URGENT - NICE consultation on crosslinking

[Anne Klepacz]

We have just received notification that NICE (the body that approves new drugs and treatments for use in the NHS) is now consulting on the safety and efficacy of collagen crosslinking for keratoconus. The consultation period runs from 30th June to 28th July. If you have had crosslinking done in the past few years, whether in the UK or abroad, please do take part in this consultation. This of course, includes anyone who might have had a negative experience as well as those for whom it has been beneficial. People who haven't had crosslinking done but are interested in contributing to the consultation are also welcome to do so. Comments can be made via the NICE website www.nice.org.uk/ip724
Anne

[oisin]

does this mean that cross- linking will be funded by the NHS??? because i know intac has NICE status but isnt funded in NI, although Professor Jonathan Moore FRCOphth, PhD is trying to change that

[Andrew MacLean]

oisin

Welcome to the forum.

I am afraid that NICE approval means that a treatment or therapy is funded by the NHS in England (and Wales?). NICE does not guarantee treatments in the other UK jurisdictions. Health is a devolved competence in Northern Ireland and in Scotland (I am afraid that I am not sure about Wales).

That said, if NICE were to approve a new therapy, it would probably not be long before the other jurisdictions followed suit.

INTACS treatment is available on the NHS in Scotland.

Andrew

[Anne Klepacz]

Just to add that NICE will look at all the responses they get to the consultation this month, and then make a decision whether to approve the treatment or not. Their website says that the decision will be announced in November.
Anne

[GarethB]

What involvement has the Keratoconus Group had so far with NICE regarding CXL prior to the consultation process begining?

[Anne Klepacz]

None - but that was the same for the Intacs consultation. It's now that people can have their say.
Anne

[GarethB]

Thaks Anne

To me there are some anomolies in the consultation paper and things we all need to consider when giving our response which I have listed below.

Description, Indications and current treatment, paragraph 2, sentence 1 - Diagnosis is based on patient having regular prescription change for glasses and/or contact lenses, poor repeatability or subjective refraction, ghosting, halos, glare and blurred/distorted vi son. The clinical diagnosis is using a slit lamp where corneal nerves are more prominent, presence of fine vertical lines in the stroma which disappear with digital pressure, iron pigment rings around the basal epithelial layer, corneal thinning and cone displacement, ecsasic protrusion of the cornea when look down and lateral illumination of the cornea producing a steeply focused beam of light near the limbus. Moderate the beam is central to the limbus and advanced beam is displaced peripherally. Scarring is generally as a result of hydrops, over wearing of contact lenses, ill fitting contact lenses or debris trapped under the lens causing corneal abrasion. Corneal scarring often renders contact lenses useless and is corrected through grafts.

Description, Indications and current treatment, paragraph 3, sentence 2 - as soon as mild keratoconus diagnosed most optometrists fit contact lenses, usually RGP but soft lenses for Keratoconus now being used. As the condition develops to moderate and advanced treatment is through more advanced RGP lenses, hybrids sclerals and soft lenses for Keratoconus to name but a few. Only in the most sever cases where there is corneal scaring, contact lens intolerance or contact lenses can no longer be fitted is surgical intervention considered. In these cases corneal ring segments may be used, Deep Anterior Lamela Keratoplasty and where scarring is apparent Penetrating Keratoplasty may be used.

The indications and current treatment is an extremely out dated overview of the condition and its management. CXL is useless to anyone with corneal scaring and is one of the contra indications. As the NICE description stands if scarring is part of the diagnosis, this consultation is a pointless one.

List of Studies Included In The Overview, Efficacy, paragraph 3, - From what we are learning from patients going through a transition from RGP contact lenses to soft lenses and those who have had CXL, there is evidence on this forum that there is a reported improvement. To say such changes are anecdotal are inaccurate and in my personal opinion wrong. Optometrists are now starting to report the effects of corneal demoulding which takes place after extended periods without contact lens wear.

Specialists Advisers' Opinions, point 6 - Safety training should be mandatory as the use of any laser if used incorrectly can ruin a persons life by essentially making a person blind rather then part time partially sighted. As such treatment should always be by a trained ophthalmic surgeon.

Specialists Advisers' Opinions, point 7 - The controversy is no longer in the EU, it is just in the USA based on ethics. this point is completely irrelevant and misleading.

Specialists Advisers' Opinions, point 8 - Procedure is only available on NHS where clinical trials are taking place such as Solihull. So for all practical purposes is completely unavailable on the NHS.

Specialists Advisers' Opinions, point 9 - This point should be clarified to WILL have a rapid uptake as seen in the private sector in the past 2 years in the UK.

Specialists Advisers' Opinions, Efficacy, point 2 - By conducting randomised studies wuold mean a patient getting either a placebo drops and/or exposed to the UV, you'll soon know if you had the proper CXL when you find your keratoconus progressing. The risk there is people coming on to the forum knowing they took part in a study and potentially stating the procedure is rubish and turning people away from a procedure which from the information we have, we know to have distinct benefits.

Specialists Advisers' Opinions, Efficacy, point 3 - Not knowing how long the procedure lasts is no different to grafts, no one knows how long they last but ophthalmologists are quite happy to repeat grafts as often as is necessary so what is the difference if you need to repeat CXL. Surgical option is still a viable one, the CXL potentially reduces the number of patients that will require Keratoplasty and potentially gives the patient a longer period where they can still see and stay a full contributing member of society until donor corneal material is available.

Specialists Advisers' Opinions, Safety, point 2 - The issues raised here are no different to the insertion of intacs or any other corneal surgery and that isn't considered a safety issue so why is it here?

Specialists Advisers' Opinions, Safety, point 4 - In addition with appropriate follow up by the consultant and training of optometrists to monitor progress as the manage the long term post operative treatment as is currently done with keratoplasty and intac treatment.

There seems to be no real consideration for the patient, we know that no treatment of Keratoconus leads to most cases progressing at varying rates. There is nothing saying the condition will still require management using either glasses of some form of contact lens. No consideration that putting a post CXL patient back into RGP lenses could lead to corneal scarring which would then lead to keratoplasty. It is as if despite consulting the Royal College of Ophthalmologists and the College of optometrists that they have failed to grasp what Keratoconus is and what they want from the consultation, it is just too vague.

I am all for CXL being available on the NHS and I feel that it is very improtant for the Keratoconus Group to be one of the Speciality Societies that are consulted in putting the consultation paper together to avoid the anomolies I have found in the paper occuring.

Can this be something that the UK Keratoconus Group puts high on their list of priorities?

A treatment such as this is beneficial to more than just the patient. The patient gets stabilised vision and in my opinion back to work place so more than just feeling they are part of the comunity again but employers benefit through what I hope to be less tim off work to visit the hospital and the government benefits as they would inevitably be paying less in disability benefits and receiving more in the way of tax revinue because more of us would be in employment.

What are the views of others regarding this matter?

[GeorgeThe2nd]

http://www.nice.org.uk/guidance/index.jsp
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