SMC Evaluation Project The View From Industry Martin Coombes Government Affairs Manager, AstraZeneca ABPI Representative SMC Evaluation Reference Group

“The Pharmaceutical Industry is recognised as a key partner by SMC and have supported the development of a robust and transparent decision-making process.”

Life Science Message Scottish Medicines Consortium Work

SMC Evaluation Project Management Group: Paul Catchpole Reference Group: Martin Coombes, Jim Swift Andrew McGuigan ABPI Scotland: Andy Powrie-Smith SMC User Group Forum

SMC Evaluation Project Stakeholder engagement Medicines utilisation –Not recommended –Accepted for use/restricted use –SMC advice on unique treatment Evaluation of Budget Impact

Stakeholder Engagement Evolving process Industry seen as partner –Continue to increase communication SMC process well recognised, timely, straightforward Consistent advice, but varying NHS Board processes and application, which would benefit from greater transparency Reduce duplication – NICE/AWMSG More proactive patient involvement

Medicines Utilisation

Not recommended

Medicines Utilisation Not recommended –10 medicines remained not recommended 0.1% of the primary care spend 2005/6 –Not added to formulary –No means No

Medicines Utilisation Not recommended –Delay of SMC advice –Limited use relative to alternative treatments –No alternative licensed products –Influence of pharmaceutical industry marketing strategy –Variation in advice issued by national bodies –Lack of engagement of relevant clinical experts in early stages of SMC

Medicines Utilisation Accepted

Medicines Utilisation Accepted/Restricted Use –Data limitations –‘Where alternative treatments already exist, implementation of advice is subject to local NHS Board decision making’ –Acceptable variation? –Yes means Maybe

Unique Treatment Etanercept for psoriatic arthritis –HDL (2003) 60 –No clean and relevant dataset –No single Scottish centre to collate data –Issues around local organisation structure

Budget Impact Variable –Actual vs Budget Impact From +£3.2m to -£11.9m –Multiple issues Derivation unclear, Trial drop-out rates, ‘Restricted Use’, lack of uptake –Compare actual uptake vs BI Between NHS Boards Other countries Forward LookSMC Budget Impact

Key Conclusions Evolving and improving Engagement –More Pt group contact & Industry communication –Need greater understanding of local NHS Board processes To provide consistency, transparency and accessibility Medicines Utilisation –Data? Variation in uptake? –When does yes mean yes? –Regular monitoring of uptake (compare with other countries) Budget Impact –Robust –Actual vs Budget Impact

R & D