Valtermed is the information system of the NHS, launched in November 2019, to determine the therapeutic value in real clinical practice of medicines with a high clinical and economic impact on the NHS¹. The aim of the Valtermed program is to pool and share knowledge of the therapeutic effectiveness in real clinical practice, and to generate evidence to improve its use in the NHS. The priority scope are medicines with high health and economic impact.

The basis of Valtermed is the pharmacotherapeutic protocol, which includes patient inclusion criteria, the therapeutic goals to be achieved, the variables that measure the effectiveness of the medicine (which are usually the same as those measured in clinical trials), and the frequency of their measurement.

Since its launch in 2019 to December 2022 (cut-off date of the present analysis), a total of 22 drugs had been included in the Valtermed program:

• Most of the drugs included were Orphan Drugs (14/22, 63%), which are therapies usually linked to higher degree of uncertainty.
• All ATMPs approved in Spain at the study cut-off date were included in the Valtermed program.
• 11 drug classes (ATC code) were represented among the 22 included drugs, being antineoplastic (5/22, 23%) the most represented class.
• Most of the drugs include an innovative agreement (63%), being the most common a performance-based agreement (10/22, 45%).

15 pharmacotherapeutic protocols have been developed,covering the range of indications of the 22 drugs included in the programme (one protocol may include several drugs if they share the same indication).

Since 2019, 15 pharmacotherapeutic protocols have been developed (plus two more that are under development) covering the range of indications of the 22 drugs included in the program (one protocol may include several drugs if they share the same indication).

Overview pharmacotherapeutic protocols

The pharmacotherapeutic protocols included in the Valtermed program have the following sections and content:

• Introduction: Includes a brief introduction of the disease, current management and treatment in Spain and a description of the therapy.

Other information included in this section might vary from treatment to treatment, such as a summary of the efficacy results, efficacy/safety uncertainties, as well the rational for the restriction of the indication.

• Treatment objective: Briefly describes the expected outcomes of the therapy.
• Patient inclusion criteria: List the criteria to define patient eligibility to the treatment. Usually, the criteria are the same inclusion/exclusion criteria of the clinical trials but might include additional conditions if the treatment is indicated only for a subpopulation of patients.
• General considerations for the treatment: Based in the information included in the SmPC regarding administration, dosing, special populations, or follow-up requirements.
• Outcome variables: This section is not included in all protocols. It includes a description and definition of the included variables and what is considered as a patient responder to the treatment.
• Assessment and monitoring: Data to be provided and assessment time-points for each patient before and during treatment. It includes both mandatory and optional variables.

It is possible that Spain will continue to promote the registration of real-life data in the future.

As a Spanish member of the PHAROS Healthcare Consulting Network, Omakase Consulting can offer further information and advise on the evolving needs of pharmaceutical companies in the areas of evidence generation, health economics, outcome research, Spanish national pricing and regional local market access.

References:

1. Sistema de Información para determinar el Valor Terapéutico en la Práctica Clínica Real de los Medicamentos de Alto Impacto Sanitario y Económico en el SNS (Valtermed). Available at: https://www.sanidad.gob.es/va/profesionales/farmacia/valtermed/home.htm