#HG2costly

Update July 2024: you did it!

Cariban is now licensed. From 1st August 2024, Cariban will be available on the Drugs Payment Scheme and medical card from any prescriber - including GPs - without any additional forms or approvals.

Official circular and details from the HSE here.

Our statement:

We are delighted to hear that from 1st August 2024, Cariban will be available under the Drugs Payment Scheme and medical card including via GP prescription, the most accessible doctor in early pregnancy for all maternity patients. While we await clarity on some aspects of implementation from the PCRS, this is very welcome progress towards better access to treatment for HG.

This much-needed change is as a direct result of all the HG patients and healthcare providers who shared their experiences and spoke up. We look forward to working with them, and the HSE, on further improving treatment for HG.

The old process (see below) will remain active until the end of August for pharmacies to use up stock.

TheJournal.ie: Women to access pregnancy sickness meds through GP from August under HSE deal

Gov.ie: Minister for Health announces an expansion of the provision of Cariban for patients with Hyperemesis Gravidarum

Irish Medical Times: Pregnant women in Ireland can now access fully reimbursed Cariban (doxylamine/pyridoxine) through their GP or specialist for the treatment of nausea and vomiting in pregnancy

My first HG pregnancy was horrific. I couldn't access Cariban, and then I couldn't afford it. My daughter stopped growing and was born tiny, and I was left with several health problems afterwards. It took years for me to feel like I was ready to get pregnant again.

This time, I was given medication by my GP to take preemptively and then Cariban at 6 weeks. Even at its worst, it was easier than the first time. And this baby is measuring right where she should be. My second pregnancy (although still very difficult) has been a night and day difference to my first, and has been very healing for me.

So I just wanted to say a massive thank you to anyone who had a hand in the campaign to make Cariban accessible. To all the women who shared their stories, sent emails to TDs, who kept the momentum going to enact actual change, to Hyperemesis Ireland who spearheaded the campaign and saw it through - and to the group members who never fail to offer help and support. - Trish, support group member.

Background to the campaign

In February 2021 we launched a campaign called #HG 2costly, calling for the first line treatment for Hyperemesis Gravidarum to be reimbursed on the Drugs Payment Scheme and Medical Card.

The first-line treatment is doxylamine/pyridoxine, available in Ireland under the brand name Cariban (sometimes Nuperal or Navalit). Other brands are licensed, but not marketed here, despite contact from us. One other brand, Xonvea - which is now licensed in the UK - was rejected for reimbursement in 2019.

In response to the campaign, the HSE and Minister for Health gave various reasons why Cariban could not be covered:

Cariban is unlicensed: this is true, however other unlicensed medications are covered under the community drug schemes and regularly prescribed by GPs e.g.: Utrogestan, Androcur, Colchicine Tiofarma
Cariban is a food supplement: this is not true: pyridoxine is Vitamin B6 but the other active ingredient is an antihistamine.The HPRA confirmed this is not the case in February 2022. In any case, certain types of food supplements are covered under the community drug schemes e.g.: high-dose folic acid.

Reimbursement for 2023

In November 2022, the government announced that the cost of Cariban would be reimbursed from January 2023, and the HSE issued a circular with the details on the 3rd of January 2023.

However, this new process introduced a number of barriers to care, most crucially that Cariban is only reimbursable when (a) prescribed by a consultant and (b) accompanied by a specific, paper form filled in by the consultant and approved by the PCRS (see link above).

This was medically unnecessary, increases burden on hospitals, and also on patients - particularly public patients. Our full statement on this is here. It was also criticised by the Irish Pharmaceutical Union as “difficult in practice and creates needless access inequalities”. The Minister responded to parliamentary questions on this issue as follows: "Because Cariban is an unlicensed [product] it is being handled in line with the established procedures around clinical governance. This is that the initial prescriber of Cariban to the patient must be a specialist or a consultant and subsequent prescriptions can come from a GP."

This was in contravention of current common practice where GPs regularly prescribe unlicensed medications without consultant input, and is particularly unnecessary in the case of doxylamine/pyridoxine which is the first-line medication in the HSE guidelines and one of the most well-researched medications in pregnancy.

We have presented to the Oireachtas on this issue, and in February 2023 the Minister for Health announced a review into the process (which was then less than two months old). We were told this review will require "several months" of data, and we repeatedly sought further clarification from the Minister and the HSE on what this review would involve, how patients and clinicians would be consulted, and when any recommendations would be implemented.

As of 31 May 2023, 1,376 women had been approved for Cariban reimbursement, but we were still concerned about patients' necessary treatment being delayed by the onerous HSE process, leading to increased illness and therefore burden on the maternity system.

In July 2023, we met with the National Women's and Infants Health Programme to share our concerns and the interim results of our survey on Cariban access. In August, we wrote to the Primary Care Reimbursement Service (PCRS) to clarify issues patients had raised with us. They confirmed in writing that:-

Any doctor "under the supervision of the lead Consultant in a maternity hospital" can sign off the form but the initial prescription still must come from a Consultant.
The three-month limit to the form no longer applies; any doctor can write a repeat prescription and there is no need to get a new form approved.
Approval of the form applies for the whole month of the date on the form (details in our guide here).

These were welcome improvements but still meant inequality of access as patients had to visit their hospital in early pregnancy - before their booking visit - which was unnecessary and particularly burdensome for more rural patients, those with disabilities, and caring responsibilities.

Only nine of the 19 maternity hospitals were able to give any information on access procedures when contacted by us in April-May 2023; whatever processes that had been put in place then needed to change again and the PCRS did not issue an updated circular, or communicate directly with maternity hospitals and pharmacies.

In December 2023, the Minister for Health told TheJournal.ie "I think the criticisms of [the current process] are very fair, in that it’s obstetric-led and women have to wait maybe 12-weeks to see their obstetrician and they may need it before then,”. He also confirmed the HSE were in discussion with manufacturers of doxylamine/pyridoxine with the aim of getting it licensed and covered with a GP prescription as for other licensed medications.

Selected press coverage of #HG2costly and Hyperemesis

East Coast FM

We are grateful to Declan Meehan and The Morning Show for covering the campaign on several occasions.

Update July 2024: you did it!

Background to the campaign

Reimbursement for 2023

Selected press coverage of #HG2costly and Hyperemesis

RTÉ

The Journal

Newstalk

Irish Examiner

Farmers Journal

Red FM

Cork's 96fm

Sunday World

Business Post

The Echo

Irish Times

Everymum.ie

Irish Independent

East Coast FM