Tumours: green light for reimbursement of profiling tests but still a long way to go

Finally, since the beginning of 2025, there has been a strong focus on reimbursement policies for profiling tests in Oncology, both at regional and national level, although there is still much to be done.

On this topic, the Multidisciplinary Innovativeness Group (MGI) - in addition to economic analyses of the profiling costs for certain neoplasms, which were incorporated into the above decrees - following the constant monitoring of scenarios has produced a mapping of regional and national 2025 tariffs.

This year a further 10 Regions/Pa have approved tariffs for oncological genomic profiling: Campania, Friuli-Venezia Giulia, Marche, Apulia, Sicily, Tuscany, Umbria, Veneto, and the Provinces of Trento and Bolzano. The structuring of the Nomenclators in the 12 Regions/Pa is similar, providing for 4 levels but with a tariff 'spread' between the different realities that widens as the number of genes referred increases: G8.01 (1 gene, rates from € 300 to € 450); G8.02 (2-20 genes, rates from € 500 to € 1,050); G8.03 (21-60 genes, rates from € 1,000 to € 1,550); G8.04 (more than 60 genes, rates from € 1,150 to € 2,070).

An important difference relates to code G8.02: although it has the same number of genes, it differs in that in Lombardy the reference is to profiling with Dna and Rna, whereas in Emilia-Romagna (and in all the other Regions/Pa) it relates only to Dna. This 'triggers at code G8.03' the evaluation of certain neoplasms for these regions: for example, for lung, breast and prostate cancers. Therefore, different rates are shown at regional level for the same profiling service.

With the Dpcm updating the Lea 2025 there has been a first step towards guaranteeing access to tests throughout the country. The Dpcm updating the Livelli essenziali di assistenza (Essential Levels of Care) presented on 18 April 2025 allocated more than EUR 38 million of the total EUR 150 million for precision oncology tests.

For the performance of molecular genetics services on bioptic material, the Dpcm has indicated the reference genes for each neoplasm, associating a different pricing with respect to the regional Nomenclators: up to 1 gene € 450 (for cholangiocarcinoma and medullary thyroid carcinoma); up to 2 genes € 800 (for melanoma, ovarian carcinoma and GIST); from 3 to 14 genes € 1.150 (for Nsclc, colorectal, breast and prostate carcinoma).

However, it is necessary to point out the lack of updates in the Dpcm regarding the inclusion of genomic tests required for the prescription of new molecular target drugs already reimbursed by Aifa. There is now an urgent need for an agreement (approval of the Dpcm) between the Ministry of Health and the Conference of Regions on the introduction of these services in the Lea, which should however be constantly updated with reference to the state of the art of reimbursed oncological drugs that require a test.

The Dpcm guarantees, on the one hand, access to profiling tests and consequent treatment with appropriate therapy throughout Italy, and, on the other hand, rates charged to the national health fund and reference for the compensation of interregional mobility, leaving it up to the individual Regions to provide for additional remuneration. Lastly, the agreement should also include the approval of the Decree on the test for HRD in ovarian cancer, a service not yet included in the Dpcm.

* Director Medical Oncology, Comprehensive Cancer Centre, Ausl-Irccs di Reggio Emilia** Director of Health Economics, Coordinator Multidisciplinary Innovativeness Group (GMI)