Abstract
Purpose
Pharmaceutical formulation and treatment process attributes, such as dose frequency and route of administration, can have an impact on quality of life, treatment adherence, and disease outcomes. The aim of this literature review was to examine studies on preferences for pharmaceutical treatment process attributes, focusing on research in diabetes, oncology, osteoporosis, and autoimmune disorders.
Methods
The literature search focused on identifying studies reporting preferences for attributes of the pharmaceutical treatment process. Studies were required to use formal quantitative preference assessment methods, such as utility valuation, conjoint analysis, or contingent valuation. Searches were conducted using Medline, EMBASE, Cochrane Library, Health Economic Evaluation Database, and National Health Service Economic Evaluation Database (January 1993–October 2013).
Results
A total of 42 studies met inclusion criteria: 19 diabetes, nine oncology, five osteoporosis, and nine autoimmune. Across these conditions, treatments associated with shorter treatment duration, less frequent administration, greater flexibility, and less invasive routes of administration were preferred over more burdensome or complex treatments. While efficacy and safety often had greater relative importance than treatment process, treatment process also had a quantifiable impact on preference. In some instances, particularly in diabetes and autoimmune disorders, treatment process attributes had greater relative importance than some or all efficacy and safety attributes. Some studies suggested that relative importance of treatment process depends on disease (eg, acute vs chronic) and patient (eg, injection experience) characteristics.
Conclusion
Despite heterogeneity in study methods and design, some general patterns of preference clearly emerged. Overall, the results of this review suggest that treatment process has a quantifiable impact on preference and willingness to pay for treatment, even in many situations where safety and efficacy were the primary concerns. Patient preferences for treatment process attributes can inform drug development decisions to better meet the needs of patients and deliver improved outcomes.
Supplementary materials
Search terms
The following search terms related to treatment process were applied to article titles and abstracts:
Route of administration: oral, pill, tablet, capsule, chewable, delayed-release, delayed release, sustained-release, sustained release, effervescent, granules, orodispersible, dissolvable, solution, suspension, parenteral, injection, subcutaneous, intramuscular, intravenous, intrathecal, depot, implant, infusion, transmucosal, buccal, nasal, ocular, transdermal, patch, microneedle, microporation, topical, cream, ointment, gel, spray, powder, rectal, vaginal, inhaled, inhaler, pump, intraperitoneal, mode of administration, delivery method, delivery system, drug administration route, drug administration routes, treatment modalities.
Dose frequency: dose, dosing.
Dose timing: food, meal.
Dose size: dosage.
Convenience: convenience, inconvenience.
Other process attributes: onset of action, dietary restriction, laboratory tests, monitoring, taste, sitting upright, treatment attributes, and process attributes.
Acknowledgments
Funding for this study was provided by Eli Lilly and Company, Indianapolis, IN, USA. The authors thank Katherine Kim for assistance with data extraction, Clarice P Hayes for assistance with study design, and Amara Tiebout for production assistance.
Disclosure
The study was funded by Eli Lilly and Company (Indianapolis, IN, USA). Four of the authors are employed by the sponsor: Joseph A Johnston, Sarah E Curtis, Henry A Havel, and Stephanie A Sweetana. Three of the authors are employed by Evidera, a company that received support from Eli Lilly and Company for time spent conducting this study: Katie D Stewart, Louis S Matza, and Heather L Gelhorn. A preliminary version of the abstract of this paper was presented at the ISOQOL 22nd Annual Conference, October 21–24, 2015 in Vancouver, BC, Canada, as a poster presentation with interim findings. The actual paper, however, has never been published. The authors report no other conflicts of interest in this work.