This page contains details of ongoing consultations where the opinion and input of BIA members is sought.
If you are commenting on any consultation as an individual or on behalf of another organisation such as RCPath and you belong to the BIA please do copy your form to BIA@Hartleytaylor.co.uk. Responders will receive a BIA Guideline Review Support Certificate which can be used to self-credit up to 10 CPD points for commenting on a consultation and we will incorporate your individual/other organisation response into the response of the BIA.
The following consultations are currently open:
- Stakeholder consultation: High Consequence Infectious Diseases Interim Paediatric Respond by: 9am, 18th July
- Notification of forthcoming consultation on NICE guideline CG165 Hepatitis B (chronic) 19 July - 1 August
- Consultation on draft NICE guidance on emergency and acute medical care in over 16s: service delivery and organisation Respond by: 9am, 14th August
- NICE draft guideline consultation: Flu vaccination - increasing uptake Respond by: 21st July
- Forthcoming consultation on NICE guideline: Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) Decision has been taken not to update this guideline.
The document below is part of the stakeholder consultation regarding an interim service specification for a High Level Isolation Unit for High Consequence Infectious Diseases, (Airborne) Paediatric. This is a two week consultation which closes on the 19th July 2017.
This is not a service specification for direct patient care nor for managing a major diseases outbreak. This is a service specification that sets out the heightened state of preparedness in which a Trust should be so that they are able to treat a patient who has a high consequence airborne infectious disease. This is analogous to the interim service specification that was agreed in 2015 for high consequence contact infectious diseases, specifically Ebola, and which was used by NHS England to maintain four Trusts in a heightened state of preparedness.
In 2015/16, NHS England established the High Consequence Infectious Disease (HCID) Programme. The objective of the programme is to ensure that there is an agreed approach to managing the end to end patient pathway for known and unknown high consequence infectious diseases (suspected and confirmed). This is turn will ensure that a sustainable response is in place, and is efficiently and effectively actionable, should the need arise.
There were a number of reasons for establishing the programme, the primary ones being:
• The challenge to the ability of the NHS to provide appropriate, scalable care for patients with suspected or confirmed Ebola (and other diseases spread through ‘contact’)
• The continuing threat of ‘airborne’ diseases such as middle-east respiratory syndrome (MERS) and, in particular, a clear pathway to treat such patients
NHS England has two permanent contracts in place for the treatment of patients with viral haemorrhagic fevers such as Ebola (at the Royal Free and Newcastle). In addition, for 2015/16 and 2016/17, NHS England also rapidly agreed arrangements with these providers, plus Liverpool and Sheffield, to maintain all four units in a heightened state of readiness should the need arise to rapidly accept patients for treatment.
NHS England does not have specific contracts in place to treat patients with high consequence airborne diseases. There have been a number of recent outbreaks (outside of the Middle East), for example, an outbreak between May and July 2015 in South Korea infected 186 patients and killed 36. Thousands of patients had to be quarantined. There have been a very small number of patients with MERS treated in NHS hospitals, notably St Thomas’ (2013). A patient suspected of having MERS caused the closure of an A&E in Manchester in 2015.
The aim of the programme will be to develop an ‘end to end’ tiered operational response for both airborne and contact HCIDs, with tier 1 (‘identify and isolate’) and tier 2 (‘test) providers being common for contact and airborne diseases and tier 3 (‘treat’) providers being separate for airborne and contact HCIDs, given the very different needs of these patients. It is key that the programme links in with the planned service review of infectious disease units,. However, there are significant concerns that a patient might present with an airborne HCID – particularly MERS – in the meantime and there would not be identified providers that were in a state of preparedness to treat them.
The proposal is therefore to develop an interim airborne HCID service specification that sets out what a Trust needs to have in place to be in a heightened state of preparedness in order to be able to treat patients with airborne HCIDs. This is not a service specification for direct patient care; this will be developed in due course. NHS England will use the service specification to select a small number of providers, up to four for the paediatric services; the proposed preferred option for service delivery, for children, particularly in a family context service is for the service to be located on the same site as the adult service. The geographical distribution of these centres is likely to be aligned to those cities that have the highest number of suspected MERS cases. It is anticipated that actual patient treatment costs would be paid for through usual contractual processes.
As this is an interim service specification, it has been agreed by the Women and Children’s Programme of Care Board that a formal public consultation is not required.
Please send your responses to Anna.Goodman@gstt.nhs.uk by 9am, 18th July.
NICE will shortly commence a 2-week consultation with registered stakeholders about the need to update NICE clinical guideline CG165 Hepatitis B (chronic): diagnosis and management.
The consultation will be open from 19 July 2017 until 1 August 2017. The relevant documents will be available once the consultation has been opened.
Consultation on draft NICE guidance on emergency and acute medical care in over 16s: service delivery and organisation
This consultation is now open. Please send any comments to Anna.Goodman@gstt.nhs.uk by 9am, Monday 14th August.
This draft guideline and its supporting evidence are now out for consultation. Although the closing date is 4th August, due to holiday commitments it would be appreciated if comments could be sent to Anna.Goodman@gstt.nhs.uk by 21st July 2017. The expected publication date is January 2018.
Forthcoming consultation on NICE guideline: Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy)
After considering the evidence and consulting with experts, NICE have provisionally decided not to update this guideline. BIA has confirmed with NICE that it endorses this decision.
UK National Screening Committee consultation: Newborn screening for cytomegalovirus
Comments are welcomed on this draft review. Please send your responses on the form available to download from the link below, to Anna.Goodman@gstt.nhs.uk, by Monday 11th September 2017.
NICE: Implementation of changes to the arrangements for evaluating and funding drugs and other health technologies appraised through our technology appraisal (TA) and highly specialised technologies (HST) programmes
I am writing to you to make you aware of the implementation of changes to the arrangements for evaluating and funding drugs and other health technologies appraised through our technology appraisal (TA) and highly specialised technologies (HST) programmes effective from 01 April 2017.
In October 2016, we (NICE) launched a joint consultation with NHS England. In the consultation we proposed to:
- Operate a ‘budget impact threshold’ of £20 million, set by NHS England, to signal the need for a dialogue with companies to agree arrangements to better manage the introduction of new technologies recommended by NICE. This would apply to a small number of technologies that, once determined as cost effective by NICE, would have a significant impact on the NHS budget.
- Introduce a ‘fast track’ technology appraisal process for the most promising new technologies. These would fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality adjusted life year), to get these treatments to patients more quickly.
- Vary the timescale for the funding requirement when the budget impact threshold is reached or exceeded, and there is therefore a compelling case that the introduction of the new technology would risk disruption to the funding of other services.
Proposed changes to our drug evaluation process were put forward to the NICE Board for approval at their meeting on 15 March 2017.
If you responded to the consultation, we would like to take the opportunity to thank you for your valued contribution.
We’ve listened carefully to what stakeholders have been told us within the consultation and made some important changes, as well as adding detail to our proposals. Significantly, we will look at the feasibility of extending the fast-track appraisal process to a wider group of treatments – not just those with a likely cost per QALY of £10,000 or less.
What was previously known as the Abbreviated Technology Appraisal (ATA) process has also been absorbed into the Fast Track Appraisal (FTA) process, with the addition of ‘cost comparison’ methodology.
The NICE board also agreed proposals to introduce a £20 million budget impact test. The test will be used to trigger discussions about potential ‘commercial agreements’ between NHS England and companies in order to manage the budget impact of introducing high cost treatments. This will apply to both the technology appraisal (TA) and highly specialised technologies (HST) programmes
The following documentation is now available on the NICE website:
· October 2016; Joint consultation document
· March 2017; NICE Board paper
· March 2017; Consultation analysis
· April 2017; Procedure for varying the funding requirement to take account of net budget impact
· April 2017; Assessing resource impact process manual: technology appraisals and highly specialised technologies
· April 2017; Fast track appraisal - Addendum to the Guide to the Processes of Technology Appraisal
· April 2017; Cost comparison - Addendum to the Guide to the methods of Technology Appraisal
Existing submission templates have been updated to address the implementation of the changes, and new templates for the application of the cost comparison methodology are also available on the NICE website.
If you have any questions about these changes, please contact Jenniffer Prescott, Associate Director (Planning, Operations and Topic Selection) by email at email@example.com.
NICE Surveillance Reports - Healthcare associated infections: prevention and control in primary and community care. Survey closed 27/06/17.
UK SMI V 04 - Investigation of hepatitis B infection. Consultation closed 26/06/17.
NICE draft guideline on sinusitis (acute): antimicrobial prescribing. Consultation closed 23/06/17. Expected publication date: 25 August 2017.
NICE draft guideline on cystic fibrosis: diagnosis and management. Consultation closed 18/06/17. Expected publication date: October 2017. Click for BIA comments.
UK National Screening Committee consultation: screening for Group B Streptococcus in pregnancy. Consultation closed 25/01/17. Expected review completion date: March 2017.
Bezlotoxumab for preventing recurrent Clostridium difficile infection ID1068. Consultation closed 19/12/16
NICE Quality Standard Topic Engagement Exercise: HIV testing: encouraging uptake. Consultation closed 5/12/16.
NICE QS topic engagement exercise: Sepsis. Consultation closed 16/11/16.
NICE guideline on Managing Common Infections. Consultation closed 28/11/16. Expected publication date tbc.
NICE Quality Standard Consultation: Vaccine uptake in under 19's. Consultation closed 29/09/16. Expected publication date: January 2017.
NICE Diagnostics Consultation Document: Integrated multiplex PCR tests for identifying gastrointestinal pathogens in people with suspected gastroenteritis (xTAG Gastrointestinal Pathogen Panel, FilmArray GI Panel and Faecal Pathogens B assay). Consultation closed 09/09/16. Expected publication date: January 2017.
NICE guideline CG139 Healthcare-associated infections: prevention and control in primary and community care. Consultation on the decision NOT to update this guideline closed 02/09/16.
NICE Consultation on Abbreviated Technology Appraisal (ATA) Process. Consultation closed 24/08/16. Comments are currently being reviewed and an updated version is due to be presented to the NICE board in November 2016.
RCPath guidance on the communication of critical results. This document was produced by Dr Bernie Croal. This document was online for consultation from 20 July to 17 August 2016 and the author is now considering the feedback. Click for consultation document.
Report from the EUCAST Subcommittee on the role of whole genome sequencing (WGS) in antimicrobial susceptibility testing. Consultation closed 24/06/16.
NICE Guideline: Sickle cell disease: managing acute painful episodes in hospital - Surveillance consultation. Consultation closed 02/06/16. Anticipated review decision publication: August 2016
UK SMI V 37: Chlamydia trachomatis infection - testing by Nucleic Acid Amplification Tests (NAAT). Consultation closed 31/05/16. Feedback currently being analysed.
NICE draft guideline consultation: Multimorbidity: clinical assessment and management. Guideline published September 2016.
NICE Quality Standard consultation: Hip fracture (update). Consultation closed 5/5/16. Anticipated publication: November 2016.
NICE Quality Standards (update): Diabetes in adults. Update published August 2016. Click for BIA response.
NICE draft guideline consultation: Non-Hodgkin's lymphoma. Guideline published July 2016.
Nice quality standard topic engagement exercise: blood transfusion. Consultation closed 01/03/16. Anticipated publication: Dec 2016
NICE draft guideline consultation: Sepsis. Guideline published July 2016.
NICE quality standard consultation: Bronchiolitis in children. Quality standard published June 2016
NICE guidelines - Cirrhosis in over 16s: assessment and management. Guidelines published July 2016
Survey on UK-wide provision of travel medicine training. Survey closed 6 January 2016.
NICE draft guideline consultation: Improving supportive and palliative care in adults (update). Consultation closed 28 January 2016.
NICE survey on diagnostic services: current practice. Consultation closed 29 January 2016.