Evolving Practices in the
Assessment of Medical Devices
An Industry Perspective
Adrian Griffin
|
April 2016
The Medical Device Sector in Context
Systems spend roughly 2x as
much on drugs than devices
Rel. Prop. of
HC spend
Medical Device
Industry
Pharma Industry
Products
Companies
The FDA approved 1,453 drugs
(to Dec ‘13) EUCOMED reports more than
500,000 medical devices
Innovative drug industry
dominated by large & medium
companies MedTech comprised mainly of
SMEs: EUCOMED report
>25,000
Life of a branded medicine can
be ~8-12 years –
Commercial lifecycle of a device
~2-3 years
REALITY for Devices:
More products; shorter ROI
window; chasing less HC spend
2
Complexity of Medical Device Pathways
In Europe, and elsewhere
Regulatory
HTA
Reimbursement
Procurement
Always
Sometimes
More often by procedure (DRG)
Local not national
3
Context of HTA in Decision-Making
Pharmaceuticals compared with Medical Devices
Pharmaceuticals
Medical Devices
WHY
Inform Pricing or
Reimbursement
No ‘routine’
Reimbursement Decision
WHEN
ASAP after
Regulatory Approval
Varies
Recognising the differences in HTA application
between drugs and devices
Hospital
HTA
Regional Contract
Local
HTA
National Contract
Local procurement
Local procurement
Local procurement
Local procurement
Coverage (DRG)
HTA
Reimbursement
Regulatory Approval
HTA
Coverage (DRG)
Reimbursement
Regulatory Approval
5
Disconnect between evaluator and purchaser (1)
Challenges with Traditional HTA of Devices
Innovative
Technology
assessed by HTA
as clinically and
cost effective
Innovation
replaces older
technology;
“disinvestment”
from old to new
HTA puts downward
pressure on price of
innovation, so relative
C-E improves against
old technology
Procurement influence
Price falls on old
technology as
suppliers
compete for
smaller market
HTA influence
Traditional HTA
methods suggest
disinvestment
from new
technology
Price difference
between old and
new increases, so
relative value of
Innovation falls
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Disconnect between evaluator and purchaser (2)
Challenges with Evidence Extrapolation
Pharmaceuticals
Devices
– Guaranteed ‘exclusivity’ period
• 5 years data exclusivity in US
• 10 years in Europe
• ‘Me-too’ products (not generics) have to
cross similar evidence hurdle
– There is no “data exclusivity”
• Innovator generates evidence for payer
• Purchasers take evidence from the first
entry and extrapolates to class
• ‘Me-too’ products have lower hurdle drive competition on price
– Provides opportunity for return on innovation
• Eco-system incentivises evidence
generation
– First mover disincentive
• Eco-system undermines the incentive for
evidence generation
• HTA seeks to evaluate all technologies by the methods / rigor applied to drugs
– Demand evidence of value before adoption; seek certainty of benefit & value
• But users procure devices like commodities;
– Demand discounts, price/volume agreements, low barriers to entry for competition
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Opportunities
• Redefine procurement
– Value based, rather than price
– BCG/EUCOMED project underway
• Support use of local (hospital) HTA
where decisions are made
– European AdHopHTA project
• Recognise evidentiary contexts
– Devices - Outcomes often accrue after use
– Drugs – outcomes often accrue during use
• So routes to evidence may well (logically) differ
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Examples of Change
• Medtronic
• Tyrx Mesh sleeve for cardiac Implants: Medtronic to cover cost of
infections if infection rate is not lowered compared with rate in
procedures without it
• Biosense
• Thermocool catheter for AF: discount on devices used in a repeat
Webster (J&J)
procedure if a patient initially treated with those products returns
within a year
• St Jude
Medical
• Quadra heart rhythm device: %age rebate for a device if revision
surgery is needed in the first year after implant due to problems with
the company’s Quartet lead wire
10
Thank You
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