Retrospectiveanalysisofpatientdataasabuildingblockforlong-termcostcoverage
A second-line treatment for patients who had undergone a lung transplant was reimbursed in Switzerland on a temporary basis. There was a lack of data on how the treatment was being used in everyday clinical practice in Switzerland and which patients were benefiting from it. To address this, the * LinkCare * conducted a retrospective cohort study in collaboration with a Swiss transplant centre.
The challenge
Starting point and systemic barriers
Following a lung transplant, the transplanted lung may experience a chronic decline in function. For patients for whom standard treatment is insufficient, a therapy (extracorporeal photopheresis, ECP) is available as a second-line option. In Switzerland, this treatment was reimbursed by compulsory health insurance (OKP) for the relevant indication on a temporary basis and subject to certain conditions. A decision on permanent cost coverage was still pending. There was a lack of reliable data on how the therapy is actually used in the Swiss healthcare system and what clinical outcomes it achieves, particularly regarding the crucial question of which patients benefit most at which stage of the disease.
Key question
How can the efficacy of an established treatment be demonstrated when randomised trials are not an option and, in particular, data on its use in ‘real-world’ healthcare is of interest?
The approach
Strategy development and market execution
Study design and analysis: The LinkCare conducted a retrospective cohort study in collaboration with a Swiss university centre, which included all patients treated between 2010 and 2020. Patients were followed up for up to five years. Survival and changes in lung function were analysed separately according to the severity and type of the disease.
The data were based on a structured review of the centre’s patient records. From these, demographic data, disease progression, treatment details and survival information were collected for each patient. Incomplete and missing data were transparently documented and taken into account in the respective analyses, ensuring that it remained clear which patients were included in which analysis.
The central question was which patients respond to the therapy. Using the statistical method of survival analysis, the relationship between the timing of treatment, the stage of the disease and survival was investigated, supplemented by the development of lung function before and after the start of treatment.
The analysis was carried out in accordance with recognised methodological standards and with the aim of withstanding peer review.
The result
Impact, resonance and next leverage point
The study showed that the decline in lung function slowed significantly following the start of treatment. Patients who were treated early – that is, at an early stage of the disease – benefited the most; their five-year survival rate exceeded the international benchmark figures for lung transplant recipients.
This provided the first data on the therapy from everyday clinical practice in Switzerland, including the clinically and economically relevant finding that starting treatment early improves outcomes. The results were published, following peer review in collaboration with the clinical team, in the *Journal of Clinical Apheresis* (2024).
The Federal Department of Home Affairs (EDI) decided to include the treatment in the compulsory benefits of the OKP for an indefinite period with effect from 1 January 2026, thereby ending the temporary restriction that had been in place since 2016.