New Medicines in Wales: The All Wales Medicines Strategy Group (AWMSG) Appraisal Process and Outcomes

Varnava, Alice; Bracchi, Robert; Samuels, Karen; Hughes, Dyfrig; Routledge, Philip A.

doi:10.1007/s40273-018-0632-7

Cited by 14 publications

(23 citation statements)

References 16 publications

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“…In contrast, in Scotland and Wales we found higher proportion of positive HTA decisions (57.3% in Scotland, and 55.9% in Wales, which includes adoption of NICE decisions by AWMSG). An analysis of recommendations given by AWMSG between 2002 and 2014 reported a similar percentage of positive recommendations (59% for orphan medicines and 73% of ultra-orphan, as cited in [17]).…”

Section: Resultsmentioning

confidence: 68%

“…Since AWMSG adopts NICE decisions, a longer delay is observed in AWMSG than NICE decisions. Varnava et al [17] argue that the time-lag due to the manufacturer submitting first to NICE makes the AWMSG process appear longer when measured from marketing authorisation to recommendation. Germany has the shortest delay from the authorisation to the availability and access, taking into account that reimbursement decisions are automatic, with no delay from marketing authorisation.…”

Section: Discussionmentioning

confidence: 99%

“…HTA decisions by the SMC do not have mandatory funding but should be followed by NHS Boards and Area Drug and Therapeutic Committees (ADTCs) reimbursement decisions. Welsh Health boards have a legal requirement to implement NICE guidance and statutory funding directives apply with regards to NICE and AWMSG technology appraisals [17]. However, for the sake of clarity in the paper, we refer to all of these statutory funding decisions in the UK as OMPs being “reimbursed” while we exclude from reimbursement nominative prescriptions through Individual Funding Requests (IFR) in England and Wales and Individual Patient Treatment Requests (IPTR) in Scotland.…”

Section: Pricing and Reimbursement Policiesmentioning

confidence: 99%

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Comparing access to orphan medicinal products in Europe

Zamora

Maignen

O’Neill

et al. 2019

Orphanet J Rare Dis

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Objectives The primary objective of this study was to compare the availability and access of orphan medicinal products (OMPs) in the devolved nations in the United Kingdom (UK), France, Germany, Italy and Spain. Availability is defined as the possibility to prescribe OMPs. Access refers to their full or partial reimbursement by the public health service. Methods Data were collated on: marketing authorisations, Health Technology Assessment (HTA) decisions, commissioning, and reimbursement decisions, and respective dates of these events for all the OMPs centrally authorised. Indicators of availability of and access to OMPs were calculated in each country and compared. Results We found that since the implementation of the OMPs Regulation in 2000 to end of May 2016, 143 OMPs obtained a marketing authorisation in the European Union. These OMPs are most widely accessible in Germany and France. In the other countries between 30 and 60% of OMPs are reimbursed. In particular in England, less than 50% of centrally authorised OMPs are routinely funded by the NHS, with one-third of these recommended by NICE. In Germany reimbursement is automatically granted to all medicines which receive a marketing authorisation, immediately after authorisation – but since 2011, there is an evaluation and potentially a pricing negotiation between companies and sickness funds (third party payers). In the other countries, the shortest time from authorisation to a reimbursement decision is observed in Italy and France where it takes 18.6 and 19.5 months respectively on average. Conclusions Marketing authorisation granted to OMPs is only the first step, as medicines reach patients when reimbursement decisions are implemented by national health systems (this applies to non-OMPs too). We found that more than a half of centrally authorised OMPs were available in the five selected countries, but that access to patients was further restricted by different national reimbursement policies, especially in the UK, Italy and Spain. Electronic supplementary material The online version of this article (10.1186/s13023-019-1078-5) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Section: Pricing and Reimbursement Policiesmentioning

confidence: 99%

See 1 more Smart Citation

Comparing access to orphan medicinal products in Europe

Zamora

Maignen

O’Neill

et al. 2019

Orphanet J Rare Dis

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“…However, the possible opportunity cost (i.e. in a health system with limited resources introduction of a new medicine may mean that other benefits will be forgone) must also be taken into account [1]. The National Institute of Health and Care Excellence (NICE) provides recommendations based on the clinical and cost effectiveness of new medicines to the National Health Service (NHS) in England and Wales (UK).…”

Section: Introductionmentioning

confidence: 99%

Estimated Versus Observed Expenditure Associated with Medicines Recommended by the All Wales Medicines Strategy Group

Keeping

Deslandes

Haines

et al. 2019

PharmacoEconomics Open

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Objectives The All Wales Medicines Strategy Group (AWMSG) appraises the clinical and cost effectiveness of new medicines being considered for National Health Service (NHS) prescribing in Wales (UK). The aim of this study was to compare the estimated expenditure on selected medicines submitted by pharmaceutical companies for appraisal with the observed expenditure on these medicines following recommendation. Methods Medicines appraised and recommended for use in NHS Wales by AWMSG between May 2005 and December 2013 were identified for inclusion in the study. Estimates of expenditure were obtained from company submissions to AWMSG. Primary and secondary care dispensing databases were used to obtain observed expenditure. The Wilcoxon matched-pairs signed rank test was used to compare the observed and estimated expenditure in each of the 3 years after introduction of the medicine. Results Forty-nine medicines appraised and recommended by AWMSG during the period of interest were included in the study. Median estimated and observed expenditure in each of the 3 years post-recommendation were as follows: year 1 £86,400 and £47,300; year 2 £175,500 and £73,200; year 3 £212,100 and £78,900 ( p = 0.03, p = 0.006 and p = 0.001, respectively). The expenditure on 42 of the 49 medicines (82%) was overestimated in at least one of the 3 years post-introduction, with 32 (65%) overestimated in all 3 years. Conclusion In their applications for health technology appraisal, pharmaceutical companies tended to overestimate the expenditure of the majority of medicines recommended by AWMSG. These findings have implications for the assessment of predicted expenditure as part of the process of medicines appraisal in Wales.

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“…Other studies analysing the time to reimbursement of drugs have been carried out in various other jurisdictions. Some of these studies have focused on time to reimbursement of cancer drugs specifically, whereas others analysed the timelines of all submissions submitted over a certain time period [9][10][11][12][13][14]. However, the HTA framework and timelines vary greatly between countries.…”

Section: The Hta Processmentioning

confidence: 99%

Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines

Connolly

O'Donnell

Lamrock

et al. 2019

PharmacoEconomics Open

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Background The National Centre for Pharmacoeconomics (NCPE) is commissioned by the Corporate Pharmaceutical Unit of the Health Service Executive (HSE-CPU) to assess the evidence for the comparative effectiveness and cost effectiveness of drugs for use by patients in Ireland. All new drugs are required to undergo rapid review (RR) appraisal by the NCPE. Following this, high-cost drugs or those predicted to have a significant budget impact then undergo a full health technology assessment (HTA) appraisal by the NCPE. Objective The objective of this paper was to quantify each stage of the timeline from marketing authorisation (MA) to completion of HTA appraisal and explore the association between submission features and the time to appraise RRs and HTAs. Methods All RRs and HTAs submitted to the NCPE (2015-2017 inclusive) were included in the dataset. Several dates and features of each submission were also listed for the purpose of analysis. Results A total of 158 RR and 49 HTA appraisals were completed by the NCPE between 2015 and 2017. The median time from MA to submission of RR was 59 days; the median time to appraise RR was 31.5 days. Only 49% of RRs appraised (2015-2017 inclusive) were recommended for HTA. The median time from RR decision to submission of HTA was 115 days, and the median time taken by the NCPE to appraise an HTA was 131 days. Conclusion This paper identifies which stages of the process make a substantial contribution to the HTA timeline. Time to submission of RR varied widely between submissions, with only a few companies choosing to submit prior to an MA being granted. The average RR appraisal time was in line with the 4-week timeframe set out in a 2016 agreement. The time to appraise an HTA was longer than the 90-day timeframe.

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New Medicines in Wales: The All Wales Medicines Strategy Group (AWMSG) Appraisal Process and Outcomes

Cited by 14 publications

References 16 publications

Comparing access to orphan medicinal products in Europe

Comparing access to orphan medicinal products in Europe

Estimated Versus Observed Expenditure Associated with Medicines Recommended by the All Wales Medicines Strategy Group

Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines

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