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Pharmaceutical Pricing, Reimbursement, and Market Access in Poland, Romania and Ukraine
Decision Resources, Inc, June 2011
Poland, Romania, and Ukraine have by far the largest populations in Central and Eastern Europe, and their pharmaceutical markets are experiencing strong growth. To succeed in these markets, however, multinational companies must overcome some daunting obstacles, including underinvestment in healthcare, deficient healthcare infrastructures, limited patient access to health insurance and drug benefits, weak intellectual property protection, and competition from local manufacturers of inexpensive generic drugs.
Questions answered in this report:
- In 2009, pharmaceutical sales in Poland totalled $6.6 billion, a 10.1% increase over the preceding year. What is the procedure for setting the prices of new drugs in Poland? What is the scope of the national positive list, and what must manufacturers do to have their products added to this list? What reforms to the pricing system has the Polish government recently proposed? What are the key elements of the government’s cost-containment strategy?
- Retail drug prices in Romania are among the lowest in the EU. How do the pricing procedures for imported and domestic drugs differ? What are the international implications of Romania’s low drug prices? How does the Casei Nationale de Asigurari de Sanatate (CNAS; National Health Insurance Fund) make drug reimbursement decisions? What changes has the government recently made to the Romanian reference pricing system?
- Compared with most other European countries, Ukraine exercises relatively limited control over prescription drug prices. To what extent does the Ukrainian government regulate drug prices, and what reforms has it proposed in recent months? How extensive is reimbursement of prescription medicines in Ukraine? How has the government tried to contain pharmaceutical spending?
Scope:
Socioeconomic and demographic background: projections of total population, senior population, and life expectancy at birth to 2030; key economic indicators; investment in healthcare.
Organization and funding of the healthcare system: healthcare provision in the communist era; key reforms in the last two decades; access to health insurance and prescription drug coverage.
Intellectual property protection: reforms adopted in recent years; duration of exclusivity periods; challenges facing international brands.
Pharmaceutical pricing: procedure for setting prices; pharmacy and wholesaler margins; use of external reference pricing.
Admission to reimbursement: bodies involved in reimbursement decision making; reimbursement procedures; data requirements for manufacturer dossiers; reimbursement rates.
Cost containment: reference pricing; pharmaceutical budgets; prescription monitoring; measures to promote greater use of generics; patient copayments.
Outlook and implications for the pharmaceutical industry: need for increased investment in healthcare; implications of low drug prices in Poland, Romania, and Ukraine for these three markets and for other European markets; challenges in securing reimbursement; prospects for increased cost-containment activity.
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