 Treatment Algorithms --
April 2008
 In This Issue...
Introduction:
Benign prostatic hyperplasia (BPH) is a common problem in
men older than age 50. The disease is characterized by an enlarged prostate,
symptoms associated with the ease and frequency of urination, and a general
decline in quality of life. BPH, a highly prevalent disease, affected nearly 20
million men in the United States in 2006. However, the disease is significantly
underdiagnosed; approximately 25% of U.S. patients with the disease are correctly
identified by physicians. Two drug classes dominate the BPH therapy market—alpha
blockers and 5-alpha-reductase inhibitors (5-ARIs)—with a third class,
anticholinergics, growing in popularity as physicians treat beyond the prostate
to reduce urinary symptoms. Boehringer Ingelheim’s alpha blocker, Flomax
(tamsulosin), currently dominates the BPH market, but it faces upcoming patent
expiry. Surveyed physicians say that their use of tamsulosin will change once
patent expiry occurs, and this event will be particularly acute for several
major brands. 5-ARIs, such as GlaxoSmithKline/Astella’s Avodart (dutasteride)
and finasteride (Merck’s Proscar, generics), effectively shrink the prostate
and may see some increased future use. An increasing prevalent population due
to age-related demographic changes, increasing diagnosis and drug-treatment
rates, and the need for therapies with improved efficacy and side-effect
profiles continues to encourage drug developers to find new treatment options
for BPH.
Questions Answered in This Report:
- Lines of therapy: While BPH treatment guidelines recommend
a "watchful waiting" strategy for mild BPH patients and moderate BPH
patients with less bothersome symptoms, most physicians turn to alpha blockers
(in particular Flomax) to quickly and effectively relieve lower urinary tract
symptoms (LUTS) for BPH patients. How much early-line patient share is
devoted to alpha blockers? In which lines of treatment do the 5-ARIs dominate?
In which lines of therapy do physicians turn to anticholinergics as a BPH
therapy? How do patient shares for branded agents compare with those of generically
available in-class agents?
- Pathways to key therapies: The alpha blockers
Flomax and Sanofi-Aventis’s Uroxatral (alfuzosin) are the market leaders for
BPH treatment in newly diagnosed patients because of their high selectivity for
prostate tissue. What drugs are used immediately prior to these class-leading
agents, and how long does it take patients to switch to them? How much in-class
switching occurs within the alpha blocker and 5-ARI drug classes? How many
patients fail to find effective LUTS relief through these leading alpha
blockers, necessitating progression to 5-ARI treatment for prostate
enlargement? How much adjunctive 5-ARI or anticholinergic use takes place with Flomax
compared with Uroxatral?
- Physician behavior: While mild patients are treated by primary
care physicians (PCPs), moderate patients are treated by urologists, who
exhibit a wider variety of alpha blocker and 5-ARI use. How do urologists
and PCPs differ in their prescriptions of Flomax and Uroxatral? How do
urologists and PCPs differ in their prescriptions of Avodart and finasteride?
What factors drive each specialty when making drug choices? Do physicians
change doses before switching or adding a therapy? What attributes of leading
alpha blockers and 5-ARIs drive physicians to choose one agent over other
possible drugs?
- Forecast: Surveyed urologists and PCPs indicate that their
use of generic tamsulosin will increase in two years when the drug loses patent
protection, as will their use of alpha
blockers and 5-ARIs in combination, while urologists also indicate that their
use of anticholinergics will change over the next two years. Are physicians
aware of the emerging therapies silodosin, marketed as Kissei/Daiichi Sankyo’s
Urief in Japan, and the Flomax/Avodart fixed-dose combination? How will
physicians change their use of 5-phosphodiesterase inhibitors in BPH treatment
as Eli Lilly’s Cialis (tadalafil) approaches approval for BPH? Will the trend
of increasing anticholinergic use continue? What agents will be replaced by
generic tamsulosin?
Includes:
Primary research: Quantitative results from our
survey of 154 physicians (79 PCPs and 75 urologists):
- 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
diverse U.S. health plans:
- 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: Flomax,
Uroxatral, doxazosin, terazosin, prazosin, Avodart, finasteride, Detrol,
oxybutynin, Sanctura, Enablex, and Vesicare.
- Flowcharts tracking the therapy patterns of patients prior to
taking each of the following key therapies: Flomax, Uroxatral, doxazosin,
terazosin, prazosin, Avodart, and finasteride.
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