U.S. Physician and Payer Forum

July 2013

Chronic Pain: How Will U.S. Payers and Prescribers Shape Market Access for Recently Launched and Emerging Products?

Report Authors
Natalie Taylor, Ph.D.

Introduction:

Although the 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.

Key products in the chronic pain market include the following:

- Janssen 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.

- AstraZeneca/Pozen's 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.

In this 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?

  *   How have/will 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?

Scope:

Markets covered: United States.

Primary research: 70 PCPs, 71 pain specialists, 30 MCO pharmacy/medical directors.

Epidemiology: 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.

Population 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.


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