Anti-HIV drug may not come under HSE scheme until 2019

A revolutionary anti-HIV drug may not be available under the HSE payment scheme until 2019, a delay that could see up to 800 new infections, health groups have warned.

Pre-Exposure Prophylaxis (PrEP) is a once-daily medication that has been proven to reduce the risk of HIV infection, particularly among members of the gay community, by up to 90 per cent.

The cost of PrEP is not covered by the HSE, although it can be obtained privately with a doctor’s prescription at a cost of €400 a month.

Gay rights activists say most people can’t afford this, leading many to import it from abroad, a practice which is illegal in Ireland.

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On Friday, the HSE said an assessment was taking place on whether it would be cost effective for it to cover the cost of the drug.

The assessment is being carried out by the National Centre for Pharmacoeconomics (NCPE). In June the NCPE conducted a “rapid review” which is an initial assessment of the drug.

This was completed in late July and a full assessment was recommended. However, this assessment cannot progress until the manufacturers of the PrEP, Gilead Sciences, make a formal application to the HSE.

This application has yet to be received. The HIV activist group Act Up has warned it might be 2019 before the process is completed.

Rise in infection

There has been a dramatic rise in HIV infection rates in Ireland in recent years. More than 500 new cases of HIV were diagnosed in 2016, the highest rate since records began.

Andrew Leavitt of Act Up said Ireland was experiencing an "epidemic" of HIV.

“The way you deal with an epidemic isn’t sitting back and waiting for the prices to become more affordable. They need to really stop worrying about paying a little bit extra for a couple of years and they need to start to deal with this in a serious way.”

On Friday activists gathered outside the headquarters of Health Products Regulatory Authority (HPRA) to protest against a crackdown on the significantly cheaper generic version of PrEP, which is being imported into the country by many people for personal use. Since the beginning of the year, eight shipments totalling 630 tablets have been seized by customs.

The protesters demanded that the HSE fast-track the PrEP evaluation process and start paying for it immediately.

Minister of State for Drugs Catherine Byrne has indicated that the assessment process will take between six months and a year. Mr Leavitt said that, assuming the assessment was positive, additional administrative and budgeting processes would then have to take place which could mean it would be 2019 before it becomes available on the HSE scheme.

According to the national clinical lead for sexual health services with the HSE, Dr Fiona Lyons, officials are preparing for PrEP while the assessment takes place to avoid delays if the review is positive.

“We have a multi-sectoral PrEP working group that has been convened,” she said. “We have been doing quite a bit of work to understand what the system needs to know to be ready for PrEP if it becomes reimbursed.”

The HPRA said it “strongly advises the public not to procure prescription-only medicines from online or other illicit sources.” It said there was no guarantee the drugs ordered online were genuine or effective.

Gilead Science’s patent on PrEP has expired meaning cheaper generic versions could soon come on the market in Ireland. However, Gilead recently launched a High Court action to prevent other companies selling the drug here.