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Patient Interest Seminar 21Patient Interest Seminar 21stst May May
Dr. Andrew PowerDr. Andrew Power
Vice Chair Vice Chair
New Drugs Sub groupNew Drugs Sub group
ObjectivesObjectives
SMC processesSMC processes NDC & SMCNDC & SMC
Health Board Formulary processes Health Board Formulary processes QALY tablesQALY tables
Scottish Medicines Consortium
SMC – multidisciplinary (30)SMC – multidisciplinary (30) Physicians, pharmacists, health economistsPhysicians, pharmacists, health economists NHS executives/finance managersNHS executives/finance managers Pharmaceutical industry nominees (ABPI)Pharmaceutical industry nominees (ABPI) Public partners (3)Public partners (3) PR, Scottish Government representativesPR, Scottish Government representatives
NDC - clinical/scientific (15)NDC - clinical/scientific (15) Physicians, pharmacists, nurse, health economists, Physicians, pharmacists, nurse, health economists,
academics, industry nomineesacademics, industry nominees Including Pharmacy Assessment Team and Health Including Pharmacy Assessment Team and Health
Economics TeamEconomics Team
CompositionComposition
Safety, quality and efficacy…
SMC RemitSMC Remit
National consortium of representatives of local drug and National consortium of representatives of local drug and therapeutic committeestherapeutic committees
Provide advice to NHS Boards on:Provide advice to NHS Boards on: New medicinesNew medicines New formulations of older medicinesNew formulations of older medicines Major new indicationsMajor new indications
Assess the need and clinical effectiveness including Assess the need and clinical effectiveness including comparative efficacycomparative efficacy
Assess the comparative cost-effectivenessAssess the comparative cost-effectiveness DO NOT assess safetyDO NOT assess safety
Assessment processAssessment process
Scottish Medicines Consortium
Submission of new product assessment form
Economic Assessors
Assessment review
Assessment team
New Drugs Committee
Final SMC detailed advice document
Applicant company
Patient interest group submission Scottish Medicines Consortium NDC detailed advice
Assessment & draft detailed advice document
Clinical Assessors
Company comments to SMC
NHS Boards
Area Drug & Therapeutic Committees
Applicant Company
Advice made public
8 weeks
6 weeks: NDC – last Tues/month; SMC – first Tues/month 4 weeks
Competitor Company
Scottish Medicines ConsortiumScottish Medicines Consortium
Produce a Detailed Advice Produce a Detailed Advice Document (DAD)Document (DAD)
SMC may:SMC may: Accept medicine for use in Accept medicine for use in
NHS ScotlandNHS Scotland Accepted for use in NHS Accepted for use in NHS
Scotland (with restrictions)Scotland (with restrictions) Not recommend for use in Not recommend for use in
NHS ScotlandNHS Scotland All advice can be found on All advice can be found on
the SMC website: the SMC website: www.scottishmedicines.org.uk
Count and annual share of SMC Count and annual share of SMC decisions, (excluding abbreviated and decisions, (excluding abbreviated and
non-submissions)non-submissions)
QALYsQALYs
They are based on the number of years of They are based on the number of years of life that would be added by the intervention. life that would be added by the intervention. Each year in perfect health is assigned the Each year in perfect health is assigned the value of 1.0 down to a value of 0 for death. value of 1.0 down to a value of 0 for death.
If the extra years would not be lived in full If the extra years would not be lived in full health, for example if the patient would lose a health, for example if the patient would lose a limb, or be blind or be confined to a limb, or be blind or be confined to a wheelchair, then the extra life-years are wheelchair, then the extra life-years are given a value between 0 and 1 to account for given a value between 0 and 1 to account for this. this.
Cost-Effectiveness vs. Cost-Effectiveness vs. EffectivenessEffectiveness
DRUG BDRUG B
96% Cure Rate96% Cure Rate
£10 / patient£10 / patient
DRUG ADRUG A
90% Cure Rate90% Cure Rate
£1 / patient£1 / patient
With thanks to Dr. Andrew Walker, University of Glasgow
Cost-Effectiveness vs. Cost-Effectiveness vs. EffectivenessEffectiveness
DRUG BDRUG B
96% Cure Rate96% Cure Rate
£10 / patient£10 / patient
96 cures / £100096 cures / £1000
DRUG ADRUG A
90% Cure Rate90% Cure Rate
£1 / patient£1 / patient
900 cures / 900 cures / £1000£1000
£270Stop smoking advice
£40k to £600kMS treatment
£12600CABG
£5000Heart transplant
£750Hip replacement
Cost per QALYIntervention
Post SMC: local formulary processPost SMC: local formulary process
New medicine / indication / formulation released onto market
SMC review medicine
SMC accept for use in NHS Scotland SMC 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?What is a formulary? Generally, a list of medicine which the vast majority of prescribing Generally, a list of medicine which the vast majority of prescribing
should come fromshould come from May be a simple listMay be a simple list May include additional information and guidanceMay include additional information and guidance
Can be applicable from anything from a single practice, to health Can be applicable from anything from a single practice, to health board to country (e.g. BNF)board to country (e.g. BNF)
Formulary Management is the term given all processes linked to the Formulary Management is the term given all processes linked to the Formulary including production, review and measurement of Formulary including production, review and measurement of adherenceadherence
Why produce a Formulary?Why produce a Formulary? Promote cost-Promote cost-
effective drug useeffective drug use Maximise given Maximise given
resourcesresources Limited resourcesLimited resources Increasing pressuresIncreasing pressures
Minimise riskMinimise risk Maximise Maximise
procurementprocurement
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.
ADTCADTC
ADTC consider SMC advice for local ADTC consider SMC advice for local implementationimplementation Consider local needs of the populationConsider local needs of the population Opinions of relevant local clinicians and groupsOpinions of relevant local clinicians and groups Consider what is on Formulary alreadyConsider what is on Formulary already
Generally, approximately 85% of medicines Generally, approximately 85% of medicines accepted by SMC will be added to the Formularyaccepted by SMC will be added to the Formulary
Formulary adherence (GGC)Formulary adherence (GGC)
The Preferred List is a subset of about 350 medicines covering The Preferred List is a subset of about 350 medicines covering conditions managed in Primary Careconditions managed in Primary Care
Current average adherence for the year is 74%Current average adherence for the year is 74% Adherence to the full formulary is unknown, but estimated at >90%Adherence to the full formulary is unknown, but estimated at >90%
0%
20%
40%
60%
80%
100%
120%
Q2 2007-08 Q3 2007-08 Q4 2007-08 Q1 2008-09
ObjectivesObjectives
SMC processesSMC processes NDC & SMCNDC & SMC
Health Board Formulary processes Health Board Formulary processes QALY tablesQALY tables
