NEW: June 2009
Validated by: National Centre for Pharmacoeconomics
Ireland

Decision Makers and Decision-Making Processes Diagram


Model description and Symbols:
The ultimate decision maker is listed at the top of the model
Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision

BACKGROUND

The Republic of Ireland has a population of 4.42 million with a life expectancy of 76.8 years for men and 81.6 years for women. The Irish public healthcare system has a budget of €14.7 billion, 7.6% of GDP. The public share of total expenditure on health in Ireland in 2005 was 78%, above the OECD average of 73%. The remaining 22% is accounted for privately. Approximately 50% of the Irish population have private health insurance cover. The three major private health insurers are the VHI, Quinn Healthcare and Hibernian-Aviva.

Approximately 15% of the €14.7 billion budget (increasing by over 10% per year over the last decade) is attributed to drug expenditure. Of this, 85% is spent on the following Community Drug Schemes: GMS, DPS, LTI, and HTD. These schemes are at the centre of the Primary Care Infrastructure of the Irish Health system. The means-tested GMS scheme is the largest by cost, covering 1.35 million people, and provides free medical services and prescription medications to those unable without undue hardship to arrange such services. Under the DPS, no family will be required to pay more than €100 for prescription medicines in any calendar month. The LTI scheme entitles patients suffering from any one of 15 specified chronic conditions .e.g. diabetes mellitus and epilepsy, to full drug reimbursement irrespective of income. The HTD scheme facilitates the supply by community pharmacies of certain high cost medicines e.g. TNF inhibitors.

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DECISION-MAKERS AND INFLUENCERS

The Department of Health and Children (DoHC)
DoHC supports the Minister for Health and the Government by advising on the strategic development of the health system including policy and legislation and evaluating the performance of the health and social services.

The Health Services Executive (HSE)
HSE functions as a single national agency delivering services specified by the DoHC. There are two main bodies within the HSE: National Hospitals Office (NHO), which is responsible for the management and co-ordination of the acute hospital sector nationally, and Primary, Community and Continuing Care (PCCC) directorate, which is responsible for the management and delivery of non-hospital services. Also within the HSE is the Corporate Pharmaceutical Unit (CPU), which is responsible for pricing, reimbursement and the provision of drugs and devices for patients.

The Health Information and Quality Authority (HIQA)
The HIQA conducts system wide HTA. It was established in May 2007 as an independent authority reporting to the Minister for Health. Its four main functions are:

  • Monitoring Health Care Quality
  • Social Services Inspectorate
  • Health Technology Assessment
  • Publishing information on Ireland's health and social care services

The Social Services Inspectorate (SSI) and the Irish Health Services Accreditation Board (IHSAB) have been integrated into this new authority.

The National Centre for Pharmacoeconomics (NCPE)
Activities of the centre include economic evaluation of pharmaceutical products and the development of cost effective prescribing. In addition, the research of the centre focuses predominantly on the economic analysis of high cost areas e.g. peptic ulcer disease, HIV therapy, lipid lowering therapy, heart failure. It was established in 1998 and is funded by the DoHC.

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DECISION-MAKING PROCESS

Under the terms of the IPHA/HSE agreement (1st September 2006), the HSE reserves the right to assess new and existing technologies (medicines, diagnostics and devices) that may incur a high cost or have a significant budget impact. In the case of new medicines to be included in the Community Drugs Schemes, economic evaluations may be conducted prior to the reimbursement application but must be completed within 90 days. Evaluations are conducted in accordance with the existing agreed Irish Healthcare Technology Assessment Guidelines (2000).

The Products Committee of the CPU of the HSE formally refers products for economic evaluation to the NCPE. The first stage in this process consists of a preliminary discussion between the NCPE and the pharmaceutical company, to determine information requirements. The pharmaceutical company then prepares a pharmacoeconomic submission, which is expected to weigh the benefit of a new technology against its costs in the Irish context. An estimate of the potential budget impact of the product must also be included. It is important that the submission specifies, addresses, and answers 10 specific study questions (see ncpe.ie). The NCPE Review Group critically appraises the company submission and invites comments from the pharmaceutical company prior to completion of the final appraisal.

Finally, in the interest of fairness and transparency, the company has access to the NCPE’s final appraisal for discussion. The final appraisal is posted on the NCPE website and sent to the CPU who makes the reimbursement decision. Evaluations are carried out by the staff of the Centre and on occasions supported by local experts, e.g. consultant clinicians.

The Minister for Health and the DoHC also has the right to request a pharmacoeconomic assessment via the NCPE, and the HIQA may conduct independent HTA.

REIMBURSEMENT AND PRICING APPROVAL PROCESS

The new IPHA/HSE agreement (1st Sept 2006) links the price of medicines in Ireland to the average of the wholesale price in 9 nominated EU states. If a new medicine is not available in any of these states, the Irish price to the wholesaler will be agreed between the manufacturer concerned and the HSE within 90 days of the date of reimbursement application.

All approved drugs under the Community Drug Schemes are 100% reimbursed with the exception of the DPS where a maximum co-payment of €100 per family per month exists.

Pharmacists currently receive a €3.59 fee for prescription items dispensed under the GMS scheme. However for items dispensed to those over the age of 70 years, the fee is €4.54. The dispensing fee for the DPS and LTI is €3.16. They also receive a 50% mark-up on drug costs under the DPS and LTI, and a €60.52 patient care fee under the HTD scheme. 

The wholesalers receive a 17.66% wholesale mark-up for delivery of drugs to community pharmacies.

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DATA REQUIREMENTS

Figure 1. Summary of the Pharmacoeconomic Process in Ireland

Summary of the Pharmacoeconomic Process in Ireland

Pharmacoeconomic evaluations will usually be in the form of cost effectiveness analysis (e.g. cost per life-year gained) or cost utility analysis (cost per quality-adjusted life year [QALY]). In practice, there is no fixed threshold above which an incremental cost effectiveness ratio (ICER) would not be considered cost effective, or below which it would. However a technology with an ICER of less than €45,000/QALY is more likely to be reimbursed. Consideration of the cost effectiveness of a technology is a necessity, but it is not the sole basis for decision-making. If a technology has an ICER that is significantly higher than other healthcare technologies that are already funded or reimbursed, other factors such as the innovative nature of the technology, the potential budget impact of the new technology or the wider costs and benefits to society, would need to be taken into account.

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ACRONYMS

OECD: Organisation of Economic Co-operation and Development
DoHC: Department of Health and Children
HSE: Health Service Executive
NHO: National Hospitals Office
PCCC: Primary, Community and Continuing Care
GMS: General Medical Services scheme
DPS: Drug Payment Scheme
LTI: Long Term Illness scheme
HTD: High Tech Drugs scheme
HIQA: Health Information and Quality Authority
IPHA: Irish Pharmaceutical Healthcare Association
ICER:  Incremental Cost Effectiveness Ratio
PEA: Pharmacoeconomic assessment
NCPE: National Centre for Pharmacoeconomics
HTA: Health Technology Assessment
CPU: Corporate Pharmaceutical Unit

SUGGESTED READING

  1. Barry M, Tilson L. Recent Developments in Pricing and Reimbursement of medicines in Ireland
  2. IPHA Agreement. http://www.hse.ie/eng/About_the_HSE/Whos_Who/IPHA_Agreement_2006.pdf
  3. Pharmaceutical Pricing and Reimbursement Information      http://ppri.oebig.at/Downloads/Results/Ireland_PPRI_2007.pdf
  4. Statistical Analysis of Claims and Payments 2007 http://www.hse.ie/eng/PCRS/PCRS_Publications/2007_Report.pdf
  5. Minister for Health announces reductions in payments to community pharmacists to reduce rapid rise in State expenditure on drugs and medicines. http://www.dohc.ie/press/releases/2009/20090618.html

USEFUL LINKS

REFERENCE

  1. Barry M., Tilson L. Recent developments in pricing and reimbursement of medicines in Ireland. Expert Review Pharmacoeconomics Outcomes Research. 2007;7(6):605-611

AUTHORS & CONTRIBUTORS

John Joseph Coughlan, Duncan Fortescue-Webb, Roisin Heaney, Gillian Judge, Dr. Lesley Tilson, Dr. Michael Barry, Members of NCPE

Contributors:
Randa Eldessouki MD, DrPH, Director, ISPOR scientific initiatives, ISPOR, NJ, USA

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