Astronomical, jaw-dropping and staggering are among the words often used to describe the potential costs of cell and gene therapy treatments. Although prices are still hypothetical, industry leaders realize that the issue of massive one-time price tags – the kind that make insurers and patients balk – needs to be tackled.
Alec Orphanidis, Senior VP at uniQure sets the scene: “You’ve made it through the research, the clinical development side, consultations with regulatory bodies all the way through to approval, but there is the last step – we brought them this far – how do we get them over that last hurdle to where they are reimbursed?”
These drugs are new, complex and hugely costly to make, but they do offer a potential cure and are one-off treatments, which means less time in hospitals for patients. These are some of the benefits that need consideration when looking at the final cost.
Even so, Orphanidis admits that the ‘sticker shock’ price remains a big problem. He urges: “We should stop looking at this as sticker shock. There are a number of parameters that need to be taken into account when we, as an industry, come up with a price and when we request reimbursement of that price.”
Orphanidis believes that companies can ease the process by thinking about price from day one: “Once early calculations and a price range are established you can start preparing the ground by talking with the HTA and reimbursement bodies.”
It’s in this area he believes the industry still needs to improve. He explains huge steps have been taken to speed up regulation, and move quicker through the process: “all that is great, and we should not be taking anything away from these initiatives, but we’re still then backing up at that bottle neck, that last hurdle which is pricing and reimbursement. Unfortunately there are still not enough mechanisms in Europe at this point, where you could begin having those kinds of discussions with the people who eventually will be asked to reimburse the product.”
Ultimately Orphanidis wants people from all sides of the industry to “have the patient ultimately in mind. We are on the verge of tremendous scientific breakthroughs, but it has to be sustainable and it has to be sustainable for the companies who are doing studies in populations with very few patients, where we are bringing significant benefit to these patients. But if we don’t get the correct return, we can’t continue to help additional very small patient groups. On the other hand, you have the people who will have to reimburse these products and if they don’t have the right price, their budgets will diminish faster than required, and they won’t have the funding to continue to support what we do to ultimately help the patients.”
Visit the Cell Therapy Manufacturing and Gene Therapy Congress website for discussions on similar issues and updates on this year’s event being held from 30thNovember to 1st December in Brussels.