Cancer treatment for Australians trailing other countries, Senate told

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Australian cancer patients and oncologists have told a senate inquiry that Australians cancer suffers may die because they can’t access some of the cancer-busting wonder drugs available overseas due to long delays in drug approvals and registration.

Oncologists have warned that delays also risk diverting pharmaceutical companies and clinical trials overseas.

Many acutely personal and deeply moving stories have been submitted by cancer sufferers, their loved ones and oncologists in response to the Senate Community Affairs Reference Committee’s inquiry into the availability of new innovative cancer drugs in Australia.

The Committee’s remit is to examine the timing and affordability of drugs for cancer patients and to look at the operation of the Pharmaceutical Benefits Advisory Committee (PBAC) and the Pharmaceutical Benefits Scheme (PBS). It is also tasked with exploring the impact of delayed drug approvals on Australian cancer patients.

The Committee is not due to report until June but a gloomy picture is already beginning to emerge that cancer treatment in Australia is falling further behind other countries because of the complicated and onerous process demanded by the Therapeutic Goods Administration (TGA), further exacerbated by a time lag before new drugs are listed under the PBS.

It is a measure of the strength of feeling sparked by the inquiry that there have been 104 submissions and the committee’s reporting date has been extended twice until June 17. The Committee was originally due to report on March 26 this year.

John Walden, who suffers from a rare blood cancer called Waldenström’s Macroglobulinemia, told the inquiry that several of the drugs he needed are still waiting for the green light from the TGA.

“Australian patients, it seems, are missing out on new cancer medicines and relying on older alternatives compared to many other countries,” Mr Walden said.

“We can’t wait the years that our present approval process takes, nor can we afford to pay the full unsubsidised costs. We understand that new cancer drugs are costly but our approval processes are slow and not designed to cater for the changes in cancer research technologies.”

The Cancer Drug Alliance (CDA), an NGO representing patients, medical staff and pharmaceutical companies, said new drugs took an average of 31 months be listed under the PBS after being approved by the TGA.

The Alliance said that Australian patients were “being denied potentially life-saving drugs available in other countries or experiencing considerable delays in accessing the many new and innovative medicines”.

The CDA added that Australians were not benefitting from the broader treatment options delivered by rapid advancements in targeted cancer therapies because of delays in drug approvals.

“Ironically, the products of this research are not being rapidly assessed by our current system and therefore are often not funded by the Pharmaceutical Benefits Scheme in a timely manner; as a result the benefits are not flowing to Australian cancer patients,” the CDA said.

“While cancer patients and their families wait for cancer medicines to be approved by the PBAC they face significant financial, physical and psychological burdens. Patients have few options other than to pay a significant amount of money out of their pocket for treatment or else accept that they will not receive the latest, most effective treatments.”

The CDA said one drug that combats lung tumours caused by genetic mutations was available in 70 countries but not on Australia’s PBS in Australia, despite being approved by the TGA in 2013.

Australia is the melanoma capital of the world, yet the CDA says other countries are leading the way when it comes to funding treatment and approving exciting new drugs.

Clinical trials found that new targeted and immune drug therapies pushed one-year survival rates for advanced stage melanoma from 30-35 per cent to 70-80 per cent. In America, the Federal Drugs Administration granted the drugs ‘breakthrough therapy” status to fast track their approval so that people could start the drugs straight away but this did not happen in Australia.

“While these drugs are currently being trialled in Australia, only patients on these trials have access to these new ‘breakthrough’ therapies,” the CDA said.

“While some of these new agents are now reimbursed via the PBS, Australia lags behind many other countries in funding these treatments, despite our incidence rates being so much higher.”

The CDA recommended drugs proposed to be listed on the PBS should not be solely assessed on cost-effectiveness but also on quality of life and end-of-life, that there be greater engagement with cancer patients and specialists and a national chemo database be set up to record outcomes from different treatments.

Some patients like Paul Hobson, who has with prostate cancer, are frustrated that Australian cancer patients have to jump through hoops to get the right drugs.

Mr Hobson has been told he must have chemotherapy before he can access anti-androgen drugs Zytiga or Xtandi on the PBS, drugs that American oncology researchers have recommended as the best treatment. American cancer patients can take these drugs before chemotherapy.

“These drugs offer good quality of life and delay progression of the cancer. In particular these drugs delay the need for chemotherapy with its unpleasant side-effects. These drugs can be self-administered at home, reducing the need for hospital-based care,” Mr Hobson said.

“The impact of delays in the approvals process means that patients and their families are aware of treatments that have been evaluated overseas and proven to be effective, treatments which could provide enhanced quality of life or extra time with their families. It is heartbreaking for them and their families to be aware that these benefits will not be available to them.”

Oncologists have also added their voices to the senate inquiry. The Medical Oncology Group of Australia (MOGA), the peak professional body for Australian medical oncologists, told the inquiry that access to cancer fighting drugs in Australia was inequitable and lacked compassion.

“It favours a user pays approach that discriminates against patients without the ability to pay for non-subsidised oncology drugs and treatments,” said MOGA’s submission.

“Regrettably, access arrangements are dependent on where a patient lives, who their physician is, their access to specialised cancer treatment and their level of private health insurance.

“Additionally, even when an oncology drugs and therapy is made available through the PBS, patients are often required to pay substantial out of pocket expenses that causes them an additional financial burden and psychological distress, that often further complicates their treatment.”

Worryingly, it said delays in drug approvals and subsequent registrations could divert the pharmaceutical industry and clinical trials away from Australia to other countries.

MOGA suggested expediting drug approvals in a similar way to other countries like the US and the UK; streamlining the current regulatory and registration system; linking the price of a drug to health outcomes in clinical trials; creating a single agency and decision-making process and assessing a drug’s economic merits more broadly, for example considering the costs for families and carers and a patient’s productivity following better functionality.

Many of the submissions called on the Australian government to recognise drug approvals by overseas regulatory agencies like the US Food and Drug Administration and the European Medicines Agency, having an interim fund to push drug registrations forward, like the UK’s Cancer Drug Fund, and to properly consider overseas advances in best practice treatment for cancer.

Australia carries a heavy cancer burden with one in two men diagnosed with cancer by 85 and one in three women in 2015.

The CDA estimates there are 125 deaths from cancer every day in Australia, accounting for nearly 20 per cent of the total disease burden in the country.


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