Louise O'Reilly (Dublin Fingal, Sinn Fein)
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312. To ask the Minister for Health if his attention has been drawn to plans to make the drug Raxone available on the general medical services scheme; and if he will make a statement on the matter. [27456/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the Reimbursement List.

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.

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.

The HSE strives to reach a decision in as timely a manner as possible. 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 on-going basis. This can lead to a protracted deliberation process.

I have been informed that Raxone for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON) is currently undergoing a full pharmacoeconomic assessment by the NCPE.

Once the assessment is complete, the application will be processed in line with the 2013 Act.