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Dáil Éireann debate -
Thursday, 22 Mar 2018

Vol. 966 No. 9

Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2018: First Stage

I move:

That leave be granted to introduce a Bill entitled an Act to amend the Health (Pricing and Supply of Medical Goods) Act 2013 to establish specific criteria applicable for orphan medicinal products for the purposes of the Health Service Executive making a relevant decision regarding adding an item to the Reimbursement List.

The purpose of this Bill is to amend the Health (Pricing and Supply of Medical Goods) Act 2013 and to put in place a structure for the Health Service Executive to appropriately assess orphan medicinal products when making a relevant decision regarding adding an item to the reimbursement list. It will provide clear guidance to the HSE over the appropriate usage of health technology assessment guidelines when assessing an orphan drug as well as establish a new criterion for the HSE to consider when making a relevant decision.

The provisions of the Bill are set out under four sections. Section 1 sets out to define the term "orphan medicinal product" while section 2 inserts same into the principal Act.

The definition used is that set out in Regulation No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.

Section 3 amends section 19 of the principal Act. Section 19(5) of the principal Act deals with the HSE's decision-making process in adding medicinal items to the reimbursement list and establishes that the HSE shall have regard to any health technology assessment, HTA, guidelines published by the Health Information and Quality Authority, HIQA, that appear to the executive to be relevant to the relevant decision. Currently, the HSE does differentiate an orphan medicinal product from other medicines in assessing the cost-effectiveness of a medicine in respect of which reimbursement is sought. Currently, HTA places a heavy emphasis on fixed thresholds on the financial value of the volume and quality of increased life expectancy a treatment provides, in other words, the quality-adjusted life years assessment. Threshold incremental cost-effective ratios disadvantage orphan medicinal products due to the often low availability of quantitative data as, by definition, a rare disease affects only a small number of patients while orphan medicinal products treat life-threatening or chronically debilitating diseases, meaning the improvements in health outcomes will be proportional to the severity of the patient population. Section 3 amends subsection (5) to qualify that for the avoidance of doubt, HIQA guidelines that include a threshold incremental cost-effective ratio or similar assessment shall not be considered relevant when considering an orphan medicinal product for reimbursement.

Section 4 amends section 3 of the principal Act. The principal Act sets out criteria under Schedule 3 against which all medicines must be considered by the HSE when making a relevant reimbursement decision. Part 3 of the Schedule contains several criteria in respect of which orphan medicinal products are particularly unfairly disadvantaged given their typically low patient population profile, high individual cost and low budgetary impact. Accordingly, section 4 establishes a new set of criteria for consideration of orphan medicinal products mitigating against low qualitative data and guaranteeing that the HSE will consider qualitative data presenting on an orphan medicinal product for patients, clinicians and others. Section 4 also aims to tackle inequality of treatment for patients with rare diseases by legislating for consideration of unmet need and for the availability of same treatment elsewhere in the EU. Additionally, section 4 would require the HSE to consider the level of certainty provided via risk sharing commercial agreements with the manufacturer of an orphan medicinal product.

Is the Bill opposed?

Question put and agreed to.

Since this is a Private Members' Bill, Second Stage must, under Standing Orders, be taken in Private Members' time.

I move: "That the Bill be taken in Private Members' time."

Question put and agreed to.
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