3. Processes and methods

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1. Processes and methods

1.3. Beyond recommendations

Recommendations about whether a product can be made available within a healthcare system may be viewed as too rigid and not offering flexibility for those who require access to new therapies. Since these recommendations are generally population-focused, they may not allow for exceptions on an individual basis. Rather than a yes/no recommendation, other mechanisms have been applied by HTA that may be more helpful.

  • Coverage with evidence development (CED): This can be used to allow access to a promising new product which, at present, has insufficient data supporting either clinical or cost effectiveness. In these circumstances, HTA can recommend use of the medicine, providing there is a formal collection of evidence to resolve those uncertainties while it is being used, for example in a registry. Alternatively, there may be ongoing clinical trials required by regulatory authorities that will deliver additional evidence at some point in the future.

  • Price determination: The price of a health technology can have a direct effect on providers and patients’ access to that technology. In some instances, payers may negotiate with the company for a price based on the perceived value of the health technology, especially when the health technology is useful in some cases but not in all. This approach ensures that those providers and patients who need a certain technology have access to it. HTA bodies may or may not be involved in this process. However, value-based pricing presents challenges, as it is difficult to ensure that all aspects of a health technology’s value are adequately considered, for instance, features that are valuable to patients such as convenience of dosage schedules or improved methods of delivery.

  • Decision aids and clinical guidelines: The HTA may indicate that the product has most value when used in a particular group of patients or in a particular sequence following other treatment options. To optimise the value, the payer may decide to reimburse the medicine in association with specific clinical guidelines (for prescribers) or specific decision aids (for patients and clinicians). Decision aids are tools for patients and doctors to use evidence to inform an individual decision. They help patients to choose between two treatments that have different risks and benefits. It enables them to have more informed discussions with their doctors about what they value most and to determine which is the best option for them. Read an example from a hospital that shows how such a decision aid might look.