John McGuinness (Carlow-Kilkenny, Fianna Fail)
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692. To ask the Minister for Health if the drug ixazomib for a person (details supplied) will be covered by the HSE; if permissions that may be needed to cover the cost and use of the drug will be expedited; and if he will make a statement on the matter. [30959/18]

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. The Act specifies the criteria for decisions on the reimbursement of medicines.

In Ireland the majority of patients’ access medicines through the publicly funded Community Drug Schemes.

In line with the Health (Pricing and Supply of Medical Goods) Act 2013, if a company would like a medicine to be reimbursed by the HSE and available through the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.

As outlined in the Framework Agreement with industry, 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, 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 moneys 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.

Following receipt and consideration of a rapid review dossier in January 2017, the NCPE recommended that a full HTA take place. The HSE commissioned a full health assessment on 23rd January 2017.

The company HTA dossier was received by the NCPE on 1st June 2017. The NCPE has published the details of its engagements on the HTA on its website and these are available at: www.ncpe.ie.

The NCPE health technology assessment report was received by the HSE on 18 December 2017 and it was reviewed by the HSE Drugs Group in March 2018 and again in June 2018.

Discussions with the manufacturer in relation to this application are ongoing.