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Italian Medicines Agency Agenzia Italiana del Farmaco

Lists of Class A and Class H medicinal products

Lists of Class A and Class H medicinal products

They contain the list of Class A and Class H medicinal products, dispensed by the National Health Service, sorted by active substance and by trade name. They allow physicians to prescribe the active substance, indicating in the prescription the name of the substance contained in the medicinal product, as required by current legislation.

The lists of Class A medicinal products include both medicines present in the AIFA Transparency Lists and patent-covered medicinal products as well as medicinal products whose patent protection has expired, but which cannot be replaced. Unlike AIFA Transparency Lists, the tables with the indication of the grouping by active substance do not set maximum reimbursement prices but the price of the medicinal product net of statutory reductions.

Both tables include all the packs of medicinal products on the market at the date of last update.

Physicians and pharmacists are invited to comply with the requirements set out in the guideline: Health Card Project, pharmaceutical prescription – update pursuant to art. 15, paragraph 11-bis of Legislative Decree 95/2012 and subsequent amendments, concerning the prescription by active substance.

Lists of Class A and Class H medicinal products

What the doctor should do when prescribing

The doctor should prescribe the medicine by indicating the name of its active substance in the prescription if both of the following conditions are met:

  • the patient is treated for the first time for a chronic disease or is treated for a new episode of non-chronic disease by the use of a certain active substance
  • there are several equivalent medicinal products on the market based on the active substance chosen by the doctor for treatment

 

In addition to the active substance, the doctor may also indicate the name of a specific medicine (brand name or equivalent) based on that active substance.

In the cases described, a prescription which only bears the name of a specific medicinal product does not comply with the law.

In the case of therapy already in progress, of medicinal products not paid by the NHS or in the absence of an equivalent medicinal product, the doctor may indicate a specific medicinal product.

Even in the cases described above, the doctor can make the prescription of a specific medicinal product binding if he considers it not replaceable for patient care (by writing its trade name in the prescription, in addition to the active substance), as already provided for in article 11, paragraph 12, of Decree-Law No. 1/2012. In this case, however, the non-replaceability clause of the medicinal product with its equivalent must necessarily be accompanied by a concise justification (for example, the patient's ascertained intolerance to certain substances included among the excipients of other medicinal products based on the same active substance). The absence of motivation, as well as the presence of an inappropriate motivation, makes the prescription non-compliant with the law.

The mandatory indication of the active ingredient does not apply in all cases where it is necessary to continue a therapy already in place for the treatment of a chronic or non-chronic disease. In these cases, therefore, the doctor may prescribe a specific medicinal product. Even in this case, however, the doctor may limit himself to indicating only the active substance, when he considers that this method is suitable for achieving the therapeutic purpose he intends to pursue.

The doctor is required to inform the patient of the presence on the market of medicinal products of equal composition in active ingredients, as well as the same pharmaceutical form, route of administration, method of release and unit dosage, as provided for by the first period of paragraph 12 of Article 11 of Decree-Law No. 1/2012.

What the pharmacist should do when prescribing

The pharmacist should comply with the provisions of Article 11, paragraph 12, of Decree-Law No. 1/2012 and behave as follows:

  • if the prescription only indicates the active substance (besides, of course, pharmaceutical form and dosage), the pharmacist, after having informed the customer, will have to deliver the medicine with the lowest price (as already required by Article 7 of Decree-Law No. 347/2001, converted with modifications by Law No. 405/2001). In the event of multiple medicinal products having a price corresponding to the lowest price, the pharmacist will take into account the patient’s preference, if any. If the latter, on the other hand, expressly requests a higher price medicinal product, the pharmacist will have to ask the patient to pay the sum equal to the difference between the price of the medicinal product requested and that of the medicinal product that can be delivered with a full charge to the National Health Service
     
  • if the prescription indicates the name (“brand” or generic) of a specific medicinal product, besides the active substance, the pharmacist, if the doctor has not indicated the non-replaceability in the prescription, is required to provide the prescribed medicinal product when no equivalent medicinal product is cheaper; in the event of the existence on the market of medicinal products at a lower price than that of the prescribed medicinal product, the pharmacist is required to supply the medicine with the lowest price (or one of the medicines with the lowest price), without prejudice to any express request of the patient to receive the medicine prescribed by the doctor, upon payment of the difference in price
     
  • if the prescription, in addition to the name of a specific medicinal product, indicates the non-replaceability of the medicinal product (either in the “simple” form for the continuation of ongoing treatments, or in the form accompanied by a concise justification, for the cases covered by paragraph 11-bis of Article 15 of Decree-Law No. 95/2012), the pharmacist should ask the patient, informing him of the reasons for the request, to pay the amount equal to the difference between any higher price of the prescribed medicine and that of the medicine that can be dispensed with a total charge to the National Health Service.
     

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