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The increasing need to contain the increase in health and related costs and expenses, especially in the area of ​​oncology, has been reflected in measures, rules and parameters in the public and private sector aiming at restricting expenditures, especially in health care providers, insurance companies and group medicine where there is a predominant and superimportant role in reimbursing high-cost drugs and targeted therapies. (MORAZ, 2015)

According to GONÇALVES (2010), several mechanisms have been used to reinvent this health management based on reimbursement and drug coverage, such as the insertion of co-payments to the beneficiary, control and monitoring of profit margins and online prices with medical and pharmaceutical products in platforms such as Bionexo and OPMEnexo, price referral and evaluation performance of health technology, and especially risk sharing.

According to FAO & WHO (2005), risk analysis can be seen as a structured procedure that seeks to identify a potential problem or need, and assess the probability of its relevant occurrence, estimate its impact against demand, and suggest necessary measures to remedy it. This risk sharing model has a series of actions aimed at a complete risk assessment, risk management and also the sharing of this risk.

An important instrument, the use of which has been frequent and growing, are contracts of Risk Sharing (GRIMM, 2016), between the pharmaceutical industry and payers, which aim to facilitate access to innovative medicines while maintaining sustainability of the system and seeking the result expected by the patient.

In a context of uncertainties and doubts about their clinical benefit, these Risk Sharing contracts allow patients to be free of innovative drugs and with a real cost-effectiveness, maturity of clinical evidence, where through biomarkers and criteria of use, and it is possible to identify the eligible patient groups that the drug acts effectively with its mechanism of action in order to reduce the risk of unnecessary costs between the two contract stakeholders. (DE POUVOURVILLE, 2006)

Through risk sharing, the payer source with its consumer demand and the Pharmaceutical Industry with the drug to be offered, establish an agreement with the functionality of collecting new scientific evidence and actual survival data on the product under negotiation. The consolidated data, obtained through the results of the patients in use of the drug, with the effective action performance, will determine the price to be paid by it, within a premise and rules previously negotiated in both parties. The main premise of this agreement is therefore the sharing of the risk between the manufacturer who was responsible for technological development and the source of the payment, which is similarly when there is a lack of knowledge about the effects and consequences of drug use and its cost interference, and the final price that will be disbursed for compliance with this agreement. HAUEGEN (2014)

In summary, Risk Sharing offers a number of potential benefits, among which the most important are:

1) Reducing the risk to paying sources of making a drug or drug purchase below ideal;

2) Bring early access to medicines and new technologies for patients with indication;

3) The parameterization and generation of efficiency in the evaluation of prices to the internal and external market; and

4) The generation of evidence and data of real survival, contributing to a scientific advance of technological evaluations.

The potential advantages presented above, coupled with a volume growth in shared risk contracts in institutions outside the United States, raise some questions as to the real reason why such agreements are in limited use in the United States, since the provisions that link in the aspect of the gain of forces with the new emphasis in organizations that act under incentives stronger and with clear objectives to manage the care of the patient with serious and chronic diseases of efficient form.