The Scottish Medicines Consortium (SMC) has approved the use of RoActemra (tocilizumab) as a single therapy for rheumatoid arthritis (RA).

The Roche drug is an alternative to the standard therapy, methotrexate (MTX), which one-third of RA patients cannot tolerate.

The approval reflects the priority of helping patients to achieve remission from a chronic disease that damages the joints, leading to progressive disability.

Tocilizumab is a biological therapy: it targets specific chemical signals or receptor cells.

It has been found to offer remission rates four times better than the most prescribed alternative, adalimumab (Humira), and to offer a reduction in joint swelling and disability.

The drug is available in combination with MTX in England, but the Scottish decision represents its first approval as a monotherapy for RA.

An auto-immune disease, RA affects 646,000 people in the UK, causing disabling joint damage within a decade in 50% of cases.

Dr David Marshall, Consultant Rheumatologist at NHS Greater Glasgow & Clyde, said: “RA is a progressive disease which can lead to irreversible joint damage and disability. We need to treat patients as quickly and aggressively as possible, using the most efficacious treatments available.

“Remission in RA is achievable for many patients and this is what we should be aiming for. This news will make a real difference to the treatment of RA and to patients’ lives, who until now have had limited treatment options.”

Roche’s rheumatoid arthritis (RA) drug RoActemra has shown greater effectiveness than Abbott’s market-leading rival Humira in a phase IV clinical test.

The ADACTA head-to-head study indicated that RoActemra (tocilizumab) performed better on all primary and secondary measures of clinical efficacy than Humira (adalimumab).

The trial result will boost Roche’s attempts to win market share for RoActemra, whose sales rose to $675m last year – a long way behind Humira’s $7.9bn.

Preliminary analysis showed a similar safety profile for the two drugs.

However, the antibody RoActemra is only available via an hour-long intravenous infusion, whereas Humira and other TNF inhibitors can be administered by subcutaneous injection.

Roche is developing a subcutaneous injection version of RoActemra, which will be filed for regulatory approval later this year.

The ADACTA study showed that patients given RoActemra achieved a significantly greater reduction in disease activity after 24 weeks than those given Humira.

RoActemra also performed better on key secondary endpoints including remission and low disease activity.

The finding reflects the growing importance of phase IV (head to head) trials in a pharmaceutical market driven by value-based pricing.

NICE has approved the first new class of treatment for rheumatoid arthritis (RA) in over ten years.

Roche’s RoActemra (tocilizumab) is recommended for treatment of RA where standard treatment with disease modifying anti-rheumatic drugs (DMARDs) has failed.

The approval offers a new therapy option to thousands of patients suffering from this painful and disabling condition.

RoActemra, which can be used alone or with methotrexate (the most commonly used DMARD), is the first licensed Interleukin-6 (IL-6) receptor antagonist.

The combination of methotrexate and RoActemra offers a clinical remission rate at one year of 47%, compared with 8% for methotrexate alone.

Until now, the only therapy option when DMARDs failed was anti-tumour necrosis factor inhibitors, which offer a clinical remission rate of 19%.

John Isaacs, Professor of Clinical Rheumatology at the Institute of Cellular Medicine, Newcastle University, said: “IL-6 receptor inhibition is an innovative and highly effective approach to the treatment of RA and NICE’s decision to recommend RoActemra in this setting provides an important addition to the armoury of treatments needed to combat the condition.

“RA is an unrelenting disease and it is vital that patients have options available to them when they are no longer responding to, or can no longer tolerate, their current treatment.”

“We are delighted with NICE’s decision, as there are so many patients with rheumatoid arthritis in need of tighter disease management,” commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society.

“We are very supportive of more aggressive implementation of NICE RA Guidelines and treat to target strategies which, with earlier referral and diagnosis, are more likely to enable patients to reach remission or low disease activity.”

NICE has recommended the use of Roche’s RoActemra (tocilizumab) for the treatment of systemic juvenile idiopathic arthritis (JIA) in final guidance.

The Final Appraisal Decision (FAD) recommends RoActemra’s use in children aged two and over where specific treatments have not produced adequate response and the treatment is provided as part of a Patient Access Scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says the recommendation “is good news for children with systemic JIA and those caring for them”.

JIA has no known cause. Systemic JIA may start with symptoms such as a fever or rash and eventually lead to joints becoming swollen and inflamed. It affects children of any age and causes severe pain which effects everyday life.

The full recommendation by NICE states that RoActemra can be used as a treatment option for youngsters with systemic JIA whose disease has not responded well to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate.

However, the treatment is not recommended in those whose disease continues to respond to methotrexate, or who have not been treated with methotrexate.

“We are pleased to be able to recommend tocilizumab for systemic juvenile idiopathic arthritis,” said Professor Longson.

“This arthritic condition has a huge impact on the lives of the children and young people with the disease, causing severe pain, fatigue and disability. This affects the child’s family and school life, as well as their physical and emotional well-being.”

Roche’s RoActemra (tocilizumab) has been recommended in draft guidance for treating systemic juvenile idiopathic arthritis (JIA).

NICE recommended the treatment after Roche provided its Appraisal Committee with further requested clinical data and it agreed a revised Patient Access Scheme with the DH.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says the recommendation is “good news for children with systemic JIA and those caring for them.”

The draft recommendation is for the use of RoActemra in children aged 2 and over where specific previous treatments have not produced an adequate response.

However, in cases where those whose disease continues to respond to methotrexate or who have not been treated with methotrexate, RoActemra is not recommended as a treatment option.

“The discount agreed as part of the patient access scheme put forward by the manufacturer, in addition to the further information they provided at the Committee’s request, has enabled the Committee to recommend tocilizumab for systemic juvenile idiopathic arthritis in today’s draft guidance,” said Professor Longson.

“The draft guidance proposes that tocilizumab should be the treatment for children aged over 2 years and young people where their systemic JIA hasn’t responded well to other treatments.”

Roche’s RoActemra (tocilizumab) has been provisionally recommended in draft guidance to treat additional stages of rheumatoid arthritis after a rapid review of an earlier appraisal.

RoActemra was originally recommended at a later stage of the treatment pathway, but NICE has now issued new guidance of TA198 fter Roche agreed a Patient Access Scheme with the DH.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, says the provisional guidance widens the choice of treatments for patients.

A rapid review can be conducted by NICE if a new Patient Access Scheme is submitted within 16 weeks of original guidance publication. However, these schemes can only be considered by NICE after ministerial approval and confirmation by the DH.

In August 2010, NICE issued guidance TA198 recommending RoActemra as an option if there had been an inadequate response to one or more TNF inhibitors and where rituximab has also produced an inadequate response, or where it is contraindicated or has produced undesirable side effects.

The new draft guidance outlines that in specific clinical circumstances – and within the terms of the Patient Access Scheme – it’s recommended where the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and the medication is used as described for other TNF inhibitor treatments in NICE guidance TA130.

The updated guidance also includes using the treatment as originally recommended after both rituximab and TNF inhibitors were tried, and a recommendation on using tocilizumab when rituximab can’t be used after TNF inhibitor treatment has failed.

“If TNF inhibitor treatments have failed and patients are unable to take rituximab, the guidance also provisionally recommends that tocilizumab could be a treatment option at this point, potentially widening the choice of treatments available,” said Professor Longson.

RoActemra was previously approved in Europe in August and the US in April 2011 for the treatment of childhood arthritis.

NICE wants further information on Roche’s RoActemra (tocilizumab) for the treatment of systemic juvenile idiopathic arthritis (JIA) after failing to recommend it in draft guidance.

The Institute’s independent Appraisal Committee has requested a range of detailed information including comparison data to existing treatments and a revised model.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says more information is required so NICE can “fully assess the benefits that tocilizumab might provide”.

A public consultation has now been opened with responses welcomed until 1^st September.

The appraisal focused on young people aged two years and older with JIA where specific previous treatments have not produced an adequate response.

But NICE says further data is required on RoActemra when it’s used in treating systemic JIA where the individual’s condition has responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate. Information about joint damage for patients receiving RoActemra, including long-term follow-up, has also been requested.

The draft guidance also does not recommend the treatment where methotrexate has not yet been tried, but NSAIDs and systemic corticosteroids have already been used.

“In the meantime, we welcome comments from patients and their carers and families, and clinicians, as part of our public consultation on the Committee’s provisional recommendations,” said Professor Longson.

Roche’s RoActemra has been approved in Europe for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA).

The medicine is intended to treat patients two years of age and older who have responded inadequately to previous therapy with NSAIDS and systemic corticosteroids.

RoActemra is known as Actemra outside of Europe can be prescribed alone or in combination with methotrexate.

Hal Barron, Chief Medical Officer and Head of Global Product Development at Roche, stated: “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”

sJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA). The disease affects about 10-20% of children with JIA, with the peak age of developing sJIA being between 18 months and two years of age, although the disease can persist into adulthood. 

Roche is a biotechnology company with focus on pharmaceuticals and diagnostics. The organisation manufactures medicines to be used in areas of oncology, virology, inflammation, metabolism and CNS.

NICE has provisionally recommended Simponi (golimumab) as a treatment option for treating rheumatoid arthritis in specific circumstances in draft guidance.

Simponi has been recommended in combination with methotrexate for adults whose condition has responded inadequately to conventional disease-modifying antirheumatic drugs (DMARDs) only, including methotrexate.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, says the guidance sets out the “circumstances” where Simponi “could be another option” for patients.

Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), MabThera (rituximab), Orencia (abatacept), RoActemra (tocilizumab) and Cimzia (certolizumab pegol) are all currently recommended treatments for rheumatoid arthritis.

The Institute says Simponi is an option if it is used as described for other tumour necrosis factor (TNF) inhibitor treatments and the manufacturer provides the 100mg doses at the same cost as the 50mg dose.

In adults whose condition has responded inadequately to other DMARDs, Simponi in combination with methotrexate is also provisionally recommended as a treatment option.

In this situation, NICE says that Simponi can only be used as described for other TNF inhibitor treatments in NICE technology appraisal guidance 195 – which covers the use of adalimumab, etanercept, infliximab, rituximab and abatacept after the failure of a TNF inhibitor – and if the drug is supplied in 100mg doses at the same cost as the 50mg dose.

Simponi is a treatment for moderate to severe active rheumatoid arthritis in adults where the response to DMARD therapy including methotrexate has been inadequate and is manufactured by Schering Plough, part of MSD.

The FDA has approved Roche’s Actemra (tocilizumab) for the treatment of Systemic Juvenile Idiopathic Arthritis (SJIA).

The drug is indicated to treat patients two years of age and older and can be given alone or in combination with methotrexate.

It is the first medicine approved by the FDA for the treatment of this rare and severe form of arthritis, which accounts for almost two-thirds of all deaths among children with arthritis.

“Today’s FDA approval marks an important advance in the treatment of SJIA, a debilitating condition affecting children,” said Hal Barron, M.D., Chief Medical Officer and Head Global Product Development, Roche.

“As the first and only approved treatment for SJIA, Actemra offers a new option for this extremely difficult to treat disease. This approval also demonstrates our commitment to science and patients with high unmet medical need, including orphan diseases.”

Symptoms of SJIA can include joint inflammation accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver or spleen and inflammation of the lining of the heart and/or lungs. In the most severe cases, children can experience chronic arthritis and could develop significant joint disabilities.

Actemra is known as RoActemra in the EU.