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Pharmaceutical Pricing, Reimbursement, and Market Access News in the First Quarter of 2011
Decision Resources, Inc, May 2011
For the international pharmaceutical industry, 2011 began as 2010 ended, with governments in the United States, Europe, and Japan looking to cut costs in the short term and to restructure healthcare systems in the longer term. Politicians in the United States clashed over proposals for healthcare reform, while the European Union launched a consultation on drug pricing and reimbursement.
Questions answered in this report:
- Rival 2012 budget proposals from President Barack Obama and Republicans in the House of Representatives present very different visions of the future of healthcare in the United States. Which elements of these proposals will have the greatest impact on healthcare and the pharmaceutical industry? How are the Medicare and Medicaid programs under increasing pressure?
- The French government has recently reduced the 35% reimbursement rate to 30%. How many products are affected by this change? How significant are these drugs in the French pharmaceutical market? How much does the government hope to save by this measure?
- The implementation of Germany’s new price-setting procedure has been delayed until the second half of 2011. What is the estimated timetable for the completion of each stage of the process? What data will manufacturers be required to submit? What criteria will be used to assess a drug’s level of additional benefit?
- The Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) recently completed a comparison of the prices of off-patent drugs in Italy with the prices of equivalent products in France, Germany, Spain, and the United Kingdom. For how many drugs has the agency cut reference prices? What is the average reduction in reference prices? What is the projected impact on the pharmaceutical market?
- The pharmaceutical industry in Spain reports that public pharmaceutical spending decreased by 2.4% in 2010 and is forecast to decrease by 4.7% in 2011. What recent measures have contributed to the contraction of the Spanish pharmaceutical market? How has reference pricing impacted the market in recent years, and how will it affect the market in the future?
- The pharmaceutical industry is generally supportive of the U.K. government’s plans for the introduction of value-based pricing in the United Kingdom, but has significant reservations regarding some aspects of the proposals. What are drug manufacturers’ main concerns about value-based pricing? What recommendations has the industry made to the government with regard to the organization of the value-based pricing system?
Scope of the report:
- Issues affecting the pharmaceutical industry in the United States: slowdown in the growth rate of national healthcare expenditures; early responses to healthcare reform; focus on healthcare savings in rival 2012 budget proposals; publication of proposed new rules for accountable care organizations; Medicaid under increasing pressure; close scrutiny of U.S. pharmaceutical prices.
- Issues affecting the pharmaceutical industry in Europe: European Commission consultation on drug pricing and reimbursement; intense criticism of the French regulatory authority; reimbursement reduction for hundreds of products in France; details of Germany’s Pharmaceutical Restructuring Act; impact of rebates on the German pharmaceutical market; increasing financial pressures on the Italian healthcare system; substantial cuts to thousands of reference prices in Italy; recent contraction of the prescription drug market set to continue; delay to U.K. healthcare reform legislation; introduction of value-based pricing in the United Kingdom; local restrictions on the reimbursement of certain drugs in England; geographic inequalities in patient access to NICE-approved therapies; planned introduction of a pathway-based tariff system in the United Kingdom.
- Issues affecting the pharmaceutical industry in Japan: forthcoming review of the impact of the premium for new drug development and elimination of off-label drug use.
- Legislation: American Recovery and Reinvestment Act of 2009 (ARRA); Department of Defense and Full-Year Continuing Appropriations Act, 2011 (H.R.1473); EU Transparency Directive (89/105/EEC); Freedom of Information Act; Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG; Pharmaceutical Market Restructuring Act); Health and Social Care Bill 2011; Health Care and Education Reconciliation Act of 2010 (HCERA); Loi de Financement de la Sécurité Sociale 2011 (LFSS; Social Security Finance Act 2011); Loi Hôpital, Patients, Santé et Territoires (Hospital, Patients, Health, and Territories Act); Patient Protection and Affordable Care Act (PPACA); Real Decreto Ley 4/2010 (Royal Decree Law 4/2010); Real Decreto Ley 8/2010 (Royal Decree Law 8/2010); Repealing the Job-Killing Health Care Law Act (H.R.2).
- Outlook and implications for the pharmaceutical industry: growing political tensions over healthcare reform in the United States; cost-cutting pressures in Europe; increasing importance of reference pricing in Europe; trend toward greater patient cost sharing in much of Europe; regionalization of European pharmaceutical markets; uncertainty of the Japanese pharmaceutical industry regarding the review of the impact of the premium for new drug development and elimination of off-label drug use and pricing reform in 2012.
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