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GfK Healthcare | April 2010 | |
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The Use and Strategies of Fixed-dose Combination Therapies  By Geoff Penney, Vice President, and Louise Gillis, Associate Vice PresidentFixed-dose combination therapies (FDCs) are an important treatment option across dozens of disease states including HIV, hypertension, diabetes and asthma/COPD. They represent an important convenience as relief from “pill burden,” particularly for the elderly patient. Physicians value the added degree of compliance and persistency, but as well the perceived synergistic efficacy that can support more aggressive treatment goals. In many therapy areas, even managed care organizations have come to embrace FDCs as both cost-effective and an important treatment option in helping to forestall disease progression and the greater expense of treatment. In response to a recent client request, GfK Healthcare’s syndicated group brought knowledge consultants in the hypertension, asthma and diabetes markets together with the all-important managed care perspective to explore the particular opportunities and challenges of using FDC therapies across several disease states. Some insights are presented here. FDCs have always been a natural line extension strategy. But in a world where generics now dominate and managed care wields unprecedented influence, how have MCOs reacted to FDCs? Managed care organizations appear gradually more accepting of fixed-dose combinations, according to GfK Healthcare’s experience. Importantly, MCOs have come to expect the generic component of the fixed-dose medication to be provided at essentially no cost to them. Success of FDCs in the managed care environment (a reasonable formulary position and associated co-pay amount) requires that the combination medication include a generic and branded medication. While MCOs lose generic co-pays with the FDC introduction, the lower relative cost of the fixed-dose combination therapy can mean cost savings. As well, MCOs recognize the value of FDCs in improved compliance, especially in disease states where the costs of non-compliance are significant – as in diabetes. It is advantageous that the generic component of the FDC be a best-in-class treatment. FDCs have always represented a key commercial life-cycle strategy, but in the diabetes market, Merck’s Janumet, metformin, has contributed to early life-cycle success with this FDC introduced within 18 months of the original brand Januvia. Janumet has exceptional blood sugar-lowering benefits that provide a solid foundation for building a viable combination therapy. Dosing flexibility (to manage symptom relief as well as provide titration options) can be a limitation for FDCs in certain markets. Our findings show specialists naturally prefer that degree of flexibility. At the same time, FDC dosing flexibility is possible in a wide range of varied combinations; Pfizer’s anti-hypertensive Caduet is available in 11 different dosing combinations. Importantly, the two medication components must provide real (or perceived) synergistic efficacy benefits. For example, in the treatment of hypertension, GfK Healthcare’s syndicated data show Novartis’ Exforge and Daiichi-Sankyo’s Azor are associated with “aggressive blood pressure control.” The strong position these two drugs enjoy is further strengthened by treatment guidelines that advocate a similar aggressive degree of symptom control. In the diabetes market, physicians rate Janumet better than Januvia in “improved glycemic control.” Similar to hypertension, Janumet’s position is bolstered by treatment guidelines that advocate “aggressive blood sugar control” (although these guidelines more recently have come under some debate.) While GfK Healthcare’s syndicated data clearly show that among the three markets explored most FDCs find success as a second- or third-line therapy option, the asthma market is unique. GlaxoSmithKline’s blockbuster asthma product Advair is often reported as first-line controller therapy for moderate-to-severe asthma. Advair clearly benefits from certain unique market dynamics: Drug delivery via inhalers makes FDCs particularly beneficial, as well as two best-in-class drug components and a therapy that aligns well with the asthma treatment paradigm. In summary, generic competition is challenging in most, if not all major markets. Generics offer not only a lower cost alternative, but often provide best-in-class symptom relief. Given the right brand and market elements described here, a brand life-cycle management plan should include an evaluation of an FDC market introduction sooner in the product life-cycle than the traditional line-extension strategy. The advantage of this approach is the production of much needed incremental revenue in an earlier timeframe. In addition, an early introduction should allow for a legitimate MCO partnership that aligns the FDC strategy with appropriate unmet market needs and avoids MCO skepticism and challenges, which commonly accompany a late life-cycle FDC approach. Want to learn more on this topic? Please contact:   |