Anti TNF therapy
NASS worked with NICE on the multiple technology appraisal for the new anti TNF drugs (TA143) which reported in May 2008. This gave access to adalimumab (Humira) and etanercept (Enbrel). (NICE guidance for adalimumab, etanercept and infliximab).
NASS worked with NICE again in 2011 when another anti TNF golimumab (Simponi) , was approved for AS.
In November 2012 NICE agreed that, an update of TA143 should take place in the context of a multiple technology appraisal to include:
- a broadening of the indication to include axial spondyloarthritis without radiographic evidence of ankylosing spondylitis'
- all TNF-inhibitors that are licensed for the relevant indications or that will be licensed within the timeline of the appraisal
This expanded remit would encompass an update of TA233 ‘Golimumab for the treatment of ankylosing spondylitis' which is currently due to be considered for review in August 2014.
In order to be completely confident that this is appropriate, NICE asked NASS, along with a whole range of other consultees and commentators with an interest in this topic, to inform them of any evidence which would suggest that an earlier review would be beneficial.
NASS welcome this news. We responded to NICE highlighting 3 issues which we believe should be considered when reviewing TA143:
- The definition of ankylosing spondylitis (AS) and introduction of the term axial spondyloarthritis (SpA)
- The use of anti TNF therapy in axial SpA
- Switching to a second anti TNF after failure of the first agent due to either side effects or efficacy
The definition of AS and introduction of the term axial spondyloarthritis (SpA)
Within current NICE guidance, AS is defined only using the modified New York Criteria. This criteria requires x-ray (radiographic) evidence of bilateral sacroiliitis. However, diagnosis has moved on over the past few years and people can now be diagnosed using MRI scanning and imaging of the spine (non-radiographic axial SpA - early AS).
Thus, AS as defined by the modified New York criteria, no longer describes the wider spectrum of disease which has been revealed by MRI scanning and by imaging the whole spine. It will be important for NICE guidance to take account of these changes.
NASS is aware from our conversations with AS patients, that people with non radiographic AS often suffer with the same symptoms as people with radiographic AS and these symptoms have the same impact on daily living with all the worries for the future that go with that.
The use of anti TNF therapy in axial SpA
Adalimumab has now gained a license for non radiographic axial SpA and we would like to see this medication made available for consultant rheumatologists to prescribe for appropriate patients.
NASS do speak to people with non radiographic axial SpA who have failed on all available medications and are really struggling with their symptoms. As an example, we are in contact with a police officer who is suffering a great deal with non-radiographic axial SpA and is really struggling in his work. He worries that he will not be able to continue much longer in the job he loves but his consultant is not able to offer him anti TNF therapy, even though he has failed on a range of other medications. This has left him living in hope of radiographic changes to his sacroiliac joint so that he can start on anti TNF therapy. He would clearly benefit from a trial on anti TNF therapy so he could continue working and supporting his young family.
Switching to a second anti TNF after failure of the first agent due to either side effects or efficacy
In current NICE guidance, AS patients can only try one anti TNF. If this does not prove effective, or if the efficacy decreases over time, there is nothing in NICE guidance to allow for a change in therapy, despite the increasing weight of evidence that moving to a second or even a third anti TNF can prove beneficial. If anti TNF therapy fails then patients have effectively reached the end of the line as far as treatment goes.
By contrast, in rheumatoid arthritis patients have access to multiple biological therapies including rituximab, abatacept and tocilizumab but these therapies have, so far, not been proven to help in AS. These leaves AS patients disadvantaged in terms of treatment options.
This puts an enormous pressure on patients to ‘pick the right anti TNF therapy' when they discuss which of the three therapies they would like to try with their nurse. We know that, unless there is a particular clinical reason for patients to have one particular anti TNF therapy they will be offered a choice. Patients can get very stressed and upset when making this choice as they are made aware they don't have the option to change to another anti TNF if this proves to be the wrong choice for them. They currently call the NASS Helpline and join the debate on the forum in an attempt to try and make the right choice.
When anti TNF therapy is first discussed, patients do hear stories of the possible ‘life-changing' results of such therapies. However, we know that, although around 7 in 10 patients get benefits from anti TNF therapy, 3 in 10 do not find them efficacious. These patients experience a great deal of disappointment and upset when their anti TNF therapy fails, especially if they cannot be offered a second anti TNF. They can be told by their rheumatology department that there is nothing more that can be done for them and are left struggling on NSAIDs and opioids. These are often relatively young people. They may have young families and be working. Anti TNF failure and the inability to try another effective therapy can destroy their lives and lead to psychological problems.
Another issue for patients is where the efficacy of anti TNF therapy slowly wears off over time, leaving patients struggling. Currently these patients are unable to try a switch to a different anti TNF to see if this improves efficacy.
What next?
You can follow the progress of the review on the NICE website.
Clinical guidelines
NASS has also asked NICE to draw up clinical guidelines for AS. Clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales. Clinical guidelines are based on the best available evidence (Source: guidance.nice.org.uk/CG).