MSAC decision disappoints Sirtex CEO

The chief executive of Sydney-based company Sirtex has expressed disappointment with the Medical Services Advisory Committee (MSAC) following its surprise rejection of a subsidy application for the company's liver cancer treatment.

Speaking to Australian Biotechnology News on Monday, Sirtex chief executive Dr Colin Sutton expressed deep concerns about the decision and said that it reflected serious problems within the Australian health system which needed to be resolved.

Last Friday's decision by MSAC - handed down after an unusually long assessment period of 24 months - fell the day after a Channel Nine news item showed a liver cancer patient, who was originally given two days to live, being discharged from hospital after being injected with Sirtex's biocompatible radioactive microspheres, or SIR-Spheres.

But Sutton said he had no desire for the matter to erupt into a slanging match over government policy. He said that it would be best for Sirtex to focus on responding to requests for more information from MSAC, which is an independent committee advising government on new and emerging medical technologies.

"I am sure that the Australian government is under a lot of pressure and is concerned about the blow-out in the [Pharmaceutical Benefits Scheme] budget," Sutton said.

In a statement to the Australian Stock Exchange on Friday the company said that while MSAC acknowledged that the treatment was "safe and had anti-tumour activity", it had requested that further data on "survival and quality of life benefits for the patient" be submitted before the committee could recommend funding from the public purse.

Citing concerns about spiralling public health costs, the Federal government recently outlined changes designed to rein in public healthcare spending. But industry representatives have been quick to criticise the revisions, arguing that they will restrict access to several important new drugs, many of which are subsidised overseas.

Sutton said that he was disappointed at the MSAC decision and said that it had hardened Sirtex's resolve to pursue overseas markets. "Our continued emphasis on the US market is reinforced by this decision," he said.

Further ahead in the US

While rejection of its Australian application took two years, Sirtex waited just two months to receive the equivalent approvals in the US where it was granted reimbursement codes spanning hospital treatment required for the SIR-Sphere technique as well as the technique itself.

"We are further ahead in the US than we are here for a locally developed product," Sutton said. "One thing I was very concerned about is that it took such a long time for the [Australian] government to give us a response."

Sutton is in the UK this week and is expected to meet with representatives of the British Standards Institute to negotiate registration for his company's SIR-spheres in Britain, which would pave the way for broader acceptance throughout the EU.

SIR-Spheres have been employed in the successful treatment of several hundred sufferers of liver cancer throughout Australia, New Zealand, Hong Kong, Singapore and Thailand, with US adoption growing rapidly. Produced at the Lucas Heights nuclear reactor, SIR-Spheres are biocompatible radioactive microspheres that contain yttrium-90 and emit beta radiation. The spheres are implanted using a syringe and travel via the blood stream and are targeted specifically to the tumours within the liver, entrapping themselves within small blood vessels.

According to Sirtex, using its specific technique for deploying the spheres, it is not necessary to identify either the number or location of the tumours within the liver as the spheres will target them regardless of where they are. Once caught within the tumour, the spheres irradiate it by a process known as Selective Internal Radiation Therapy (SIRT), leading to the destruction of the tumour with minimal damage to normal liver tissue.

The spheres can be manufactured from a variety of different materials and act as transport vehicles to carry anti-cancer agents such as ionising radiation (SIR-Spheres), anti-cancer drugs (Dox-Spheres) or materials that can generate heat within the cancer, known as thermo-spheres.

Speaking last Thursday on Channel Nine news, Prof David Morris from St George Hospital expressed concern that the highly expensive SIRT treatment was not as accessible in Australia as it could be. "This treatment is really proven [to be] valuable in a number of settings, and it's awfully expensive, and we're really struggling to be able to pay for it," Morris said.

A spokeswoman for MSAC explained that the committee's role was to undertake scientific, evidence-based research of new medical technologies, assessing their cost and overall effectiveness and safety.

"Based on this assessment, MSAC recommends to the Minister for Health and Ageing whether public funding should be supported for the technology," she said. "United States approval has no bearing on Australian deliberations."

In relation to SIRT, the committee concluded that "the treatment is reasonably safe and has anti-tumour activity. However, it is not clear whether this anti-tumour activity translates into a survival or quality of life benefit to the patient."