WellPoint's Internal Data Led It To Limit Use Of Drug Boniva
WellPoint Inc. (WLP), the largest U.S. managed-care concern by
membership, made it harder last year for its members to gain
approval for use of the Boniva osteoporosis drug after internal
research linked it to higher fracture rates, lower patient
compliance and higher total costs of care than two other drugs, a
WellPoint executive said Thursday.
WellPoint, which conducts its own research into the comparative
effectiveness of various treatments, studied 26,000 members on
osteoporosis drugs. The health insurer sought to compare Boniva,
which is marketed by Roche Holding AG's (RHHBY) Genentech and
GlaxoSmithKline PLC (GSK), with two others in the same class. The
others were Actonel, marketed by Sanofi-Aventis SA (SNY) and Warner
Chilcott PLC (WCRX), and Merck & Co.'s (MRK) Fosamax.
From randomized clinical trials, it appeared the three drugs
should be equivalent, yet WellPoint's data on results with its
members found differences with Boniva, said the company's chief
pharmacy officer, Brian Sweet, who was participating in an industry
symposium on comparative-effectiveness research.
As a result, WellPoint requires that members with osteoporosis
try other drugs in the class before they can be approved for
Boniva. The drug remains where it was in the company's formulary,
or list of covered drugs, on tier 3, which is a nonpreferred level.
Fosamax, which has a generic equivalent, and Actonel elicited
better prescription compliance and had lower fracture rates and
total costs of care, even though Boniva's cost was attractive,
according to Sweet.
WellPoint made the change in mid-2009, according to a company
spokeswoman. A GlaxoSmithKline spokeswoman referred a request for
comment to a spokesman for Genentech, who wasn't immediately
Last month, WellPoint announced it had developed standardized
comparative effectiveness research, or CER, guidelines to evaluate
drugs' ability to improve health outcomes. This type of research
has come into the spotlight as the nation prepares to implement an
overhaul of its health-coverage laws.
The economic stimulus bill provided more than $1 billion for
CER, and the Obama administration supports the use of such data to
help doctors and patients make informed health-care decisions.
Earlier this year, the Food and Drug Administration said it was
conducting a safety review of bone-building drugs known as
bisphosphonates--the class that includes Boniva, Actonel and
Fosamax--to see whether they increase the risk of femur
At the time, the agency said the data it had reviewed hadn't
shown a clear connection between use of the drugs and atypical
fractures of the thigh bone; two medical studies presented around
then, however, suggested that long-term use might increase the risk
and adversely affect bone quality.
Health insurer Aetna Inc. (AET) said that on its open-formulary
plans, Boniva is a Tier-3, or nonpreferred, drug with requirements
to try Actonel and generic Fosamax first. Cigna Corp. (CI), in
contrast, lists Boniva as a preferred osteoporosis drug, with
Fosamax and Actonel nonpreferred.
WellPoint says it uses such research to complement data from
randomized clinical trials that evaluate drug safety and
effectiveness, which it primarily uses in designing its drug
After a company clinical review committee of physicians
evaluates clinical trial data and ranks drugs--without seeing any
cost information--they pass their findings to another company panel
of doctors that looks at other types of studies, Sweet said. Data
is next reviewed by a value-assessment committee that examines
total cost of care, he said.
"These studies really help us to add to the literature and
evidence around randomized clinical trials," which don't always
provide enough information on health safety and outcomes, Sweet
-By Dinah Wisenberg Brin, Dow Jones Newswires, 215-656-8285;
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