Evidence from AposTherapy – MT 29

David Rees AM

Chairman

Health and Social Care Committee

Bae Caerdydd / Cardiff Bay

Caerdydd / Cardiff

CF99 1NA

By email and letter: HSCCommittee@wales.gov.uk

22^nd October 2013

Inquiry into access to medical technologies in Wales

Dear Mr Rees,

1. I am writing to you from AposTherapy, a small Medical Technology Company focused on the research, development and commercialisation of an approved biomechanical treatment for musculoskeletal disease, which is comprised of an innovative biomechanical device and an assessment and treatment regime administered by qualified physiotherapists. Using knee replacement as one example, this treatment fully assesses each patient’s gait and whether there is a need for a surgical intervention, or if alternative non-surgical interventions may be suitable including AposTherapy. This novel approach to assessment augments the current NHS pre-surgical assessment and in itself adds value to the NHS management and care of patients, saving costs and improving outcomes. However the AposTherapy treatment offers an innovative, personalised, non-surgical and drug-free programme for knee and back pain which also has the potential to enable significant cost savings in the NHS.

2. Thank you for the opportunity to respond to this inquiry into access to medical technologies in Wales. As a relatively new company to the UK, AposTherapy are in a good position to provide feedback based on our early experience and we are very keen to work with the Health and Social Care Committee with the aim of improving patient, care provider and carer access to important therapeutic innovations.

3. We understand that the terms of reference of the inquiry are:

· To examine how the NHS assesses the potential benefits of new or alternative medical technologies;

· To examine the need for, and feasibility of, a more joined up approach to commissioning in this area;

· To examine the ways in which NHS Wales engages with those involved in the development/ manufacture of new medical technologies;

· To examine the financial barriers that may prevent the timely adoption of effective new medical technologies, and innovative mechanisms by which these might be overcome.

4. AposTherapy as a company has the benefit of concentrating efforts on bringing an innovation to patients in the UK without having to manage a broader existing portfolio. This allows us to present a real life case study describing what it is really like to enter the UK healthcare market while offering some suggestions of measures, which may improve access to innovative treatments while reducing burden on the NHS, which in the current times of austerity, we understand is a high priority in Wales.

5. Currently, we are working extensively with the Private Healthcare sector, collecting vast quantities of clinical and cost outcome data which is shared with the patient and healthcare professional, and beginning to work with the NHS to shift care of patients towards treatment at home, potential postponement and improved outcomes of surgery, thereby reducing secondary care and overall NHS costs. This is initially relating to total knee replacement but expanding from there into other related areas.

6. AposTherapy is an innovative, personalised, non-surgical and drug-free programme for knee and back pain, based on a foot-worn biomechanical device, which is individually calibrated by specially trained chartered physiotherapists. Developed by medical doctors coming from the fields of orthopaedics and sports medicine and founded on well-established scientific principles, AposTherapy is clinically proven to deliver long-lasting pain relief and to improve function, mobility and quality of life. More than 40,000 patients have benefited already worldwide.

7. AposTherapy has, after a two-year pilot in the UK private healthcare sector, successfully launched a treatment in the UK, which supports a wide range of patients with musculoskeletal disease, reducing pain while improving function and quality of life. This provides hope for patients who wish to postpone and potentially avoid surgical interventions, which are costly in terms of short-term quality of life, as well as financially for the NHS.

8. While navigating processes in the private health sector, AposTherapy has also endeavored to succeed in the NHS, however this has been very difficult and we are keen to explore the reasons for this and potential solutions which may not only help us, but will help other companies in our position.

9. Key Challenges Summary

Transparency

i. The NHS is a complicated organisation. A small innovative company needs clear and simple processes with transparency of decision making if they are to make innovations available

ii. Support for UK based research is vital, we have been encouraged and have submitted applications for funding research, however the process appears to have lacked transparency and we have found this difficult to navigate.

Difficulties in reimbursement

iii. There needs to be clarification of the appraisal process in primary and secondary care

iv. NHS payment tariffs are difficult to understand and justification of the cost of new interventions, especially devices, becomes near impossible unless their costs are explicitly built into a tariff

Uptake of Innovation

v. Academic Health Science Networks and similar bodies are a good step forward in England; in Wales, the National Leadership and Innovation Agency for Healthcare seemed like the appropriate route to highlight where innovation could be identified and its uptake accelerated; however with its functions being split and taken over by Welsh Government, Public Health Wales NHS Trust and the Shared Services Partnership, we are currently less clear on how innovation should be identified in Wales

vi. We hope that the new wave of NHS enthusiasm for identifying and encouraging uptake of cost saving and quality of life improving innovations supports us as we try to support the NHS and its patients

9. Recommendations

Appraisal process– this must be streamlined to support companies to navigate appraisal processes and gain meaningful relationships with the NHS, which lead to rapid appraisal and decisions on uptake.

i. Reimbursement links in primary and secondary care – secondary and primary care organisations need to forge closer links and be encouraged to assess medical technologies through one unified process instead of individual hospital assessments and a national drug tariff for products to be used in primary care. This is in the context of having the potential to reduce the percentage of patients with moderate to severe joint disease receiving AposTherapy going on to have surgery in the short and long term.

ii. Research support– Support for UK based research is vital, we have been encouraged and have submitted applications for funding research, with the support of internationally renowned experts, however the process appears to have lacked transparency and we have found this difficult to navigate.

10. In addition to raising these points in our response to the inquiry, I would greatly appreciate the opportunity to meet you and to discuss some of the matters I’ve raised in more detail.

Yours sincerely,

Phil Krzyzek

UK General Manager

AposTherapy