Recent developments in pricing and reimbursement of medicines in Ireland.

In 2006, the drugs bill exceeded euro1.84 billion or approximately 15% of total healthcare expenditure in Ireland. The majority of this expenditure (85%) related to community prescribing. An agreement between the Health Service Executive (HSE) and the Irish Pharmaceutical Healthcare Association (IPHA) on the pricing and supply of medicines to the Irish Health Service came into effect on the 1st September 2006. The new agreement links the price of medicines in Ireland to nine EU states including Belgium, Denmark, France, Germany, The Netherlands, Spain, the UK, Finland and Austria. Following receipt of market authorization a new product will be reimbursed within 60 days of the reimbursement application. However, the HSE reserves the right to assess the cost-effectiveness of new and existing technologies that may be high cost or have a significant budget impact. Where such a review is requested the 60-day rule will not apply. Where a new medicine is subjected to pharmacoeconomic assessment the reimbursement decision will be notified within 90 days of receipt of the reimbursement application. Products will be reimbursed within 40 days of a positive decision. Should reimbursement be refused an appeal may be made to an expert committee whose final decision will be made within a further 90 days. A cost-effectiveness threshold in the region of euro45,000/quality-adjusted life year has been adopted. An important component of the IPHA/HSE agreement is the 35% two-stepped price reduction for off-patent substitutable products. The new Health Information and Quality Authority (HIQA) was established under the Health Act 2007 and will lead the development of Health Technology Assessment (HTA) across the health service.