From babygrows to buggies, co-sleepers and cots, babies cost a lot of money. But usually, these are cute and fun purchases.

An expense that many pregnant women and their partners don’t anticipate when they see those double lines is expensive medication.

And one of the most expensive medications that some pregnant women have to buy is a drug called Cariban.

Cariban is prescribed to women who suffer from hyperemesis gravidarum. Many women experience morning sickness especially in the early weeks of pregnancy.

However, hyperemesis is an extreme form of nausea and vomiting which can last right throughout the 40 weeks of pregnancy. It affects about 1% of women who are usually admitted to hospital due to dehydration and malnourishment.

However, it is thought to affect even more women who never get an official diagnosis.

High costs

Forget dry crackers and ginger ale, there are very few things that offer relief, apart from a drug called Cariban which contains the ingredient doxylamine/pyridoxine which alleviates the nausea and vomiting. And Cariban is hitting the headlines recently as there is a campaign building to help women with the price of it.

That’s because Cariban is not covered under the Drugs Payment Scheme (DPS), which as of last week is now capped at €80. Instead Cariban can cost as much as €280/month, over triple the amount that is covered by the DPS.

A spokesperson from Hyperemesis Ireland, a voluntary organisation to support women dealing with the condition, says: “Based on a survey of over 1,000 women in our support group, the average price they were paying per tablet is €1.80. If someone is taking the prescribed four tablets a day, they are looking at €7.20 a day, which adds up to €201/month. Over 20 weeks, which would be quite conservative, women are paying €1,008.

“And that’s the average price. Some women are being charged up to €2.50 a tablet, which means they could be paying as much as €280.”

Government needs to step up

For many years, there has been a call to bring Cariban in under the DPS. After all, since 2015, the HSE has listed Cariban as the first line of treatment for hyperemesis. That is seven years of recommending the drug but not supplementing it.

In recent weeks, the campaign has gathered traction, spurred on by the support of some pharmacies around the country who are now selling Cariban at cost price (see below). It has been discussed in Cabinet and put before Minister for Health Stephen Donnelly. However, the HSE is still not forthcoming enough with information.

Answers needed

The Government has publicly stated that Cariban is not a licenced drug and therefore, cannot be supplemented under the DPS. In a statement to Irish Country Living, the HSE stated that: “The HSE advise that Cariban (doxylamine/pyridoxine) does not have a marketing authorisation from the HPRA or the EMA. Therefore, as Cariban is an unlicensed product in Ireland, it is not reimbursable under the community drug schemes.”

However, through pharmacists, Irish Country Living is aware of 10 medications that are also unlicensed and yet they are permitted under the DPS. These include Androcur, a medication to control sexual desire in men who have an increased sex drive, Utrogestan to supplement progesterone and Colchicine Tiofarma to treat gout flare ups.

Irish Country Living asked the HSE why they are permitted but Cariban is not and despite the query sitting with the HSE for two weeks and multiple emails, we received no reply from this State body.

Food supplement versus medication

In its statement, the HSE also stated that “as Cariban is considered to be a food supplement rather than a medicinal product in Ireland, it cannot be considered for reimbursement as an Exempt Medicinal Product under the GMS and Community Drug Schemes, or reimbursement under Discretionary Hardship Arrangements”.

Yet pharmacists have challenged this, saying that Cariban is treated as a medicinal product in VAT terms by Revenue, it cannot be sold over the counter like a food supplement and it can only be dispensed with a valid medical prescription

Irish Country Living asked why this drug, essential to some women to combat vomiting, is considered a food product. Again we received no reply.

The statement also read that: “The HSE has asked the Medicines Management Programme to examine the appropriateness and feasibility of a patient specific arrangement for the product.” Irish Country Living asked for a timeline on this, to give women some indication of action on the subject. Once again, we received no response.

The real issue here isn’t Cariban, it is the medical ingredient doxylamine/pyridoxine. There are other licensed versions of doxylamine/pyridoxine: Exeltis (which was granted its licence quite recently, in December), Navalem and Xonvea. If the pharmaceutical companies sold these products in Ireland, then one could assume that as licenced products, they would be available under the DPS.

In its statement, the HSE did advise that to date, it has not received a pricing and reimbursement application from Navalem.

It did, however, receive a pricing and reimbursement application for Xonvea on the 23 July 2019 and commissioned the rapid review process on the same day.

It states: “The Rapid Review assessment was completed by the Na-tional Centre for Pharmacoeconomics (NCPE) on 15 August 2019 in line with agreed processes.

“However, in late 2021, the company responsible for the commercialisation of this product advised that they are not in a position to launch Xonvea in Ireland at this time. The HSE therefore cannot currently progress this application further within the national pricing and reimbursement processes.” In short, the one strong progression of the issue came to a standstill late last year.

What does it mean that a drug is ‘unlicensed’?

There are a lot of unlicensed drugs, including Cariban, that are safe to use – after all, the HSE recommends Cariban as the first line of treatment for hyperemesis. It means the company hasn’t invested in getting a licence in this country, most likely due to cost. It is often because the market is too small for the investment. Although hyperemesis affects a lot of women, it is still a relatively small percentage of the population who only use the medication for a finite amount of time, ie during the nine months of pregnancy. And the Irish market would be considered very small compared to other European countries.

Pharmacists make their stand

Despite lack of progress from the Government, it is the pharmacists of Ireland who are making a difference to the lives of women affected by hyperemesis.

Last month, Stratus Healthcare Pharmacy in Waterford became the first pharmacy to offer Cariban at cost price, and since then over 40 pharmacies nationwide have followed suit.

Supervising pharmacist and pharmacy manager Paula Clancy says: “We have been following the campaign for years but more importantly, we are seeing what is happening on the ground. We have had pregnant women hand in their prescription and absolutely baulk at the price.

“Some pay but we have seen the situation where others, have had to leave the medication on the counter because they cannot afford it. Others take less than prescribed, maybe one or two to get through the day rather than the four tablets that are prescribed.

“Because the medication is unlicensed, it is coming in from abroad, and so the price varies. So women are looking at between €70 and €80 a week. We decided that because the campaign needed help to progress, we would offer at cost price which works out about €40 a week in the hope that it would help women financially and encourage other pharmacies to follow suit.”

Now, Paula says that women are travelling cross-county to get their prescriptions from them and as they deliver nationwide, are sending the medication as far as Cavan, Dublin and Limerick.

What’s happening in other countries?

  • Doxylamine/pyridoxine is available over the counter in Spain at approximately €0.80/tablet and as a result, many women will ask friends and family to bring supplies back from holidays.
  • In the UK, all prescriptions and NHS dental treatment are free while you are pregnant and for 12 months after your baby’s due date. Xonvea is licensed in the UK and available on prescription.
  • In Germany, Cariban is available by prescription there. It is almost fully covered through health insurance and women would pay no more than approximately €5/prescription. CL
  • Personal experience: my story

    For articles like this, we usually call upon a reader to give their own personal experience. But for this piece, I didn’t need to look far.

    I suffered from hyperemesis throughout my pregnancy in 2019. I remember the day, even the hour when it hit. It was exactly one week after I found out I was pregnant. I came home from work and was feeling tired so I went for a nap. I woke up an hour later and it felt like I was on a small boat on a rough sea. I vomited that night and it felt like I stayed on that boat throughout my pregnancy, although it did ease in the later weeks.

    At its peak, I was vomiting between five and seven times a day. There was no rhyme or reason to it. I could eat a plain chicken dinner one day and that would be the very thing that made me sick the next day. I would go from bed to work and back to bed.

    The very worst day was a Sunday when I was 16 weeks pregnant. I vomited all day and couldn’t keep down water. Up until this point, I just assumed it was morning sickness, like so many other women suffer in pregnancy.

    I happened to have a hospital appointment the following day and after my consultant took a urine sample, she admitted me straight away as I was severely dehydrated from the vomiting. She said I would probably only be in overnight. It was five days later, after 10 bags of fluid before I was discharged with the diagnosis of hyperemesis gravidarum.

    I had been prescribed Cariban a few weeks before that but because I was so petrified of taking medication while pregnant and due to the cost, I was taking it once or twice a day. My doctor advised that it was much safer for me to be on this medication rather than vomiting and dehydrated.

    After that, I stayed on Cariban four times a day every day until the end of my pregnancy. It wasn’t a magic pill that made all my symptoms disappear but it certainly allowed me to live my life more normally.

    However, the cost was crippling. Due to another condition, I had to get other prescription medication. At the time, the cap on DPS was €124/month. I was also buying Cariban on top of that, which was €200/month. So there were some months in my pregnancy when I was paying €334/month on medication, and that didn’t include the over-the-counter supplements to ensure the baby was getting nutrients when I was sick.

    I say ‘some months’ because as my pregnancy progressed, I coped onto the fact that Cariban was available over the counter for a quarter of the price in Spain. I could get a month’s worth of Cariban in Spain for the same price as one week in Ireland. So friends and family that were off on their holidays used to stock up on the medication for me. This isn’t right but it was the reality.