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The Chinese government has implemented a series of efforts to improve access to novel oncology therapies, one example of this is the significant reductions via state-level price negotiations. The National Health Commission of China, the Health...
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In March, leaders from our health economics team, Tom Goss and Jordan Hinahara shared insights on health technology assessments in the US under the...
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As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark...
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We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health...
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April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...
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In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...
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Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps...
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In DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics we identified several potential payment models for monetizing the value of...
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From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28...
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The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...
