Dáil Éireann Debate, Tuesday - 22 March 2016
377. Deputy Robert Troy asked the Minister for Health the progress he has made in discussion with a drugs company to provide the life-saving drug Soliris to a person (details supplied) under the compassionate drugs access scheme; and if he will make a statement on the matter. [5147/16]
Amharc ar fhreagraEculizumab (Soliris®) is an ultra-orphan medicine manufactured by Alexion Pharma and licensed for the treatment of paroxysmal nocturnal haemaglobinurea (PNH) and atypical haemolytic uraemic syndrome (aHUS). Reimbursement support is provided for these two indications, for which the European Medicines Agency has completed assessments in relation to safety and efficacy. The drug is not licensed for the treatment of Degos disease by either the European Medicines Agency or the U.S. Food and Drug Administration.
At an individual cost of over €400,000 per patient per year, this drug is expected to cost the HSE approximately €8m in 2016. Given these substantial costs, the Director General of the HSE has put in place formal procedures to ensure that each case in which Soliris is used is the subject of clear advance authorisation. Treating clinicians are required to apply to the HSE's Medicines Management Programme in order to commence a screening process for their respective patients. These arrangements would not permit the drug to be used for the treatment of a condition beyond the terms of the Marketing Authorisation and where evidence of clinical benefit has not been demonstrated. To date, there is a lack of convincing clinical evidence or research to support the use of Soliris for the treatment of Degos disease.
It is open to a drug’s manufacturer at any time to submit an application to the European Medicines Agency to have a product licensed for use for a specific indication. Once that drug is approved by the EMA, the manufacturer can, if it wishes, submit an application for pricing and reimbursement to the HSE.
It is not in my power as Minister for Health to licence any new drug or medicine, or to sanction experimental trials of new drugs. As you will appreciate, I cannot comment on the case of any individual, or intervene in individual patient cases.
