As medicine evolves, so many innovative products/technologies have been developed, including for the most severe and rare diseases. However, the more complex a product or disease is to treat, the more expensive is the development process and consequently the price of the product. This scenario challenges the limited health budget since resources are scarce and not enough to cover all options. Therefore cost & benefit tools have been requested to support health authorities in the resource allocation decision. The Health Technology Assessment (HTA), as defined by the World Health Organization (WHO), consists of a “systematic evaluation of properties, effects, and impacts of a health product/technology.”
By providing robust, complete and evidence-based information about product/technologies, HTA becomes the most important tool in the market access process since it allows the evaluation of the economic impact of having the technology implemented and supports the making of well-informed decisions about the best therapeutic options available and the price negotiation in a specific context. The main tool for health technology economic evaluations is the pharmacoeconomic evaluation. This compares the value of the medical product vs standard care in terms of incremental costs and outcomes, which could be measured in terms of health improvement effectiveness (cost-effectiveness study), life years adjusted for quality of life (cost-utility), monetary terms ( cost-benefit ), or even cost-minimization, which assumes no difference in terms health impact, but only costs.
Focusing on reporting and negotiation, once the therapeutic value of the product is recognized by the authorities, the process moves to an economic phase. An economic dossier is prepared and submitted to local authorities to be evaluated by the HTA bodies. Confidential negotiations on pricing start as a final step of the process, driven by the client with CTI support in the background.
Once achieving Marketing authorization, HTA highlights the product added value and justifies the expected economic impact, with the ultimate goal of real access to market.
In terms of the reimbursement process, decision-makers in different countries may face different political backgrounds and different health care system organization. CTI has local expertise to prepare robust reports according to the type of project and HTA body involved. In the USA, our experience is reflected in more than 300 in peer-reviewed medical, economic and health services journals. In Europe and LATAM, our experience is reflected in the interaction with regulators and payer bodies, within more than 100 studies supported and more than 50 reports developed.