TAR Cancels Regional Guidelines for Prescription and Dispensing of Low Molecular Weight Heparins
With judgment no. 3739 of 20 June 2023, the TAR for Campania, Naples, has canceled the regional guidelines for the prescription and dispensing of low molecular weight heparins (LMWHs). The decision was made on the grounds that the guidelines included limitations on the originator’s prescription that were incompatible with the prescriptive freedom of doctors. This decision confirms the previous precautionary measure adopted in the same judgment (order no. 217 of 17 January 2023), which immediately suspended the guidelines.
The guidelines in question were adopted in November 2022 after a survey of the consumption of enoxaparin in the regional territory revealed an overprescription of the originator. Despite a regional tender identifying three lower-cost biosimilars, the originator continued to be prescribed excessively. The guidelines aimed to promote the use of biosimilars over the originator to reduce regional pharmaceutical expenditure. However, the prescribing doctor had the option to prescribe the originator by adding the specific wording of “non-substitutability” to the prescription, along with an exhaustive justification for this decision.
The guidelines also included a sanctioning system that held prescribing doctors solely responsible for non-compliance. Pharmacists were not held responsible for the non-delivery or non-dispensing of the prescription. The Health Authorities were tasked with enforcing the guidelines and ensuring compliance.
The TAR’s decision to cancel the guidelines was based on the argument that the biosimilars and the originator were not in a relationship of “substantial equivalence”. However, this argument is incorrect, as established by previous jurisprudence. The relationship between a biosimilar and its originator implies a non-inferiority of the biosimilar in terms of safety and efficacy. Therefore, the biosimilar is more than equivalent to the originator.
The dispute over the guidelines revolves around the balance between the preference for biosimilars over originators and the prescriptive freedom of doctors. The Council of State has established that the right to health is financially conditioned, allowing regional interventions to direct prescriptions and consider the cost of therapy. Prescribing doctors have a duty to choose the least expensive product with equal therapeutic efficacy, except for specific subjective situations of individual patients.
While the cancellation of the guidelines by the TAR recognizes the prescriptive freedom of doctors, the debate on the relationship between biosimilars and originators continues. The jurisprudence has made it clear that the biosimilar is not inferior to the originator and should be preferred for cost reasons. The regions, however, must ensure that their interventions do not unlawfully restrict the prescriptive freedom of doctors or impose monitoring and sanctioning systems that go against this principle.
In conclusion, the cancellation of the regional guidelines for the prescription and dispensing of LMWHs in Campania highlights the ongoing debate on the balance between promoting biosimilars and respecting the prescriptive freedom of doctors. The decision emphasizes the importance of considering cost-effectiveness in healthcare while ensuring that doctors’ autonomy in prescribing is not unduly restricted.