Allergen-free infant formulas for cow's milk allergic babies under threat

Nathalie Newman's four-year-old son Callum is severely allergic to the proteins in cow's milk so she understands how vital access to cow's milk free formula is for babies like Callum.

She is extremely worried by the cost cutting measures being imposed by some Clinical Commissioning Groups which may mean that such formulae are no longer available on prescription.

To read about Nathalie and Callum's experience first, read on; to go straight to the issue, click here.

When you become a parent, it’s the most magical time. You stare in wonder at this incredible little being that you’ve created, and have a fiercely protective streak that is overwhelming. All you want to do is protect them, keep them safe and make sure that they don’t suffer.

So, imagine when just a few days or weeks old, they become colicky. It’s ‘normal’ for a baby you’re told, it’ll pass as they get a little older. Then add ‘reflux’ style symptoms, and it’s still classified as ‘normal’, but your little baby really isn’t happy or very well. In fact, most feeds it seems as if they’re throwing up more than they’re keeping down, so much so that you could even say it was projectile vomiting. How about an angry looking rash that becomes eczema, with weepy sore cheeks that don’t clear up in spite of moisturiser and topical steroids?

Throughout all of this there’s also a serious lack of sleep for both the baby and you, which is incredibly hard on the whole family, especially if there are other children who need your attention too!

Does this sound familiar?

We had all of these with Callum, especially the projectile vomiting, and severe eczema. He was breastfed, and most feeds I would have to line the floor with a towel to catch the volume of sick that would bounce back out of his little tummy.

Callum also never slept for more than 20 minutes at a time. He was so uncomfortable all the time he simply couldn’t. When his exhausted little body did let him sleep, it was troubled with itching, discomfort and more. His moses basket regularly looked like a murder had been committed, so sore was his skin.

For the best part of 2 years I survived on 3 hours broken sleep a night. To say it was torture was an understatement, and I still do not know how I functioned every day and held a job down too! It’s no wonder that mothers going through this situation often end up battling PND at the same time!

Despite numerous visits to the hospital for Callum, and eventually dermatology nurses for the eczema, it was regularly passed off as ‘normal eczema’ for him. The trouble is, it wasn’t. He was getting increasingly more ill, his symptoms getting worse and worse, and all the while, his little body was effectively being poisoned.

There is always a reason for symptoms the trick is figuring out what the cause is! In Callum’s case we now know that multiple allergies were at play, but most likely if these symptoms are occurring, it is because of dairy, or more specifically milk protein.

Cow's Milk Protein Allergy and specialist CMP-free infant formulae

One of the most common types of allergies in infants and young children is CMPA (Cow’s Milk Protein Allergy). It’s believed that as many as 1 in 5 children are now affected, although many go on to grow out of it by the age of 2.

Baby formula contains milk protein, and breastfeeding will transfer milk protein from the mothers’ diet. It’s difficult to get an initial diagnosis, as it is often passed off as colic or reflux, but once confirmed, a dairy-free exclusion diet for the mother or a specialist baby formula will be prescribed.

Specialist Baby Formula

There are a number of specialist baby formulas available, with two different stages being available.

The first is extensively broken down milk protein (hydrolysed). With the protein broken down so much, it is harder for the body to detect, and most babies won’t react.
For those babies that still react to this broken down protein, there is the second stage, an amino acid based formula such as Neocate which contains no milk protein at all.

These specialist formulas are prescribed by GP’s, Consultants, Health Visitors and Dieticians and are a medical treatment for CMPA so are not readily available over the counter. The best practice to date has been to trial a specialist formula for a minimum of 2 weeks to see if it makes any difference. If yes, then prescription continues and a referral to a Paediatric Consultant and Dietician should follow.

A tin is half the size of a standard formula tin, and costs significantly more. A standard tin is around £10-£12 while these specialist formulas cost around £30-£48.

Why is this so important?

A number of Clinical Commissioning Groups (clinically-led statutory NHS bodies responsible for the planning and commissioning of health care services for their local area) are voting to no longer prescribe specialist infant formulae. Croydon CCG was the first to do this, with Richmond CCG swiftly following suit. There are now a number of other CCG’s in consultation and considering doing the same thing.

Why are they doing this? Because the formulae cost too much.

We all know that the NHS is struggling and quite simply doesn’t have enough funds to keep running the way it has been. The thinking behind this decision is that by cutting the cost of these prescriptions, Croydon CCG will save the best part of £300,000 a year. A similar amount is proposed by Richmond.

But, this will mean that babies who need this formula will no longer be able to have it prescribed by their GP or Health Visitor.

With a very real struggle to gain initial diagnosis anyway, it means that babies and their parents who desperately need the support to diagnosis may well get missed. And those already diagnosed will no longer receive the prescriptions they require to keep their little ones well.

If a referral is made to a Consultant, then it will be up to the Consultant to prescribe the formula, and the cost will be out of their budget and not that of the GP. But the big point to make here is ‘if’ a referral is made! It certainly is not in all cases.

What are the implications?

This is a huge worry for parents, not least because it means they will no longer have the support they need from their GP.

Then there is the cost factor. As I mentioned before, a normal tin of formula is roughly £10-£12 and will last for around 1 week. Specialist baby formula costs up to £48 a tin, and the tin is half the size of normal formula. So:

Normal formula:

£12 per week (approx.)
£54 per month (approx.)
£624 per year (approx.)

Specialist formula:

£96 per week (approx.) based on 2 tins
£432 per month (approx.)
£2,496 per year (approx.)

As you can see, the cost implications are huge! And as these specialist formulae are not readily available over the counter, this could cause supply issues as well.

What cost to childrens' health?

I can understand why the CCG’s are attempting to save money where possible – we all do. And there has been a suggestion that the system has been abused as a means of getting ‘free’ formula when it’s not really needed for any medical need.

But by removing the cost from Primary Care, it becomes an immediate hit on Secondary Care budgets, which are already beyond stretched. And if there is no more budget available, it will be a challenge to find more. I’ve heard of allergy clinics being cancelled because they have run out of budget. Callum’s own Consultant admitted that his clinic is oversubscribed by almost 50%....

So it does beg the question, why do this at the potential cost of children’s health?

These parents will have struggled to gain a diagnosis, and will have finally found something that is helping their poorly child. But imagine if you are a low-income parent - how on earth will you find the money to feed your child with the specialist formula needed to keep them well?

And will a supply even be available over the counter? These formulas are regulated by the FDA and the rules for promoting them are very strong. Unless they have been prescribed, the pharmaceutical companies are not allowed to promote them.

My fear is that parents may turn to ‘normal’ formula as they have no other choice, which will result in their child becoming seriously ill again with potentially disastrous consequences.

The long-term costs to the NHS will be far greater

It’s all very well removing prescription formula from Primary Care budgets with a declaration that £300,000 will be saved off the CCG’s bottom line, but what if these babies become acute admissions to Secondary Care?

A missed diagnosis, extensive waiting lists to be referred to a Paediatric Consultant, and a severe allergic reaction, or a staph infection in severe eczema will result in an emergency admittance. These often mean a 4-5 day stay, requiring intravenous antibiotics, drips, and more to stabilise the baby/ child, along with further drugs to continue to stabilise once discharged home – with all the damage to the child's longterm health that this may involve.

How do I know this? Because I’ve had to go through it with Callum on a number of occasions!

The cost to the NHS? Between £2,000 - £5,000 depending on the level of care required.

Now imagine just 20 babies in this situation, and break the cost down:

20 babies using formula for 1 month = £4,320 (approx.) using 2 tins a week
20 babies admitted for 4-5 days = £100,000 (approx.)

Suddenly, that £48 tin should seem more appealing to their bottom line!

What is going to happen?

Social media has been inundated with worried parents pleading with CCG’s not to allow this to happen. There’s a real fear that their children won’t get the support they need, and that they will struggle desperately with the cost.

Specialist Allergy Consultants including Dr Adam Fox at Guy's and St Thomas' Childrens' Allergy Service have also provided evidence to suggest this really isn’t the way forward. They are at the front of the fight, seeing many patients a week affected by CMPA, and know first-hand the implications if these specialist formulas aren’t available to them.

I also work with some of the pharmaceuticals who manufacture the specialist baby formulas, and they have also provided evidence. It’s not about losing business for them. Indeed you’d be surprised to hear that many of the staff have had children affected by CMPA and want to stop other children going through what theirs did.

I really don’t know how this situation will end up, but I do know that if I was a parent with a baby relying on these specialist formulas, I would be desperately worried right now! It’s hard enough being an allergy parent and trying your hardest to keep your little one safe and well, let’s hope it doesn’t become any harder!

What you can do

Sign the petition to Parliament here.
Check into the Campaign for Milk Prescription Access (CMPA) here.
Individual CCGs release information when they go into consultation and invite the public to write in with their views. Contact your local group – you can find there details here on the NHS Choices website – find out when the consultation might be and write in to them with your objections. Be as brief as possible but make the short and long term health and financial implications for your family very clear. Do use Nathalie's figures above.
Write to your local MP. You can find his or her details here. Explain the issue briefly but once again make the short and long term health and financial implications for your family very clear.
Speak to your local paper and see if you can get them to write about it.
For more information about CMA, understanding the symptoms and how to get a diagnosis see www.cowsmilkallergy.co.uk

If you would like to talk to Nathalie, please email her here.

February 2017

For many many more articles and research reports on cow's milk allergy, cow's milk intolerance and lactose intolerance, including a video introduction – see here.