Difficulties and Challenges in the Management of Market Access for Innovative Oncological Therapies

La complessità e le sfide dell'accesso al mercato delle terapie innovative in oncologia

Abstract

The market access of current/future innovative therapies is linked to the capability of payers and industry of negotiating price and reimbursement agreements that reflect drug value for patients and health care systems. Clinical research has provided therapeutic options quite effective, but complex from the perspective of market access management. An example are biological drug combinations, or therapies tailored to the patient, with different therapeutic indications. From this point of view, drugs approved for multiple indications are a great challenge for the definition of an appropriate price; each indication is related to a different value, which in its turn is related to the clinical benefit and to the availability of therapeutic alternatives. If new mechanisms for drug pricing are not implemented, the only possible trade-off is to keep out of the market the indications with lower value, or reduce the price of indications with higher value to the level of indications with lower value. In Italy, the AIFA Register was established in order to guarantee appropriate utilization of costly innovative drugs, i.e. pharmacoutilization patterns able to reduce resources misuse (inappropriate utilization) and to optimize the clinical benefit for patients. In addition to this primary goal, during the last few years innovative price agreements were introduced through the AIFA Register, based on different approaches, such as cost-sharing and payment-by-results. The rationale was to minimize the risk that the Italian National Health Service (NHS) pays for therapeutic failures. Among these examples, it is worth mentioning bevacizumab that, given its seven different indications, negotiated with AIFA a different agreement for each of them. Every agreement reflects bevacizumab value in a different setting; this allows to the drug complete access to the market, though the cost for NHS is differentiated. The challenge/opportunity for the future will be to reassess drugs values taking into account clinical practice data extracted from population registries, that is from populations much larger than those enrolled in pivotal clinical trials.