Pharmaceutical and biologic therapies are increasingly demonstrating their effectiveness in the treatment of multiple diseases. As the trend of therapies being studied and demonstrating effectiveness across multiple indications accelerates, manufacturers are pursuing different approaches to realize the value provided to the healthcare system and enhance the return on R&D investments. This paper focuses on situations in which, for a single molecule being used to treat multiple conditions (with distinct unmet needs, disease burden, prevalence, and other attributes), there are significant differences in effectiveness, dosing, formulation, or route of administration (RoA). A dual-brand approach may be appropriate in these situations, but a careful review of the factors associated with dual brands reveals some insights and important considerations when evaluating whether a dual-brand approach is viable.
Perhaps the most notable examples of products that demonstrate effectiveness in multiple indications have been in the immunology area. Humira’s (adalimumab) initial approval with an indication to treat patients with rheumatoid arthritis in 2002 was followed by a succession of other indications, including (among others) Crohn’s Disease, moderate-to-severe plaque psoriasis, and ulcerative colitis.[1] Dupixent (dupilumab) provides another example of expansion across many indications, with its first approval in atopic dermatitis in 2017, and subsequent approvals for asthma and chronic rhinosinusitis, among others.[2]
Across most of the approved indications for both Humira and Dupixent, there were no significant differences in formulation, route of administration, and maintenance dosing. Both Humira and Dupixent have maintained a single brand approach with one list price and rebates based on the overall value across indications and payers’ willingness to pay. In these situations, dosing and formulation similarities across indications can limit the ability to offer dual brands to align price with value, since the ability to direct patients to the lower cost brand is more straightforward. While indication-based pricing can be applied in these situations to realize differential value across indications (e.g., differential rebates by indication, tracked through prior authorization), when there is limited differentiation in dosing, formulation, or route of administration, the challenges to dual brands are clear.
Recently, there has been a heightened focus on dual-brand approaches in which the same molecule is approved for multiple indications and packaged, priced, and distributed under different brand names. Public interest has centered on Novo Nordisk’s semaglutide, with its dual brands Ozempic[3] (type-2 diabetes) and Wegovy[4] (weight loss), both once-weekly, self-administered subcutaneous injections (a third brand of semaglutide, Rybelsus is an oral formulation, administered once daily). Ozempic and Wegovy are available with different dosage strengths (Ozempic in three strengths, Wegovy in five) and at different prices per pen and per unit. Ozempic’s monthly list package price is approximately $969 compared with Wegovy’s approximate $1,349.[5] Given relatively limited differences in dosage strengths and labeled dosing for the two brands, the price difference has led to many patients requesting, and providers prescribing, Ozempic for weight loss. In addition, many payers have applied utilization management through prior authorization criteria to limit Ozempic use to patients with type-2 diabetes, as they typically would not reimburse for weight-loss medications. Dual branding of semaglutide, with high-profile celebrity testimonials, has shone a light on dual-brand benefits and complications as patients attempt to minimize out-of-pocket costs. Recently, Eli Lilly received approval for its dual-brand medication Zepbound (tirzepatide injection), a once-weekly therapy for weight loss, following its 2022 approval as Mounjaro for treating type-2 diabetes.
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