Neo Insight’s Post

IQWiG Implements Updated Methods in German Cost-Benefit Assessments: Version 7.0 in Effect The Institute for Quality and Efficiency in Health Care (IQWiG) has released General Methods version 7.0, which includes updates to adapt to the changing healthcare landscape and improve transparency. Stakeholder input was invited and led to revisions and improvements. Key changes include revisions to cost-benefit assessments, streamlining the process, and narrowing the focus. IQWiG also integrates a new methodological framework to address real-world evidence (RWE) and the review of indication registries, enhancing decision-making processes. These updates reflect IQWiG's commitment to evidence-based healthcare. For more details please click the link! https://lnkd.in/d6fqey7F #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

The cost of medications continues to rise, spurred in part by the introduction of new and costly drug therapies. These increased costs have caused policymakers, public payers (i.e., Medicare and Medicaid), and commercial health insurers to closely examine the results achieved by such therapies and consider the growing disparities in drug access and outcomes. One potential vehicle for improving access to and benefit from pharmaceutical drugs is using value-based payment (VBP) models, which tie payment for delivery of health services to outcomes on cost, quality, and equity of care. #valuebasedpayment #healthcare #pharmaceuticals https://lnkd.in/g4XcfdDD

I am proud to share my latest bylined article, entitled “Doubling Down on Adherence,” which appears now in the August 2023 issue of Pharmaceutical Commerce Magazine. My article examines the many ways in which stakeholders are using high-tech and high-touch interventions to address the rampant issue of patient non-adherence to prescribed therapies ~ a problem that creates: * Clinical crises and quality-of-life issues for patients in terms of unchecked disease progression, preventable hospitalization and potential mortality * An enormous economic toll on payers who shoulder the burden of preventable medical expenditures, and * Missed financial opportunities for pharma brands that are essentially leaking sales when prescriptions go unfilled (as patients abandon their prescribed medications) and weakening the overall data-driven profile of their meds in real-world use scenarios Thanks as always to the thoughtful and generous thought leaders I interviewed from #EVERSANA, #SyneosHealth, #Exponent, #DrReddysLaboratories and #EveryDose. Check it out if you’re so inclined 👇👇

The FDA's accelerated approval process is great for patient access to new therapies, but what happens if those therapies don't work? --- The FDA created the Accelerated Approval Program to facilitate earlier conditional approval of drugs that treat serious conditions. The goal was to fill an unmet medical need based on a surrogate endpoint=an easily tracked biomarker that is thought to predict clinical benefit (but isn't itself proof of clinical benefit). This pathway shortens the time required prior to receiving initial FDA approval. --- In theory, this sounds great. Patients get access to new drugs earlier. #Pharma can start getting revenue earlier. The problem is most of the drugs that have taken the #AcceleratedApproval pathway ultimately showed no clinical benefit (article and supporting study in the comments). The FDA requires confirmatory #ClinicalTrials to prove clinical benefit after accelerated approval, but 40% of the drugs approved through this pathway (since it was created in 1992) still haven't completed their trials. These trials can take an extra 7-9 years to complete, and there's no real financial incentive to finish them. Plus, it's difficult to talk a patient into doing a trial for the drug when they can make sure they get the real thing from their doctor (instead of the chance of a placebo). --- There are three great adjustments mentioned in the article to help combat these misaligned incentives: 1. Require starting the confirmatory clinical trial BEFORE accelerated approval to ease recruitment challenges. 2. Require routine reassessment and renewal of accelerated approvals (instead of a one-time approval forever). 3. Don't pay the full #DrugPrices until the confirmatory trials are complete and clinical benefit is proven. #PatientAccess is important, particularly to therapies for conditions with an unmet need. But access only matters if the drugs have a clinical benefit.

Patient-guided drug development and Pharma Landscape For patients living with unmet medical needs, the development of effective therapies is critical. To ensure solutions deliver the most meaningful benefits possible, it is the responsibility of sponsors and CROs to develop a complete understanding of any given condition, the literature and seek an array of expert opinions. And yet, even this comprehensive approach does not provide the full picture without involvement from the ultimate end users – the patients themselves. Patients are the experts on their disease. They understand treatment hurdles and can express which outcomes are most meaningful to them, which may not always align with those deemed of greatest importance by clinicians and industry. Only by including patient insights across the entire process can we efficiently mitigate risk while navigating the incredibly complex environment of drug development. #healthcare #Drugdevelopment #Patientexperience #CRO #Sponsors https://lnkd.in/d4C6uRTM

#DrugRxiv is the new #preprint server for any research around #drug #discovery, #repurposing, #repositioning and #development including #insilico work, #bioinformatics, #wetlab, #diagnostics, #clinical, #patenting, #regulatory and #HTA health technology assessment. Moreover we are preparing the first issues of the Diamond open access #journals, #DRUGREPURPOSING and #NETWORKMEDICINE. All funded by the EU via REPO4EU

We are thrilled to announce a significant milestone for Celadon Pharmaceuticals Plc (AIM: CEL). Today, we proudly share that our private pain clinic, LVL Health, has received approval from the National Health Service ("NHS") Research Ethics Committee to commence a chronic pain clinical trial for up to 5,000 patients. The journey towards this approval has been marked by dedication and collaboration. Previously holding conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA), we embarked on an intensive Feasibility Study, culminating in positive outcomes for quality of life, pain, sleep, and a significant reduction in opioid usage. Our approved Clinical Trial stands as a remarkable step towards making cannabis-based medicines more widely accessible in the UK. It aims to establish a comprehensive data set that will support doctors' prescriptions, and in time, enable potential reimbursement by the NHS and insurance companies. In a groundbreaking move, General Practitioners can now prescribe this medicine to patients participating in the clinical trial alongside specialist doctors. We believe this development will not only improve patient well-being but also revolutionise the UK market for cannabis-based medicines. #CeladonPharma #Celadon #ClinicalTrial #ChronicPainManagement #MedicalAdvancements #HealthcareInnovation #Pharmaceuticals #PatientCare #UKHealthcare #ResearchEthics #NHS #MHRA #uklifesciences #lifesciences #lifescienceindustry #pharmaceuticals #gmp #cannabiscultivation #pharmaceuticalmanufacturing #pharma #medicalcannabis #investors #investor #aim #londonstockexchange #lse #investing #invest #RNS #companyannouncement #investorupdate #rns #rnsupdate #investormeet

Exciting new research sheds light on the clinical development landscape for high-spend Medicare Part D small molecule drugs and the potential impact of the Inflation Reduction Act of 2022 (IRA) on subsequent indications. Among the top 50 drugs by Medicare Part D spending in 2020, 30 were multi-indication small molecule drugs, with subsequent indications often receiving FDA approval within 2 years of initial approval. However, those based on postapproval research typically weren't approved until more than 7 years post approval. These findings suggest that the IRA may affect time to first launch, post approval research investments, and patient access. Understanding these dynamics is crucial for navigating the evolving healthcare landscape. Check out the full study here: https://lnkd.in/ecmmbFdv #MedicarePartD #MJHxAJMC AJMC - The American Journal of Managed Care MJH Thought Leaders

In our latest blog post, we explore why alternative access models are beneficial for the pharmaceutical market and how they can become vital options when traditional models, such as public or governmental reimbursement, fail. In today's healthcare environment, timely and comprehensive public reimbursement for innovative products for the full population is no longer guaranteed. To ensure launch success—defined as providing fast and broad access to innovative medicines—modern pharmaceutical companies should explore, consider, and incorporate innovative and alternative access models early in the development of their market access strategy, in addition to pursuing the more traditional access route. 👉 Find out more here: https://lnkd.in/dBiyh5tK 👈 #marketaccess #patientaccess #accessforall #reimbursement #hta #healthtechnologyassessment #innovativemedicine

Just submitted a pre-print article to the journal #DrugRxiv, which is an open community resource for preprints from the field of Drug Repurposing, run by REPO4EU, entitled "Using Interventional Pharmacoeconomic Clinical Trials and Outcomes-Based Contracts to Repurpose Generic Drugs with Cost Savings". The article discusses how health insurers can fund clinical trials for low-cost or off-patent drugs without any party taking on financial risk, by comparing low-cost therapies (e.g. repurposed generic drugs) to more expensive therapies (e.g. patented drugs), where the cost savings generated during the trial itself exceed the costs of running the trial. This "interventional pharmacoeconomic" (#IVPE) mechanism is being used by Public Good Pharma to build a scalable business model for #opensource and #affordable #medicine 💊 https://lnkd.in/dWf__eHB Harald H.H.W. Schmidt Stephanie Dawson Sundeep Dugar Zan Lowe-Skillern Jason Cross Bill Crown Kevin Knopf MD MPH Irni Mark Gemzon