open access

Vol 11, No 1 (2015)
Guidelines / Expert consensus
Published online: 2015-03-12
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Clinical relevance of therapeutic benefit in anti-cancer drugs assessment

Rafał Zyśk, Maciej Krzakowski, Jacek Jassem, Krzysztof Krzemieniecki, Piotr Potemski, Piotr Wysocki
Onkol. Prak. Klin 2015;11(1):1-8.

open access

Vol 11, No 1 (2015)
EXPERTS' OPINION
Published online: 2015-03-12

Abstract

The added values of new medical technologies can be defined in many different ways. Patient-oriented approach requires consideration of clinical relevance and cost necessary to obtain additional health effects. Well-designed clinical trials provide the highest standard in evaluating therapeutic effectiveness. Therefore, the American Society of Clinical Oncology has developed a document defining minimal — clinically relevant — therapeutic benefit offered to patients with selected tumors. Obtaining these values should be the aim for anti-cancer drug manufacturers and organizations designing clinical trials. However, reliable verification of patient’s therapeutic benefits seems to be particularly difficult in respect to the financing of drugs that are used off-label, novel therapeutics, and in rare cancers. In response to the growing needs for selection of the most valuable medical technologies that will also stay within a limited budget, some countries have designed mechanisms that are effective in describing the added value by assessing the efficacy, toxicity and cost of anti-cancer drugs. They initiate the discussion on optimization of value in cancer care.

Abstract

The added values of new medical technologies can be defined in many different ways. Patient-oriented approach requires consideration of clinical relevance and cost necessary to obtain additional health effects. Well-designed clinical trials provide the highest standard in evaluating therapeutic effectiveness. Therefore, the American Society of Clinical Oncology has developed a document defining minimal — clinically relevant — therapeutic benefit offered to patients with selected tumors. Obtaining these values should be the aim for anti-cancer drug manufacturers and organizations designing clinical trials. However, reliable verification of patient’s therapeutic benefits seems to be particularly difficult in respect to the financing of drugs that are used off-label, novel therapeutics, and in rare cancers. In response to the growing needs for selection of the most valuable medical technologies that will also stay within a limited budget, some countries have designed mechanisms that are effective in describing the added value by assessing the efficacy, toxicity and cost of anti-cancer drugs. They initiate the discussion on optimization of value in cancer care.

Get Citation

Keywords

clinical benefit significance, health technology assessment, drug off-label use evaluation, MediScore, Cancer Drugs Fund, anti-cancer drug reimbursement, early access

About this article
Title

Clinical relevance of therapeutic benefit in anti-cancer drugs assessment

Journal

Oncology in Clinical Practice

Issue

Vol 11, No 1 (2015)

Article type

Guidelines / Expert consensus

Pages

1-8

Published online

2015-03-12

Bibliographic record

Onkol. Prak. Klin 2015;11(1):1-8.

Keywords

clinical benefit significance
health technology assessment
drug off-label use evaluation
MediScore
Cancer Drugs Fund
anti-cancer drug reimbursement
early access

Authors

Rafał Zyśk
Maciej Krzakowski
Jacek Jassem
Krzysztof Krzemieniecki
Piotr Potemski
Piotr Wysocki

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