• NICE asked by NHS England to analyse the “finance impact” of new potential treatments
  • Second programme in which a NICE review of treatment costs could potentially impact access
  • NICE will grade clinical evidence available for each treatment, which may impact rare disease medicines

The National Institute for Health and Care Excellence has been asked to routinely assess the financial impact of specialised commissioning treatments for NHS England, a document seen by HSJ reveals.

In the presentation to the pharmaceutical industry in last month, NICE proposed to analyse the “finance impact” of new treatments to help NHS England decide which drugs to fund. The proposal was developed after NICE was appointed last year to provide specialised commissioning support to NHS England’s national programme.

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NICE will grade the clinical evidence available for each treatment

NICE will provide a monetary figure for the cost of a proposed treatment for each of the first five years in which it may be funded. In addition, it will estimate the number of people affected by the proposed funding decision, the total cost per patient over five years, and the net cost per patient treated over five years.

The task of developing the clinical evidence base and financial impact for any new proposed treatments was previously the responsibility of NHS England’s clinical effectiveness team with “finance analytical support” from NHS England’s specialised commissioning finance team.

This is the second programme in which a review of the cost of treatments by NICE could impact patients’ access. It follows the controversial NICE policy to allow NHS England to delay NICE certified treatments by three years or more if the treatment is deemed “unaffordable” in the medium term.

In its new role providing commissioning support, NICE is clear it will have “no involvement” in the final decisions on which new treatments will be funded by NHS England’s specialised commissioning team or in the “prioritisation process” of which drugs get funded first.

However, NHS England’s three decision making bodies – the clinical priorities advisory group, specialised commissioning oversight group and specialised services commissioning committee – are expected to use the NICE evidence to inform its judgements.

An NHS England spokesman told HSJ that the medicines considered by the programme will remain the responsibility of NHS England.

NICE will provide two evidence “summary sheets” to the CPAG: one on the financial impact of the treatment and one on the clinical evidence available on the potential treatment benefits.

The clinical evidence review will evaluate the benefits and safety of the proposed treatment, “unmet need [and] innovation”, and any “crossover with existing guidelines and policies”.

The review will also give an A, B or C grade to the evidence, based on the quality of data available, which it will score out of 10. The highest grades are reserved for treatments with multiple studies that are directly applicable to the treatment available and can show the treatment’s benefit in “comparison to UK current practice”.

Jayne Spink, chief executive of the charity Genetic Alliance, warned that this aspect of the review process would “systematically devalue the evidence base for rare disease medicines”. She said: “With the European Medicines Agency prepared to licence a rare disease medicine based on one pivotal study, NHS commissioning processes need to be prepared to operate with the same level of evidence.”

However, the documents said the aim of the commissioning support programme is to ensure “transparency in decision making” and “fairness in assessment” – two areas of criticism around NHS England’s specialised commissioning process.

NICE has proposed to publish clinical evidence reviews on its website and is debating publishing some of the evidence for pre-licensed technologies, to work around the need for the CPAG to only consider clinical evidence that has been previously published in a peer reviewed journal.

It is unclear how treatments will be referred to the programme but the documents suggest this can be done by NHS England, “clinical experts [or the] public”, or those that are not progressed through NICE’s own drug approval certification process.

NICE expects the review process to take approximately six months but did not say how long NHS England’s decision making process will last once NICE passes its evidence summaries to the CPAG. The document also does not provide a date for when the programme will start.