Engaging with NICE: The Office for Market Access
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Nina Pinwill, NICE Day One, Pop-up University 4, 11.00
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Engaging with NICE: The Office for Market Access
- 1. Engaging with NICE: The Office for Market Access Nina Pinwill, Office for Market Access, NICE
- 2. Policy Landscape • Policy landscape evolving with initiatives aiming to ensure timely patient access to products addressing unmet medical need: – Accelerated access review (England) – The NEW Cancer Drugs Fund (England) – Early Access to Medicines Scheme (UK) – EMA adaptive pathways pilots (Europe) – EMA PRIME (Europe) • So NICE get products to appraise sooner & therefore with less evidence
- 3. Exciting Times! • Very strong pipelines of pharma and biotech products with potential for major patient benefits • Patients and healthcare systems need these products • Challenges – High cost of some products – Timely patient access while the evidence is still emerging • Effective engagement necessary to address challenges – NICE Scientific Advice – The Office for Market Access
- 4. NICE Office for Market Access (OMA) • Opened in October 2015 • Through tailored engagement and expert advice, the Office for Market Access (OMA) helps companies optimise the journey through NICE • OMA provides opportunities to engage with NICE at any stage in the development to adoption pathway • Covers all health technology products
- 5. OMA services Bespoke packages to meet company needs •Early engagement – to help companies understand NICE methods, processes and evidence requirements – To discuss managed access approaches for products that are expected to first come to market with immature evidence – To discuss NICE methods and processes related to the Early Access to Medicines Scheme and products included in the EMA led Adaptive Pathways pilots •Portfolio reviews •Multi-stakeholder safe-harbour meetings
- 6. The story so far
- 7. Multi-stakeholder Safe Harbour They are collaborative events, including participation from a range of stakeholders, designed to help companies deliver a market access plan that is patient & healthcare system focussed A safe harbour meeting is a multi- stakeholder discussion that is supported by rules of engagement to ensure a broad, open and free discussion within a confidential framework
- 8. Areas of discussion could include: EAMS, managed access, methods and processes, adaptive pathways, evidence requirements, meeting patient and NHS needs The Background • Complex pathway from product R&D to widespread NHS adoption of health technologies • Need to get innovative products addressing unmet need to patients asap • Many organisations involved who all need to engage effectively with product developers In response… • NICE Office for Market Access brokers discussions between companies, NICE and other key stakeholders in a ‘safe harbour’ environment • Available, for a fee, on a not-for-profit basis • Non-binding and non-attributable discussions – no obligation, advice • A multi-stakeholder safe harbour discussion gives the opportunity for: • Collaboration • Understanding • Barriers to be exposed – participants think beyond own area • Broad exploration of the issues • Facilitated, confidential, safe, open & free discussions
- 9. Benefits Collaborative approach can help companies deliver a market access plan that is patient and healthcare system focussed Engaging at an early stage provides the greatest opportunity for the company to understand what is feasible and desirable for the health system The discussions can help the company prepare for the processes they will need to follow as they move toward product launch
- 10. The safe harbour pilot
- 11. Feedback “The meeting was valuable – there was a breadth and depth of relevant stakeholder input” “NICE’s Office of Market Access fostered a safe environment to have open discussions”
- 12. Looking forward; focus, priorities and challenges NICE Strategic plan 2014-17: System Partnerships: ….. Work with government and industry to help promote innovation and growth in the life science industries…. NICE Health Technology Evaluation (medical devices, medicines, diagnostics & digital): • managing access to promising new medicines, devices and diagnostics • assessing value • scientific advances • budget impact
- 13. Follow us on Twitter @NICEcomms Keep up to date with the latest from NICE... Subscribe online to NICE News, our monthly newsletter - containing information about new guidance, quality standards and implementation resources launched each month. Sign up at: www.nice.org.uk/newsletter
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Editor's Notes
- The fast-paced world of life sciences means that new drugs, devices and diagnostics are constantly becoming available. Yet it can often take years for patients to benefit from these new treatments. Navigating the maze towards market access can be time consuming and difficult and NICE's Office for Market Access (OMA) is there to help optimise this journey.
- The NICE Office for Market Access (OMA) has hosted the first ever multi-stakeholder safe harbour meeting in April 2016. Safe harbours form part of the support to companies to accelerate patient and NHS access to medicines and technologies. The aim of a safe harbour is to work with companies to smooth their passage through the processes on the overall pathway followed to get their products to patients. They are collaborative events, including participation from a wide range of stakeholders, designed to help companies deliver a market access plan that is patient and healthcare system focussed. The intention is for this service to be chargeable to the company on a cost recovery basis in the future. Having the key players on the pathway present at the discussion, allows for consideration of barriers as well as an understanding of what is the optimum path for the product to follow to achieve faster patient access. How did it come about? The concept for safe harbour meetings was generated from a similar style of meeting held at a European level through the European Medicines Agency (EMA) Adaptive Pathways, more information can be found here. These EMA meetings aim to improve timely access for patients to new medicines. The OMA initiated and held preliminary discussions with key stakeholders and developed a plan to run a pilot in the autumn of 2015. As NICE had already been in discussions with two pharmaceutical companies (that had suitable products going through the EMA’s Adaptive Pathways) it was desirable for both to be selected as the products to use in the pilots. The two pilots have not incurred charges for the companies and have been offered free of charge by NICE to help gain the necessary experience, feedback and knowledge to develop a strong service. Rules of engagement In order to stimulate an open and free discussion, all multi-stakeholder safe harbour meetings subject to the confidentiality agreements so all are parties are reassured that any information discussed will not be shared more widely. This approach is designed to reassure those taking part that a safe harbour discussion a safe space in which to discuss any issues, which results in a broad exploration of possibilities through the help of an expert facilitator who chairs each discussion
- Multi-stakeholder ‘safe harbour’ discussions through the NICE Office for Market Access 2.The pathways from product R&D to widespread NHS adoption of medicines, medical devices and diagnostics are typically complex involving multiple processes and organisations. These change rapidly, driven through innovation in R&D and regulatory science, and the need to get innovative products addressing unmet need to patients. 3.Organisations responsible for regulation, health technology assessment, pricing, paying, and service commissioning need to ensure that their processes evolve and align to remain fit for purpose in the changing landscape. NICE’s methods and processes of health technology assessment continue to adapt to keep pace with requirements and include formal reviews every few years. 4.In addition, there is the need to engage effectively with product developers. The NICE Office for Market Access gives companies the opportunity to engage with NICE at any stage in the pathway from initial development to final adoption. Areas of interest where companies may seek discussions with NICE include: •Options for managed access approaches for products that are expected to first come to market via expedited regulatory processes with immature evidence •NICE processes related to the Early Access to Medicines Scheme (EAMS) and opportunities for evidence collection and preparation for NICE appraisal during the EAMS period •NICE methods and processes related to products included in the European Medicines Agency (EMA) led Adaptive Pathways pilots •Preparatory discussions to help companies understand NICE methods, processes and evidence requirements across all health technology product types. 5.In some cases, meaningful assistance to companies requires discussions not only with NICE but with other stakeholders in the system such as Department of Health, NHS England, clinical commissioning groups, regulators, UK clinical experts, research networks (RCTs and real-world data) and patient organisations. Where appropriate, the NICE Office for Market Access brokers discussions between companies, NICE and other key stakeholders in a ‘safe harbour’ environment. 6.NICE, through its Office for Market Access, is in a strong position to provide the necessary infrastructure and coordination of successful safe harbour discussions. NICE is also widely experienced in contributing at all stages in the development to adoption pathway. Its evaluation activities are positioned between regulation and clinical use in the NHS. Upstream activities include NICE Scientific Advice (providing advice on clinical development plans) and downstream activities include NICE Adoption and Impact (supporting uptake after publication of guidance). There is scope for more than one safe harbour discussion as a company strategy evolves in response to the first discussions. 7.The NICE Office for Market Access can organise and participate in safe harbour discussions on a not-for-profit, fee-for-service basis. Safe harbour discussions 8.Safe harbour discussions a confidential, honest and open discussion between relevant organisations and the company. They provide a safe environment to bounce ideas between each participant, allowing participants to think beyond their own area of interest and work together. 9.10.In some cases, addressing complex issues may require coordinated consideration by multiple stakeholders and in such cases, the NICE Office for Market Access will work hard and make every reasonable effort to secure the necessary input. It does this by providing coordination, the rules of engagement, and the contracts to allow input in a safe harbour environment. Stakeholder participation is voluntary and it is not envisaged that these safe harbour discussions will involve the exchange, discussion or storage of patient-identifiable or patient-level data. 11. ••Participants are not assumed to be speaking officially on behalf of their organisation •Statements made in the discussion cannot be attributed to individuals outside of that meeting •The discussions are non-binding and they cannot be interpreted as official or binding advice from participating stakeholders, nor as a commitment to action following the discussions •The meeting is for the participants alone and there will be no transmission of detail and substance of the discussion to a third party. This approach should hopefully reassure those taking part that this is a safe space in which to discuss any issues and result in an open and honest discussion and a broad exploration of possibilities through the help of an expert facilitator who will chair the discussion.
- This collaborative approach helps companies deliver a market access plan that is patient and healthcare system focussed. Holding safe harbour discussions at an early stage provides the greatest opportunity for the company to understand what is feasible and desirable for the health system. The discussions are intended to help the company prepare for the processes they will need to follow as they move toward product launch. For example the discussion can help the company consider what questions the health care system would ask about their product and what the practical considerations for the system are.
- Who was there? First pilot in April 2016 30 attendees (+18 joining by teleconference) 3 hour discussion What was discussed? Safe harbour concept Intro to the product Specific areas the company wanted discussed Feedback received at the Adaptive Pathway EMA/HTAs stage II & from the MHRA Potential reimbursement options at a conceptual level What was achieved? First meeting of its kind to be held in the context of the NHS in England Having all the players from the English health system in one meeting was a momentous and unique opportunity for them all to be heard Opportunity to review and evaluate the first pilot to inform developing plans for the second pilot
- Following the meeting, the OMA requested responses from all participants via a specially designed feedback survey. This included those who joined the meeting via teleconference as well as those who attended in person. Full results can be found on page 12. The feedback survey concentrated on three areas: 1.Preparation – the build up to the meeting 2.Meeting content – including feedback on things such as the type of content, interaction and outcomes. 3.Logistics – including the materials, agenda order and venue. 14 responses were received from attendees –including those from the company, the MHRA, patient experts, clinicians and NICE staff. The full table of results can be found at the end of this appendix. The responses indicated the pilot was very successful and well received by attendees. In the feedback there was not a single ‘strongly disagree’ response – a significant achievement for a pilot meeting. NICE OMA is now looking to build on the success of the first multi-stakeholder safe harbour and the team are currently in the process of developing their next pilot, expected in August 2016. Preparation Feedback This was overall very positive – in response to the overall question of ‘I felt that the preparation ahead of the meeting was well handled, relevant and suitably thorough’, all those who responded selected strongly agree or agree. However, there were a few areas to note where we received some negative feedback – these included where two attendees were not clear on what type of input they were expected to give at the meeting . Out of all the responses from this section 6 responses were recorded as ‘disagree’ and none as ‘strongly disagree’. Session Content Feedback This section was again predominantly positive with the responses to the question ‘Overall the session delivered what I expected and required’ being largely agree and strongly agree. However this section also contained more critical feedback, which centred on feedback to the question of whether the correct people were present. This reflected physical presence from NHS England was preferred (NHS England joined the meeting via teleconference). This is something we are setting in motion for the second pilot. Early indications suggest there will be appropriate NHS England representation in person. Session Format Feedback This section looked at whether the session itself was run effectively. This included questions on timing, agenda, materials and more. The feedback was again mostly positive though there were some clear areas for improvement. Responses to the question ‘Overall the session was run effectively’ were all responded to with agree and strongly agree. The areas that were identified where improvement could be made were on the provision of materials, the venue, time for networking and the way introductions were carried out. We are working on developing a more structured and systematic approach including a timeline and checklist which will improve these areas in the future. The feedback process from the first meeting has helped with this process – allowing the OMA to look at what works, what could be done better and plan further successful multi-stakeholder safe harbour meetings.
- Changing landscape, recognition of the importance of earlier patient access to effective products…products are likely to come to NICE sooner in their development cycle with less evidence through regulatory mechanisms for expedited approval such as European Medicines Agency (EMA) conditional marketing authorisation, EMA adaptive pathways pilots and PRIME work as well as UK Early Access to Medicines Scheme at the MHRA. What do we anticipate that mean for NICE? - wider use of patient access schemes to achieve equitable sharing of risks across stakeholders - post marketing authorisation “real world” evidence collection to reduce uncertainty over time - increased emphasis on “recommended with research” type recommendations and incorporating burden of illness as an additional value element in NICE decision-making framework - innovative pricing and reimbursement models In response to the UK Regenerative Medicine Expert Group report, NICE is engaging in a study to test the application of NICE appraisal methods & processes to regenerative medicines, identifying challenges and any areas where research or adaptation of methods & processes is appropriate, including the decision-making framework. Just some of the policy areas NICE are working on…