Medialis Ltd

As medical affairs specialists here at Medialis Ltd, we’re aware of the challenges faced by stakeholders in medicine adoption. Our research has shown the benefit of defining medical affairs as a medical specialty to ensure that the protection of patients is the pharmaceutical industry’s highest priority. As a medical affairs consultancy, we generate real-world evidence targeted to meet the needs of each stakeholder with patients at the centre of our purpose. This means applying our unique approach to developing highly accurate construct measures to anything from patient registries designed to generate evidence with clinical utility to prescribers to health economic cost estimations that ensure accuracy in cost-effectiveness decision-making. Get in touch with us at info@medialis.co.uk and let us help you help patients by generating high-quality real-world evidence for regulatory, payor, and prescriber needs. #MedicalAffairs #RealWorldEvidence #RWE #Reimbursement #Patients #Prescriber #Payor #Regulator 3D Medicines Inc, Aeglea BioTherapeutics, Agios Pharmaceuticals, Amylyx Pharmaceuticals, Apellis Pharmaceuticals, Atara Biotherapeutics, Beijing Hotgen Biotech Co., Ltd, Blueprint Medicines, Capricor Therapeutics, Inc., Catalyst Pharmaceuticals, Inc., Cothera Bioscience Inc, Cytokinetics, Eisai Co., Ltd., Epygenix Therapeutics, Inc., Forma Therapeutics, Gannex Pharma, GlycoMimetics, Healx, Infinity Pharmaceuticals, Jazz Pharmaceuticals, Kezar Life Sciences, Kyowa Kirin International plc., Lytix Biopharma, Medexus Pharmaceuticals, Zogenix, Inc., Nobelpharma America, LLC, Octapharma, Polaryx Therapeutics, Inc., REVERAGEN BIOPHARMA LIMITED, Santhera Pharmaceuticals, SciPharm AG, Spectrum Pharmaceuticals, Inc., Synlogic, TG Therapeutics, Inc., uniQure, Virogin Biotech, Zogenix, Inc., Zynerba Pharmaceuticals, VISEN Pharmaceuticals

Real-World Evidence (RWE) is reshaping healthcare, playing a crucial role in accelerating patient access to treatments, broadening the scope of patient eligibility at the regulatory stage, and enabling healthcare professionals to initiate treatments promptly with reliable, data-backed insights. The importance of RWE highlights the need for a precise, scientifically sound definition. We are proud to have contributed to this area by offering the only scientifically derived and peer-reviewed RWE benchmark in published literature. This exact definition is essential for professionals dedicated to generating and applying RWE to enhance patient care. Discover more in our publication: https://lnkd.in/dBCkKYb7 Our sincere thanks go to the Medical Affairs Pharmaceutical Physicians (MAPP) advisory panel and all contributors who played a role in this significant effort: Dr. Andrew Pain, Daniel Franks, Dani Thomas, Gerd Möller, MD, PhD, Health Economist, John Bolodeoku, Lisa Moore-Ramdin, Peter Stonier, Raj Rout, Tim P, William Spencer, Michael Smyth, Pundalik Nayak, Judith Livingstone, Guy Yeoman, Jan Sabbat, Philip Cruz, Maciej D. Zatonski, and Arun Mistry. To learn more about our RWE initiatives or find out how our medicine adoption model can support faster patient access to new treatments, reach out to us at info@medialis.co.uk. #RealWorldEvidence #PatientCare #MedicalAffairs #MarketAccess #RWE #RareDisease 3D Medicines Inc, Aeglea BioTherapeutics, Agios Pharmaceuticals, Amylyx Pharmaceuticals, Apellis Pharmaceuticals, Atara Biotherapeutics, Beijing Hotgen Biotech Co., Ltd, Blueprint Medicines, Capricor Therapeutics, Inc., Catalyst Pharmaceuticals, Inc., Cothera Bioscience Inc, Cytokinetics, Eisai Co., Ltd., Epygenix Therapeutics, Inc., Forma Therapeutics, Gannex Pharma, GlycoMimetics, Healx, Infinity Pharmaceuticals, Jazz Pharmaceuticals, Kezar Life Sciences, Kyowa Kirin International plc., Lytix Biopharma, Medexus Pharmaceuticals, Zogenix, Inc., Nobelpharma America, LLC, Octapharma, Polaryx Therapeutics, Inc., REVERAGEN BIOPHARMA LIMITED, Santhera Pharmaceuticals, SciPharm AG, Spectrum Pharmaceuticals, Inc., Synlogic, TG Therapeutics, Inc., uniQure, Virogin Biotech, Zogenix, Inc., Zynerba Pharmaceuticals, VISEN Pharmaceuticals

Unveiling the Hidden Costs: The Additional Strain Costs in nAMD Clinics In the current healthcare landscape, we often overlook the true cost of diseases. Traditional cost-effectiveness assessments (CEAs) tend to focus primarily on direct drug costs, neglecting a substantial portion of non-drug costs. This narrow view can lead to an underestimation of the actual financial burden on healthcare systems and may influence the perceived value of treatments. What does this mean? • Incomplete cost observations: We only capture a portion of relevant costs, sometimes including irrelevant ones, leading to an underestimation of the true cost of diseases. • Risk of inaccurate assessments: By not accounting for the full range of benefits provided by treatments, we risk not achieving cost-effectiveness and subsequent reimbursement. Medialis Ltd has developed the nAMD Service Non-Drug Cost Instrument (nAS instrument) using Neutral theory and the Jandhyala Method, providing groundbreaking evidence for including non-drug costs in CEAs. Our comprehensive analysis revealed that a recent NICE appraisal included only three non-drug costs, while our Neutral list identified 237 non-drug costs, 36 of which differentiated between treatments. Under the traditional approach, Drug 1 was favoured over Drug 2 based on drug costs alone. However, using the nAS instrument, which includes a more extensive list of non-drug costs, Drug 2 emerged as the more cost-effective option, emphasising the importance of a comprehensive cost analysis. The durability and robustness of treatments are critical, especially under strained conditions. Incorporating non-drug costs into CEAs provides a more accurate representation of the financial burden on healthcare services. This approach is a significant step toward more comprehensive assessments in healthcare, ensuring that new treatments are appropriately valued for their full benefits. Let's work towards more inclusive and accurate evaluations of healthcare costs! For all your real-world evidence (RWE) needs, contact us at info@medialis.co.uk #nAMD #HealthcareEconomics #CostEffectiveness #HTA #HealthcareInnovation #DiseaseSpecific #nASInstrument 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

A timeline for the development of the PAC-19QoL by Medialis Ltd: The first long-COVID disease-specific QoL instrument. In early 2020, as the COVID-19 pandemic reshaped our world, Medialis Ltd recognised the urgent need for a disease-specific quality of life (QoL) instrument for long COVID patients. This, led to the development of the PAC-19QoL. Rapid development timeline: We received ethical approval in October 2020 and initiated the development of the PAC-19QoL on November 23, 2020. The PAC-19QoL was completed in just 27 days, finalising it on December 20, 2020. Validation and publication: The PAC-19QoL was validated on December 29, 2020, and our findings were published in September 2021. For a comprehensive understanding of our work, you can read the full publication here: https://lnkd.in/dPRV3XdS Unique and reliable outcome measure: To the best of our knowledge, the PAC-19QoL is the only validated outcome measure for Long COVID. Our PAC19QoLReg registry (NCT04586413), established to gather data, has confirmed the instrument's reliability in predicting long-term outcomes and assessing patient variation from baseline. Interested in developing disease-specific instruments? Contact us at info@medialis.co.uk to learn how we can assist you. Together, let's continue to innovate and improve patient outcomes! #MedialisLtd #PAC19QoL #LongCOVID #QualityOfLife #HealthcareInnovation #DiseaseSpecific #COVID19 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

Just over 3 weeks to go! Medalis Ltd is thrilled to announce that we’ll be presenting a poster at ISPOR Europe 2024 on November 19th in Barcelona! Our poster, titled “Evaluating the Economic Impact of Real-World Costs in nAMD Treatment Using Neutral Theory: A UK Perspective,” delves into the economic challenges faced by nAMD clinics. Our research highlights the often-overlooked non-drug costs and clinic strain impacts, which are essential for more accurate cost-effectiveness assessments. If you're passionate about real-world evidence, health economics, and advancements in nAMD treatment, we invite you to join us and explore our findings! Scan the QR code below to book a meeting with us on November 19th. We’re looking forward to meaningful conversations and sharing our research with the ISPOR community. See you there! #ISPOREurope2024 #nAMD #HealthEconomics #MedalisLtd #CostEffectiveness #ResearchInnovation

Uncovering Hidden Costs in nAMD Clinics In the quest for cost-effectiveness, are we missing a crucial piece of the puzzle? Our latest publication "Real-world service costs for neovascular-AMD clinics in the United Kingdom: Structured literature review and scenario analysis" published in Current Medical Research and Opinion, reveals the significant strain costs impacting nAMD clinics, often overlooked in traditional cost-effectiveness analyses. In our scenario analysis, Drug A may appear cheaper with a lower upfront cost (£10), the associated strain costs (£13,115) paint a different picture compared to Drug B (£100 upfront with no additional strain costs). What does this mean? • Drug A: Lower initial cost but significant long-term strain costs. • Drug B: Higher initial cost but no additional strain costs. Impact on decision-making: When evaluating options, it's essential to consider not just the drug costs, but also the broader economic impact on the service as a whole. Incorporating strain costs into Health Technology Assessments (HTA) provides a more comprehensive view, ensuring sustainable and efficient healthcare delivery. Read the full article to explore our findings and methodology in detail: https://lnkd.in/d2-gjXba Get in touch with Medialis Ltd at info@medialis.co.uk to help shift your focus to more holistic evaluations that account for all costs, fostering better decision-making and improved patient care. Join the conversation and share your insights on how we can better integrate these findings into our practices. #nAMD #HealthcareEconomics #CostEffectiveness #HTA #HealthcareInnovation #nASInstrument #DiseaseSpecific 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

The Role of the Payor in Medicine Adoption: Overcoming Reimbursement Challenges with Real-World Evidence Payors are crucial in the adoption of new medicines, especially in markets that prioritise cost-effectiveness. While HTA agencies and payors often prioritise clinical trial data, there are significant evidence gaps that these trials do not cover. Real-world evidence (RWE) becomes crucial in this scenario, offering additional context and data to support reimbursement applications. Submitting incomplete or inadequate RWE alongside Randomised Clinical Trial Evidence (RCTE) can severely impact the reimbursement process. Relying on assumptions not only increases uncertainty but also reduces the accuracy of the data presented, ultimately decreasing the chances of successful reimbursement. To address these challenges, it is essential to enhance the impact of RWE in meeting the specific concerns of payors. By doing so, we can reduce dependence on potentially flawed assumptions and accelerate patient access to new medications. Creating a comprehensive list of disease costs using the Jandhyala Method ensures all relevant expenses are considered, including direct medical and non-medical costs, indirect costs, and even those difficult to measure, offering a more complete picture than clinical trials alone. At Medialis Ltd, we specialise in developing robust RWE strategies that complement RCTE, filling crucial evidence gaps and facilitating smoother reimbursement negotiations. Connect with us at info@medialis.co.uk to learn how our expertise can streamline your product's path to market. #RealWorldEvidence #RWE #MarketAccess #MedicalAffairs #Payor #Reimbursement #DiseaseSpecific #NeutralTheory #Costs 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

The Importance of Neutrality: Seeing the Whole Picture In today's complex healthcare landscape, our current methods often only observe a fraction of the relevant information. This means we are missing out on crucial information that could significantly impact the answers to our healthcare questions. Neutral Theory offers a robust framework to observe constructs with high accuracy. This theory has already been validated for use in quality of life and disease severity measurements, showcasing its reliability and effectiveness. By utilising the Jandhyala Method, which leverages Neutral Theory, we can generate comprehensive measurement tools allowing us to truly 'see the whole picture’ by ensuring that we consider all relevant factors. For more information and to discuss how our methods can benefit your organisation, get in touch with us at info@medialis.co.uk. We are here to support all your real-world evidence needs. Video Credit: The Guardian, 'Points of View' 1986 #Healthcare #NeutralTheory #JandhyalaMethod #ClinicalStudies #RealWorldEvidence #Neutrality 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

Why Medialis Ltd is your go-to partner for real-world evidence (RWE) solutions In the ever-evolving landscape of healthcare, are you confident your organisation is generating thorough, accurate evidence? At Medialis Ltd, we specialise in producing high-quality RWE that empowers informed decisions and accelerates patient access to new treatments. Our expertise covers the development of Quality of Life instruments, Disease severity scores, Core datasets, and Cost lists, leveraging the following approaches: • Neutral Theory application: Ensuring unbiased, scientifically robust methodologies. • The Jandhyala Method: Employing advanced techniques for consensus in observational studies. • Cross-disciplinary standardisation: Harmonizing disease observations across regions and medical disciplines, applicable to both on- and off-treatment patient monitoring. • Identifying the right patients: Enhancing early diagnosis and treatment by accurately screening at-risk populations. • Long-term outcome prediction: Providing insight into future trends in disease progression. • Comprehensive costing services: Delivering detailed cost analyses that enrich economic evaluations. For more details on how our innovative methods can support your organisation, reach out to us at info@medialis.co.uk. #RWE #RealWorldEvidence #CoreDatasets #DiseaseSeverityScore #PatientOutcomes #JandhyalaMethod #NeutralTheory #Neutrality #MedicalAffairs 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals

Medialis Ltd, we recognise the challenges stakeholders face in the adoption of new medicines. Through our research, we've demonstrated the value of defining medical affairs as a distinct medical specialty, emphasising patient protection as the top priority within the pharmaceutical industry. As a medical affairs consultancy, we create real-world evidence tailored to meet each stakeholder's needs, always keeping patients at the heart of our mission. Our unique approach ensures the development of precise construct measures for various applications, from patient registries that produce clinically useful evidence for prescribers to health economic cost analyses that enhance accuracy in cost-effectiveness assessments. Connect with us at info@medialis.co.uk and let us support you in advancing patient care by generating high-quality real-world evidence for regulatory, payor, and prescriber needs. #MedicalAffairs #RealWorldEvidence #RWE #Reimbursement #Patients #Prescriber #Payor #Regulator 4SC AG, Acceleron Pharma, Akari Therapeutics, Plc, Amgen, Annexon Biosciences, Applied Therapeutics, Inc., Arrowhead Pharmaceuticals, BioCryst Pharmaceuticals, Inc., Boston Scientific, Cellectar Biosciences, Inc., CRISPR Therapeutics, Dimerix Limited, Ipsen, FibroGen, Inc., GENFIT, Hi-Q Marine Biotech International Ltd, IMAGO BIOSCIENCES LTD, 益方生物 InventisBio, JCR Pharmaceuticals, Kartos Therapeutics, Inc., Keros Therapeutics, Lumos Pharma, Marinus Pharma, Neurocrine Biosciences, Oyster Point Pharma, Principia Biopharma, Redx Pharma, Rhythm Pharmaceuticals Inc., Rocket Pharmaceuticals, Sarepta Therapeutics, Seagen, Stealth BioTherapeutics, transposon therapeutics, UCB Biopharma SPRL, VaxCell Biotherapeutics Co., Ltd., Viracta Therapeutics, Inc., Visterra Inc., X4 Pharmaceuticals