Patient Advocacy pays off: Drug approved in Norway after several rejections

In June 2023, there was not a dry eye in the Norwegian Breast Cancer Association. After two rejections, the drug Trodelvy (sacituzumab govitecan) was finally approved for the treatment of women with incurable triple negative breast cancer.

A great deal of tireless work on the part of the association throughout the spring of 2023 had borne fruit. 50-60 Norwegian women now benefit from a treatment that extends life significantly compared to the standard treatment up to now. The reason for the previous refusals was based on the price.

"The patients who benefit from the new drug do not have time to wait for endless price negotiations," says chairman of the Breast Cancer Association Ellen Harris Utne. The breast cancer association became involved in the case regarding the approval of Trodelvy on 13 January after a member had contacted the association. She had negative breast cancer with metastases, and via her oncologist she was made aware of Trodelvy, as the only possible treatment for her. The medicine was not approved as standard treatment, but an application for approval had been submitted to Nye Metoder, which approves new medicines.

Pending price offers

"On January 17, we approached Nye Metoder to get information about how far Trodelvy was in the approval process, and the answer was that they were waiting for a price offer from the pharmaceutical company," says Ellen Harris Utne. The Breast Cancer Association contacted the pharmaceutical company and asked to speed up the process, after which the company took the initiative for a meeting with a specialist on 1 February.

A high-profile politician became involved in the case and directed a query regarding the application for approval in the Storting to the Minister of Health and Care. The Breast Cancer Association thanked the politician in an email for getting involved in the case. The association then had two telephone conversations with the politician, where they discussed how the case could be accelerated.

In parallel with this, the Breast Cancer Association moved New Methods to get Trodelvy on the agenda for the decision-making meetings. On March 13 and April 24, 2023, approval was refused due to the price. After this, the association had a chronicle published on the Statskanalen's debate page, NRK Ytring with the title: Progress costs: New and effective cancer medicine is not cheap. But women's lives are valued less in Norway than in other countries. And on June 19, 2023, Trodelvy was finally approved for the treatment of triple negative breast cancer.

Triple negative breast cancer

Triple negative breast cancer mainly affects young women. Sacituzumab govitecan (Trodelvy) is a so-called drug conjugate, where a cytotoxic agent is bound to an antibody that binds to the cancer cells. The antibody binds to a protein on the cancer cells and is absorbed into the cells, where the cytotoxic agent causes the cancer cells to die. In this way, you can stop the spread of the cancer. The medicine is available in 15 European countries, including Sweden, Finland, Scotland and England. In Denmark, it is not approved with reference to the price.