chronic pain market is largely saturated with reformulations of
well-established molecules, developers continue to pursue products that have
potential to fulfill the remaining unmet clinical need for analgesics that are
well tolerated and can safely and effectively control pain over a long period
of time. Historically, U.S. PCPs and pain specialists routinely prescribed
strong opioid analgesics such as hydrocodone/acetaminophen (AbbVie’s Vicodin,
generics) or controlled-release oxycodone (Purdue Pharma’s OxyContin) for the
treatment of moderate to severe chronic noncancer pain. However, the use of
opioids for the long-term management of chronic noncancer pain may decline as a
result of increased public awareness of the prescription opioid abuse epidemic
and the FDA’s introduction of the class-wide Risk Evaluation and Mitigation
Strategy program in March 2013 for extended-release and long-acting opioid
products. Unfortunately, the late-stage chronic pain pipeline is composed
largely of reformulations of already-available molecules and features few
agents that are truly novel. With the availability of multiple generic
analgesic options, and with several key chronic pain therapies facing an end to
their U.S. market exclusivity in the near term, factors driving treatment and
reimbursement decisions in the United States are certain to change.
in the chronic pain market include the following:
Pharmaceuticals’ dual-acting opioid analgesic Nucynta ER (tapentadol ER), a
mu-opioid receptor agonist and norepinephrine reuptake inhibitor that became
available in 2011 for the management of moderate to severe chronic pain in
adults when an around-the-clock opioid is needed for an extended period of time
and was subsequently approved (in August 2012) for painful diabetic neuropathy,
making it the first and only opioid approved for a neuropathic pain indication.
Vimovo (naproxen/esomeprazole), a fixed-dose combination tablet containing the
NSAID naproxen and the proton pump inhibitor esomeprazole that became available
in 2009. Vimovo is indicated for the relief of the signs and symptoms of
osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to
decrease the risk of developing gastric ulcers in patients at risk of
developing NSAID-associated gastric ulcers.
- Purdue’s BuTrans
(buprenorphine transdermal patch), a seven-day transdermal patch delivering 5,
10, or 20 mcg/hr buprenorphine that became available in 2011 for the management
of moderate to severe chronic pain in adults when a continuous,
around-the-clock opioid is needed for an extended period of time.
report, we explore the use, reception, and formulary status of these key
current and recently approved chronic pain therapies across multiple chronic
pain populations in a survey of 70 primary care physicians (PCPs), 71 pain
specialists, and 30 managed care organization directors. We also gauge payer
and physician outlook toward four late-stage emerging therapies: Pfizer’s
Remoxy, Pfizer’s tanezumab, Zogenix’s Zohydro, and BioDelivery Biosciences’
BEMA buprenorphine. By understanding the attitudes and expectations of
prescribers and payers toward current, recently approved, and emerging chronic
pain therapies, stakeholders can gain an understanding of the treatment
paradigm and changing reimbursement climate for chronic pain.
Questions Answered in This Report:
How does use of
select chronic pain drugs vary based on physician type and patient population
treated? What factors are primarily impacting physicians’ treatment decisions
and MCO directors’ coverage decisions?
What is the
current state of reimbursement for key chronic pain therapies? How has the
replacement of OxyContin and Opana ER with abuse-deterrent formulations
affected prescribing and reimbursement? How do physicians and payers perceive
the value of an FDA-approved labeling claim of abuse-deterrence?
physicians incorporate Nucynta ER, Vimovo, and BuTrans into clinical practice?
How has/will MCO reimbursement constraints, including tiering and formulary
restrictions, impact uptake?
How do physicians
expect to incorporate emerging agents (Remoxy, tanezumab, Zohydro, and BEMA
buprenorphine) into clinical practice? What restrictions will MCO directors
impose? What does physician and payer receptivity to these emerging therapies
imply for drug developers hoping to enter the chronic pain space?
70 PCPs, 71 pain specialists, 30 MCO pharmacy/medical directors.
2011, 2016, and 2021 prevalent cases of the following chronic pain populations
are presented: cancer pain, chronic low back pain, fibromyalgia, chronic daily
headache, chronic migraine, osteoarthritic pain, rheumatoid arthritis pain, and
painful diabetic neuropathy.
segments: Where appropriate, our data and analyses are segmented by the
following chronic pain populations: cancer pain, chronic low back pain,
fibromyalgia, chronic daily headache, chronic migraine, osteoarthritic pain,
rheumatoid arthritis pain, painful diabetic neuropathy, and postherpetic neuralgia.