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Pharmaceutical Pricing, Reimbursement, and Market Access News in the Third Quarter of 2011
Decision Resources, Inc, Nov 2011
In the third quarter of 2011, politicians in the United States, Europe, and Japan faced the unpleasant task of having to make substantial budget cuts. Healthcare spending was a major target for cost cutting, and further economies can be expected in the coming months.
Questions Answered:
- Recently published U.S. data show increases in the number of uninsured residents and Medicaid beneficiaries, but a decline in the number of people covered by employer-sponsored health benefits. Which are the most important sources of health benefits for the population overall, the working-age population, and senior citizens? What changes are employers making to health benefits in general, and drug benefits in particular? What are the implications for the U.S. healthcare system of efforts to reduce the budget deficit and legal challenges to recent healthcare reform legislation?
- The French government recently unveiled plans to overhaul its regulatory system and to reduce healthcare expenditures. What prompted this action, and what are the key reforms? What measures have been proposed to control pharmaceutical spending in 2012?
- Germany has begun the implementation of a radical new price-setting procedure based on a rapid assessment of a drug’s additional benefit. What impact has the new system had to date? How has the pharmaceutical industry reacted to the new pricing procedures?
- In 2010, total spending on pharmaceuticals in Italy amounted to €26.068 billion ($34.533 billion). How fast did the market grow? How have pricing and sales trends for reimbursed outpatient drugs compared in recent years?
- Effective November 1, 2011, the Spanish government implemented major new cost-containment measures. What are the key reforms? How much are these measures projected to save? What role will the new Comité de Coste-Efectividad de los Medicamentos y Productos Sanitarios (Cost-Effectiveness Committee for Medicines and Healthcare Products) play in market access in the future?
- The U.K. government has published its responses to a consultation on the new value-based pricing system scheduled to take effect in January 2014. Which drugs are likely to be included in the new system? How will the government incentivize manufacturers to develop innovative drugs? How could more-extensive use of real-world data improve market access for new drugs?
- The next biennial price revision in Japan is scheduled for April 2012. What is the outlook for the premium for the development of new drugs and the elimination of off-label drug use? How might price cuts for long-listed drugs and repricing in response to market expansion be changed?
Scope:
- Issues affecting the pharmaceutical industry in the United States: changing patterns of health insurance; drug benefit management trends; struggle to reduce the budget deficit; healthcare reform legislation referred to the Supreme Court; renewed criticism of authorized generics; insurers to supply data to a new Health Care Cost Institute.
- Issues affecting the pharmaceutical industry in Europe: plans for an overhaul of the French regulatory system; French proposals for healthcare savings in the 2012 social security budget; initial impact of new pricing procedures in Germany; burden of increased mandatory rebates on leading manufacturers in Germany; price erosion in Italy; Spanish government’s pledge to tackle healthcare budget deficit; new cost-containment measures in Spain; U.K. government’s response to consultation on value-based pricing; U.K. market trends; industry call for greater use of real-world data to demonstrate value in the United Kingdom.
- Issues affecting the pharmaceutical industry in Japan: prospect of general spending to pay for reconstruction in the aftermath of the March 2011 earthquake and tsunami; potential cost-containment measures for the April 2012 biennial price revision.
- Legislation: American Recovery and Reinvestment Act of 2009 (ARRA); Arzneimittelgesetz (Medicines Act); Budget Control Act of 2011; Gesetz zur Änderung Krankenversicherungsrechtlicher und Anderer Vorschriften (Act for the Amendment of Health Insurance and Other Regulations); Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG; Pharmaceutical Market Restructuring Act); 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); Projet de Loi de Financement de la Sécurité Sociale 2012 (PLFSS; Social Security Finance Bill 2012); Real Decreto Ley 9/2011 (Royal Decree Law 9/2011).
- Outlook and implications for the pharmaceutical industry: changing patterns of health insurance and introduction of more-restrictive health benefits in the United States; price cuts in Europe; the growth of health economic evaluation in Europe; the potential impact of pricing and reimbursement reform in France, Germany, and the United Kingdom; outlook for the April 2012 biennial price revision in Japan.
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