WHO Model List of Essential Medicines Revised
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New anticancer medicines included in the list
Date: 22 May 2015
Topic: Bioethics, legal and economic issues / Anticancer agents & Biologic therapy
On 8 May 2015, the World Health Organization (WHO) published the new edition of its Model List of Essential Medicines which includes ground-breaking new treatments for a variety of cancers. The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally.
New breakthroughs have been made in cancer treatment in the last years, which prompted WHO to revise the full cancer segment of the Model List of Essential Medicines: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines included in the list.
The committee of expert reviewers underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries.
Several important anticancer drugs have been added to the list, including three targeted therapies (rituximab, imatinib and trastuzumab), and a number of drugs for solid tumours (capecitabine, gemcitabine, filgrastim, irinotecan, oxaliplatin, vinorelbine, anastrozole, bicalutamide and leuprorelin) and other for haematologic malignancies.
Also new in this edition is the tumour specific indication for all the drugs.
WHO Model List of Essential Medicines
WHO Global Action Plan on Prevention and Control of Noncommunicable Diseases (NCDs) 2013-2020 has as a target 80% availability of essential medicines and technologies for NCDs by 2025.
The first WHO Essential Medicines List was published in 1977 with 6 cancer drugs included. In 1984, the first review of oncology medicines on the list was performed that resulted with 14 cancer drugs included in the list. In 1995, the second review was performed and the list was expanded to 24 anticancer drugs. In 1999, the third review has occurred. In 2013, 30 anticancer medicines were published in the WHO list. The latest review has started last year; albeit not perfect, the new list represents an important advance.
In 2014, the UICC responded to an invitation by the WHO to convene a task team charged with creating a new framework for evaluation of drugs for inclusion. The Core Task Team included representatives of UICC, Dana Farber Cancer Institute, ESMO, ASCO, SIOP, US National Cancer Institute, NCCN International plus collaborations from the outset with the WHO was critical to this work.
All authors, peer reviewers, and coordinating team were volunteers. Only Secretariat role was hired, with the kind support of NCI Center for Global Health, USA and the Livestrong Foundation.
ESMO has been actively participating in the latest revision, in the process of defining the criteria and providing information for the proposal documents, through the Emerging Countries Committee and active participation of Dr Alexandru Eniu, ESMO Board member and Chair of the Emerging Countries Committee.
Methodology
Methodology to develop proposal for revisions decisions focused on diseases/treatment outcomes and not individual medicines. Two primary axes were considered: What is the burden of disease and what is the clinical benefit from systemic therapies. More specifically, what is the potential harms/benefit of regimens of medicines for a particular disease and what are the supportive services that are required and does that influence the recommendation (such as blood product availability, pathology testing for genomic mutations and hormone receptor status).
The publishing of this new edition of WHO's Model List of Essential Medicines comes on the heels of the First Strategic and Technical Meeting on Management of Cancer hosted by WHO at its headquarters on 27-28 April, 2015. With technical experts from around the world, a set of priority actions has been identified that WHO will undertake to best support national efforts to develop and strengthen the early detection, diagnosis and treatment of cancer.
These actions include expansion of the WHO Package of Essential NCD Interventions for Primary Health Care; updates of the WHO cancer fact sheets and WHO modules on cancer control; guidance on screening; and regional trainings on cancer control. Participants underlined the need to encourage countries and international donors to invest in cancer control as many lives could potentially be saved if more resources were available.
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