New final NICE guidance on AbbVie, BMS, Pfizer and Roche drugs
pharmafile | December 16, 2015 | News story | Sales and Marketing | BioMarin Pharma, Enbrel, Humira, Ikervis, MPS IVa, NICE, NICE guidance, Orencia, RoActemra, Santen, apremilast, ciclosporin, dry eye syndrome, juvenile idiopathic arthritis, otezla, psoriatic arthritis, vimizin
NICE has published final guidance on several drugs, approving therapies for juvenile idiopathic arthritis, dry eye disease and Morquio A syndrome, but rejecting a treatment for psoriatic arthritis in draft guidance.
Juvenile idiopathic arthritis
The regulator approved BMS’ Orencia (abatacept), AbbVie’s Humira (adalimumab),Pfizer’s Enbrel (etanercept) and Roche’s RoActemra (tocilizumab). NICE said that where more than one drug is suitable, treatment should commence with the least expensive.
All four drugs belong to a group of medicines called disease-modifying anti-rheumatic drugs, which aim to reduce or halt joint damage by reducing or stopping disease activity. They are all licensed for use where previous treatment has been associated with an inadequate response or with intolerance.
Dry eye syndrome
The UK regulator also said yes to Santen Pharmaceutical’s Ikervis (ciclosporin), for the treatment of severe keratitis in adults with dry eye disease, a chronic inflammation of the eyes caused by reduced tear production or excessive tear evaporation.
Dry eye disease can be triggered by a number of factors, including dry or air-conditioned environments, auto-immune diseases (such as rheumatoid arthritis, and lupus), and the adverse effects of some medications. Symptoms include irritation and redness in the eyes, blurred vision, and a sensation of grittiness or a foreign body in the eye. It can result in blindness, in severe cases, if left untreated. Ikervis helps patients increase their eyes’ natural ability to produce tears, and also reduces inflammation in the eye.
MPS Iva
NICE also recommended BioMarin Pharma’s Vimizim (elosulfase alfa) for treatment of an extremely rare life-limiting genetic disorder, under a managed access agreement, as part of its Highly Specialised Technologies Programme.
BioMarin created a managed access scheme to obtain the approval, following NICE’s previous draft guidance. As a result, the disease now has its first treatment option; due to its rarity, there was no existing standard treatment or pathway of care.
Mucopolysaccharidosis type IVa (MPS Iva) is an extremely rare, life-limiting, inherited lysosomal storage disease, which affects only around 88 people in England. Those born with the disease lack an enzyme that breaks down large sugar molecules (glycosaminoglycans) the body’s cells can’t use. The resulting accumulation of glycosaminoglycans in the cells of tissues and organs lead to worsening symptoms including joint and skeletal abnormalities, hearing and vision loss, heart valve disease, pain, fatigue, and progressive loss of endurance leading to increasing dependence on wheelchairs.
The average life expectancy in people with this condition is about 25 years – primarily because of respiratory failure and heart problems.
Psoriatic arthritis
However, in draft guidance, NICE did not recommend Celgene’s Otezla (apremilast) for psoriatic arthritis, citing a lack of clinical efficacy when comparing the treatment to existing TNF-alpha inhibitors. This was despite the Committees’ recognition of the need for range of treatment options. Some 10% of patients stop taking TNF-alpha inhibitors each year, because they are contraindicated, or because they effectiveness or cause adverse effects. NICE said the costs saved by use of Otezla did not justify its approval in the face of the health losses.
Joel Levy
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