In 2012, painful diabetic neuropathy (PDN) affected more than 7.4 million people in the major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan); due to an aging population and increases in obesity and type 2 diabetes, this market is expected to grow to more than 9.5 million by 2022. In addition to offering a rather large treatable patient population, PDN has and will continue to serve as a gateway indication into the broader, more-lucrative neuropathic pain (NP) market. No available therapies for PDN, and NP in general, can fully alleviate patients’ pain; interviewed experts report that, despite the availability of a large array of therapies from multiple drug classes, physicians are at best able to achieve 50% pain relief in 50% of their PDN patients with any single therapy. The limited efficacy and tolerability of currently available therapies translate into a high level of unmet need and potential opportunity for novel agents. However, emerging pain therapies will enter a market that contains many well-established, relatively inexpensive early-line therapies and will encounter a growing generics presence. As a result, emerging therapies attempting to attain premium pricing in this market will need to offer substantial improvements in efficacy, safety, and/or delivery over currently available therapies to achieve commercial success.
Attributes included in conjoint analysis-based assessment of target product profiles for PDN:
- Reduction in 11-point pain intensity score.
- Percentage of patients achieving ≥ 50% reduction in pain intensity score.
- Percentage of patients reporting “much improved” or “very much improved” on the Patient Global Impression of Change (PGIC) scale.
- Incidence of weight gain; percentage of patients reporting a gain of 7% or more over baseline.
- Dosing frequency.
- Dosage formulation.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for PDN:
- Patient responder rate (percentage of patients achieving a ≥ 50% reduction in pain).
- Effect on global outcomes (percentage of patients reporting “much improved” or “very much improved” on the PGIC scale).
- Delivery characteristics.
- Average weight change (pounds [lbs] lost or gained).
Physicians surveyed: 62 U.S. and 30 European neurologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Pregabalin (Pfizer’s Lyrica)
- Gabapentin (Pfizer’s Neurontin, generics)
- Duloxetine (Eli Lilly/Shionogi’s Cymbalta/Xeristar, generics)
- 5% lidocaine patch (Endo’s Lidoderm, Grünenthal’s Versatis, generics)
- Tapentadol ER (Janssen’s Nucynta ER, Grünenthal’s Palexia SR)
- Pregabalin CR (Pfizer)
- Capsaicin topical solution (Acorda Therapeutics’ NP-1998)
- Clonidine topical gel (BioDelivery Sciences)
- XEN-402 (topical) (Teva/Xenon)
- Eslicarbazepine acetate (Bial)