations within the studied beneficiaries.
  • These policies should be designed to minimize the risk of adverse effects on disadvantaged populations with poor access to medicines, and potential adverse effects on disadvantaged populations should be monitored.
ECONOMIC CONSIDERATIONS
  • None of the studies provided a full analysis of cost-effectiveness.
  • Evaluations of the economic impact of the interventions at the system and household level are needed.
MONITORING & EVALUATION
  • Most of the studies did not evaluate effects on health outcomes.
  • Consideration should be given to monitoring and evaluating potential impacts on health outcomes, as well as impacts on system and household expenditures, and on drug utilisation.

*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: www.supportsummaries.org/methods

Additional information

Related literature

Acosta A, Ciapponi A, Aaserud Met al. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database of Systematic Reviews 2014, Issue 10. Art. No.: CD005979.

 

Luiza VL, Chaves LA, Silva RM, et al. Pharmaceutical policies: effects of cap and copayment on rational use of medicines. Cochrane Database of Systematic Reviews 2015, Issue 5. Art. No.: CD007017.

 

Wagner AK, Ross-Degnan D. The potential for insurance systems to increase access to and appropriate use of medicines in Asia-Pacific countries. In: K. Eggleston, ed. Prescribing Cultures and Pharmaceutical Policy in the Asia-Pacific. Brookings Press 2009.

 

Carapinha J, Ross-Degnan D, Desta A, Wagner AK. Health insurance systems in five Sub-Saharan African countries: Medicines benefits and data for decision making. Health Policy 2011; 99: 193-202.

 

This summary was prepared by

Taryn Young, South African Cochrane Centre, South African Medical Research Council, Cape Town, South Africa.

Conflict of interest

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

Acknowledgements

This summary has been peer reviewed by: Anita Wagner and Carolyn Green

This review should be cited as

Green CJ, Maclure M, Fortin PM, Ramsay CR, Aaserud M, Bardal S. Pharmaceutical policies: effects of restrictions on reimbursement. Cochrane Database of Systematic Reviews 2010, Issue 8. Art. No.: CD008654.

The summary should be cited as

Young T. How do pharmaceutical policies that restrict reimbursement for selected medications effect health outcomes, drug use and expenditures, and healthcare utilization? A SUPPORT Summary of a systematic review. August 2016. www.supportsummaries.org

Keywords

evidence-informed health policy, evidence-based, systematic review, health systems research, health care, low and middle-income countries, developing countries, primary health care Restrictions, reimbursement, pharmaceutical policy

This summary was prepared with additional support from:

The South African Medical research Council aims to improve the South Africa’s health and quality of life through promoting and conducting relevant and responsive health research.www.mrc.ac.za/

The South African Cochrane Centre, the only centre of the international Cochrane Collaboration in Africa, aims to ensure that health care decision making in Africa is informed by high quality, timely and relevant research evidence. www.mrc.ac.za/cochrane/cochrane.htm



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