The HIV preventative treatment pre-exposure prophylaxis (PrEP) has been approved for use within the NHS in Scotland.
The Scottish Medicines Consortium (SMC), which reviews newly licensed medicines, has today published advice accepting five new medicines for routine use by NHS Scotland.
“PrEP has rightly been described as a ‘game changer’”
Among them was emtricitabine/tenofovir disoproxil (Truvada) to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected – more commonly known as PrEP.
Emtricitabine/tenofovir disoproxil should be given as PrEP is “one aspect” of an HIV-prevention strategy and be used in combination with safer sex practices such as using condoms, said the SMC.
The consortium noted that patient groups had highlighted that current prevention methods have not managed to reduce the spread of HIV in Scotland over the last 10 years.
SMC chair Dr Alan MacDonald said: “Emtricitabine/tenofovir disproxil PrEP, when used together with safer sex practices may help to reduce the spread of HIV, which is an ongoing priority for the Scottish government.”
The British Association for Sexual Health and HIV (BASHH) welcomed the decision to approve PrEP, which can be taken daily or before sex to reduce the risk of acquiring HIV.
BASHH president Dr Elizabeth Carlin said: “PrEP has rightly been described as a ‘game changer’ and has been shown to reduce the risk of acquiring HIV infection by 86%.
“It is cost-effective for those at the highest risk and is one of the best evidence-based tools for reducing onward HIV transmission,” she said.
“As a next step, we urge that treatment is made available to the people that need it as quickly as possible, both in Scotland and ultimately across the whole United Kingdom,” she added.
The decision in Scotland follows a stand-off among public sector bodies over who would fund PrEP if it were introduced south of the border.
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NHS England had argued that it should solely be the responsibility of councils to fund PrEP, rather than the NHS, following the transfer of responsibility for public health commissioning.
However, in December, NHS England changed its stance and announced a major extension of the national HIV prevention programme via a largescale PrEP trial, to “pave the way” for its full roll-out.
The joint move, with Public Health England, followed a Court of Appeal ruling that NHS England, alongside local authorities, had the power, although not an obligation, to fund PrEP.
As well as PrEP, treatments for breast cancer, multiple sclerosis and leukaemia were also accepted by the SMC today for use in NHS Scotland.
Trastuzumab emtansine (Kadcyla) was accepted for use in Scotland to treat an aggressive, advanced type of breast cancer known as HER2-positive metastatic breast cancer.
It can offer patients a significant increase in overall survival and quality of life, allowing them to spend more time with their family and in some cases return to work, said the SMC.
Also accepted was ibrutinib (Imbruvica) to treat the rare blood cancer chronic lymphocytic leukaemia (CLL) in patients with disease that has relapsed after previous therapy.
Ibrutinib is an oral preparation that is better tolerated than currently available alternatives and has been shown to delay progression of the disease with potential improvement in quality of life.
“There were concerns about the relative safety of the clinical benefits it might offer”
In addition, the SMC backed daclizumab (Zinbryta) to treat severe or relapsing forms of multiple sclerosis. The disease modifying treatment drug can reduce the frequency of relapses and the progression of disability, and can be self-administered by the patient as a monthly injection.
Lastly, the SMC accepted ixekizumab (Taltz) for treating the inflammatory skin condition plaque psoriasis, extending the range of options for those who have failed to respond to standard therapies.
However, the SMC said it was unable to recommend ticagrelor (Brilique) for use for more than a year after a heart attack, due to “uncertainties” around the clinical benefit versus side effects.
The drug may be used together with aspirin to prevent problems caused by blood clots and hardening of the arteries, and is currently approved for up to one year after a heart attack.
Dr MacDonald added: “We were not able to accept ticagrelor for use in this setting as there were concerns about the relative safety of the clinical benefits it might offer.”
Scottish Liberal Democrat health spokesperson Alex Cole-Hamilton said he was “delighted” that the SMC had agreed to approve PrEP.
Mr Cole-Hamilton said: “One of my first questions as an MSP was about whether PrEP will be adopted. This is a massive victory for the campaigners and charities such as HIV Scotland who have been pushing for the introduction of PrEP. This decision will undoubtedly save lives.”