Fieldfisher guides Myeloma UK through NICE U-turn, securing vital treatment approval | Fieldfisher
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Press Release

Fieldfisher guides Myeloma UK through NICE U-turn, securing vital treatment approval



United Kingdom

European law firm Fieldfisher has led health charity, Myeloma UK, to a final victory as the National Institute for Health and Care Excellence (NICE) reverses a previous decision and grants approval for the DaraCyBorD treatment for AL amyloidosis on the NHS.

Myeloma UK's relentless advocacy efforts, backed by Fieldfisher's legal expertise, have led to a new and entirely different decision by the National Institute for Health and Care Excellence (NICE), ensuring that up to 600 patients annually will benefit from DaraCyBorD treatment in England and Wales.  

Fieldfisher’s leading healthcare regulatory team played an important role in navigating the appeal process last summer, highlighting procedural deficiencies and advocating for a fair reassessment based on comprehensive evidence. Last June, this resulted in a victory for Myeloma UK when the technology appraisal appeal against NICE was successful. The treatment DaraCyBorD was initially rejected for newly diagnosed patients in England and Wales due to concerns over cost-effectiveness but the appeal meant that this decision was quashed and had to be retaken. In March of this year the new decision was that the treatment should be funded. This decision marks a significant triumph for patient advocacy and underscores the transformative impact of collaborative action in shaping healthcare policy.  

Lead partner on this case, Sarah Ellson, co-head of the Regulatory group at Fieldfisher, commented: “Securing the approval of DaraCyBorD for AL amyloidosis patients on the NHS is not just a legal victory, but a profound testament to the power of collaboration and perseverance in advancing patient-centric healthcare. We are honoured to have played a pivotal role in Myeloma UK's successful campaign, working tirelessly to ensure equitable access to life-saving treatments for individuals facing this devastating disease. This landmark achievement reaffirms our commitment to championing patient rights and driving positive change in the healthcare landscape.” 

The successful outcome of this case exemplifies the potency of the NICE appeal process in safeguarding patient rights and driving substantive change within the healthcare landscape. The process is very similar to the judicial review process, both of which provide a legal process for challenging decisions that carry profound implications for individuals and communities alike.

Fieldfisher's in-depth understanding of judicial review often comes into play at different stages of decision-making by public bodies. Initially, the mere threat of scrutiny and challenge may be used to prompt decision-makers to diligently consider all relevant information before making a decision. Subsequently, the challenge to the decision itself, as demonstrated in Fieldfisher's efforts in the NICE appeal, may uncover procedural flaws and substantive errors. While it's uncommon for courts or appellate bodies to outright replace decisions, the judicial review process facilitates a comprehensive review, often resulting in decisions being remade.

Associate Chloe Williams also played a pivotal role in the proceedings. 

Areas of Expertise

Public and Regulatory

Related Work Areas

Life Sciences