To ask the Secretary of State for Health, whether the six technologies undergoing Commissioning through Evaluation for which a positive commissioning policy is developed will be (a) required to be assessed by the Clinical Priorities Advisory Group for funding and (b) funded through the Innovation and Technology Payment.
To ask the Secretary of State for Health, what the timetable is for the Commissioning through Evaluation process for (a) Selective Dorsal Rhizotomy, (b) Selective Internal Radiation Therapy, (c) Percutaneuous Mitral Valve Leaflet Repair, (d) Patent Foramen Ovale Closure, (e) Left Atrial Appendage Occlusion and (f) Stereotactic Ablative Radiotherapy.
NHS England’s Commissioning through Evaluation (CtE) programme provides the opportunity for a limited number of treatments which show promise, but where there is currently insufficient evidence to take a routine commissioning decision, to gain ‘real world’ evidence as part of a formal evaluation programme.
The six procedures undergoing Commissioning through Evaluation are:
- Selective Dorsal Rhizotomy (SDR);
- Selective Internal Radiation Therapy (SIRT);
- Mitraclip™ ;
- Patent Foramen Ovale (PFO) Closure;
- Left Atrial Appendage Occlusion (LAAO); and
- Stereotactic Ablative Body Radiotherapy (SABR).
NHS England has not made an assessment of the cost of continuing to fund the treatments currently in the CtE programme once recruitment has closed as, until the evaluation is complete, the clinical commissioning policy to ‘not routinely commission’ remains in place. However, NHS England recognises the importance of minimising the gap between a CtE scheme closing to new recruits, the updating of its clinical commissioning policy in light of the new evidence and taking final funding decisions.
Similarly, given that treatments that have entered the CTE programme for evaluative purposes are currently covered by a 'not routinely commissioned' clinical policy, no formal assessment has been made of the number of patients who might have accessed this treatment had a 'routinely commissioned’ policy been in place at the point the scheme completed recruitment.
Through the collection and evaluation of data, NHS England is better able to reconsider its clinical commissioning policy for these treatments. Where the evidence generated by the scheme supports a routine commissioning recommendation, final funding decisions are taken in line with NHS England’s published Service Development Policy. This could result in the policy being entered into NHS England’s biannual clinical prioritisation process for funding or, if the relevant criteria are met, being introduced as an ‘in year service development’. Both these routes are supported by advice from NHS England’s Clinical Priorities Advisory Group.
Entry into the CtE programme does not, therefore, signal the start of routine commissioning. Rather, it is a mechanism for generating clinical evidence for innovative new treatments, which are often experimental, that would not normally be selected for National Institute for Health Research funded research.
NHS England supports clinicians who might consider a treatment that is not currently routinely funded by the National Health Service due to insufficient evidence of clinical and / or cost effectiveness and is covered by a time limited CtE scheme. This includes ethics approval where appropriate (for example in the handling of evaluative data), scheme-specific patient information leaflets and formal consenting arrangements so that patients are aware in advance about the questions remaining about the treatment’s effectiveness. Clinicians will be able to guide patients and their families through any available routinely funded NHS treatment options alongside any potentially accessible via the CtE programme.
The timetable for the completion of evaluation reports takes into account the patient follow up period specific to each scheme. For example, the scheme may require data to be submitted at one and two years post treatment to assess whether clinical improvements achieved by a procedure are maintained over a given time period.
The timetable for the six procedures undergoing CtE (which includes issues like access to treatment) are:
- SIRT - NICE evaluation report published October 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report;
- Mitraclip™ - NICE evaluation report expected to be available for publication in March 2018;
- PFO Closure - Patient recruitment completed March 2016. NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published;
- LAAO - NICE evaluation report expected to be available for publication November 2017. A review of the clinical commissioning policy is already underway and will be informed by the NICE evaluation report once published; and
- SABR – Patient recruitment planned to be completed March 2019. NICE evaluation report expected to be available thereafter.