We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byFaith Knight
Modified over 2 years ago
Pharmaceutical Policy and Pricing: How are Countries Getting Greater Value? Commonwealth Fund/ Alliance for Health Reform Briefing on Capitol Hill Dr. jur. Rainer Hess Federal Joint Committee, Germany (G-BA) Page 1 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Pharmaceutical Policy and Pricing Page 2 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess Development of RX drug sales and prices (index Q1/2007) Generic drugsOn patent drugs Source: NVI (INSIGHT Health); pharmacy retail prices (Apothekenverkaufspreise).
A.State/Federal Physicians organisation B. State/Federal Hospital organisation C. State/Federal Sickness Fund-Ass. Patient / Insuree Decision Platform for defining the services delivered as statutory health insurance Federal Joint Committee (G-BA) A. C. B. Patient Organisations Advisory membership Institut for Quality and Efficiency (IQWiG) Commissioning Legal Framework for Healthcare established by law and the Ministry of Health Pharmaceutical Policy and Pricing Page 3 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess Industry: Transparency of assessments and drafts of decisions; written and oral hearings; justified decisions; right to sue
Pharmaceutical Policy and Pricing Pharmaceutical steering tools: 1.Federal level: Reference price setting for comparable drugs including patented drugs Early assessment of new pharmaceutical agents within 6 months after market access and based on the assessed value (started in 2011) Negotiation or setting of a reimbursement price 12 months after market access (starts in 2012) Exclusion of drugs in case of inappropriateness compared with treatment alternatives OTC-exemption list; lifestyle-negative list Page 4 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Pharmaceutical steering tools: 2. State level: Negotiation of savings goals on the basis of DDD- recommendations IT-based drug prescribing check of physicians Discount negotiations between sickness funds and pharmaceutical companies based on tendering procedures including the possibility of risk-sharing and price-volume payback agreements Binding on the pharmacists to dispend a discount negotiated drug, if the physician does not exclude aut similar. Pharmaceutical Policy and Pricing Page 5 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Manu- facturer Market access Manu- facturer Market access G-BA Efficiency assessment (published) G-BA Efficiency assessment (published) IQWIQ Control and assessment Evaluation request G-BA Manufacturers price Free price setting Prepares assessment Submits dossier G-BA Efficiency assessment decision G-BA Efficiency assessment decision Manufact./ Head associa. statutory health ins. Price negotiation Manufact./ Head associa. statutory health ins. Price negotiation Arbitration authority Arbitral verdict Arbitration authority Arbitral verdict IQWIQ Cost-benefit assessment IQWIQ Cost-benefit assessment Hearing manuf. experts Add. Benefit No agreement Not accepted Reference price Maximum GKV reimbursement price Reference price Maximum GKV reimbursement price Market access No add. Benefit No reference price applicable Agreement Rebate Freely decided on Rebate Freely decided on Rebate On ex-factory price Rebate On ex-factory price Retro- active Valid until the end of the procedure 3 months6 months12 months15 months Pharmaceutical Policy and Pricing We are here Page 6 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Free market access of a new pharmaceutical 2. Reference prices 8. OTC exemption list 6. Prescription restrictions 7. Therapeutical advice 3. Reimbursement price agreements for new pharmaceuticals with additional benefit 4. Cost-benefit assessment (second line) 1. Early benefit assessment of new pharmaceuticals 5. Subsequent benefit assessment Health care research/ Health care studies Pharmaceutical Policy and Pricing Page 7 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Benefit-package decisions must be justified by an evidence- based process to determine whether services, pharmaceuticals or technologies are medically effective to reach patient relevant objectives: morbidity, mortality and life-quality. Evidence based assessments in Germany only could be used to select the most appropriate (efficient) service etc. from others; if a costly innovation has a significant additional benefit, the sickness funds must pay for it (rationalizing not rationing). Pharmaceutical Policy and Pricing Page 8 | 7th November 2011 | Commonwealth Fund/ Alliance for Health Reform© 2011, Dr. jur. Rainer Hess
Prof. Jean-Luc Harousseau Chair of the Board Haute Autorité de Santé, France Washington DC, 7th November 2011 Control of Pharmaceutic Costs in France.
Health Care Reform and the New MTM Provisions: What does this Mean for Community Pharmacy? Christopher R. Gauthier, RPh Board Coordinator Maine Pharmacy.
This project has been funded with support from the European Commission under Seventh Framework Programme (FP7) Innovative PROcurement techniques to support.
Medicines Pricing Policies in Europe Richard Laing with materials provided by Kees de Joncheere WHO HQ and WHO Regional Office for Europe and Claudia Habl.
Kiev, 04/12/2007 Analysis of EU MRP/DCP procedures regarding to generic applications Dr.Raimonds Lozda, FMS Baltic Ltd.
What You Wanted to Know About Formularies Emmanuelle Mirsakov Pharm.D. Candidate 2007 USC School Of Pharmacy.
Pharmaceutical Compliance Congress June 9, 2003 HHS OIG Guidance: Key Risk Areas John T. Bentivoglio Arnold & Porter Copyright, Arnold & Porter,
Exhibit ES-1. Key German and Dutch Policies for a Multipayer System, with Insights for U.S. National Reforms Insurance Markets –Insurance exchanges with.
Pricing and paying for medicines Ad Antonisse AstraZeneca BV April 2005.
Understanding Mail Order Community pharmacists provide a valuable service desired by patients. Very rarely are mail order and community pharmacies allowed.
FP7-ICT-2013 Pre-Commercial Procurement (PCP) Lieve Bos (lieve.bos AT ec.europa.eu) European Commission DG CONNECT F2 unit (Innovation)
Switzerlands Health Care System from the viewpoint of the UK NHS Panos Kanavos, PhD London School of Economics Bern, 26 October 2012.
National experiences of regular price monitoring Klara Tisocki, WHO/HAI medicine price project Towards equitable and affordable medicine prices policy.
State Aid and Public Procurement for European Territorial Cooperation programmes Overview and Principles of Public Procurement Katrin Stockhammer, INTERACT.
What lies ahead for employers in 2013? 7 March 2013.
World Bank Training Program on HIV/AIDS Drugs Training Module 5 Procurement based on the World Bank document Battling HIV/AIDS: A Decision Makers Guide.
Changes to the ABPI Code of Practice for the Pharmaceutical Industry.
The new State Aid Package for SGEI DG Competition.
European government procurement policy and experience Rita Beuter Senior Expert, European Policies, EIPA, Maastricht (NL) © EIPA – 2008.
U.S. Regulation of Prescription Drug Marketing and Promotion October 21, 2004 Bill Ross.
U.S. Regulation of Drug Development and the Role of The Information Professional Alberto Grignolo, Ph.D. Corporate VP and General Manager PAREXEL Consulting.
Determining value for new medicines in Europe Panos Kanavos, PhD London School of Economics, UK AcademyHealth, Boston, 26 June 2005.
The Medicare Part D Prescription Drug Benefit Understanding the Formulary Requirements and Related Implications Michael Sharp, R.Ph, Pharmacy Consultant.
By Larry Grudzie n Attorney at Law 1. The following describes key elements of the health care reform legislation that affect employers for years 2010,
Some Utilitarian Considerations Regarding Discouraging Pharmaceutical Incentivizing in Emerging Markets: Andrew Gustafson Creighton University Vincentian.
Implementation of Bridging Study-Taiwans Experience Meir-Chyun Tzou, Ph.D. Senior Officer, and Director of Section III, Bureau of Pharmaceutical Affairs.
1 JFDA & HAI Workshop Towards equitable and affordable medicine prices policy in Jordan 4-5 December 2007 Strategies to increase the use of low priced.
Mr. Heinz HilbrechtDirector Mr. Jean-Arnold VinoisHead of Unit Ms. Catherine EginardTEN-E Project Officer Mr. Patrick BourrelTEN-E Project Officer Ms.
An Overview of the United States Regulatory Environment (FDA and Healthcare) for Global Pharmaceutical Compliance Professionals May 28, 2008 Lynn Shapiro.
1 Professional qualifications Presentation of main components of Commission proposal IMCO 9 January 2012 Priority under Single Market Act.
© 2017 SlidePlayer.com Inc. All rights reserved.