November 2011 also saw the publication of a Brief by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) on the use of Percutaneous Venoplasty to relieve the symptoms of Multiple Sclerosis by improving Cerebrospinal Venous Drainage. HealthPACT is a sub committee of Australian Health Ministers’ Advisory Council (AHMAC) and a body that comprises representatives from health departments in all States and Territories, the Australian and New Zealand governments. It is understood that the ongoing representations by the Australian MS community to Australian Parliamentary representatives (from every Australian State and Territory) may have been a factor in the commissioning this Brief  - which, inter alia, referenced aspects of the PBN. This brief was prepared by Dr Prema Thavaneswaran from the Australian College of Surgeons as related to the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical in providing quality and timely assessments of new and emerging surgical technologies and techniques. While key elements of the HealthPact Brief are summarised below it is important that they be read in consideration with other sections of the Brief and the intent of the Brief as a whole. Figure 3 - The Diffusion of New Knowledge about Relieving MS Symptoms.The HealthPACT report highlighted:The evidence that Percutaneous Venoplasty is an established, routine procedure, with a proven safety and efficacy. In saying this HealthPact went on to say that the outcomes of from randomised, controlled, clinical trials with long term follow up of patients will need to be evaluated before the procedure can be widely adopted. Such trials to also formally assess Percutaneous Venoplasty in the treatment of CCSVI in patients with MS.Research that the reestablishment of a normal cerebrospinal venous return through percutaneous venoplasty significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up, in MS patients diagnosed with CCSVI. At this stage this research is limited to low level case series studies and that outcomes over longer term studies are not yet available.That the cost-effectiveness of percutaneous venoplasty for this new indication cannot be determined at this time; however, it is unlikely that the costs associated with performing this procedure for the new indication would differ significantly from the cost of existing percutaneous venoplasty procedures. That it is still unclear what proportion of the MS patient population meets the diagnostic criteria for CCSVI, and would therefore benefit from this procedure. The outcomes from (additional) randomised, controlled, clinical trials with long-term follow-up of patients will need to be evaluated before this procedure can be widely adopted. There are a number of ongoing clinical trials assessing the use of percutaneous venoplasty for the relief of symptoms in MS patients with CCSVI being conducted in Italy NCT01371760 - ongoing), Poland (NCT01264848 - since completed) and the US (NCT01089686 - since terminated NCT01201707 since terminated NCT01205633 - recruitment temporarily suspended, That in Canada the National Government has announced that it will provide funding, through the Public Health Agency of Canada, to support the development of a national monitoring system, which will capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS, That searches of clinical trials registers failed to identify any ongoing trials in Australia. That MS Australia has reported actively encouraging Australian researchers to pursue research into CCSVI; however, this has resulted in only two small scale projects.

Diffusion Strategies.

 HealthPACT drew attention to RM1722MS recommendations by the MS Network of Care, in particular: That there is strong evidence that testing for possible CCSVI irregularities should be mandatory during the diagnostic stages of MS and that the Australian government could tie its immunotherapy subsidies for MS to requirements that information be provided to individual patients about possible vascular irregularities in MS, and vascular (including CCSVI) screening be undertaken. Authorising general practitioners to refer patients for Doppler ultrasound CCSVI screening may be a key step in achieving this. In relation to this suggestion HealthPACT observed "Given that an estimated 1000 patients are newly diagnosed with MS each year in Australia, the potential cost impact of routine Doppler ultrasound screening during the diagnostic stages of MS will need to be considered'bNetwork of Care Summati These HealthPACT findings are consistent with the spirit of the issues raised by the Australian MS Network of Care in its September 2011 Parliamentary Briefing Note (PBN). By providing an impartial overview of the role of Percutaneous Venoplasty in the relief of many of the most common MS symptoms and issues they provide a strong foundation to underpin the further development of the Network's draft CCSVI >action strategy. They also serve to strengthen the Australian and New Zealand Parliament's understanding of this aspect of CCSVI. Regarding Safety. On 28 March 2011, researchers at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago, in releasing details of a study of 231 patients treated for CCSVI conditions, said "Angioplasty, the nonsurgical procedure of threading a thin tube into a vein or artery to open blocked or narrowed blood vessels, is a safe treatment.  Our study will provide researchers the confidence to study it as an MS treatment option for the future and encourage additional studies for its use as a treatment option for individuals with multiple sclerosis. Angioplasty is a process used by Interventional radiologists to widen the veins in the neck and chest to improve blood flow" -read the study about this research. These findings build upon and confirm >earlier research by Dr Simka from Poland in a study involving 347 patients
Regarding CCSVI association with MS. There is ongoing fact finding about the prevalence of CCSVI conditions in pwMS as compared to the general community. Commencing around October 2011 details of the outcomes of this fact finding began to appear in the literature. In summary, these findings (that primarily relate to screening of jugular veins via doppler ultrasound) identify a CCSVI prevalence in the range 70% to 86% amongst MS populations and 10% to 14% in the general community. A need for more comprehensive operator training was cited as an important factor in these fluctuations. While these findings provide a very important 'baseline' it is important to remember that CCSVI can occur elsewhere in the vascular system requiring more extensive testing - Regarding Evidence of Outcomes in Australia While no formalised clinic trials have been conducted in Australia (as at 31 December 2011) several hundred people have been tested and treated in what is an ongoing process. Unfortunately all of the outcomes of this groundbreaking work are not being tracked as part of a national CCSVI registry reporting system. Were such a system in place Australia would have an extremely important research resource - Australia's first clinical trial at the Alfred Hospital in Melbourne received final approval to proceed early in February 2012 under the guidance of Professor Ken Thomson. CCSVI Australia have strongly advocated for this trial in $95,700 in donations from the MS community. Details of this trial are currently being recorded in Australian New Zealand Clinical Trials Registry established at the NHMRC Clinical Trials Centre, University of Sydney,  More such trials are
needed with a specific focus on the benefits of Percutaneous Venoplasty in the relief of many of the most common MS symptoms..

One of the major reasons that uniformly consistent data relating to CCSVI prevalence is yet to emerge relates to
shortfalls in training relating to doppler ultrasound screening of the jugular vein area. Also the outcomes of jugular vein testing are indicative only - the 'gold standard' involves more comprehensive  testing via Catheter Venography.  

Re Point 14 -  The 'ball park' annual costs of such a program could be in the general range of $200,000 to $500,000 before Medicare Rebates. Given that the envisaged screening may well need to go beyond what may currently be construed as CCSVI related conditions the costs may be at the higher end of things. For example, in a case in the Northern Rivers Region the comprehensive screening process identified one MS patient with six previously undetected holes in the heart requiring surgery. There is also a
recommendation that screening to eliminate other conditions is needed.

What is not yet clear are the processes by which HealthPACT will become aware of the outcomes of the aforementioned (and other relevant research) for the purposes of supporting the wide adoption of Percutaneous Venoplasty for the relief of MS symptoms/issues. Advice on this matter will be sought.   Click here to read the full report