Road map to market access for cell therapies in Italy

Maxer Consulting has completed a detailed analysis of the market access processes most relevant to cell therapies in Italy. This project was awarded to us by the Cell Therapy Catapult and was conducted in collaboration with ValueVector.

The Cell Therapy Catapult believes that through science and industry, along with its expertise in cell and gene therapies,

we will one day have better treatments that will ease suffering and improve quality of life, whilst building a global industry the UK can be truly proud of. The Cell Therapy Catapult, suppor

ted by Innovate UK (formerly the Technology Strategy Board), advances products into early clinical trials, providing clinical, technical, manufacturing, regulatory, health economics and market access expertise. There is a strong focus on collaboration and lowering barriers to investment and funding.

The study consisted in a combination of secondary and primary research, involving 25 Italian stakeholders at the national, regional, and local level.

Where available, examples of cell therapies already launched in Italy were used as analogues from a market access and funding perspective

In particular, we explored how the regulatory status, the size of target population, the hospital-only status (specialist-centre vs. general hospital), and the high cost of cell therapies influence market access routes, evaluation processes and funding options.

The project lasted from October 2014 to February 2015, providing the Cell Therapy Catapult with “..incredibly useful reference documents”, detailing market access pathways for the different classes of Advanced Therapy Medicinal Products as defined by the EMA classification.