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Analytical White Papers

Free analytical and research White Papers on the topic of reimbursement, HTA and evidence requirements for medical devices and IVD tests in Europe

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Health economists from MTRC co-authored study presented at the 34th Annual Meeting of the Italian Society of Uro-Oncology (SIUrO)

Health economists and evidence synthesis specialists Oleg Borisenko, Andrey Maslov and Agni Baka co-authored research titled "Utility of MpMRI and phi in detection of prostate cancer in Italy: a decision analytic modeling" presented on 3-5th of October 2024, in Bologna, Italy. 

The analysis aimed at the evaluation of clinical and cost consequences of different diagnostic options for prostate cancer in Italy.

The abstract of the study:

Background/Aim: Research indicates that Prostate Health Index PHI can be used alongside imaging technologies to increase diagnostic accuracy (1). This analysis aimed to determine the clinical consequences of different diagnostic strategies, including multiparametric magnetic resonance imaging (mp-MRI) and phi test for diagnosing prostate cancer (PCa) in Italy. 

Materials and Methods: A decision analytical model using a decision tree was developed and validated thanks to 12 Subject Matter Experts (Laboratory, Radiology, Urology, Oncology Specialties). The population included men with PSA >2 − <10 with suspicious or negative digital rectal examination (DRE). Three diagnostic strategies and two phi cut-offs were considered. Positive results of mp-MRI or phi were confirmed by prostate biopsy. Model inputs were obtained from peer-reviewed literature. Outcomes included the numbers of diagnosed and missed overall PCa and clinically significant PCa (csPCa, Gleason Grade ≥7). Analysis was limited to the diagnostic phase of the patient pathway; further diagnostics and treatment of PCa were not considered. 

Results: At phi cut-off=25 mp-MRI followed by phi gave the best clinical outcome results identifying the higher number of PCa (46) and all csPCa, requiring, however, 38 unnecessary biopsies (defined as biopsies performed but no PCa present). At phi cut-off=28 the same performances were obtained: 45 PCa and 19 csPCa were identified, requiring 33 unnecessary biopsies. In both cases mpMRI alone missed 10 and 9 PCa and one csPCa. 

Conclusion: A PCa diagnostic strategy of mpMRI followed by phi provides the largest clinical benefit in the Italian healthcare system.

Read other abstracts of the conference here