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NICE versus SMC: Are our pharmaceutical evaluators performing effectively?
What is the reason that some medications are accessible through the NHS in specific regions of the UK but not in others?
Should the government and relevant institutions address this disparity?
Patient advocates assert that it should, but what is the perspective of medicinal evaluators, and is the system functioning as intended?
Operational Mechanisms Across Various Nations
The evaluation procedure for new services and medications in England is regulated by the National Institute for Health and Care Excellence (NICE). NHS England is mandated to finance and provide resources for medications and therapies endorsed by NICE’s technology appraisals within three months of their publication date.
NICE guideline on health technology in Wales requires a funding decision from the Welsh government’s minister for health and social services. The All Wales Medicines Strategy Group (AWMSG) conducts assessments that complement those of NICE, focussing solely on novel medications not included in NICE’s 12-month work schedule. Furthermore, NICE guidance may take precedence over AWMSG recommendations.
Northern Ireland possesses a distinct procedure for endorsing and executing NICE health technology assessment (HTA) advice.
Wales and Northern Ireland generally adhere to the majority of NICE recommendations.
Scotland, being a devolved entity, administers its own governance system. The Scottish Medicines Consortium (SMC) offers guidance on the clinical and economic efficacy of all new pharmaceuticals for NHS Scotland.
NICE and the SMC both strive to guarantee patients prompt access to effective and cost-efficient treatments; yet, they employ distinct rules and procedures for evaluating the clinical and economic advantages of submitted pharmaceuticals.
NICE conducts a comprehensive and rigorous examination of each product, evaluating various variables and provided evidence, albeit often requiring extra time.
The SMC expedites decision-making due to its limited scope, and its recommendations lack legal enforceability.
Are the systems functioning effectively?
In response to Medscape News UK’s inquiry regarding the efficacy of the Scottish medicines appraisal process for patients and the health sector, SMC Chair Dr. Scott Muir stated: “SMC strives to guarantee that individuals in Scotland have prompt access to advantageous new medications that offer value for money.” The perspectives of the public are considered through our three voluntary public partners, and patient groups are represented throughout the SMC process. SMC consistently evaluates and refines our processes to guarantee their suitability and alignment with stakeholder requirements.
Helen Knight, director of medicines evaluation at NICE, stated to Medscape News UK: “NICE aims to lead in assisting practitioners and commissioners in providing NHS patients with access to valuable, evidence-based innovative medicines, medical devices, and diagnostics, while ensuring taxpayer value.” NICE takes pride in its esteemed reputation for employing rigorous methodologies and processes to measure and evaluate health outcomes, which is central to its vision and objective of prioritising what is most significant while producing practical and applicable advise for the health system.
Financial Implications
Despite residing in a golden era of medical innovation, characterised by the swift introduction of new pharmaceuticals, the costs of these drugs are escalating exponentially.
A recent analysis (2023) from the London School of Economics (LSE) indicated that NHS expenditure on branded pharmaceuticals has increased annually by over 5% since 2018. In the fiscal year 2021/2022, the overall expenditure on prescription medications by the NHS in England, after considering confidential discounts and rebates, amounted to an astonishing £17.2 billion. This figure omits COVID-19 vaccinations and therapies. The LSE analysis identified that numerous new medications are excessively priced relative to the advantages they provide to patients, even when considering possible cost savings.
Equitable Access
Meanwhile, healthcare professionals and patient advocacy organisations persist in their efforts to get equitable access to the latest pharmaceuticals throughout the UK and to eliminate the disparities in medicine availability based on geographic location.
Baroness Delyth Morgan, chief executive of Breast Cancer Now, stated to Medscape News UK: “All breast cancer patients merit the highest quality of care and treatment, regardless of their location.” The existence of a detrimental postcode lottery that restricts patients’ access to essential medications, which could extend their lifespan and enhance their quality of life, is wholly intolerable. Currently, the potentially life-prolonging drug, trastuzumab deruxtecan, is unjustly inaccessible to women in England, despite its availability on the NHS in Scotland.
“Women have been compelled to endure a distressing five-month wait to ascertain their access to essential treatment, and the tragic truth is that, for some, this access will arrive too late.”
“We emphatically call upon NICE, NHS England, and pharmaceutical companies AstraZeneca and Daiichi Sankyo to collaborate in examining all potential solutions to promptly overturn this provisional decision.”
