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  3. > IMS Pharmaceutical Pricing & Reimbursement Concise Guide: Italy

The Pharmaceutical Pricing & Reimbursement Concise Guides are established as the definitive reference and training text for P&R professionals around the world, drawing on the long-standing expertise of the IMS pricing and reimbursement specialists to provide industry players and decision makers with a thorough understanding of the rules and regulations governing P&R in international markets. This report covers key developments in P&R, market access, cost containment, trade margins and healthcare issues.

Table Of Contents

IMS Pharmaceutical Pricing and Reimbursement Concise Guide: Italy
ITALY..1
HEALTHCARE SYSTEM..1
Facts and Figures ..1
Market Indicators2
Provision and Funding ...4
Healthcare Services 4
Financing .5
PRICING...5
Prescription Drugs..5
Pricing Process5
Managed Entry Agreements6
Innovation Algorithm7
Guidelines on Pricing Negotiations .7
Generic Drugs 7
First Generic Version...7
Subsequent Generic Versions.8
Hospital Drugs8
Pricing Process8
Tenders8
OTC Drugs ...10
REIMBURSEMENT 10
Admission to Reimbursement ..10
Managed Entry Agreements..10
Fast-track Process for ‘Exceptional', Hospital and Orphan Drugs 11
Fast Track for Generics and Biosimilars ...11
Decision Making 11
Algorithm for the Assessment of Therapeutic Innovation..12
New Therapeutic Algorithm ...14
Regional Reimbursement ..14
Reimbursement Categories .15
Reimbursement Prices.15
Active Ingredient-based Reference Pricing ...15
Therapeutic Reference Pricing ..16
Hospital Reimbursement..16
Formularies16
Automatic Inclusion of Innovative Drugs on Regional Hospital Formularies.17
Listing Delays 17
Funding Arrangements ..18
Changes in Reimbursement Status .18
Regular Reviews ...18
Reimbursement List Review/Ensuing Negotiations...19
Class Cnn ..19
Changes in Reimbursement Prices .19
Regular Reviews ...19
Innovative Drugs Fund ..19
Managed Entry Schemes ..20
Across-the-board Price Cuts .20
Non-reimbursed Products..20
2015 Pricing Negotiations..20
PHARMACOECONOMICS.21
Pharmacoeconomic Requirements..21
National Level21
Regions..22
PRICE BUILD UP ...22
Wholesalers .22
Margins ..22
Discounting23
SSN Discount 23
Background23
Retail Pharmacies 23
Margins ..23
Discounting23
SSN Discounts...24
Clawback System ..24
Background24
E-pharmacy ...25
Unit-dose Dispensing 26
Mass Market/Non-reimbursed Drug Sales 26
Additional Pharmacy Services...26
Direct Distribution to Patients 26
Dispensing Doctors ..27
Sales Tax .27
COST CONTAINMENT ..27
Industry Paybacks27
Overview27
Pharmaceutical Expenditure Ceilings27
Ceilings to be Changed with Effect from 2017 ..28
Overspend Payback Arrangements ..28
Modifications for Innovative Drugs 28
5% Price Cuts 29
Controversy over Implementation of System 29
Paybacks Following 2015 Pricing Negotiations.29
Managed Entry Agreements..30
SSN Discount 30
Promotional Costs30
Patient Co-payments31
Pharmaceuticals 31
Healthcare .31
Proposed National Co-payment System ...31
Prescribing Controls.31
National Measures.31
Regional Initiatives 33
Generics...33
INN Prescribing .33
Substitution34
Biosimilars Substitution .34
AIFA Promotes Generics and Biosimilars .34
Regional Measures35
Rx-to-OTC Switches 35
Switching Process .35
OTC Market ...36
Parallel Trade...36
Parallel Exports .36
Parallel Imports..36
FUTURE DEVELOPMENTS ..37
Outlook.37
2017 Budget Law...37
Regional Proposals ...38
Parliamentary Motion.38
New Therapeutic Algorithm for Innovative Products .39
Other Ongoing Developments ...40
NAMES and ADDRESSES 41

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