WIREDGOV

NHS England yesterday (2 July) set out its planned investment decisions for certain specialised services as part of its annual commissioning round.

The decision follows a three month public consultation on the principles and processes NHS England will follow when making investment decisions. Feedback from the consultation has helped inform the way these decisions have been made. NHS England has listened to the views of patients and service users and also taken advice from clinical experts and the independently chaired Clinical Priorities Advisory Group.

Thirty nine proposed new investments have been carefully considered against the principles NHS England follows when making investment decisions. The principles can be found in:

http://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/06/nhse-respns-publictn-17-06-15.pdf

The following treatments and services will be routinely commissioned:

• Duodopa as a treatment to control the symptoms of patients with advanced Parkinson’s Disease
• A programme of BRCA1/2 gene testing, helping women to discover if they have harmful genetic mutations which can increase the likelihood of developing breast or ovarian cancer
• A raft of new genetic tests to be provided by the UK Genetic Test Network
• Widening access to Proton Beam Therapy for certain types of cancer, for both children and adults
• New treatments – bedaquiline and delamanid – for drug-resistant tuberculosis
• Robotic-assisted surgery for early stage prostate cancer
• Cervical disc replacement to address spinal degeneration
• Extending treatment with Ivacaftor for Cystic Fibrosis with the G551D mutation
• Riociguat for use in chronic thromboembolic pulmonary hypertension
• Sildenafil and Bosentan for digital ulceration in systemic sclerosis
• Intrathecal drug delivery for cancer pain
• Occipital nerve stimulation for intractable headaches & migraine
• Rituximab for steroid sensitive nephrotic syndrome in children
• Rituximab for steroid resistant nephrotic syndrome in children
• Rituximab for acquired haemophilia
• Biologics for Juvenile Idiophatic Arthritis in children and adults
• Sacral nerve stimulation for urinary incontinence and retention
• Management of fetal anaemia secondary to red cell alloimmunisation (Fetal transfusion)
• A new service for hand transplants, giving those with amputated forearms an alternative to prosthetics
• New guidelines on the use of Positron emission tomography–computed tomography (PET-CT)
• Elvitegravir/cobicistat/emtricitabine/tenofovir for treatment of human immunodeficiency virus (HIV) Type 1 infection in adults
• Cobicistat for booster in treatment of HIV positive adults and adolescents
• A Treatment as Prevention programme for patients with HIV, to both reduce mortality and illness for the patients themselves and the risk of transmission by reducing viral load

The following treatments and services will not be routinely commissioned:

• Two separate policies on Deep Brain Stimulation for chronic pain and refractory epilepsy
• Three separate policies on new types of prosthetic limbs
• The use of Sapropterin to treat the rare genetic condition Phenylketonuria (PKU) in children.
• Eculizumab and Bortezomib for prevention of organ rejection post kidney transplantation
• Cytoreductive surgery with HIPEC for peritoneal mesothelioma
• Intrathecal Drug Delivery for chronic non-cancer pain
• Infliximab (Remicade) and Adalimumab (Humira) Anti-TNF treatment options for adults and children with severe refractory uveitis

NHS England has agreed with the recommendations from CPAG that final funding decisions on the following two treatments should be made after NICE has concluded its Highly Specialised Technology Appraisal process:

• Elosulfase alfa (Vimizim) for Morquio A Syndrome.
• Ataluren (Translarna) for Duchenne muscular dystrophy.

The NICE appraisal of elosulfase alfa (Vimizim) should conclude in 12 – 16 weeks’ time. NICE has said that doubts exist about the benefits and cost of this treatment in its recent draft guidance, and is therefore “minded not to recommend” the treatment for patients with Morquio A Syndrome. The manufacturer now has the opportunity to present additional evidence to NICE to address these concerns. If NICE ultimately does recommend the NHS funds this treatment then NHS England will do so. NHS England believes the manufacturer has an ethical duty to continue to support those patients it enrolled in clinical trials of elosulfase alfa whilst the NICE process is still ongoing.

NICE is expected to produce draft guidance on ataluren (Translarna) in October, with final guidance to follow shortly after. The medicines regulator has also asked the manufacturer to undertake further studies of the treatment for completion in October.

Three further clinical policies – one on new service standards for Gender Dysphoria treatment options and two policies on the use of Rituximab – that were due to be considered as part of this round of prioritisation are now expected to be considered later in the year once more evidence has been gathered and there has been further public engagement and consultation.

James Palmer, NHS England’s Clinical Director for Specialised Commissioning, said: “These are really difficult decisions, which is why we rely on NICE wherever possible, and make use of the best available evidence as well as extensive engagement with clinical experts, patient representatives and the public. The new policies we have been able to approve will help us to improve and extend thousands of lives for years to come through prevention, identification and treatment.”

Specialised services are those services which are provided from relatively few specialist centres. Conditions treated range from long-term conditions, such as renal (kidney services), to rarer conditions such as uncommon cancers, burn care, medical genetics and specialised services for children.

The clinical commissioning policies considered as part of this process will be made available on the NHS England website from tomorrow (Friday 3 July)

Groups representing patients and services users, and other stakeholders have been told the outcome of the decisions and have been 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 typically forms clinical commissioning policies as part of the annual round of service commissioning. Where more rapid interim decisions need to be made policies can also be developed through the In Year Service Review policy or through the development of a Policy Statement.

Additions to the work programme for policy development either come from recommendations from the relevant Clinical Reference Group, from the Individual Funding Request process if an intervention is declined as it is part of a ‘cohort’, or where a Critically Clinically Urgent policy decision has been made.

NHS England clinical policies will be replaced where NICE form either a Technology Appraisal or a Highly Specialised Technology Appraisal. It is the responsibility of provider Trust clinicians to maintain their knowledge of both NICE and NHS England national clinical policy for specialised services so they can inform their patients of treatment choice.

Routes remain open to clinicians for patients with exceptional or critically clinically urgent need, to access a certain treatment or service, even where a clinical commissioning policy has not been approved through this process.