Debate contribution: Givinostat: Early Access Programme
Debate contribution by Mr Mike Nesbitt on .
- MLA
- Mr Mike Nesbitt
- Party at the time
- Ulster Unionist Party
- Date
- 10 March 2025
- Type
- Debate contribution (made as a minister)
- Business
- Oral Answers to Questions
- Heading
- Givinostat: Early Access Programme
- Assembly identifier
- Official Report component 4841194
Read the official Assembly record
Text
One of my duties is to ensure that Northern Ireland has timely access to clinically effective and cost-effective medicines. We do that through a formal link with the National Institute for Health and Care Excellence (NICE). As givinostat is a new treatment, routine access in the Health and Social Care (HSC) system is based on the outcome of considerations from NICE. NICE is currently evaluating givinostat. Final guidance is not expected until July. There is a route through an early access programme (EAP) ahead of NICE decisions, but responsibility for participation in those EAPs lies with the trusts. A compassionate use scheme such as that works well for therapies and conditions in which no close monitoring of patients is required. However, when monitoring is required, which is the case for givinostat, clinical centres need additional resources — for example, to carry out blood tests and hold additional clinics — to undertake the monitoring safely and sustainably. Although medicines under EAPs are typically provided for free, additional implementation costs will fall to the relevant trust, which is, in this case, the Belfast Trust. Having considered the resource required to administer givinostat safely and efficiently, the trust has advised that it is not able to facilitate this early intervention. Members will be aware of the huge budgetary pressures and saving targets facing all trusts at this time. It would be inappropriate for me or my Department to intervene in the trust's decision, as that risks undermining our well-established processes with NICE that ensure that our population has access to new medicines that have been demonstrated to be clinically effective and cost-effective. Should NICE recommend givinostat, my Department will consider it under the usual processes and endeavour to make the drug available as quickly as possible.
293 words. Text as published by the Northern Ireland Assembly.
Assessment
Jev’s structured answers met the documented threshold for “not flagged”.
- Overall probability that the activity is being used to promote, exploit or escalate an identity-based controversy: 0.02 (flagging needs at least 0.70; at or below 0.30 is not flagged).
- None of the five culture-war criteria was met (each was below 0.60).
- Assessed as legitimate policy scrutiny (0.74).
- No identity-based framing was identified (1.00).
- The overall probability was at or below the not-flagging threshold.
This is an AI-generated assessment of the text, made against published criteria. It is not a finding of fact about the MLA or their intentions. The Assembly record itself is the fact.
Jev’s structured answers
| Question | Probability | Met? |
|---|---|---|
| Identity framing | 0.02 | No |
| Sectarian or communal antagonism | 0.01 | No |
| Cultural grievance politics | 0.01 | No |
| Dog-whistle messaging | 0.01 | No |
| Controversy escalation | 0.02 | No |
| Legitimate policy scrutiny | 0.74 | Yes |
| Overall judgement | 0.02 | At or below not-flagging threshold |
| Option | Probability |
|---|---|
| No identity-based framing (chosen) | 1.00 |
| Reports or questions it | 0.00 |
| Criticises or condemns it | 0.00 |
| Adopts it | 0.00 |
| Subject | Probability |
|---|---|
| No identity-related subject | 0.96 |
| Disability (including neurodivergence and mental health), disabled people and disability or sickness benefits | 0.04 |
| Flags, emblems, symbols, names and memorials | 0.00 |
| Parades, bonfires and commemorations | 0.00 |
| Irish language, Ulster-Scots and language policy | 0.00 |
Assessed 21 October 2026 at 12:03 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.
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