Osteoarthritis (OA) and Chronic Low Back Pain (CLBP) are two of the most common chronic pain conditions worldwide. Both conditions are associated with substantial humanistic and socioeconomic burdens (Bindawas et al., 2015; Farr et al., 2013; Gore et al., 2012; Gore et al., 2011; Ma et al., 2014). Pharmacologic therapy for OA and CLBP often includes non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, typically in a step-up approach (McAlindon et al., 2014; Qaseem et al., 2017).
There is an unmet need for novel, nonopioid treatments for the management of chronic pain conditions because available therapies often have limited effect or work for only some patients (Kissin, 2010). In addition, there are major risks associated with NSAIDS and opioids that limit their usefulness, particularly for patients with comorbidities who are not appropriate candidates for NSAID and/or opioid treatment (Aronson, 2009).
Patient preferences for pharmacologic treatments for chronic OA pain and CLBP have been formally measured; however, existing studies are limited in their ability to provide results that can inform the benefit-risk tradeoffs that patients are willing to make among NSAIDs, opioids, and the long-acting injectable treatments currently being investigated.
Pfizer and Lilly are collaborating on the development of tanezumab, a novel treatment for chronic pain. Tanezumab, a nonopioid analgesic administered subcutaneously every 8 weeks, is being investigated in difficult-to-treat patients with moderate-to-severe pain due to knee and hip OA or CLBP who have taken or tried three or more classes of pain treatment in the past 2 years, for whom NSAIDs are contraindicated, or who are intolerant of NSAIDs or unwilling to take opioids.
To quantify patients’ perspectives of the value of tanezumab compared with other products, Pfizer and Lilly were interested in conducting a DCE in patients with OA only, CLBP only, and concurrent OA and CLBP in the US. Specifically, Pfizer and Lilly hoped to quantify patient preferences for the characteristics of tanezumab relative to those of NSAIDs, opioids, and other NGF-inhibitor products. Separate preference studies were conducted in the US and UK using the same survey instrument. This report contains only the US results because of the limited generalizability of preference data and different data-collection periods across the regions (i.e., UK study was fielded later).
|Therapeutic area||Chronic pain|
|Study led by||Pfizer
|PREFER leads team||Leo Russo
|MPLC decision point of interest||Pre-approval and late development|
|PREFER case study acromym||Pfizer-Lily|
|Clinical objectives||Quantify patient preferences for pharmaceutical treatments for chronic moderate-to-severe musculoskeletal pain associated with osteoarthritis (OA) and chronic low back pain (CLBP).
Understand patients’ preferences for, and potential trade-offs among, treatment attributes that are most relevant to them and that correspond to existing and future treatment options
|Patients from||Patients recruited from US and UK online panels maintained by a company called Dynata.
Panel members are recruited via partnerships with trusted loyalty programs, as well as through banner ads, pop-ups and messages on websites, television
|Methods in Qualitative study||Focus groups|
|Methods in Quantitative study||
Discrete Choice Experiment (DCE)
|End-date qualitative data collection||US data collection: 7 December 2017
UK data collection: TBC
|End-date quantitative data collection||US data collection: 20 March 2019
UK data collection: TBC
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