Helen McEntee (Meath East, Fine Gael) | Oireachtas source

I thank the Deputy for raising this very important issue which has featured in the media quite a lot in recent days in the context of developments in the provision of new cystic fibrosis and cancer drugs. Nobody should have to pay 45 times more than what is paid elsewhere. It is not right. There should always be equal access.

Decisions on the reimbursement of new drugs are matters for the HSE. They are not political decisions, as much as we would sometimes like them to be. Every drug undergoes a scientific and evidence based assessment in line with the HSE's statutory obligations. In many cases, the prices companies seek to charge are most definitely too high and, as a result, the product does not deliver health benefits in a cost effective manner. Unfortunately, we must look at what is cost effective. I know that the Deputy is not suggesting the HSE should simply accept the first price proposed by manufacturers for their products, regardless of their clinical benefits or cost effectiveness.

As with all new drugs developed, the HSE must follow a process. I understand how patients and their families must feel in these circumstances as they await a decision by the HSE on reimbursement. I dealt with a similar matter when a gentleman in my constituency needed a life-saving drug which cost too much. This is something we see all too frequently, which is why I am eager to ensure the process is concluded as efficiently as possible for each drug.

Yesterday the National Centre for Pharmacoeconomics, NCPE, published a recommendation that the cystic fibrosis drug Orkambi not be reimbursed by the HSE, as it was not considered cost-effective at the price of almost €160,000 per patient per year as submitted by the manufacturer. The high number of people who require it means that the cost is absolutely astronomical. The NCPE estimates the cost-effective price in this instance as being closer to €30,000, a significant difference. It estimates the five year gross budget impact of reimbursing Orkambi at more than €390 million and notes the significant opportunity cost associated with reimbursing the drug. Every additional euro paid to pharmaceutical companies is a euro less for investment in other critical health services and public services generally.

This is not the end of the reimbursement process. The HSE will now enter negotiations with the manufacturer to seek significant price reductions. It will then consider the outcome of these negotiations, together with the NCPE's recommendation, in making a final decision on reimbursement. I welcome the confirmation by the company to the NCPE this morning that it will continue to provide the drug for Irish patients who are involved in an expanded access programme until the issue of reimbursement is finalised in Ireland.

Two new cancer drugs have also been discussed by the HSE and in the House in recent days. I welcome yesterday's decision by the HSE to approve Pembrolizumab for reimbursement and I am sure this news will be welcomed by patients affected and their families. For the second drug, Nivolumab, I understand the assessment process is ongoing. I welcome the supplier's decision to extend its compassionate access programme for patients with advanced lung cancer to the end of June 2016 and the confirmation that all patients currently receiving treatment under the programme will continue to receive it.

The single biggest challenge in the assessment of new drugs for reimbursement is, as we have discussed, presented by the very high prices sought by suppliers. Let me be very clear - the process followed by the HSE is scientific, evidence-based and designed to deliver the best health outcomes for the patients in a cost effective manner. It is essential that the HSE have the support of everybody in the House in its efforts to achieve the very best result for Irish patients.

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