2. • To accept for use newly licensed medicines which clearly represent good
value for money to NHS Scotland
• Analyses information supplied by the medicine manufacturer on the
health benefits of the medicine and justification of its price
• Works to ensure that those medicines which represent good value for
money are accepted for use as quickly as possible so that patients can
benefit
• The Consortium is made up of lead clinicians, pharmacists and health
economists, together with representatives of NHS health boards, the
pharmaceutical industry and the public
The Role of SMC
3. Recent Changes…
• Scottish Parliament inquiry:
‘Access to New Medicines’ - July 2013
• Scottish Government response – October
2013:
– Existing cost-effectiveness thresholds are
not always appropriate for end of life
medicines or for medicines to treat very
rare diseases
– SMC directed to apply different
approaches in the evaluation of these
medicines in order to increase access
4. New Medicines Review Recommendations
• Meetings in Public – since May 2014
• New processes for end of life medicines and medicines for very rare
conditions – submissions from May 2014
– More flexible approach in evaluating these medicines
– PACE meetings – giving patient groups and clinicians a stronger voice
– Ultra-orphan Framework
• Pharmaceutical companies at SMC meetings – since Nov 2014
• Early engagement with companies – ongoing
• Strengthening of patient and public involvement – ongoing
5. 2014 – A New Approach to Public Involvement
1. New public involvement team
2. Full stakeholder review
3. Implementation plan to strengthen public involvement
6. About SMC Public Involvement
How do patient and carer experiences add to the review process?
Help SMC members fully understand the impact of a new medicine to patients and
carers
• What is it like to live with a condition?
• How well are patients managing with currently available medicines?
• What is the real quality of life impact of a new medicine?
• How would a medicine improve experience of care?
• What is the impact to carers and family members?
7. Public Partner Role
An integral part of the SMC Public Involvement Team.
• Full voting public member of SMC.
• Prepare presentations of Patient Group Submissions, and present them during SMC
committee meetings.
• Member of SMC Public Involvement Network (PIN) Advisory Group.
• Participate in Patient & Clinician Engagement (PACE) meetings.
9. Roll Out of New Registration System
• Promotes partnership approach
to working with patient groups
• Reduces need to provide duplicated
information
• Clear and transparent capturing
of pharmaceutical company funding
10.
11. Patient Group Partners
gathering evidence from the
people they represent and capture
it in in a Patient Group Submission
Form
SMC Meeting Papers
Each full submission form is
included in the SMC meeting
papers, which members receive
two weeks before the meeting.
Presentation
Public partner delivers
presentation during the
consideration of each medicine.
Public Partners
Collate submissions and write
presentation highlighting key
points.
12. Increase in Number of
Patient Group Submissions
Qr. 1 Qr. 2 Qr. 3 Qr. 4
0
10
20
30
40
Number of Patient Group Submissions
2015
2014
76% increase over two years
(96 in total in 2015)
13. 66% 78% 88%
34% 22% 12%
0
20
40
60
80
100
120
2014 2015 Jan/June
2016
No Patient Group
Submission
At least one
Patient Group
Submission
Appraisals Supported by a Patient Group Submission
Reduction in Number of Appraisals
with no Patient Group Submission
14. PACE (Patient and Clinician Engagement)
Additional step in SMC appraisal process for:
• End of life - a medicine used to treat a condition at a stage that usually leads
to death within 3 years with currently available treatments
• Orphan - a medicine with European Medicines Agency (EMA) designated
orphan status (conditions affecting fewer than 2,500 people in a population
of 5 million) or a medicine to treat an equivalent size of population
• Ultra-orphan - a medicine used to treat a condition with a prevalence of 1 in
50,000 or less (100 people or fewer in Scotland)
15. PACE in Practice
• PACE meeting held at the request of the submitting company
• Structured round table discussion between relevant clinical experts and
patient group representatives to produce consensus statement
• Focus on added value (esp. not already captured), such as:
– Family/carer impact
– Health benefits
– Manageable tolerability
– Psychological benefit
– Hope for the future
– Normality of life
– Opportunity for treatment choice
– Convenience
• PACE output has major impact on SMC decisions
17. Montgomery Government Review of
Access to New Medicines 2016
Key themes:
1. Data
What is it actually telling us and how do we interrogate it?
2. Access v benefit
Can it be demonstrated that improved access actively benefits patients.
3. PACE
The single biggest issue that people want to speak about when asked by the review.
The general feeling is that it is a good thing but not the finished article.
Report expected Autumn 2016
18. New Public Involvement Network (PIN)
Advisory Group
3 Public Partners, ADTC Collaborative Member, SMC Committee Member
Role
• Forum to enable patient/carer groups and Public Partners to engage
constructively and productively with SMC respected partners.
• Provide advice to SMC to strengthen key relationships .
• Work with ADTC Collaborative on relevant public involvement issues.
Membership
19. PIN Advisory Group Recommendation
1. Early Release of Embargoed Decisions
Patient groups highlighted
the challenges of not
having advance notice of
SMC decisions which
impact their work.
PIN Advisory group
recommended SMC
Executive to release
embargoed advice 5 days in
advance – change in
process accepted and
implemented.
20. PIN Advisory Group Recommendation
2. Overhaul of Summary of Information for
Patient Groups (SIP) form
Patient groups
highlighted the need for
clear information about
positioning, and quality
of life impact of medicine
from manufacturer.
SLWG setup bringing together
PIN reps, industry reps and
SMC. New Summary of
Information for Patient
Groups (SIP) form and
guidance produced
21. PIN Advisory Group Recommendation
4. Presentation of PACE Medicines
Patient groups and SMC
committee members
highlighted the
repetition of PACE and
Patient Group
presentation.
Change of order of
presentations at SMC and
change of focus of Patient
Group presentation.
22. PIN Advisory Group Recommendation
5. Need for ongoing Patient Group Support and Education
Patient Group
Representatives on PIN
Advisory Group
highlighted need for
ongoing support and
education.
Annual National Patient
Group Meeting, continued
strengthening of support
offered to submitting patient
groups...121, website
example, videos...
23. Summary of SMC Strengthening of
Public Involvement
• New Public Involvement Team
• Formalised role of SMC Public Partner
• Patient and Clinician Engagement (PACE)
• SMC Meetings in Public
• Public Involvement Network (PIN) Advisory Group
• Patient Group Partners
• New submission process
• 121 support and information offered to submitting patient groups
• New Summary Information for Patient Groups (SIP) form
• Embargoed early release of decision to submitting patient groups
• National patient group training/update event
• Improved public involvement website content