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First mover advantage: ASCO 2012

Companies with enhanced strategic planning and careful forethought in structuring clinical trials will maximise opportunities in the oncology market

Chess piece

In the crowded therapeutics market for managing patients with renal cell carcinoma (RCC), there are seven agents (excluding cytokines) currently approved for use, five of which are approved for use in the first-line setting, with four of these being VEGF pathway inhibitors. With so many options, and few definitively differentiating factors, how is a physician (or patient) to choose the best course of therapy?

Perhaps in anticipation of this, GlaxoSmithKline took the bold move of initiating a patient preference study shortly after gaining regulatory approval for Votrient in advanced or metastatic RCC. The PISCES trial randomised patients to sequential treatment with Votrient (10 weeks) followed by Sutent (10 weeks) and vice versa, and patients completed preference questionnaires at the end of each treatment period.

This unique design allowed direct evaluation of drug preference among patients who had been equally exposed to both agents.

The results, presented at an Oral Genitourinary Cancers session at ASCO 2012, were overwhelming – 70 per cent of patients who completed both treatments and questionnaires preferred Votrient, with just 22 per cent preferring Sutent (8 per cent had no preference). Overall quality of life and all queried toxicities were cited as favouring Votrient, with the issue of fatigue standing out from the patients' perspective.

Recognising your weaknesses and threats, and leveraging your strengths and opportunities is one of the first things taught in business school and should be incorporated into any strategic development plan. GSK is going out guns blazing in a valiant attempt to position Votrient as the preferred first-line agent for advanced RCC. Just a few years ago this was a tiny market – almost insignificant in financial terms. Consensus analyst projections now predict that by 2018 the RCC market will have a combined value of $4.0bn, with Avastin, Afinitor, Sutent, Nexavar and Votrient as the top five products (source: EvaluatePharma).

Treating late-stage disease
Questions about targeted therapy, biomarkers and progression-free survival (PFS) came thick and fast at ASCO 2012.

While impressive data as shown for several compounds questions from the audience as well as the presentation of separate educational tracks made access to new treatment, affordability and policy implications a recurring theme of the meeting.

For example, when segmentation of non-small-cell lung cancer (NSCLC) started, it was hailed as a way to limit the use of an expensive therapy that would ultimately prove to be non-effective in the majority of patients.

Biomarkers were deemed the wave of the future to identify the patients most likely to benefit, and clinical trial data showed impressive response rates in these identified patients. As more subtypes of NSCLC continue to be identified, the issue being raised is the cost of identifying a patient's genetic subtype. The cost of a single genetic test (ALK FISH test for crizotinib) is estimated in a 2011 Forbes article at approximately $1,500, which includes the cost of the test (approximately $250) plus pathology services.

An article in the American Journal of Managed Care states: 'While fluorescence in situ hybridisation (FISH) has been the “gold standard” of detecting ALK gene rearrangement, several clinical trials evince limitations in this method — in terms of both cost and effectiveness — and oncologists and other medical professionals suggest administering a combination of screening methods to adequately identify ALK-positive NSCLC.

'Crizotinib (Xalkori), an orally taken ALK inhibitor, is currently the only FDA-approved drug treatment for ALK non-small-cell lung cancer, and since its prescription is entirely contingent upon positive FISH results, many researchers promote the standardisation of other screening methods, which could be more accurate and cost efficient.

'Much like its companion FISH test, however, crizotinib comes with a high cost … and with its reliance on the FISH probe kit as a companion test, the total cost of ALK screening and treatment would be prohibitive for many.' (Beagin K, Testing for ALK-Positive NSCLC, American Journal of Managed Care, 2012;18(SP3).

If protocols are adopted calling for multiple genetic tests the cost of screening patients could become almost as expensive as therapy.

While PFS data continues to be impressive for new late-stage treatment options, overall survival (OS) has not significantly increased. The cost curve of treating patients (The Cost of Lung Cancer Care: Screening, Personalised Medicine, and Palliative Care) calculated that 43 per cent of NSCLC care was spent in initial treatment and 41 per cent of the cost occurred at end of life. In parallel, the use of hospice care (Costs of Cancer Care: Affordability, Access, and Policy) is used primarily in the last weeks of life as patients are often receiving chemotherapy treatment up to their last month. Studies have shown the quality of life for patients in hospices is higher than those receiving chemotherapy. Does that mean treatment should stop sooner?

Unfortunately, the answer is not that simple. Some patients are willing to accept more toxicity from their treatment than their physicians are willing to accept. Payers continue to look at late-stage and end-of-life treatment to try to find a way to manage these costs better. This may include requiring physicians to discuss the various options, including hospice care earlier in the patient's treatment. While payer coverage will affect the decision, patients, along with their physicians, will need to determine what works best for them. The key takeaway is that treatment will continue to be (and may be even more so in the future) an individual patient choice.

EuropaColon initiative

EuropaColon, a pan-European colorectal cancer (CRC) organisation has launched a new initiative – Young Voices United against Colorectal Cancer – aimed at providing an online forum for young people affected by CRC to share and exchange information that will help empower and support them.

The global burden of CRC is rising largely due to ageing, growth of the world population and a steady increase in cancer-causing behaviours, particularly smoking, in economically developing countries.

While CRC is rare in developing countries, it is the second most frequent malignancy in affl uent societies. In Europe, each year, more than 450,000 people are diagnosed with CRC and about 230,000 will die of the disease.

Unfortunately, it is not just the over 50's who are at risk of developing CRC. In contrast to the overall declining rates of this disease, incidence and mortality rates among young adults under the age of 50 years are on the increase.

Professor Dr Gabriela Möslein, from the Department of General and Visceral Surgery, Coloproctology, Helios St.Josefs Hospital, Bochum and Past Chairperson of InSiGHT (International Society for Hereditary Colorectal Cancer) said: “CRC is on the increase and mainly affects those people 65 years old and above. However, some 5-8 per cent of patients will present at a much younger age and as such have a very different experience due to their youth and quite different perspective on life.

“I firmly believe Young Voices United against Colorectal Cancer will provide a platform for young people to help them fi nd comfort, hope and support in the broadest sense and last but not least have access to a network of professionals available to guide them through their own and their families' individual risk assessment.”
Communicating aspects of CRC, such as individual risk factors, diagnosis and treatment options and the need for prevention and early diagnosis, to the older generation has traditionally been hard. And getting the message out to young adults is even more challenging.

EuropaColon's Survivorship Ambassador Milan Djordjevic of Serbia was diagnosed at the age of just 24 years old. “More than 10 years ago I was diagnosed with CRC and I am now a survivor. At that time, I had great support from my family and friends, however I did not have anyone to talk to who was going through the same experience as me. I would like for Young Voices United against Colorectal Cancer to become Europe's largest support community for young adults affected by the disease. Young Voices United aims to provide a unique opportunity through this forum by offering programmes and tools which directly address the specifi c needs of this group of people.”

Commenting on the initiative, Jola Gore-Booth, CEO and Founder of EuropaColon, said: “I hope all these young people will unite together to form a strong army of ambassadors and spread the word about the need of knowing your risks of developing the disease... the need to have a healthier diet and lifestyle, and to be aware of the symptoms of the disease.”

Treatment affordability
While affordability of cancer treatments is an important issue in industrialised markets, it is a significant challenge in the developing world. A key central theme in many of the presentations during the Affordability of Cancer Care: A Global Perspective session at ASCO, was that it is in the global healthcare community's best interests to share resources and collaborate on solutions that produce sustainable and affordable global cancer care.

In his presentation, Cost of New Cancer Treatments in Relation to Their Effectiveness, Ian Tannock, MD, PhD, questioned Western nations' choice to frame 'effectiveness' instead of 'cost effectiveness' as the main criterion for new drug approvals. Tannock believes that cost effectiveness is a better metric because it would yield a more equitable distribution of limited healthcare resources.

He went on to recommend that pharma should be incentivised to develop new uses for older cancer drugs both through the adoption of cost-effectiveness criteria by the FDA and EMA for drug approvals, and by being allowed to recover their R&D costs for developing these older drugs.

In his presentation A Vision of Global Cancer Research in the Future, Dr Richard Schilsky said industry should move away from large clinical trials that offer only modest improvements.

He suggested focusing on clinical trials that have the greatest potential for patient benefit, and recommends selecting trial participants based on use of biomarkers. This gives researchers a better opportunity to demonstrate greater benefits and thereby decrease the associated costs of clinical trials, he said.

Schilsky also noted that no single country or stakeholder can work in isolation while attempting to solve the problems associated with the affordability of cancer treatments. To achieve long-term sustainability and affordability, Schilsky believes all cancer research and development stakeholders must embrace cooperation (versus competition) and recognise that cooperatively addressing and solving these problems is in long-term best interests of each stakeholder.

Cancer is big business
We have made a number of references to the amount of money manufacturers might be able to reap and indeed have provided a few examples for consideration.

The question that often comes to the fore is: How long can we continue with ever-increasing prices for cancer treatment? The truth is, no one has the answer.
In the US the cost of treating cancer is increasing for a number of reasons, including the disproportionately ageing population and improved technologies that extend life rather than provide a cure. Thus, more patients are living longer with their disease. Oftentimes this extension of life occurs in the metastatic stage — the stage of disease characterised by the greatest number of newer, more costly drugs.

In the end, we pay for our success. However, there are very clear signals that ability and willingness to pay are decreasing.

Payers are seeking new ways to control costs, including the heretofore protected area of cancer. (Kantar Health Oncology Market Access, Healthcare Reform, Spring 2012.)

When considering an emerging market, the issue becomes that much more complex. Countries like Brazil, Russia, India and China (BRIC) boast a developing middle class, as well as a growing affluent population. More people are able to afford basic healthcare than ever before, and a growing segment of the population has access to the latest premium drug brands (Emerging Markets: Mining the Opportunities, Stephen Potts, Kantar Health).

According to Forecasting and Market Segmentation in China (June 2012): 'Prices for premium innovative products (PIPs) in China can be just as expensive as in the West. Most of these types of products are not reimbursed and thus fall into the cash/self-pay segment of the market. For oncology products, the cost may be higher, but possibly more finite than chronic therapies. We might want to consider overall potential patient wealth rather than annual income, because patients might use savings to pay for the therapy.'

Manufacturers need to make the most of opportunities presented to them for maximising return on investment. However, in so doing, it is important that they keep in mind that there appears to be increasing demand for greater value for new oncologic (and other) therapeutics and it is feasible that over time there may be greater governmental restrictions on the pricing that the market will need to bear.

Enhanced strategic planning and careful forethought in structuring clinical trials will be required in order to maximise opportunities.

Information overload
Dr George Sledge, co-director of the breast cancer programme at Indiana University and a past president of ASCO, said of the exponential increase in information and clinical knowledge regarding cancer: “We've had this biological revolution that has sliced the pie for these cancers finer and finer as we've learned more about the genomics of cancer.”

Sledge said he knows of at least 17 different subtypes of acute lymphoblastic leukaemia (ALL), the most common type of leukaemia in children. “Even trying to wrap your head around that is hard.”

Writing in the journal Oncology (April 17, 2012), Dr Edward P Ambinder noted: 'We are living in unprecedented times, in which oncologists and their patients are facing disruptive changes in healthcare, research, education, governmental politics, business, communication, and finance – changes brought on by the individual growth and merging of the fields of information technology, biology, and physics.

'This dramatic increase in the quantity, quality, and ease of finding information – and the effortlessness of connecting everyone and everything – all of which has been brought about by the internet, has changed our lives forever.'

Certainly these same dynamics affecting oncologists and patients also impact manufacturers, payers and all of the other participants within the healthcare system.

The Authors
Tony Faustino, Chris Gage, Ian Hicks, Anne LaPrade and Song Li. or contact our team at

14th November 2012


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