Patient Interest Seminar 21 st May Dr. Andrew Power Vice Chair New Drugs Sub group

Objectives  SMC processes NDC & SMC NDC & SMC  Health Board Formulary processes  QALY tables

Scottish Medicines Consortium

SMC – multidisciplinary (30)  Physicians, pharmacists, health economists  NHS executives/finance managers  Pharmaceutical industry nominees (ABPI)  Public partners (3)  PR, Scottish Government representatives NDC - clinical/scientific (15)  Physicians, pharmacists, nurse, health economists, academics, industry nominees  Including Pharmacy Assessment Team and Health Economics Team Composition

Safety, quality and efficacy…

SMC Remit  National consortium of representatives of local drug and therapeutic committees  Provide advice to NHS Boards on: New medicines New medicines New formulations of older medicines New formulations of older medicines Major new indications Major new indications  Assess the need and clinical effectiveness including comparative efficacy  Assess the comparative cost-effectiveness  DO NOT assess safety

Assessment process

Scottish Medicines Consortium  Produce a Detailed Advice Document (DAD)  SMC may: Accept medicine for use in NHS Scotland Accept medicine for use in NHS Scotland Accepted for use in NHS Scotland (with restrictions) Accepted for use in NHS Scotland (with restrictions) Not recommend for use in NHS Scotland Not recommend for use in NHS Scotland  All advice can be found on the SMC website: uk uk uk

Count and annual share of SMC decisions, (excluding abbreviated and non-submissions)

QALYs  They are based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0 for death.  If the extra years would not be lived in full health, for example if the patient would lose a limb, or be blind or be confined to a wheelchair, then the extra life-years are given a value between 0 and 1 to account for this.

Cost-Effectiveness vs. Effectiveness  DRUG B  96% Cure Rate  £10 / patient  DRUG A  90% Cure Rate  £1 / patient With thanks to Dr. Andrew Walker, University of Glasgow

Cost-Effectiveness vs. Effectiveness  DRUG B  96% Cure Rate  £10 / patient  96 cures / £1000  DRUG A  90% Cure Rate  £1 / patient  900 cures / £1000

£270Stop smoking advice £40k to £600kMS treatment £12600CABG £5000Heart transplant £750Hip replacement Cost per QALYIntervention

Post SMC: local formulary process New medicine / indication / formulation released onto market SMC review medicine SMC accept for use in NHS ScotlandSMC do not accept for use in NHS Scotland Medicine cannot be considered for addition to the GGC Formulary Manufacturer can make a re-submission to SMC Formulary and New Drugs Sub-committee (FND) consider medicine and make recommendation Accepted for addition to Formulary (restrictions may apply) Rejected for addition to the Formulary Area Drug and Therapeutic Committee review FND recommendation Formulary Appeals Process

What is a formulary?  Generally, a list of medicine which the vast majority of prescribing should come from May be a simple list May be a simple list May include additional information and guidance May include additional information and guidance  Can be applicable from anything from a single practice, to health board to country (e.g. BNF)  Formulary Management is the term given all processes linked to the Formulary including production, review and measurement of adherence

Why produce a Formulary?  Promote cost- effective drug use  Maximise given resources Limited resources Limited resources Increasing pressures Increasing pressures  Minimise risk  Maximise procurement

Fact or Fiction?   Medicines not accepted by SMC can not be prescribed by GPs Fiction – GP in general should follow SMC advice, but in exceptional cases may prescribe ‘non-SMC’ medicines   In most health boards, GPs are able to appeal to have a medicine reconsidered for inclusion in the local formulary Fact – most health boards have an appeal process that GPs can access   GPs are independent contractors and do not have to stick to any agreed local formulary Fact with some fiction – GPs are independent contractors and can prescribe non-formulary medicines where they see fit, though they are requested to follow local formularies. However, it should be noted that GPs are contracted to an NHS health board and widespread prescribing of medicines not accepted by SMC or non-Formulary without good reason could be deemed as inappropriate prescribing which may be considered a breach of contract.

ADTC  ADTC consider SMC advice for local implementation Consider local needs of the population Consider local needs of the population Opinions of relevant local clinicians and groups Opinions of relevant local clinicians and groups Consider what is on Formulary already Consider what is on Formulary already  Generally, approximately 85% of medicines accepted by SMC will be added to the Formulary

Formulary adherence (GGC)  The Preferred List is a subset of about 350 medicines covering conditions managed in Primary Care  Current average adherence for the year is 74%  Adherence to the full formulary is unknown, but estimated at >90%

Objectives  SMC processes NDC & SMC NDC & SMC  Health Board Formulary processes  QALY tables