Phil Garner’s Post

In this Deep Dive article, we cover the ISPOR—The Professional Society for Health Economics and Outcomes Research 2024 session, “No Longer Business as Usual: Establishing Value in an Uncertain and Dynamic Landscape.” Moderator, Laura T. Housman, MPH, MBA, DrPH(c) (Avalere) and speakers, Mike Ciarametaro (Avalere) and Jan McKendrick (Avalere Health) delved into the pressing need for life science companies to evolve their value demonstration methodologies to keep pace with the rapidly changing global #healthpolicy landscape following the introduction of #JointClinicalAssessment (#JCA) in Europe and the #InflationReductionAct in the US. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #hta #healthtechnologyassessment #healthdata #healthequity

Next week sees the highly anticipated ISPOR—The Professional Society for Health Economics and Outcomes Research 2024 Conference, taking place May 6–8, 2024 at the Georgia World Congress Center in Atlanta, GA, USA. Here, we overview what attendees can expect at ISPOR 2024 and how The Evidence Base® Base can help you stay up to date with the conference. Thank you to our #ISPORAnnual partners: Avalere, Cardinal Health, Carrot Recruitment, Flatiron Health, LCP Health Analytics, Maxis Clinical Sciences and Medlior Health Outcomes Research Ltd. #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #inflationreductionact #jointclinicalassessment #artificialintelligence #healthpolicy

What was your favorite thing about #ISPORAnnual? Check out this video compilation from AJMC - The American Journal of Managed Care with KOL responses to that question, and share your own answer in the comments!

ISPOR—The Professional Society for Health Economics and Outcomes Research has unveiled its new Strategic Plan 2030 representing a new vision for the society to advance #HEOR globally. Read at The Evidence Base® #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

Nominations are now open for the 2024 #ACTATrialOfTheYear Awards. This year we have four categories: 𝐀𝐂𝐓𝐀 𝐓𝐫𝐢𝐚𝐥 𝐨𝐟 𝐭𝐡𝐞 𝐘𝐞𝐚𝐫 𝐀𝐰𝐚𝐫𝐝 - trials considered for the ACTA Trial of the Year Award will be collaboratively developed, multicentre, investigator-driven, randomised controlled trials that were designed to improve patient-centred outcomes or healthcare delivery. 𝐀𝐂𝐓𝐀 𝐒𝐓𝐈𝐧𝐆 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐢𝐧 𝐓𝐫𝐢𝐚𝐥 𝐒𝐭𝐚𝐭𝐢𝐬𝐭𝐢𝐜𝐬 𝐀𝐰𝐚𝐫𝐝 - alongside the judging process for ACTA Trial of the Year, nominated trials can be reviewed by an expert panel of statisticians convened by the ACTA Statistics in Trials Interest Group (ACTA STInG) for the ACTA STInG Excellence in Trial Statistics Award. This panel will consider the statistical methods summary provided within the trial nomination form, along with the trial’s published statistical analysis plan and primary results paper. 𝐀𝐂𝐓𝐀 𝐂𝐨𝐧𝐬𝐮𝐦𝐞𝐫 𝐈𝐧𝐯𝐨𝐥𝐯𝐞𝐦𝐞𝐧𝐭 𝐀𝐰𝐚𝐫𝐝 - applicants should demonstrate exceptional creative and collaborative initiatives that involved consumers, incorporating the needs and values of patients and the public into trial protocol development (including priority setting) and design. Non-finalised/in-progress trials are eligible for this award providing recruitment for the trial is complete (as per the enrolment target) at the time of nomination. 𝐀𝐂𝐓𝐀 𝐇𝐄𝐀𝐓 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐢𝐧 𝐓𝐫𝐢𝐚𝐥 𝐁𝐚𝐬𝐞𝐝 𝐇𝐞𝐚𝐥𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐢𝐜𝐬 𝐀𝐰𝐚𝐫𝐝 - the nominated analyses will be reviewed by an expert panel of health economists convened by the ACTA Health Economics Alongside Trials Interest Group (ACTA HEAT) for the ACTA HEAT Excellence in Trial-Based Health Economics Award. These awards honor outstanding Australians who make notable contributions to enhancing our healthcare system by pioneering, implementing, or participating in groundbreaking clinical trials. We extend our appreciation for the crucial roles fulfilled by trialists, trial teams, consumers, and industry collaborators in the effective execution of clinical trials, and proudly recognise their invaluable contributions. 𝐍𝐨𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧𝐬 𝐜𝐥𝐨𝐬𝐞 𝐚𝐭 𝐦𝐢𝐝𝐧𝐢𝐠𝐡𝐭 𝐅𝐫𝐢𝐝𝐚𝐲 𝟐𝟗 𝐌𝐚𝐫𝐜𝐡 𝟐𝟎𝟐𝟒. Visit the ACTA website to nominate and find out more. https://bit.ly/TOTY-Awards

In this Guest Column, Sreeram Ramagopalan (LCP Health Analytics), Alejandra Castañon (LCP Health Analytics), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) provide a multistakeholder perspective of #TargetTrialEmulation in the context of #RWD submissions for #HTA. Based on the session ‘Target Trial Emulation in HTA RWD Submissions: A Best Practice Not Embraced – Methodological Challenge or Manufacturers’ Reluctance?’ presented at ISPOR—The Professional Society for Health Economics and Outcomes Research 2024. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata #ISPORAnnual

ISPOR takes place next week – meet our team on stand 827 🎉 Final preparations are under way for the ISPOR—The Professional Society for Health Economics and Outcomes Research conference next week. If you haven’t reached out already, there’s still time to set up a meeting via the conference app. Our extended team with colleagues from MAP Patient Access Limited, AxTalis and SKC Beratungsgesellschaft mbH will be happy to meet with you on stand 827. Below is a list of poster presentations that will be happening over the three days, so make sure you stop by to join the discussion. MONDAY: ➡️EU HTA is like a box of chocolates, you never know what you are going to get – Necessity for EU PICO simulations - poster presentation on 18 November, 10:30 AM - 1:30 PM ➡️How To Preserve Patient Access in Germany – a Performance Analysis of Products That Are no Longer Available on the German Market - poster presentation on 18 November, 10:30 AM - 1:30 PM TUESDAY: ➡️Outcomes of Benefit Reassessments of Orphan Drugs in Germany after Exceedance of the Lowered Sales Threshold of 30 Million Euros - poster presentation on 19 November, 10:30 AM - 1:30 PM ➡️Accurate description and interpretation of clinical endpoint results using commodity large language models - poster presentation on 19 November, 4:00 PM - 7:00 PM ➡️Long-Term Outcomes in Hemophilia: The Impact of the Pettersson Score on Cost-Effectiveness Modelling – poster presentation on 19 November, 4:00 PM – 7:00 PM WEDNESDAY: ➡️🏆Increasing Termination Rates of NICE Technology and Highly Specialised Technology Appraisals (top 5%) – poster presentation on 20 November, 9:00 AM - 11:30 AM ➡️Utilizing Expert Consensus Through Delphi Panels in Reimbursement Decisions in England: A Retrospective Analysis of NICE Appraisals - poster presentation on 20 November, 9:00 AM - 11:30 AM ➡️Impact of improved adherence to insulin injection technique recommendations on health care expenditures in insulin-treated people with diabetes in Belgium – poster presentation on 20 November, 9:00 AM - 11:30 AM It would be great to see you there! #ISPOR #HEOR #MarketAccess #EUHTA

Throughout this week, The Evidence Base® is bringing you updates direct from ISPOR—The Professional Society for Health Economics and Outcomes Research 2024. Here, we round-up some of the sessions from ISPOR 2024 Day 2. #ISPORAnnual #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

Yesterday, accompanied by a cheeseboard for the boss' birthday (happy birthday Amanda Strickson!), I delivered an internal seminar to the Tolley Health Economics Ltd on structured expert elicitation (SEE) for obtaining parameters to inform health economic analyses for treatments undergoing #healthtechnologyassessment (#HTA).   SEE has been a hot topic of discussion in recent years and is becoming more accepted and acknowledged by HTA bodies, evidenced by updated guidance from NICE - National Institute for Health and Care Excellence. Our most recent SEE exercise contributed towards the successful reimbursement of Filsuvez® for the treatment of partial thickness wounds in #EpidermolysisBullosa patients, through the HST route, where the exercise obtained key healthcare resource utilisation parameters, alongside progression estimates, for use in base case and scenario analysis of a cost-effectiveness model. I presented our SEE study at #ISPOR Europe 2023; take a look at the poster (link in the comments) to learn more about the study we conducted. Here are the key takeaways from our discussions yesterday:   📝 SEE framework: The appropriate choice of SEE framework can depend on the type of evidence needed. For most HTA needs, however, structured expert elicitation resources (STEER) have recently recommended the medical research council (MRC) protocol, where experts provide their individual judgement, and results are aggregated across respondents mathematically post-elicitation. Any deviation from the MRC protocol should be justified; if a group discussion is warranted, other approaches such as a modified Delphi Panel may be suitable.   🔎 Transparency: It is key to develop a detailed protocol for your SEE exercise, and document the process from beginning to end. Transparency in methods and results goes a long way in reducing uncertainty and potential bias, down to minute details such as reasons for experts not reaching a consensus.   💤 Respondent fatigue: Ensure that experts are briefed and trained on what to expect, and what is expected from them. Do not inundate experts with a large number of questions to complete. Check your study focuses on key data needs to get the most out of your experts.   👑 Hierarchy of evidence: Whilst SEE is an accepted method for obtaining data to address areas of uncertainty relevant to an HTA submission, it should be used in conjunction with recommended methods of data collection such as clinical trials, direct data elicitation from patients etc. as outlined in NICE TSD 13.   What are your thoughts of SEE as a tool to generate evidence for treatments undergoing HTA? Is it an appropriate evidence source, especially in rare disease treatments for which published data may be limited? But is it more difficult to apply in rare diseases where numbers of clinical experts are limited? Where should SEE evidence rank versus more traditional methods of data generation? Let’s discuss. #LetsDiscuss #SEE #HealthEconomics #HTA

Join the Mtech Access Team live on Thursday 3rd October at 1.00pm (BST) for an insightful webinar exploring how real-world evidence (RWE) can support health technology assessment (HTA), featuring experts from Mtech Access, Arcturis, and Delta Hat. Register now at: https://lnkd.in/eQis_D5y Dan Howard (Associate Director – Health Economics, Mtech Access) will discuss the challenges that our clients face when developing HTA-ready economic models with limited clinical trial data. Joseph O'Reilly (Principal Medical Statistician, Arcturis) will then introduce solutions to these challenges using RWD and RWE approaches. Nick Latimer (Analyst, Delta Hat; Professor of Health Economics, University of Sheffield; former NICE Appraisal Committee member) will share insights on how RWE is assessed by HTA committees. Samantha Gillard (Director – HTA, Mtech Access) will facilitate the discussion and put your questions to our experts. The panellists will explore: ✅ The evidence required for health economic modelling, with a focus on partitioned survival modelling for oncology ✅ Challenges posed by immature data or single-arm studies ✅ How RWD can fill the gap ✅ What RWD look like in practice ✅ How RWD and RWE can support the HTA process ✅ How RWD can be used to generate external control arms ✅ Using RWD in an HTA submission – the assessor’s perspective Learn more at https://lnkd.in/emDdqga6 #realworldevidence #HTA #healthtechnologyassessment #healtheconomics #healtheconomicmodelling #marketaccess #oncology #realworlddata