National Health Service patients with rheumatoid arthritis living in Scotland will now, like their peers in the rest of the UK, have access to UCB’s novel biologic Cimzia after a u-turn approval by Scottish cost regulators.
Following in the footsteps of sister body the National Institute for Health and Clinical Excellence, which regulates funding for medicines on the NHS in England and Wales, the Scottish Medicines Consortium has now also endorsed the use of Cimzia (certolizumab pegol) as a treatment for moderate-to-severe active rheumatoid arthritis when response to disease-modifying anti-rheumatic drugs (DMARDs) is inadequate.
The move follows a rejection of the drug in June this year, on grounds that the manufacturer failed to present “a sufficiently robust economic analysis” to gain acceptance by SMC, and a subsequent offer by UCB of a patient access scheme to improve the drug’s cost-effectiveness and sweeten the deal.
Doctors in Scotland can now freely prescribe Cimzia both in combination with methotrexate and as a standalone therapy when patients are intolerant to the latter, giving patients wider access to a drug - the first PEGylated anti-TNF therapy to be launched in the UK - that significantly improves the signs and symptoms of RA for at least two years and is also able to halt the progression of joint damage for at least 100 weeks.
Cimzia competes on the UK scene with rival TNF inhibitors Remicade (infliximab; Johnson & Johnson/Schering-Plough), Humira (adalimumab; Abbott Laboratories’) and Enbrel (etanercept; Amgen/Wyeth's) – but still offers patients a new option for disease management and comes in an innovative pre-filled syringe, designed to address challenges such as limited dexterity patients face when self-injecting.
“[Cimzia] represents a further important therapy choice for people living with the debilitating effects of RA in Scotland, and brings the country into line with guidance benefiting those in England and Wales,” said Professor Peter Taylor, Medical Advisor to the National Rheumatoid Arthritis Society and Professor of Experimental Rheumatology, Imperial College NHS Healthcare Trust, London.
RA remains a significant health challenge in Scotland as well as the other UK nations, and a recent survey published by the National Rheumatoid Arthritis Society found that over 30% of respondents believe the disease has been detrimental to their career progression, and thus has affected financial wellbeing and social circumstance.
“Ongoing evidence of the impact of this devastating condition underscores the need for therapeutic options which not only help control and alleviate the most common symptoms of RA, but can help patients make a significant difference in their day to day lives,” commented Mike Russell, general manager of Immunology at UCB.
Other approvals, rejections
Elsewhere, the SMC also issued approvals for Consilient Health’s oral contraceptives Rigevidon (ethinylestradiol/levonorgestre), Gedarel (ethinylestradiol and desogestrel), Millinette (ethinylestradiol and gestodene), and TriRegol (ethinylestradiol and levonorgestrel).
However, others were not so lucky. The SMC turned down Eli Lilly’s Alimta (pemetrexed) as a maintenance treatment of locally advanced for metastatic non-small cell lung cancer. Despite the fact that in a sub-group analysis of patients with non-squamous NSCLC progression free survival and overall survival were significantly longer for Alimta plus best supportive care (BSC) compared to placebo plus BSC, the treatment's cost in relation to its benefits was not sufficient to gain NHS entry.
In addition, Nycomed’s Daxas (roflumilast) was deemed too expensive for use in NHS Scotland as a maintenance treatment of severe chronic obstructive pulmonary disease, while Shire’s Fosrenol (lanthanum carbonate) was rejected as a phosphate binding agent to control hyperphosphataemia in adults with chronic kidney disease, after the firm failed to put forward a sufficiently robust clinical or economic case for funding.