High court decision on NHS England’s power to fund PrEP
Last Reviewed 2/08/2016
By Louise Coleman
We have now heard that the National AIDS Trust (NAT) has won their judicial review against NHS England on HIV preexposure prophylaxis (PrEP).
What is the history here?
Pre-exposure prophylaxis is the use of antiviral medicines for the prevention of HIV. These are the same medicines used to treat HIV, but given before exposure to people who are at high risk of contracting the virus. This has been shown in a number of studies to be quite effective at reducing the spread of the disease in high risk populations, if the medicines are taken regularly.
The HIV Clinical Reference Group drafted a policy for commissioning PrEP, which it proposed for consideration as part of NHS England’s specialised services annual prioritisation process. However, NHS England decided that it would not include the PrEP policy in the prioritisation process, due to take place at the June Clinical Priorities Advisory Group (CPAG) meeting. They cited a regulation which described local authorities as the responsible commissioner for HIV prevention services, along with other sexual and public health functions.
NHS England said that this meant that they did not have the legal power to commission HIV prevention, and that including PrEP for consideration in competition with specialised commissioning treatments as part of the annual CPAG prioritisation process could present a risk of legal challenge from proponents of other treatments and interventions that could be displaced by PrEP if NHS England were to commission PrEP.
What was the High Court case about?
NAT, on the other hand, argued that local authorities do not have sole responsibility for HIV prevention in England, and that there is nothing to prevent NHS England from commissioning PrEP should it wish to. They made a claim for judicial review of NHS England’s decision that they are not the responsible commissioner.
Judicial review is a type of court proceeding in which a judge reviews the lawfulness of a decision or action made by a public body. They are a challenge to the way in which a decision has been made, not whether conclusion reached was correct. In this case, Mr Justice Green in the High Court said NHS England had erred and that both it and local authorities were able to fund PrEP if they so chose.
So NHS England is now going to commission PrEP?
Well, not necessarily. This judgement does not mean that NHS England will automatically commission PrEP, only that they should not have excluded the proposal to commission PrEP from its prioritisation process. As a result, they need to rerun the prioritisation process, with the PrEP commissioning policy included.
We do not yet know which priority level the PrEP commissioning policy will fall into, as this will depend on the price the manufacturer offers NHS England and how the members of CPAG weigh different factors in their decision making.
What happens now?
NHS England has announced its intention to appeal this decision, however the outcome will not be known for some time.
In the meantime, NHS England will publish a draft policy proposition for the potential commissioning of PrEP for public consultation as soon as possible. The CPAG will be then be asked to re-run the prioritisation process as soon as practicable, likely in October. They will assign each policy (PrEP and the policies and treatments from level 3-5 of the previous prioritisation process) to one of five priority levels relative to the other policies considered, just as they did at the June CPAG meeting. Then policies and treatments will be funded as far down the priority rankings as the funding will stretch, as was the case previously. This prioritisation will then form the basis of commissioning decisions for what remains of the 2016/2017 commissioning cycle, if NHS England is unsuccessful in its appeal against the High Court decision.
What does this mean for people affected by genetic and rare conditions?
Those policies and services considered to fit into levels 3 and 4 of the original Clinical Priorities Advisory Group prioritisation round, and previously provisionally set to be funded, will be placed on hold, pending the outcome of a new prioritisation round. These policies, which may yet be displaced and not therefore funded, include:
brainstem implants for children with missing auditory nerves
ivacaftor for children aged 2-5 with cystic fibrosis (named mutations)
pegvisomant for acromegaly as a third-line treatment (adults)
haematopoietic stem cell transplantation for lymphoplasmacytic lymphoma in adults
pasireotide for Cushing’s disease
sodium oxybate for narcolepsy with cataplexy in children
rituximab for immunoglobulin G4 related disease
Those policies which fell into levels 1 and 2 have had their funding confirmed, and will shortly be made available to patients. These include:
plerixafor for stem cell mobilisation in children
stereotactic radiosurgery/radiotherapy for ependymoma, haemangioblastoma, pilocytic astrocytoma and trigeminal schwannoma
tocilizumab for Takayasu arteritis
treatments for graft versus host disease following haematopoietic stem cell transplantation
treatment of iron overload for patients with inherited anaemia
Several treatments for genetic and rare conditions were placed in level 5 and so not prioritised for funding. These include:
eculizumab for treatment of recurrence of C3 glomerulopathy post-transplant
everolimus for subependymal giant cell astrocytoma associated with tuberous sclerosis complex
riociguat for pulmonary arterial hypertension
second allogeneic haematopoietic stem cell transplant for relapsed disease in adults
However, as NHS England have suggested in their statement that prioritisation process will be completely run again for all treatments and policies which did not receive a ranking of 1 or 2, there is a chance that these medicines may be commissioned after all. Manufacturers of these treatments, as well as those in levels 3 and 4 listed above, will be offered the opportunity to reduce their pricing to increase their likelihood of being prioritised when the process is repeated.
If PrEP is prioritised for funding, it is likely that one or more of the policies or treatments which had provisionally agreed funding will be displaced and no longer funded. However, due to the opportunity for manufacturers to offer revised pricing arrangements, there may be some changes to the priority rankings previously given to other policies and treatments. As a result, we may see a policy or treatment not previously prioritised for commissioning ranked higher against alternative interventions by CPAG, and so be able to be commissioned.
If NHS England is successful in its appeal, on the other hand, the prioritisation decisions made in June will stand, and these will be implemented, after several months more delay to a process which has already taken far too long.
We share the frustrations of the rare and genetic disease patient communities regarding the further delay and uncertainty in specialised commissioning decisions for 2016-17. We see this as a further example of the need for NHS England to become better organised in the planning of resource allocation, to stop the regular occurrences of patients and their families being asked to wait around for crucial decisions.
We are eager to see the rationale for the ranking of treatments in this year’s prioritisation decisions, and will judge the process based on this evidence. We will then continue to engage with NHS England to ensure this process works for the rare and genetic disease patient communities.
If you have any questions or comments about this article please contact our Policy Officer, Louise Coleman.