Evolving Practices in the Assessment of Medical Devices An Industry Perspective

Transcription

1 Evolving Practices in the Assessment of Medical Devices An Industry Perspective Adrian Griffin April 2016

2 The Medical Device Sector in Context Systems spend roughly 2x as much on drugs than devices Rel. Prop. of HC spend Products Companies The FDA approved 1,453 drugs (to Dec 13) - EUCOMED reports more than 500,000 medical devices Medical Device Industry Innovative drug industry dominated by large & medium companies - MedTech comprised mainly of SMEs: EUCOMED report >25,000 Pharma Industry 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

3 Complexity of Medical Device Pathways In Europe, and elsewhere Regulatory Always HTA Sometimes Reimbursement More often by procedure (DRG) Procurement Local not national 3

4 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

5 Recognising the differences in HTA application between drugs and devices Hospital HTA Regional Contract Local HTA Local procurement Local procurement National Contract Local procurement Local procurement Coverage (DRG) Coverage (DRG) HTA Reimbursement HTA Reimbursement Regulatory Approval Regulatory Approval 5

6 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 Procurement influence HTA puts downward pressure on price of innovation, so relative C-E improves against old technology 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 7

7 Disconnect between evaluator and purchaser (2) Challenges with Evidence Extrapolation Pharmaceuticals Guaranteed exclusivity period 5 years data exclusivity in US 10 years in Europe Me-too products (not generics) have to cross similar evidence hurdle Devices 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 8

8 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 9

9 Examples of Change Medtronic Biosense Webster (J&J) St Jude Medical 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 Thermocool catheter for AF: discount on devices used in a repeat procedure if a patient initially treated with those products returns within a year 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

10 Thank You 11