From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.
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So far Sam Barnum has created 21 blog entries.
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.
The Boston-based Institute for Clinical and Economic Review (ICER) recently announced that in 2020, they are considering selecting two or more non-drug topics for assessment.
In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation”, which is expected to be approved by the parliament early November.
For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could lead to new opportunities for market access of their products.
China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.
Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. Boston healthcare outline procurement trend in the Italian reimbursement environment.
A recent proposal by Jens Spahn, Federal Minister for Health in Germany, would limit the decision-making power of the Joint Federal Committee (G-BA) and lead to new evidence approaches for healthcare decision making.
Earlier this month, the Food and Drug Administration announced a new draft guidance for companion diagnostics. The guidance describes considerations for the development and labeling of companion diagnostics to support the indicated uses of multiple therapeutic oncology products.
Boston Healthcare spoke at the MedTech Access Leaders Forum in Berlin, Germany on 3-5 December 2018. Vice President, Rob Wenthold spoke on maximizing the organizational impact of the market access function, and CEO, Joe Ferrara spoke on global considerations for companion diagnostics. Register your details to receive your copy!