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Pricing. Prices of reimbursed drugs, negotiations, and risk sharing PDF file - 3.5 MB Authors: Krzysztof Łanda, Kamila Malinowska, Joanna Lis, Jakub Adamski, Katarzyna Bondaryk, Cezary Głogowski, Jakub Gierczyński, Małgorzata Budasz-Świderska, Gabriela Ofierska-Sujkowska, Iwona Skrzekowska-Baran, Magdalena Władysiuk, Anna Klim Scientific editing: Krzysztof Łanda Krakow/Warsaw 2009 332 pp ISBN: 978-83-928558-1-1 Tables: 55, Graphs: 24 Figures: 23 Page size: 6,69 x 9,44 in File size: 3,45 MB (3 613 587 Bytes)

The question of determining the appropriate price for health technologies, in particular pharmaceuticals, has occupied the minds of health economists and other health service researchers for many years. In the absence of a perfectly functioning market for health care, pricing is about striking the appropriate balance between securing a fair deal for the health care system, whilst offering a suitable reward for innovation, the latter being important if future research into the discovery of new treatments is to be maintained. Pharmaceutical pricing is also needs to take account of the international dimension, given the possibilities for parallel trade and the different levels of ability to pay for new technologies across countries. Most of the published literature focuses on the description of different pricing systems and the impact of alternative pricing policies. The main contribution of the book by Landa et al is the comprehensive way in which it addresses the topic. Not only are the various pricing and reimbursement mechanisms discussed, the issue of determining price is explored from the perspective of the manufacturer and the public authorities. This is a prelude to discussing strategies for price negotiation. In addition, the specific issues surround the pricing of generics and drugs for rare diseases (aka orphan drugs) are explored. The book is also very timely, in that in recent years there has been a growth in the use of evidence on the value for money of drugs, generated through economic evaluations, in pricing and reimbursement discussions. Therefore, the authors discuss the underlying principles of ‘value based pricing’ and the pros and cons of the ‘risk- sharing’ schemes that have proliferated over the last few years. The book ends with an analysis of the possible role of a national pricing agency in Poland. However, the book is not at all parochial and should be of wide interest to researchers and health care decision-makers in other countries. Michael Drummond Professor of Health Economics University of York United Kingdom August 2010

Chapter 1. Mechanisms of drug price regulation and control

1. Pricing as a tool for the state health policy makers
2. Basic principles of drug price regulation and control
3. Reimbursement as a mechanism of access regulation and price control of drugs – Polish examples
4. Reference price system
5. Co-payment – sharing treatment costs between the payer and the patient
6. Good prescribing practice
7. Profit control
8. Rebates as a mechanism for price regulation on the supply side
9. Parallel import and its effect on prices of innovative drugs
10. Economic effects of introducing drug price regulation and control – selected examples evaluated from the patient’s perspective

Chapter 2. Risk Sharing Schemes, RSS

1. Financial Risk Sharing Schemes
2. Risk Based Pricing Schemes and Managed Entry Schemes
3. Outcome-Based Pricing Schemes
4. Polish legal environment within the scope of risk sharing schemes

Chapter 3. Pricing of medicinal products by manufacturers

1. Place of medicinal products on the free and regulated market from the manufacturer’s point of view
2. Factors affecting the product’s pricing on the pharmaceutical market on the manufacturer’s side
3. Selected elements affecting the Product’s price on the pharmaceutical market

Chapter 4. Pricing of medicinal productsby public authorities

1. Social value assessment according to NICE
2. Role of health technology assessment in pricing policy
3. Rewarding innovation
4. Innovation and reimbursement– legal aspects

Chapter 5. Rewarding innovation versus generic substitution

1. Definition of an innovation
2. Innovative drug pricing
3. Definition of a generic product
4. Biosimilar medicines
5. Innovative and generic drugs in drug policy
6. Generic drugs vs. branded drugs – market relations
7. Trends and tendencies worldwide
8. Strategies for innovation on the national level and in the EU

Chapter 6. Specifi city of pricing of orphan drugs and technologies used to treat rare diseases

1. Rare and ultra-rare diseases
2. Orphan medicinal products
3. Prices and reimbursement of orphan drugs
4. Proposed system solutions for very high cost orphan drugs in Poland

Chapter 7. Central drug purchase

1. Definition of central drug purchase
2. Justifi cation of central drug purchase for different categories of medicinal products
3. Central purchase of vaccines
4. Central tenders in three selected health care systems – foreign experience
5. Legal basis for central drug purchase in Poland

Chapter 8. Price negotiation

1. Introduction to negotiation
2. Trade negotiation
3. Price negotiation
4. Specifi city of drug price negotiation

Chapter 9. Pricing Agency in Poland – a feasibility study

1. Analysis of the current situation concerning pricing in Poland
2. Benchmarking – a review of the European experience
3. Pricing Agency in Poland – a design
4. Tasks of the Agency
5. The Pricing Agency’s place in the system
6. Benefi ts resulting from the functioning of the Pricing Agency