NICE vs SMC: Are our medicines assessors doing a good job?

Why are some medicines available through the NHS in certain parts of the UK but not others? 

Is this disparity something that should be addressed by the government and organisations involved? 

Patient campaigners believe it should, but what do medicines assessors think, and is the system working as it should?

How It Works in the Different Countries

In England, the appraisal process for new services and medicines is governed by the National Institute for Health and Care Excellence (NICE). NHS England is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals within 3 months of their date of publication.

In Wales, NICE guidance on health technologies is subject to a funding decision by the Welsh government’s minister for health and social services. The All Wales Medicines Strategy Group (AWMSG) can also carry out assessments, but its work is complementary to that of NICE, only including the assessment of new pharmaceuticals that are not on NICE’s 12-month work programme. Moreover, NICE guidance can supersede AWMSG recommendations. 

Northern Ireland also has its own process for endorsing and implementing NICE health technology assessment (HTA) guidance. 

Wales and Northern Ireland tend to follow most NICE recommendations. 

Scotland, as a devolved nation, operates its own system. The Scottish Medicines Consortium (SMC) provides advice on the clinical and cost effectiveness of all new medicines for NHS Scotland. 

Both NICE and the SMC aim to ensure that patients have timely access to effective treatments that are also cost-effective, but they have differing policies and processes for assessing the clinical and cost benefits of submitted medicines. 

NICE runs an extensive, robust, though often more time-consuming review of each product, assessing multiple factors and submitted evidence. 

The SMC makes speedier decisions as it has a narrower remit and its recommendations are not legally enforceable.

Do the Systems Work Well?

Asked by Medscape News UK if the Scottish medicines appraisal process worked well for patients and the health service, SMC Chair Dr Scott Muir said: “SMC aims to ensure that people in Scotland have timely access to beneficial new medicines that provide value for money. The views of the public are taken into account via our three volunteer public partners, and patient groups have a voice throughout the SMC process. SMC regularly reviews and evolves our processes to ensure they are fit for purpose and meet the needs of our stakeholders.”

Helen Knight, director of medicines evaluation at NICE, told Medscape News UK: “Our vision at NICE is to be at the forefront of helping practitioners and commissioners deliver access for patients in the NHS to valuable, evidence-based innovative medicines, medical devices, and diagnostics while ensuring value for the taxpayer. NICE is justly proud of its world-leading reputation for the robust methods and processes it uses for measuring and valuing health outcomes that is at the heart of this vision and of its aim of focusing on what matters most and to create useful and useable guidance for the health system.” 

Cost Considerations

While we live in a golden age of medical innovation, with new medicines coming on stream at a rapid pace, drug costs are also rising exponentially. 

A recent report (2023) from the London School of Economics (LSE) showed that, since 2018, NHS spending on branded medicines has risen annually by more than 5%. In the fiscal year 2021/2022, the total cost of prescription medicines to the NHS in England, after accounting for confidential discounts and rebates, reached a staggering £17.2 billion. This figure excluded COVID-19 vaccines and treatments. The LSE report found evidence that many new medicines are too expensive for the benefits they offer to patients, even after accounting for any potential cost savings.

Equality in Access 

In the meantime, clinicians and patient representative groups continue to campaign for equal access to the latest medicines across the UK and an end to the medicines postcode lottery. 

Baroness Delyth Morgan, chief executive at Breast Cancer Now, told Medscape News UK: “All breast cancer patients deserve the best care and treatment no matter where they live. It’s entirely unacceptable that a devastating postcode lottery denies patients access to vital medicines that could give them more time to live and live well. Yet, right now, a potentially life-extending treatment, trastuzumab deruxtecan, is cruelly being kept out of reach of women in England, despite it being made available on the NHS in Scotland.

“Women have already been forced to endure an incredibly anxious 5-month wait to find out if they’ll have access to the crucial treatment in time, and the heart-breaking reality is that, for some women, access will come too late.

“We strongly urge NICE, NHS England, and drug companies AstraZeneca and Daiichi Sankyo to work together to explore all possible solutions to ensure this provisional decision is reversed without delay.”