Precision medicine and monoclonal antibodies: breach of promise?

Sustainability of costs of novel biologicals: Are we all heading for bankruptcy?

“…2,3 In the era of precision medicines with a promise of optimized drug efficacy and safety, where therapies are administered according to the patient's and/or disease's genomic profiles, it should come as no surprise that monoclonal antibodies and other biological molecules are being approved at twice the rate of small therapeutic molecules while also commanding exorbitant market prices. 4 This has been the case particularly in the field of oncology, where targeted biologicals have offered increased chances for survival to a proportion of patients at a high cost. Another example of increased expenditure is the case of orphan drugs, where a very low number of patient demands makes it financially unappealing for the pharmaceutical industry to develop drugs for orphan indications.…”

“…In the era of precision medicines with a promise of optimized drug efficacy and safety, where therapies are administered according to the patient's and/or disease's genomic profiles, it should come as no surprise that monoclonal antibodies and other biological molecules are being approved at twice the rate of small therapeutic molecules while also commanding exorbitant market prices 4 …”

Pricing vaccines and drugs in Europe: worth differentiating?

“…Research and promotion have always been the major cost items for developing and marketing drugs, whereas manufacturing costs hardly ever account for a substantial proportion of total costs, with the last generation of sky-high priced mABs no exception [9]. In general, it is difficult to estimate single cost items per product in a research-oriented industrylike pharmaceuticals.…”

HTA for pharmaceuticals in Europe: will the mountain deliver a mouse?

“…The underlying strategy is fostered by the (popular) 'political creed' that new drugs have to be made available to patients as soon as possible [42], somehow implicitly attributing an incremental therapeutic value to all of them. The most paradigmatic example is new anticancer drugs [43], whose added benefits vary widely and are often based on weak clinical evidence and surrogate endpoints [44], leading to different decisions at the national level mainly on account of the high degree of clinical uncertainty [45]. In practice, as national HTA agencies increasingly suffer the lack of robust clinical evidence for REAs [10], many regulatory authorities slow down and/or restrict the national reimbursement of new (expensive) drugs approved under these expedited regulatory pathways, because of scientific uncertainty [26,46].…”