Access to cancer medicines is highly unequal across Europe both for new drugs in clinical development and for currently approved drugs.  This conclusion stems from two studies presented during the 2020 European Society of Medical Oncology (ESMO) Virtual Congress.[1][2] According to the studies, unequal access is caused by huge disparities in healthcare spending by different countries.

Limitations in spending results, according to one analysis, in limited access to clinical trials. One analysis of active clinical trials in Europe demonstrated that that country in Western Europe run a higher number of clinical trials for new,  investigational, drugs compared to countries in Eastern and Central Europe, leading to large differences in access to new treatments in development for cancer patients, depending on the country where they live.[1]

“Our study gives us proof of what we previously suspected, that there is a huge asymmetry in the number of clinical trials for cancer treatments in different countries,” said study co-author Teresa Amaral, M.D., from University Hospital Tubingen, Germany.

“Having access to clinical trials confers several benefits to cancer patients. It means they can potentially access novel therapies earlier during the trial phase rather than having to wait for licensing and reimbursement,” Amaral explained.

“Also, all trial participants benefit from the regular follow-up and monitoring involved in taking part in a clinical study,” she added.

As part of their study, the researchers searched for interventional phase I-III clinical trials in adults with neoplasms conducted in Europe between June 2009 to June 2019. They identified 18,454 trial-entries, of which 12% were phase I, 10% phase I/II, 32% phase II, 2% phase II/III, and 44% phase III.  They also noted that 74% of the studies were industry-sponsored, 15% were academic studies and 11% were developed and funded as part of an academic/industry partnership.

Analyzing the number of trials in 34 European countries revealed huge differences. For example, Albania had the lowest number of active clinical trials for cancer (0.14 clinical trials per 100 000 population) while Belgium had the highest number (11.06 per 100 000).

Further results showed that the total number of oncology clinical trials performed in European countries increased by 33% between 2010 and 2018, with a much greater increase in early phase trials than late-phase trials. Early-phase trials, phase I-II, 61%, increased by 61% while the volume of late-phase trials (phase II-III) increased by 7%

Countries including Portugal, Ireland, Finland, Greece, and Norway registered the largest percentage increase in early-phase trials, while Ireland, Spain, Norway, Italy, and Belgium led the largest percentage increase in late-phase trials.

Spain (90/40), France (45/16), UK (45/13), Italy (38/19), and Belgium (35/12) dominated in terms of an increase in the absolute number of total trial-entries in both early- and late-phase trials. During this period there was no significant variation in the distribution of industry and academic sponsored trials but an increase in industry/academic partnerships was observed (≈ 8%).

No clear progression
“There is no longer a clear progression from first-in-human studies to phase I, phase II, and then much larger phase III trials. Instead, we tend to have more trials in an earlier phase II, which might expand to later phases,” Amaral noted, suggested that the larger number of phase II trials might be due to a shift in clinical trial design.

Interestingly, Amaral and her colleagues noted that the increase in early phase trials was also asymmetrical and the growth rate depended on the baseline number of trials.

“Countries need to have the necessary infrastructure and expertise to conduct trials of any type, including early phase trials,” she added.

“A higher number of phase I trials is a sign of more active research going on in a particular country, with the appropriate infrastructure and necessary incentives to conduct clinical trials,” said Thomas Cerny, Professor of medical oncology at the University of Berne, Switzerland, and member of the ESMO Principles of Clinical Trials and Systemic Therapy Faculty.

“And the only way to develop new cancer drugs is to be able to put patients into clinical trials,” he added.

“The difference in the number of clinical trials per head of population, with more trials in wealthier countries, means access to clinical trials and innovative drugs is just not possible for cancer patients living in many less wealthy countries,” Cerny noted.

Although the study is descriptive, he considered it made the best use of the available data to evaluate differences in clinical trial availability in different countries.

“Clinical studies require a solid infrastructure in terms of personnel and equipment, and this depends on a country’s overall financial situation. These requirements are increasing so the gap in clinical trial capacity is not likely to reduce soon,” he concluded.

“There is still a lot to do to increase access to clinical trials for cancer patients in different countries,” Amaral agreed.

“The voluntary harmonization procedure, in which trial sponsors can submit trial documentation to several countries at the same time, has streamlined the process and reduced the approval time for trials. But more is needed to increase access to clinical trials in countries where the number of trials is currently low,” she concluded.

The research group is currently exploring the reasons for the asymmetry to inform potential solutions.

Health economics: The costs of cancer
A health economics analysis under the auspices of the Swedish Institute for Health Economics, Lund, Sweden and funded by the European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium, presented during the virtual ESMO 2020, showed that wealthier European countries spent, on average, ten times as much as poorer countries per inhabitant on cancer medicines.*  This follows a similar pattern to that seen for clinical trials. [2]

Nils Wilking, MD, PhD / Associate professor Karolinska Institutet, Stockholm, Sweden. Photo courtesy: © 2018 – 2020 Karolinska Institutet, Stockholm, Sweden

“[In our study we found] that there was a huge difference in spending on cancer medicines,” said Nils Wilking, M.D., Ph.D., an associate professor at the Karolinska Instituet, Stockholm, Sweden, and the lead author of a study presented at ESMO.

“We found that inequalities are mainly related to countries’ economic strength and not to the disease burden of cancer,” Wilking added.

The researchers estimated cancer-specific health expenditure and access to medicines for 31 countries (EU-27 plus Iceland, Norway, Switzerland, and the UK) using country-specific data from 2018. The study extends a previous analysis for 1995–2014.

Per capita spending
The available data for the total cost of cancer was € 199 billion in 2018. After adjustment for price differentials, these costs ranged from € 160 per capita in Romania to € 578 in Switzerland. Expenditure for cancer care was € 103 billion, of which € 32 billion were spent on cancer drugs. In addition, the costs of informal care were estimated at € 26 billion, while the total loss of productivity was € 70 billion, which included € 50 billion from premature mortality and € 20 billion from morbidity.

The study listed Austria, Germany, and Switzerland, on average spending € 90.00 to € 108.00 per capita, as the top spenders in oncology drugs, while the Czech Republic, Latvia, and Poland spend, on average between € 13.00 to € 16.00 per capita. The largest differences in spending between countries were seen for immuno-oncology drugs.

The researchers noted an increase of 50% in cancer incidence in Europe between 1995 and 2018. However, their report showed that cancer mortality increased only by 20%.

Overall, cancer-related healthcare spending doubled from € 52 billion to € 103 billion (in 2018 prices and exchange rates), while the share of cancer care on the total healthcare expenditure remained stable at around 4–7%. The researchers believe that a shift from treatment in inpatient care to ambulatory care is likely to save costs.

The researchers further noted between 2005 and 2018 spending on cancer medicines tripled, from € 10 billion to € 32 billion (excluding confidential rebates).

Factors
“There are two main factors accounting for the differences in spending on cancer medicines: one is a shortage of money and the other is drugs not being approved for use by some healthcare systems,” Wilking suggested.

Wiling also noted that although the study did not consider data at an individual patient level, the difference observed in access to cancer medicines would affect patient outcomes.

“It is difficult to assess the real costs in any country because systems vary in different countries and there are many hidden costs not reflected in the databases used. But the study essentially shows the more a country has to spend, the more its inhabitants have access to cancer medicines,” Cerny commented.

“We need a model in which we incentivize innovation of valuable medicines through outcome-based payment models and consider a disease area and what society is able to pay for treatment,” Wilking suggested.

Considering how to widen access to cancer medicines, Wilking concluded: “The work of health technology assessment organizations has been important and critical scrutiny and evaluation of new drugs should always be applied.”

Note
* 2018 data
** Data on cancer drug sales were obtained from IQVIA
*** Productivity loss from premature mortality was estimated from data from Eurostat and the WHO.

References
[1] Carneiro A, Amaral TMS, Brandao M, Scheffler M, Bol K, Ferrara R, Jalving M, Lo Russo G, Marquez-Rodas I, Matikas A, Mezquita L, Morgan G, Onesti CE, Pilotto S, Saloustros E, Trapani D. Disparities in access to oncology clinical trials in Europe in the period 2009-2019. Proffered paper session (Public Policy) presented on Monday, September 21, 2020, 14:25-16:05 CEST. Annals of Oncology, Volume 31 Supplement 4, September 2020. Abstract LBA66_PR
[2] Wilking N, Brådvik G, Lindgren P, Svedman C, Jönsson B, Hofmarcher T. A comparative study on costs of cancer and access to medicines in Europe. Mini Oral session (Public Policy) presented on Friday, September 18 at 09:00 CEST. Annals of Oncology, Volume 31 Supplement 4, September 4, 2020 Abstract 1588MO_PR

Featured image: 2018 – 2019 annual ESMO conference. Photo courtesy: © 2018 – 2020 European Society of Medical Oncology (ESMO). Used with permission.

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