However, there are existing barriers that are described below, making it difficult to design and implement value-based contracts in the current context. In the United States, value-based contracting activity has been limited to date. But there is a great deal of interest in these agreements, both between paying agencies and among biopharmaceutical producers, and the changing health environment could generate more activity in this area in the future. In the real world, there are many issues and challenges in negotiating, implementing, and pursuing value-driven agreements. Actual outcome data can be difficult to obtain and even if results are tracked, it is difficult to account for other factors that influence treatment effectiveness and patient outcomes. In addition, paying agencies often focus less on certain treatment outcomes than on reducing total medical costs over time. For most, if not all, paying agencies, another hurdle for BSVs may be the systems that support reimbursement – which are based on the implicit model that you pay for therapy on the first day and that you concluded with that transaction. All relevant systems – from authorization to refund to payment to security – are designed to support one-time payments. So you can imagine the billing problems that arise when a paying agency only reimburses half the price of the therapy on the first day and then makes additional payments for quarterly steps, for example, to align them with the measured results. There are convincing arguments for manufacturers and paying agencies to consider value-based contracts: it has been recognised that agreements based on damages are not attractive to lawyers because of the risk they run.

As a result, a reduced number of agreements have been concluded (with the restriction of access to legal advice for individuals in the economy). Value-based contracts can offer pharmaceutical manufacturers the opportunity to improve patient access to innovative medicines and meet overall revenue expectations, but they involve unique challenges.11 Operationally, it can be difficult to set appropriate levels of results and set values on a specific criterion and timeline. Other complications are the acquisition, management and cost of data collection. In addition, paying agencies are concerned about the duration of the agreement, which may be influenced by the longevity of the beneficiary in the plan and the lack of portability of the terms.8 In addition, the Affordable Care Act has influenced a shift in volume to value, which has extended to payment models between health insurers (or paying agencies) and pharmaceutical manufacturers. Such a sourcing strategy is a value-based contract, designed to tailor the price of medicines to the performance of the medicine outside of clinical trials or in practice.3 There are certainly good reasons why pharmaceutical companies and healthcare providers should be cautious and selective in value-based drug contracts. In some cases, enthusiasm for BSVs may be little more than a new approach for payers looking for a discount. In such contract negotiations, “innovation” is the code word for “we want to pay less.” How might a manufacturer react? We propose to test some value-based models, which are proven to be results-oriented. If the therapy gives the results and the payer still wants to pay less, the discount is the goal; If the sponsor is willing to pay above the list price, if the treatment provides exceptional value, the goal is to improve patient outcomes. . . .