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Current Challenges and Future Developments in HTA in the UK. Frances Macdonald, 23 rd September 2008 (A personal, Industry View). Agenda. Office of Health Economics (OHE) review of SMC Decisions : 2002 - 2008 Pharmaceutical Price Regulation Scheme. SMC Decisions – OHE Project. AIMs
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Current Challenges and Future Developments in HTA in the UK Frances Macdonald, 23rd September 2008 (A personal, Industry View)
Agenda • Office of Health Economics (OHE) review of SMC Decisions : 2002 - 2008 • Pharmaceutical Price Regulation Scheme
SMC Decisions – OHE Project AIMs • Overview of the trend in SMC decisions, over time • In-depth analysis of the restricted decisions (normally counted as accepted)
All SMC submissions by submission type* * ‘2008’ includes only the fist six months (January-June)
Count and annual share of SMC decisions (excluding abbreviated submissions)
Count and annual share of SMC decisions, (excluding abbreviated and non-submissions)
Conclusions • Excl. abbreviated submissions, the rate of ‘Not recommended’ (NR) increased from 26- 38% (2002-2005) to approx 50% in 2006-7 • Explanation? • Excl. non-submission, the proportion of NR decisions stabilises and appears to be decreasing from the 2006 peak • The proportion of non-submissions has grown, from 8% of decisions (excl. Abbrev. Subs) in 2006 to 29% in the first half of 2008. • If the ‘yes-equivalent’ decisions are counted as ‘yes’ decisions, the overall trend for ‘acceptance’ has not changed significantly over recent years, averaging 37% of all decisions during the period 2005 to H1 2008. (excl. abbreviated submissions and non-submissions) • Further work is needed to fully understand the trends eg • Analysis of resubmissions • Implications of incr. restricted submissions/approvals
PPRS- a significant factor now and future • Pharmaceutical Price Regulation Scheme • Covers all 4 Nations, to a large extent • Currently under renegotiation, to be effective from January 2009
Principle Objectives of the PPRS Government and Industry agree on the following aims: • Deliver value for money • Encourage and Reward Innovation • Assist the Uptake of new Medicines • Provide Stability, sustainability and predictability Details still under discussion SMC has a role in 3, possibly 4, of these aims Ultimate aims – to ensure availability of cost-effective medicines to patients - to supportive innovation, uptake and competition Price cut on medicines likely from January 2009
Assessing ‘Value’ in HTA • Health Select Committee recommended that NICE take into account a wider definition of ‘value’. • What does this mean, and how can it be measured systematically? • Cost per QALY – doesn’t address everything • What are societal preferences on ‘value’? • Rarity? Severity of disease?…. • How to assess the value of long-term benefits to the NHS? • Value of Innovation, where this adds demonstrable benefits? • How broad should the perspective be eg NHS costs only or carer costs? • What would happen to the ‘threshold’ if any such changes made?
Uptake of Innovation • Innovation is only sustainable if there is uptake • HTA is only of benefit if CE medicines are subsequently available, equitably & in good time • So……… • England – DH is investigating options to ensure HTA recommendations are implemented, and access is faster – to be written into new PPRS • Scotland – the Evaluation project is already underway • Some of the challenges: • Ascertaining when variation is acceptable, and when not • Quality of the data sources, although perfection not required
Supporting Uptake • Single UK horizon scanning tool by end 2009 • Will support consistent forward planning and budget planning • Market Access Schemes are being discussed for potential inclusion within the new PPRS • This aspect of the PPRS is relevant to England and Wales…but…. • Scottish Government has already expressed interest in evaluating such options • Ideal opportunity for Scotland to embrace such schemes for the benefit of Scottish patients
Early Assessment of new Medicines is a Challenge • The SMC assesses all new products and indications close to launch, and NICE is moving in the same direction ..understandable need, but…… • By definition, at this point uncertainty is high and all the answers don’t exist • It increases the risk that a medicine may be assessed as not CE, due to uncertainty, and thus ‘not recommended’ • Result - increased pressure from all sides to consider Market Access Schemes for high need products
Market Access Schemes • May be considered where a medicine might otherwise be evaluated as not cost-effective….and medical need is high eg • Financial – eg total cost capped • Clinical – eg outcome guarantee • Challenges exist eg • Suitable database to evaluate outcomes • Suitable standardisation to allow evaluation ………but… • Some schemes are relatively simple • The potential value to patients is considerable • Post-code variability can be targeted and reduced
Summary • HTA methods are constantly developing – current focus is on assessing ‘value’ • The Scottish Evaluation project and the PPRS both indicate that there is a significant shift beyond HTA methods , to the next decision points in the chain, eg to supporting timely & equitable uptake of cost-effective (and valued) medicines ….. • Scottish patients will benefit