A Payer’s Perspective on CAR-T Pricing and Reimbursement
Does the clinical evidence of CAR-T and other ATMPs justify the cost of treatment?
From the payer’s perspective a clear “no”. CAR-T prices today are neither affordable nor sustainable. The evidence is promising but derives from one arm studies without any comparator arm, but this would be the most important information: what is the additional benefit of CAR-T compared to standard alternatives? Without a massive price reduction, especially outside orphan diseases, no health care system will be able to afford such sky-rocketing prices.
Do you think NICE has made the right decision on Yescarta?
It is not my job to comment on NICE decisions but I would be happy if we would have the possibilities in Germany that NICE has in the UK. In Germany, generally, all drugs are reimbursed as long as they are approved by EMA, prescribed by a qualified physician within the labelled indication and available in Germany. In some indications restrictions in the sense of “not recommending the use of” could be potentially helpful but to make this perfectly clear, this statement is not aimed at Novartis’ or Gilead’s CAR-T products, it has a more general perspective.
What are the best examples of pricing and reimbursement models we currently have for advanced therapies?
We would be happy to restrict the reimbursement to positive treatments only, for example for one-year survivors, to have a risk share agreement that also includes the treatment costs for complications like CRS and CRES and, of course, we would prefer a payment by instalments over a period of at least five years. This definitely is a wish list and nothing that is “in place”. To include all these options, changes in the German reimbursement system are needed, especially as we have an overlap of the hospital and ambulatory system reimbursement aspects.
Do we need an entirely new approach for the assessment and funding of advanced therapies? What might that involve?
Yes and no. It is a big step forward, that the GBA has decided in January 2018 also to include hospital only drugs in the AMNOG assessment process. Before January 2018, all drugs were excluded upon request by the manufacturer if the sales at the retail pharmacy were to be expected less than 1 Mio. Euro per year. Of course, there are still a lot of questions to be answered. The AMNOG assessment is a learning system, so we may generate a few answers by assessing Kymriah® and Yescarta®.
From a payer’s perspective, what would you say is the most important criteria for approving funding for advanced therapies?
Simple answer: evidence, evidence, evidence, that derives from RCTs with appropriate comparator arms.