Transcript Health Technology Assessment for Pharmaceuticals and New

Health Technology Assessment for Pharmaceuticals and
New Medical Technologies - Where are we now?
The industry perspective
Jenny Hughes, Director, Vaccines & External Affairs
GlaxoSmithKline Mission & Strategy
To improve the quality of human
life by enabling people to do
more, feel better and live longer
Deliver More Products of Value
“To be successful in the healthcare marketplace in
the next few years its all going to be about
delivering value.“
Andrew Witty, CEO
1.
2.
3.
Enhanced R&D productivity and increased externalisation for drug
discovery
Sustaining a late stage pipeline
Number of filings & reimbursable product approvals
Bridging the “Value Gap”
What R&D
provided in the
past
Short-term data
Surrogate endpoints
Limited Comparators
Broad population
The Value Gap
What is needed
now
Evidence of
meaningful
benefit on
survival/QOL over
relevant comparators
in a select well-defined
population at a
justifiable
price
Bridge: the Reimbursable File
How does a reimbursable file relate to a
regulatory file?
Incremental clinical benefit is a necessary, but not sufficient
condition.
Payers look at the:
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Unmet economic as well as clinical needs
Incremental benefit relative to the payer’s choice of comparator
Economic (and social) significance of the clinical benefit
Confidence that benefits will be replicated in real world practice
Quality of evidence
Extent of risk of inappropriate resource use and budget overspend
Health Technology Assessment
 What is HTA?
– It is the process of using existing evidence to evaluate the clinical effectiveness, cost
effectiveness & broader impact of a health technology on patients and the healthcare
system
Health Technology Assessment
at is Cost Effectiveness?
Cost-effectiveness Test =
Cost (new drug) – Cost (existing drug)
QALY (new drug) – QALY(existing drug)
<=
€ Threshold
Irish Cost-effectiveness Test =
Cost (new drug) – Cost (existing drug)
<=
QALY (new drug) – QALY(existing drug)
Approx € 20,000
1 QALY
Health Technology Assessment
Putting into balance the extra-benefit against the extra-cost at
threshold level
€ 20,000
1 QALY
HTA guiding principles
1. HTAs should be based on a clear, sophisticated and differentiated
view of what constitutes value
2. HTAs should be transparent and balanced
3. HTAs should be based on early and inclusive dialogue, including
with patients
4. Evaluations should be flexible to allow new data to be considered
5. Risk-sharing and flexibility is required in handling uncertainty
6. Comprehensive understanding of the benefits of a drug in disease
management is needed
7. Payers should commit to rewarding added value
8. Positive HTA outcomes should be implemented
9. HTA should apply to all healthcare interventions
“Earning Trust,
Leading Innovation,
Helping More Irish Patients”
Reimbursement process for new medicines
 Pre 2006, Automatic reimbursement for new medicines
 September 2006, “HSE reserves the right to assess new and existing
technologies (pharmaceuticals, diagnostics and devices) that may be
high cost or have a significant budget impact on the Irish healthcare
system.”
 September 2009, All new products applying for reimbursement
subject to a preliminary rapid review to determine if HTA is required.
Irish Reimbursement Process
Present pipeline CPU/NCPE
Licence granted
Company submit reimbursement application
to CPU
NCPE ask company to complete rapid review
form
Yes HTA
No HTA
Considerations during the rapid review
process
 Therapeutic area?
 What is the appropriate comparator ?
 Is there a significant price difference between the new product and the
comparator ?
 Are there advantages over the comparator ?
 Budget impact?
 Any pharmacoeconomic data available?
 What is the situation in UK/Europe?
Examples
Rapid Review
Criteria
Eltrombopag (ITP)
Pazopanib (RCC)
Is SOC clear?
No
Yes
Is it better/as good
as comparator?
Comparator unclear
Yes
Is it cheaper than
comparator?
Comparator unclear
Yes
Budget impact?
Comparator unclear
No
No
Yes
Is the NCPE familiar
with the area?
Yes HTA
No HTA
HTA Process
Yes HTA
NCPE scoping meeting
Company submit HTA dossier
+90 days NCPE evaluation time
NCPE publish recommendation on
website
CPU decide whether to reimburse
Company re-submit reimbursement
application
The HTA Content
Executive Summary
Section 1 – Background
Section 2 – Clinical Evidence
Section 3 – Description of Economic
Evaluation
Section 4 – Results of Cost-Effectiveness
Analysis
Section 5 – Analysis of Uncertainty
Section 6 – Budget Impact Analysis
Value for money?
Health Technology Assessment
Positive HTA
Uncertain HTA
Accept
Negative HTA
Reject
Price
negotiation
Accept
Reject
Risk sharing
schemes
Accept
Reject
HTA guiding principles – How does the
Irish system
1. HTAs should be based on a clear, sophisticated and differentiated
view of what constitutes value
2. HTAs should be transparent and balanced
3. HTAs should be based on early and inclusive dialogue, including
with patients
4. Evaluations should be flexible to allow new data to be considered
5. Risk-sharing and flexibility is required in handling uncertainty
6. Comprehensive understanding of the benefits of a drug in disease
management is needed
7. Payers should commit to rewarding added value
8. Positive HTA outcomes should be implemented
9. HTA should apply to all healthcare interventions
Reimbursement Timelines
Scheme
GMS
Rapid
Review
HTA
Pricing
Licence to
Launch
+2-4weeks
No
+3/4months
+3/5months
+2-4weeks
Yes
+3 months
+3/4months
+6/8months
No
+4/5months
+4/6months
Yes
+3 months
+4/5months
+7/9months
No
+1-2weeks
+1month
Yes
+3 months
+1-2weeks
+2-4weeks
HT
+2-4weeks
+2-4weeks
Hospital
+2-4weeks
+3/4months
Conditional reimbursement now a feature of the Irish system
Conclusions
Reimbursement & HTA processes are evolving
Requirements are more sophisticated
Greater role of “expert patients” in HTA process
Need for guiding principles around risk sharing
arrangements
Time to market is more unpredictable, greater transparency
on decision making post HTA decision required