Abstract
Introduction:
Approximately 90 pharmaceuticals achieved blockbuster status in 2006,
generating more than $200 billion in sales-approximately 30% of the global
pharmaceutical market. However, in 2007, eight blockbuster brands- with
combined 2006 sales of $13 billion in the United States alone-face patent
expiration. Additionally, the future presents great challenges to the creation
of new blockbuster drugs: health care payers are becoming more cost-conscious,
restricting patient access to expensive, blockbuster therapies. And the
upcoming expiration of patents on many current blockbuster drugs will trigger
the widespread launch of generics. Finally, the prospective launch of
“biosimilars” -generic versions of biologics-will present
unprecedented challenges for stakeholders.
Questions Answered in This Spectrum Report:
- A key patent on simvastatin recently expired in many parts of the world.
The loss of protection prompted payers in some countries to introduce measures
promoting the use of generic simvastatin in place of patentprotected drugs
within the same class. How has the loss of simvastatin' s patent protection
affected pricing policies on patent-protected drugs?
- After many years of stagnation, the Japanese generics market is now widely
expected to undergo vigorous growth. Which drug classes do Japanese physicians
expect to experience the most robust growth in generics penetration?
- Despite having the largest population of any country in the European
Union, Germany exhibits relatively modest spending on blockbuster
pharmaceuticals. Why are German physicians wary of prescribing these popular
medications?
- As more and more blockbuster products lose patent protection, payers
become more and more eager to increase the rate of generics prescribing. What
pharmacy benefi t management strategies have been gaining favor among
employers? What strategies have been losing support?
Scope:
- U.S. employers' views on strategies to increase prescription drug benefi t
values: the relative importance of generics substitution, patient compliance,
cost-effective products, pharmacy deals, maximization of rebates.
- Challenges drug manufacturers face in creating new blockbuster drugs:
cost-conscious health care payers; targeted therapies; the launch of generics
triggered by upcoming patent expirations.
- Future patent expirations of blockbuster drugs in the seven major markets:
total sales fi gures in each of the seven major markets of blockbuster drugs
that lose patent protection in a given year; patent expiration timetable for
2006 blockbuster drugs; the dominant position of the United States; France as
the largest European market for blockbuster drugs; Germany' s modest spending
on blockbuster drugs; the impact of price cuts in Italy; Spain as the smallest
European market for blockbusters; the generics prescribing culture in the
United Kingdom; the absence of blockbuster brands from the Japanese market.
- Barriers to generics competition: navigating the patent maze; logistical
obstacles in the manufacturing and handling of generics; the unique challenges
posed by biologics.
- Payers' support for generics: U.S. employers' views of PBMs; new
prescription forms, reimbursement programs, and solutions to supply defi
ciencies in Japan.
- Outlook: Major changes expected; growing patient acceptance of generics;
increased payer incentives for generics; increasing physician comfort with
generics; the prospective launch of blockbuster biosimilars.
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