The clinical access policies published by NHS England mean that specialised services will be commissioned using a nationally consistent approach, thereby resulting in equal access to high quality services for patients, regardless of where they live. A short public consultation exercise was conducted between December 2012 and February 2013 to gauge views from patients, carers, the general public and wider stakeholders on draft versions of the policies. The consultation included a total of 135 service specifications and 44 clinical access policies. The draft service specifications are undergoing further engagement and consultation with stakeholders.
In addition to clinical commissioning policies, NHS England will also be developing a new approach for widening access to some services that are not routinely commissioned by the NHS. ‘Commissioning through Evaluation’ enables treatments or procedures to be commissioned initially on a limited basis whilst further evaluation is carried out to determine whether a substantive commissioning policy should be developed for future use. A number of treatments and medical devices are being considered by NHS England as potential subjects for the ‘Commissioning through Evaluation’ approach.
Clinical commissioning policies – medicines related
These are the versions that NHS England will adopt for the 2013/14 annual commissioning round.
1. Targeted Therapies for Pulmonary Hypertension Functional Class II (NHSCB/A11/P/a)
Treatments for patients with functional class II pulmonary hypertension will be commissioned in accordance with the criteria outlined in the policy.
2. Mecasermin (Increlex®) For Treatment of Growth Failure in Children and Adolescents With Severe Primary Insulin-Like Growth Factor-1 Deficiency (NHSCB/EO3/p/a)
Mecasermin will be commissioned for children and adolescents with growth failure due to severe primary insulin-like growth factor-1 deficiency (SPIGFD) in accordance with the criteria outlined in the policy.
3. Rituximab for Anti-Neutrophil Cytoplasmic Antibody-Associated (ANCA) Vasculitis (NHSCB/ A13/P/a)
Rituximab will be commissioned for ANCA associated vasculitis, in accordance with the criteria outlined in the policy document, for patients with relapsing disease, with primary treatment failure or with adverse reactions or contra-indications to cyclophosphamide.
4. Treatment of Acute Attacks in Hereditary Angioedema (NHSCB/B09/P/b)
Treatments for acute attacks in hereditary angioedema (includes C1 inhibitors, bradykinin receptor antagonists, icatibant, and recombinant C1 inhibitor) will be commissioned in accordance with the criteria outlined in the policy document. The policy notes that although there is some evidence to suggest that prophylaxis has a place in the management of a severe subset of patients, long term regular prophylaxis with any of the products will currently require prior approval by an Individual Funding Request Group Prior Approval from commissioners where there is a clinical indication for its use.
5. Disease Modifying Therapies for Patients with Multiple Sclerosis (NHSCB/D04/P/a)
Beta interferon, glatiramer acetate, natalizumab and fingolimod will be commissioned for the management of Multiple Sclerosis (MS) according to the starting and stopping criteria outlined in the policy document.
6. Intrathecal baclofen (NHSCB/D04/P/c)
Intrathecal baclofen (ITB) will be commissioned for patients with spasticity in accordance with the criteria outlined the policy document.
7. The Use of Hyperbaric Oxygen Therapy (NHSCB/ D11/P/a)
Hyperbaric oxygen therapy (HBOT) will be commissioned in accordance with the criteria outlined in the policy document for the following indications: decompression illness; gas embolism; acute carbon monoxide (CO) poisoning. HBOT will not be commissioned routinely for other indications. If exceptional clinical circumstances arise for patients with conditions other than those listed above these will be considered under the NHS CB Individual Funding Request Policy.
8. Sapropterin (Kuvan®) For Phenylketonuria: Use In Pregnancy (NHSCB/E12/p/a)
Sapropterin will be commissioned for phenylketonuria (PKU) in accordance with the criteria outlined in the policy document.
Existing national clinical policies and clinical policy statements which NHS England is adopting are:
1. Ivacaftor for Cystic Fibrosis (NHSCB/A01/P/b)
Ivacaftor will be routinely commissioned for the treatment of cystic fibrosis in patients aged six years and above who have the G551D mutation in their gene for the protein called cystic fibrosis transmembrane conductance regulator (CFTR) in accordance with the criteria outlined in the policy document and only if the manufacturer provides it with the discount agreed in the Patient Access Scheme.
2. Inhaled Therapy For Adults And Children With Cystic Fibrosis (NHSCB/A01/PS/a)
The policy covers the drugs aztreonam lysine, colistimethate sodium, dornase alpha and tobramycin. The drugs are to be routinely funded for the treatment of appropriate adults and children with cystic fibrosis in accordance with national clinical criteria (see Appendix 1 of policy document). Products that are available for administration by dry powder inhaler are available as an option only if they are supplied at a cost no greater than for the equivalent nebulised formulation. The policy notes, “At this time the known discount on dry powder inhalers is applied only if supplied via hospital or home delivery. Therefore GP shared care prescribing of dry powder inhalers is not supported.”
The policy remains effective until a final report is published by NICE, at which point it will be reviewed.
3. Targeted therapies for the treatment of pulmonary hypertension in adults (NHSCB/A11/PS/b)
Targeted therapies for adults with pulmonary hypertension will be commissioned in accordance with the criteria outlined in the policy document.
Clinical policy statements are interim statements which set out NHS England’s current position in relation to these services:
1. Amifampridine(Firdapse®) for Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS)
Amifampridine (Firdapse®) will not be routinely commissioned for the treatment of Lambert-Eaton Myasthenic Syndrome
2. Fampridine for Multiple Sclerosis
Fampridine is not routinely funded for the licensed indication.