Lessons from the RA market (claims data analysis)

The second half of 2017 has seen FDA approvals of two intravenous (IV) therapies, i.e., BMS’s Orencia and Janssen’s Simponi Aria, for the treatment of psoriatic arthritis (PsA), providing more choices to rheumatologists and dermatologists who previously relied solely on Remicade when seeking IV options. While subcutaneous (SC) therapies are perceived as more convenient, with various mechanisms of action (MOAs) and, in some cases, with a lower risk of adverse events, subsidies for IV therapies and wide coverage by the Centers for Medicare & Medicaid Services has enabled their long-standing presence in the treatment paradigm for chronic diseases, including PsA and rheumatoid arthritis (RA). Even though they have been available for PsA for a short time, rheumatologists already have many years of experience with Orencia (over ten years) and Simponi Aria (over three years) in RA patients. Furthermore, off-label use of these agents in PsA patients was previously not uncommon.

With the new FDA approvals, rheumatologists are finally at ease in prescribing Orencia and Simponi Aria to their PsA patients. But will the additional IV therapies increase the market share of IV therapies? To answer this question, we can look to the RA market where multiple IV therapies have launched in the past two decades. Before 2014, Orencia, Actemra, Remicade, and Rituxan had been available in the RA market for more than 5 years and captured most of the RA patients who were eligible for an IV therapy. Between 2014 and 2016, the new entrant, Simponi Aria, gained patient share at a moderate speed, but the share of all the IV agents in the U.S. RA market in 2016Q3 was no different from 2013Q4 (CARG = 0), indicating that availability of a fifth IV agent did not persuade physicians to prescribe more IV RA therapies. However, the impact of a fifth IV agent on the RA market is arguably much lower than that of a second and third IV agent on today’s PsA market, and access to Orencia and Simponi Aria may markedly increase the share of the IV agents in the PsA market. But the market dynamic has to follow the rule of supply and demand. If Remicade, with its over two decades of market presence, is already being used by all of the IV-desiring PsA patients, Orencia and Simponi Aria can only gain market share at Remicade’s expense. Nonetheless, a small window exists for the new IV entrants to take share away from the SC market, as they could win over Remicade-intolerant patients by leveraging superior safety profiles.

Both Remicade and Simponi Aria are developed and marketed by Janssen; the two although differ by recombinant technology essentially target the same cytokine, tumor necrosis factor-alpha (TNF-alpha), making it less challenging to convince physicians switching therapies. It makes sense for Janssen to shift commercial focus from Remicade to Simponi Aria, as the key patent of the former therapy expired in 2015, to avoid declining sales due to biosimilar erosion. Indeed, it is not surprising to see that the combined patient share of Remicade and Simponi Aria in the RA market is fairly constant between 2013Q4 and 2016Q3. A successful switch strategy in the RA market foresees a similar approach likely shaping the PsA market right now.

With regard to Orencia’s potential in the PsA market, one may have to evaluate its SC and IV formulations separately. As discussed previously, the IV formulation is used by a relatively stable population, and Orencia-IV can stand out with its alternative MOA and its better safety profile than the TNF inhibitors. As for Orencia-SC, which was approved for PsA at the same time as the IV formulation, even though it features an alternative MOA, it barely has had any chance to be preferred over the market-leading TNF inhibitors or the IL-17 inhibitors, which boast a more favorable risk-benefit profile.

In the RA market, Orencia gained share at a modest CAGR at 2.7% from 2013Q4 to 2016Q3, with the IV and SC formulations each roughly occupying half of the share. This roughly 1:1 split is also observed in Actemra’s presence in the RA market: in 2013Q4 a new SC formulation launched, and after its initial uptake, by 2016Q3 Actemra’s two formulations follow the similar split seen in Orencia in PsA. Here, the Actemra brand has gained market share primarily due to the new formulation, and at the same time, the market of the original formulation looks mature, not affected by the launch of the new formulation. Again, a similar observation is found when we look into Simponi-SC and Simponi Aria (IV)’s past performance in the RA market.

In a nutshell, physicians attending the 2017 ACR meeting in San Diego are excited about the approvals of the new IV therapies in the PsA market. But based on the findings from the RA market, we expect that the positive influence of the new IV agents will be limited by the fixed demand for IV therapy in the PsA market. Second, while the introduction of a new formulation can increase the share of Simponi (SC+IV), the share gained is more likely linked to the marketing efforts shifted from Remicade to Simponi Aria. Last, while the market may welcome the IV formulation of Orencia, the same may not go as well for its SC version.

 

References:

Treatment Algorithms | Rheumatoid Arthritis | US | 2017

Treatment Algorithms | Rheumatoid Arthritis | US | 2015

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