Essential treatments: the paradox of medicines that are reimbursed but not accessible to patients

“It is clear that the system for updating the Essential Levels of Care (LEA) needs to be completely rethought: it must be dynamic, in step with the times, streamlined, transparent and open to the participation of all stakeholders,” observes Tonino Aceti. “For this reason, we should seriously consider establishing an independent body, with regulatory powers and responsibilities, including those relating to expenditure management, which, by liaising between central government and the regions, can ensure the continuous updating of the LEAs on the basis of the most up-to-date scientific evidence, as is already the case today for medicines under AIFA. ‘The aim cannot be simply to keep chasing innovation, but rather to manage it effectively and in a timely manner, making it available promptly whilst ensuring equity, appropriateness and sustainability.’

In fact, AIFA’s decisions on the reimbursement of medicines and those required to ensure that genomic tests are reimbursed by the NHS are still proceeding along separate tracks: the paradox is that, whilst increasingly innovative targeted therapies are available, patients are at the same time unable to access the relevant molecular tests. For those who need to undergo NGS profiling (next-generation sequencing tests, which identify the molecular alterations needed to select the most appropriate therapies for each patient), this can mean having to turn to the private sector, travelling long distances, delays in treatment and, in the most serious cases, a loss of opportunities for treatment. Salutequità calls for the availability and financial coverage of these tests to be guaranteed and regulated in tandem with the reimbursement of medicines, including through the design of a specific dynamic mechanism for authorisation and reimbursement by the National Health Service (SSN). The issue of the current access criteria also remains. The new LEA Prime Ministerial Decree introduces genomic panels for cancer by disease, linking eligibility criteria to specific drug treatments included in a rigid and now outdated table/list within the Decree itself. Salutequità proposes designing a mechanism to ensure the list remains increasingly up to date and aligned with the medicines for which AIFA defines reimbursement eligibility; to ensure that the National Health Service covers the appropriate test based on the condition, the patient’s clinical presentation and the available scientific evidence, whilst guaranteeing appropriateness and sustainability.

New rights may be held up by out-of-date regional lists, inadequate referral criteria and booking arrangements, inconsistent laboratory procedures, and Molecular Tumour Boards that have been set up but are not always operational. We need regional plans setting out timelines and responsibilities, functioning cancer networks, and standardised procedures for test requests, sampling, reporting and multidisciplinary discussion; qualified laboratories, accreditation and external quality control. Specialisation should not necessitate travel: a more extensive network of sample collection points, teleconsultation and secure, interoperable information systems must link specialist centres with local areas, thereby avoiding duplication.

Finally, patients need to know what tests they can have, where and how: up-to-date information from healthcare organisations, guidance – including in person – training for healthcare professionals and the involvement of patient organisations.

The report was presented in Rome during the event ‘Essential Levels of Care and Next-Generation Sequencing – The challenge of innovation: balancing updates and access”, organised by Salutequità, attended by representatives from institutions and the political sphere, scientific societies, experts, professional bodies and patient organisations, and produced with the non-conditional support of Servier Italia.