Ireland is looking to amend the pricing and reimbursement process to account for the difficulties faced by orphan drugs. John Brassil, Fianna Fáil’s Deputy, introduced a Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2018 in the Dáil yesterday (22 March 2018). It would amend the Health (Pricing and Supply of Medical Goods) Act 2013 act in two core ways:
- The Bill will amend the process by which the HSE utilise ICER-based Health Technology Assessments, as set out by HIQA. The Bill seeks to qualify that in the case of orphan drugs, a QALY will not be considered relevant in the evaluation of a drug’s cost-effectiveness
- The Bill sets out new criteria against which the HSE must consider orphan drug applications. Currently, the HSE consider all applications of licensed medicines against the criteria in Schedule 3, Part 3 of the 2013 Act. The Bill proposes to create a new set of criteria for orphan drugs, placing limitations/removing current criteria that may disproportionately and negatively impact an orphan drug’s likelihood of reimbursement (such as the current consideration of clinical effectiveness, level of certainty and the cost-effectiveness of treatment compared to other health services. Significantly, the Bill also creates new criteria for HSE consideration, such as unmet need, or the availability of that same medicine elsewhere in Europe.
The Bill will now move to the Second Stage, where it will be discussed in detail in Private Members’ Time. From there, there are several scenarios that can play out, including the obvious standard progression into law, a referral to the Health Committee for ‘detailed scrutiny’, a withdrawal of the Bill for the Minister for Health to provide his own legislation/policy to achieve same, or the less likely decision by the Dáil to vote down the Bill altogether.
As the Bill was introduced before the Dáil yesterday afternoon (22 March 2018), it is expected it to be published in full shortly.