Hurdles and delays in access to anti-cancer drugs in Europe

Abstract

Demographic changes in the world population will cause a significant increase in the number of new cases of cancer. To handle this challenge, societies will need to adapt how they approach cancer prevention and treatment, with changes to the development and uptake of innovative anticancer drugs playing an important role. However, there are obstacles to implementing innovative drugs in clinical practice. Prior to being incorporated into daily practice, the drug must obtain regulatory and reimbursement approval, succeed in changing the prescription habits of physicians, and ultimately gain the compliance of individual patients. Developing an anticancer drug and bringing it into clinical practice is, therefore, a lengthy and complex process involving multiple partners in several areas. To optimize patient treatment and increase the likelihood of implementing health innovation, it is essential to have an overview of the full process. This review aims to describe the process and discuss the hurdles arising at each step.

Drug Registries and Approval of Drugs: Promises, Placebo, or a Real Success?

“…To improve the knowledge of new drugs, the value of registries depends not only on recruitment but also on quality and completeness of the data collected; some articles suggest that improvements need to be made in this context as well. 32,33 Although postapproval registries are, however, just one part of the realworld evaluation, the poor performance of studies in these registries challenges the authorization of drugs. This situation can only be improved if regulators are explicit about data that are needed and what the consequences will be if data are not timely delivered.…”

New oral targeted therapies for metastatic breast cancer disrupt the traditional patients’ management-A healthcare providers’ view

“…They lead to major changes by transferring part of the hospital care out of hospital (Geynisman & Wickersham, 2013) and affecting all the actors in charge of the patient. It is not always easy for practitioners to modify their treatment practices (Ades et al, 2014). With the extensive number of possible treatment, it is increasingly difficult for the oncologist to choose which to prescribe.…”

“…Thus, some oncologists will sometimes take longer to change their practices or even be reluctant to do so. It is not always easy for practitioners to modify their treatment practices (Ades et al, 2014). It is easier for an oncologist to prescribe intravenous chemotherapy, which is administered in hospital, and matches the classic pattern of treatment, rather than an oral targeted therapy.…”

Factors affecting access to treatment of early breast cancer: Case studies from Brazil, Canada, Italy, Spain and UK: Implications for future research, policy and practice

“…In order for new oncology drugs to be incorporated into the public health system in Brazil, they must be approved by the Brazilian Health Authority and Brazil's HTA body (Ades et al 2014). Brazil's HTA process has been criticised for offering confusing and vague assessments of new drugs, with some critics charging that it rejects high-cost drugs because of societal pressure over costs to the health system (Ades et al 2014).…”