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Highly Specialised Technologies Evaluations

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Presentation on theme: "Highly Specialised Technologies Evaluations"— Presentation transcript:

1 Highly Specialised Technologies Evaluations
Josie Godfrey, Associate Director – Highly Specialised Technologies and Topic Selection

2 Topic Selection & Scoping
Process starts approximately 2 years before a drug is licensed Suggestions received from topic sources Reject or refer elsewhere e.g. National Screening Committee Suggestions are assessed according to NICE/DH criteria to prioritise topics Decision point 1 DH/NICE jointly agree on topics that should proceed to draft scope creation Decision point 2 DH/NICE/NHS England jointly agree on draft scopes to be issued for consultation Decision point 3 Consultation on the draft scope and scoping workshop DH/NICE/NHS England post-scoping meeting Decision point 4 Ideally 12–15 months before a drug is licensed Referral by Minister Decision point 5

3 Highly specialised technologies programme: prioritisation criteria
The target patient group for the technology in its licensed indication is so small that treatment will usually be concentrated in very few centres in the NHS The target patient group is distinct for clinical reasons The condition is chronic and severely disabling The technology is expected to be used exclusively in the context of a highly specialised service The technology is likely to have a very high acquisition cost The technology has the potential for life long use The need for national commissioning of the technology is significant Good to emphasize here that all criteria need to be meet for inclusion in the HST programme

4 HST criteria Nature of the condition Impact of the new technology
Cost to the NHS and Personal Social Services Value for money Impact of the technology beyond direct health benefits Impact of the technology on the delivery of the specialised service

5 HST: other considerations
Para 41… When evaluating cost to the NHS and PSS, the Committee will take into account the total budget for specialised services, and how it is allocated, as well as the scale of investment in comparable areas of medicine. The committee will also take into account what could be considered a reasonable cost for the medicine in the context of recouping manufacturing, research and development costs from sales to a limited number of patients.

6 Highly specialised technologies programme: process
NICE produces provisional list of topics Consultees identified Scope prepared and consulted on – all comments considered during scoping workshop Topics referred by Minister to NICE Evidence submitted by manufacturer and other consultees, comments invited on potential clinical effectiveness and value Evidence review group (ERG) report independently commissioned and prepared Committee papers prepared: Evidence submissions from manufacturer, patients, clinical specialists and NHS England, ERG report, pre-meeting briefing Evaluation committee considers all evidence Evaluation committee document (ECD) produced only if recommendations are more restrictive than license; public consultation for 4 weeks Evaluation committee considers responses to public consultation Final evaluation determination (FED) produced; any appeals considered Guidance issued ~27 weeks from submission* * Excludes appeal period and reconsideration points

7 How patients and carer organisations can contribute to a NICE Highly Specialised Technology Evaluation

8 Overview of patient involvement
Stage 1 Scoping Pre-referral Scoping usually occurs: before a licence has been granted for a technology Before the topic has been referred Guidance development is usually: After referral As close to issue of licence as possible (the licence has to be issued before the evaluation consultation can begin) Stage 2 Guidance Development Post-referral

9 Scoping (pre-referral)
Patient organisations can: Comment in writing on the draft remit scope matrix (stakeholder list) Participate in scoping workshop

10 Key information in a scope
Population –informed by clinical trial populations and anticipated marketing authorisation Intervention – name of technology and whether it is given alone or in combination with other treatments Comparators – alternative treatment options currently used to treat condition in established clinical practice Outcomes – important outcomes to show the effects of treatment Subgroups – any subgroups of the population in which the intervention is likely to be more clinically effective or provide more value for money Equality issues – consideration of whether the evaluation could lead to recommendations that have a different impact on people protected by the equality legislation than on the wider population  The scope also contains the remit/evaluation objective, a brief background to the condition and current treatment options, a short description of the technology and any relevant clinical trials.

11 Guidance development after referral
Provide written evidence submission to Committee Nominate patient experts to attend Committee meeting Comment on Evaluation Consultation Document After the Final Evaluation Determination is issued – provide factual inaccuracies or appeal against decision

12 What information do patients and carers provide to NICE?
What it is like to live with the condition Outcomes that patients and carers most value Perceived risks and benefits of treatment Difference the treatment will make to physical wellbeing Impact of condition on daily activities (work, social life, relationships) Psychological health of patients/carers (mood, anxiety) Emotional health of patients/carers (wellbeing, relationships) Balance between health related quality of life and length of life Treatment choices that matter to patients Impact of condition on the lives of family members and carers

13 How patients and carers can contribute to a NICE Highly Specialised Technology evaluation

14 The role of patient experts
provide statements which will help the Committee consider key criteria such as the nature of the condition attend Committee meetings as individuals They will have experience of the broader patient population relevant to the evaluation and/or relevant personal experience

15 How can NICE support patient experts?
Provide help to patient organisations with the process from scoping to guidance publication Support patient experts before, during and after the committee meeting Providing patient support materials – hints and tips and factsheets. Liaise with patient groups to include their details in the patient version of the guidance

16 Ataluren for Duchene Muscular Dystrophy – next steps
Scoping: Deadline for written responses to consultation: Wednesday 11 February 2015 Scoping workshop: NICE offices, central Manchester on Monday 16 March 2015 at 14:00 (refreshments from 13:30) If you would like to discuss your organisation’s representatives, please contact Heidi Livingstone, Public Involvement Adviser, Public Involvement Programme If you have any queries please contact Michelle Adhemar, Scoping Project Manager,

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