White Paper – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ Mon, 08 Apr 2024 05:53:15 +0000 en-AU hourly 1 https://wordpress.org/?v=6.6.2 https://i0.wp.com/clinicalvalue.com/wp-content/uploads/2023/01/apple-touch-icon.png?fit=32%2C32&ssl=1 White Paper – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ 32 32 225041835 Patient-centric and ecosystem insights into hepatocellular carcinoma across Asia-Pacific – LEAP https://clinicalvalue.com/en-au/patient-centric-and-ecosystem-insights-into-hepatocellular-carcinoma-across-asia-pacific-leap/ Mon, 02 Oct 2023 02:36:24 +0000 https://clinicalvalue.com/patient-centric-and-ecosystem-insights-into-hepatocellular-carcinoma-across-asia-pacific-leap/ In this white paper, insights on the liver ecosystem are uncovered, with the intention of facilitating action among various stakeholders to reduce liver cancer incidence and mortality in APAC. Read the whitepaper to find out more about the various active initiatives and recommendations for next steps. ...

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Hepatocellular carcinoma (HCC) is largely preventable, with decades of time to intervene, yet millions still die from it. It is however not incomprehensible why this happens. The journey from liver disease to liver cancer is complex—a myriad of broken healthcare systems, patient behaviors, cultural influences, stigma, funding, and limited healthcare professional (HCP) capacity. At first glance, it seems overwhelming, leaving us with the question—where should we intervene?

Some cancers like breast cancer have high incidence but comparatively low mortality1. Liver cancer is the opposite; it often goes undetected until it reaches a late stage, resulting in dismal prognosis. Late presentation is a top issue in liver cancer. Without pain receptors, the liver has minimal symptoms until it is damaged beyond cure. People usually die within 6 – 22 months of a late-stage HCC diagnosis.2 HCC is known as the ‘silent killer’ and is typically diagnosed at a late stage, which has a <5% 5-year survival rate. If diagnosed early, the 5-year survival rate increases to 40 – 70%.3&4

Given the complexity, there is no single solution. Rather, it will take concerted action from multiple stakeholders in the system to bring about positive change. That said, there are logical places to start. First, we need to understand the ecosystem. An ecosystem represents factors required to deliver a service, in this case, liver care. It helps identify solution, scope, and strategy by providing a holistic view of actors, processes, flow, influence, and relationships.

Hepatitis B and C are the major causes of chronic liver disease and liver cancer in the world. An ongoing infection causes inflammation in the liver. This extended inflammation can cause scarring, called cirrhosis, and can ultimately lead to liver cancer. The Asia-Pacific region bears the highest overall burden of HBV, with 59% of those living with chronic HBV, 26% of new infections, and 79% of deaths.5 Given the shifting etiology with rising fatty liver disease, there is a pressing need to re-assess risk factors and stratify patients to ensure we are not failing to detect. Being able to optimize surveillance protocols based on patient risk will improve efficiency and ability to catch early HCC and drastically improve survival.

To further maximize the benefit of a surveillance program, or any other initiative, it is important to consider surrounding opportunities up- and down-stream. For example, surveillance programs will benefit from upstream awareness efforts to improve throughput, and down-stream availability of treatments. This paper provides an appreciation for the end-to-end patient journey and their needs along the way. Fundamentally, it advocates for the improvement of human life in the midst of receiving liver care, both clinically and experientially.

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From the research, a central theme emerged – ultrasound used in HCC surveillance is a major bottleneck. It is the cause of delayed or even missed diagnosis, and stark inequities in care. Biomarkers such as PIVKA-II complementing AFP show promise in lessening this problem while also offering improved sensitivity and specificity for HCC detection.

This White Paper intends to facilitate concerted action among HCPs, patient advocacy groups, payers, and policy makers to reduce liver cancer incidence and mortality in APAC. It shares both holistic ecosystem and detailed human-centric insights as a starting point for change. Working with Key Opinion Leaders (KOLs) we provide tangible examples of active initiatives, and recommendations for taking the next steps.

Download or read the white paper below to find out more.

Stay tuned for interviews with select KOLs featured in the white paper, as they share about their insights and learning points on the initiatives piloted in their country.

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Building modern hepatocellular carcinoma surveillance programmes: taking steps to address a leading cause of liver cancer death in Asia https://clinicalvalue.com/en-au/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ Wed, 23 Aug 2023 02:51:53 +0000 https://clinicalvalue.com/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program....

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Quick Summary

HCC is a leading cause of cancer mortality in Asia. Causes of HCC include viral hepatitis B and C infections, with recent increases in metabolic disorders, such as NAFLD, also playing a factor.

Early HCC interventions are highly effective and can lead to improved patient outcomes and survival. Therefore, HCC surveillance programs are pivotal in detecting HCC early and making the appropriate interventions.

In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs in Asia, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program:

  1. Include HCC surveillance in national program and strategic plans
    HCC surveillance programs should be fit into the national health strategy where appropriate, taking into account the local incidence and prevelance rates, and existing priorities and resources.
  2. Secure sustainable funding commitments
    Long-term resourcing and financing is key to making HCC survaillance programs successful. The current health financign system in the area, and ability to pay should be assessed, while exploring various funding methods such as centralised healthcare coverage or private insurance.
  3. Collect, analyse, and utilise data to inform program design
    The development of HCC surveillance program should be based on data, such as HCC epidemiology, patient outcomes, human and economic cost of HCC. These data should be collected and analysed.
  4. Adopt optimal technologies to advance HCC surveillance
    Technology can help to improve access to HCC surveillance programs, as well as improve patient outcomes by detecting HCC early. Some examples include: including additional biomarkers such as PIVKA-II, using biomarker based digital algorithms and diagnostic models, using more advanced imaging techniques, and adapting IT systems to support surveillance programs.
  5. Mobilise existing resources for HCC surveillance
    Tapping on exisiting resources to expand capacity for HCC care and surveillance., For example increasing the range of HCPs who can diagnose and manage HCC like primary and community HCPs, expanding private healthcare capacity in HCC care.
  6. Engage a broad spectrum of stakeholders to further surveillance goals
    Governmental decision-makers, physicians, patients and PAGs, payers and industry need to come together to drive implementation of a robust HCC surveillance programs that address needs of all stakeholders.
  7. Raise awareness and provide education on the need for HCC suveillance
    Raising the knowledge among the general population and HCPs on HCC and the importance of surveillance can improve uptake and compliance to surveillance programs.

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International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma https://clinicalvalue.com/en-au/international-liver-cancer-association-ilca-white-paper-on-biomarker-development-for-hepatocellular-carcinoma/ Tue, 14 Mar 2023 08:00:20 +0000 https://clinicalvalue.com/international-liver-cancer-association-ilca-white-paper-on-biomarker-development-for-hepatocellular-carcinoma/ This white paper, which was developed by a group of experts in biomarker development, provides a framework on best practices to design, execute, and interpret biomarker studies for risk stratification, early detection, diagnosis, prognostication, and treatment response assessment in HCC.

Singal AG, Hoshida Y, Pinato DJ, Marrero J, Nault JC, Paradis V, Tayob N, Sherman M, Lim YS, Feng Z, Lok AS, Rinaudo JA, Srivastava S, Llovet JM, Villanueva A...

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Quick Summary

ILCA logo

Biomarkers are biological molecules found in blood, other body fluids or tissues that can indicate a normal or abnormal process, condition, or disease. They play an important role in the clinical management of cancer patients by facilitating risk stratification, early detection, diagnosis, and prediction of prognosis or treatment response. In hepatocellular carcinoma (HCC), there is a need for better biomarkers to stratify patients at different stages of clinical management. Guidelines such as the Tumor Marker Utility Grading System (TMGUS) and the Reporting recommendations for tumor marker prognostic studies (REMARK) provide useful frameworks for biomarker development and validation in cancer. However, modifications may be required for specific clinical scenarios, such as risk stratification and treatment response assessment in HCC. To address these issues, the International Liver Cancer Association has assembled a group of experts on biomarker development to provide a framework on best practices for biomarker studies in HCC.

Authors: Amit G. Singal, Yujin Hoshida, David J. Pinato, Jorge Marrero, Jean-Charles Nault, Valerie Paradis, Nabihah Tayob, Morris Sherman, Young Suk Lim, Ziding Feng, Anna S. Lok, Jo Ann Rinaudo, Sudhir Srivastava, Josep Llovet, Augusto Villanueva

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APACMed White Paper – Strengthening Healthcare Systems Through the Critical Role of Diagnostics https://clinicalvalue.com/en-au/apacmed-white-paper-strengthening-healthcare-systems-through-the-critical-role-of-diagnostics/ Fri, 09 Dec 2022 05:03:16 +0000 https://clinicalvalue.com/apacmed-white-paper-strengthening-healthcare-systems-through-the-critical-role-of-diagnostics/ Diagnostic technologies are used across the entire patient journey of multiple disease states, and provide the tools to prevent, detect, and monitor the required interventions. Despite its important role, diagnostics have been historically under prioritized. Read how APACMed seeks to improve the value recognition of diagnostic solutions.
Hardesty CL, Sarno R, Pelou C, Teng G, Aslam B, Bourcet A, Nair AKR, Wang J, Lina Y, Wearne D, Panth A, Rua C, Ho R, Kumar SA, Freitas E, Charafi N, Tan V, Chen JS, Veigas V, Teo P...

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Quick Summary

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Diagnostic technologies are used across the entire patient journey of multiple disease states, and provide the tools to prevent, detect, and monitor the required interventions. Despite its important role, diagnostics have been historically under prioritized. In this white paper, read how APACMed seeks to improve the value recognition of diagnostic solutions.

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