Approval for One Neuropathic Pain Indication is Sufficient to Support Physician Prescribing and Payer Reimbursement Across Multiple Neuropathic Pain Populations

BURLINGTON, Mass., May 28, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that expanded labeling for additional neuropathic pain (NP) populations and/or broader NP labeling (peripheral NP) will not ensure increased physician prescribing or improved formulary coverage. Instead, survey findings reveal that primary care physicians, pain specialists and neurologists are comfortable prescribing NP therapies to an array of NP populations for which the agents are not specifically labeled, and the majority of surveyed managed care organization (MCO) directors will reimburse these therapies for any form of NP, at the physician's discretion.

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"Most surveyed payers recognize the difficulty in treating NP and agree that reimbursement for NP will be less restrictive than reimbursement for other forms of chronic pain," said Decision Resources Principal Business Insights Analyst Andrea Buurma. "However, newer agents like Depomed's Gralise and XenoPort's Horizant face more restrictive coverage on surveyed payers' commercial plans and Medicare prescription drug plans, likely because these agents' parent molecule, gabapentin, is available generically and has widespread, favorable formulary coverage."

The U.S. Physician & Payer Forum report entitled Neuropathic Pain: U.S. Payer and Prescriber Attitudes Toward Recently Approved and Emerging Therapies—Implications for Market Access finds that safety and/or tolerability advantages could positively influence formulary decisions owing to subsequent improvements in patient quality of life, thus offsetting downstream healthcare costs. However, emerging therapies that are reformulations of already-available molecules—and offer limited advantages beyond improved delivery—will likely face significant market access hurdles, particularly if priced at a premium to their parent molecules. Indeed, MCOs have largely excluded, unfavorably tiered, or attached prior authorization and/or step therapy protocols to Gralise and Horizant, gabapentin reformulations that offer less frequent dosing than generic gabapentin.

The findings also reveal that the ability of Janssen's Nucynta ER to reduce pain intensity is the primary factor driving its use for NP among surveyed physicians who currently prescribe or plan to prescribe the drug. Furthermore, although Nucynta ER is approved for only one NP indication—painful diabetic neuropathy—many surveyed physicians report that they prescribe or will prescribe the drug to patients with other forms of NP, such as neuropathic back pain. However, Nucynta ER is and will be largely reserved as a second-line or later therapy, likely resulting from its Schedule II status; the entrenchment of early-line therapies such as gabapentin, Pfizer's Lyrica and Eli Lilly's Cymbalta; and step therapy and prior authorization requirements instituted by surveyed MCO directors.

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SOURCE Decision Resources