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Italian Medicines Agency Agenzia Italiana del Farmaco

Negotiation and reimbursement

Negotiation and reimbursement

AIFA and its technical and advisory committees are responsible for defining the system of eligibility for reimbursement and supply for all authorized medicinal products, as well as negotiating the price of those to be paid by the National Health Service (SSN), after negotiation with pharmaceutical companies.

Negotiation and reimbursement

Classification of medicinal products and reimbursement

In Italy, medicinal products reimbursed by the NHS are classified in Class A, while Class H are those borne by the NHS, but dispensed in a hospital or equivalent facilities (art. 8, paragraph 10, letter A, Law No. 537 of 24 December 1993, as amended). Medicines reimbursed by the NHS include essential medicinal products, including those intended for the treatment of chronic diseases, that are reimbursed for each authorized therapeutic indication, except when there is an AIFA Note that limits reimbursement only to some indication or there is one of the following prescriptive instruments ensuring the appropriateness of use in the context of the reimbursed indications (paper therapeutic plans, prescription paper cards or o web-based monitoring registers).

Medicinal products are classified in class C when they are not paid by the NHS, with the exception of those for subjects with a lifetime war pension (Article 1, Law No. 203 of 19 July 2000), in cases where the general practitioner certifies their proven therapeutic utility for the patient. Class C medicines are non-essential medicinal products and can be dispensed to the citizen upon presentation of a medical prescription (Class C with prescription), or they can be purchased directly by the citizen without a medical prescription. The latter category (Class C-bis) includes both over-the-counter (OTC) and Class C-SOP medicines, without prescription but not over-the-counter, dispensed by the pharmacist. Advertising to the citizen is allowed only for medicinal products in the Class C-OTC.

Moreover, the so-called "Balduzzi Decree" established that medicinal products that have obtained the Marketing Authorization with centralized, mutual recognition, decentralized and national procedure, as well as parallel import, are automatically classified in the group "C Non Negotiated" (C-NN) pending the submission by the company concerned of an application for a different classification and for price negotiation, after the presentation of a specific dossier structured in accordance with the provisions of CIPE Resolution No. 3 of 1 February 2001. Before the start of marketing, the MAH is obliged to communicate to AIFA the price ex factory and the price to the public of the medicinal product classified in class C-NN, as well as the data of placing on the market.

Criteria for negotiating the price of medicinal products

The negotiation of the price of a new medicinal product takes place according to the following criteria, indicated in the CIPE Resolution No. 3/2001:

  • positive cost/effectiveness ratio: the medicinal product is considered useful for the treatment of diseases for which there is no effective therapy, or provides a more adequate response than medicines already available for the same therapeutic indications;
  • more favorable risk/benefit ratio compared to medicinal products already available for the same indications;
  • assessment of the economic impact on the NHS;
  • more favourable cost of therapy compared to products with equal effectiveness;
  • estimation of the market shares which can be acquired;
  • comparison with the prices and consumption of other European countries.

The negotiation procedure

In assessing the effectiveness and price of a medicinal product, AIFA uses the support of the Scientific Technical Committee (CTS) and the Prices and Reimbursement Committee (CPR) and the data on pharmaceutical consumption and expenditure provided by the Medicines Utilization Monitoring Centre (OsMed).

The process of pricing and classification for drug reimbursement occurs in four stages:

  1. a pharmaceutical company applies for the pricing and reimbursement procedure submitting the dossier to AIFA, in line with the provisions of the Guide for submitting the application published on the Agency's website;
  2. the CTS expresses a binding opinion on the therapeutic value of the medicinal product (defining its place in therapy), on its supply method, as well as on its possible innovative character;
  3. the CPR evaluates the dossier and, if necessary, convenes the applicant company for negotiation;
  4. if a medicinal product is considered eligible for reimbursement by the NHS, the result of the negotiation is submitted to the final assessment of the Board of Directors of AIFA. The decisions of the CTS and the opinions of the CPR are rendered, in general, within 180 days from the date of presentation of a correctly completed application, with subsequent publication of the P&R provisions in the Official Journal of the Italian Republic.

There is an online price negotiation system  that allows companies to submit the necessary documentation for the pricing and reimbursement procedure for medicinal products and to monitor the progress of the various stages of the negotiation procedure.

AIFA is also responsible for maintaining the economic balance relating to the ceiling set for NHS pharmaceutical expenditure and direct purchases through the application of appropriate countermeasures in the case of overruns of the named ceilings, such as payback and incentives for the use of equivalent medicinal products.

The medical prescription: types and validity

The classification of medicinal products can be summarized in the following categories:

  • medicinal products subject to repeatable medical prescription (RR);

The repeatable prescription is the most common type of prescription. It has a six-month validity period, during which the patient can use the prescription for a maximum of ten times. A peculiar case is represented by the prescription of psychotropic medicinal products (tranquilizers, sedatives, hypnotics), for which the prescription has a thirty-day validity period and can be used for no more than three.

  • medicinal products subject to non-repeatable medical prescription to be renewed each time (RNR);

The non-repeatable prescription is required for all medicines with potential risks of acute or chronic toxicity, or of addiction and tolerance and possibility of abuse by the patient. This kind of prescription is more restrictive than the previous one, as it is based on the patient's inability to access the drug without the intervention of the general practitioner, who issues the necessary prescription each time the patient needs this kind of medicine.

c) medicinal products subject to a special medical prescription (RMS) (Consolidated Law on narcotics Presidential Decree no. 309 of 9 October 1990, as amended);

d) medical products subject to restricted medical prescription, including:

  • medicinal products dispensable only with a prescription issued by hospital facilities or specialists (RRL, RNRL);
  • medicinal productsthat can only be used in hospital facilities or similar healthcare structures (OSP);
  • medicinal products that can only be used by specialists identified according to the provisions of the Regions or Autonomous Provinces (USPL); the pharmacist cannot sell medicinal products of the USPL category to the public but can hold these drugs, which can also be supplied directly to the specialist by manufacturers and wholesalers.

The repeatable restricted prescription and the non-repeatable prescription are used for limiting the prescription and use of certain types of medicines to certain specialists or healthcare facilities. This category includes:

  • medicinal products for exclusive hospital use (Art. 92, Legislative Decree no. 219/2006);
  • medicinal products provided only if prescribed in hospital facilities or by specialists (Art. 93, Legislative Decree n. 219/2006);
  • medicinal products for exclusive use by specialists in the clinic (Art. 94, Legislative Decree n. 219/2006);

e) medicinal products not subject to medical prescription, including:

  • over-the-counter medicinal products (OTC);
  • other non-prescription medicinal products (SOP).

The medical prescription is valid for 30 days for the number of packs indicated (for magistral preparations not containing narcotic substances, it is valid for three months). 

 

The following table summarizes the classification of medicinal products in relation to the supply system, as regulated by Legislative Decree 219/2006, and to eligibility to reimbursement by the NHS.

The table does not include non-prescription medicines (OTC: over-the-counter medicines; SOP: non-prescription medicines).

Here are the various types of supply system and reimbursement class with the details for filling out the prescription.

As for the restricted prescription it is important to underline the following points:

  • the supply system OSP identifies medicinal products that can only be used in hospital facilities or similar healthcare structures;
  • the supply system RRL (repeatable restricted prescription) - RNRL (non-repeatable restricted prescription) identifies medicinal products that can be prescribed by specialists belonging to a hospital facilities and/or by specific specialists identified by the CTS: for outpatient care (out of hospital), the prescription of the medicinal product can be carried out by the specialists identified by the CTS, while in hospital facilities or similar healthcare structures, the prescription is not limited to the specialists identified;
  • the supply system USPL (medicines subject to restrictive medical prescription, usable only by specialists) identifies medicinal products that can only be used by specific medical specialists identified by the CTS, even in hospital facilities, excluding particular exceptions appropriately specified by the CTS itself.

 

As regards the non-repeatable prescription (RNR), the legislation does not provide, in addition to the time duration of the prescription and the fact that the prescription is retained by the pharmacist, a maximum number of packages to be indicated in the prescription itself. The attending physician will then specify the number of packs necessary to cover an appropriate treatment period (for example, until the next specialist examination).

 

The dispensing of medicinal products

In the organization of pharmaceutical assistance, it is possible to identify different methods of dispensing medicines charged to the NHS, depending on their dispensing and use in both the territorial and hospital settings. In particular, the consumption of medicines for outpatient care occurs following the prescription by general practitioners and freely chosen paediatricians, as well as upon the prescription or release of therapeutic plans by specialists working within public health structures. While in the first case the medical prescription implies the dispensing of the medicine prescribed to the patients through the affiliated pharmacies, public and private, spread throughout the territory (conventional dispensing system), in the second case the dispensing of the medicine - taken by the patient at home - is carried out either directly by the health facilities (direct distribution) or, alternatively, as a result of specific agreements signed locally, through the affiliated pharmacies (in name and per conto distribution). Article 8 of Legislative Decree No. 347 of 18 September 2001, converted with modifications by Law No. 405 of 16 November 2001 and subsequent amendments has introduced direct and per conto distribution as an alternative method of distributing medicines to the conventional one. According to these methods, the purchase of high-consumption medicines by public health facilities and their dispensation takes place in two different ways:

  • by Public Health Facilities to patients for the first cycle of therapy, on discharge from hospitalization or following specialist outpatient visits, or to patients who require periodic checks. This dispensing system does not exclusively assume a cost containment value, but has above all the purpose of clinically protecting patients and guaranteeing the therapeutic continuity between hospital and outpatient care, along with the appropriateness of use of medicinal products;

 

  • on behalf of the ASL (local health authorities), by pharmacies open to the public on the basis of specific agreements concluded by the Regions and Autonomous Provinces with the Associations of the pharmacies affiliated with the NHS, in order to allow patients suffering from chronic pathologies and requiring continuous pharmaceutical assistance to obtain supplies from local pharmacies (the so-called per conto distribution).

 

Criteria and procedures according to which the Italian Medicines Agency negotiates prices of medicines reimbursed by the National Health Service, for the submission of applications for negotiation

Ufficio di riferimento

Reference offices

HTA & Pharmaceutical Economy Division

Francesco Trotta

f.trotta@aifa.gov.it

Innovation and Pharmaceutical Strategy Division

Paolo Foggi

p.foggi@aifa.gov.it

Nested Applications

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