Abstract
To examine the current EU5 market access landscape for ATMPs. Assessed the regulatory path, HTA assessments and funding mechanisms for ATMPs with EMA approval as of May 2016. Eight ATMPs are EMA approved as of May 2016. Of these, one was suspended (matrix-induced autologous chondrocyte implantation) and another withdrawn (sipuleucel-T). Germany: All ATMPs need to be authorised by the Paul Ehrlich Institute (PEI). Furthermore, the GBA could classify an ATMP as a procedure rather than a drug thereby bypassing AMNOG (e.g. autologous human corneal epithelial cells). The two ATMPs assessed under AMNOG (alipogene tiparvovec and sipuleucel-T), were both assigned “non-quantifiable additional benefit”. Talimogene laherparepvec is currently undergoing assessment with a final decision expected in mid-Dec 2016. Currently, alipogene tiparvovec is a hospital use only drug with reimbursement negotiated by the hospital and sickness funds on a case by case basis. In France, HAS assessed only two ATMPs (autologous cultured chondrocytes and alipogene tiparvovec) with reimbursement not being granted for either. Autologous cultured chondrocytes is the only ATMP that hospitals in Italy can currently import while it is available for hospital use only in Spain. Preliminary UK recommendation for autologous cultured chondrocytes and matrix-induced autologous chondrocyte implantation was for use in research only. Draft guidance on talimogene laherparepvec issued by NICE in March 2016 did not recommend use in melanoma. No other ATMP is currently routinely commissioned. All EMA approved ATMPs to date have faced EU5 market access challenges, with Germany being particularly complex. HTA assessments have been unfavourable largely due to the uncertainty with available data and – possibly – costs. The ATMP landscape is beginning to form and evolve. It will need to solidify for AMTPs to be viable for the companies seeking to market them and the patients who will benefit.
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