BACKGROUND

In 2018, Arturo López Pérez Foundation Oncology Institute created a Health Technology Assessment Unit (FALP-HTA) to assist decision-making processes related to high-cost drugs (HCD).

OBJECTIVES

To assess the methods developed by FALP-HTA for the Complex Treatment Evaluation Committee (CTEC), where HCD indications have been reviewed to decide treatments for FALP patients between 2018 and 2020.

METHODS

First, a literature revision was performed to identify recommendations for hospital-based HTA (HB-HTA) processes. With this input and in agreement with CTEC decision markers, a HTA process was designed, including inputs, activities, and products. Among the inputs: (i) A value framework for HCD decisions and (ii) methods for rapid reviews were defined. Afterwards, stakeholders’ activities and roles were coordinated. Regarding products, the following were established: (i) rapid HTA reports for HCD, (ii) repository of the evidence and (iii) CTEC cases database. Lastly, a periodic evaluation to verify compliance with stakeholder’s agreements was set.

RESULTS

Adophta project recommendations for HB-HTA were used as main guidelines. The most relevant value elements were overall survival, progression free survival and health related quality of life improvement. Decision criteria include these value elements and a cost limit (USD $ 62,000 per year per HCD per patient). A scoping review-like method was developed to identify regulatory approval, HTA agencies recommendations and clinical trials evidence.

Between 2018-2019, cases of 694 patients have been reviewed, representing 116 indications. 76.4% of the cases were approved, where 21.7% exceeded the cost limit, 4,2% did not fulfilled the clinical value criteria and, 1.7% did not meet any of our criteria.

CONCLUSION

In two years, FALP-HTA have been able to develop and organize a HB-HTA process for HCD with a transparent, participative and local value framework. The value framework is currently under revision for better representation of CTEC values.