Transcript From license to Formulary: the rocky path of a new drug

Patient Interest Seminar 21st May
Dr. Andrew Power
Vice Chair
New Drugs Sub group
Objectives
 SMC

processes
NDC & SMC
 Health
Board Formulary processes
 QALY tables
Scottish Medicines Consortium
Composition
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
Safety, quality and efficacy…
SMC Remit


National consortium of representatives of local drug and
therapeutic committees
Provide advice to NHS Boards on:




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New medicines
New formulations of older medicines
Major new indications
Assess the need and clinical effectiveness including
comparative efficacy
Assess the comparative cost-effectiveness
DO NOT assess safety
Assessment process
Submission of new product
assessment form
Scottish Medicines Consortium
Clinical Assessors
Assessment team
Economic Assessors
Assessment review
Assessment & draft detailed advice
document
New Drugs Committee
NDC detailed advice
Scottish Medicines Consortium
Applicant company
Final SMC detailed advice
document
Patient interest group submission
NHS Boards
Company comments to SMC
Area Drug & Therapeutic Committees
Applicant Company
8 weeks
6 weeks: NDC – last Tues/month; SMC –
first Tues/month
4 weeks
Competitor Company
Advice made public
Scottish Medicines Consortium


Produce a Detailed Advice
Document (DAD)
SMC may:




Accept medicine for use in
NHS Scotland
Accepted for use in NHS
Scotland (with restrictions)
Not recommend for use in NHS
Scotland
All advice can be found on
the SMC website:
www.scottishmedicines.org.
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
 90%
 £1
A
Cure Rate
/ patient
 DRUG
 96%
 £10
B
Cure Rate
/ patient
With thanks to Dr. Andrew Walker, University of Glasgow
Cost-Effectiveness vs.
Effectiveness
 DRUG
 90%
 £1
A
Cure Rate
/ patient
 900
cures /
£1000
 DRUG
 96%
 £10
 96
B
Cure Rate
/ patient
cures / £1000
Intervention
Cost per QALY
Stop smoking advice
£270
Hip replacement
£750
Heart transplant
£5000
CABG
£12600
MS treatment
£40k to £600k
Post 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
Formulary and New Drugs Sub-committee (FND)
consider medicine and make recommendation
Medicine cannot be considered for addition to
the GGC Formulary
Manufacturer can make a re-submission to SMC
Area Drug and Therapeutic Committee review
FND recommendation
Accepted for
addition to
Formulary
(restrictions may apply)
Rejected for
addition to the
Formulary
Formulary Appeals
Process
What is a formulary?

Generally, a list of medicine which the vast majority of prescribing
should come from


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May be a simple list
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 costeffective drug use
 Maximise given
resources



Limited resources
Increasing pressures
Minimise risk
 Maximise
procurement
Fact or Fiction?

Medicines not accepted by SMC can not be prescribed by GPs

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In most health boards, GPs are able to appeal to have a medicine reconsidered for
inclusion in the local formulary

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Fiction – GP in general should follow SMC advice, but in exceptional cases may prescribe
‘non-SMC’ medicines
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

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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


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Consider local needs of the population
Opinions of relevant local clinicians and groups
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%



120%
100%
80%
60%
40%
20%
10
.M
Q2 2007-08
Q3 2007-08
Q4 2007-08
Q1 2008-09
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Objectives
 SMC

processes
NDC & SMC
 Health
Board Formulary processes
 QALY tables