Dara Calleary (Mayo, Fianna Fail)
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416. To ask the Minister for Health when the HSE will make a decision on the reimbursement for a second line lung cancer drug (details supplied); his views on the delays in the drug reimbursement process and the stress this places on persons with serious illnesses; and if he will make a statement on the matter. [17895/18]

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 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 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 by the HSE that they are currently assessing the following indication for reimbursement:

- KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.

The NCPE is currently conducting a HTA on this indication. Once completed, the HSE will evaluate this application for reimbursement in line with the criteria laid out within the 2013 Act.