NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper44 and Longfellow95,

Thank you. I found some additional information about the status of dcvax-l in September 2016. It was at that moment NUB Status 2.(Hospital Exemption)

***) NUB-Status 2 means that the product does not fulfill the
requirements for a NUB, Institute for Hospital Fee Systems (InEK) 2016.

A few months later it probably changed to Status 4.

**) NUB-Status 4 means that information provided is insufficient
to meet the eligibility criteria for an additional reimbursement according to the NUB procedure.

https://www.ecker-ecker.de/pdf/Poster-Current-Reimbursement-Situation20161018.pdf

https://www.valueinhealthjournal.com/article/S1098-3015(16)31913-1/pdf

BONN 2014 The Hospital Exemption, a regulatory option for unauthorised
advanced therapy medicinal products.

P.28

“NW Bio also announced today that the German reimbursement authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK) has determined that DCVax-L treatments for glioma brain cancers are eligible to obtain reimbursement from the Sickness Funds (health insurers) of the German healthcare system.

Applications for such reimbursement eligibility may only be submitted to InEK by German hospitals, not by a company. Six major hospital centers across Germany applied for such reimbursement eligibility for DCVax-L for glioma brain cancers. The amount and terms for such
reimbursement will now be negotiated by NW Bio, the hospitals and the Sickness Funds over the coming months, and will be applied to patients case by case. In the meantime, patients may self-pay for DCVax-L.” (78).

As was the case for DCVax-L, applications for NUB reimbursement can already start before the ATMP is authorised under the HE. Of note, the centrally authorised ATMPs ChondroCelect” indicated for cartilage repair in the knee, has also so far been reimbursed on a case-by-case basis via
the NUB procedure (76).

https://dgra.de/media/pdf/studium/masterthesis/master_schnitger_a.pdf