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 ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →