 Treatment Algorithms --
August 2008
 In This Issue...
Introduction:
Through mid 2007, the type 2 diabetes market seemed fairly
impenetrable for most new brands. Generic metformin and sulfonylureas had
locked up early-line treatment, and the PPAR-gamma agonists were very strong
second- and third-line brands. Merck’s Januvia (sitagliptin), Amylin/Eli
Lilly’s Byetta (exenatide), and other new entrants were left to vie primarily
for third- and later-line use. However, the publication of the Nissen report in
May 2007 outlining the cardiovascular risk associated with GlaxoSmithKline’s
Avandia (rosiglitazone) is changing the market’s dynamics. Avandia and Takeda’s
Actos (pioglitazone) now have black box warnings, and Byetta and Januvia are
being seen in a more favorable light.
In this year’s report, we compare patient-level claims data
from before and after publication of the Nissen report to identify the shifts
in physician prescribing by line of therapy. With these unique data, we can
quantify the shift in Avandia (and Actos)’s patient share within the treatment
paradigm and show which brands have filled the void. Not only have Januvia and
Byetta campaigned for switching patients, but new ADA guidelines pushing early
insulin use have brought Lantus and Levemir into competition for second-line
patient share. Coupled with our survey of 151 specialists and PCPs to determine
why key drugs are chosen over others, this report is critical for any brand
team looking to take advantage of the competitive openings the decline in the
use of PPAR-gamma agonists has created.
Includes:
Primary research:
Quantitative results from our survey of 151 physicians (76 endocrinologists and
75 PCPs):
- Physician opinions of how the use of the various drug classes
differs.
- The drug attributes that influence physicians the most when they are
choosing between agents.
- Anticipated changes in which of the different “lines” of therapy
physicians use key agents.
Primary patient-level data:
Quantitative findings from our analysis of data covering 55 million lives from
more than 80 geographically dispersed U.S. HMOs:
- Quantified "lines-of-therapy" analyses 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: metformin,
metformin ER, sulfonylureas, Avandia, Actos, Januvia, Byetta, Amylin
Pharmaceuticals’ Symlin (pramlintide), GlaxoSmithKline’s Avandaryl
(rosiglitazone/glimepiride), Takeda’s Actoplus Met (metformin/pioglitazone), Bristol-Myers
Squibb’s Metaglip (metformin/glipizide), glyburide-metformin FDC, GlaxoSmithKline’s
Avandamet (metformin plus rosiglitazone), Merck’s Janumet (metformin plus
sitagliptin), Takeda’s Duetact (glimepiride plus pioglitazone), Novartis’s
Starlix (nateglinide), Novo Nordisk’s Prandin (repaglinide), Sanofi-Aventis’s
Lantus (insulin glargine), rapid-acting insulin, short-acting insulin, intermediate-acting
insulin, and mixed insulin.
- Flowcharts tracking the preceding therapy patterns for patients
taking each of the following key therapies: Avandia, Actos, Starlix, Prandin,
Januvia, Byetta, Lantus, Novo Nordisk’s Levemir (insulin detemir), glyburide-metformin
FDC, Avandamet, Actoplus Met, Avandaryl, Janumet, and Duetact.
Questions Answered in This Report:
- Lines of therapy: Metformin is the dominant first-line
therapy because physicians believe it offers an optimal combination of
efficacy, low cost, and tolerability, as well as a low risk for weight gain and
hypoglycemia. Branded agents are vying for a limited share of first-line
prescriptions and are competing intensely for a share of second- and third-line
treatment. Which branded drug captures the greatest first-line patient
share? How much headway has Januvia made in second- and third-line therapy?
Where in the treatment algorithm is the injectable therapy, Byetta, receiving
most use? How does the share of fixed-dose combinations (FDCs) change through
the lines of therapy?
- Pathway to key therapies: When first-line therapy is not
effective in bringing patients’ glucose to target levels, patients often add,
or switch to, PPAR-gamma agonists (i.e., Actos or Avandia), FDCs, or insulin
(e.g., Sanofi-Aventis’s Lantus [insulin glargine]). How long does a patient
receive a previous pharmacological therapy before progressing to one of these
key therapies? What percentage of these agents’ total use comes as a first-line
therapy? How much of each FDC’s use is preceded by prescriptions of its
individual components versus other agents? Are Byetta and Lantus being added to
previous therapies or are previous therapies dropped in favor of these agents?
Which agents are physicians using before Byetta and Januvia?
- Physician behavior: Although type 2 diabetes is associated
with considerable comorbidity, nearly 70% of all diagnosed patients do not
receive any drug treatment within the first year. Why do physicians delay
prescribing pharmacological therapy to some patients diagnosed with type 2
diabetes? What are the key drug attributes that drive a physician to choose a
PPAR-gamma agonist such as Actos over metformin or a sulfonylurea? Why might a
physician select the relative newcomer, Januvia, over an established therapy
such as Actos? What do physicians perceive as the competitive advantages and
disadvantages of injectable Byetta when choosing between this drug and Lantus?
Do PCPs and endocrinologists agree on the key advantages of Januvia and Byetta,
or do these drugs need to be marketed differently to penetrate each segment?
- Forecast: Type 2 diabetes treatment is shifting toward
more aggressive use of polypharmacy and insulin in earlier lines of treatment.
Januvia and Byetta are expected to benefit from physicians’ desire to minimize
the risk of hypoglycemia and weight gain. As the use of Januvia and Byetta
grows, which agents stand to lose share over the next two years? How do
physicians anticipate their first- and second-line prescribing of the insulin
analogues Lantus and Novo Nordisk’s Levemir (insulin detemir) will change over
the next two years? How do physicians expect to prescribe emerging therapies (e.g.,
Eli Lilly/Alkermes/Amylin’s Byetta LAR, Novo Nordisk/Scios’s GLP-1 analogue
liraglutide, Takeda’s DPP-IV inhibitor alogliptin) in lines of therapy?
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