 Treatment Algorithms --
July 2007
 In This Issue...
Introduction:
Osteoporosis is a major public health problem In the United
States, where an estimated 1.5 million fractures occur each year as a result of
the disease. (In 2002, fractures accounted for an estimated $18 billion in
direct medical costs.) A woman’s risk of sustaining a hip, forearm, or
vertebral fracture in her lifetime is approximately 40%; in contrast, the
lifetime risk of developing breast cancer is only 13%. The 2004 U.S. Surgeon
General’s report on bone health in the United States says that 50% of all
residents over the age of 50 will be at risk of osteoporotic fractures by 2020.
Despite increasing awareness of osteoporosis and osteopenia (the precursor to
osteoporosis) in the medical community, the proportion of patients diagnosed
remains low. The condition is frequently unrecognized until a patient suffers a
fracture, and even then, few patients are treated with pharmacological agents. In
2005, the market for osteoporosis therapies reached $4.3 billion in the United States. In view of the rising prevalence of osteoporosis and increasing awareness of
the disease’s significant morbidity, mortality, and cost to the health care
system, its prevention and treatment represent substantial commercial
opportunity.
Questions Answered in This Report:
- Lines of therapy: Osteoporosis is a disease dominated by
two big brands--Merck’s Fosamax (alendronate) and Sanofi-Aventis and Procter
& Gamble’s Actonel (risedronate)—but these brands have critical
shortcomings in tolerability and administration. Roche and GlaxoSmithKline’s
oral Boniva (ibandronate), which was launched in April 2005, offers better
dosing and is more tolerable. What is Fosamax’s first-line share compared
with Actonel and Evista? In which line does Boniva gain share? When is hormone replacement
therapy (HRT) predominantly used, and is it prior to or after Evista use?
- Pathway to key therapies: Forteo differentiates itself
from existing agents through its mechanism of action: it is the only drug that
actually builds bone mineral density (BMD). As the only agent of its kind,
in which line of therapy are physicians prescribing Forteo? What agents precede
Forteo use, and are these agents discontinued when Forteo is prescribed or is
Forteo added into the regimen? How long does it take a patient to move through
preceding therapy to Forteo?
- Physician behavior: The pharmaceutical arsenal for
osteoporosis treatment is quite fragmented: bisphosphonates are the most widely
used, but calcitonins, selective estrogen-receptor modulators (SERMs) like Evista,
and Forteo all have their niches. What are the attributes that encourage a
physician to choose Fosamax over Actonel and vice versa? What are the main
triggers for practicing physicians to move a patient to a drug other than a
bisphosphonate? Do physicians change dose before switching or adding therapy?
What attributes of SERMs, calcitonins, and Forteo are the leading reasons for
choosing these agents over other possible drugs?
- Forecast: Three new osteoporosis drugs--Novartis’s Aclasta
(zoledronate), Wyeth and Ligand Pharmaceuticals’ Viviant (bazedoxifene), and
Amgen’s denosumab--will launch in the United States by 2009. These agents will
likely be expensive and will drive competition in this still-underserved market
upward. Complicating matters, Fosamax’s patent expires in 2008, and we expect
generic alendronate to flood the market. How many physicians are aware of
these novel agents, and what do they perceive as their advantages? Which agents
do PCPs and gynecologists expect to be using early in the treatment algorithm,
and which agents will be used later? Will Forteo gain traction over the next
two years, or will it continue to be reserved for patients who fail
bisphosphonates?
Includes:
Primary research: Quantitative results from our
survey of 158 physicians (78 gynecologists and 80 PCPs):
- Physician opinion on how drug use differs by patient severity.
- Most influential drug attributes when physicians choose between
agents.
- Anticipated changes in the line of therapy in which physicians
use key agents.
Primary patient-level data: Quantitative findings
from our analysis of data covering 55 million lives from more than 80
geographically disperse U.S. HMOs:
- Quantified lines of therapy analysis showing exact share of each
agent in each line of therapy, including rate of progression between lines and
length of time patients are on each line.
- Progression flowcharts through one year of treatment for newly
diagnosed patients receiving each of the following first-line agents: Actonel,
oral Boniva, etidronate, Fosamax, intravenous Boniva, pamidronate, Zometa,
Evista, HRT, nasal Fortical, nasal Miacalcin, injected calcitonins, and Forteo.
- Flowcharts tracking the preceding therapy patterns for patients
taking each of the following key therapies: Actonel, oral Boniva, etidronate,
Fosamax, intravenous Boniva, Zometa, Evista, nasal Fortical, nasal Miacalcin,
and Forteo.
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