Subcutaneous nivolumab: Advancing operational efficiency and patient-centred care in the NHS

The Medicines and Healthcare products Regulatory Agency (MHRA)'s approval of subcutaneous (SC) nivolumab on 30th April 2025 marks another milestone for how immune checkpoint inhibitors (ICIs) are delivered within the NHS. With administration times of 3–5 min, ¹ SC formulations offer faster, more efficient treatment option while easing pressure on NHS services. ¹ As demand for systemic anti-cancer therapy continues to rise and aseptic units’ capacity remains limited, innovations like SC nivolumab represent a vital step toward more scalable patient-centred care. Although approved, it awaits a formal commissioning route before it can be integrated into practice. This commentary explores the clinical and operational implications of SC nivolumab for the NHS, exploring its impact on workforce and patients, pharmacokinetics, administration challenges and the necessary steps for successful implementation.

Nivolumab (anti-PD-1) has been a cornerstone in treating multiple cancers, including melanoma, bowel, kidney, bladder, oesophageal, skin, and head and neck.^1,2 However, its intravenous (IV) administration can be time-consuming, requiring patients to spend extended periods in clinical settings. SC nivolumab offers a more convenient alternative, significantly reducing administration time and providing greater flexibility for both patients and clinicians. ¹

Subcutaneous administration is not a novel concept. Monoclonal antibodies (mAbs) such as trastuzumab (anti-HER2), rituximab (anti-CD20) and daratumumab (anti-CD38) have demonstrated that SC delivery can reduce chair time, increase chemotherapy unit capacity, and enhance patient satisfaction.^3,4,5,6 In August 2023, the MHRA approved SC atezolizumab (anti-PD-L1) for all licensed indications, making it the first ICI to receive both FDA and EMA approval for this administration route. A subsequent positive EMA opinion further supports the growing European adoption of SC ICIs, reinforcing the shift towards this type of drug delivery. ⁷

The 2023 CheckMate 67 T study demonstrated that SC nivolumab achieved noninferior pharmacokinetics and objective response rates compared to its IV counterpart, with a comparable safety profile. ⁸ Findings from CheckMate 8KX further reinforced its clinical viability, with patients reporting high satisfaction and a strong preference for SC administration. ⁹ Ongoing studies are investigating SC combinations of nivolumab with other ICIs with the aim of streamlining treatment pathways and reducing the time spent in hospital. ¹⁰ While some trials exploring SC nivolumab with ipilimumab (anti-CTLA4), have been discontinued, the accumulating evidence continues to support the clinical and operational benefits of SC administration as a preferred route for many ICIs. ¹⁰

As pressure on the NHS intensifies, cancer services are increasingly affected by critical staff shortages, limited space, and ethical dilemmas driven by rising demand and constrained capacity. ¹¹ In this context, the need for sustainable operational solutions is more pressing than ever. Despite a modest reduction in cancer waiting times, the risk of delays remains high, with every month a patient is delayed from starting treatment the risk of death is increased by 10%. ¹² This underlines the significant ethical burden placed on oncology teams, as they strive to provide timely care with limited resources.^11,12 Subcutaneous therapies therefore offer a compelling solution. By reducing treatment administration times, SC formulations enable more patients to be treated in the same time frame, thereby increasing overall treatment capacity without the need for additional infrastructure. Moreover, SC delivery methods can alleviate pressure on an already overstretched pharmacy and nursing workforce, allowing staff to focus on more clinically intensive tasks. This operational relief has been highlighted by Professor Peter Johnson, NHS England's National Clinical Director for Cancer, who praised SC immunotherapy for improving hospital capacity and freeing clinician time, aligning with the NHS's goal of transformative cancer care. ¹³

These operational efficiencies combined with patient-centred benefits, form a powerful case for SC ICIs, offering tangible advantages to the NHS. Fixed dosing streamlines prescribing and pharmacy checking processes, while prefilled devices reduce administration complexity. The possibility of dual ICI injections could further enhance these benefits, raising the question: could this be the next frontier in ICI delivery?

From the patient's perspective, the benefits of SC administration are well documented. Studies consistently show a preference for SC delivery due to its convenience, ease of administration, and positive impact on emotional wellbeing.^4,5,14,15 Additional evidence from Bittner et al. highlights that patients found SC trastuzumab administration faster, less painful, and more comfortable; factors that contribute to a more positive treatment experience.

Similarly, preferences for SC atezolizumab also align with those observed for trastuzumab. In the IMscin002 cross-over study, 70.7% of patients preferred the SC route over IV, citing reasons such as less time spent in hospital (64.4%), greater comfort (46.0%), and reduced emotional distress (29.9%). ¹⁶ Although not directly reported, the absence of line insertion and reduced time spent in chemotherapy units may lower infection risk, further supporting the benefits of SC delivery. These patient-focused benefits complement operational efficiencies, making SC delivery of nivolumab a promising option for improving both treatment experience and capacity.

Given that emotional distress is a key factor in patient preference, SC administration in the home setting may further alleviate the psychological burden associated with hospital visits. A notable example is the self-administration programme for SC dual HER2-targeted therapy at Mount Vernon Cancer Centre, where healthcare professionals have adopted a health coaching model to support patients in administering their treatment at home. ¹⁴ This model, developed through collaboration between clinicians, pharmacists, and nurses, empowers patients to take an active, informed role in managing their treatment.^11,14 However, while commercial partnerships have enabled a more patient-centred and convenient model of care, dependence on outsourced services may introduce variability and fragility into patient pathways, potentially compromising the quality of treatment delivery.

Despite these advantages, several challenges remain. Achieving pharmacokinetic and bioavailability equivalence between SC and IV formulations is critical to maintaining efficacy. Subcutaneous bioavailability typically ranges from 60–80% of that achieved via IV dosing. To address this, enzyme-enhanced dispersion using recombinant human hyaluronidase (rHuPH20) has been employed to facilitate the absorption of large-volume biologics in the subcutaneous space. ¹⁷ Both SC nivolumab and atezolizumab incorporate this technology to overcome bioavailability limitations.^2,17

However, larger SC volumes may still be required to achieve therapeutic equivalence, which can complicate administration.^17,18 Innovations such as high-concentration formulations, rHuPH20, and infusion pumps have helped mitigate these barriers. ¹⁸ Nevertheless, repeated administration of high-volume injections presents ergonomic challenges for nursing staff and may impact service delivery.

The potential for immunogenicity also warrants consideration. Switching from IV to SC formulations has been linked to anti-drug antibody development, suggesting higher immunogenicity with SC biologics; however, this remains a hypothesis and is not universally supported, highlighting the need for further research.^17,18,19

Effective implementation of SC nivolumab requires both operational and clinical readiness, underpinned by strategic planning and multidisciplinary (MDT) collaboration. As the NHS integrates SC nivolumab into its oncology services an MDT approach will be crucial to unlocking the full potential of SC ICIs. Effective communication among healthcare professionals will ensure seamless integration into existing treatment protocols. Shared learning, supported by case studies and pharmacoeconomic evaluations, will further refine best practices for SC delivery. Simultaneously, national policy development will be key to ensuring equitable access to SC ICIs across the UK. A flexible and responsive approach will enable the NHS to adapt to ongoing advancements in cancer care.

Collaborative working between the British Oncology Pharmacy Association (BOPA), the UK SACT Board, and the Immuno-Oncology Clinical Network will be essential. BOPA has developed an IV to SC toolkit, offering practical guidance for healthcare providers transitioning to SC administration. ²⁰ This resource outlines patient selection criteria, governance considerations, and the operational steps necessary for the safe implementation of SC ICIs. ²⁰ As more ICIs adopt SC formulations, this toolkit will play a vital role in preparing oncology services for effective and consistent delivery. Ongoing engagement with these organisations is key for equipping the cancer services workforce with the necessary training and support.

The approval of SC nivolumab signals a broader shift in cancer care delivery, aligning with NHS priorities to boost productivity and patient-centred services. Alongside clinical benefits, SC administration offers operational efficiencies that, once embedded, could support wider adoption across other ICIs. Successful integration will rely on strong clinical governance, multidisciplinary collaboration, and streamlined processes reflecting the NHS's commitment to innovation and adaptability. Subcutaneous nivolumab is well positioned to reduce patients’ treatment burden, improve healthcare efficiency, and contribute to a more sustainable future for oncology care in the UK. In doing so, the NHS sets a powerful precedent for global ICI advancement, ultimately benefiting patients worldwide.