Micheál Martin (Cork South Central, Fianna Fail) | Oireachtas source

Melanoma is a cancer predominately of the young with potentially many lost years of life and with devastating effects on many families. Ireland is the 14th most susceptible country to melanoma in the world. We are very far behind in terms of treatments for advanced or progressive melanoma and a proper national screening programme, which we do not have. If we had one, it would avoid many of the expensive immunotherapy treatments available. The problem is that, notwithstanding the very considerable advances that have been made in treatments which can extend life for people with melanoma, particularly advanced melanoma, we are far behind as a country. The drug, nivolumab, or nivo for short, is one treatment. In the European Union, only Ireland and Portugal have not approved this drug for reimbursement.

It is an extraordinary situation.

All EU countries, with the exception of Ireland, France, Italy and Portugal have decided to fund the combination therapy of ipilimumab, known as ipi, and nivolumab, known as nivo. This combination therapy has proven to be truly radical and transformative in medical research. Immunotherapy is the new revolution in cancer treatment but we have not approved these particular drugs, notwithstanding the fact they are licensed by the Food and Drug Administration, FDA, the European Medicines Agency, EMA, and by our own licensing authority, the Health Products Regulatory Authority, HPRA. Historically, survival rates were very low prior to the arrival of these particular treatments but since these treatments have come on stream, the impact has been quite transformative, particularly for patients with advanced melanoma. In Ireland, there may be up to 150 patients per year with advanced melanoma, 50% of whom could be suitable for the ipi-nivo combination.

The National Institute for Health and Care Excellence, NICE, in the UK is normally one of the slower agencies in this area but it has been one of the quickest out of the traps in approving this particular drug combination because of the data that has emerged. The most recent and dramatic data has come from the American Association for Cancer Research at its annual meeting in Washington showing positive responses among 60% to 70% of patients. This is very exciting but we are way behind. We have not approved nivo or the combination of ipi and nivo. Professor Carole Longson, the director of health technology at NICE, has said that after one of the fastest drug appraisals carried out by NICE, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition. Dr. James Larkin, a melanoma specialist at the Royal Marsden hospital was one of the leaders in a ground-breaking clinical trial of the combination therapy and 60% of his patients responded well to it.

I do not know why we are so slow in this area. I have been pointing out for more than two years that our system is not working. Since the enactment of the 2013 Act, it most certainly is not working and many patients are being left behind in respect of ground breaking treatments that can prolong their lives and lead to significant remission.

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