Inequalities exist in availability and patient costs, especially for newer, more expensive drugs, but drug shortages also affect several essential, old and inexpensive drugs, and this should be unacceptable!
—Alexandru E. Eniu, MD, PhD
Access to cancer medicines—including some old standbys—is inconsistent across Europe, depriving many patients of treatments that are the standard of care elsewhere,1 according to Alexandru E. Eniu, MD, PhD, Chair of the European Society for Medical Oncology (ESMO) Emerging Countries Committee and Head of the Day Hospital Unit at the Cancer Institute Ion Chiricută, Cluj-Napoca, Romania.
“Inequalities exist in availability and patient costs, especially for newer, more expensive drugs, but drug shortages also affect several essential, old and inexpensive drugs, and this should be unacceptable!” Dr. Eniu said at the ASCO/ESMO Joint Session on Global Perspective on Value at the 2015 ASCO Annual Meeting.
Disparities in Cancer Outcomes
“For a number of years, we have known there are important disparities in cancer outcomes across Europe,” he said. The recent EUROCARE-5 study documented the age-standardized incidence vs 5-year relative survival for breast cancer, prostate cancer, and melanoma by European region.2 Survival in Eastern Europe was generally low and below the European mean, particularly for cancers with good or intermediate prognosis, the study found.
Regarding breast cancer, for example, Eastern European countries had approximately half the risk of developing the disease compared with Northern European countries. However, their 5-year relative survival rate was only about 70%, vs 85% in Northern Europe.
Factors accounting for cancer outcome disparities are numerous, including the general population’s health and lifestyle, health-system infrastructure, cancer-care infrastructure, stage at diagnosis, cancer “workforce,” and presence or absence of screening programs.
Factors Linked to Lack of Access
“Patient access and availability of cancer medication are also very important,” he said. “Without the drugs, you cannot influence the condition.”
He said the main contributors to the problem of access are the “dramatically increased pricing” by pharmaceutical companies and the “incoherent reimbursement strategy” of the various national bodies, as they “face the problem of trying to accommodate within budgets the new drugs and new indications.”
Health professionals also contribute, in a way, by “not raising the bar high enough” in terms of the benefits demanded of expensive new drugs. “We have to ask more from ourselves,” he suggested.
Clinical Examples of Access Variability
The recent ESMO antineoplastic medicines survey shed light on the variability in access to cancer medicines across Europe, including drugs listed on the World Health Organization (WHO) Essential Medicines list (www.who.int/medicines/publications/essentialmedicines/eml2015). The survey gathered information on new drug approval status, drug reimbursement and patient out-of-pocket costs, and actual availability of drugs (drug shortages were a critical issue at the time) across the continent, focusing on 14 solid tumor types.
Dr. Eniu used tamoxifen in adjuvant breast cancer as an example of the information gathered regarding its formulary inclusion and availability. “Tamoxifen was widely available across Europe, but when we questioned how patients found the drug in the pharmacy, we found that it was not available in certain countries,” he said. “You can imagine this is a big issue. We showed that drug shortages affect several essential old and inexpensive drugs, not just new ones, and this is not an issue of resources.”
Similarly, adjuvant trastuzumab (Herceptin) is widely available across Europe, usually at no cost to patients, but some countries require preapproval, which causes weeks of delay in its use. Variability is also observed in the availability and out-of-pocket costs of drugs for metastatic breast cancer. For example, for anti-HER2 therapy, the newer agents are not widely available or available only at full cost to patients.
A similar scenario is seen with targeted treatments for lung cancer, and for melanoma, many cutting-edge drugs are not available at all or only at full cost.
Search for Creative Solutions
Although the European Medicines Agency (EMA) process is very transparent, and its decisions regarding safety and efficacy of new drugs are valid for the entire European Union, there are 28 different countries with complicated reimbursement systems. The many national commissions and expert committees often work with “weak data” and are “replicating at a lower level” the same assessment performed by the EMA, he said.
These groups, he added, are looking for “creative and desperate strategies.” In Dr. Eniu’s own country, Romania, it took almost 8 years to approve trastuzumab in the metastatic setting. “The problem is we cannot always accommodate the cost of new drugs,” he said.
Dr. Eniu further noted that the prices proposed by pharmaceutical companies are increasing substantially, that prices are often unrelated to their magnitude of benefit, and that there is little if any transparency in how these prices are set.
He added that many drugs ranked high on ESMO’s new Magnitude of Clinical Benefit Scale (MCBS) [see The ASCO Post, August 10, 2015] may not be available in some countries. In fact, none of the top-ranked drugs—ipilimumab (Yervoy), vemurafenib (Zelboraf), trametinib (Mekinist), or dabrafenib (Tafinlar)—is available in Romania.
Dr. Eniu and his team will be looking at their survey data in conjunction with the WHO Essential Medicines List and the Magnitude of Clinical Benefit Scale to better understand the availability of the most critical drugs per country, and they are expanding their survey internationally.
Solutions to problems related to access must be multimodal, he said. For one thing, health professionals must be more concerned about benefit and “raise the bar,” he suggested. “You wouldn’t buy a new car if it only drives 5 mph faster. You wouldn’t consider the investment worth it.”
The Magnitude of Clinical Benefit Scale can help improve access to cancer medications by informing the process of drug prioritization when resources are limited. National bodies should find ways to reimburse for “reasonable medicines” and apply these sound principles to public policy, he said. Finally, he added, the pharmaceutical industry should strive for “Justum pretium,” ie, “the just price.” ■
Disclosure: Dr. Eniu has received honoraria from and served as a consultant or advisor to AstraZeneca, Novartis, and Roche. He also has received research funding from AstraZeneca, GlaxoSmithKline, Novartis, and Roche.
1. Eniu AE: Disparities of cancer medicine access in Europe. 2015 ASCO Annual Meeting. ASCO/European Society for Medical Oncology (ESMO) Joint Session: Global Perspective on Value.
2. De Angelis R, Sant M, Coleman MP, et al: Cancer survival in Europe 1999-2007 by country and age: Results of EUROCARE-5—a population-based study. Lancet Oncol 15:23-34, 2014.