How to get Cariban on the DPS/medical card
If you have tried to get Cariban covered since January 2023, and/or you are a healthcare provider in maternity care - please give your insights and experience anonymously here. Your experience & knowledge could help the next patient navigate their care, and let the HSE know how this process needs to change.
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. Other brands are licensed, but not marketed here, despite contact from us. One other brand, Xonvea, 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 is medically unnecessary, increases burden on hospitals, and also on patients - particularly public patients. Our full statement on this is here. It has also been criticised by the Irish Pharmaceutical Union as “difficult in practice and creates needless access inequalities”. The Minister has 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 is 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 have been told this review will require "several months" of data, and we have repeatedly sought further clarification from the Minister and the HSE on what this review will involve, how patients and clinicians will be consulted, and when any recommendations will be implemented.
As of 31 May 2023, 1,376 women have been approved for Cariban reimbursement, but we are 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, 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 write the initial prescription and sign off the form - access is no longer Consultant-only.
- 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 are welcome improvements but still mean inequality of access as patients must visit their hospital in early pregnancy - before their booking visit - which is 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 this year; whatever processes that have been put in place will need to change again and the PCRS have no plans to issue an updated circular, or to communicate directly with maternity hospitals and pharmacies.
We have not yet heard anything further on the report promised by the Minister for Health for end of July 2023.
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.
How you can support #HG2costly