NHS England agrees to commission PrEP – but implementation questions remain

PrEP, the HIV prevention drug, will become available through an NHS England trial, it has been decided – ending a long-running dispute about responsibility for the drug.

NHS England announced in June this year that it would stop funding the drug on the grounds that local councils should take responsibility for HIV prevention, since they have a legal duty over sexual health services.

The National AIDS Trust (NAT) applied for judicial review of the decision, and the High Court ruled that NHS England should take responsibility for the drug.

An NHS England appeal against the ruling was rejected last month, after a controversial debate which saw the organisation accused by the Terrence Higgins Trust of using homophobic language.

But putting an end to the row, NHS England, in partnership with Public Health England (PHE), announced yesterday that it has decided to commission the drug after comparing its value for money to other treatments.

However, PHE warned of “significant outstanding implementation questions” that meant it is not yet clear how the drug can be commissioned sustainably on a large scale. It will therefore initially be available via a clinical trial, beginning early in the 2017-18 financial year. The three-year trial is estimated to cost £10m and reach at least 10,000 patients.

The clinical trial is then intended to answer these outstanding questions, “paving the way for a full roll-out”.

Deborah Gold, chief executive of NAT, said she was “absolutely delighted” at the news, but she added: “We continue to seek reassurance that access to PrEP will not be unduly limited by geography, that routine commissioning will continue seamlessly at the end of the trial and that all those expected to be eligible through routine commissioning will be able to access PrEP via the trial.”

Dr Jonathan Fielden, director of specialised commissioning and deputy national medical director at NHS England, also confirmed that NHS England will routinely commission 10 new treatments, following “tough decisions” about the funding process. These are:

  • Pegvisomant for acromegaly as a third-line treatment for adults
  • Auditory brainstem implants for congenital abnormalities of the auditory nerves or cochleae
  • Haematopoietic stem cell transplant :  Lymphoplasmacytic lymphoma /Waldenstrom’s Macroglobulinaemia (adults)
  • Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
  • Rituximab for immunoglobulin-G4 related disease (IgG4-RD)
  • Microprocessor controlled prosthetic knees
  • Tolvaptan for hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) for patients who require cancer chemotherapy
  • Ivacaftor for children (2-5 years) with cystic fibrosis (named mutations)
  • Sodium oxybate for symptom control for narcolepsy with cataplexy (children)
  • Pasireotide for Cushing’s Disease

Professor Kevin Fenton, PHE’s director of health and wellbeing, said that PrEP would hopefully help to cut the rate of HIV infections, which stands at around 5,000 a year.

“Given we are in the fourth decade of this epidemic there are too many new infections occurring, and we need to use all tools available to save lives and money,” he added.

Cllr Izzi Seccombe, chair of the community wellbeing board at the Local Government Association, which will work with NHS England to carry out the trial, said: “We are pleased that NHS England has acted quickly and chosen to fund the commissioning of this trial and rollout of PrEP. We now want to stand united with the NHS to defeat the spread of HIV.”

NHS England also said it would ask Truvada, which manufactures PrEP, to make proposals to participate in the trial, as well as generic manufacturers.

Call for routine HIV testing

On World AIDS Day on 1 December, NICE issued new guidance recommending that doctors offer HIV testing when patients come in with unrelated problems in the 20 local authorities with the highest rates of HIV prevalence.

Professor Gillian Leng, deputy chief executive of NICE, said: “We want to normalise HIV testing so it isn’t viewed any differently from any other blood test. There are now highly effective treatments for HIV and it should no longer be seen with fear or stigma.”

Dr Philippa Matthews, clinical lead for HIV, sexual and reproductive health at the Royal College of General Practice, said that while she welcomed the recommendation, it might be difficult to implement due to “immense resource and workforce pressures” at GP surgeries.

These included a lack of funding from local authorities and the difficulty of broaching the question of HIV testing during a 10-minute consultation for an unrelated problem.

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