TO REIMBURSE OR NOT TO REIMBURSE? A recent judgement on scientific evidence and appropriateness of care.

A judgment by the Italian Supreme Court published on April 10, 2015, determined that an alternative cure must be covered by the Italian National Health Service even in the absence of compelling scientific evidence as to its efficacy.

Health is protected by Italian law as a fundamental right of the individual, as well as a collective interest of the community, and dignity and freedom of the human being must always be respected. These general principles are enshrined in the Italian Constitution (section 32) and in section 1 of Legislative Decree no. 502/1992. Therefore, the right to health is framed as an absolute and fundamental right, a theoretical approach that – given the many restraints affecting patients’ access to care – may appear almost fictional.

Further, Italian legislation sets forth that the National Health Service must offer uniform essential levels of care and assistance, taking into account human dignity, equal access to care, quality and appropriateness of therapy, as well as economic factors. (These latter economic factors often appear most pressing, as patients affected by hepatitis C are currently learning!).

With regard to reimbursement, the Italian National Health Service must cover assistance services which show, for specific clinical or risk conditions, scientific evidence of a significant health benefit, from an individual and collective standpoint, compared to the resources employed. Such concept is often called “appropriateness” and is something with which doctors, hospitals, patients and authorities struggle daily. Nobody will deny that all the above mentioned factors are of primary importance, but balancing them can be difficult in practice.

The recent decision by the Italian Supreme Court (Corte di Cassazione, judgement no. 7279 of 2015) determined that a quadriplegic patient was entitled to free access to a non conventional therapy (so called “DIKUL” therapy), even in the absence of compelling scientific evidence as to its efficacy, when it was proven that the patient benefited from it through a sworn appraisal of a Court appointed expert. The Court pointed out that, while no compelling scientific evidence was offered, the efficacy of the therapy was in doubt, but not openly proven as not efficacious.

In its reasoning, the Court reiterated the higher hierarchy of the constitutional right to health over the discretional administrative decision of the hospital to administer a certain therapy. Further, the Court emphasized that the efficacy principle set forth in Italian law may be based on actual benefits to the patient brought by the DIKUL therapy: the mere absence of available scientific evidence in favor of the DIKUL therapy was not sufficient to deny its access to the patient. Only if there had been scientific evidence proving that the DIKUL therapy was inefficacious, then its reimbursement could have been denied.

We have already commented on the infamous Stamina case in this blog, a case where the well intentioned desire of Courts and Parliament to help otherwise helpless patients prompted the recourse to a therapy which completely lacked any scientific basis and breached many legal provisions actually aimed at protecting patients (e.g., GMP manufacturing requirements, informed consent of patients).

The recent Supreme Court decision confirms the sometimes difficult relationship between scientific evidence and access to a certain therapy, particularly in cases of patients affected by diseases for which there are limited therapy options.

About Paola Sangiovanni

Partner of GITTI and Partners. Seasoned transactional and regulatory legal counsel with a thorough understanding of the life sciences industry.

Leave a Reply

Please log in using one of these methods to post your comment: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s