Blog
RSS FeedPosted by Michael Wonder on 07 Nov 2022
Can we use existing guidance to support the development of robust real world evidence for health technology assessment/payer decision-making?
2 November 2022 - Advances in the digitisation of health systems and expedited regulatory approvals of innovative treatments have led to ...
Posted by Michael Wonder on 22 Oct 2022
Patient centred health technology assessment: a perspective on engagement in health technology assessment by three patient organisations and a health technology assessment body
20 October 2022 - Patient engagement in health technology assessment has become increasingly important over the past 20 years. ...
Posted by Michael Wonder on 14 Sep 2022
Has there actually been early resolution for early resolution resubmissions?
15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look ...
Posted by Michael Wonder on 08 Sep 2022
Large scale population based surveys linked to administrative health databases as a source of data on health utilities in Australia
8 September 2022 - It is ideal that modelling studies apply health utility values that are compatible, derived using common methods, ...
Posted by Michael Wonder on 08 Sep 2022
Is IQWiG's 15% threshold universally applicable in assessing the clinical relevance of patient reported outcomes changes? An ISPOR Special Interest Group report.
8 September 2022 - To assess the clinical relevance of patient reported outcomes, a response threshold of ≥ 15% of the ...
Posted by Michael Wonder on 08 Sep 2022
Esketamine: NICE’s appraisal was unfair, appeal panel rules
8 September 2022 - The decision by the UK National Institute for Health and Care Excellence not to recommend esketamine ...
Posted by Michael Wonder on 07 Sep 2022
Doctors call for vaccine u-turn from PHARMAC after surge in preventable pneumococcal cases
8 September 2022 - When drug-buying agency PHARMAC switched to a cheaper vaccine covering fewer strains of potentially deadly pneumococcal ...
Posted by Michael Wonder on 07 Sep 2022
The FDA needs to be more flexible in assessing treatments for rare diseases, like the one that seemed to help my son
7 September 2022 - Every time I read about clinical trials testing possible treatments for rare diseases, I think of ...
Posted by Michael Wonder on 06 Sep 2022
ICR criticises NICE rejection of olaparib for advanced prostate cancer
6 September 2022 - The Institute of Cancer Research, London, has expressed disappointment that NICE has confirmed its decision not ...
Posted by Michael Wonder on 05 Sep 2022
PHARMAC releases its interim response following PHARMAC review
5 September 2022 - As part of its ongoing commitment to transparency, Te Pātaka Whaioranga – PHARMAC has today shared their ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
Posted by Michael Wonder on 18 Aug 2022
Stability of changes in health status: next step in comprehensively assessing patient reported outcomes
18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...
Posted by Michael Wonder on 17 Aug 2022
UK will not buy Evusheld owing to “insufficient data” on protection, Government says
15 August 2022 - The UK Government has said that it will not procure the COVID-19 drug Evusheld—a combination of ...
Posted by Michael Wonder on 11 Jul 2022
The (harsh) reality of real-world data external comparators for health technology assessment
8 July 2022 - We read with great interest the recently published article by Patel et al. and commend the authors ...
Posted by Michael Wonder on 30 Jun 2022
From FDA to MHRA: are drug regulators for hire?
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...