Current Reimbursement Situation of Advanced Therapy Medicinal Products (ATMP) in Germany: Which Strategy to Secure Adequate Funding ?

Advanced therapy medicinal products: current and future perspectives

BACKGROUND Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. OBJECTIVE The aim of this study was to characterise the ATMPs in development and discuss future implicatio...

Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials

OBJECTIVE Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to...

The current economic situation in Germany - Overview

Considerations on paediatric investigation plans for advanced therapy medicinal products

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA). Because ATMPs are different from ‘conventional’ medicinal products, defining t...

Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland.

On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of products subject to publicly financed reimbursement. First of all, the prices...