An expensive cancer drug that treats an aggressive form of lymphoma will be subsidised from next month, making it affordable for hundreds of patients.
The drug Imbruvica is used to treat mantle cell lymphoma when there’s a relapse after chemotherapy and would cost patients about $134,000 a year if it is not subsidised.
Federal Health Minister Greg Hunt has announced that from August 1, Imbruvica will be available through the Pharmaceutical Benefits Scheme.
It will join three other medicines that treat head and neck cancer, blood cancer and the side effects of chemotherapy.
“Its total cost of $250 million will help save and protect the lives of thousands of patients each year,” Mr Hunt told reporters in Melbourne on Sunday.
“This will give life-saving or life-changing access to families.
“I hope there are many families who will be able to take a big sigh of relief, a sigh of relief on financial grounds, but most importantly on health grounds.”
The four medicines are expected to help 4000 to 5000 people a year, Mr Hunt said.
Associate Professor Constantine Tam has been treating patients with Imbruvica in a clinical trial at Melbourne and said the drug worked by targeting a gene the cancer needs to survive, but is not needed by the rest of the body.
Patient Ertugrul Delibalta is a 70-year-old aged care pensioner who was first diagnosed the mantle cell lymphona about six years ago and relapsed after about three years.
“They said we cannot do the chemotherapy again because if we do the chemotherapy again we kill you,” Mr Delibalta told reporters.
Mr Delibalta said he was put on Dr Tam’s trial – a life and cost saving move – because “it would have been too hard and I would have died” if he had to pay for the drug.
Alcohol misuse is a major public health concern, and there is considerable evidence that heavy drinking is associated with a range of negative health outcomes, including cancer. However, the link between light to moderate drinking and health is more complex.
Previous studies have consistently found that light to moderate drinkers live longer than lifetime teetotallers. The evidence from cancer research gives a different impression: even light to moderate alcohol consumption is linked with an increased risk of cancer. These differences have led to confusing public health messages about the health impacts of light to moderate alcohol consumption and what counts as drinking in moderation.
To help give a clearer message, we decided to assess both cancer and mortality outcomes together, using the same methods and same population, to see what the overall link between alcohol and these major outcomes are.
Previous studies have tended to separate former drinkers from current drinkers and classed them as non-drinkers. This separation can underestimate the negative health effects of drinking, as former drinkers may have stopped drinking due to health scares related to their drinking habits. Instead, we looked at the average lifetime alcohol intakes, which avoids separating former drinkers from current drinkers.
We then linked this data to data that showed which of these people were diagnosed with cancer, or died over an average of nine years after completing the questionnaire. This allowed us to assess whether the combined risk of developing cancer or dying within these years differed between people with various levels of alcohol intake.
We attempted to account for as many other differences between these groups as possible, such as smoking and diet, so that we could be more sure that any differences in risk between drinkers and never drinkers were due to differences in their alcohol intake.
The results indicated that a J-shaped relationship (see graph below) between alcohol and combined risk of cancer or death was apparent, with the lowest risk apparent in people drinking less than seven alcoholic drinks per week (less than one drink per day) – where one drink equates to about the units found in a medium strength bottle of beer – compared to never drinkers or heavier drinkers. Heavier drinkers (who drank more than three drinks per day) were at a 20% higher risk of getting cancer or dying prematurely than light drinkers.
Drinking alcohol is a personal choice and it is not our aim to tell people whether they can or can’t drink. The aim of this study is to provide robust evidence so that people can make informed, healthy decisions about their alcohol intake.
We urge caution in interpreting the results comparing light drinkers to lifetime teetotallers, though, as the reasons for the reduced risk of cancer or early death in light drinkers are still being debated by scientists.
It has been suggested that light drinking may have beneficial effects on heart health, though this has not yet been proven. Light drinkers may also be at a lower risk of premature death as they tend to be wealthier, so may have better access to healthcare and may follow other healthier lifestyle behaviours, such as being more physically active. Until the debate is settled, it would be unwise to suggest that non-drinkers should begin drinking as a way to benefit their health.
Guidelines may need updating
There are large differences between countries in alcohol-related guidelines about what is considered to be drinking in moderation. The UK recently lowered its guidelines to suggest that both men and women do not drink more than six alcoholic drinks per week. The US guidelines are higher for men and recommend less than 14 drinks per week for men and less than seven drinks per week for women.
We hope that our results will help to inform future public health guidelines around the world regarding alcohol consumption. It’s time for consistent messages about what counts as drinking in moderation. Our findings suggest that drinking in moderation might be less than seven drinks per week.
A surprisingly high number of incident cancer cases involve people who have already survived a previous cancer, US researchers have found.
Their study, published in JAMA Oncology, looked at around 750,000 people diagnosed with a new cancer from 2009 to 2013. It found that a quarter of patients over the age of 65 had already survived at least once cancer, while 11% of younger patients had a prior cancer history.
Prevalence of a prior cancer ranged from 3.5% to 37%, depending on the type of incident cancer diagnosed and the age of the patient.
In younger patients, prior cancer was most prevalent in those diagnosed with leukaemia (25%), bowel cancer (18%), cancers of the female reproductive organs (15%) and lung cancer (14.6%).
In those over the age of 65, more than a third of melanoma patients had a prior history of cancer. This was also the case for patients with incident leukaemia and cancers of the bone and joints. Most prior cancer among the older age group occurred in a different site.
Over 30% of older people diagnosed with cancers attributable to human papilloma virus or tobacco use had a prior cancer.
The high rate of prior cancer in leukaemia patients might reflect the leukaemogenic effects of earlier cancer treatments, the study authors from the University of Texas said.
They noted that prior cancer has important implications for cancer care delivery.
“Patients may have competing priorities concerning treatment decisions: a new diagnosis may interrupt management, treatment adherence, or outcomes related to a prior cancer. Differences in the prevalence of prior cancer by incidence cancer type also highlight underlying or shared risk factors that may be amenable to targeted surveillance,” they wrote.
In a linked editorial, clinical oncologist Dr Nancy Davidson argued that the findings “should spur us to revisit our long-accepted policies of excluding many otherwise well patients with a history of previous early-stage invasive cancer from participation in cancer treatment trials”.
She said these common restrictions greatly limit the participation of older patients, the very population where cancer is most commonly diagnosed and where we are most in need of strong evidence to guide treatment.
“As the population of cancer survivors continues to grow, understanding the nature and impact of a prior cancer is critical to improving clinical trial accrual, generalisability of results from trials and observational studies, disease outcomes and patient experience,” the study authors concluded.
Rare cancers are just that: rare. This means research into each of these particular types of rare cancers is limited, and so are the treatment options. As a consequence, patients diagnosed with rare cancers face significant challenges.
The minister also commissioned new work on evaluating cancer medicines that treat multiple tumours and have a specific genetic feature (biological marker). This could improve access to therapies that might benefit some patients with rare cancers.
These recent steps are in recognition of the significant challenges associated with undertaking research into rare cancers. By their nature, rare cancers include small and variable patient populations making gold-standard randomised trials challenging or even impossible.
The lack of evidence resulting from few or no randomised trials creates challenges for registering and reimbursing new medicines. This ultimately leads to a lack of subsidised medicines for these patients. As a result, the improvements seen in patient outcomes related to new therapies for more common cancers like lung cancer, melanoma and bowel cancer over the last two decades do not extend to rare or less common cancers.
What is a rare cancer?
The definition of a rare cancer is debatable. The RARECARE collaboration in Europe uses an operational definition of fewer than six cases per year per 100,000 population. In Australia, the medicines regulator, the Therapeutic Goods Administration (TGA), has recently updated the eligibility criteria for medicines treating rare diseases to fewer than five cases of the disease in a population of 10,000 people.
Historically cancers were categorised by the anatomical location, such as the breast or kidney. But with the discovery of new biological markers, common cancers can be grouped into smaller, more homogeneous and genetically similar subsets. So the number of rare cancers will continue to grow as medical technology advances.
Why don’t they have many available medications?
The lack of government-approved and subsidised medicines to treat rare cancers primarily stems from the lack of evidence supporting their use. Submissions to the current inquiry also cited problems such as a lack of research funding; the need for international collaboration; lack of investment by industry; attracting sufficient interest of researchers and recruiting sufficient patients.
Even if patients can be identified and recruited to a trial, it’s difficult to generate meaningful data from so few patients.
The lack of evidence presents challenges for new medicines trying to meet registration and reimbursement criteria in Australia. To be registered through the TGA, a new medicine must have demonstrated efficacy and safety.
In order for new medicines to be listed on the Pharmaceutical Benefits Scheme (PBS), it must have a demonstrated benefit over standard treatment, as well as being considered an efficient use of tax payer dollars.
New medicines for rare cancers are often expensive, especially when randomised trials are not possible.
What can we do to improve this situation?
With the changing nature of medicine and research, new opportunities are emerging to address the current inequity. The shift to treating patients based on the genetic profile of their tumour rather than the location of the cancer has increased treatment options for rare cancer patients.
To harness the benefits, changes are required with input from multiple stakeholders, including government, industry, clinicians, researchers and patients.
Better access to new medicines ultimately starts with better research. To achieve this, experts have called for additional targeted funding, innovative trial designs, and better partnerships between industry and researchers.
There is also the opportunity to collect better “real world” data via platforms such as the My Health Record, which could supplement existing research and allow performance monitoring of recently approved new medicines.
Organisations such as Rare Cancers Australia and the Cancer Drugs Alliance are liaising with government regarding changes that could improve access to novel medicines for patients with rare cancers. This includes greater input from patients and more flexibility in the way we evaluate medicines for public reimbursement.
It should also be recognised the problems faced in providing innovative treatments to patients with rare cancer extends to rare diseases in general. With modern medicine providing the potential to improve outcomes for patients with rare cancers as well as other serious chronic diseases, we need to have a broader conversation about what we can afford and what we are willing to pay for new medicines.