Market Access, Pricing, & Reimbursement
Ghaleb Ahmed Al Ahdab, PhD, President, ISPOR United Arab Emirates Regional Chapter, Pharmaceutical Advisor, Drug Registration Department, Ministry of Health and Assistant Professor of Pharmacy Practice, College of Pharmacy, Sharjah University and Ajman University of Science and Technology, Abu Dhabi, United Arab Emirates, ISPOR Washington DC, 2012.
The German pharmaceutical market still looks inviting to drug manufacturers. Germany has one of the highest levels of health care spending in the world and has the largest pharmaceutical market in Europe. (Source: United BioSource Corp. “Evidence Matters” Newsletter, Oct 2010)
Plans to price medicines according to their value will have an impact throughout the supply chain and the government must consider "the implications for wholesalers and those who dispense", AAH has said. (Source: Emma Weinbren, Chemist and Druggist, C+D)
This course you will develop a detailed understanding of where, when and how in the R&D process to build evidence payers require for Market Access, and turn this into a compelling Value Dossier. In addition you will learn innovative pricing techniques, risk share and early access schemes. This course is essential for anyone involved in providing input to the R&D process in global, region and country roles.
The AMCP eDossier System is a centralized, secure, web-based platform, that provides qualified health care decision makers the opportunity to easily access, review, and evaluate research to make informed, evidence-based decisions.
This is an update of the October 2007 AMCP Guide to Pharmaceutical Payment Methods which was created by the AMCP Task Force on Pharmaceutical Payment Methods. Includes payment benchmarks, payer/payment methods, product flow through channels of distribution, stakeholder issues, and more.
AMCP supports legislation to prohibit financial agreements for delaying marketing of lower-cost generic drugs
An Economic Assessment of the Relationship Between Price Regulation and Incentives to Innovate in the Pharmaceutical Industry
This white paper explores the possible consequences that pricing and reimbursement regulation may have on pharmaceutical innovation. (Source: Friederiszick et al.)
In Europe, pricing of Biosimilars already has begun to affect the market for biologics. France’s compulsory price discounts for generic drugs have been applied to EPO and somatropin biosimilars; the ensuing mandatory price reductions for the originator in the French system have made prices roughly equivalent. (Source: OHE News, June 30, 2010)
New White Paper offers ideas to curb prescription cost drivers
Can We Alleviate Current Market Failures from International Price Referencing of Pharma in Middle In Middle Income Countries?
PPT, Presentation at ISPOR Europe, Nov. 2011, Iga Lipska, MD, Former Director, HTA Department, Agency for Health Technology Assessment in Poland (AHTAPol), Warsaw, Poland
View of An Academic Expert from a Middle Income Country, Presentation at ISPOR Europe, Nov. 2011, by Zoltán KalóMD, MSc, PhD, Director, Health Economics Research Centre, Eötvös Loránd University, Budapest, Hungary
Contains description of reimbursement programs, coverage specifics (drugs, % patients covered, etc.) by territory, plan names, etc.
Article provides a comparative look at countries that have implemented the Bismarck model of health care, which emphasizes a mixture of private and public administration to deliver services. Countries compared include US, France, Canada, UK, Taiwan, Germany, and Japan.
CPI database, inflation calculator, etc. The Consumer Price Indexes (CPI) program produces monthly data on changes in the prices paid by urban consumers for a representative basket of goods and services.
Presentation at ISPOR Europe, Nov. 2011, by Lieven Annemans, PhD, MMan, MSc, Professor of Health Economics, I-CHER, Ghent University and Brussels University, Ghent, Belgium
Presentation 3 of 3. Presentation by Ulrich Kaiser, PhD, MSc, Professor, Department of Business Administration – Entrepreneurship, University of Zürich, Zürich, Switzerland. Presented at ISPOR Germany 2012.
Do Existing Examples of Personalized Medicines Reflect "Ideal" Principles of Value-Based Reimbursement
by Anke-Peggy Holtorf, PhD, MBA, Managing Director, Health Outcomes Strategies, GmbH, Basel, Switzerland
Prices of a basket of 150 medicines can vary by up to 25% across EU member states or, in the case of generics, the difference can be as much as 16-fold. Wide variations due to market size, regulatory policy, price controls, reference pricing, generic use incentives, culture, taxation, etc. Report by London School of Economics and Political Science (Source: 5/27, Lynne Taylor, Pharma Times)
Daoud Al-Badriyeh, PhD, Assistant Professor of Pharmacoeconomics, College of Pharmacy, Qatar University, Doha, Qatar, ISPOR Washington DC, 2012.
This presentation, by Jorge Mestre-Ferrandiz, covers the key issues in the UK medicines market from drug development through health technology assessment and market access. The presentation agenda looks at the supply side (R&D), demand for medicines, NICE, and regulating medicine prices.
The research shows how drug information tools are being used by consumers. This editorial discusses a various online drug and plan price comparison tools (Source: JMCP, March 2011. Author: Alexander Grunewald, PhD)
When discussing pharma pricing analysis, we are very careful to examine all of the strategic options. In order to maximize market access and pharma reimbursement, it is critical understand all of the compounding pricing factors. In the past, we have scrupulously examined global prescription revenues across various therapeutic disease indications
Pharma pricing and market access case study
Learn how to maximize mature brand uptake in an emerging market, complete with numerous case studies and market data. Download this presentation by Aleksandra Mislorowska, Merck Serono’s Emerging Markets Business Director.
External referencing (ER) imposes a price cap for pharmaceuticals, based on prices of identical or comparable products in foreign countries. This article describes a model that inspired by the wide European experience with this cost-containment policy.
French culture favors a a public system of healthcare delivery with price control and total physician autonomy.(Source: Managed Care Executive)
In January 2011, Germany introduced price controls for new prescription drugs through its AMNOG legislation. AMNOG has created a lot of uncertainty for regulators and affected the industry alike, as many of its elements have not been clearly defined. The jury is still out as to how the system works , let alone its ultimate impact.(Source:Julian Upton, Editor of Pharm Exec Global Digest)
From 2011 onwards new medicines will have to undergo a benefit assessment. The GBA will commission this to IQWIG or other third parties. Prices can be freely set for the first six month, if no additional benefit can be demonstrated the drug will thereafter automatically be part of the therapeutic reference price system. If an additional therapeutic benefit is established manufacturers will negotiate prices with the statutory health insurance funds, if no agreement can be reached prices will be fixed by an independent arbitrary commission taking into consideration the EU price level.(Source: Health Economics Blog)
Germany's Decision Rule for Setting Ceiling Prices of Drugs: A Comparative Analysis with Other Decision Rules
Love this site! Click on the map for where you want a price for a drug - worldwide
Global Health Care Reimbursement Systems and Decision Processes Working Group of the ISPOR HTA SIG Forum: Health Care Decision Makers around the World: A Global Road Map and Country–specific Decision-Making and Reimbursement Processes
Presentation at ISPOR Europe, Nov. 2011, by Hans-Georg Eichler, MD, MSc, Professor & Senior Medical Officer, European Medicines Agency and CBI Visiting Scholar & Robert E. Wilhelm Fellow, Massachusetts Institute of Technology, London, UK
Presentation at ISPOR Europe, Nov. 2011, by Marc L. Berger, M.D., Executive VP & Senior Scientist, OptumInsight, New York, NY, USA
This report examines the current role of HTA in Europe, from its impact on reimbursement and pricing to market access. The report focuses on the experiences of five European nations, reviewing the history of HTA and the key agencies in each.
This white paper highlights several decisions IQWiG has made public for recently reviewed drugs. Now a body of evidence exists which can shed some light upon how restrictive and timely access will be under the new AMNOG legislation. To better understand how the future access environment in Germany will take shape, each of the brands reviewed to date has been assessed for key learnings as brand managers plan for the new Germany.
Peter J. Neumann, ScD, Professor and Director, The Center for the Evaluation of Value and Risk in Health, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA, ISPOR Washington DC, 2012.
Increase Reimbursement Success by Understanding When, What, and How to Effectively Communicate with Payers
Manufacturers invest heavily into the development of products that deliver more effective treatment and many invest in the development and communication of a payer value proposition during the launch phase. (Source: Webinar, Xcenda, March 25, 2010)
Manufacturers, in more countries, are proposing risk-sharing and value-based schemes more often.
ISPOR has developed an electronic index (Digest) of key attributes of health care databases around the world available at the ISPOR website, which is accessible to the public. The digest is grouped by country and allows key word searches and searches by type of database. (Source: ISPOR, Nov 2009)
Presentation 1 of 3. PPT presentation by Kees de Joncheere, PharmD, MBA, MSc, Director, Department of Essential Medicines and Health Products, WHO, Geneva. Presented at ISPOR Germany 2012.
PPT presentation by Thomas B. Cueni, MSc, Secretary General, Interpharma, Basel, Switzerland. Presented at ISPOR Germany 2012.
Leela Barham explores whether pharma firms can use value-based pricing (VBP) to improve market access.
Developed in partnership with subject-matter experts from Campbell Alliance, Managed Markets Excellence® is a robust training solution that addresses the critical need for specialized training in the complex and constantly evolving managed markets environment. This series addresses the critical need for specialized training in the complex and constantly evolving managed markets environment for pharmaceutical and biologic products.
Leela Barham explores the potential for patient access schemes (PAS) to help companies achieve market access.There has been a rise in the number of patient access schemes (PAS), or risk-sharing schemes, in the UK and other countries. They are “simply a response to uncertainty,” says Jim Furniss, director, market access solutions at Bridgehead International Ltd. That uncertainty is two-fold—about the benefits of a product in real-life use and about budget impact. (Source:eyeforpharma, August 10, 2010)
Citing the existence of over 6,000 rare diseases Joff Masukawa, Senior Director, Government Relations and Public Policy, Shire details his role in orphan product development and explains the importance of early engagement. Jeff was a speaker at the marcus evans Market Access and Reimbursement Conference taking place on November 16-17, 2010 in Philadelphia, PA. (Source: Marcus Evans Conferences)
Summarized are some of the key challenges, critical success factors and key changes / change management tools required for pharma to effectively tackle the issue of market access.
This is a presentation by Janice Haigh at Market Access Europe 2010 that took place March 2-3, 2010.
This article breaks it all down for you, from the definition of market access, to developing a call strategy that positions you to address key market access stakeholders. (Source: Pharmaceutical Field)
With increasing frequency in Europe, and now starting to show up in the US, biopharma companies and payers are entering into agreements to provide some form of risk sharing or price protection as new drugs are adopted into formularies. (Source: eyeforpharma, August 10, 2010)
These key issues, as well as other dynamics, create an increased need for strategic planning to ensure that the new products are adopted by key stakeholders and therefore accessible upon approval and launch with minimum barriers to use. This is how market access is defined. (Source:United BioSource Corp, “Evidence Matters” Newsletter, Oct 2010, Robinson, S, et. al.)
Thomas Bramley, RPh, PhD, Vice President, Global Value Strategies, Xcenda, Salt Lake City, UT, USA; Kara Suter, MS, Director, Health Policy, Xcenda, Washington, DC, USA; Peter Neumann, ScD, Professor of Medicine, Tufts University School of Medicine, Boston, MA, USA; Trent McLaughlin, PhD, Senior Director, Global HEOR Oncology & Cardiometabolic Disease, Abbott, Abbott Park, IL,USA, ISPOR Washington D.C. 2012.
Presentation at ISPOR Europe, Nov. 2011 by Edward Kim, MD, MBA, Executive Director, Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Presentation at ISPOR Europe, Nov. 2011 by Rachael Fleurence, PhD, Director, Oxford Outcomes, Bethesda, MD, USA
The National Business Coalition on Health (NBCH) recently launched its Value-Based Purchasing (VBP) Guide, a tool developed to support the critical role purchasers and purchaser-led coalitions play as change agents in improved health and health care. The guide serves to educate such stakeholders on how they can implement value-based purchasing programs in their own organizations and local communities.
Pharma pricing and reimbursement analysis. This comprehensive industry review focuses exclusively on the differential costs (and reimbursement to physicians) of Avastin and Lucentis in the treatment of Age-related Macular Degeneration.(Source: Pharma Pricing)
Money Since the advent of the PBMs, the concept of reference pricing for pharmaceuticals has seen multiple waves of interest and policy discussion but only minimal uptake. Reference pricing, sometimes referred to as a therapeutic MAC, requires patients to pay the full difference between the price charged at the pharmacy and a reference price reimbursed by the insurer. The reference price is the price of a low-cost drug in a therapeutic cluster of drugs considered clinically equivalent in the treatment of a condition.(Source: RX Outcomes Adviser)
The short video revenue analysis examines global sales of Onyx/Bayer’s Nexavar and Pfizer’s Sutent since the drugs were approved for the treatment of renal cell carcinoma (RCC), and hepateceullular carcinoma (HCC) subsequently, in the case of Nexavar.
Find value in the following quick video (2-5min each) case study, free!(Source: Pharma Pricing)
The Institute said that from March 2000 to June 2010 it published 49 single technology appraisals, 141 multiple technology appraisal and a total of 378 individual recommendations on the use of drugs and treatments on the NHS, which have now been published on a new webpage to offer a better overview of where it stands. (Source:Pharma Times Industry News)
The existing roles and responsibilities of NICE are however expected to remain unchanged. Rawlins was not so forthcoming on one issue of particular interest to the pharmaceutical industry, however: value-based pricing. He claimed that NICE would play a critical role in developing such pricing for medicines in the U.K., but said the details of how this would work in practice have yet to be decided.
Potential reduction of oncology drug prices in Italy starting in 2011 after an initial analysis of registry data from the outcomes based schemes implemented in Italy since 2006/2007. Italy is one of the most active markets for risk sharing agreements, and has been launching performance based risk sharing schemes in the recent years. Guido Rasi, dircetor of AIFA, the Italian drug agency stated that according to this preliminary analysis of two year data selected drugs could be reduced by 30 to 40 percent.
Recent reforms to the National Health Service (NHS) in England include important changes in the regulation of prices for new medicines. From January 2014, the existing Pharmaceutical Pricing Regulation Scheme (PPRS) will be replaced by “value based pricing” (VBP) for branded medicines sold to the NHS. This will apply only to new medicines; those marketed before 2014 will continue to be governed by the PPRS.
Optimizing Market Access: Your Guide to Effective Pricing, Reimbursement and Messaging Strategies Webcast
Xcenda's Managed Markets consultants discuss how manufacturers are revamping their approach to managed care messaging to increase their products' market opportunity. Key points for their presentation include impact of payer environment, building value props throughout the life cycle, and communicating this message with respect to FDAMA Sect. 114. (Source: Xcenda, April 20, 2010)
Drug prices typically rise when legislation is pending. With the 9.3% increase, Congress is taking Pharma to task.
Blog by Jeff Waite, Pharma Pricing Strategist. Blog provides updates and reports on health technology assessment, pharmaceutical price regulation schemes, market access, and pricing and reimbursement.
Revised Interactive Resource Library provide an unbiased description and analysis of the multiple methods used by public and private sector programs to purchase pharmaceutical products and pay providers who prescribe and dispense them.
This report analyzes the practices of some of the industry’s top pricing departments to provide the steps pricing managers must take to make their functions more integral pieces of the development puzzle. The report provides pricing leaders the tools to improve their pricing departments by comparing their spending, staffing, structure and strategies to those of top pharmaceutical companies.
An interactive and dynamic simulator for optimizing transnational pricing strategy.
Leeanne Larson, MHA, Vice President, Evidence Development, PAREXEL International, Waltham, MA, USA , ISPOR Washington D.C. 2012.
Larry Gorkin reviews pricing opportunities for tofacitinib for moderate-to-severe RA vs. competitors, and notes the considerable price elasticity of the market. He suggests setting price at >50% of -a blocking agents.
The pharmaceutical industry has largely been vilified in the media and in the recent presidential debates, for fueling healthcare inflation and setting what many perceive to be ‘unfair’ prices in light of the profit margins on their life-saving products. (Source: Informahealthcare.com, March 2001, Vol. 2, No. 3 , Pages 377-383)
PRMA Insights is a unique series of reports that address the critical global pricing, reimbursement and market access challenges and opportunities by disease area. Each comprehensive report critically reviews all the major health technology assessment (HTA) and pricing and reimbursement decisions by disease area in the US, UK, France, Germany, Spain, Italy and Japan, and unravels the complexity around pricing and reimbursement. It delivers actionable insights to apply to your clinical development program in order to develop a robust evidence-based payer-value proposition. Written by a team of industry-experienced individuals, each report provides comprehensive secondary research, experience-based insight, and validation by payers and key opinion leaders (KOLs) across markets. PRMA Insights helps to minimise the market access risk and to maximize the market opportunity for commercial success.
PRMA Virtual is a flexible subscription-based service providing best in class strategic, commercial and technical based pricing, reimbursement and market access advisory services at your fingertips.
Presentation at ISPOR Europe, Nov. 2011
Presentation at ISPOR Europe, Nov. 2011
M. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, Heslington, York, UK, PPT Presentation: "Pros and Cons of a Centralized European Pricing and Reimbersement Agency"
Reimbursement and value-based pricing: stratified cost-effectiveness analysis may not be the last word
During recent discussions, it has been argued that stratified cost-effectiveness analysis has a key role in reimbursement decision-making and value-based pricing (VBP). It has previously been shown that when manufacturers are price-takers, reimbursement decisions made in reference to stratified cost-effectiveness analysis lead to a more efficient allocation of resources than decisions based on whole-population cost-effectiveness analysis. However, we demonstrate that when manufacturers are price setters, reimbursement or VBP based on stratified cost-effectiveness analysis may not be optimal. (Source:Neil Hawkins and David A. Scott, Health Economics. 2011(June):20;6)
The purpose of this article is to show: When may a company obtain reimbursement through a distributor and when it should not. (Source: Amir Inbar, MEDIClever)
To date, much of the risk in product reimbursement has been borne by the payer; however, the appearance of new, very high cost drugs frequently supported by a weaker evidence base has increased the risk of the reimbursement decisions dramatically, with obvious consequences for decision-makers and ultimately taxpayers. (Source: ISPOR Connections)
This study focused on decisions about the initial price and reimbursement status of innovative drugs and discussed the consequences for market access and cost. Four countries were studied: Germany, The Netherlands, Sweden and the United Kingdom. (Source:Springerlink,European Journa of Health Economics, Authors; Michael Drummond, Bengt Jonsson, Frans Rutten and Tom Stargardt)
Of all factors contributing to product success, payer access could be the most critical. Without the best reimbursement status for a drug, the investments your company made during drug development may end up as a lost cause. Securing Market Access: Reimbursement, Payer Relationships and Healthcare Reform examines the processes, strategies and best practices that industry leaders have implemented to build strong relationships and gain payer access
Of all factors contributing to product success, payer access could be the most critical. Without the best reimbursement status for a drug, the investments your company made during drug development may end up as a lost cause.
Pricing and reimbursement arrangements for prescription medicines are summarized. Spending by Spain’s National Health Service (NHS) on pharmaceuticals was €12.1 billion in 2010.(Source: OHE News)
Excellent report containing great metrics and trends on health care costs
Until now, Germany has been one of Europe's last bastions of "free" upfront drug pricing. Sure, the hurdles come afterwards, but both there and in the UK drug firms have--until now--been allowed to set more or less the price they like for new drugs. (Source: The IN VIVO Blog, March 8, 2010)
Journal article describing the use of pharmacoeconomics as a life cycle management tool. (Source: Denise Mysoko, PharmaVoice, May 2008)
There are now over 40 national agencies globally, each with its own standards and procedures for HTA evaluation, but evaluation methods vary and are continuously changing. In order to understand the landscape for HTAs across the world, United BioSource Corporation (UBC) conducted a review of HTA requirements in 10 markets. (Source: United BioSource Corporation Evidence Matters Newsletter, March 2010).
Discusses Pharmaceuticals Pricing Board, decision-making in the PPB, and health economic evaluations in decision-aking
Report from House of Parliament.
The pioneering and influential National Institute for Health and Clinical Excellence (NICE) in London currently assesses drugs and decides whether they are cost-effective and should be available through the country's National Health Service (NHS). But the coalition government is making plans to pay drug companies only what a medicine is worth, promising to shake up the industry — and it is not yet clear what part NICE will play in the new system.(Source: Naturenews)
Links for Pricing and Reimbursement reports
Despite billions in research investment and consistently high revenues for the pharma industry, the number of new drugs emerging in the U.S. pharmaceutical market is at a low point. FDA approved an average of 22.6 new drugs and biologics per year from 2005 through 2009, down from 37.2 a decade earlier (1995 through 1999). (Source: NEJM, Nov.2010)
The first in the series covers Value Based Pricing and covers some insightful topics including how value based pricing will affect pharma on a global scale and how this will affect your products chance of reimbursement; how therapies will be assessed in order to increase the chances of approval; what impact VBP will have on innovation initiatives and how you can overcome the challenges created by the new system
Presentation at ISPOR Europe, Nov. 2011, by Jens Grueger, PhD, Vice President & Head, Global Market Access Primary Care, Pfizer Ltd., Tadworth, Surrey, UK
Value-Based Approaches to Healthcare Systems and Pharmacoeconomics Requirements in Asia: South Korea, Taiwan, Thailand and Japan
Asian healthcare systems are very diverse, representing cultures, political systems and economies from more than 30 countries with varying histories. Despite the diversity in the region, there has been enormous growth in health economics and outcomes research since the beginning of the 21st century (Source:PharmacoEconomics, Volume 28, Number 10, 1 October 2010 , pp. 831-838(8), Author; Kamae, Isao1).
Value-based pricing for pharmaceuticals: Its role, specification and prospects in a newly devolved NHS
In December 2010, the Government launched its consultation on its plans to change the way medicines are priced in the UK. By 2014, a system of ‘value-based pricing’ (VBP) will replace the current Pharmaceutical Price Regulation Scheme (PPRS), which is a voluntary agreement between the Department of Health (DH) and the pharmaceutical industry whereby companies negotiate profit rates from drug sales to the National Health Service (NHS) every 5 years utilising price and profit controls.
The new value-based pricing strategy will radically overhaul the way medicines are paid for. Once the PPRS scheme has run its course by 2014, grug prices will be set according to the value the medicines provide. The White Paper also proposes changes to the role of NICE (National Institute of Clinical Excellence) and structural shifts in the way that budgets are managed – with 80% of control being handed over to GP’s. (Source: InPharm.)
Presentation at ISPOR Europe, Nov. 2011, by J.-Matthias Graf von der Schulenburg, PhD, Professor of Economics & Director, Institute of Risk and Insurance, Gottfried Wilhelm Leibniz Universität Hannover, Hannover, Germany
In December 2010, the UK Department of Health released a consultation document to elicit comments on 'proposals for a new value-based system of pricing medicines which aims to recognise and reward innovation. The document sets out the principles that would underpin the move to value-based pricing, outlines how the new system could work across the UK and seeks views on a number of key issues'. Responses were requested by 17 March 2011.
Presentation at ISPOR Europe, Nov. 2011, by John Brazier, PhD, Professor, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
The Wall Street Journal article, based on a tentative settlement of litigation in which First DataBank and the McKesson Corporation were accused of unilaterally increasing AWPs, included the findings that (a) at least since 2003.
White Paper: An Economic Assessment of the Relationship between Price Regulation and Incentives to Innovate in the Pharmaceutical Industry
In this paper, we explore the possible consequences that pricing and reimbursement regulation may have on pharmaceutical innovation. We first investigate qualitatively how a pharmaceutical firm is likely to strategically respond in its R&D activities to pricing and reimbursement regulation. We then quantitatively evaluate these effects in the context of a calibrated decision-theoretic model of drug development in which a pharmaceutical firm is forward-looking and takes future pricing regulation into account in making current development decisions. Source: Hans Friederiszick, ESMT CA Nicola Tosini, ESMT CA Francis de Ve´ricourt, ESMT Simon Wakeman, ESMT