Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

I am taking this issue on behalf of the Minister for Health, Deputy Harris, who sends his apologies for not being here. I thank Deputy Brassil for raising the issue.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. In reaching its decision, the HSE examines all of the evidence which may be relevant in its view to the decision, including the dossier submitted by the company. The HSE will take into account such expert opinions and recommendations which may have been sought by it at its sole discretion, for example, from the National Centre for Pharmacoeconomics, the NCPE. Under section 19(4) of the Act, the HSE is prohibited from making a decision to reimburse a medicine "except in accordance with the criteria specified in Schedule 3" of the 2013 Act. In the interest of time, I do not propose to read out the statutory criteria.

In line with the statutory assessment process the HSE has confirmed it has received a request from the manufacturer of Respreeza for maintenance treatment of emphysema in adults. The NCPE, following a health technology assessment, determined that the manufacturer failed to demonstrate cost-effectiveness of the drug at the price submitted and did not recommend it for reimbursement. Respreeza was also considered by the HSE drugs group and it did not make a recommendation for reimbursement. The HSE considers the NCPE assessment, the drugs group recommendation and other expert advice as part of its decision-making process. The HSE leadership team has accepted the drugs group recommendation. In line with the 2013 Act, the HSE is required to provide formal written notice of its proposed decision to the company.

Following receipt of the notice, the company may make further representations to the HSE if it so wishes and the latter will consider any such representations in advance of a formal decision. As the statutory process is still ongoing, the company will have the opportunity to have further discussions with the HSE.

I note the decision by the manufacturer, CSL Behring, to extend the compassionate access scheme by a further two months. It is important to point out that the operation of such schemes is at the discretion of manufacturers. However, the Minister, Deputy Harris, has previously stated that any attempt by manufacturers to link continued access for patients already being treated with a new medicine with decisions under the statutory reimbursement process is both inappropriate and unethical. Manufacturers should operate such schemes in a compassionate manner and not on the basis of commercial motivation. There should be no link between compassionate use schemes and reimbursement decisions, and manufacturers should be upfront with patients and clinicians from the outset.

See this speech in context