With an ever increasing need to improve patients’ access to new medicines as close to marketing authorisation as possible, the National Institute for Health and Care Excellence (NICE) is looking at new ways to increase capacity and streamline their technology appraisal programme; with the outputs of the most recent consultation published last month.
The key aims of the public consultation are to:
- Provide clear, recognisable milestones for companies and other stakeholders, linking them to key stages in regulatory pathways, providing more time for NICE to engage with companies early in the appraisal process
- Release capacity for the appraisal committees as more of the scientific and technical elements are pulled forward into the workup of topics; allowing NICE to publish up to 75 appraisals per year
- Enhance NICE’s ability to deliver the ambitions set out in the Accelerated Access Review and the emerging Life Sciences Strategy, when requested to do so
In response to the original consultation, it was recognised that there is strong support to incorporate more points within the process for formal discussions with companies on the technical and commercial elements of their submissions. Furthermore, a ‘technical team’ will be developed to allow more opportunities for scientific and technical issues to be addressed prior to the appraisal committee decision stage. It is envisaged that this team will work with NICE and the submitting company to manage the evidence submission, and will develop a report for the committee. This will allow time for the company to respond in consultation prior to the formal committee meeting.
The most significant change to the original proposals is that NICE will not be taking forward the proposal for all medicines it reviews to have guidance published within 90 days of marketing authorisation. This decision was made as the Department of Health has indicated that it wishes to consider the proposal to align the publication schedule for non-cancer and cancer topics in the context of the forthcoming renegotiation of the Pharmaceutical Price Regulation Scheme.
NICE has also made the following amendments to its original proposals:
- Attendance of clinical experts and patient representatives at the appraisal committee – Instead of a ‘need assessment’ to determine whether patient and clinical representatives should attend committee meetings, NICE will continue to invite patient, clinical, and commissioning experts to the first appraisal committee meeting, but will provide them with an opportunity to opt-out of attendance should they feel that their views have been adequately addressed by the technical team
- Membership of the technical team – NICE accepted that the roles and responsibilities of those involved in the new technical team must be defined. NICE also recommended that members of the Evidence Review Group will not be formal members of the technical team, and there would be a greater emphasis on participation of the committee Chair
- Providing for more efficient consultation mechanisms – The consultation recommends that shorter, targeted Appraisal Consultation Document (ACD) consultations will not be taken forward for optimised recommendations, and as such, NICE will revert to the standard 20 working day consultation period. In addition, NICE proposed that the decision making process between ACD and Final Appraisal Determination (FAD) could be streamlined, with the Chair (with support from the technical team) being given the authority to make a final decision in cases where the company responds to the ACD with an updated commercial offer only. In such cases, the Chair may decide that a second formal appraisal committee meeting is not required
The document also notes that NICE will consider its approach to ‘process discipline’ and the circumstances under which new evidence will be accepted after the committee has met. Whilst NICE accepts that as a result, companies may be reluctant to provide submissions at the point at which they have been invited, NICE hopes that this will ensure that companies treat the first committee meeting as the definitive opportunity to submit evidence and their best offer at the first committee meeting. Furthermore, NICE has reiterated that it will be open to discussing individual cases with companies if pivotal evidence is not available at the proposed time, in order to ensure that committees are able to consider as much of the evidence base as possible when making recommendations. However, it notes that in cases where timelines are altered, NICE will require the company to agree to ‘complete transparency to allow other stakeholders to be informed’.
In terms of next steps, NICE conducted a 6-week consultation on the updated Guide to the process of technology appraisal, and a phased implementation of the proposals is expected from 1st April 2018 onwards. The most recent consultation on the process guide closed on 1st March 2018. Further information on the consultation can be found here.
If you would like to discuss how these proposals are likely to affect your ongoing/upcoming NICE technology appraisals, and how OPEN Access Consulting can support you with maximising the reimbursement opportunities of your medicines, please get in contact with Cathy Wright, Managing Director at firstname.lastname@example.org or call on +44 (0) 1628 897 909.