Complaint to the NHS/GOV

[IanJ]

Hi all,

Thought this might interest some. I wrote an complaint to the NHS and the Government regard the archaic approach I believe they have to dry eyes.

The main basis of my email was that Restasis didn't even appear on the radar, the docs I had talked to about it having never even heard of it......yet it's prescription in th USA

I got one reply so far.

Dear Ian,

Thank you for your e-mail of 19 September about the availability of Restasis at NHS expense for the treatment chronic dry eye. Your e-mail has been forwarded to Pharmacy Division and I have been asked to reply.

I can fully understand why you would want to receive treatment with Restasis for what can be an extremely painful condition.

I have contacted colleagues in the Medicines and Healthcare products Regulatory Agency (MHRA) the UK regulatory authority responsible for licensing all UK medicines They have advised that there is no UK or EU licence or ongoing application for a licence.

Licensed medicines are rigorously tested against the MHRA criterion of safety, quality and efficacy. The safety of unlicensed medicines can not be guaranteed. However, there is provision within the medicines legislation which allows a doctor to prescribe an unlicensed medicine if there is no safe licensed alternative available. In such circumstances the prescribing doctor is held clinically responsible.

I do hope that this information clarifies the position.

**name/email removed for privacy**
Pharmacy Division
1 October 2007

[stella]

Very interesting - this means you could get your GP to perscribe restasis , but they would be held responsible -
Would we have to pay for it then?
If you cant get it at health service perscription rates (which is obviously much cheaper than buying it on the net,and would be free for some people ie OAP's unemployed)then there is no point in having a perscription for it ?
The only advantage in having it perscribed as i see it ,would be to make sure you got the "pure" stuff - like from Leiters rather than risking internet sources

[dianat]

So now you have clarification, but that doesn't exactly get you any closer to getting the drug. Do you intend to ask your doctor to prescribe a cyclosporin drop for you or can you order it from the States? Will a doc there stick his/her neck out for you in this manner?

I assume your docs would consider Restasis a low-risk drug. It is unlikely you will end up in critical condition from it.

D

[IanJ]

I don't mind paying the internet rates for Restasis for the purposes of testing...i.e. 6 months......but if at some point it starts to work for me (fingers crossed!) then I'll take all this info to my GP and put him on the spot.

I've been on Restasis a week or so now, and I've calculated it's costing me about 75p a day.

PS> I'm Scottish, so it goes without saying I'm as grippy as they come!

Ian.

[Rebecca Petris]

Cyclosporine was prescribed occasionally in the UK for dry eye on an unlicensed basis years before Restasis came along... so it can be done but obviously finding a willing doctor, or (more likely) a doctor who can be pestered, coaxed or harassed into it... that's another matter. One would have thought that having Restasis now a commonly prescribed med in the US ought to make it easier to get a doctor to see merit in the suggestion, but apparently not.

[brd888]

Manufacturers

So why arent the makers of Restasis trying to get it more widely licensed?

[dianat]

So why arent the makers of Restasis trying to get it more widely licensed?

Maybe they are. If I'm not mistaken, Restasis wasn't a shoo-in here either. My guess is that its effectiveness wasn't terribly easy to prove. The control group using castor oil (the vehicle for the cycolosporin) probably did nearly as well as the drug users.

Perhaps Restasis was approved here because a lot of people stood to make a lot of money on it.

I don't intend to sound critical of our system here. On the contrary. I'm satisfied that we at least have Restasis as an option and that some are successful with it. What's more is the more money spent on it, the more likely pharmaceutical companies will be to invest in dry eye research.

[Rebecca Petris]

So why arent the makers of Restasis trying to get it more widely licensed?

I haven't ever looked into what if any efforts are being made to get regulatory approvals for it in other countries. But if they are trying anything across the pond they'd be working on EU-wide approval. I doubt they would bother with the MHRA on its own, for the usual reasons: Restasis is a blockbuster drug and the UK is a very small, poorly developed market for them. The sales they could get post approval might not make it worth it to them before the market opens up for generics. If they go after any other markets they'll go after big ones.

[Tash]

Hi

My Opthamologist has prescribed me Optimmune (cyclosporin 0.2%), as I understand it this is the dog version of Restasis but rather than 0.05% its 0.2% so 4 times the strength.

I have this prescribed by the bristol eye hospital so just pay the prescription charge. I was told that they had to prescribe the veterinary product as its the only version available in the UK.

Now I might just be lucky, but if I can have this on the NHS I don't see any reason why anyone else shouldn't. Perphaps you should ask for this. I'm fairly certain that a GP wouldn't be able to prescribe this but there must be other eye hospitals in the UK prescribing this ointment.

In fairness, I probably would prefer Restasis as its specifically designed for humans. The Optimmune I find very greasy, blurry & a bit irritating. Having said that it does seem to help.

I do hope it works out for you

[bluebrit]

Suggestion for those in UK

Hi Ian

I am a Brit living in NZ and have the same problems here as you do in the UK - GPs and opthalmologists are quite clueless about dry eyes (Sjogren's in my case), and lots of the meds and treatments we read about on these forums are not available. However, similar to one of the earlier posts here, my opthalmologist says that though Restasis is not available, he can get a cyclosporine ointment made up if necessary, which is like a generic version of Restasis. May be worth asking about (you may have to google the exact makeup of Restasis and print it out if he is particularly clueless)

[stephgurl1986]

Ian, why don't you let a pharmacy produce you cyclosporine drops? My health insureance didn't pay for Restasis either but they do pay to cyclosporine drops and in additionan you can chose whether you want 0.05% - 0.2%.