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c/da Tonicello snc, Capo Vaticano, (VV), ITALIA

1,3 km da Stazione Treni


Yescarta Managed Access Agreement

Methodology: Secondary research, complemented by primary research with key market players. What we still need to refine is how to integrate all of these pillars (i.e., ETS, implementation, and RWE) to maximize both access and value of CAR-T for patients, clinicians, and payers. Given the important future CAR-T pipeline, it is essential that Canada develop a framework that provides access to these products while addressing relevant clinical and economic uncertainties. To complete the review of the evidence, we mainly studied with a key market player the introduction of CAR-T cell therapy in each of the EU5 countries. In addition, we have based ourselves on the experience and ideas of the activities of our employers` organizations in the field of cell and gene therapies, including A. Primary research for the development of the Alliance for Regenerative Medicines (ARM) report on timely access to cell and gene therapies [8]. B. Through the coordinating role of the Cell and Gene Therapy Catapult for the treatment of advanced therapies in the UK, including regular updates from Commissioners and Clinicians of Key Opinion Leaders (KOLs) on adoption status, with a particular focus on the requirements and challenges of clinical infrastructure. In England, Kymriah® and Yescarta® in their EMA-approved indications are reimbursed by the Cancer Drugs Fund (CDF), a cancer-specific funding source that provides access to drugs for which there is a plausible potential for them to meet routine commissioning criteria, but where there is significant clinical uncertainty. NICE felt that both products could not be recommended for routine use due to the high uncertainty and limitations of clinical data, but approved patient access via sfAO provided that more evidence of efficacy in the real world (i.e. coverage with evidence development) [47]. NICE was the first HTA body in the EU5 to issue a favourable reimbursement recommendation for CAR-T cell therapy, Kymriah®, which was reimbursed for ALL by the CDF less than 10 days after receipt of ma “MA” [48].

Subsequently, Kymriah`s DLBCL indication® and Yescarta`s two indications® received positive NICE recommendations and were also approved for reimbursement by the SFAO, subject to confidential discounts and the obligation to collect and submit additional data for future price revaluation [49-51]. As mentioned above, one of the elements of HTERP`s recommendations was a price reduction for the two CAR-T agents. It should be noted that neither Kymriah nor Yescarta have entered into negotiations through the Pan-Canadian Pharmaceutical Alliance (pCPA), according to the pCPA website. It is believed that the negotiations were limited to the first two provinces to grant access (i.e., Quebec and Ontario). Listing agreements for CAR-T are confidential as they would be for any product; Therefore, it is not clear whether there have been innovative results-oriented agreements, as proposed in other countries. .


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