LABA/ICS FDCs: Winners and Losers?
LABA/ICS FDC therapies are frequently used as maintenance treatment of asthma and COPD. In the United States, LABA/ICS FDCs comprise a lucrative market, worth more than $4 billion in sales in 2017.1 Four LABA/ICS FDC brands—GSK’s Advair (salmeterol/fluticasone propionate) and Breo (vilanterol/fluticasone furoate), AstraZeneca’s Symbicort (formoterol/budesonide), and Merck’s Dulera (formoterol/mometasone)—as well as two recently launched generic products, Teva’s branded-generic AirDuo (salmeterol/fluticasone propionate) and its authorized generic, are available in the United States and compete fiercely for their share of the market. (Here we define a branded-generic as an inhaled product that delivers genericized molecular components in a proprietary inhaler device).
Considering the intense rivalry between the LABA/ICS FDC agents, manufacturers of these therapies employ a variety of strategies to differentiate their products and appeal to stakeholders and, hopefully as a result, promote better uptake. For instance, the newest LABA/ICS FDC brand, Breo, contrasts itself from other members of the class with its more-convenient once-daily dosing. In another example, to expand the size of the targeted patient population, manufacturers of Advair Diskus (where Diskus designates the type of the device used to deliver salmeterol/fluticasone propionate into the lungs) and Symbicort secured FDA approval for pediatric asthmatics as young as four and six years of age, respectively. Some LABA/ICS FDC manufacturers are attracting the attention of physicians and patients alike by packaging their medicine into a well-designed device that is effective and easy to use. Physicians surveyed and interviewed by DRG tend to prefer the newer, more-advanced devices, such as GSK’s Ellipta—a dry-powder inhaler used to deliver Breo—compared with the older types of inhalers (e.g., Diskus and HFA, both used to deliver Advair).2 To further strengthen the competitive advantage of their device, some companies will chose to house several of their respiratory products in the same inhaler type, allowing for an easier transition between different drugs, when change in therapy is required. Finally, manufacturer rebates and discounts are a widely-used—and probably most-effective—way to compete in the crowded LABA/ICS FDC market, as payers typically do not differentiate the available LABA/ICS FDC therapies based on their clinical features and tend to give a preference to the most cost-effective agent(s) instead. As such, brands failing to provide sufficient discounts/rebates could be penalized with stricter controls, unfavorable tiering, or exclusion from formulary, making their prescribing more difficult for physicians. Indeed, a lower price is exactly what Teva bids on to drive uptake and sales of its salmeterol/fluticasone propionate generic, which entered a crowded market but offers an unmatched price discount (an approximate 70% markdown to available brands, based on the wholesale acquisition cost per package).3
To better understand how the above—and related—factors impact the current prescribing of marketed LABA/ICS FDCs in the United States, we sought to analyze the switching patterns between these therapies and to identify those that are gaining vs. those that are losing business to competitors. We examined pharmacy claims records from November 2017 to February 2018—sourced from DRG’s robust RWD repository—for patients treated with a LABA/ICS FDC in February 2018 who had switched from another LABA/ICS FDC at some point during the previous three months. For each agent in our analysis, we determined the net gain or loss in patients against other therapies in the LABA/ICS FDC class.
Our research shows that overall, despite a relatively low volume of patients treated with Teva’s new salmeterol/fluticasone propionate generic (approximately 1% of all LABA/ICS FDC-treated patients in February 2018), the agent is the ultimate winner in our switching analysis, gaining business from all other LABA/ICS FDC agents on the market. The generic’s low price, favorable tiering in some formularies4, and more-recent launch are driving its uptake at the expense of other branded LABA/ICS FDCs. Breo is another success story based on our analysis; the agent acquired business from all other FDCs in the class, with the exception of Teva’s generic. Breo’s uptake is likely fueled by its convenient once-daily formulation, superior Ellipta device, and aggressive marketing support from GSK.
Among the more surprising findings, Symbicort came out on top of its main competitor Advair, picking patients from both Advair Diskus and HFA, as well as patients previously treated with Dulera. Symbicort’s strong performance could be attributed to the fact that in 2018, the agent was added back to the formulary of one of the largest PBMs, CVS Caremark (it was excluded from the list of the preferred drugs in 2017).5, 6 Patients switching to Symbicort are possibly drawn to formoterol’s rapid onset of action and, as such, the ability to use the combination on as-needed basis. Although Symbicort is not approved for as-needed SMART dosing in the United States, some physicians interviewed by DRG report prescribing Symbicort for use as a rescue inhaler, as well as a maintenance therapy. Another factor contributing to Symbicort’s positive performance could be AstraZeneca’s willingness to sign outcomes-based contracts with regional payers, potentially easing market access hurdles for the agent.7
On the other—less-fortunate—side of the story is Advair Diskus, which lost business not only to Teva’s generic but also to almost all major brands, except for Dulera. The likely explanation for Advair’s subpar performance is the diminishing support from GSK, which, ahead of the anticipated launch of an AB-rated Advair generic, directed its efforts towards Breo, the company’s newer LABA/ICS FDC brand. As for Dulera, with Merck’s fading presence in the respiratory market, it is difficult for this older and undistinguished agent to compete with products marketed by such respiratory powerhouses as GSK and AstraZeneca. As a result, the agent lost business to all other marketed LABA/ICS FDC agents. Indeed, CVS Caremark excluded Dulera from its list of the preferred LABA/ICS FDC agents in 2018, likely prompting many Dulera patients to switch to the available alternatives.
The dynamic of the LABA/ICS FDC market could change soon, if an AB-rated Advair generic finally manages to secure FDA approval. The launch of an AB-rated generic is likely to have a negative impact on Advair sales, but its effect on other LABA/ICS FDC brands and on Teva’s generic is more difficult to predict and will largely depend on market access negotiations.
- https://www.gsk.com/media/4626/fy-2017-us-dollar-translation.pdf; https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2017/annualreport2017.pdf; http://investors.merck.com/news/press-release-details/2018/Merck-Announces-Fourth-Quarter-and-Full-Year-2017-Financial-Results/default.aspx.
- Please see DRG’s Asthma | Unmet Need | Special Topics: Devices (US): https://decisionresourcesgroup.com/report/407491-biopharma-special-topics-devices-us/
- Redbook Online, accessed on April 12, 2018.
AB-rated: substitutable (generic)
COPD: chronic obstructive pulmonary disease
DRG: Decision Resources Group
FDA: The Food and Drug Administration
LABA/ICS FDC: long-acting beta2 agonist/inhaled corticosteroid fixed-dose combination
RWD: real-world data
SMART: Symbicort maintenance and reliever therapy
U.S.: United States