The lancet oncology
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The lancet oncology · Jan 2016
ReviewPostmarket policy considerations for biosimilar oncology drugs.
Oncology biological products are some of the most expensive drugs on the market and are a growing financial burden on patients and health-care systems. By 2020, numerous major biological cancer drugs will lose their patent protection allowing follow-on competitors, known as biosimilars, to enter the market. Clinical and regulatory considerations for biosimilars have begun to harmonise in Europe and the USA to help to define and streamline the pathway for biosimilar market authorisation. ⋯ Differences in national postmarket policies for biosimilars might explain these disparities in pricing and uptake. In this Policy Review, policy approaches to competition between biosimilars and originators used by seven European countries--Belgium, France, Germany, Italy, the Netherlands, Norway, and the UK--and the USA are discussed, chosen because these countries represent a variety of postmarket policies and build on conclusions from previous work. We discuss these policies within the context of interchangeability, physician prescribing, substitutability, pharmacist dispensing, hospital financing and tendering, and pricing.
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The lancet oncology · Jan 2016
ReviewBarriers to access to opioid medicines: a review of national legislation and regulations of 11 central and eastern European countries.
Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. ⋯ The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.
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The lancet oncology · Jan 2016
ReviewA new classification for mandibular defects after oncological resection.
No universally accepted classification system exists for mandibular defects after oncological resection. Here, we discuss the scientific literature on classifications for mandibular defects that are sufficiently presented either pictorially or descriptively, and propose a new classification system based on these findings. Of 167 studies included in the data analysis, 49 of these reports sufficiently described the defect for analysis. ⋯ On the basis of these findings, a new classification is proposed based on the four corners of the mandible (two angles and two canines): class I (lateral), class II (hemimandibulectomy), class III (anterior), and class IV (extensive). Further classes (Ic, IIc, and IVc) include condylectomy. The increasing defect class relates to the size of the defect, osteotomy rate, and functional and aesthetic outcome, and could guide the method of reconstruction.