Key finding: After Lyrica loses market exclusivity in the United States (expected in late 2018), approximately half of surveyed pharmacy directors and medical directors (PDs/MDs) expect their managed care organizations (MCOs) will mandate generic substitution of Lyrica with generic pregabalin products. Also, at least one-fifth of surveyed MCO PDs/MDs expect that Lyrica will be moved to a less-favorable formulary tier or that utilization management controls could be used to encourage the use of generic pregabalin when it becomes available. Only a minority (13%) of respondents indicated that Lyrica would be removed from their formulary altogether once generic pregabalin launches.

 

The “so what” for strategists: The pending loss of U.S. market exclusivity of Lyrica is expected to negatively affect the coverage and prescribing of the branded product and of launching neuropathic pain therapies. Emerging neuropathic pain therapies may be subject to step therapy controls requiring treatment failure with generic pregabalin prior to coverage. Marketers should consider comparator studies against pregabalin or perform cost-benefit analyses in order to convince payers of a new drug’s benefits, or should be prepared to price their product competitively, offer copay assistance to patients, and/or offer rebates to payers.

 

What else are payers saying about emerging neuropathic pain treatments?

 

Key questions answered in the analysis:

  • What are the current drivers and barriers to prescribing neuropathic pain (NP) therapies in the United States, and how do cost and reimbursement pressures or clinical concerns restrict prescribing of current treatments for NP?
  • What formulary coverage do key NP therapies receive, and what approaches do payers employ to manage utilization and costs?
  • How are MCO PDs/MDs performing value assessments for therapies, and what are the preferred pharmacoeconomic models?
  • What will be the impact of Pfizer’s pregabalin CR on NP reimbursement dynamics, and how will the emergence of future generic pregabalin formulations impact formulary and prescribing decisions?
  • How will emerging therapies (e.g., Biogen’s BIIB-074) be reimbursed and prescribed in an increasingly genericized NP market?

 

Markets covered: United States

Methodology: Surveyed 50 primary care physicians, 25 pain specialists, and 25 neurologists in the United States and 30 U.S. managed care organization (MCO) pharmacy and medical directors (PDs/MDs).

Key drugs covered: Lyrica/Lyrica CR, Gralise, Horizant, Equetro, Nucynta ER, OxyContin, Qutenza, vixotrigine (BIIB-074)

Key companies mentioned: Acorda Therapeutics, Biogen, Depomed, Janssen, NeurogesX, Pfizer, Purdue Pharma, Validus Pharmaceuticals,  XenoPort

 

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