Decisive Consulting Ltd

We’re thrilled to welcome Tommy Hoare to #teamdecisive! With an MSc in Economics from the University of Leeds and a strong foundation in statistical analysis and health economics, Tommy brings valuable experience in cost-benefit analysis and budget impact models. His focus on early diagnosis in infectious diseases and cancer will be a great asset to our team and clients. Please join us in welcoming Tommy to the team! #rebelthinkers #teamdecisive #HEOR #marketaccess #healtheconomics

We are delighted to announce that we are now members of #EUCOPE! We are proud to be a part of this prestigious network of small and mid-sized companies contributing to and advancing innovations in healthcare across Europe. See the announcement and find out more about about EUCOPE below. #heor #hta #marketaccess #publicaffairs #teamdecisive #rebelthinkers

🚨 Just a few days to go! 🚨 Esther Nzenza, Nic Gwatkin, and Steven Fountain are looking forward to attend #WODCEurope in Barcelona next week! At #teamdecisive, we’re passionate about supporting companies in the development of innovative medicines for #raredisease and #ultrararedisease. Our expertise covers key areas like #marketaccess, #HEOR, and #HTA, with a commitment to making sure the right medicines reach the right patients at the right time. If you're attending WODC, we’d love to connect! You'll find us at stand 28 in Hall 2 #rebelthinkers #marketaccess #heor #hta #JCAready #PICOpredict

📢 Health Policy Update – France 📢 The latest draft PLFSS measures of October 10th, bring mixed news for pharmaceutical companies with reimbursed medicines in France. On one hand, the reduction of the Safeguard clause and a €1.1 billion savings plan could present financial challenges. However, efforts to speed up access to innovative medicines will potentially benefit companies focused on cutting-edge treatments. Find out more below. #France #PLFSS #healthcarepolicy #pharma #innovation #marketaccess

Preparing for Joint Clinical Assessment: The increased importance of Indirect Treatment Comparisons A key component of the new EU-centralised Joint Clinical Assessment (JCA) process – now less than 90 days away for ATMPs and oncology products - is for health technology developers (HTDs) to demonstrate comparative effectiveness against multiple potential comparators. HTDs must provide evidence that reviews their novel technology in the context of existing standard of care across the 27 member states. Relevant comparators across EU countries may differ substantially based on local treatment guidelines, accessibility and prescribing patterns. Given the impracticality of multiple head-to-head clinical trials and considering the evolving treatment landscape across countries, indirect treatment comparisons (ITCs) will be a central consideration for products undergoing JCA. ITCs allow HTDs to assess relative effectiveness of their technology against the comparators selected as part of the PICOs (population, intervention, comparator, outcome) submitted by each country and consolidated during the JCA process. HTDs can prepare for challenges posed by an increased need for a range of ITCs by: - Assessing internal capacity, budget, and capability to perform multiple ITCs under time pressure - Conducting a JCA readiness assessment – our new tool can support you to assess, track and plan across your organisation - Predicting PICOs early – our AI-enabled process https://lnkd.in/dr82QKvc provides an understanding of likely comparators and hence enables you to anticipate evidence synthesis strategy well in advance of JCA dossier preparation Read our full Decisive Dialogue article written by Milind Sood for more detail Contact Esther Nzenza or Kevin Asher to discuss how Decisive can support you! #teamdecisive #jca #itc #jcaready #heor #pico #marketaccess

🎉 Exciting news! 🎉 We’re thrilled to announce that Esther Nzenza, our CEO, has been recognized as One to Watch in the LDC Top 50 Most Ambitious Business Leaders programme for 2024, in partnership with The Times This prestigious recognition programme, now in its 7th year, celebrates entrepreneurs who show remarkable ambition and are making a significant impact in their industries. With over 700 nominations this year, it’s truly an honour to see Esther celebrated for her vision, leadership, and positive influence on our team, business and industry. At the heart of this recognition is the drive to create jobs, promote social equality, champion sustainability, and grow with purpose. We are immensely proud of Esther for her inspiring leadership and continuing our exciting journey. Please join us in celebrating this amazing achievement. Find out more about the LDC Top 50 and this year’s Ones to Watch: https://bit.ly/3YaJvWe   #LDCTop50 #onestowatch #inspirational #leadership #teamdecisive #rebelthinkers

As we continue to explore the implementation of JCA, we have produced a short explainer video on the timelines of the JCA dossier development, submission and publication. Advance planning for the possible evidence requirements will be essential to enable companies to respond to the consolidated PICOs that will be shared in the scoping proposal. The timelines for producing the dossier are short, so early prediction of PICOs and development of integrated evidence plans and deliverables such as systematic literature reviews to address the predicted PICOs are essential. The timelines for responding to additional requests for additional information are also short, so understanding what may be requested and how the evidence will be provided in advance will be critical to meeting the timelines. Finally, assessing your integrated publication planning will be vital to ensure your data is released in a planned way and in the sequence you choose taking into account the visibility of the JCA report, which may include sub-analyses and indirect treatment comparisons. If you would like to understand how you can be JCA ready, please contact Kevin Asher or Esther Nzenza for an informal discussion. #hta #heor #euhta #jcaready #picopredict www.picopredict.com 

Esther Nzenza, Nic Gwatkin and Steven Fountain are looking forward to attending #WODCEurope in Barcelona later this month. Across #teamdecisive we have a wide range of experience in supporting companies developing innovative medicine for #raredisease and #ultrararedisease. Some of the more common topics we address are shown below. We believe passionately in ensuring the right medicines are accessible to the right patients at the right time around the world and work closely with a wide range of companies at different stages of development to help to enable this vision. We'd be delighted to talk more at WODC so do let us know if you're planning to attend. #rebelthinkers #marketaccess #heor #hta #JCAready #PICOpredict

🌍The European Commission has launched an online public consultation on the draft implementing act on joint scientific consultations (JSC) for medicines as part of the Health Technology Assessment (HTA) Regulation that comes into force in January 2025. 🪟The overall framework contains little information beyond that already defined in the regulation and doesn't yet provide clarity on the capacity for conducting these consultations.  The implementing act does state a minimum of 2 request periods to be run each year and that by end of November each year the  HTA Coordinating Group will set out their plan for the following year with the dates of request periods. 📃The templates for submitting JSC requests are still in development and slated for delivery in Q1 2025.  The draft IA specifies that all relevant materials are to be provided 10 days before the scheduled advice discussion but few tangible details are provided at this stage. It was clarified in the JCA regulation that JSC interactions will be reserved only for medicines where the pivotal study is in the planning phase - e.g. not yet underway. ⏰The timing of the JSC process for new medicines also means that it will be out of step with the need to anticipate PICOs across the member states (www.picopredict.com) as there is a high likelihood of practice evolution in the intervening years. 🔮This is why predicting the PICOs at a National level using a systematic, repeatable process is so key - and why we are working with a number of companies to help with just that. We will continue to monitor the progress of policy and regulation and to incorporate this learning into our #JCAready toolkits.  If you would like to discuss alternative ways to gain HTA input into your development plans in the interim, please reach out to Esther Nzenza or Kevin Asher and we'll be delighted to help. Link here: https://lnkd.in/e-qh3Uib #picopredict #jcaready #jsc #euhta #hta #marketaccess

Population, Intervention, Comparator, Outcomes (PICO) #teamdecisive have created a short explainer video on PICOs – the research question at the heart of a Health Technology Assessment.  For some people this is a newer concept and one that’s discussed widely in the context of Joint Clinical Assessment (JCA) so here we demystify the terminology and explain why PICOs are important and how easily you can generate multiple PICOs for a single treatment when considering different country settings and practice. We are working with a number of clients on predicting PICOs, if you would like a discussion to understand our approach to this, please reach out to Kevin Asher or Esther Nzenza   #HTA #EUHTA #PICO #PICOpredict #JCAready #HEOR #marketaccess  #teamdecisive #rebelthinking