• NHS England clinical director warns of delays in Commissioning Through Evaluation reports
  • Delays could have “knock on effect” on future commissioning decisions
  • Charity claims patients are being denied access to potentially life saving treatment

Patients are being denied access to heart treatments that could prevent strokes or save lives, after an NHS England project was delayed, a charity has told HSJ.

NHS England’s Commissioning Through Evaluation programme enables limited numbers of patients to receive treatment that shows “significant promise” but is not currently funded by the NHS.

Left atrial appendage occlusion (LAAO), which could reduce strokes in people with atrial fibrillation, is one of the CTE projects under consideration.

Patent foramen ovale (PFO) closure, aimed at preventing recurrent strokes and improving survival rates, and percutaneous mitral valve leaflet repair for mitral regurgitation (MitraClip) used to treat patients with heart failure and prevent the need for open heart surgery, are also part of the CTE scheme.

However, NHS England is warning patient groups and charities of a two month delay in evaluating data, making “a knock on effect” on future commissioning decisions possible.

A charity representing people with abnormal heart rhythms believes the delay will deny high risk patients access to treatment that could prevent AF related strokes or even save lives.

The Arrhythmia Alliance and AF Association said LAAO already has approval in the US and has written to NHS England expressing concern over the delay.

A letter dated 28 June from James Palmer, NHS England’s clinical director of specialised services, said centres participating in the LAAO and PFO reviews have not submitted enough patient follow up data for evaluation to begin, and an extension had been granted until 31 July.

While the extension will not affect the timeline of the MitraClip scheme, Mr Palmer said NHS England wanted to gather the best evidence before considering policy changes to all three procedures.

His letter, seen by HSJ, said: “Unfortunately, this will delay the publication of the final evaluation reports for both the LAAO and PFO schemes by around two months, and may have a knock on effect on the timing of consideration of any future revised policy proposals.

“I understand that you may be disappointed with the decision.

“However, the clinical panel wants to ensure that future commissioning decisions for all three procedures are properly informed by all available evidence and that best use is made of the very considerable patient, clinical and financial investment made in each of the Commissioning Through Evaluation schemes.”

The letter said the National Institute for Cardiovascular Outcomes Research had been due to extract data for the LAAO and PFO schemes on 31 May to inform analysis. However, it highlighted a shortfall in patient follow up data, which could “reduce the validity of evaluation”, Mr Palmer said, so the extension was granted.

An NHS England spokeswoman said“The clinical reason for evaluating these schemes before they are routinely commissioned is because there wasn’t enough evidence that these procedures work well enough.

“If more high quality evidence becomes available before the independent evaluation is complete, we will of course bring forward the review decision.”

Story updated at 8am on 26 July after NHS England provided a statement