Pearse Doherty (Donegal South West, Sinn Fein)
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565. To ask the Minister for Health the average time a pharmacoeconomic evaluation of a drug takes. [15202/14]

Alex White (Dublin South, Labour)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE receives applications for the inclusion of medicinal products in the GMS and community drugs schemes. The applications are considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) uses two different types of pharmacoeconomic evaluation - rapid review process and full pharmacoeconomic evaluation. The rapid review process is used to try to identify or triage out any medicines which do not require a full evaluation. The rapid review process typically takes between 2 and 4 weeks. In 2013, 43 rapid reviews were completed and 51% of those resulted in positive recommendations typically within 2-4 weeks.

A full pharmacoeconomic evaluation is reserved in general for those medicines which are of high cost or have significant budget impact and which have not been approved via the rapid review process. The process used involves the pharmaceutical company in question submitting a detailed clinical and economic dossier to support the price it has chosen to seek. There is wide variation in the time taken by companies to submit these dossiers, in the amount of detail provided in initial dossiers and in the extent to which the initial dossier address relevant concerns. There is frequently a significant amount of clarification which the NCPE must require from companies. When the NCPE requests that data the clock is stopped on the assessment until the company provides that necessary data. The NCPE completes all phamaco-economic evaluations within the 180 day timeline set out in the Health (Pricing and Supply of Medical Goods) Act 2013. The Act allows for stop clocks where companies are required to provide additional data. In 2013 the NCPE completed 11 full pharmacoeconomic evaluations. The average length of time taken was 67 days.

The pharmacoeconomic evaluation process is an important input into the decision making process around new medicines.

Pearse Doherty (Donegal South West, Sinn Fein)
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566. To ask the Minister for Health the date the pharmacoeconomic evaluation of Nalmefeme Selincro began and when it is likely to conclude and if there are any particular reasons this evaluation might be more complicated than usual; and if he will make a statement on the matter. [15203/14]

Alex White (Dublin South, Labour)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE received an application for the inclusion of Nalmefeme (Selincro) in the GMS and community drugs schemes. The application is being considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) commenced a pharmacoeconomic evaluation of Nalmefeme (Selincro) on 21 October 2013, which will provide detailed information on the potential budget impact of the medicine. It also assesses whether the medicine is cost effective at the price quoted by the company in question. The NCPE report is an important input to assist the HSE in its decision making process.

No further comment is possible at this time while the NCPE assessment process is ongoing.