The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.
The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
The HSE strives to reach a decision in as timely a manner as possible and within the 180 days. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.
The price that some companies are seeking to charge means that the innovative products may never reach the patients as health systems cannot afford the price. In many case the main driver of the price is an estimate of the maximum amount that health care systems can pay and is not connected to the health benefit of the treatment or indeed the development costs.
These high costs cause unnecessary delays in the reimbursement process.
In many cases the price submitted is an artificially high price which will be reduced following rounds of resource intensive negotiations. For example, in 2015 price reductions were negotiated for almost two thirds of medicines that underwent a full health technology assessment.
When the decision is taken not to reimburse a medicine, there is an extension in this timeline. This is due to the requirement of the HSE to issue a “notice of proposal”, and to allow 28 days for manufacturers to make representations to reconsider their decision. The HSE must then consider those representations and it is only after then that they make a formal decision.