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[:pb]The incorporation of technologies in the healthcare sector is a complex process and requires careful study.Healthcare Technology Assessments (HTA), already fulfil this role in many countries and, in Brazil, they are mandatory for medicines, procedures or equipment’s to be adopted by the Unified Health System (SUS). However, even with all the necessary steps in an HTA, which include technical analysisand health economics, among others, the adoption of a new technology brings a series of uncertainties.

Especially in times of financial crisis, a new drug, procedure or equipment is seen as a risk to the medical community. A tool that can reduce these risks for the parties involved and, thus, encourage the adoption of new technologies in the sector, is the so-called risk sharing (sharing contract or sharing of risks). Understand more in this article.

What’srisk sharing

As this is a new model, there is no fully established concept for risk sharing, butHealthcare Technology Assessment International (HTAi) defines it, briefly, as an agreement between the producer and the payer for access to a technology in accordance with certain conditions. These contracts can use a variety of mechanisms to address uncertainty about the technology’s performance, to maximize its use, or even minimize its financial impact.

No matter what form the deal takes, the risk will always be on the manufacturer’s or the payer’s side, and never on the patients’ side. The idea, on the contrary, is that the final public benefits from the possibility of choice and access to adequate treatment, without any prejudice.

In this way, risk sharing contracts can be basically divided into:

  • Financial agreements – only take into account the price of the technology to be incorporated, with the objective of reducing financial risks;
  • Agreements based on clinical outcomes – link values to technology performance. In this case, actual data collection is required, so the payment from the payer to the technology provider is made based on the observed results. The modality is ideal for when there is some type of uncertainty regarding the effectiveness of the product or service.

Use of risk sharing in cancer drugs

One of the reasons for using risk sharing contracts is to allow patients’ access to certain technologies without compromising the sustainability of the healthcare system, as occurs with drugs for the treatment of cancer. A study carried out in Italy showed that the use of this type of contract resulted in a reduction of 259 days (from 343 to 84) in the average authorization time for cancer drugs. According to another Italian survey, one in two doctors believe in risk-sharing agreements (APR) as the right path.

The use of risk sharing can also be indicated for technologies with different indications and applied to different populations. This happens, for example, with cancer drugs: in 2014, more than 50% of them were approved for more than one type of cancer. By 2020, this percentage is expected to rise to 75%.

If the same drug can have different results according to the indication and line of treatment, one would imagine that its value would also vary. However, this is not what usually happens and, thus, it opens up the possibility that some drugs will never be developed for a particular indication, as they are not financially interesting. Risk-sharing contracts can also be an important tool in this task, being applied by indication and, thus, contributing to the so-called definition of price by indication (PPI).

Drug combinations

Another situation in which risk sharing contracts can help with pricing is the combination of different drugs into a single product. This is important for diseases such as cancer, HIV, hepatitis C and diabetes, on which there are constant studies and, consequently, each day more combinations to be tested. This importance is even greater when it comes to bringing together drugs from different manufacturers, as the risks can be shared between more than one company.

The Portuguese experience

In Portugal, risk-sharing contracts have already been used, for example, for medicines for diseases such as melanoma, rheumatoid arthritis, hepatitis C and breast cancer. In the case of hepatitis C, risk sharing brought clinical benefits to patients and, consequently, reduced treatment costs, as the disease started to bring fewer complications.

Example de risk sharing in Brazil

An example of the application of this model in Brazil was a partnership between UNIMED São José do Rio Preto and GSK Oncologia, which enabled breast cancer patients to have access to a new drug. In case of successful treatment, the health plan pays for the drug. Otherwise, the cost is a responsibility of the manufacturer, which gives even more reasons for the industry to develop an effective product

In the context of public health, the model was adopted for the new treatment offered to SUS patients diagnosed with hepatitis C.

To learn more about our solutions for incorporating healthcare technologies, download the MAPES e-book: MAPES: Cases &Soluções.[:]

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