Disagreement on cancer drug decisions in Europe

Maynou, Laia; Cairns, John

doi:10.1017/s026646232000032x

Cited by 3 publications

(3 citation statements)

References 22 publications

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“…In our study, there was disagreement between SMC and NICE on recommendation or non-recommendation for a minority of technologies (12.6%). This is consistent with previous work that has shown a high degree of agreement between SMC and NICE for cancer therapies compared to other European countries [ 18 , 19 ]. We found that NICE published faster guidance for solid organ therapies but not haematological malignancy therapies than SMC, although the reasons for this are unclear.…”

Section: Discussionsupporting

confidence: 93%

Appraisal of Novel Oncological Therapies by the Scottish Medicines Consortium and the National Institute for Health and Care Excellence: A Comparative Study of Six Years of Data

Taylor

2023

Cureus

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Background and aims Pharmacoeconomic assessment of novel oncological therapies is an increasingly important factor in determining patient access to therapies. Organisations such as the National Institute for Health and Care Excellence (NICE) in England and the Scottish Medicines Consortium (SMC) in Scotland assess medications for their cost-effectiveness through health technology assessments (HTA) and provide guidance on whether the public health service should fund a therapy. We assessed six years of data to determine if there were any differences in timescales and decisions between NICE and SMC for new oncological therapies. Methods and results Time (days) from marketing authorisation (MA) to publication of final HTA guidance was calculated for single technology appraisals published by NICE and SMC between January 1, 2017, and December 31, 2022, for oncological therapies. We assessed 161 HTAs by NICE and 148 HTAs by SMC published in the study period. The median time from MA to publication of HTA guidance was 291 days (IQR 222-406) for SMC and 257 days (IQR 167-448) for NICE (p=0.054). For solid organ cancer therapies, NICE was significantly faster in publishing guidance, with a median of 231.5 days (IQR 148-392.25), compared to SMC, which took 273 days (IQR 202-378) (p=0.039). Overall recommendation of technologies was similar between the SMC and NICE (90.5% and 89.4%, respectively), with discordance in a minority of cases (12.6%). Conclusions Recommendation rates for single HTAs are similar between NICE and SMC for oncological therapies with discordance in a minority of cases. The time from MA to publication of HTA guidance was similar overall, but NICE was faster in publishing HTA guidance for solid organ cancer indications. Differences in methodology and process between the two organisations, in particular the presence of the Cancer Drugs Fund in England, may explain this difference in publication times.

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Section: Discussionsupporting

confidence: 93%

Appraisal of Novel Oncological Therapies by the Scottish Medicines Consortium and the National Institute for Health and Care Excellence: A Comparative Study of Six Years of Data

Taylor

2023

Cureus

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“…Our results are also in line with those of another article ( 55 ), which compares the agreement of cancer drug reimbursement decisions in nine European countries. Although there is no comparison between France and Italy (Italy is not among the selected countries), this study reported a medium agreement among decisions adopted from 2002 to 2014 by Belgium, Germany, France, Spain, Sweden, Portugal, Poland, England, and Scotland.…”

Section: Discussionsupporting

confidence: 92%

“…Although there is no comparison between France and Italy (Italy is not among the selected countries), this study reported a medium agreement among decisions adopted from 2002 to 2014 by Belgium, Germany, France, Spain, Sweden, Portugal, Poland, England, and Scotland. The adopted methodology is similar, being based on the Cohen's kappa ( 55 ). In addition, our analysis investigated partial agreement, considered a more recent timeframe (July 2017–September 2021), and is not limited to cancer drugs.…”

Section: Discussionmentioning

confidence: 99%

Value assessment of medicinal products by the Italian Medicines Agency (AIFA) and French National Authority for Health (HAS): Similarities and discrepancies

Xoxi

Bidino

Leone³

et al. 2022

Front. Med. Technol.

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The evaluation of pharmaceutical innovation and therapeutic value is an increasingly complex exercise for which different approaches are adopted at the national level, despite the need for standardisation of processes and harmonisation of public health decisions. The objective of our analysis was to compare the approaches of the AIFA (Agenzia Italiana del Farmaco) and the HAS (Haute Autorité de Santé) in assessing the same medicinal products. In Italy, the 1525/2017 AIFA Deliberation introduces a transparent scheme for the evaluation of innovative status (innovative, conditional, not innovative) based on the therapeutic added value (TAV), therapeutic need, and quality of evidence. In contrast, in France, the HAS makes judgements using the effective clinical benefit (Service Médical Rendu) and improvement of effective clinical benefit (Amélioration du Service Médical Rendu, ASMR). This analysis focused on medicinal products evaluated both by the AIFA and by the HAS from July 2017 to September 2021. Similarities between AIFA and HAS evaluations were investigated in terms of the TAV, recognition of innovativeness, and the ASMR. Both total and partial agreements were considered relevant. Therefore, raw agreement, Cohen's kappa (weighted and unweighted), and Bangdiwala's B-statistic were estimated. A total of 102 medicinal products were included in this study. Out of these, 38 (37.2%) were orphan drugs, while 56 (54.9%) had a clinical indication for the treatment of cancer. The AIFA and HAS reached a higher level of agreement on the innovativeness status compared with the TAV. A moderate total agreement emerged in the recognition of innovativeness (k = 0.463, p-value ≤0.0001), and partial agreement was substantial (equal weight k = 0.547, squared k = 0.638), while a lack of agreement resulted in a comparison of the TAV according to the AIFA and the ASMR recognised by the HAS. Indeed, whereas the AIFA determined the TAV to be important, the HAS considered it to be moderate. In addition, whereas the AIFA identified a bias towards a moderate TAV, the HAS identified a bias towards a minor ASMR. A higher level of agreement was reached, both on the TAV and on innovative status, for less critical medical products (non-cancer-related, or non-orphan, or with a standard European Medicines Agency approval). These results underline the importance of implementing European procedures that are more broadly aligned in terms of value definition criteria.

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Promoting innovation while controlling cost: The UK's approach to health technology assessment

et al. 2022

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Disagreement on cancer drug decisions in Europe

Cited by 3 publications

References 22 publications

Appraisal of Novel Oncological Therapies by the Scottish Medicines Consortium and the National Institute for Health and Care Excellence: A Comparative Study of Six Years of Data

Appraisal of Novel Oncological Therapies by the Scottish Medicines Consortium and the National Institute for Health and Care Excellence: A Comparative Study of Six Years of Data

Value assessment of medicinal products by the Italian Medicines Agency (AIFA) and French National Authority for Health (HAS): Similarities and discrepancies

Promoting innovation while controlling cost: The UK's approach to health technology assessment

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