Managing the costs of emerging oncology therapies

ESMO as an organisation is not shying away from the current global economic crisis and is conscious of the growing need to address issues of health economics in the field of oncology.

 The Young Oncologist’s breakfast session, which took place on Monday Oct. 1st at ESMO 2012, was a forum exploring the management of the costs of emerging therapies.

Professor Jose Martin-Moreno from the University of Valencia, Spain, told the delegates that the annual EU cost of cancer care was a staggering €124 billion each year. In addition to health care costs, he added, this figure took into account additional factors such as the loss of productivity and mortality. Research suggests that European countries are spending between 4.1% and 10.6% of health care resources on cancer care.

Across Europe, cancer spending is being limited, said Professor Martin-Moreno. The Greece-bail-out package limits health system spending to 6% of GDP, he said, and furthermore patient co-payments are being introduced on hospital care and drugs in Portugal. “The financial crisis has exacerbated social inequality, including health. Co-payments represent a ‘de facto’ tax on the sick. Inequity in drugs and treatment stems from differences in income, social strata and geography. These are very important challenges that need to be addressed,” said Professor Martin-Moreno.

In the long run, he said, personalised medicine, offers the potential for cost savings. “But is comes with implications for large short-term investments,” he cautioned.

Changes needed to be introduced in the way randomised trials are conducted.

Ms Elena Nicod, from the London School of Economics (LSE), UK, provided an overview of how Health Technology Assessments (HTAs) actually work across Europe. Differences and similarities, she said, exist in the way HTAs assessed the same drugs.

“The aim of HTA is to provide efficiency in health care resource allocation and value for money,” said Ms Nicod. But while therapy X may be deemed cost-effective in country A, it may not be considered cost effective in country B because of differences in the level of evidence presented.
“We need to identify the reasons for these differences and differentiate whether they are a consequence of national-specific considerations or HTA processes. We believe that it is also important to differentiate HTA processes per therapy area.”

The LSE, she said, has recently undertaken a study comparing HTA recommendations across England, Scotland, Sweden, Canada, and Australia.
“Our study showed that some therapies are more likely to be covered in some countries than others. For example, in Canada CNS drugs are more likely to be rejected than orphan drugs and cancer drugs, while in Scotland orphan drugs were more likely to be rejected than cancer and CNS drugs.”
The differences, she said, are a consequence of context specific considerations, such as national preferences, HTA processes and the way evidence is collected, and interpreted.

In the question and answer session, it was suggested that in future, there might be a possibility for European countries to join forces for joint HTA.
In the final session, Professor Andy Grieve from the SVP Clinical Trials Methodology Innovation Centre, Cologne, Germany, described the innovative new process of adaptive design.

“An adaptive design is one that uses accumulating data from the ongoing trial to modify aspects of the study without undermining the validity and integrity of the trial,” said Professor Grieve.

Aspects of studies that could be modified, he explained, included the number of subjects, study duration, endpoint selection, treatment duration, patient population, number of treatments, number of interim analyses and hypotheses.

An adaptive design requires the trial to be conducted in several stages with access to the accumulated data. “At any stage, the data may be analysed and next stages redesigned taking into account all available data,” explained Professor Grieve.

But the long lag times of months and years that it takes to observe survival endpoints can make it difficult to introduce adaptive design. In leukaemia, for example, the most commonly used response criteria in phase 2 trials of complete remission, could be used instead. “It’s relatively easy to implement adaptive randomisation if endpoints are available soon after treatment,” explained Professor Grieve.

A good example of adaptive design, he said, was the phase 2 I-SPY-2 neoadjuvant breast cancer study in moderate to high-risk primary breast cancer.

“Here a single control arm was compared with multiple drugs, with the idea of identifying biomarker signatures that predict outcomes to drugs. When you see that one agent is doing better than the others you can bias randomisation towards that drug,” said Grieve.

“What’s particularly interesting is the I SPY is being run by a consortium out of MD Anderson, but the drugs have been provided by 5 different Pharma companies. It shows that the way forward in future, in order to reduce the cost of trials, we should organise more such collaborations,” said Professor Grieve.

At the end of the session audience questions included whether a special QALY system should be introduced for cancer drugs.

Furthermore, in addition to the cost of the drugs, people felt there was also a need to assess the cost of the condition to society. “With the new targeted agents we also need to be able to take into consideration factors such as whether patients can stay in employment. There is a real need to develop novel HTA methodologies because at present they’re very clunky,” said Professor Gore.

Commenting on the Forum, Professor Jean- Pierre Armand, from the Institute Gustave Roussy, Villejuif, France, said, “This session really introduced young doctors to the reality of practising oncology in Europe. They will see clearly that across different countries they don’t have access to the same drugs at the same time for their patients.”

In countries like Lithuania, he said, just €35 per head of the population per year is provided for cancer, whereas in countries like Germany and France provide €150 per head of the population per year.

One of the reasons for the high cost of drugs, added Professor Armand, has been the failure of drugs to get through phase 3 trials. “We need to be intelligent and make sure that we’re not running huge phase 3 trials when we have early indications that drugs may not be effective, and also not running long-lasting trials when we know that the drug works. This was particularly the case with the crizotinib data presented for ALK-positive lung cancers at ESMO 2012,” he said.