This publication has been discontinued on July 19, 2011.
This latest strategic publication from HBS
Consulting"Medical Device Technology - changing reimbursement environment
in key markets" provides:
- An up to date analysis of current regulatory andreimbursement guidelines
as they pertain to the countries researched for this report
- An assessment of the principal factors whichdictate and impact upon
medical device reimbursement
- Case studies reviewing reimbursementexperiences of companies within the
medical device and diagnostic sectors
Through the use of primary research methodology the report's author has
gathered the views of professionalswithin the regulatory affairs industry and
officials involved in guiding reimbursement strategies in government
organizations.
Additionally, interviews with business development and
marketing personnel within medical device and medical technology companies offer
ideas and perceptions on some of the key trends which may determine success and
failure in the medical device market.
Every single market covered in this report - the US, Japan, France, Germany,
Italy, Spain and the UK - are in the process of either overhauling their medical
device reimbursement systems or creating new ones.
Executive Summary
Even if a product is approved through regulatory procedures for sale in a
market the company may be unable to find buyers for it. This is because the few
purchasers would either expect, or be able, to pay the whole cost of the device
themselves and rely on at least part payment from their healthcare provider, be
it Staterun or insurance-based. This third party payment is termed
reimbursement.
At a meeting of health ministers in May 2004 entitled
"Towards high-performing health systems" the conclusion was reached
that, "Countries must strive to get better value for money if they are to
reconcile rising demands for health care with public financing
constraints." There is little that is new in this statement and, so far as
medical device companies and healthcare providers are concerned, it is not even
ground-breaking news.
What is newsworthy is that the pressure on medical
device companies has been drastically increased in recent years as the pressure
on governments to contain costs has reached a climactic point. The result? This
report reviews developments in these markets and assesses the implications for
the medical device industry and furthermore, discusses the strategies that will
be needed in the new regulatory and reimbursement environments.
Provisional Table of Contents
1. EXECUTIVE SUMMARY 7
2. INTRODUCTION 9
- 2.1 Pressures on bringing a medical device to the market. 9
- 2.2 Commonalities to some reimbursement systems 10
- 2.2.1 Diagnosis related groups 10
- 2.2.2 Health technology assessment 12
- 2.3 The target audience 12
3. THE TWO R' s 13
- 3.1 Regulations ? being allowed into a market 13
- 3.1.1 US medical device and diagnostic regulations 13
- 3.1.2 Europe' s medical device and diagnostic regulations 14
- 3.1.3 Japan' s medical device and diagnostic regulations 15
4. GLOBAL REIMBURSEMENT STRATEGIES 17
- 4.1 Health technology assessment 17
- 4.2 Clinical trial architecture for reimbursement 20
- 4.3 Pricing 25
- 4.3.1 Price skimming 26
- 4.3.2 Penetration pricing 27
- 4.3.3 Cost-based pricing 27
- 4.3.3.2 Experience curve pricing 28
- 4.3.4 Demand-based pricing 29
- 4.3.4.1 Prestige or premium pricing 29
- 4.3.4.2 Product line pricing 29
- 4.3.4.3 Pricing differentiation 30
- 4.3.5 Competition-based pricing 31
- 4.3.5.1 Economy pricing 31
- 4.3.5.2 Competitive parity 32
- 4.3.6 Cost-benefit pricing strategy 32
5. THE MAJOR MARKETS 34
- 5.1 The US 34
- 5.1.1 Regulations 35
- 5.1.1.1 51 0(k) Pre-Market Notification 35
- 5.1.1.2 Pre-Market Approval Application 38
- 5.1.1.2.1Product Development Protocol 39
- 5.1.1.3 Investigational Device Exemption 39
- 5.1.1.4 Post-marketing regulations 40
- 5.1.2 Reimbursement 40
- 5.1.2.1 Medicare 41
- 5.1.2.2 Medicaid 42
- 5.1.2.3 Private insurers 43
- 5.1.2.4 Uninsured 43
- 5.1.2.5 Health technology assessment 43
- 5.1.3 Reimbursement system 44
- 5.1.3.1 Company issues with reimbursement 46
- 5.2 Japan 49
- 5.2.1 Regulations 49
- 5.2.2 Reimbursement 55
