Transcript Coverage With Evidence Development

Current Challenges and Future
Developments in HTA in the UK
Frances Macdonald, 23rd September 2008
(A personal, Industry View)
Agenda
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Office of Health Economics (OHE) review of
SMC Decisions : 2002 - 2008
Pharmaceutical Price Regulation Scheme
SMC Decisions – OHE Project
AIMs
 Overview of the trend in SMC decisions,
over time
 In-depth analysis of the restricted
decisions (normally counted as accepted)
All SMC submissions by submission type*
* ‘2008’ includes only the fist six months (January-June)
Count and annual share of SMC decisions
(excluding abbreviated submissions)
Count and annual share of SMC decisions,
(excluding abbreviated and non-submissions)
Counting ‘Yes-equivalent’ as yes
45%
41%
40%
40%
35%
35%
33%
30%
25%
30%
22%
20%
18%
14%
15%
10%
5%
0%
2005
2006
Original share of Yes %
2007
Final share of Yes %
2008
Conclusions

Excl. abbreviated submissions, the rate of ‘Not recommended’ (NR)
increased from 26- 38% (2002-2005) to approx 50% in 2006-7
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Excl. non-submission, the proportion of NR decisions stabilises and
appears to be decreasing from the 2006 peak
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Explanation?
The proportion of non-submissions has grown, from 8% of decisions (excl.
Abbrev. Subs) in 2006 to 29% in the first half of 2008.
If the ‘yes-equivalent’ decisions are counted as ‘yes’ decisions, the
overall trend for ‘acceptance’ has not changed significantly over recent
years, averaging 37% of all decisions during the period 2005 to H1
2008. (excl. abbreviated submissions and non-submissions)
Further work is needed to fully understand the trends eg

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Analysis of resubmissions
Implications of incr. restricted submissions/approvals
PPRS- a significant factor now and future

Pharmaceutical Price Regulation Scheme

Covers all 4 Nations, to a large extent

Currently under renegotiation, to be effective
from January 2009
Principle Objectives of the PPRS
Government and Industry agree on the following aims:
 Deliver value for money
 Encourage and Reward Innovation
 Assist the Uptake of new Medicines
 Provide Stability, sustainability and predictability
Details still under discussion
SMC has a role in 3, possibly 4, of these aims
Ultimate aims – to ensure availability of cost-effective medicines to
patients
- to supportive innovation, uptake and competition
Price cut on medicines likely from January 2009
Assessing ‘Value’ in HTA

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Health Select Committee recommended that NICE
take into account a wider definition of ‘value’.
What does this mean, and how can it be measured
systematically?

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Cost per QALY – doesn’t address everything
What are societal preferences on ‘value’?
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Rarity? Severity of disease?….
How to assess the value of long-term benefits to the NHS?
Value of Innovation, where this adds demonstrable benefits?
How broad should the perspective be eg NHS costs only or
carer costs?
What would happen to the ‘threshold’ if any such changes
made?
Uptake of Innovation
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Innovation is only sustainable if there is uptake
HTA is only of benefit if CE medicines are
subsequently available, equitably & in good time
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So………
England – DH is investigating options to ensure HTA
recommendations are implemented, and access is
faster – to be written into new PPRS
Scotland – the Evaluation project is already underway
Some of the challenges:

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Ascertaining when variation is acceptable, and when not
Quality of the data sources, although perfection not required
Supporting Uptake

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Single UK horizon scanning tool by end 2009
 Will support consistent forward planning and
budget planning
Market Access Schemes are being discussed for
potential inclusion within the new PPRS
 This aspect of the PPRS is relevant to England and
Wales…but….
 Scottish Government has already expressed
interest in evaluating such options
 Ideal opportunity for Scotland to embrace such
schemes for the benefit of Scottish patients
Early Assessment of new Medicines is a Challenge

The SMC assesses all new products and indications
close to launch, and NICE is moving in the same
direction
..understandable need, but……
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By definition, at this point uncertainty is high and all
the answers don’t exist
It increases the risk that a medicine may be assessed
as not CE, due to uncertainty, and thus ‘not
recommended’
Result - increased pressure from all sides to
consider Market Access Schemes for high need
products
Market Access Schemes
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May be considered where a medicine might otherwise be
evaluated as not cost-effective….and medical need is high eg
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Financial – eg total cost capped
Clinical – eg outcome guarantee
Challenges exist eg
Suitable database to evaluate outcomes

Suitable standardisation to allow evaluation
………but…
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Some schemes are relatively simple
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The potential value to patients is considerable
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Post-code variability can be targeted and reduced
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Summary
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HTA methods are constantly developing – current
focus is on assessing ‘value’
The Scottish Evaluation project and the PPRS both
indicate that there is a significant shift beyond HTA
methods , to the next decision points in the chain, eg
to supporting timely & equitable uptake of costeffective (and valued) medicines …..
Scottish patients will benefit