Most of the suggested policy changes have the aim of transforming the way pricing and reimbursement works for diagnostics. Oncotype DX has set an important precedent for pricing of a diagnostic by value, although it took several years for the test to achieve comprehensive coverage in the US (Garau et al., 2013). These factors combined have enabled Oncotype Dx to achieve full reimbursement at a price of 4’175 $. The prognostic and predictive value of Oncotype DX has since been validated through three large adjuvant randomized trials.Īs well as the robust clinical evidence demonstrated, Oncotype DX had an holistic offer, including the use of complex proprietary algorithm to calculate a recurrence score for result interpretation and the availability of centralized laboratory services with high quality standards. Accordingly, it has proven to be cost effective and sometimes even cost-saving due to reduced use of chemotherapy (Genomic Health). The value of the test was confirmed when it demonstrated that 44% of patients would benefit from a change of treatment (Asad et al.,2008). Of all the genomic tests for breast cancer, this test has the strongest research behind it. The benefit for pharmaceutical companies is an increased chance of obtaining a higher pricing, assuming value is demonstrated. The benefit to healthcare systems and payers is a reduction in risk, offering almost a “try before you buy” level of security. VBPs are usually subject to an agreement or contract where reimbursement is conditional based on a series of agreed criteria. Demonstrating efficacy is not always enough – it is about demonstrating improved outcomes that justify the price versus established therapies. It has signalled a transition from a “price-per-pill” mentality to one based on improved patient outcomes at a competitive cost compared with existing standard of care. In an environment where increasingly restricted healthcare budgets must cope with increasing demand for care, pharmaceutical companies are under pressure to demonstrate the value of their products. Value-based pricing (VBP) has gained significant traction in recent years in the field of pharmaceutical pricing and reimbursement.
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