Table 7c.

Applications with Interim Recommendations*

App.	Description	Safety	Effectiveness	Cost-effectiveness	Comment	Type
1014	TransUrethral Needle Ablation for benign prostatic hyperplasia	Relatively safe	Relatively effective procedure for the short-term management	Additional clinical data is required	Limited role as an alternative treatment for symptomatic benign prostatic hyperplasia with the following restrictions: men with moderate to severe lower urinary tract symptoms that require specific treatment (ie those who would normally be recommended for TURP); not be medically suitable for TURP.	Surgical
1015	Directional, vacuum-assisted breast biopsy	Safe	Seems to be more effective	Not undertaken	Currently claimable under the MBS. The costs associated with the procedure should be investigated; and pending review of the costs, the procedure should receive interim funding at a higher remuneration than is currently available under existing items for nonpalpable breast lesions.	Diagnostic
1026	Near patient cholesterol testing using the Cholestech LDX	Safe	Improved diagnostic accuracy over conventional	Problematic due to uncertainties	The unrestricted use of near patient cholesterol testing using the Cholestech LDX is not recommended. The restricted use of near patient cholesterol testing, as an alternative to laboratory testing of lipids, should be considered in settings or circumstances where there is adequate training, accreditation and quality assurance.	Diagnostic
1029	Brachytherapy for the treatment of prostate cancer	May offer less risk	There has not been a successful randomised controlled trial	Slightly higher direct budgetary costs but may involve less indirect costs	Patients with prostate cancer at clinical stages T1, T2a or T2b, with Gleason Scores of less than or equal to 6, prostate specific antigen (PSA) of less than or equal to 10 ng/ml, a gland volume less than 40 cc and with a life expectancy of more than 10 years; and where the treatment is conducted at approved sites.	Surgical
1031	Deep brain stimulation for symptoms of advanced Parkinson's disease	limited evidence suggests	Some evidence – more long-term studies of improved methodological quality are needed.	Costs more than alternative over 5 years.	For patients where their response to medical therapy is not sustained and is accompanied by unacceptable motor fluctuations; and subject to the patients' participation in an appropriate controlled trial to obtain information on adverse events, longer-term patient outcomes and costs in the Australian setting.	Surgical
1041	Intravascular Brachytherapy – Commercial-in-Confidence application	Acceptable	Based on level II and III-3 evidence.	Estimated to be approximately $31,500 per TLR prevented.	There is insufficient evidence on the safety and effectiveness of implanting radioactive stents to support public funding for this procedure. The short- and medium-term data on the safety and effectiveness of catheter based intravascular brachytherapy for the treatment of coronary artery restenosis is sufficient to warrant interim funding for this procedure.	Surgical
10541	Hyperbaric Oxygen Therapy (Resubmission)	Adverse events self-limited and resolved after termination of therapy	RCT evidence was of low methodological quality, failing to meet relevant validity criteria.	Clinical evidence was inadequate to substantiate claims that (HBOT) was cost-effective.	The clinical evidence was inadequate to substantiate claims that hyperbaric oxygen therapy (HBOT) was cost-effective in the treatment of refractory soft tissue radiation injuries or non-diabetic refractory wounds. However, MSAC recommended that, as there are no effective alternative therapies and in view of the progress of local data collections and an international trial, funding for HBOT continue.	Therapeutic
1057	M2A® capsule endoscopy for the evaluation of obscure gastrointestinal bleeding in adult patients	Infrequent and mild adverse events.	Little available data on this technology's effect on patient management and long-term clinical outcomes.	Lower total health care costs overall.	Funding should be supported for this procedure for patients with confirmed recurrent obscure gastrointestinal bleeding following previous colonoscopy and endoscopy without identifying bleeding source.	Diagnostic
1065	Sentinel Node Biopsy for Breast Cancer	Appears to be safe	Long term outcomes are uncertain	Based on cost minimisation, the cost to avoid lymphoedema. Therefore, the procedure appeared cost-effective.	Long term outcomes are uncertain. Funding for sentinel node biopsy should be provided pending the outcome of trials already in progress and should be reviewed in five years.	Diagnostic – Biopsy
1082	SIR-Spheres® for the treatment of non-resectable liver tumours				Patients with hepatic metastases secondary to colorectal cancer which are not suitable for resection or ablation. Not funded for non-resectable, non-ablatable hepatocellular carcinoma.	Therapeutic
10892	Brachytherapy for the treatment of prostate cancer	Unchanged from 1029	Unchanged from 1029	Unchanged from 1029	As a result of re-assessment of further evidence – interim public funding should continue for patients with prostate cancer at clinical stages T1 and T2 with Gleason Scores of less than or equal to 6, prostate specific antigen (PSA) of less than or equal to 10 ng/ml, gland volume less than 40 cc and with life expectancy of more than 10 years.	Surgical

¹ Re-application for Application 1018–20

² Re-application for 1029

* As a general rule all interim funding is subject to data collection and is for a period of three years.

Source: MSAC Reviews http://www7.health.gov.au/msac/msacapps.htm. Accessed 6th Jan'06