NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium

Ford, John; Waugh, Norman; Sharma, Pawana; Sculpher, Mark; Walker, Andrew

doi:10.1136/bmjopen-2011-000671

Cited by 18 publications

(20 citation statements)

References 13 publications

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“…Focusing on how they perform in practice and how much it costs for one additional quality adjusted life year. Similar organisations exist in both Scotland (Scottish Medicines Consortium, SMC) [76] and Wales (All Wales Medicines Strategy Group, AWMSG) [77].…”

Section: Box 2: United Kingdommentioning

confidence: 99%

Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review

et al. 2015

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Pharmaceutical expenditure has increased rapidly across many OECD countries over the past three decades. This growth is an increasing concern for Governments and other third party payers seeking to provide equitable and comprehensive healthcare within sustainable budgets. In order to create headroom for increasing utilisation, and to fund new high cost therapies there is an active push to 'disinvest' from low-value drugs. The aim of this article is to review how reimbursement policy decision makers have sought to partially or completely disinvest from drugs in a range of OECD countries (UK, France, Canada, Australia and New Zealand) where they are publicly funded or subsidised. We employed a systematic literature search strategy and the incorporation of grey literature known to the authorship team. We canvass key policy instruments from each country to outline: key approaches to the identification of candidate drugs for disinvestment assessment (passive approaches versus more active approaches); Methods of disinvestment and value-based purchasing:de-listing, restricting treatment, price or reimbursement rate reductions, encouraging generic prescribing; Lessons learnt from the various approaches; The potential role of coverage with evidence development, and; The need for careful stakeholder management. Dedicated sections are provided with detailed coverage of policy approaches (with drug examples) from each country. Historically countries have relied on 'passive disinvestment', however due to (i) the availability of new costeffectiveness evidence or (ii) 'leakage' in drug utilisation or (iii) market failure in terms of price competition, there is an increasing focus towards 'active disinvestment'. Isolating low-value drugs that would create headroom for innovative new products to enter the market is also motivating disinvestment efforts by multiple parties, including industry. Historically disinvestment has mainly taken the form of price reductions, especially when market failures are perceived to exist, and restricting treatment to sub-populations, particularly when a drug is no longer considered value for money. There is considerable experimentation internationally in mechanisms for disinvestment and the opportunity for countries to learn from each other. Ongoing evaluation of disinvestment strategies is essential, and ought to be reported in the peer-reviewed literature.

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Section: Box 2: United Kingdommentioning

confidence: 99%

Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review

et al. 2015

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“…However, an exception is the processing times for guidance on cancer drugs. Mason et al [20] and Ford et al [24] reported that for cancer drugs the STA process had not shortened the timelines. Casson et al [25] obtained similar findings; the group suggested that STAs of cancer-related technologies were slower to complete compared with non-cancer technologies, and that the difference was no longer significant when adjustments were made for other variables, including appeals.…”

Section: Discussionmentioning

confidence: 98%

“…Casson et al [25] obtained similar findings; the group suggested that STAs of cancer-related technologies were slower to complete compared with non-cancer technologies, and that the difference was no longer significant when adjustments were made for other variables, including appeals. Other possible explanations for the longer wait time for cancer drugs are that they are more expensive and that there is limited evidence at the time of their appraisal; Ford et al [24] considered that limited evidence at the time of appraisal generated delays when there were attempts to identify subgroups and stop/start rules for additional analysis. The use of independent evaluation groups was part of a broader strategy of encouraging independence and transparency in NICE's activities.…”

Section: Discussionmentioning

confidence: 98%

Differences in cancer drug assessment between Spain and the United Kingdom

Blázquez

Dickson

Fraga-Fuentes

et al. 2015

European Journal of Cancer

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“…In their study comparing the NICE STA process with the Scottish Medicines Consortium process, Ford et al 3 found that, overall, the STA process reduced the average time to publication compared with NICE MTAs (median 16.1 months compared with 22.8 months). However, for cancer medications, the STA process took longer than the MTA process (25.2 months compared with 20.0 months).…”

Section: Historical Perspectivementioning

confidence: 99%

The use of exploratory analyses within the National Institute for Health and Care Excellence single technology appraisal process: an evaluation and qualitative analysis

Kaltenthaler

Hill‐McManus

Scope

et al. 2016

Health Technol Assess

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BackgroundAs part of the National Institute for Health and Care Excellence (NICE) single technology appraisal (STA) process, independent Evidence Review Groups (ERGs) critically appraise the company submission. During the critical appraisal process the ERG may undertake analyses to explore uncertainties around the company’s model and their implications for decision-making. The ERG reports are a central component of the evidence considered by the NICE Technology Appraisal Committees (ACs) in their deliberations.ObjectiveThe aim of this research was to develop an understanding of the number and type of exploratory analyses undertaken by the ERGs within the STA process and to understand how these analyses are used by the NICE ACs in their decision-making.MethodsThe 100 most recently completed STAs with published guidance were selected for inclusion in the analysis. The documents considered were ERG reports, clarification letters, the first appraisal consultation document and the final appraisal determination. Over 400 documents were assessed in this study. The categories of types of exploratory analyses included fixing errors, fixing violations, addressing matters of judgement and the ERG-preferred base case. A content analysis of documents (documentary analysis) was undertaken to identify and extract relevant data, and narrative synthesis was then used to rationalise and present these data.ResultsThe level and type of detail in ERG reports and clarification letters varied considerably. The vast majority (93%) of ERG reports reported one or more exploratory analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category ‘matters of judgement’, which was reported in 83 (89%) reports. The category ‘ERG base-case/preferred analysis’ was reported in 45 (48%) reports, the category ‘fixing errors’ was reported in 33 (35%) reports and the category ‘fixing violations’ was reported in 17 (18%) reports. The exploratory analyses performed were the result of issues raised by an ERG in its critique of the submitted economic evidence. These analyses had more influence on recommendations earlier in the STA process than later on in the process.LimitationsThe descriptions of analyses undertaken were often highly specific to a particular STA and could be inconsistent across ERG reports and thus difficult to interpret.ConclusionsEvidence Review Groups frequently conduct exploratory analyses to test or improve the economic evaluations submitted by companies as part of the STA process. ERG exploratory analyses often have an influence on the recommendations produced by the ACs.Future workMore in-depth analysis is needed to understand how ERGs make decisions regarding which exploratory analyses should be undertaken. More research is also needed to fully understand which types of exploratory analyses are most useful to ACs in their decision-making.FundingThe National Institute for Health Research Health Technology Assessment programme.

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NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium

Cited by 18 publications

References 13 publications

Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review

Disinvestment and Value-Based Purchasing Strategies for Pharmaceuticals: An International Review

Differences in cancer drug assessment between Spain and the United Kingdom

The use of exploratory analyses within the National Institute for Health and Care Excellence single technology appraisal process: an evaluation and qualitative analysis

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