epilepsy medication

epilepsy medication



 Generic drugs for epilepsy. Worried doctors: «They are not interchangeable»
The controversy breaks out: patients who want to use "branded" drugs will have to pay the price difference

When a drug that works best for him is identified in a patient with epilepsy, it is very inappropriate to change it. It is changed if it does not start to work properly or if it causes significant side effects and in any case not without first making any attempt to adjust the dosage. On 17 September, the AIFA (Italian Drug Agency, the Italian equivalent of the famous American FDA), following the natural bureaucratic deadline of the patents of two of the best known anti-epileptics (leviracetam and topiramate), placed them in the so-called transparency lists, which allow the generic fee to be used instead. But in a disease like epilepsy, equivalent and generic drugs are safely interchangeable?

EPILEPTIC THERAPY - Antiepileptic therapy has its own unstable equilibrium, which one must always try not to disturb. In this disease there is always some risk even when using the same drug because the factors that can influence the concentration in the blood, the only real guarantee against the onset of the crises, are not only pharmacokinetic, but also metabolic, neurochemical or simply emotional. For this reason, the AIFA Technical-Scientific Committee has also issued a communication on the procedures that physicians will have to follow in prescribing these drugs, referring in particular to patients who are completely controlled by the therapy already in progress or from which they have still taken significant improvements: in this case the drug should not be replaced, regardless of whether it is a brand (ie an original drug) or an equivalent. In fact, all scientific papers, international guidelines and national ones published by LICE (Italian League Against Epilepsy) recommending the absolute non-substitutability of an original drug with a generic and the non-substitutability of a generic with another generic .

THE CONCERNS OF LICE - The Italian League against Epilepsy (LICE), the scientific society of Italian epileptologists, has expressed its concerns by reiterating that it is completely discouraged to replace the drug in use with a fee (be it an original brand or a generic) when the patient reports complete control or marked improvement of the seizures, an indication that is widely reported in the scientific literature. Using a corresponding drug, but in fact "new" for the patient, we must also consider the effects of unforeseen pharmacological toxicity brought in dowry by the new molecule and that can be verified only with time.

THE COST PROBLEM - For patients, however, there is a further problem. Almost all the Regions seem to have ignored the AIFA recommendations regarding the non-opportunity to replace the two anti-epileptics in patients who respond well to the therapy they are used to: the consequence is that the price difference between generic and original medicine is now borne by patients. In practice, the patient who must continue to use the "branded" drug must shoulder the "surcharge": 50 euros per pack (some patients use up to three packs a month). And another aspect that should not be underestimated, both from an economic point of view and from a clinical point of view, is that in case of drug replacement, patients will have to undergo (with additional expense) to check the dosage in the blood (as however, reported in the same AIFA recommendations) with a frequency far greater than before. "In Italy we are thinking only about the containment of spending, spending review and plans to return - says neurologist Antonino Romeo, Director of the Lombardy Regional Center for epilepsy of Fatebenefratelli in Milan - imposing generic drugs in the same way both in chronic diseases such as epilepsy, both in passing conditions. "

THE PROTESTS OF THE PATIENTS - It stops the positions taken by national and local associations representing people affected by epilepsy, such as the FIE (Italian Epilepsy Federation) and the AICE (Italian Association Against Epilepsy). In a note, the AICE states, in short: "You can not joke on the skin of the sick. The non-substitutability of drugs for epilepsy, especially if they control seizures, is shared by the entire scientific world responsible for epilepsy and by AIFA itself ".

EXCEPTION - The Province of Bolzano intervened in favor of those suffering from epilepsy. «Some interested people have complained that generics would not have the same effect as traditional drugs, "Governor Luis Durnwalder explained.The provincial council has therefore decided to adopt a transitional solution until the end of the year."We will pay the difference in cost between the original drugs and the generic, in the future you trust find a definitive solution for the 977 epileptics in South Tyrol, "concluded Durnwalder.