The cost-effectiveness watchdogs at the National Institute for Health and Care Excellence (NICE) have put their money behind biosimilars. Remicade biosimilars, to be exact, in new guidance for treating rheumatoid arthritis.
As reported by PMLiVE, NICE folded biosimilar versions of Merck & Co.'s ($MRK) Remicade--sold by Hospira ($HSP) and Napp Pharmaceuticals--right into the new guidance, which stipulates that the least expensive drug be used ahead of more costly options. That's a standard directive, and in this broad disease-related guidance, also includes pills such as the now-generic methotrexate.
But NICE officials told the London-based pub that the "least expensive drug" also applies to biosimilars versus branded products. So, biosimilars should be used ahead of Remicade to help the National Health Service save money, PMLiVE says.
According to the draft guidance, Remicade costs £419 per 100 ml vial, or about $660. Both biosimilar versions are listed at £377 per vial, or about $593. That's a little more than 10% less. Treatment costs more for the first year, with three initial doses and treatment every 8 weeks after that, NICE says, coming to £7,049 for the brand and £6,344 for the biosim.
Two important implications here: One, the discount for biosimilars in this case isn't much; certainly, it's nowhere near the size of the price cut U.S. payers desire. In Norway, one biosimilar version of Remicade--Remsima, sold by Orion Oyj under license from South Korea's Celltrion--is selling at a discount of nearly 70%. It has also amassed 50% of that market.
Two, NICE treats biosimilars as interchangable with Remicade. Like the brand, they are approved as add-ons for methotrexate and as first-line treatments for severe, progressive RA. Plus, "[t]he contraindications, adverse reactions and administration schedule are the same as for infliximab," NICE states in its guidance.
Hospira and Napp didn't even have to submit data for the RA guidance, NICE told PMLive, because the agency simply used information from Remicade's original application. England's Department of Health enables NICE to apply its assessments "to relevant licensed biosimilar products which subsequently appear on the market."
"As biosimilars are deemed to be identical to the reference products, companies are not asked to make new applications for the drug's appraisal by NICE," the agency added (as quoted by PMLiVE). The agency has opened up the guidance for comments, and it could change. The final version is due in October.
NICE's position follows new data on Hospira's version of Remicade, dubbed Inflectra. In a switching study unveiled earlier this month, Remicade patients moved to the copy did just as well as they had on the brand--with no unexpected side effects.
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