The impact of health technology made simple...

...from the implications of new medical procedures, technologies and policies...

...to measuring their impact on current clinical practices...

...through close collaboration with health care professionals, researchers, and regulators.

Vital Transformation is a small, unique consultancy focused on addressing the challenges of today’s modern healthcare system. We partner with your organisation to help you find answers to hard to solve problems.

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  • Market Research and Access

  • Horizon Scanning

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  • Communications

Contact us to learn how Vital Transformation can help your organisation.

LATEST RESEARCH

Are CAR-T therapies living up to their hype? A study using real-world data in two cohorts to determine how well they are actually working in practice compared with bone marrow transplants

18th July 2019

With the increasing demands being placed on HTAs in Europe, a methodology allowing for a valid assessment of the clinical effectiveness and costs for indications targeting small patient populations and orphan conditions, such as ALL, at the time of a reimbursement decision is vital. This is particularly true when the costs of these interventions are significantly high, such as in the case of CAR-T, where costs exceed US$375 000. By extracting RWD from live hospital EHRs, we were able to demonstrate a novel methodology that allows us to move beyond the use of proxies for clinical effectiveness measures extrapolated from clinical trials to obtain an assessment of the long-term outcomes and total costs of new therapies, such as CAR-T, compared with the next-best legacy treatment option.

LATEST COMMUNICATIONS

Our Communication Services

EVENT: Making Real World Data Real – New RWE Methodologies for HTAs

4 October, 12.00-13.30 CET,
EHFG 2019 Kursaal C, Gastein, Austria

With the increasing use of accelerated regulatory tools like the Food and Drug Administration’s breakthrough designation, there are mounting challenges for European health technology assessors (HTAs) to make an accurate assessment of the long- term value and performance of many new therapies. Data presented in evidence is often extrapolated from outcomes six months or less, and what’s good enough for regulatory approval often doesn’t meet the needs for comparative effectiveness, value, and outcomes measures for HTAs. Vital Transformation’s recent BMJ publication demonstrates a novel, practical approach to harnessing electronic health records and RWE to help solve this problem. However, access to robust deidentified patient records in Europe is key.

Topics covered:

  1. RWE used in comparative effectiveness
  2. GDPR and its impact on deidentified patient-level data access
  3. HTA needs for new RWE methodologies
  4. H2020 programmes that can help meet the RWE gaps in the EU

Find all our communication projects on Better Science, Better Health

MORE RESEARCH

Making Real World Data Real – New RWE Methodologies for HTAs

With the increasing use of accelerated regulatory tools like the Food and Drug Administration’s breakthrough designation, there are mounting challenges for European health technology assessors (HTAs) to make an accurate assessment of the long- term value and performance of many new therapies. Data presented in evidence is often extrapolated from outcomes six months or less, and what’s good enough for regulatory approval often doesn’t meet the needs for comparative effectiveness, value, and outcomes measures for HTAs. Vital Transformation’s recent BMJ publication demonstrates a novel, practical approach to harnessing electronic health records and RWE to help solve this problem. However, access to robust deidentified patient records in Europe is key.

Webinar: RWE, CAR-T and Cancer – New Methods for Comparative Effectiveness

August 29th, 1-2 pm CET With the increasing use of new regulatory tools, like the FDA’s breakthrough therapy designation, there are increasing demands for European health technology assessors (HTAs) to make an accurate assessment of the long-term value and performance of CAR-T therapies from smaller datasets and shorter outcomes. This webinar will highlight our recent publication in the BMJ, sponsored by ZIN, which showcases a novel approach to harnessing RWE and develops a longitudinal data set that can be used for effectiveness measures, even in orphan conditions.

Azar’s Plan To Tie U.S. Drug Prices To Foreign Ones Will Impact Investments In R&D

Photographer: Al Drago/Bloomberg © 2019 BLOOMBERG FINANCE LP Publish date: June 21, 2019 By John LaMattina, Contributor for Forbes Azar claims that HHS can reduce spending on Medicare Part B drugs with little impact on biopharmaceutical R&D investment. Duane Schulthess, Managing Director at VitalTransformation, questioned Azar’s claim on this. As he delved into specific compounds on Azar’s list of 27, he found some startling data. One striking case is with Biogen’s Multiple Sclerosis drug, Tysabri.

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