As a cluster of new biologic therapies, including Cimzia, Actemra and Golimumab, prepare to enter the rheumatoid arthritis market in 2009, an analysis of recent market entrant Orencia’s successes and shortcomings indicates that new products must be prepared to prove efficacy while battling persistent concerns over biologics’ long-term safety and infection risk, according to new research by GfK Market Measures. 

Orencia, a biologic representing a unique mechanism of action, entered the rheumatoid arthritis market in February 2006.  Given its almost three-year track record and successful breakthrough as an important alternative therapy in cases of treatment failure with first- and second-line biologics, Orencia appears to be in the best position to compete most directly in 2009 with the market mainstays – Enbrel, Humira and Remicade – also knows as the TNF biologics.  Another close competitor is the other non-TNF, Rituxan, which has enjoyed similar success.

One formidable challenge for Orencia and all new market entrants in 2009 will be to break through the TNF cycling that occurs among these three well-established therapies and steal market share in the form of more second-line therapy switches.  The strength of this cycling trend is evidenced by GfK’s research over the past three years in this market, where rheumatologists consistently report approximately 80 percent of patients currently on a TNF biologic are switched to another TNF biologic following first-line therapy failure.

Despite the fact physicians’ perceptions of Orencia have improved since 2006 for areas including long-term safety, tolerability and low risk of infection, key hurdles for the drug’s further penetration remain.  For example, efficacy ratings for Orencia remain unchanged since 2006.  A look at Orencia’s perceived strengths and weaknesses, in comparison with the TNF biologics, may serve as an indicator of opportunities and challenges for future market entrants. 

On the down side, overall, Orencia seems to have less positive perception among rheumatologists for efficacy measures – a trend that has been consistent for three years.  On a seven-point scale, the TNF biologics are rated highest by rheumatologists for “inhibits disease progress,” with average ratings among the three therapies of 5.80, while Orencia receives an average rating of 5.12.  However, it should be noted that as third- and fourth-line biologics, Orencia and Rituxan face a significant challenge to produce consistently positive efficacy experiences, given the more severe patients trialed on these products.  One might believe Orencia’s poor ratings are the result of treating the more severe patient, yet efficacy ratings as measured by the attribute “inhibits disease progression” are actually lower than Rituxan (5.25), implying that, at least among rheumatologists, Orencia faces true efficacy shortcomings.  

On the positive side, Orencia is associated with two important underlying drivers of physician and patient satisfaction: “low risk of infection” and “fewer side effects/well tolerated.”  On a seven-point scale rating for “low risk of infection,” Orencia was rated slightly higher than Enbrel – the lead biologic in the market (4.59 compared with 4.50) – and higher than Humira (4.38) or Remicade (3.97).  It is important to note here that Remicade, which as a competing infusion-administrated TNF biologic is the brand Orencia would naturally look to displace, was rated lowest among the biologics on this attribute.  In addition, since 2006 physicians have reported steady satisfaction rating gains for Orencia on the attribute “fewer side effects/well tolerated.”  In fact, Orencia (5.34) is now on par with Humira (5.42) on this important attribute and, once again, ahead of Remicade (4.70).

“Orencia’s unique mechanism of action makes it an important alternative therapy in cases of TNF biologic treatment failure, yet our data show that physicians’ perceptions of Orencia are less positive regarding efficacy,” said Geoff Penney, Vice President and Category Business Leader, Neurology, GfK Market Measures.  “At the same time, our data show that physicians and patients remain wary of the biologics in terms of long-term safety and related attributes such as low risk of infection and tolerability—and it is here that Orencia is better positioned than most of the TNF biologics.  Taken as a whole, Orencia is perceived by physicians as a solid alternative therapy for patients who face greater infection risk.”

Contact: Geoff Penney, VP, Category Business Leader, Neurology
gpenney@gfkmm.com