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Stelara hit by final NICE rejection

pharmafile | March 28, 2014 | News story | Sales and Marketing Janssen, NICE, UK, arthritis, psoriatic, stelar 

In final draft guidance released today NICE says it cannot recommend Janssen’s psoriatic arthritis drug Stelara.

Specifically, the pricing watchdog says the NHS should not fund Stelara (ustekinumab) either as a stand-alone therapy, or in combination with methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Sir Andrew Dillon, NICE chief executive, says that NICE’s specialist Committee accepted that Stelara is ‘clinically effective’ when compared with conventional DMARD treatment, but it concludes that Janssen’s drug ‘appeared less effective’ than TNF alpha inhibitors.

The Committee also notes that it was not a cost-effective option for the NHS and whilst recognising the severity of the disease, the Committee believes that Stelara “could not be considered a good use of NHS resources”.

The list price for the treatment is £2,147 per 45mg vial, and NICE estimates that the average annual cost for a 45mg and a 90mg dose are £10,735 and £21,470 in the first year, and £9,304 and £18,608 per year thereafter respectively.

NICE says that these costs mean the most plausible incremental cost-effectiveness ratio (ICER) for Stelara is likely to exceed the £30,000 threshold for quality-adjusted life year (QALY) gained. NICE does not normally allow a drug through with a QALY of more than £30,000.

Sir Andrew points out that NICE currently recommends four medicines for this disorder, namely: Janssen/MSD’s Simponi (golimumab), AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanercept) and Janssen’s Remicade (infliximab).

Psoriatic arthritis is an inflammatory disease affecting the joints and connective tissue, and is associated with psoriasis of the skin or nails.

It is a progressive disorder, ranging from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

Stelara is a monoclonal antibody that acts as a cytokine inhibitor (blocker of molecular messages) by targeting interleukin-12 (IL-12) and interleukin-23 (IL-23) (interleukins are proteins produced by white blood cells for regulating immune responses).

Ben Adams 

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