NICE Draft Guidance
First of all I want to share with you the NICE Consultation document for over 16’s.
Here is the Summary of the consultation and guidance on comments and at this link you will find the comments form.
Please take the time to read through this if you are in the UK and want to get involved by making your voice heard. The draft Guidance is 41 pages long so grab a cuppa and take a look….The consultation closes at 5pm on Tuesday 22 August.
I am a Stakeholder for the Guidance, so if you would like to send me your comments on the Draft too I will send these in and they will be published. Your comments sent directly to NICE on the draft will be read and acknowledged but will not be published.
You can read a discussion on it in the media here too. (Thank you for sending it Suzie!)
We are over nine years in on this story and I want to bring you up to date with all the goings on over the past few weeks and months. There are always long gaps between the communication and I don’t want to keep giving you flimsy information piece meal so this post will help to bring you up to date.
What has happened since my last post on B12 OTC?
Lots of to-ing and fro-ing with my MP Jane Hunt in trying to arrange meetings. There have been many names involved in our trying to access B12 OTC and the job titles and positions held change so often is hard to keep up.
I regularly send Jane emails saying ‘have we heard anything?’ I also send her information on how it is for patients I’m either working with, or who are in the news detailing how B12 deficiency is affecting them. For example Charlotte who won a clinical negligence claim due to permanent damage caused by a late diagnosis and treatment. Giving information about real people all adds to our cause.
On the 10th of March 2023 I also sent Jane the following Query answer report – Alternatives to intramuscular administration of hydroxocobalamin from the West Midlands Medicines Information Service March 2020 – (144230-vitamin-b12-west-midlands-ukmi-march-2020-1586185691). It details that hydroxocobalamin injections are only licensed for IM (Intramuscular) in the UK and the bizarre notion that cyanocobalamin would be preferable to hydroxocobalamin ‘if subcutaneous administration is necessary’.
Subcutaneous administration of hydroxocobalamin
• There is very little information available regarding the subcutaneous administration of hydroxocobalamin, although it has been done. This should therefore be considered as an option only if other options are not available or not suitable.
Subcutaneous administration of cyanocobalamin
• The UK-licensed cyanocobalamin injection is only licensed for intramuscular administration. However, there is considerably more information available regarding the administration of cyanocobalamin via the subcutaneous route. If subcutaneous administration is necessary, it would be preferable to use cyanocobalamin rather than hydroxocobalamin. However, note that as cyanocobalamin is excreted more quickly, injections must be more frequent (monthly rather than every 3 months).
We no longer use cyanocobalamin injections on the NHS but as they are both preparations of B12 why on earth would there need to be a differentiation in the treatment route?
In the references from this same document we find this in Canadian paper Cobalamin (vitamin B12) and Folate Deficiency
Canada use cyancobalamin they state – Injection (IM or subcut): 1000 mcg/mL
Where they state: …1 mg hydroxocobalamin administered subcutaneously once per week…
Many people have no choice but to buy safely and cheaply from online pharmacies in order to keep themselves well in the absence of any help from their GP. In the German manufacturers PIL (Patient information leaflets) for hydroxocobalamin they state that B12 can be given subcutaneously or intramuscularly, so why when other countries understand that B12 can be given by both routes did the UK only license it for intramuscular?
More MP’s in the game
Jane has now heard from more MP’s who have had communication from their constituents on this issue and they are: Peter Aldous, Alex Chalk and David Duguid.
We have been trying to meet with Ministers since the Westminster Hall debate. On the 24th of April Jane Hunt had a meeting with Minister Maria Caulfield who was Parliamentary Under-Secretary of State for Mental Health and Women’s Health Strategy regarding our request to make B12 OTC. Jane stated that the meeting was positive and that the Minister understood the case. They discussed the letter from the MHRA and the Minister felt it was was very encouraging. This is the letter that stated that we needed to wait until NICE published its new Guidance.
Now though, our OTC request case has been passed to Will Quince the Minister of State and he sent the following letter to Jane on the 26th of June 2023.
Years ago I explored the cost of Marketing Authorisation Holders (those who sell produce and supply B12 in the UK) applying for a new classification. This cost, in the grand scheme of things, is peanuts but there was always the legislation of injectables in the way. So, who would apply for something that wouldn’t be allowed? Absolutely no one. Lets hope this road block is about to change.
Jane heard yesterday that a meeting had been arranged with the MHRA and this take place in September.
When I first met with the MHRA in London years ago, they invited me down to an early morning meeting in London just to tell me “there is nothing we can do to help” It was expensive, frustrating and depressing and there’s been many of those occasions over the years. In all that time my both MP and the CEO of the MHRA has changed. MP Jane Hunt has heard me ‘chinning on’ for 10 years about B12 because she was my former MP’s case worker and consequently she is very aware of just how devastating this deficiency can be.
Let’s hope that maybe now, all these years on, that we sit in a different and more helpful landscape?
Fingers, toes and everything else crossed!