Introduction:
The approval of Pfizer’s Lyrica (pregabalin, the first
agent approved for fibromyalgia in June 2007), and subsequent approvals of Eli
Lilly’s Cymbalta (duloxetine, one year later) and Forest Laboratories/Cypress
Bioscience’s Savella (milnacipran, in January 2009), has transformed the U.S. fibromyalgia
market over the last few years—driving increases in awareness and acceptance of
fibromyalgia among physicians and patients. With FDA approval for fibromyalgia,
Lyrica and Cymbalta (and more recently, Savella) have been able to
differentiate themselves in a crowded market that had been exclusively defined
by off-label use of generically available therapies (e.g., amitriptyline,
tramadol, NSAIDs). Fibromyalgia treatment is increasingly involving nonspecialists,
whose prescribing decisions are influenced by regulatory approval. Indeed, surveyed
physicians project increased use of these more-expensive, branded drugs for the
treatment of fibromyalgia by 2011.
This report uses insight from 151 U.S. rheumatologists and
PCPs to determine the role each physician type plays in diagnosing and treating
this condition, their preferred treatment choices for common comorbid
conditions, and how fibromyalgia treatment is likely to change over the next
two years with the recent launch of Savella and the expected approval of Jazz
Pharmaceuticals’ sodium oxybate (JZP-6) in 2010. Our primary research also
shows which drug attributes are most important to physicians in first-line
treatment and compares how several key fibromyalgia agents perform on each of
these attributes versus one another, thus making this report a critical asset
for any brand team looking to enter the fibromyalgia market or optimize their
drug’s positioning within this market. Our survey results are coupled
with an analysis of patient-level claims data for the 4-digit ICD-9 code 729.1
(myalgia and myositis not otherwise specified [NOS], which includes
fibromyalgia. Patients newly diagnosed with a claim for 729.1 between April
2007 and September 2007 (during the time period when the first agent Lyrica was
approved for fibromyalgia) were followed for 360 days to determine the share of
each currently marketed drug by line of therapy and identify the rate of
patient flow from one line of treatment to the next in newly diagnosed
patients. We also analyze the previous treatment history for all patients
starting treatment with leading fibromyalgia agents
between July 2008 and September 2008 (one year following Lyrica’s approval for
fibromyalgia and immediately following Cymbalta’s) to determine what drugs are
used directly before these key agents, how long patients stay on their previous
line of treatment before starting each therapy, and how are these key agents
used (as monotherapy or in combination with the previous therapy).
Questions Answered in This Report:
*
Lines of therapy: Antidepressants and antiepileptics are
the dominant drug classes in fibromyalgia and boast the only agents approved
for this condition (i.e., Lyrica, Cymbalta, and Savella); however, no single
agent commands the majority of physicians’ first-line use.
What does
combination treatment look like in newly diagnosed patients, and how long does
it take for these patients to move to a new line? Which drugs and drug classes dominate first-line treatment, according
to claims data? Which drugs are prescribed first-line for fibromyalgia patients
with common comorbid conditions (e.g., fatigue)? What percentages of surveyed
physicians’ prescriptions for branded, FDA-approved agents are in each line of
therapy?
*
Pathways to key therapies: Lyrica and Cymbalta were the
first two agents approved for fibromyalgia and had only recently been approved
for this condition at the time of our patient-level claims data collection
period.
How are Lyrica and Cymbalta positioned relative to each other in
lines of therapy? What agents precede Lyrica’s or Cymbalta’s use, and
are agents discontinued in favor of Lyrica or Cymbalta or used in combination
with these agents? How long does it take a patient to move through preceding
therapy to Lyrica or Cymbalta? Are patients more likely to switch from Cymbalta
to Lyrica, or vise versa? How often are these agents prescribed in combination
with each other? When do physicians turn to other key fibromyalgia agents
(e.g., amitriptyline, tramadol), and how could these agents’ use limit uptake
of fibromyalgia-approved therapies?
*
Physician behavior: Since the approval of the first agents
for fibromyalgia, this condition is increasingly being diagnosed and treated in
the primary care setting. Our survey data indicate that rheumatologists and
PCPs show slight differences in their prescribing patterns for fibromyalgia.
What role do PCPs play in the diagnosis and
treatment of fibromyalgia? How do rheumatologists and PCPs differ in their prescriptions
of branded, fibromyalgia-approved agents versus generic alternatives? What key
drugs do physicians use to treat comorbid conditions associated with fibromyalgia
(e.g., fatigue, depression, insomnia), and how does this differ depending on
the physician subset? What factors drive each specialty when making drug
choices? How do Lyrica, Cymbalta, and Savella perform on the attributes
evaluated most highly by surveyed rheumatologists and PCPs when considering a
first-line therapy for fibromyalgia?
*
Forecast: Many surveyed rheumatologists and PCPs predict
they will increase their use of fibromyalgia-approved therapies (i.e., Lyrica,
Cymbalta, Savella) by 2011.
Which specific therapies are surveyed physicians
most likely to increase their prescribing of between now and 2011, and how will
rheumatologists and PCPs use these agents by line of
therapy over the next two years? How will they integrate the recently launched Savella
and emerging therapies sodium oxybate (JZP-6) and tapentadol ER (Nucynta ER, expected
to launch for chronic pain and achieve some off-label use in fibromyalgia) into
their treatment of fibromyalgia; what agents will they replace? According to
surveyed physicians, what other changes in medical practice are most likely to influence
future patient share and market dynamics?Scope:
Primary research: Quantitative results from our
survey of 151 physicians (75 rheumatologists and 76 PCPs):
- Physician opinion on how drug use differs by presence of comorbid
conditions (e.g., fatigue, insomnia).
- 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 61 million lives from 98 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 cases of ICD-9 code 729.1 (myalgia and myositis NOS, which includes
fibromyalgia) patients receiving each of the following first line agents: Lyrica,
gabapentin, other antiepileptics, Cymbalta, amitriptyline, other tricyclic
agents, modified cyclics, Effexor XR, venlafaxine IR, SSRIs, tramadol,
tramadol/acetaminophen, cyclobenzaprine, tizanidine, NSAIDs, Celebrex, hydrocodone/acetaminophen,
oxycodone CR and acetaminophen FDC, other opioid analgesics, zolpidem IR,
Ambien CR, Lunesta, other sedative hypnotics, dopamine agonists.
- Flowcharts tracking the preceding therapy patterns for 729.1 patients
taking each of the following key therapies: Lyrica, gabapentin, Cymbalta,
amitriptyline, cyclobenzaprine, and tramadol.