WIREDGOV

NHS England yesterday (11th July) set out the results of its annual process for deciding which new treatments and services it will make available to patients.

Around a hundred policies were considered over the course of the year.

Many of these were considered as ‘In Year Service Developments’ – policies which are cost-saving or cost neutral. Twelve new treatments and services in this category have been confirmed today, and are listed below.

Policies which require new investment are considered as part of the Annual Prioritisation process. Eighteen new treatments and services, together with some new genetic tests for rare inherited conditions, have provisionally been identified as affordable within the resources available for this category of additional treatments this year.

However, final decisions on whether or not to commission these services cannot now be taken until the outcome of a judicial review on HIV prevention, the result of which may require the prioritisation process to be run again.

Draft versions of each policy have been guided by relevant Clinical Reference Groups – which comprise patients and clinical experts – and published for public consultation on the NHS England website on a rolling basis throughout the year.

Feedback received has been factored into the final policy propositions and helped to inform recommendations made on them by the independently-chaired Clinical Priorities Advisory Group (CPAG).

Annual Prioritisation – provisional results

In considering policies placed before it, CPAG followed the published procedure, which was subject to recent public consultation.

Policies were first grouped by CPAG into three categories of patient benefit, and then three categories of cost. This methodology allows for the proposals to be split into five levels of cost/benefit.

Policies with the greatest clinical benefit and lowest cost attracted the highest priority recommendation (level 1), while those with lowest clinical benefit and high cost attracted the lowest (level 5).

These recommendations are then used to inform commissioning decisions by the Specialised Commissioning Oversight Group (SCOG), which are then ratified by the Specialised Services Commissioning Committee of the NHS England board.

22 policies which would require additional expenditure were considered by CPAG across the five priority levels.

There is sufficient funding available in the expanded specialised commissioning budget for 2016/17 to enable the proposals in levels 1-4 of cost/benefit priority to be routinely commissioned. This means that they will be made available to patients who meet the clinical criteria set out in each policy.

However, this investment remains subject to the outcome of a judicial review which will determine whether NHS England has the power to commission the use of antiviral drugs for the prevention of HIV, given before exposure (known as PrEP, or Pre-exposure Prophylaxis) to individuals who are at high risk of contracting the virus – specifically, men who have condomless sex with multiple male partners.

Should the High Court decide that NHS England does have the power to commission this preventative service, a clinical commissioning policy on PrEP will need to be finalised, publicly consulted on, and then given a relative priority ranking against the other proposals listed below. This means that the policies in each priority level may change and some of the services provisionally set to be funded could be displaced and not therefore funded.

View NHS England’s legal advice on PrEP.

The 18 policy proposals which will be routinely commissioned, subject to the outcome of the judicial review, are:

Level 1

• Complex obesity surgery (children) for severe and complex obesity
• Use of plerixafor for stem cell mobilisation (update to include paediatrics)

Level 2

• Bone morphogenic protein-2 for spinal fusion
• Robotic assisted surgery for kidney cancer
• Stereotactic radiosurgery/radiotherapy for ependymoma, haemangioblastoma, pilocytic astrocytoma and trigeminal schwannoma
• Tocilizumab for Takayasu arteritis
• Treatments for Graft versus Host Disease (GvHD) following Haematopoietic Stem Cell Transplantation
• Treatment of iron overload for transfused and non-transfused patients with chronic inherited anaemia
• Penile prostheses for end stage erectile dysfunction (this is a service currently being commissioned by CCGs which will become NHS England’s funding responsibility from April 2017)

Level 3

• Auditory brainstem implants for children with deficiency or missing auditory nerves
• Ivacaftor for children (2 to 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 4

• 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

In addition NHS England will be routinely commissioning 30 new genetic tests for rare inherited conditions.  These tests have been recommended to NHS England for adoption by the UK Genetic Testing Network (UKGTN).

The four proposals with the lowest cost/benefit priority (level 5) are not currently affordable and will proceed to be published as not routinely commissioned – this will not be affected by the outcome of the judicial review. These policies will be considered again next year in the relative prioritisation process for 2017/18.

Those policies are:

• Eculizumab for treatment of recurrence of C3 glomerulopathy post-transplant
• Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
• Riociguat for pulmonary arterial hypertension
• Second allogeneic haematopoietic stem cell transplant for relapsed disease

Dr Jonathan Fielden, NHS England’s National Director for Specialised Commissioning and Deputy National Medical Director, said: “We want to thank the many patients, members of the public, clinical experts and groups who have contributed to designing and informing this process.  We’re pleased that we have been able today to announce new treatments and services to enhance the care and outcomes for many patients although we are frustrated, that we cannot yet confirm funding for an additional eighteen services whilst we await the outcome of a judicial review.”

“This is because, if NHS England loses the judicial review, we will need to consider displacing some of the proposed new treatments depending on the PrEP decision. NHS England is doing all it can to expedite these proceedings, which are preventing us confirming the new opportunities for so many.”

In Year Service Development Decisions

As described above, policies developed which are assessed as cost-neutral or cost saving are processed as In Year Service Developments – these are not subject to the ongoing judicial review.

NHS England will be publishing the following 12 policy proposals as In Year Service Developments for routine commissioning:

• Bone conducting hearing implants for hearing loss (all ages)
• Cinacalcet for complex primary hyperparathyroidism
• Immune tolerance induction for haemophilia (all ages)
• Palliative radiotherapy for bone pain
• Prophylactic treatment of hereditary angioedema (HAE) types I and II
• Radiotherapy for after primary surgery for breast cancer
• Rituximab for cytopaenia complicating primary immunodeficiency
• Rituximab for dermatomyostitis and polymyostis in adults
• Rituximab for immunobullous diseases
• Surgical sperm retrieval for male infertility (previously commissioned at CCG level)
• Tenofovir alafenamide containing treatments for HIV
• Ureothroplasty for benign urethral strictures in adult men (previously commissioned at CCG level)

NHS England has also published the policy proposals which were processed as In Year Service Developments and will not be routinely commissioned – these are listed below.

The clinical commissioning policies considered and finalised as part of this process will be made available on the NHS England website in due course, and communicated directly to relevant providers.

Groups representing patients, services users and other stakeholders will be told the outcome of the decisions and invited to meet with senior NHS England staff, where they will have the opportunity to hear in detail the rationale for each decision.

NHS England will be consulting on revised policies on In Year Service Developments and Individual Funding Requests later in the year.

The following treatments and services were considered and will be published as In Year Service Developments not for routine commissioning:

• Amifampridine phosphate – Lambert Easton Myasthenic Syndrome
• Argus II prosthesis – Vision
• Autologous Chondrocyte Implantation – Osteochondral lesions of the talus
• Chemosaturation – For metastases from an ocular melanoma where standard treatment options are not available
• Deep Brain Stimulation – post stroke pain
• Dornase Alfa inhaled therapy – Primary Ciliary Dyskinesia (All ages)
• Everolimus – Prevention of organ rejection following heart transplantation
• Extra corporeal membrane oxygenation service – Adults with cardiac failure
• Fampridine – Multiple Sclerosis
• Gastroelectrical stimulation – Gastropaerisis
• Infliximab – Hidradenitis suppurativa
• Inhaled Therapies Aztreonam (continuous use) – People with Cystic Fibrosis chronically colonised with Pseudomonas B
• Intravenous Immunoglobulin – Acute disseminated encephalomyelitis and autoimmune encephalitis
• Pasireotide – Acromegaly
• Personalised External Aortic Root Support (PEARS) – Surgical management of enlarged aortic root  (adults)
• Proton Beam Therapy – Prostate Cancer
• Renal Denervation – Resistant Hypertension
• Robotic assisted lung resection surgery – Primary lung cancer
• Robotic assisted surgery – Oesophago-gastric Surgery
• Robotic assisted surgery for bladder cancer
• Robotic assisted transoral surgery – Throat and voice box cancers
• Selexipag – Pulmonary hypertension
• Stereotactic ablative body radiotherapy – Hepatocellular carcinoma or cholangiocarcinoma
• Stereotactic ablative body radiotherapy – –previously irradiated tumours of the pelvis, spine and nasopharynx
• Stereotactic ablative body radiotherapy – Renal cancer
• Stereotactic ablative body radiotherapy for oligometastatic disease
• Stereotactic ablative body radiotherapy for prostate cancer
• Stereotactic radiosurgery – Adults with Parkinson’s tremor and Familial Essential Tremor
• Temperature-controlled laminar airflow device – Persistent allergic asthma (children)
• Teraparitide – Oesteogenesis imperfecta
• Tocilizumab – Giant Cell Arteritis
• Ziconitide – Intrathecal delivery for chronic refractory cancer pain