Clarity needed on hyperemesis gravidarum drug reimbursement

Women affected by hyperemesis gravidarum (HG) still do not know if and when a vital treatment will be reimbursed on the Drugs Payment and medical card schemes.

HG is a complication of pregnancy in which women experience extreme levels of nausea and vomiting. Unlike regular pregnancy sickness which affects up to 80% of pregnant women to some degree, HG can be potentially life threatening without adequate treatment.

Around one in 100-150 pregnant women will be admitted to hospital due to the condition.

Only one brand of the medication used to treat HG (pyridoxine/doxylamine) is currently available in Ireland. This particular brand, Cariban, is unlicenced, but it is prescribed in hospitals and is recommended as the first line treatment in the HSE's own clinical guidelines for treating nausea and vomiting related to HG.

The medication can cost up to €2.50 per tablet and is usually prescribed to be taken four times a day, putting the monthly cost at around €300.

A year ago, the charity, Hyperemesis Ireland, launched the #HG2costly campaign calling for Cariban to be reimbursed on the Drugs Payment Scheme and the medical card.

The charity has had to support women who, due to the high cost of the medication, have had to  give up rental accommodation, take mortgage breaks, built up credit card debt, taken out loans and sought cheaper but potentially unsafe options online and abroad.

The #HG2costly campaign has received universal support from politicians across the political spectrum and from the medical community, including over 40 pharmacies who have joined an initiative started by Stratus Healthcare in Waterford to offer the medication at cost price until the matter is resolved.

The charity noted that for a long time, the HSE maintained that Cariban could not be reimbursed because it was unlicensed and said there was an application for reimbursement from a licensed brand, Xonvea, under consideration. The National Centre for Pharmacoeconomics recommended rejecting the Xonvea application on cost grounds in 2019, but the charity understands that no further discussions around pricing took place after this initial assessment.

As a result of the charity’s campaign and letters it wrote to the company behind Xonvea, the HSE and the company re-established contact but ultimately in late 2021, the company decided it was not in a position to proceed with bringing its product to market.

Following this development, the charity again called for Cariban to be included on the HSE's list of medications which are unlicenced but reimbursed. This time the HSE said in a statement that Cariban could not be reimbursed because it was classed as a food supplement.

However, the charity has been contacted by pharmacists who have challenged this for a number of reasons:

-Cariban is classified as an exempt medicinal product on the Health Products Regulatory Authority website

-It is treated as a medicinal product in VAT terms by Revenue

-It cannot be sold over the counter like a food supplement - it can only be dispensed with a valid medical prescription

-Pharmacists must maintain records regarding the drug for five years unlike with food supplements.

The charity has asked the HSE why Cariban is classed as a food supplement, but has not received a response.

Meanwhile, the HSE has asked the Medicines Management Programme to look into 'patient specific arrangements' to reimburse the drug, while the Minister for Health, Stephen Donnelly, has also asked the Women's Health Task Force to look into funding options.

However, Hyperemesis Ireland insisted that a clear timeline for a decision on funding is needed so that no more women with HG face financial hardship accessing basic treatment.

“A year on, we have been overwhelmed by the support we have received for our campaign and welcome the Minister for Health’s commitment to progress this matter. However, we need a clear timeline for a decision on how the situation will be resolved.

“This has been dragging on for too long now. Hyperemesis Ireland is doing all we can to support women. Now we need the HSE and the Women's Health Task Force to step up and do the same,” a spokesperson for the charity commented.

The charity also said that now would be a good time to prioritise the ongoing review of the clinical guidelines for treating HG, as these have not been updated since they were first written in 2015 and were due an update in 2018.

For more information on Hyperemesis Ireland, click here.