CURRENT REIMBURSEMENT SITUATION OF ADVANCED THERAPY MEDICINAL PRODUCTS (ATMP) IN GERMANY- WHICH STRATEGY TO SECURE ADEQUATE FUNDING?

Author(s)

Campion M, Bot D, Ecker T
Ecker + Ecker GmbH, Hamburg, Germany

OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) regroup products for gene therapy, cell therapy or tissue engineering. Twelve ATMPs are approved in Germany as of mid-June 2016. Their reimbursement status depends whether they are used in an outpatient or inpatient setting and whether they are considered as a medicinal product and fall under AMNOG, or as part of a procedure with potentially an adequate funding within a Diagnosis Related Group (DRG). If not the case, hospitals can submit a so-called NUB request for additional reimbursement. For outpatient methods, G-BA has to decide on funding before this method can be applied. The aim of the study is to review current reimbursement situation of the twelve ATMPs approved in Germany by focusing on the opportunity of falling under AMNOG as well as implications of a NUB classification securing reimbursement through inclusion in the DRG system. METHODS: For each ATMP approved in Germany, reimbursement status and funding issues have been analyzed in official sources and databases taking into account regulatory status, class specificities and inpatient or outpatient setting. RESULTS: While Glybera®, Imlygic® and Provenge® have been so far assessed under AMNOG, G-BA explicitly acknowledged Holoclar® and MACI® as methods. Status of the other approved ATMPs remains unclear. A specific coding for ATMPs is provided for in the DRG but with no additional reimbursement. Therefore, a NUB request has been submitted for 9 ATMPs. For 4 ATMPs, NUB requests have been denied, so that the method is not being reimbursed as a NUB. For 5 NUB, information provided was insufficient or inadequate but can lead to individual funding decision as a NUB. No information on outpatient reimbursement is available. CONCLUSIONS: It is essential for manufacturers already in early stages of developments to identify funding opportunities to secure funding in Germany.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP11

Topic

Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Disease Classification & Coding, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Multiple Diseases

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