the future of market access – the national picture
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The future of market access – the national picture
PM Society / Wellards Forum
London 29 November 2012
Meindert Boysen
Programme Director Technology Appraisals & PASLU
National Institute for Health and Clinical Excellence
No part of this talk can be reproduced without the expressed permission of NICE
Health and Social Care Act - 2012: paying for value
Outcomes Framework and Standards
NHS OUTCOMES FRAMEWORKDomain 1
Preventing people from
dying prematurely
Domain 2Enhancing the quality of life for
people with LTCs
Domain 3Recovery
from episodes of ill health /
injury
Domain 4Ensuring a
positive patient
experience
Domain 5Safe
environment free from avoidable
harm
NICE Quality Standards (Building a library of approx 150 over 5 years)
Commissioning Outcomes Framework
Commissioning Guidance
Provider payment mechanisms
Commissioning / ContractingNHS Commissioning Board - Specialist services and primary care
GP Consortia – all other services
1
2
3 4
7
Duty of quality
Du
ty o
f qu
ality
Du
ty o
f qu
ality
tariffstandard contract
CQUIN QOF
5
6
Duty of quality
NHS OUTCOMES FRAMEWORKDomain 1
Preventing people from
dying prematurely
Domain 2Enhancing the quality of life for
people with LTCs
Domain 3Recovery
from episodes of ill health /
injury
Domain 4Ensuring a
positive patient
experience
Domain 5Safe
environment free from avoidable
harm
NICE Quality Standards (Building a library of approx 150 over 5 years)
Commissioning Outcomes Framework
Commissioning Guidance
Provider payment mechanisms
Commissioning / ContractingNHS Commissioning Board - Specialist services and primary care
GP Consortia – all other services
1
2
3 4
7
Duty of quality
Du
ty o
f qu
ality
Du
ty o
f qu
ality
tariffstandard contract
CQUIN QOF
5
6
Duty of quality
http://review2011-2012.nice.org.uk/
BRAND MAP HERE
Current NICE products & services
New system relationships
NHS constitution 2012
• You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.
• We will introduce a NICE Compliance Regime to reduce variation and drive up compliance with NICE Technology Appraisals.
• We will require that all NICE Technology Appraisal recommendations are incorporated automatically into relevant local NHS formularies in a planned way that supports safe and clinically appropriate practice.
• We will establish a NICE Implementation Collaborative to support prompt implementation of NICE guidance.
• We will develop and publish an innovation scorecard to track compliance with NICE Technology Appraisals.
Use of NICE appraised medicines in the NHS in England – 2010 and 2011
Experimental publication of the Health and Social Care Information Centre 2012
Value Based PricingThe Government view:
“We need a system that encourages the development of breakthrough drugs addressing areas of significant unmet need. And we need a much closer link between the price the NHS pays and the value a new medicine delivers, sending a powerful signal about the areas that the pharmaceutical industry should target for development.”
“Most importantly, using our cancer drugs fund in the interim, and value-based pricing for the longer-term, we will move to an NHS where patients will be confident that where their clinicians believe a particular drug is the right and most effective one for them, then the NHS will be able to provide it for them.“
Quote from A. Lansley in Guardian 29 Oct 2010
Overview of rationale for VBP
Current Process Issues VBP solutions
Does drug give enough benefit* to justify moving funds and depriving some other patients of their treatment?
We may care more about some patients…
Apply QALY weightings
Include “Wider Societal Benefits”
Treatments affect people beyond patients
Right decision if:
•Care equally about all patients
•Only care about patients
•eg with severe condition, large unmet need
• Burden of Illness
• Therapeutic Innovation and Improvement
• Effect on contribution to society…
• …and use of society’s resources
•Family, carers
•Beneficiaries of goverment spending
*measured in Quality-Adjusted Life Years (QALYs), the universal unit of health gain
VBP key features• Applies to new medicines on the market from 1 Jan 2014• Government to set out a range of thresholds or maximum prices
reflecting different values that medicines offer• Use of a (basic) cost effectiveness threshold• Use of QALYs• Application of weighting to benefits implying of maximum price
thresholds• Higher price thresholds for medicines that tackle disease of high
unmet need or severity• Higher price thresholds for medicines demonstrating greater
therapeutic improvement and innovation• Higher price thresholds for medicines that can demonstrate wider
societal benefits• Categories and weights will be determined by the Secretary of
State, on the basis of expert advice, within a framework determined in advance.
VBP consultation 2010/11
So, how about NICE?
“As enshrined within the NHS Constitution, the NHS in England will continue to fund existing drugs that have been recommended by NICE. And that right will continue and will apply to new medicines to which VBP applies.“NICE will examine the evidence on the potential clinical and cost effectiveness of new drugs as they become available; drawing on its world-leading expertise in the field.“And, importantly, under the new system of VBP, NICE will no longer be obliged to make yes/no decisions on access, based on its own cost per QALY thresholds.“Instead, you'll be free to focus on the rigorous appraisal of evidence to show the relative benefits of a new medicine.
Andrew Lansley, Secretary of State for HealthNICE Conference, 17 May 2012
Appraising value
Procedural Principles
Accountability for re
asonableness
Most technologies are worth using ...
Recommendation categories
Single Technology Appraisal
Multiple Technology Appraisal
Total
Recommended 63 (58%) 234 (64%) 297 (62%)
Optimised 15 (14%) 68 (19%) 83 (18%)
Only in Research 3 (3%) 22 (6%) 25 (5%)
Not Recommended 27 (25%) 43 (11%) 70 (15%)
Total 108 (100%) 367 (100%) 475 (100%)
Based on 493 recommendations published in 265 technology appraisal guidance between March 2000 and October 2012
80% of NICE recommendations are positive
Timeliness targets
Preliminary Preliminary recommendationsrecommendations
Evidence Evidence SubmissionSubmission Committee Committee
meeting meeting
PublicationPublication
ConsultationConsultation
Appeal (or not)Appeal (or not)
[ 26-34 weeks]
Review
Evidence Evidence ReviewReview
Final guidanceFinal guidance Committee Committee meeting meeting
InvitationInvitation
8 weeks
8 weeks
4 weeksScoping
ClarificationC
larification
Experts(incl PCT)
STA Process
DecisionProblem
CHMP +
MA
MA
Meet company
Including company
Experts?
Including company?
The Quality Adjusted Life Year
Hea
lth-r
elat
ed q
ualit
y of
life
Length of life (years)
QALYsgained
Currenttreatment
New treatment
Initial QALY loss due to side effects
0
1
Fixed Budget & Opportunity Cost
Consideration of cost effectiveness: threshold range
less than £20,000 per QALY gained
between £20,000 and £30,000 per QALY gained
more than £30,000perQALY gained
Probably cost effective
Make explicit reference to thesefactors:• Certainty • Health related Quality of lifeadequately captured?• Innovative nature technology
Need to identify an increasingly strong casewith regard to same factors.
Application of the ‘end-of-life’ advice in 2009 - 2012
End-of life criteria considered
37
Criteria met & recommended 10
Criteria met & not recommended
6
Criteria not met & not recommended
21
Application of ‘special circumstances’
Rawlins, Barnett, Stevens Br J Clin Pharmacol 2010
Ferner R., Hughes D. and Aronson J. ‘NICE and new: appraising innovation’ BMJ 2010; 340: 245-247.
“different ways of doing things which bring improved outcomes”(Cooksey)
“new, constitutes an improve-ment on existing products , step-change” (Kennedy)
“…a plausible gain of at least 1 QALY would be a reasonable threshold for judging the usefulness of a supposedly innovative technology…” (Ferner et al, 2010)
“…..whether a new medicine represented a significant improvement relative to existing treatments...” (DH Consultation Paper on VBP)
How often were the HR-benefits not captured in the QALY?
30 published appraisals or consultation documents*
7 some HR-benefits not captured in the QALY
2 Impact on decision
HR-benefits of reduced hospital visits in last year of lifeHR- benefits of delaying toxic chemotherapy
5No impact on decision
(changing utility values had little effect on
ICERs)
*July 2010 to January 2011
Schemes in operation in England and WalesPre-PASLU
*See http://www.nice.org.uk/guidance/ta/published/index.jsp
NICE TAG*
Product & clinical area Details
129 Bortezomib (Velcade) – multiple myeloma Rebate for non-responders
155 Ranibizumab (Lucentis) – age related macular oedema Dose cap
162 Erlotinib (Tarceva) – non-small cell lung cancer Simple discount
169 Sunitinib (Sutent) – renal cell carcinoma Free stock
171 Lenalidomide (Revlimid) – multiple myeloma Dose cap
176 Cetuximab (Erbitux) – colorectal cancer Rebate
179 Sunitinib (Sutent) – gastro intestinal stromal tumour Free stock
180 Ustekinumab (Stelera) – psoriatic arthritis Free stock
185 Trabectedin (Yondelis) – soft tissue sarcoma Dose cap
186 Certolizumab pegol (Cimzia) – rheumatoid arthritis Free stock
192 Gefitinib (Iressa) – non-small cell lung cancer Single fixed price
Schemes in operation in England and WalesPASLU
*See http://www.nice.org.uk/guidance/ta/published/index.jsp
NICE TAG*
Product & clinical area Details
202 Ofatumumab (Arzerra) – chronic lymphocytic leukaemia Simple discount
205 Eltrombopag (Revolade) – thrombocytopenic purpura Simple discount
215 Pazopanib (Votrient) – renal cell carcinoma Simple discount
218 Azacitidine (Vidaza) – myodysplastic syndromes Simple discount
220 & 225 Golimumab (Simponi) – psoriatic & rheumatoid arthritis Free stock
221 Romiplostim (Nplate) – thrombocytopenic purpura Simple discount
227 Erlotinib (Tarceva) – maintenance advanced or metastatic nsclc Simple discount
233 Golimumab (Simponi) – ankylosing spondylitis Free stock
235 Mifamurtide (Mepact) – non-metastatic osteosarcoma Simple discount
238 Tocilizumab (RoActemra) – juvenile idiopathic arthritis Simple discount
241 & 251 Nilotinib (Tasigna) – Chronic myeloid leukaemia Simple discount
247 Tocilizumab (RoActemra) – moderate to severe rheumatoid arthritis Simple discount
250 Eribulin (Halaven) – advanced breast cancer Simple discount
254 Fingolimod (Gilenya) – relapsing remitting multiple sclerosis Simple discount
Quality evidence submissions; a real challenge ...
Highly Specialised Technologies
Patients’
Need
Needs of
patients and
society
Accessibility and
balanced
geographic
distribution
Stimulating
research and
innovation
Sever
ity a
nd
abili
ty o
f
patie
nts to
benef
itClin
ical
effe
ctiv
enes
s &
potentia
l for
impro
ving h
ealth
Overa
ll co
st
impac
t and
affo
rdab
ility
incl
. opportu
nity c
ost
Avera
ge co
st
per p
atie
ntVal
ue fo
r
money
com
pared
to
alte
rnat
ives
Best clinical
practice in
delivering the
service
Continuity of
provision
Economic
efficiency
of provision
Clinic
al s
afet
y
and ri
sk
The ‘new’ challenge for HTA; ‘adaptive licensing’!
Eichler et al. 2012 www.nature.com/cpt
?
For discussion …?• How will the new commissioning structure in the NHS
deal with, and shape, NICE’s approach to technology appraisals?
• What is to (further) gain in market access from VBP knowing that the majority already receives positive guidance.
• Will VBP reflect all value, and if not, how much of a role should there be for a deliberative process?
• Do patient access schemes have a future in the context of VBP and sPPRS?
• How different is (should) the situation (be) for highly specialised technologies?
