The Interministerial Commission on Prices of Medicines and Health Products (CIPM) has given the green light to the expansion of the funded indications for the drugs Enhertu and Trodelvy, aimed at patients with metastatic breast cancer. This approval comes after several previous unfavorable decisions by the commission itself and after pharmaceutical companies presented new financial offers.
Enhertu (trastuzumab deruxtecan) is indicated for patients with advanced breast cancer who have low expression of the HER2 receptor and who have already been treated with chemotherapy, either due to disease progression or recurrence shortly after adjuvant chemotherapy. .
For its part, Trodelvy (sacituzumab govitecan) is intended for patients with hormone receptor (HR)-positive and HER2-negative advanced breast cancer, who have received hormonal treatment and at least two prior systemic therapies for their advanced disease.
Javier Padilla, Secretary of State, has stressed the importance of “continuing to delve deeper into ensuring that the process of evaluation, positioning and financing of medicines and health products is increasingly transparent and increasingly traceable and public, in relation to with the publication of the evaluations and the data we have in this regard to make decisions.”
Currently, work is being done on this through the Royal Decree on the Assessment of Health Technologies, as well as the reform of the consolidated text of the Law on guarantees and rational use of medicines and health products, and the Royal Decree on the Price and Financing of Medicines, which will soon be in public consultation. “It is good news that the medicines that contribute to the health of our population are financed and that the medicines that we finance contribute to the health of our population,” Padilla added.
A new option for patients with advanced breast cancer
The green light for funding has come three years after these therapies were approved by the European Medicines Agency (EMA) for these indications, and their coverage was rejected in the four previous CIPM meetings in December 2023, January 2024, March 2024 and June 2024. Both compounds have already received approval for funding in 2022 and are antibody-drug conjugate drugs or immunoconjugates that combine a monoclonal antibody that allows the targeted release of a chemotherapy drug. In this way, it is possible to release high doses of chemotherapy in a targeted manner, reducing side effects.
“It is good news that the medicines that contribute to the health of our population are financed and that the medicines that we finance contribute to the health of our population”
In the case of Enhertu, the indication at that time – which is maintained and added to the approved one – was for patients with unresectable or metastatic HER2-positive breast cancer who have received one or more previous regimens targeting HER2. Trodelvy is indicated for the treatment of patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, including at least one for advanced disease.
The CIPM, attached to the Secretary of State for Health, is the body in charge of setting the maximum industrial price (PVL) of the medicines that are part of the pharmaceutical provision of the National Health System. So far this year, the CIPM has issued positive resolutions for 34 new active ingredients, including eight orphan drugs intended for rare diseases, and has approved 21 new indications for drugs already funded in other areas. All information regarding the CIPM is available on the website of the Ministry of Health.
Source: Ministry of Health
