AIFA announces funding of CAR-T cell therapy using new reimbursement approach

The Italian Medicines Agency (AIFA) has announced that it will be reimbursing CAR-T cell therapy Kymriah, using a new reimbursement model ‘payment at results’.

Funding for the cancer drug will come from the Special Fund for Innovative Oncology Drugs. Acting President of AIFA’s administrative council, Stefano Bonaccini, commented that:

“This marks a very important step for public health and for our National Health Service, which has seen a change in relation to the past around this negotiation.”

Payment at result is similar to the current payment by results approach, which manages uncertainty for drugs with unfavourable benefit to risk ratios by requiring the manufacturer to repay treatment costs for non-responsive patients.

However, the payment at results approach differs in that it spreads payments, paying in three instalments:

  • Upon enrolment in the treatment programme
  • Whilst treatment is ongoing
  • In the 5th year of survival of the patient

The Italian Health minister, Giulia Grillo, stressed the importance of a consistent funding stream for CAR-T treatments:

“When we speak about CAR-T, we are talking about not just administration to eligible patients, we are talking about a complete therapeutic journey that requires structures, dedicated staff and specific know-how to protect patients’ lives.”

Funding for Kymriah will be from the Special Fund for Innovative Oncology Drugs which has an annual budget of around €500 million.

The announcement from AIFA can be found here.

Further information about the reimbursement process in Italy can be found on MAP Online.

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Published 9. August 2019 in News, News Italy