Neale Richmond (Dublin Rathdown, Fine Gael)
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294. To ask the Minister for Health the estimated timeline for the process of adding a new drug to the primary care reimbursement service from product review to inclusion; and if he will make a statement on the matter. [28213/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, 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 line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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 (the NCPE). They use a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an 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.

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 ongoing basis. This can lead to a protracted deliberation process.

When there is a proposed decision by the HSE not to support reimbursement of a medicine, there is an extension in this timeline. This is due to the requirement of the HSE to issue a “notice of proposal”, and to allow 28 days for manufacturers to make representations to reconsider their decision. The HSE must then consider those representations and make a formal decision.