Description of Health Care System
The National Healthcare System SSN (Servizio Sanitario Nazionale) provides healthcare coverage to the Italian population. Although it is under the responsibility of the Ministry of Health, the system is decentralized resulting in three levels:
- National level: The Ministry of Health formulates every three years a healthcare plan PSN (Piano Sanitario Nazionale) that determines healthcare policies.
- Regional level: Twenty regions implement the PSN with their own resources and can adjust to region-specific needs. As a consequence, geographic disparity in terms of healthcare access or the level of co-payments exists.
Local level: Local health units ASL (Azienda Sanitaria Locale) provide the health care services – e.g. primary medical services, coordination of all non-emergency admissions to public hospitals.
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Reimbursement and Pricing Approval Process
In Italy, the general conditions of the reimbursement system are established on a national level and implemented at a regional level by governmental bodies. When marketing authorization is granted either by the European Medicines Agency (EMEA) or the Italian Medicine Agency AIFA (Agenzia Italiana del Farmaco), the company may apply for reimbursement on the National Pharmaceutical Formulary PFN (Prontuario Farmaceutico Nazionale). A product can be assigned to Class A, H or C.
- Class A includes essential products and those intended for chronic diseases and are fully reimbursed by the NHS.
- Class H includes products that are only fully reimbursed in the hospital
- Class C includes other products which do not have the characteristics of Class A and are not reimbursed.
Besides the possibility to apply for a price premium for an innovative product, recently a new ranking system has been introduced for these types of products. First, AIFA will allocate the product into one of three classes (in decreasing order of importance):
- Treatments for serious diseases - those which cause death, require hospitalisation or endanger life or permanent disability (e.g. neoplastic diseases, Parkinson's disease, AIDS).
- Treatments that reduce or eliminate the risk of serious disease (e.g. hypertension, obesity and osteoporosis).
- Treatments for non-serious diseases (e.g. allergic rhinitis).
For each of the three above classes, the degree of innovation will be investigated, looking 1) availability of existing products and 2) extent of therapeutic benefit. Subsequently, scores will be allocated for the availability of pre-existing treatments:
- Drugs for the treatment of diseases with no adequate treatment to date (this is the case of many orphan drugs for the treatment of rare diseases) or aimed at sub-groups of patients with absolute contraindications for using the drugs already on the market and for whom the new drugs represent the only feasible therapeutic option;
- Drugs designed for the treatment of diseases in which sub-groups of patients are resistant or non-responders to first line therapy (this is the case of anti-HIV drugs and some anticancer drugs);
- Drugs for the treatment of diseases for which recognized treatments already exist.
In the case of C-grouping (sufficient treatment alternatives already exists), a product will be allocated to one of the below 3 subgroups:
- C1. Products offering better safety and efficacy or a better pharmacokinetic profile.
- C2. Products that represent a pharmacological innovation - such as a new method of action - but no improvement over existing therapies.
- C3. Products offering a technological innovation but not a therapeutic advantage over existing products.
Then, when the extent of a new treatment's therapeutic benefit is considered, AIFA looks at principal and surrogate clinical endpoints and uses three classifications:
Major benefits on clinical end-points (reduction of mortality and morbidity) or on validated surrogate end-points
- Partial benefit on the disease (clinical end-points or validated surrogate end-points) or limited evidence of a major benefit (non-conclusive results).
- Minor or temporary benefit on some aspects of the disease (for example, partial symptomatic relief in a serious disease).
Scores on each of these scales are combined to determine whether a product represents an important, moderate or modest therapeutic innovation.
On top, the authorities can decide to put restrictions in place for certain products or product classes, which are known as “note AIFA” (“note CUF” in the past).
Pricing Approval Process
If a manufacturer seeks for reimbursement, the price for the product will be set through a negotiation between the manufacturer and the Pricing and Reimbursement Committee CPR (Comitato Prezzi e Rimborso). Among criteria used during the negotiations are:
- Cost-effectiveness for pharmaceuticals where no effective therapy exists
- Risk-benefit ratio compared to alternative pharmaceuticals for that indication
- Therapy costs per day in comparison to products of the same efficacy
- Evaluation of the economic impact on the national health system
- Estimated market share of the new pharmaceutical
- Prices and consumption data in European countries
The prices for products included in category C (non-reimbursable by the SSN) are free.
According to the Directive 89/105/EEG, the pricing & reimbursement process should not take longer than 180 days. However, various studies in the past years indicated that it is not unusual that it takes the Italian authorities longer to get to a decision.
Although the Italian healthcare system is decentralized, pricing & reimbursement of products is mainly decided on the national level and published in the official journal (Gazetta officale). Regions, however, can decide upon patient copayments resulting in price difference of pharmaceuticals for the patients across the country.
Finally, pharmaco-economic studies are recommended in the pricing & reimbursement process with AIFA for innovative drugs. Published Italian pharmaco-economic guidelines are available since 1995.
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AIFA: Agenzia Italiana del Farmaco / Italian Medicines Agency
ASL: Azienda Sanitaria Locale / Local Health Unit
CPR: Comitato Comitato Prezzi e Rimborso / Pricing & Reimbursement Committee
CST: Comitato Scientifico e Tecnico / Scientific-Technical Commission
PFN: Prontuario Farmaceutico Nazionale / National Pharmaceutical Formulary
PSN: Piano Sanitario Nazionale / Healthcare Plan
OsMED: Osservatorio Nazionale sull'impiego dei Medicinali / National Observatory on the Use of Pharmaceuticals
SSN: Servizio Sanitario Nazionale / National Healthcare System
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Reimbursement Organizations/HTA Organizations
AIFA (Agenzia Italiana del Farmaco)
Within the Italian Medicines Agency (AIFA), two committees are involved in the pricing and reimbursement procedure for pharmaceuticals.
CTS (Comitato Scientifico e Tecnico)
This committee makes a decision on the reimbursement, local marketing authorization and positive list revisions.
CPR (Comitato Prezzi e Rimborso)
This body will assess the manufacturers applications, collect information from the National Observatory on the Use of Pharmaceuticals (OsMED) and will negotiate with the manufacturers.
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- Danzon PM, Furukawa MF. International Prices And Availability Of Pharmaceuticals In 2005. Health Affairs.2008; 27: 221-233
- ÖBIG (2006). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. Available at: http://ec.europa.eu/comm/competition/mergers/studies_reports/oebig.pdf
- France G, Taroni F, Donatini A. The Italian health-care system. Health Econ. 2005 Sep;14(Suppl 1):S187-202.
- Danzon PM, Wang YR, Wang L. The impact of price regulation on the launch delay of new drugs - evidence from twenty-five major markets in the 1990s. Health Economics 2004; 14(3): 269-292.
- Dickson M, Hurst J, and Jacobzoon S. OECD Health Working Papers No. 4. Survey of Pharmacoeconomic Assessment Activity in Eleven Countries (2003). Available at: http://www.oecd.org/dataoecd/27/25/2955828.pdf
Donatini A, Rico A, D’Ambrosio MG, Lo Scalzo A, Orzella L, Cicchetti A and Profili S (2001). Health Care Systems in Transition: Italy. Copenhagen, WHO Regional Office for Europe. Available at: http://www.euro.who.int/document/e73096.pdf
- Capri et al. Guidelines for the economic evaluation in Italy: recommendations from the Italian group of pharmacoeconomic studies. Drug Information Journal, Vol. 35, pp. 189–201, 2001.
- Garattini L, Grilli R, Scopelliti D, Mantovani L. A proposal for Italian Guidelines in pharmacoeconomics. Pharmacoeconomics 1995; 7: 1-6.
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