ANNUAL REPORT 2012 - TiGenix

state. In general, inclusion of a product in
reimbursement schemes is dependent on
many factors.
These factors include proof of the product’s
therapeutic value (efficacy, safety,
effectiveness, convenience, etc.) and
economic value as compared to existing
alternatives, for a specific disease with a
clear medical need. Reimbursement is
subject to considerations of cost, use and
often volume, which again vary from country
to country.
centers. This convention covers a period
of three years and defines the specific
treatment criteria and follow-up measures
applicable to the reimbursable use of
ChondroCelect.
In the Netherlands, ChondroCelect has been
evaluated within the special reimbursement
procedure for innovative expensive medicines
(“Beleidsregel Dure Geneesmiddelen”). A
positive decision has been granted in June
2012, offering retrospective reimbursement
back to January 2011.
Because, different from other ACI
procedures, ChondroCelect is a
pharmaceutical product, a pricing and
reimbursement dossier must be submitted to
the national authorities. Based on the clinical
data and health-economic studies, TiGenix
has developed a detailed Core Value
Dossier to support these applications and the
negotiations with the national reimbursement
agencies and private payers.
After having received Marketing Authorisation
for ChondroCelect, reimbursement dossiers
were submitted in Belgium, the Netherlands,
Germany, Spain and France. Being the first
approved cell-based medicinal product
in Europe, ChondroCelect is pioneering
the reimbursement track for ATMPs and
timelines may vary from currently known
pharmaceutical product reimbursement
timelines.
In Belgium, TiGenix received the notification
by the Minister of Social Affairs of the
approval of a convention agreement (Art.
81 of the Belgian Royal Decree of December
21, 2001 on the reimbursement of medicines)
between the RIZIV/INAMI and TiGenix for the
reimbursement of ChondroCelect for wellindicated
patients in specialized treatment
In Luxembourg, TiGenix intends to apply
for reimbursement in the course of 2013
and expects to commercially launch
ChondroCelect before the end of 2013.
In the United Kingdom, TiGenix has achieved
some early reimbursement successes. In
the National Health System (NHS), two
primary care trusts (PCTs) agreed to fund
ChondroCelect treatment for a number of
individual requests. In the private sector,
two of the largest private medical insurance
(PMI) providers have agreed to routinely
fund appropriately indicated patients
for CCI using ChondroCelect. Other PMI
providers continue to fund via a single case
decision methodology, and to date there
has been no privately insured patient refused
access to CCI. For future routine access to
ChondroCelect in the NHS, NICE is currently
producing a scoping document with a
view to processing CCI with ChondroCelect
through the Single Technology Appraisal
(STA) system. A positive STA would provide
a mandate for PCTs/clinical commissioning
groups (CCGs) to allow NHS patients to gain
access to CCI therapy using ChondroCelect.
In Germany, ChondroCelect obtained
positive NUB status 4 (“Neue Untersuchungs
56 TiGenix I annual report 2012