Winter 2012 - Western University of Health Sciences

Anew study published in the New
England Journal of Medicine
examines the economic impact and
potential precedent set by the delay
in lipid-lowering drug Lipitor
becoming available in generic form.
Lipitor was the top-selling
prescription medication in the U.S.
in 2010, earning its manufacturer
Pfizer more than $7 billion in total
revenue, according to the study
“Generic Atorvastatin and Health Care Costs.” The article’s
lead author is WesternU College of Pharmacy Associate
Professor Cynthia Jackevicius, BScPhm, MSc, PharmD,
FCSHP, BCPS (AQ Card). Co-author Mindy Chou, PharmD
’11, is a College of Pharmacy alumna who worked with
Jackevicius during her advanced elective rotation.
Lipitor’s patent expired in June 2011, but Pfizer made an
agreement with Ranbaxy, the first company to develop a
generic atorvastatin, to defer the first generic’s introduction
into the U.S. market from June to November. This five-month
delay cost Americans an estimated $324 million in savings.
This cost estimate is very conservative since in the first five
months of a first generic, the product price usually only drops
by about 20 percent, Jackevicius said.
Although generic-substitution laws and tiered formularies
have been deployed for years in attempts to promote the use
of generic products, patients’ and physicians’ preference for
brand-name medications persists, according to the study.
Examination of primary care prescribing patterns with regard
to statins alone reveals that such preferences may result in
$5.8 billion in excess expenditures annually.
Pfizer has employed aggressive business tactics to retain
Lipitor revenue, including strategic agreements with several
prominent pharmacy-benefits management and insurance
companies to provide Lipitor at less than the cost of the first
generic atorvastatin, with a generic-level copayment for
patients, in exchange for a monopoly on dispensed
atorvastatin prescriptions, according to the study.
The tactics employed by Pfizer are much broader and allencompassing
that what has been done previously to try to
maintain market share, Jackevicius said.
“Because of Pfizer’s aggressive tactics, other companies with
patents about to expire may mimic their actions if they prove
U.S. Statin Market Share before and Projected Market Share after the Entry of Generic Atorvastatin.
Data for 2002 through 2009 are from IMS Health National Prescription Audit.
to be successful,” Jackevicius said. “There is concern that
some of these tactics may delay other generic companies from
making a generic product if they don’t think they will get
much market share after the first six months of exclusivity
with the first generic.”
In the short term, a consumer may not be negatively impacted
financially, especially if they get the brand name product at
less than the generic price. Then this is really a win-win. The
questions arise in terms of whether there will be enough
generic competition in the long term to promote enough
competition, Jackevicius said.
“Usually about six or seven generic products are needed after
the first six months to drive the generic product price down to
about 20-30 percent of the generic, the usual price at that time
with that many generics available,” Jackevicius said. “The
other concern is, who gets the savings from the agreements
with Pfizer to keep using brand name Lipitor? Does the
pharmacy benefits management company or insurance
company give the savings back to the employer, or do they
keep these savings for themselves? If the employer is still
having to pay the higher Lipitor price, then the costs to the
employer, and indirectly to the employee, for the health care
plan is not reduced. It is uncertain, according to the current
agreements that Pfizer has, who retains the savings.”
Whatever happens, Lipitor’s generic transition should be
watched closely, since Pfizer’s strategies may set a new
precedent for the other blockbuster drugs on the verge of
losing their patents, the study concluded. To read the full
article please visit www.NEJM.org. ■
“Generic Atorvastatin and Health Care Costs” (10.1056/NEJMp1113112) was published on
December 7, 2011, at NEJM.org.
WesternU, College of Pharmacy RxBound | 23