Welcome to the second issue of the HealthPACT Bulletin for 2011.

Since the June issue of the Bulletin, HealthPACT has been involved in

some exciting activities, while undertaking more proactive scanning of new

technologies.

At the August HealthPACT meeting, a number of jurisdictions presented

their experience with mapping of technologies employed in various clinical

streams. Similarities and differences in the maps were evident, influenced by

clinical preferences, predicted clinical demand, and current exposure to

various technologies. There is potential to coordinate technology mapping

nationally to reduce the potential for duplicated effort, and to offer more

rapid progress through those disorders with the greatest burden of disease

and potential for benefit from the technologies. It was agreed to focus on

new and emerging technologies by disease category, looking at burden of

disease, volume, and cost.

In November, HealthPACT facilitated a workshop on intestinal

transplantation, in collaboration with the Nationally Funded Centres

Reference Group (NFCRG). The workshop examined the provision of

intestinal transplantation services within the Australian and New Zealand

health care systems, with participants describing an optimal system where

the service system would be defined as a continuum for the management of

intestinal failure. The next steps following this workshop will be considered

by NFCRG and HealthPACT.

Health Policy Advisory Committee on Technology Bulletin Issue 18 – December 2011

Issue 18, December 2011

HealthPACT Bulletin Health Policy Advisory Committee on Technology

Australia and New Zealand New and Emerging Technology

In This Issue... Technologies for the inactivation of pathogens in blood products 2 Peptide receptor radionuclide therapy for the treatment of neuroendocrine tumours 4 Extracorporeal photopheresis for the treatment of graft-versus-host disease 5 Total artificial heart 6 Faecal microbiota transplantation 7 Intestinal transplant workshop 8 Selective internal radiation therapy for the treatment of liver cancer 9 MRI-guided, high-intensity focussed ultrasound for the treatment of cancer 10 High sensitivity troponin assays for the diagnosis of myocardial infarction 12 News round-up 13 HTAi 2012 14

From the Chair

HealthPACT continues to prepare or commission a range of

new and emerging technology reports and technology briefs,

some of which you will find summarised in this issue.

On behalf of HealthPACT, I would like to wish our colleagues in the health technology industry a safe and happy Christmas, and all the best for 2012.

Best Regards, Brendon Kearney

Chair of HealthPACT

Technologies for the inactivation or reduction of

pathogens in blood products: Executive Summary

This New and Emerging Health Technology Report was

commissioned by HealthPACT on behalf of CTEPC and the

Jurisdictional Blood Committee.

Existing pathogen reduction/inactivation strategies employed

by the Australian Red Cross Blood Service (ARCBS) include

epidemiological control of donors and leucocyte depletion,

complemented by routine serological and nucleic acid testing

(NAT) of the end product. Serologically and NAT negative

plasma is forwarded on to CSL Biotherapies for use in the

manufacture of plasma derived products.

The 2 main pathogen reduction technologies (PRT) identified

for inclusion in this report were: the INTERCEPT Blood

System™ and the Mirasol® Pathogen Reduction Technology,

both of which are designed for use at the blood collection

centre level. Neither system is listed on the Australian Register

of Therapeutic Goods, nor approved by the FDA, however

both products are CE marked for use in the European Union.

Both systems use agents which form cross-links between the

base pairs of nucleic acids, halting transcription (see figure

below). Both systems inactivate a range of pathogens (viruses,

bacteria and parasites) in the non-nucleated components of

blood: plasma, platelets and potentially red blood cells, how-

ever both systems are ineffective against infectious prions.

The INTERCEPT Blood System™ uses the psoralen,

amotosalen, which is activated after exposure to ultraviolet-A

light. The Mirasol® system uses riboflavin, or vitamin B2, as

its photosensitising agent, which binds to pathogen nucleic

acids and is oxidised after exposure to ultraviolet-B or visible

light.

The advantages of these PRT systems include:

the potential to eliminate the threat from as yet unknown pathogens;

the inactivation of residual white blood cells, ne-gating the need to gamma irradiate plasma or platelet products for the prevention of graft-versus-host disease (GVHD);

the elimination of the risk of transfusion transmit-ted infection during the so-called “window pe-riod”, when viral and antibody levels are too low for detection in infected blood obtained from asymptomatic donors; and

increased shelf life of platelets from 5 to 7 days, which may lead to a significant reduction in wast-age due to expired product.

The disadvantages of these PRT systems include:

a reduction in product volume (a 10-15% loss of platelet yield during treatment);

the INTERCEPT™ system is reported to be in-effective at inactivating hepatitis A, a non-enveloped virus; and

both systems are ineffective against infectious

prions.

Above: The mechanism for the use of psoralens to destroy pathogen DNA or RNA

Bryant, B. J. & Klein, H. G. (2007). 'Pathogen inactivation: the definitive safeguard for the blood supply', Arch Pathol Lab Med, 131 (5), 719-733.

HealthPACT Bulletin

2. Issue 18 – December 2011

Mirasol® Pathogen Reduction Technology System

Only one randomised controlled trial describing the use of the

Mirasol® system was included in this report. Adverse events

among thrombocytopenia patients transfused with Mirasol®-

treated or standard platelets were reported. The frequency of

all adverse events, including serious adverse events and death

were similar for both groups, and while almost all patients

experienced an adverse event of some sort, few of these were

attributable to platelet transfusions. Of all the adverse events

reported, including death, none could be attributed to the use

of the Mirasol® system, but were rather a reflection of under-

lying morbidity among both groups of thrombocytopenic

patients.

On the basis of the between group difference in mean

corrected count increments (CCI) at one hour following

platelet transfusion, Mirasol®-treated platelets were found to

be inferior to standard platelets (p<0.0001). However, an

examination of patient bleeding episodes did not show any

significant differences between the treatment groups. The

odds of achieving a successful platelet transfusion as measured

at one hour post-transfusion were lower for patients who re-

ceived Mirasol®-treated platelets than for patients transfused

with standard platelets (OR=0.28; 95% CI [0.11, 0.77];

p=0.013).

Intercept Blood System/amotosalen

Three RCTs indicated similar safety profiles for throbocyto-

paenic patients transfused with INTERCEPT™/amotosalen-

treated platelets and those who received standard platelets. In

an RCT of 645 patients, adverse events were experienced by

almost all patients regardless of whether they received

amotosalen or standard-treated platelets, but less than a third

of patients in either arm had treatment related adverse events.

No significant differences in safety outcomes were observed

and most of the 28 reported deaths were due to infectious or

respiratory complications. A RCT of 242 patients reported

adverse events among a third of patients in both the

amotosalen and standard platelets study arms, with 9.5 and

6.6% of these events attributed to platelet transfusion (p=NS),

respectively. The 6 deaths that occurred were considered to be

related to underlying disease in all but one patient from the

amotosalen arm, who experienced a severe immune reaction

with haemorrhaging. An additional analysis of the safety data

from this RCT indicated that amotosalen-treated platelets may

be associated with substantially higher incidences of acute

respiratory distress syndrome (ARDS). Given ARDS is associ-

ated with a 40% mortality rate, the potential gains in terms of

infections averted due to PRT with amotosalen may be out-

weighed by an increase in clinically serious pulmonary

complications. In contrast, the evidence included in this

assessment primarily indicates that amotosalen-treated

platelets are not inferior to standard platelets in clinical

effectiveness. One RCT did report conflicting results which

prompted the US Food and Drug Administration to recom-

mend duration of bleeding as a preferable measure of haemo-

static efficacy over the proportion of patients experiencing

bleeding.

Two additional pathogen reduction agents were identified:

S303 and methylene blue. S303 had a favourable effectiveness

and safety profile based on the assessed evidence, while the

lack of comparative evidence for methylene blue makes the

effectiveness of this method uncertain, although it does

appear to be safe.

Several cost-effectiveness studies were included in this report,

the most recent was conducted in Canada, and as such may be

generalisable to the Australian health system. This study re-

ported on the use of the Mirasol® system as an addition to cur-

rent pathogen reduction measures rather than as a replacement

technology to reduce TTIs against known pathogens and non-

infectious threats, including GVHD. The overall incremental

cost-effectiveness ratio in Canadian dollars was $1.3 million

and $1.4 million per QALY when used for whole blood and

platelets and plasma, respectively. PRT became more cost-

effective when the risk of infection increased.

The choice of whether to adopt universal PRT will depend on

a risk assessment which characterises the potential for

exposure to known and unknown blood-borne pathogens and

determine whether further diminishment of risk is worth the

additional costs of PRT. It is recommended that a cost-

effectiveness analysis in the context of the Australian health

system be conducted assessing the use of PRT as both an

additive and replacement risk reduction measure.

Written by Ben Ellery and Linda Mundy, AHTA

For a full copy of the report please contact the HealthPACT

Secretariat

Issue 18 – December 2011 3.

HealthPACT Bulletin

Peptide receptor radionuclide therapy for the

treatment of neuroendocrine tumours:

Executive Summary

Neuroendocrine tumours comprise a heterogeneous group of cancers that often remain asymptomatic until the primary tumour has metastasised. Once the cancer has spread treatment becomes difficult with complete surgical resection unlikely. Several treatment options exist to treat advanced neuroendocrine tumours including surgery, somatostatin analogues, chemotherapy, growth factor inhibitors and liver-directed therapies. The choice of therapy employed is deter-mined by the stage of disease, and the size and aggressiveness of the tumour(s).

Peptide receptor radionuclide therapy (PRRT) has been trialled for almost 20 years as an alternative treatment for advanced progressive neuroendocrine tumours. A somatostatin analogue is labelled with a high-energy radioiso-tope, usually Yttrium-90 (90Y) or Lutetium-177 (177Lu), and administered to the patient intravenously. These peptides target and bind to somatostatin-receptors most commonly expressed on neuroendocrine tumour cells, resulting in a highly specific systemic treatment option for advanced neuro-endocrine tumours.

Available evidence suggests that PRRT is highly effective in controlling advanced progressive neuroendocrine tumours. Although complete response rates are relatively low, the percentage of patients with partial remission and stable disease following treatment is high. Haematological and/or renal toxicity is relatively low.

4. Issue 18 – December 2011

To date, clinical trials designed to assess the safety and efficacy of PRRT have limitations that diminish the utility of data produced. Firstly, the nature of the tumours treated (i.e. the size, location and extent of liver involvement) varies significantly, both within and between studies, making it difficult to determine which patient populations respond best to treatment. Secondly, there are no studies that assess the safety and efficacy of PRRT in patients with newly diagnosed neuroendocrine tumours, as the vast majority of included patients have presented with advanced disease after having unsuccessfully undergone alternative treatment options. Thirdly, there are no randomised controlled trials or other comparative studies through which to objectively assess the benefit of PRRT compared with other modes of treat-ment.

Many avenues can be explored with the aim of improving the safety and efficacy of PRRT. These include the development of new somatostatin analogues with higher receptor affinities, improved drug delivery, the establishment of more accurate dosimetry profiles and by combining radionuclide therapy with other modes of treatment. Unfortunately, due to the relatively low number of patients with neuroendocrine tu-mours, a lack of financial investment by pharmaceutical companies may delay the time needed for PRRT to reach its full potential.

Written by Heath White and Deanne Forel, ASERNIP-S

For a full copy of this report please contact the HealthPACT

HealthPACT Bulletin

NEWS FLASH Billion-dollar saving beckons from IV drip research

The NHMRC is providing $1.56 million funding for a study that aims to

examine the use of IV drips in intensive care units and hospital wards. Cur-

rent clinical practice dictates that IV tubing is changed every three to four

days which that costs Australia about $1 billion annually. This practice is

not based on evidence and early trials have demonstrated the safety of pro-

longed use of IV tubing. The RSVP study, conducted by Professor Claire

Rickard from the Griffith Health Institute, will involve 6,500 patients

across five Queensland hospitals, and will compare infection rates and

costs of IV tubing changes on four and seven days.

ECP for the treatment of GVHD Graft-versus-host-disease (GVHD) is a major cause of mor-

bidity and mortality following allogeneic stem cell transplants.

Its pathogenesis is poorly understood, however it is essentially

caused by T lymphocytes from the donor graft recognising the

tissue of the transplant recipient as foreign and mounting an

immune response.1 Symptoms of GVHD resemble those of

autoimmune disorders, affecting the skin, liver, GI tract, lungs

and lymphoid tissue.2 The incidence of acute GVHD ranges

from 20-80% depending on the stem cell source. Mortality

may be as high as 50% in patients with moderate to severe

acute GVHD. The incidence of chronic GVHD ranges from

30 to 70% depending on donor source.2,3

HOW IT WORKS

Extracorporeal photopheresis (ECP), using the Therakos™

system, involves drawing whole blood from the patient. The

red blood cells are separated from the white cells (WBCs) and

returned to the patient. 8-methoxy-psoralen (8-MOP), is

added to the purified WBCs where it cross-links the strands of

DNA. After mixing, the treated WBCs are circulated through

a photo-activation chamber between 2 banks of UVA light.

After UVA treatment, the WBCs are returned to the patient.4

Initial therapy may consist of 3 treatments per week for 2-3

months, with follow-up weekly treatments for up to 12-

months. The mechanism of ECP action aims to strengthen

the response of the suppressor cells responsible for

recognition of self, or tolerance, “tipping” the immune

response away from an active response towards tolerance.4,5

THE EVIDENCE

A retrospective case series reported on the clinical and survival

outcomes of 27 paediatric patients who developed GVHD (6

acute and 21 chronic GVHD) and were treated with ECP fol-

lowing treatment failure with standard steroid regimes. 48% of

patients underwent allogeneic haematopoietic stem cell

transplantation for acute lymphoblastic leukaemia. Donors

were HLA matched in 17 cases and 14 donors were related to

the recipient.6

A total of 225 ECP procedures were performed (median 6 per

patient) with a median time spent on ECP of 30 days (range 2-

442 days). Of the 21 aGVHD patients, 11 reached complete

remission (responders) and 8 reached partial remission. Of the

cGVHD patients, 3 (50%) achieved complete remission, with

2 in partial remission. One cGVHD and two aGVHD patients

were considered non-responders. Median time to response

was two and four cycles in aGVHD and cGVHD patients.

Adverse events related to the procedure were observed in 5

patients: 3 developed mild hypotension and 3 had a catheter–

related infection, all of which were resolved. During follow-up

16 patients died. As a whole group, the probability of disease-

free survival was 43 ± 9%. In a multivariate analysis only com-

plete remission had an effect on disease-free survival

(p<0.0001). The probability of disease-free survival was sig-

nificantly higher in responders who experienced complete

remission (69 ±12%, n=14) compared to non-responders (16

±10%, n=13, p=0.02). Results of the all of the studies in-

cluded for assessment may be viewed in the full brief available

from the HealthPACT Secretariat.

Written by Linda Mundy, HealthPACT Secretariat

Issue 18 – December 2011 5.

REFERENCES

1. Salmasian, H., Rohanizadegan, M. et al (2010). 'Corticosteroid regimens for treatment of acute and chronic graft versus host disease (GvHD) after allogenic stem cell transplanta-tion', Cochrane Database Syst Rev, (1), CD005565.

2. Penas, P. F. & Zaman, S. (2010). 'Many faces of graft-versus-host disease', Australas J Dermatol, 51 (1), 1-10; quiz 11.

3. Foss, F. M. (2003). 'Extracorporeal photopheresis in the treatment of graft-vs-host disease', J Cutan Med Surg, 7 (4 Suppl), 13-17.

4. Ward, D. M. (2011). 'Extracorporeal photopheresis: How, when, and why', J Clin Apher.

5. Chiesa-Fuxench, Z. C. & Gonzalez-Chavez, J. 'Extracorporeal photopheresis: a review on the immunological aspects and clinical applications', P R Health Sci J, 29 (4), 337-347.

6. Gonzalez Vicent, M., Ramirez, M. et al (2010). 'Analysis of clinical outcome and survival in pediatric patients undergoing extracorporeal photopheresis for the treatment of ster-

oid-refractory GVHD', J Pediatr Hematol Oncol, 32 (8), 589-593

7. Matthews, L. (2011). Lyme Arthritis Treatment – Photochemotherapy [Internet]. Lyme Disease Guide.org. Available from: http://lymediseaseguide.org/lyme-arthritis-treatment-photochemotherapy [Accessed 21st September].

HealthPACT Bulletin

Below: Extracorporeal photopheresis (printed with permission7).

End-stage refractory biventricular heart failure is the most life-

threatening manifestation of the heart-failure syndrome. Treat-

ment options available to patients with this condition include

palliation, placement of a biventricular assist device (BiVAD),

or orthotopic heart transplantation. Heart transplantation is

only available to a small percentage of eligible patients due to a

shortage of donor hearts, while the reported survival rate with

BiVADs has been shown to be between 40 and 50%.

HOW IT WORKS The total artificial heart (TAH) has been developed for use as a

bridge-to-transplant, with the aim of increasing the survival rate

of cardiac transplant-eligible patients. This device is capable of

completely restoring systemic and pulmonary blood circulation

and organ perfusion in patients who are at risk of imminent

death, due to end-stage refractory biventricular heart failure.

There are 2 commercially available TAH devices: the SynCardia

TAH (SynCardia Systems Inc, Tucson, Arizona) and the AbioCor

TAH (Abiomed Inc, Danvers, Massachusetts).

The SynCardia TAH, which completely replaces a patient’s native

ventricles and all 4 cardiac valves, is a biventricular pneumatic

pulsatile pump consisting of 3 components: prosthetic ventricles,

drivelines, and an external pneumatic driver. The SynCardia TAH

is intended for in-hospital use mainly due to the need to be

attached to a large power supply. However, recently a portable

power source has been developed which allows patients to be

discharged home once their condition has stabilised. Discharge

home has been further eased with the replacement of the initial

mobile driver with the lighter SynCardia Freedom portable driver

which can be carried in a shoulder bag or worn in a backpack.

Initial use of this driver has been positive, and patients have re-

ported feeling well, and being self-ambulatory, with a significant

return to normal function while at home.1

THE EVIDENCE

One study assessed the co morbidity and survival of patients

awaiting heart transplants while receiving circulatory support

with the SynCardia TAH. 2 This study reported that optimal

haemodynamic function was restored following TAH

implantation. The main cause of death was multiple organ

failure; however, no device dysfunction-related deaths were

reported. A rate of survival to transplantation of 71.5% was

reported, while long-term survival after transplantation was

76% at 10 years.

Another study demonstrated that aerobic exercise training, as

part of a physical rehabilitation program early after TAH

implantation, is safe and feasible in a supervised setting;

however, when compared with patients on LVADs, TAH

patients have a blunted BP response to exercise.3 The results

of this study are particularly relevant, with the rehabilitation

and mobility of patients following TAH implantation

becoming increasingly important, as the portable SynCardia

Freedom portable drive is introduced and more patients are

able to return home after device implantation

FUTURE STEPS

Given the significant costs associated with this technology, it

is suggested that it be targeted at eligible younger patients who

have developed heart failure prematurely. There are currently

2 clinical trials in progress assessing this technology, one of

which is an FDA approved IDE trial of the SynCardia

Freedom portable driver. Therefore, HealthPACT have

recommended that this technology be monitored for 12-

months, as the results of this ongoing trial may determine

whether patients can function adequately with the TAH and

Freedom portable driver outside of the hospital setting

Written by Dr Prema Thavaneswaran from ASERNIP-S

REFERENCES 1. Slepian MJ. The SynCardia temporary total artificial heart – evolving clini-

cal role and future status. US Cardiology 2011; 8: 39-46.

2. Roussel JC, Sénage T, Baron O, Périgaud C, Habash O, Rigal JC, Treilhaud M, Trochu JN, Despins P, Duveau D. CardioWest (Jarvik) total artificial heart: a single center experience with 42 patients. Annals of Thoracic Surgery 2009; 87:124-129.

3. Kohli, H.S., Canada, J. et al (2011).. Exercise blood pressure response during assisted circulatory support: Comparison of the total artificial heart with a left ventricular assist device during rehabilitation. Journal of Heart and Lung Transplantation; 30: 1207-1213

HealthPACT Bulletin

Total artificial heart for end-stage refractory

biventricular heart failure

The SynCardia implantation procedure: the 4 native heart valves are removed, the TAH is implanted and attached via 4 quick connects. When a donor heart

becomes available, the SynCardia TAH and quick connects are removed and the

donor heart is transplanted (printed with permission SynCardia Inc).

6. Issue 18 – December 2011

Clostridium difficile is the most common cause of infectious hos-

pital-acquired diarrhoea in developed countries, resulting in

significant patient morbidity and mortality in addition to in-

creasing health-care costs. Rates of C. difficile infection have

been increasing, in particular, a highly virulent, novel strain,

referred to as B1/NAP1/027. Infection is associated with:

antibiotic use, which disrupts the normal flora of the colon;

gastric acid suppressive therapy; old age; nasogastric feeding;

immunosuppressive therapy; prolonged hospitalisation or

residence in a long-term care facility.1,2

HOW IT WORKS

Faecal bacteriotherapy or transplantation has been proposed

as a means of reconstituting the diversity of the normal flora

of the colon. On the morning of the procedure, a stool sample

is collected from a healthy donor who has been screened for

any potential infectious disease, and for the presence of C.

difficile toxin. Donors from the same domestic household, ide-

ally a spouse or partner, have been preferred as it has been

suggested that pathogens and flora are likely to have been

shared by both participants. The collected stool sample is liq-

uefied sufficiently into a suspension using non-bacteriostatic

saline to allow passage through a syringe, whilst minimising

the volume and maximising the bacterial concentration. The

suspension is filtered to remove any large particulate matter.3,4

The donor stool suspension is instilled into the upper gastro-

intestinal tract via a naso-duodenal catheter, or into the colon

through a colonoscope or a retention enema catheter.

THE EVIDENCE

The largest study included for assessment was a retrospective

case series (n=40) that reported on the use of faecal transplan-

tation in patients who had been hospitalised due to recurrent

C. difficile-associated disease (CDAD).5 CDAD had developed

in all patients (mean age 75 years) following antibiotic treat-

ment for other infections. Patients were treated with antibiot-

ics until symptoms of CDAD were reduced. Antibiotic ther-

apy ceased the evening prior to transplantation. Donor stool

samples were obtained from close relatives or household

members. Two patients underwent colonic instillation of do-

nor stool, and of these, one required a second instillation. The

remaining 38 patients underwent duodenal instillation, and of

these, 4 required a second instillation. Successful treatment

was defined as no clinical symptoms of CDAD 80-days post-

transplantation. Faecal transplantation was considered a

success in 29 (73%) patients after the first instillation, 28 of

who underwent duodenal and one colonic instillation. Of the

11 patients who did not respond to the initial transplantation,

6 underwent a second instillation, which was successful in 4

cases: 3 duodenal and one colonic instillation. Overall 33

patients (82.5%) responded to transplantation. Of the 7 who

failed to respond, 2 responded to treatment with

corticosteroids. The remaining 5 patients had serious

co-morbidities and died from causes not related to the treat-

ment. No adverse events associated with the procedure were

reported.

Results of the all of the studies included for assessment may

be viewed in the full brief available from the HealthPACT

Secretariat.

FUTURE STEPS

There is considerable uncertainty surrounding the efficacy of

the faecal transplantation procedure as a treatment option for

refractory C. difficile infection. It would be prudent to await the

publication of results from the randomised controlled trial

conducted in the Netherlands; therefore HealthPACT have

recommended that information on this technology be noted

and that no further research by HealthPACT is warranted at

this time.

Written by Linda Mundy, HealthPACT Secretariat

REFERENCES 1. McGregor, A., Riley, T. & Van Gessel, H. (2008). 'Clostridium difficile associ-

ated disease', In: Cruickshank, M. and Ferguson, J. (eds), 'Reducing harm to patients from health care associated infection: the role of surveillance', Aus-tralian Commission on Safety and Quality in Health Care, Sydney, NSW.

2. Stuart, R. L. & Marshall, C. (2011). 'Clostridium difficile infection: a new threat on our doorstep', Med J Aust, 194 (7), 331-332.

3. Bakken, J. S. (2009). 'Fecal bacteriotherapy for recurrent Clostridium difficile infection', Anaerobe, 15 (6), 285-289.

4. Rohlke, F., Surawicz, C. M. & Stollman, N. (2010). 'Fecal flora reconstitution for recurrent Clostridium difficile infection: results and methodology', J Clin Gastroenterol, 44 (8), 567-570.

5. Garborg, K., Waagsbo, B. et al (2010). 'Results of faecal donor instillation therapy for recurrent Clostridium difficile-associated diarrhoea', Scand J Infect Dis, 42 (11-12), 857-861.

HealthPACT Bulletin

Faecal microbiota transplantation

Below: High magnification micrograph of C. difficile

Issue 18 – December 2011 7.

HealthPACT Bulletin

Intestinal Transplantation Workshop 10 November 2011

ence of providers varies. There is no formalised service sys-

tem configuration in any jurisdiction. In addition, there was

discussion without consensus about whether (or how)

paediatric and adult intestinal failure services should be linked,

recognising that services for children should be provided in

paediatric settings.

The suggestion that some patients could be considered for

overall referral while the local service is gaining volume and

experience was not supported by participants. It was strongly

proposed that a local service should be supported and

resourced to provide high quality services and overseas

referral of any patients would be inappropriate.

Participants agreed that the following should be undertaken:

Development of an economic model to clarify the

economic impact of various approaches and to determine

whether intestinal transplantation is a cost-effective

approach in suitable patients.

Clear definition of the preferred service system

configuration, model of care and referral pathways with

encouragement to jurisdictions to implement them and

fund them appropriately.

The Workshop Report will be available on the HealthPACT website early in 2012.

The Government announced on 8th December 2011that they

will introduce a comprehensive package of reforms for

Australia’s Therapeutic Goods Administration (TGA) to

ensure the regulation of medicines and medical devices is

more effective and transparent. Releasing TGA reforms: A blue-

print for TGA’s future, the Parliamentary Secretary for Health

and Ageing, Catherine King, said that several important re-

views of the TGA regulatory system have highlighted a num-

ber of issues of concern to consumers, health professionals

and the regulated industry. “In recent times, the TGA has

been hampered by concerns around transparency and an in-

ability to tackle some of the core issues that concern

consumers” Ms King said. “These include the effectiveness of

complementary medicines, their promotion and the adequate

evaluation of some high risk medical devices” Ms King said.

“The reforms will enhance the regulatory framework, ensuring

that it remains adaptable to community and industry

expectations”.

NEWS FLASH

“They will also improve the Australian community’s under-

standing of the TGA’s regulatory processes and decisions and

enhance public trust in the safety and quality of therapeutic

goods.” Ms King said over the past 18 months the govern-

ment has received more than170 public submissions across

seven separate reviews into the operations of the TGA. The

reforms would be implemented in stages, with the TGA work-

ing closely with consumers, health professionals and industry

to ensure the new regulatory arrangements are appropriate,

efficient and fully transparent.

8. Issue 18 – December 2011

On 10 November 2011, HealthPACT facilitated a workshop

which brought together clinicians, health service managers

and policymakers to examine the provision of intestinal

transplantation services within the Australian and New Zea-

land health care systems.

The impetus for the workshop was a previous

unsuccessful submission for intestinal transplantation ser-

vices to be included in the Nationally Funded Centres (NFC)

program. The NFC Reference Group had concluded that the

service system for intestinal failure is underdeveloped in Aus-

tralia and that further work may be required to develop an

evidence-based patient pathway from diagnosis, initial

management and intestinal rehabilitation through to

transplantation. The workshop explored issues relevant to

the current service system for intestinal failure and com-

menced defining the scope of any future work.

The first Australian transplant was performed successfully at

the Austin Hospital in July 2010. Professor Julie Bines, Chair

of Paediatrics, Royal Children’s Hospital and Dr Adam

Testro, Gastroenterologist and Liver Transplant Physician,

Austin Health, presented the Austin and Royal Children’s

Hospital experience.

It was agreed that the adult service system is more

distributed than the paediatric service system and the experi-

The incidence of liver cancer has steadily increased in recent

years with the most common form of primary liver cancer in

adults being hepatocellular carcinoma. Surgical resection is the

best curative option for liver cancer with chemotherapy play-

ing an important role in the treatment of liver metastases.

Selective internal radiation therapy (SIRT) is a new modality

for the treatment of primary and metastatic liver cancer. It is

used in the treatment of patients with non‑resectable

hepatocellular carcinoma or liver metastases.

HOW IT WORKS

Radioactive microspheres containing the beta radiation

emitting isotope yttrium-90 are delivered to the tumorous part

of the liver via injection into the hepatic artery.

SIRT involves the delivery of high-energy beta particles or

spheres loaded with yttrium-90 (with a half-life of 64 hours

and maximum tissue penetration of 11 mm) that are delivered

to the tumourous part of the liver via the hepatic artery,

through either a surgically implanted permanent hepatic artery

port or a percutaneous transfemoral hepatic artery catheter.

The increased yttrium concentration within the microvascula-

ture of the liver tumour produces a local radio-therapeutic

effect. SIRT, also known as radio-embolisation or transarterial

radio-embolisation (TARE), is a new and developing modality

for managing liver cancers that are not amenable to surgery.

Two products have been identified for use in SIRT (at the

time of writing): SIR-Spheres® (Sirtex Medical Limited,

Australia) and TheraSphere® (Nordion, Canada).

THE EVIDENCE

Results from the three randomised controlled trials included in

this assessment are summarised below:1-3

Safety issues relating to grade 3 and 4 toxicity

(against standard treatments);

SIRT patients demonstrated higher tumour response rates

than patients who received comparator treatments (none

statistically significant);

SIRT patients showed better outcomes in terms of hepatic

progression;

Progression-free survival and overall survival were better in

SIRT patients (none statistically significant);

Two reported QOL outcomes not significantly different

between treatment groups;

Indications that there is a likelihood of achieving better

tumour response, and time to progression or progression-

free survival using SIRT; and

Effectiveness outcomes measured included tumour

response rate, time to disease progression in the liver,

survival rate and QOL. All results significantly favoured

using SIRT for treatment of liver metastases.

This technology is currently at a stage of near development in

Australia.

FUTURE STEPS

The available evidence appears promising and highlights the

potential benefits of SIRT for the treatment of liver cancer;

however, a company-based trial is currently underway, the

results of which are scheduled to be presented to Medical

Services Advisory Committee in due course. As such, Health-

PACT have recommended that no further assessment of SIRT

is required at this time. For a full copy of this brief please con-

tact the HealthPACT Secretariat.

Written by Dr Yasoba Atukorale from ASERNIP-S

HealthPACT Bulletin

REFERENCES 1. Hendlisz A, Van den Eynde M, et al. Phase III trial comparing protracted

intravenous fluorouracil infusion alone or with Yttrium-90 resin micro-spheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. Journal of Clinical Oncology 2010; 28(23): 3687-3694.

2. Van Hazel G, Blackwell A, et al. Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer. Journal of Surgical Oncology 2004; 88(2): 78-85.

3. Gray B, Van Hazel G, et al. Randomised trial of SIR-Spheres plus che-motherapy vs. chemotherapy alone for treating patients with liver metas-tases from primary large bowel cancer. Annals of Oncology 2001; 12(12): 1711-1720.

Selective internal radiation therapy

Schematic demonstrating the injection of SIR-Spheres via a catheter inserted into the groin, with the SIR-Spheres lodging in the small blood vessels which

surround the tumour. Printed with permission SIRTEX

Issue 18 – December 2011 9.

MRI-guided, high-intensity focussed ultrasound for

the treatment of cancer

There has been a great deal of interest in the use of MRI-

guided, high-intensity focussed ultrasound (MRgFUS) for the

treatment of indications other than uterine fibroids including

cancer of the breast, liver, prostate, brain and bone. This

summary presented a brief overview of the evidence for these

indications.

HOW IT WORKS

High-intensity focussed ultrasound (FUS) is a non-invasive

means of focusing thermal energy to ablate deep soft tissue

targets such as tumours, which otherwise may only be excised

using open surgery. The high-intensity ultrasound deposits

localised energy, causing rapid vibration of molecules within

the focal spot. This results in localised heating (65-95°C) at the

focal point of the target tissue, avoiding damage to the

surrounding tissue but resulting in tissue necrosis, apoptosis

and cell death of the target. MRI clearly visualises the

boundaries between the normal and cancerous tissue and

when combined with FUS allows for precise targeting of

tumours.1,2

THE EVIDENCE

Breast cancer

MRgFUS allows for accurate targeting of breast lesions for

ablation as the breast may be isolated relatively easily, avoiding

potential damage to other organs and structures. MRgFUS

may potentially be used to replace surgical procedures such as

lumpectomy and wide local incision, in so doing conserving

the breast with the added cosmetic and psychological

benefits.3 Several issues have been identified with the use of

MRgFUS for the ablation of breast cancer, specifically the

importance of adequate tumour-free margins following

ablation and appropriate patient selection. Patients with large

tumours >5cm and those with tumours close to the chest wall

should not be selected.4

A recent review reported on the results of one of the largest

case series of MRgFUS ablation of biopsy-proven breast

cancer to date. Results were presented for 47 out of 57

enrolled women with small breast tumours ≤ 1.5cm with a

distance of more than 1.0cm from the skin. All patients under-

went core needle biopsy 3-weeks after the MRgFUS

procedure. Mean MRgFUS treatment duration was 108

minutes and after a mean follow-up time of 44 months no

local recurrences or significant adverse events were reported.5

Bone cancer

Up to 30% of all cancer patients will develop secondaries in

the bone and approximately half of these patients will go on

to develop pain from these lesions. The current treatment

option for these lesions is radiotherapy; however 20-30% of

patients will gain no relief from pain from radiotherapy and

of those who do experience relief, 27% will have recurring

pain once radiotherapy ceases. Bone actively absorbs FUS

and a large area at the periosteal margin of the bone can be

rapidly heated and in so doing may destroy neural pain fibres

in the periosteum, resulting in palliation of painful bone

lesions.2,6

Several case series were included for assessment in this brief.

All reported good patient outcomes with the majority of pa-

tients experiencing an improvement in pain scores measured

by the visual analogue scale (VAS) or a reduction in pain

medication. Many patients reported a reduction in pain

within 3-days of treatment.7-9

Brain cancer

Previous attempts to use transcranial focused US have been

unsuccessful due to the increase in the acoustic attenuation

of the skull, which is 30-60 times higher than in soft tissue.

To avoid this issue, a hemispherical transducer operating at a

lower frequency to produce the US beam, combined with a

specialised cradle capable of holding the head in place in a

cooling water bath (15-20°C) has been developed.10 There

was limited data available describing the use of MRgFUS for

HealthPACT Bulletin

Positioning of the patient for the treatment of breast cancer with MRgFUS (printed with permission InSightec Ltd)

10. Issue 18 – December 2011

MRI-guided, high-intensity focussed ultrasound for the treat-

ment of cancer continued.........

the treatment of brain tumours, however an interesting

potential use of MRgFUS is for the delivery of therapeutic

magnetic nanoparticles across the blood brain barrier for the

treatment of brain tumours such as gliomas. Low-energy FUS

is used to increase the permeability of the blood brain barrier

in a localised and reversible manner, allowing for the diffusion

of magnetic nanoparticles containing chemotherapeutic

agents. Diffusion of nanoparticles is usually passive, however

the application of an external magnetic force allows

concentration of a therapeutic dose at the target site, with

MRI used to monitor the procedure. The integrity of the

blood brain barrier is re-established within 24-36 hours. To

date only animal studies have been conducted.11-13

Prostate cancer

Phase I and II protocols have been finalised for the treatment

of prostate cancer, with studies set to commence in 2012.

FUTURE STEPS

Based on the low-level, preliminary evidence it would appear

that MRgFUS may be a useful tool for the treatment of pa-

tients with tumours who may have limited treatment alterna-

tives available to them. The range of applications for this tech-

nology are potentially wide-ranging and therefore Health-

PACT have recommended that a New and Emerging Health

Technology Report be commissioned late-2012 to allow suffi-

cient time for the results from the randomised controlled trials

to be published in addition to the publication of initial studies

into the use of MRgFUS for the treatment of prostate cancer

and neurological conditions.

For a copy of the full brief please contact the HealthPACT

Secretariat.

Written by Linda Mundy, HealthPACT Secretariat

HealthPACT Bulletin

REFERENCES 1. Fennessy, F. M. & Tempany, C. M. (2005). 'MRI-guided focused ultra-

sound surgery of uterine leiomyomas', Acad Radiol, 12 (9), 1158-1166.

2. Gedroyc, W. M. & Anstee, A. (2007). 'MR-guided focused ultrasound', Expert Rev Med Devices, 4 (4), 539-547.

3. Wu, F., ter Haar, G. & Chen, W. R. (2007). 'High-intensity focused ultra-sound ablation of breast cancer', Expert Rev Anticancer Ther, 7 (6), 823-831.

4. Schmitz, A. C., Gianfelice, D. et al (2008). 'Image-guided focused ultra-sound ablation of breast cancer: current status, challenges, and future directions', Eur Radiol, 18 (7), 1431-1441.

5. Brenin, D. R. (2011). 'Focused ultrasound ablation for the treatment of breast cancer', Ann Surg Oncol, 18 (11), 3088-3094.

6. Dick, E. A. & Gedroyc, W. M. (2010). 'ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications', Expert Rev Med Devices, 7 (5), 589-597.

7. Catane, R., Beck, A. et al (2007). 'MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience', Ann Oncol, 18 (1), 163-167.

8. Liberman, B., Gianfelice, D. et al (2009). 'Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicen-ter study', Ann Surg Oncol, 16 (1), 140-146.

9. Gianfelice, D., Gupta, C. et al (2008). 'Palliative treatment of painful bone metastases with MR imaging--guided focused ultrasound', Radiology, 249 (1), 355-363.

10. McDannold, N., Clement, G. T. et al (2010). 'Transcranial magnetic reso-nance imaging- guided focused ultrasound surgery of brain tumors: initial findings in 3 patients', Neurosurgery, 66 (2), 323-332; discussion 332.

11. Chen, P. Y., Liu, H. L. et al (2010). 'Novel magnetic/ultrasound focusing system enhances nanoparticle drug delivery for glioma treatment', Neuro Oncol, 12 (10), 1050-1060.

12. Liu, H. L., Hua, M. Y. et al (2010). 'Blood-brain barrier disruption with focused ultrasound enhances delivery of chemotherapeutic drugs for glioblastoma treatment', Radiology, 255 (2), 415-425.

13. Liu, H. L., Hua, M. Y. et al (2010). 'Magnetic resonance monitoring of focused ultrasound/magnetic nanoparticle targeting delivery of therapeutic agents to the brain', Proc Natl Acad Sci U S A, 107 (34), 15205-15210.

Schematic of the procedure demonstrating the localised permeability of the

BBB using FUS flowed by the diffusion of the magnetic nanoparticles, which

are then guided and concentrated by an external magnetic force13

Liver cancer

Invasive radiofrequency or laser ablation has recently been

used as a method to treat local tumours of the liver, with

probes being inserted percutaneously into the target tissue.

Application of power causes local heating followed by the

thermal destruction of tissue. MRgFUS has been suggested

as a non-invasive approach for the destruction of localised

areas of the liver, especially when underlying liver disease is

present, which is common in patients with hepatocellular

carcinoma. MRgFUS of the liver presents technical diffi-

culties due to the presence of the rib cage and movement

of the liver with respiration. Treating patients under

general anaesthesia overcomes the latter problem, however

a MRI-compatible ventilator is required. Currently

MRgFUS treatment can only be applied to areas of the

liver not covered by the rib cage, however it is anticipated

that modified transducers will allow treatment between the

ribs in the near future.2-6

Issue 18 – December 2011 11.

Although chest pain may be indicative of myocardial

infarction (MI) there may be many other causes including

indigestion and muscle strain. Patients with MI or acute

coronary syndrome (ACS) should be rapidly and accurately

identified to ensure that the appropriate treatment is

administered. Patients with chest pain are frequently admitted

to hospital until a negative biomarker, eg creatine kinase-MB

test excludes myocardial injury.1 Recently the cardiac

contractile protein troponin has become the preferred and

recommended biomarker.2,3

HOW IT WORKS

Troponin is a complex of 3 structural proteins (C, T and I)

that are integral to cardiac muscle contraction and are released

when cardiac myocytes are damaged. The higher the

concentration of troponin in the blood, the greater the dam-

age to the cardiac muscle. As such levels of troponin may be

used to diagnose MI in the presence of ischaemia.

Conventional troponin testing requires serial blood sampling

over a 6-12 hour period. High-sensitivity immunoassays

measure very low concentrations of troponin, allowing

diagnosis or exclusion of MI/ACS to occur earlier, thereby

expediting discharge in patients who test negative for an acute

cardiac event. Conversely, the increased sensitivity of these

assays may lead to an increase in hospital admissions, due to

the detection of lower, previously undetectable levels of

troponin that may not necessarily be due to MI.1,2 A positive

troponin result should be followed up by a search for an

alternative plausible diagnosis and/or cardiac consultation if

ACS is suspected in the context of the clinical presentation.4

THE EVIDENCE

Three non-randomised comparative studies were included for

assessment in this brief.5-7 Only the results of the largest study

are presented, however for a copy of the full brief please

contact the HealthPACT Secretariat.

1,818 consecutive patients presenting with chest pain and a

high pre-test probability of acute MI were recruited in a multi-

centre study. Troponin levels were measured and compared at

the time of admission to hospital, and at 3 and 6 hours post-

admission. Primary diagnosis was based on conventional

troponin assays, using Roche Troponin T or Siemens

Dimension RxL Troponin I. These conventional troponin I

assays were used only for the diagnosis of MI and not for

comparison with the sensitive troponin I assay. The final

diagnosis at discharge was based on all available clinical,

laboratory and imaging findings. A total of 413/1818 patients

(22.7%) had a final discharge diagnosis of acute MI, including

130 patients (7.2%) who presented with MI with ST-segment

elevation. The diagnostic accuracy of sensitive troponin I was

highest, with an area under the receiver-operating-

characteristics curve of 0.95 within 3 hours of presentation of

symptoms and 0.96 by 6-12 hours follow-up. The sensitivity

and specificity of sensitive troponin I was 90.7% and 90.2%,

respectively, compared to 72.7% and 94.1% for the standard

troponin T tests. Using the sensitive troponin I assay, 88% of

MIs were detected on admission in patients presenting 6 hours

after the onset of symptoms, and 95% were detected in those

presenting between 6-12 hours after the onset of symptoms.6

FUTURE STEPS

HealthPACT noted the concerns raised by the evaluators

regarding a potential conflict of interest of the authors of the

studies included for assessment. Based on the uncertainty

surrounding the potential advantages and disadvantages of

using high sensitivity troponin assays for the routine diagnosis

of MI, HealthPACT have recommended that the technology

be monitored for 12-months, awaiting the potential

publication of higher quality, preferably randomised, trials

become available could provide clarity in regards to the risk/

benefit profile for the use of the technology

Written by Deanne Forel from ASERNIP-S

HealthPACT Bulletin

REFERENCES 1. Baker JO, Reinhold J, Redwood S, Marber MS. Troponins: redefining their

limits. Heart 2011;97(6):477-452.

2. Masson S, Latini R, Anand IS. An update on cardiac troponins as circulat-ing biomarkers in heart failure. Current Heart Failure Reports 2010;7(1):15-21.

3. Omland T. New features of troponin testing in different clinical settings. Journal of Internal Medicine 2010;268(3):207-217.

4. Chew DP, Aroney CN, Aylward PE et al. 2011 Addendum to the National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand Guidelines for the Management of Acute Coronary Syndromes (ACS) 2006. Heart, Lung and Circulation 2011;20(8):487-502.

5. Aldous SJ, Florkowski CM, Crozier IG et al. Comparison of high sensitivity and contemporary troponin assays for the early detection of acute myocardial infarction in the emergency department. Annals of Clinical Biochemistry 2011;48(3):241-248.

6. Keller T, Zeller T, Peetz D et al. Sensitive troponin I assay in early diagno-sis of acute myocardial infarction. New England Journal of Medicine 2009;361(9):868-877.

7. Reichlin T, Hochholzer W, Bassetti S et al. Early diagnosis of myocardial infarction with sensitive cardiac troponin assays. New England Journal of Medicine 2009;361(9):858-867

High sensitivity troponin assays for the diagnosis of

myocardial infarction

12. Issue 18 – December 2011

The Regulatory Standards for the approval of Medical Devices in Australia The Senate Standing Committee on Community Affairs completed its Inquiry into "The Regulatory Standards for the Approval of Medical Devices" and tabled its report in the Senate on 22 November 2011. The Report (including its 18 Recommendations) can be found at: http://www.aph.gov.au/Senate/committee/clac_ctte/medical_devices/report/index.htm

HealthPACT Bulletin

News round-up

Technology Key Messages

Aerosol-Generating Procedures and Risk of Transmission of Acute Respiratory Infections : A Systematic Review

Very low-quality evidence suggests that some procedures potentially capable of generating aerosols have been associated with increased risk of SARS transmission of SARS-CoV from infected patients to HCWs, with the most consistent association across several studies being with tracheal intubation.

Email and Electronic Communication of Patient Information: Clinical Evidence and Guidelines

Evidence suggests that email or electronic communication use between health-care providers and patients is beneficial and improves communication; how-ever, there are concerns about confidentiality and security, and inadequate ad-herence to recognised guidelines

Wireless Nurse Call Technologies: Clinical Evidence and Guidelines

The evidence suggests the use of wireless nurse call technologies in acute and long-term health care facilities can improve overall clinician-clinician and clinician-patient communication as well as increase clinician response times.

Screening and Diagnostic Tests before Endo-scopy: Clinical Evidence and Guidelines

Although faecal occult blood testing in patients at-risk for neoplasia is useful in preventing unnecessary colonoscopies, the evidence suggests that the identified alternatives to endoscopy for adult dyspeptic patients are less effective than initial endoscopy. Evidence-based guidelines recommend that standard tests and screening for patients before undergoing endoscopy be performed based on perceived level of risk for the patient; adults over 50 years of age with dyspepsia should undergo endoscopy.

CADTH Rapid Response Service The Canadian Agency for Drugs and Technologies in Health (CADTH) provides a Rapid Response Service with a range of products e.g. a reference list or summary with critical appraisal. An excerpt of their Summary for November 2011 is shown below. For more information, see http://www.cadth.ca/en/products/rapid-response/2011/06?

In September Singapore’s Agency for Science, technology and Research (A*STAR) and the NHMRC signed a Memorandum of Understanding to promote exchange between the 2 countries in the areas of health and medical research. Under the MOU, the 2 agencies will fund collaborative research projects in areas such as emerging infectious diseases, regenerative medicine, non-communicable diseases, bioinformatics and nanotechnology. In addition, scientific symposia will provide a platform for researchers from both countries to share their latest research and a forum to establish networks. The first symposium is scheduled to take place in Australia in 2012.

In 2011, the NHMRC is celebrating 75 years of enabling health and medical research in Aus-tralia. To celebrate this milestone, a 3-day scientific symposium titled, Research for a Healthy Future, was held in Canberra. The Symposium was attended by approximately 200 out-standing early to mid-career researchers, nominated by their institutions as future research leaders with some Australia’s leading researchers, including Nobel Laureates Professors Peter Doherty and Ian Frazer, as key-note speakers. Themes discussed included the challenges facing health and medical researchers across the globe such as combating non-communicable disease, collaborating to ensure health policy and practice is evidence-based, and providing for the health needs of the present while planning for the future. Topics within this scope included mental health and dementia; patient care, policy and practice; and economic and industry benefits of health and medical research as well as a broad examination of the future of health and medical research. A copy of the symposium handbook can be accessed via this link in addition a video presentation of many of the speakers may be accessed here.

Issue 18 – December 2011 13.

HealthPACT Bulletin

For more news on the 2012 HTAi Conference go to the web site of the meeting: http://www.htai2012.org, or follow news and be updated through the social networks: Facebook https://www.facebook.com/pages/HTAi-Bilbao-2012/246259402058890 and Twitter http://twitter.com/#!/htai2012.

The theme for HTAi 2012 is “HTA in integrated care”. The conference hopes to share and discuss the experiences of

health care practitioners, researchers, policy makers, industry representatives, consumer and patient organisations

and other stakeholders as they grapple with new technological innovations, challenges and solutions being developed

to integrate health care.

14. Issue 18 – December 2011

Other New and Emerging

Technologies

The following technologies were also considered by the

Health Policy Advisory Committee on Technology

(HealthPACT) in August 2011.

Regional hyperthermia for soft-tissue sarcoma

90Y-Zevalin for the treatment of non-Hodgkin's lym-

phoma

And in November 2011

Peripheral Vascular Stents including drug-eluting

balloons

Percutaneous Venoplasty

An update of Implantable Baroreflex Stimulation for

Hypertension

An update of Rapid Tests for Chlamydia

An Update of Extracorporeal Shockwave therapy for

the treatment of angina

For copies of these briefs please contact the Health-

PACT Secretariat

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

14. Issue 18 – December 2011

HealthPACT Bulletin

PRODUCTION NOTES The HealthPACT Bulletin is published by its Secretariat on behalf of the Health Policy Advisory Committee on Technology (HealthPACT) and funded by the Australian Government Department of Health and Ageing. Sources of many articles herein are reports prepared by Adelaide Health Technology Assessment (AHTA) and the Australian Safety and Efficacy Register of New Interven-tional Procedures – Surgical (ASERNIP-S) who were con-tracted to support HealthPACT’s work.

- - - - - - - - - - - - - - - - - - - - - - - - Editors: Elizabeth Garrigan and Linda Mundy Design: Elizabeth Garrigan and Linda Mundy Writers/Information Specialists: Linda Mundy, Ben Ellery, Deanne Forel, Heath White, Prema Thavaneswaran and Yasoba Atukorale. Contact: Manager, HealthPACT Secretariat c/o Access Improvement Service, Centre for Healthcare Improvement, Queensland Health Citilink Business Centre, Lobby 2, 153 Campbell Street, Bowen Hills, QLD 4006 email: HealthPACT@health.qld.gov.au Tel: +61 7 3239 6483 Fax: +61 7 3405 6108 - - - - - - - - - - - - - - - - - - - - - - - - Please forward any feedback on this Bulletin or advice re-garding medical or surgical technologies, procedures, or health programs that are new or emerging in Australia to: Tel: +61 7 3239 6483 Email: HealthPACT@health.qld.gov.au