PRICING & REIMBURSEMENT IN ITALY
AT A GLANCE
Although there is a national pricing and reimbursement process in Italy, regions control their own budgets and formularies.
Italy has pioneered risk-sharing agreements, employing them for over a decade; manufacturers of expensive treatments, or those with uncertain benefits, should be prepared to negotiate on a payment-by-result or cost-sharing basis.
Reimbursement submission
Submission review
Assessment of innovation
Submission of additional information
Price negotiation Price negotiation
Managed entry agreement proposed
Price agreement
Regional HTARegional formulary
listing
If therapeutic need and value and quality of evidence are found to be high, the drug will be classed as innovative* and should be reimbursed by the regions.
Regions may charge a copayment on Class A drugs, which were previously a small flat fee (~€3), but may now include a percentage of the drug price to encourage patients to select cheaper drugs if possible.
Class C drugs are freely priced by the manufacturer**, but must be sold at 50% discount to hospitals.
The majority of the regions in Italy have a binding formulary to which drugs need to be added in order to be prescribed. Five regions have formal HTA processes, while 13 conduct some HTA activity.
For hospital-only drugs, orphan drugs or drugs with exceptional therapeutic or social relevance, pricing/reimbursement negotiations can begin before marketing authorisation, and may take up to a maximum of 100 days***.
In addition to cost effectiveness and risk-benefit ratio vs comparators, CPR also considers the:
• Financial impact on the national health system
• Expected sale volumes
• Prices and consumption in other European countries
Italy has been employing risk-sharing agreements for over a decade.
CTS OF AIFA
MANUFACTURER
CPR OF AIFA
REGIONS
POSSIBLE STEP *First-in-class drugs are classified as innovative for a maximum of 36 months, potentially innovative drugs can be reassessed after 18 months; **The price must be the same across the country and can only be increased every two years in line with inflation; ***This means that drugs may be commercialised prior to receiving a classification from AIFA (automatically assigned Class “Cnn”) and may be reimbursed by some regions or paid for by patients directly
AIFA=Agenzia Italiana del Farmaco; CPR=Comitato Prezzi e Rimborso; CTS=Commissione Tecnico Scientifica; HTA=Health Technology Assessment
1. Giovanni Murri. Registri di Monitoraggio AIFA. 2017.
2. Prada M et al. Med Access @ point care 2017;1(1):e29–36.
PRICING AND REIMBURSEMENT PROCESS KEY CONSIDERATIONS IN PRACTICE
Reimbursement categorisation
Managed entry agreements 20171
Presence of regional formulary and mean time to patient access following national
decision (days)1
Presence of local binding formularies
Presence of local non-binding formularies
Absence of local formularies
Presence of area formularies
Cost-sharing
Capping
Cost-sharing + capping
Payment-by-result
Payment-by-result + capping
210
day
sV
aria
ble
100
–180
day
s
Class Reimbursement Applicable drugs
A ≤100% Innovative, cost effective or essential drugs for chronic and serious diseases; can be limited to particular patients
H ≤100% Drugs that are fully reimbursed in the hospital setting and require specialist supervision
C 0% Drugs without proven efficacy or with proven efficacy for minor diseases; over-the-counter products
29
7167
3
234.7
205.9
102.5127.2
264.1
127.2
196.7
208.4
213.1
193.0251.3
172.2
275.4
167.5
140.6
279.2
149.7
175.0
258.6
228.5
n=107
≥5 days before negotiation date
Reimbursement submission
Submission review
Assessment of innovation
Submission of additional information
Price negotiation Price negotiation
Managed entry agreement proposed
Price agreement
Regional HTARegional formulary
listing
If therapeutic need and value and quality of evidence are found to be high, the drug will be classed as innovative* and should be reimbursed by the regions.
Regions may charge a copayment on Class A drugs, which were previously a small flat fee (~€3), but may now include a percentage of the drug price to encourage patients to select cheaper drugs if possible.
Class C drugs are freely priced by the manufacturer**, but must be sold at 50% discount to hospitals.
The majority of the regions in Italy have a binding formulary to which drugs need to be added in order to be prescribed. Five regions have formal HTA processes, while 13 conduct some HTA activity.
For hospital-only drugs, orphan drugs or drugs with exceptional therapeutic or social relevance, pricing/reimbursement negotiations can begin before marketing authorisation, and may take up to a maximum of 100 days***.
In addition to cost effectiveness and risk-benefit ratio vs comparators, CPR also considers the:
• Financial impact on the national health system
• Expected sale volumes
• Prices and consumption in other European countries
Italy has been employing risk-sharing agreements for over a decade.
CTS OF AIFA
MANUFACTURER
CPR OF AIFA
REGIONS
POSSIBLE STEP *First-in-class drugs are classified as innovative for a maximum of 36 months, potentially innovative drugs can be reassessed after 18 months; **The price must be the same across the country and can only be increased every two years in line with inflation; ***This means that drugs may be commercialised prior to receiving a classification from AIFA (automatically assigned Class “Cnn”) and may be reimbursed by some regions or paid for by patients directly
AIFA=Agenzia Italiana del Farmaco; CPR=Comitato Prezzi e Rimborso; CTS=Commissione Tecnico Scientifica; HTA=Health Technology Assessment
1. Giovanni Murri. Registri di Monitoraggio AIFA. 2017.
2. Prada M et al. Med Access @ point care 2017;1(1):e29–36.
PRICING AND REIMBURSEMENT PROCESS KEY CONSIDERATIONS IN PRACTICE
Reimbursement categorisation
Managed entry agreements 20171
Presence of regional formulary and mean time to patient access following national
decision (days)1
Presence of local binding formularies
Presence of local non-binding formularies
Absence of local formularies
Presence of area formularies
Cost-sharing
Capping
Cost-sharing + capping
Payment-by-result
Payment-by-result + capping
210
day
sV
aria
ble
100
–180
day
s
Class Reimbursement Applicable drugs
A ≤100% Innovative, cost effective or essential drugs for chronic and serious diseases; can be limited to particular patients
H ≤100% Drugs that are fully reimbursed in the hospital setting and require specialist supervision
C 0% Drugs without proven efficacy or with proven efficacy for minor diseases; over-the-counter products
29
7167
3
234.7
205.9
102.5127.2
264.1
127.2
196.7
208.4
213.1
193.0251.3
172.2
275.4
167.5
140.6
279.2
149.7
175.0
258.6
228.5
n=107
≥5 days before negotiation date
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.
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