Friday, March 25, 2011

UK recommendation for Merck's Simponi but it may struggle to make an impact in the rheumatoid arthritis market

For further information on the rheumatoid arthritis market:

The National Institute for Health and Clinical Excellence has recommended Simponi for psoriatic arthritis. Based on this, Datamonitor believes that the drug will gain further positive recommendations in other rheumatology indications. However, while Simponi does have dosing advantages over other approved biologics, it is unlikely to make a huge impact on the UK market.

The recommendation of Simponi (golimumab; Merck & Co.) for the treatment of active and progressive psoriatic arthritis (PsA) represents a u-turn by the UK's National Institute for Health and Clinical Excellence (NICE). Having previously issued negative draft guidance, NICE's newfound faith in the drug is based on a review of additional information. This is positive news for Merck & Co., although NICE is yet to issue the final guidance to the NHS (likely due by April 2011).

Simponi represents the fourth tumor necrosis factor (TNF) inhibitor to become available for psoriatic arthritis in the UK, following in the wake of Enbrel (etanercept; Amgen/Pfizer), Remicade (infliximab; Johnson & Johnson/Merck), and Humira (adalimumab; Abbott). However, the recommendation comes with the condition that Simponi should be used in the same way as other TNF inhibitors, namely after patients have failed two prior traditional disease-modifying antirheumatic drugs, administered either individually or in combination. NICE arrived at this conclusion after deeming that there was no clinical evidence to distinguish Simponi from its competition. Furthermore, NICE has demanded that Merck provide the higher 100mg Simponi prefilled syringe at the same price as the 50mg dose. Explaining this, the Appraisal Committee felt that Simponi was not as cost-effective as Enbrel, and that the 50mg dose had acceptable comparability to Remicade and Humira.

NICE is still reviewing Simponi for ankylosing spondylitis (AS) and rheumatoid arthritis (RA), with outcome dates expected in October and June 2011, respectively. The PsA recommendation bodes well for Simponi in these additional indications. Indeed, the potential recommendation in RA may well mirror what happened in PsA.

In October 2010, NICE did not recommend Simponi for the treatment of RA in patients who have had therapy with a TNF inhibitor and for whom rituximab is appropriate, placing it further behind recent entrant and close competitor Cimzia (certolizumab; UCB), which was approved for RA under a cost-sharing scheme in February 2010. While Cimzia was approved ahead of Simponi in the UK for RA, Merck wisely submitted Simponi for RA, PsA, and AS in the EU simultaneously (Cimzia is still in Phase III for PsA and AS). Together with its monthly subcutaneous dosing, this may generate advantages for Simponi in all three indications.

Datamonitor forecasts that, if approved, Simponi could generate RA sales of over $20m by 2019 in the UK. However, opinion leaders have warned that as a new drug Simponi may not be a preferred agent in RA or indeed in PsA, with rheumatologists likely to remain loyal to established, tried and tested brands.

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