With Advanced Therapy Medicinal Products (ATMPs), especially those for the treatment of rare diseases – innovative but also very expensive therapies – entering the market, a new challenge for payers has arisen. How can innovative medicinal products be financed in the future? A question two invited experts were asked during the Bayreuther Gesundheitsdialog Digital.
Dr. Volker Leienbach, a representative of private health insurance, made clear that increasing drug costs were of concern – also for his sector of the insurance market. He first suggested ways to avoid EU orphan drug status in Germany, as this was associated with higher prices. One way would be to lower the threshold of €50 million value of sales at statutory health insurance expense or even abolish it altogether or at least to also consider private insurance sales, he said. Another way would be to abolish so-called indication-slicing to increase the target population of a new drug. He commented that the high level of requirements for the healthcare centres that offer advanced therapies, and the restriction of the treatment to stationary healthcare delivery are solutions he supports. Finally, he admitted that these measures alone were insufficient to address the problem.
Professor Herbert Rebscher, a representative of the statutory health insurance system, was more optimistic. He explained that in his former position as chairman of the board of DAK-Gesundheit, he took the risk and financed the first gene therapy, a one-time treatment, and that the single patient is still doing well years later. He encouraged payers to see how the one million euro treatment costs that seemed so threatening at the beginning were amortised by the long-term savings in opportunity costs as well as patient suffering. Furthermore, cost regulation would work better when more competing innovations enter the market. He was pleased that good suggestions were being considered and even followed by the G-BA for the definition of specialised centres that could finally be introduced in Germany. In the long-term, he imagined that individual ATMPs could also be produced there. He doubted that all products in the pipeline will reach the launch stage and if so, predicted that existing instruments to regulate costs will be adjusted accordingly. In addition, he suggested the introduction of a “clean cost-benefit analysis” in the mid-term. Currently, cost-benefit analyses are only in theory part of the AMNOG procedure.