NHS England has lost a judicial review about whether it has the power to commission a preventative HIV drug.
The decision, which NHS England intends to appeal, means the arm’s length body will have to include pre-exposure prophylaxis (PREP) in its “prioritisation process”.
“We believe this will provide much-needed clarity”
However, NHS England has warned that other treatments that it had provisionally earmarked for commissioning could now get displaced if it ends up having to fund the drug.
Earlier in the year, NHS England said it could not consider funding PREP – which involves HIV negative people taking an antiretroviral drug to avoid getting HIV – because it it did not have the legal power to commission it.
The responsibility for commissioning preventative medicine in relation to sexually transmitted diseases rested with local authorities, NHS England claimed.
The National Aids Trust (NAT) lodged a judicial review to challenge the decision. Local authorities were also respresented in the litigation by the Local Government Association.
“The potential victims of this disagreement are those who will contract HIV/AIDS”
Mr Justice Green
At the Royal Courts of Justice today, Mr Justice Green said NHS England had “erred in deciding that it has no power or duty to commission” PREP, and in his judgment the organisation has a “broad preventative role”. He said even if he was wrong on this it was still his view that NHS England had erred.
In his ruling, he said NHS England had “mischaracterised the PREP treatment as preventative when in law it is capable of amounting to a treatment for a person with infection”, and it any event the body had the power to commission preventative treatments because it supported “the discharge of its broader statutory functions”.
The judge said at its core the judicial review was about “the allocation of budgetary responsibility in the health field”.
“[NHS England] says it has no power to provide the service and the local authorities say that they have no money,” he said. “The claimant is caught between the two, and the potential victims of this disagreement are those who will contract HIV/AIDS but who would not were the preventative policy to be fully implemented.”
The decision does not necessarily mean NHS England will commission PREP. Pending the outcome of its appeal, NHS England will put PREP through its prioritisation process, which it intends to re-run in October.
It said that to ensure it had sufficient funding to cover the £10m-20m annual cost of PREP if it was prioritised, it could no longer guarantee it would be able to commission nine treatments and services that it had provisionally earmarked for funding (see box below).
NHS England said it would invite Gilead – the company that makes the PREP drug – and the manufacturers of the drugs at risk of not being commissioned to submit “best and final prices” so the treatments could be “properly compared”.
Deborah Gold, NAT’s chief executive, said the judge’s decision was a “vindication for the many people who were let down when NHS England absolved itself of responsibility for PREP”.
Izzi Seccombe, the LGA’s community wellbeing portfolio holder, said: “By successfully challenging NHS England’s interpretation of the law, we believe this will provide much-needed clarity around the future roles of councils and the NHS on prevention services.”
In a joint statement, the British Association for Sexual Health and HIV and the British HIV Association said they “strongly welcomed” the outcome of the judicial review.
But in response to the ruling, NHS England said it had been advised to “seek to appeal against the conclusions reached by the judge as to the scope of NHS England’s legal powers under the National Health Service Act 2006”.
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“In parallel with that we will set the ball rolling on consulting on PREP so as to enable it to be assessed as part of the prioritisation round,” said Dr Jonathan Fielden, NHS England’s director of specialised commissioning and deputy national medical director.
Dr Fielden added: “Of course, this does not imply that PREP – at what could be a cost of £10-20m a year – would actually succeed as a candidate for funding when ranked against other interventions.
“But in those circumstances, Gilead – the pharmaceutical company marketing the PREP drug Truvada – will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned,” he said.
Proposals which NHS England cannot guarantee funding for
Level three priority ranking in last commissioning round:
- Auditory brainstem implants for children with deficiency or missing auditory nerves
- Ivacaftor for children (aged 2-5) with cystic fibrosis (named mutations)
- Pegvisomant for acromegaly as a third line treatment (adults)
- Prosthetics for lower limb loss
- Tolvaptan for hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) for patients who require cancer chemotherapy
Level four priority:
- Haematopoietic stem cell transplantation (Lymphoplasmacytic Lymphoma, adults)
- Pasireotide for Cushing’s Disease
- Sodium oxybate for symptom control of narcolepsy with cataplexy (children)
- Rituximab for immunoglobulin G4 related disease