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

 

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

RTÉ

TU Dublin research suggests improvements in severe morning sickness treatment (radio version here)

Calls to reform access over drug to treat severe vomiting in pregnancy

Calls to reform access over pregnancy drug Cariban

Anti-Nausea Pregnancy Drug Still Not on the Drugs Payment Scheme Nor Covered by the Medical Card

The Journal

Women to access pregnancy sickness meds through GP from August under HSE deal

Talks underway with pharma companies to ensure women can access pregnancy sickness meds through GP

Obstetrician: 'Some women with Hyperemesis are choosing not to continue with their pregnancy'

Overcomplicated: Reimbursement scheme for pregnancy drug criticised by pharmacists

HSE looking into whether 'special arrangement' possible for access to severe pregnancy sickness drug

Minister 'hopeful' positive outcome can be reached to help women with severe pregnancy sickness

Health Minister insists State won't reimburse cost of drug to treat severe pregnancy sickness

Group to investigate options for funding severe pregnancy sickness drug to make it more available

Newstalk

Hyperemesis: 'No rationale whatsoever for needing consultant to prescribe drug'

How common is Hyperemesis in Ireland? 

'Like Having a Hangover for Eight Months', goverment urged to pay for costly pregnancy medication

Irish Examiner

Study finds why morning sickness is more severe for some pregnant women

Hyperemesis: 'I couldn't move without vomiting. I couldn't sit up or go to the bathroom'

Hyperemesis: I wouldn’t be able to walk, talk, or work without Cariban 

Government moves to reduce the cost of pregnancy medication

Viagra is on the medical card but Cariban cost me €3k

Farmers Journal

Consumer Watch: The Cost of Cariban

Red FM

Cork mother of two calls on Health Minister to meet with Hyperemesis suffers as he considers funding Cariban. 

Cork's 96fm 

The Opinion Line Podcast Extra

Sunday World

New mum who vomited 20 times a day gave up home due to cost of anti-nausea meds

Business Post

Top medic: ‘If the state can pay for Viagra, it can pay for extreme pregnancy sickness drugs’

The Echo

'It stole the joy of my pregnancy...'

Irish Times

State refunds Viagra costs but women must pay for severe pregnancy sickness drugs, Seanad told

Everymum.ie

How a crippling medical condition made it tough for me to enjoy being pregnant

Irish Independent

Extreme pregnancy sickness: I couldn’t afford the medication and three years on, I’m still suffering the consequences

East Coast FM

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