SIR-SPHERES Y90, the first medical device for Selective Internal

Radiation Therapy (SIRT) reimbursed in France

SIR-SPHERES Y90 manufactured by Sirtex Medical Ltd (Australia) and distributed by Sirtex Medical Europe
GmbH (Germany) has been registered for reimbursement in France at the price 12,660 (published in the
French Official Journal on February 16th, 20171,2). The product will be reimbursed to hospitals on top of DRG3.

The resin microspheres SIR-SPHERES Y90, a permanent implant for SIRT in liver tumors, contain Yttrium
Yttrium-90, a
high-energy beta-emitting
emitting isotope without any primary gamma emission. Once injected into the hepatic artery,
the microspheres
crospheres lodge preferentially in the microvasculature surrounding the tumor, maximizing anti
anti-tumor
4
effects and minimizing damage of healthy liver tissue .

SIR-SPHERES Y90 is the first medical device for Selective Internal Radiation Therapy (SIRT) accepted to
reimbursement by the French National Insurance covering about 99% of the French population.

SIR-SPHERES Y90 was assessed by the HAS (French HTA body) for the fir first
st time in 2010; the HAS issued a
negative opinion judging the available clinical evidence insufficient for reimbursement but recognized the
eligibility of the product to an exceptional funding mechanism allowing for conducting further clinical trials in
France5. However, this exceptional funding mechanism could not be activated. Another nother Yttrium-90
Yttrium

microspheres for SIRT, THERASPHERE manufactured by MDS Nordion (Canada) assessed by the HAS one year
later was also given a negative opinion for reimbursement
reimbursement; the Committee pointed out the weakness of the
clinical trials methodology and the low number of patients enrolled in the studies6.

In 2015, the initial SIR-SPHERES Y90 -specific

specific clinical data clinical data completed by 6 new clinical studies went
through a new assessment procedure and finally convinced the HAS Medical Device Committee Commi that has
granted to the product a minor added value (level IV) vs. best supportive care in patients with liver metastases
of colorectal cancer refractory to all chemotherapies
chemotherapies, and issuedsued a positive opinion for reimbursement7.

SIR-SPHERES Y90 reimbursement is limited to patients refractory to all available chemotherapies, with a good
general state (ECOG performance index 2), a tumor invasion of the liver below 25%, and no evidence of
extra-liver metastases. The target population of patient eligible to reimbursement has been estimated at 300
patients/year.

The positive opinion of the HAS has been issued and published on the official HAS site on Apri
April 9th, 2015. It took
almost two years to get the registration on the list of expensive products reimbursed on top of DRG ((liste en
sus)) and to reach an agreement on the reimbursement pri price
ce with the Ministry of Health.

ation granted by the HAS, the SIR-SPHERES Y90 sales in France can reach
Within the limits of the target population
EUR 3.6 million by 2022.

1
https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000034050041
2
https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000034050613
3
https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000034050058
4
http://www.sirtex.com/eu/; http://www.sirtex.com/au; http://www.sirtex.com/us
5
http://www.has-sante.fr/portail/upload/docs/application/pdf/2012
cs/application/pdf/2012-03/sir_spheres_2952__english_version.pdf
6
http://www.has-sante.fr/portail/upload/docs/application/pdf/2011
sante.fr/portail/upload/docs/application/pdf/2011-06/therasphere-31_mai_2011_3508_avis.pdf
7
http://www.has-sante.fr/portail/upload/docs/evamed/CEPP
sante.fr/portail/upload/docs/evamed/CEPP-4825_SIR-SPHERES_24_mars_2015_(4825)_avis.pdf