Associate Professor Gary Richardson is the Director of Oncology Clinics Victoria, Director of Cabrini Academic Haematology and Oncology Services and an Associate Professor of Medicine at Monash University. He previously held the position of Director, Department of Medical Oncology and Clinical Haematology at Monash Medical Centre. He is a Fellow of the Royal Australasian College of Physicians. Specialised Therapeutics sought his insights on medical and pharma interactions.

By Assc. Prof. Gary Richardson, Director of Oncology Clinics Victoria and Oncology Services and Assc. Prof. of Medicine, Monash University

Specialised Therapeutics’ new business model can’t be a bad thing, because interactions between pharma companies and the medical profession have definitely changed, thanks to the digital revolution.

In the old days when doctors saw pharmaceutical company representatives, it was all paper. That meant that part of a rep’s role was to bring papers, show you evidence, outline details from a recent scientific meeting as well as spend some time selling the drug.  Those days have gone, because everything is on the web now. You get the alerts and the data is there. There are not that many practice-changing things that occur on a day to day basis and if there are, you will find out about it straight away.

What do I want when a pharma company representative comes to my office?  I want information about new clinical trials and about drug access programs. I also want to know what’s in the pipeline, what’s coming to Australia and what we can do in the space we operate. I don’t really want old information about drugs that are already available – I already know that information. What I would like is early information, that I may not yet have seen or been able to access. That kind of information is really good, but that is not so easy to get all the time.

(Under the Medicines Australia Code of Conduct), pharmaceutical representatives are prohibited from speaking openly and freely about access programs for medicines that are not yet approved for marketing in this country – despite the fact these drugs may be already approved and available overseas.

There needs to be a rethink. It is ridiculous that you can’t discuss medicines that are ‘off-label’ or drugs that are potentially coming in the future. There seems to be a fear you will somehow break the rules. I find it insulting that authorities think you might be swayed by these sorts of discussions.

Consider the landscape around five years ago, when all the immunotherapy trials were being done in melanoma overseas. Abiding by the letter of the law, no-one in Australia could discuss any of those medications with anyone, at all. You understand that a trial is going to come, and these drugs are being used overseas, but you are not allowed to talk about it. It just seems crazy, as not all oncologists attend overseas meetings or has seen an original presentation –  particularly if it’s not in their own area of expertise.

As a doctor, you should be able to make a decision whether a drug should be able to benefit any particular patient you have. The doctor has to make the decision to benefit the patient, because that’s what we do.

In terms of other interactions with pharma, I have no problem with transparency reporting, (where pharmaceutical companies acknowledge payments to individual doctors for services or contributions towards them attending education activities, including flights and accommodation). But I do think it should be the same across all industries – it should be the same for politicians or lawyers. I am not worried if someone puts my name in the paper and notes that I’ve been paid (by a pharmaceutical company) to attend a meeting. The doctors that worry about these things the most I think, are the younger doctors. And particularly the ones that are still working in the public system, because it seems to me that they are very wary of pharma.

At the end of the day, working with pharma is a double edged sword. Pharmaceutical companies provide good drugs and sponsor clinical trials. The downside is that the industry as a whole, is largely perceived to be about money and many of the big pharma companies are beholden to shareholders.

What would I say to younger doctors who might be wary? At the end of the day, pharma companies are in the business of creating drugs that work. And there are some really amazing drugs that have been made. There are a lot of positives. And this move to remove financial incentives from reps based on volume of sales achieved takes away that pressure to sell and paves the way for a more open discussion.”

*Associate Professor Gary Richardson spoke with Specialised Therapeutics in August 2017.

Oncotype DX^® breast cancer assay may spare thousands of women from chemotherapy
Medical Services Advisory Committee has now rejected five funding applications for Oncotype DX

Melbourne, Australia, 4 October 2017: THE Federal Government’s peak advisory committee for Medicare funding has rejected calls from doctors, patients and the pharma industry to fund a novel breast cancer test that may spare thousands of Australian women from enduring unnecessary chemotherapy.

The Health Department’s Medical Services Advisory Committee (MSAC) recommended against funding the expensive Oncotype DX breast cancer assay for Australian women – despite it being reimbursed and freely available to women in many other countries, including the United States, Canada, the United Kingdom and throughout Europe.

This genetic test identifies those women who could safely avoid chemotherapy, by analysing the activity of specific cancer genes taken from a single sample of tumour tissue. It is suitable for breast cancer patients who have hormone receptor positive, HER2 negative, early stage breast cancer, which is a common form of breast cancer affecting thousands of Australian women.

The test provides a prognosis of the likelihood the cancer will recur. It is also able to provide medical teams with predictive information, identifying tumours that would be more sensitive to chemotherapy.

Specialised Therapeutics Australia has made the test available in Australia since 2014 to those women who are able to afford the $4500 out of pocket cost. Since 2014, more than 1,000 men and women diagnosed with breast cancer have paid for an ODX test allowing them and their medical team to make a more informed decision about their treatment.

In the US, Canada, the UK and Europe, the Oncotype DX test is reimbursed, widely available and consistently shown to be cost-effective. It has spared many patients from enduring unnecessary and debilitating chemotherapy.

Respected Australian surgical oncologist and specialist breast surgeon, Professor Bruce Mann said he was “very disappointed” by the decision, noting the test had been shown to change treatment decisions in many cases. He said that most frequently, it enabled patients to avoid chemotherapy. But sometimes, test results indicated that chemotherapy was the best treatment path.

“Many breast cancer patients simply cannot afford the high costs of this test and so are making treatment decisions without all potentially available information,” Professor Mann said.

“Having access to funded tests would allow limited health resources to be directed towards those who will benefit most.”

Australian breast surgeon Miss Jane O’Brien said that while the test frequently helped identify those women who could avoid unnecessary chemotherapy, it was also able to identify those for whom chemotherapy should be recommended.

“Without Oncotype, some patients may face the prospect of being under-treated,” she said.

“I have had patients who have taken the test and been advised to proceed with chemotherapy, when perhaps medical oncologists would have been confident in recommending anti-hormone therapy alone, based on the standard criteria that we have historically used. I think it is a great pity this test is not widely funded for all appropriate Australian patients.”

The Oncotype DX breast cancer assay measures the expression of 21 cancer-related genes to provide a Recurrence Score^® result, a number between 0 and 100.

A low Recurrence Score result is associated with a better prognosis and the likelihood that there would be little to no benefit in being treated with chemotherapy. Conversely, a high result would indicate a poorer prognosis, however chemotherapy is likely to be effective and reduce the risk of recurrence.

The Oncotype DX breast cancer assay is suitable for women diagnosed with hormone-receptor positive, HER-2 negative breast cancer. The test is performed on tumour tissue removed during original surgery and patients are advised to have the test soon after surgery and before commencing follow up treatment.

The Oncotype DX test was developed by Genomic Health, Inc. (NASDAQ: GHDX) a world leading provider of genomic-based diagnostic tests that optimise treatment for early stage cancer. The company is based in California in the USA.
The Oncotype DX breast cancer assay is made available in Australia by international biopharmaceutical company Specialised Therapeutics Australia at a cost of $4,500.

Specialised Therapeutics’ Chief Executive Officer Mr Carlo Montagner said he was dismayed and frustrated by the latest MSAC decision, which follows five funding applications for Oncotype DX in Australia.

“This simply means that Australian women continue to be at a disadvantage,” he said. “This test is widely available and reimbursed for women in most developed countries, including the United States and the United Kingdom.

“It seems that in Australia, only the ‘haves’ of our society can benefit from this cutting edge technology. What a pity, in this age of personalised medicine and especially at a time when the Government has acknowledged a commitment to innovation. Our belief in this technology is validated by clinical data and the experience of doctors and patients from around the world. We are lagging behind.”

Specialised Therapeutics Australia will now seek to meet with health department authorities to reconsider the funding application.

Ends.

About the Specialised Therapeutics Group 

The Specialised Therapeutics (ST) group of companies collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases in Australia, New Zealand and throughout South East Asia. ST is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, urology and ophthalmology. Further information can be found at www.STAbiopharma.com

About Oncotype DX^®

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumour in order to optimise cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score® test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. With more than 800,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalised medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com or  www.MyBreastCancerTreatment.org.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that help optimise cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ^® Genomic Intelligence Platform™, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company’s flagship line of Oncotype DX^® gene expression tests that have been used to guide treatment decisions for more than 800,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ^® Liquid Select™ test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

Our company has enjoyed a long-standing relationship with Rare Cancers Australia, supporting this organisation’s ongoing endeavour to provide all cancer patients with timely and affordable access to new cancer therapies. We are proud to introduce guest blogger Richard Vines, the CEO and co-founder of RCA, as he passionately but simply explains the need for change and how it can be achieved.

IN MY OPINION

By Richard Vines, Chief Executive Officer and Co-Founder Rare Cancers Australia

Consider this: There are two brothers and both are diagnosed with cancer. One has a rare tumour and one is diagnosed with melanoma. Both go to the same oncologist and both are prescribed the same immunotherapy drug. One brother walks out paying $30 a month because the drug is PBS listed  for melanoma, while the other one needs to find $10,000 per month.

Does that pass the ‘pub test’? But this scenario gets worse. We know that when a drug is listed on the PBS, the PBS does not pay pharma companies the official retail price because they have huge buying power and they can negotiate the best financial deal. This is normal and acceptable commercial behaviour. The rare cancer patient has already contributed his tax to help the Government pay for that drug’s broad accessibility for more common cancers, like melanoma. But then, he has to go and pay full retail price. So, you can see, the inequity just builds and builds.

In my role as CEO of Rare Cancers Australia (RCA), this scenario for patients is heartbreaking, and it is not uncommon. The frustration is palpable, it’s ongoing and I am seeing this with our patients every day. There are 240 acknowledged ‘rare cancers’, impacting thousands of patients in Australia.

These patients inevitably reach a point where they run out of PBS funded treatment options. Then, the affordability factor means they have nowhere to turn, despite the fact that there are often life-saving, or life-extending, medicines available. These patients – tax-paying Australians – are looking at prohibitive costs, of perhaps $6 – 8,000 a month.

The PBS System is one designed to carefully steward taxpayer funds with strict guidelines for evidence and cost-effectiveness. But in reality, the level and quantity of evidence required by the PBS is not attainable for rare and super rare cancers. This means that medicines invariably struggle to get reimbursed for these small patient populations. We need realism and flexibility.

I was talking to a mesothelioma patient the other day. The drug that he wants, or will need as a next step in trying to survive, is going to cost him $10,000 per month. He is about 55 years old and he can trace his disease back to a time when he was working in a factory at about 19 or 20 years old. The possibility of him getting any legal compensation is minimal however, and he wants an immunotherapy drug. We can’t get him enrolled in a trial, because the selection criteria is really tight, so what option is he left with? Nothing. Should he re-mortgage his house and leave his family with fewer funds to buy himself some extra time?

There are drugs that are already available in this country and I call these medicines the ‘low hanging fruit’ in this whole debate. These medicines have been approved by the TGA for at least one common cancer type so we know that they are safe (within reasonable bounds) and that the supply chain has been verified. We also know that they are effective in rare cancers. Let’s find a way to use them, for this mesothelioma patient and all the others.

To fix this we need everyone at the table, not just the Government but also the pharmaceutical industry, the clinical community, public servants and of course, patients and patient advocacy groups like ours.

For a start, the Federal Government needs to take a pragmatic approach. It must acknowledge that it is not always going to have all the evidence it needs to list a medicine for rare indications – it’s just not possible, given the size of the patient populations we are dealing with. We have seen, and applaud, instances where Government authorities demonstrate this kind of flexibility

Take the recent case of Vorinostat. This medicine was TGA approved in 2009 for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) with progressive, persistent or recurrent disease subsequent to prior systemic therapies.

A subsequent PBAC submission  was rejected for this rare indication due to ‘unacceptably high and uncertain cost-effectiveness ratios.’

Advising the knock-back, the PBAC noted that the quality of data within the submission was extremely limited, due to  small study sizes and heterogeneous, non-comparative data.

In  2016, we (RCA)  worked with the company involved to invest in an additional analysis that would support a high quality resubmission.

The PBAC showed its  flexibility in assessing this submission (e.g. allowing comparison to palliative care for the cost effectiveness analysis) and then, following successful price negotiations, Vorinostat was finally PBS listed on 1 July 2017.

This was a great outcome and something we, at RCA, are very proud of. Now I believe we must continue seeking new ways of collecting both trial and real world data. To do this, clinical trials especially Government-funded investigator trials need to have broader and wider inclusion criteria.

We would particularly like to see an allowance made so that 10% of places on all clinical cancer trials are reserved for rare cancer patients. This would not cost much, and could be done in such a way as to not detrimentally affect the main trial outcome, should the rare indications produce lower quality results. Companies and universities could do this tomorrow. Clinical trials are the best, safest and smartest way for cancer patients to access new and experimental therapies.

Government and industry also need to look at how they can make small changes, to ensure it is commercially attractive for industry to go to the effort and expense of applying for drug listings for small populations.

In our recent ‘Rare Solutions’ report we called for the introduction of multi-indication submissions as a means of allowing companies to apply for rare indications at the same time as common ones – thereby saving some of the inevitable double up that happens when  applying for the same drug multiple times. We were very encouraged that the Health Minister announced, at the launch of our report, that he has instructed the chair of the PBAC to begin looking at mechanisms for pan-tumour applications, but we all need to work hard together to make this a reality.

Pharmaceutical companies can’t just sit there with medicines on the shelf that might help rare cancer patients and not try to make these drugs available. Companies need to be assertive and get on the front foot. If they have a drug listed for breast cancer, then anything they can add on to that is a bonus. I say to them, ‘Do a bit of extra work and open up other indications so that more patients can access the treatment’.

And oncologists need to get active and advocate. At the end of the day, they are the people who have to look a patient in the eye and say, ‘I am sorry, there is a drug that can help you but it is going to cost you $10,000 a month’.

Speaking generally, medical professionals are not traditionally political creatures, but when it comes to rare cancers, they need to be. Sometimes these doctors may just need to ruffle a few feathers to get a good outcome for the people whose lives are in their hands.

At the end of the day, who gets to decide a patient’s treatment? It should be a patient’s oncologist, not an economist. It’s time to act.

For more information, please go to www.rarecancers.org.au

See below Specialised Therapeutics’ inaugural edition of Inspire, a magazine for women living with breast cancer. To view this publication, move your mouse over the image below and click on the Click to read button.

ST is a longstanding supporter of the GI Cancer Institute, which saves lives by funding important research into gastro-intestinal cancers, including pancreatic cancer. In a few days, medical oncologist Dr Lorraine Chantrill will walk the Larapinta Trail in the Northern Territory to raise new funds. In this short video, she explains her mission and motivation.

Please click on the following video link to view the video.

Wendy Dunstone was diagnosed with early breast cancer and chose to have her tumour tested using the genomic test, Oncotype DX to guide decisions on her treatment.

59 year old Wendy was preparing to embark on the ‘trip of a lifetime’ when a routine breast screening revealed a hidden tumour. “I was feeling the healthiest I had ever felt, probably ever in my adult life,” she recalls. “Then I got a phone call from BreastScreen saying, ‘We want you to come back for another look’. And that’s how it all started really.” Wendy underwent a lumpectomy. Subsequent pathology results revealed a 12 mm tumour that had not spread to lymph glands. In addition, it was found to be hormone receptor positive “although perhaps not as strongly as we would hope”, her surgeon Miss Jane O’Brien remembers. Before treatment decisions were made, Wendy decided to proceed with the Oncotype DX breast cancer assay, which examined tumour tissue from the original surgical specimen. The following video outlines her experience.

To view Wendy’s story, please click on the following video link.

Linda Wilson is an Australian mother, wife, grandmother and nurse who was diagnosed with pancreatic cancer five years ago. She had surgery, but was devastated when her cancer recurred. While she was given just months to live, she has steadfastly refused to abandon hope. She says, “I don’t consider I am dying from pancreatic cancer, I consider I am living with pancreatic cancer.” This is her story.

Please click on the following video link to view Linda’s story.