The U.K.'s cost effectiveness gatekeepers are giving their final blessing to a slew of rheumatoid arthritis biologics--but only for patients with advanced forms of the disease. And drugmakers aren't exactly happy about it.
The National Institute for Health and Care Excellence has recommended the NHS cover AbbVie's ($ABBV) Humira; Pfizer's ($PFE) Enbrel; Merck's ($MRK) Remicade--as well as a pair of biosimilars from Pfizer's Hospira and Napp Pharmaceuticals; UCB's Cimzia; Merck's Simponi; Roche's ($RHHBY) RoActemra; and Bristol-Myers Squibb's ($BMY) Orencia for patients with severe RA who haven't responded to other conventional biologics. And for patients whose arthritis is just moderate? Forget it.
NICE knows its view isn't exactly a popular one; it's issuing this final word after multiple unsuccessful appeals against the draft guidance, it said. But it's doing its best to make sure it considers "at what stage it's clinically and cost effective to start using biological therapies as treatment options" for the 60,000 people in the country living with severe RA, Carole Longson, director of NICE's Health Technology Evaluation Center, said in a statement.
Speaking of cost effectiveness, in the case of Cimzia, Simponi, Orencia and RoActemra, they'll only make the cut with NICE if they honor already agreed-upon discounts--the so-called "patient access schemes" that companies often must offer to get their meds through the watchdog's door.
And within that group, the new guidance says patients should start on whichever drug is the least expensive once admin costs, number of doses, and price-per-dose are all taken into account.
In this case, that likely means the Remicade biosimilars. NICE folded the Hospira and Napp products--dubbed Inflectra and Remsima, respectively--into the guidance back in June to help the NHS save money. As the agency said at the time, Remicade costs £7,049 for the first year, with both biosimilars tallying £6,344 for the same period.
The decision should help the biosims keep their sales train rolling. Market share for Remsima had already pushed to 15% in the U.K. and Germany after launching in most major EU markets in the second quarter of last year, Bernstein analyst Ronny Gal wrote in a December note to clients. With another copy on the way from Biogen ($BIIB) and Samsung, Gal expects the knockoffs to keep gobbling up share, accumulating 40% by the end of 2017.
- read the release
Special Reports: Top 10 rheumatoid arthritis drugs 2013 | The 25 most influential people in biopharma today - 2013 - Carole Longson - NICE