Navigating the Prescribing Dilemma: High-Cost Biologics for Ulcerative Colitis

This case example explores the complexity of prescribing high-cost drugs in the context of patient-centred care. A list of the skills required to manage such situations — mapped to the Royal Pharmaceutical Society’s ‘Competency framework for all prescribers’ — can be found at the end of this article. Case presentation A 35-year-old female patient with a five-year history of ulcerative colitis (UC) presented to a specialist inflammatory bowel disease (IBD) clinic with worsening symptoms over the previous eight weeks, including up to eight loose stools per day, intermittent rectal bleeding, abdominal cramping and fatigue. Despite optimal use of mesalazine (oral and rectal formulations) and a recent short course of oral corticosteroids, her symptoms persisted. A recent flexible sigmoidoscopy confirmed moderate-to-severe disease activity, while her faecal calprotectin was significantly above the reference range of 100–250 μg/g. Her inflammatory markers were also elevated, with a CRP 27mg/L greater than reference range of 0–5mg/L. She had no previous exposure to biologic therapies, was up to date with vaccinations and had no contraindications to immunosuppressive treatment. The dilemma The patient was referred to the pharmacist prescriber and gastroenterology consultant to discuss escalation of therapy, where she expressed significant concern over work absences and the impact on her role as a full-time teacher. According to National Institute for Health and Care Excellence (NICE) guidelines and British Society of Gastroenterology (BSG) guidance, patients with moderate-to-severe UC who fail to respond to aminosalicylates and steroids should be considered for advanced therapies, such as biologics (e.g. infliximab, adalimumab, vedolizumab) or small-molecule inhibitors (e.g. tofacitinib)​1,2​. The patient met the clinical criteria for advanced therapy; however, the first-line options in the local commissioning formulary were limited to biosimilar infliximab and adalimumab, which was based on cost-effectiveness considerations under the local high-cost drugs commissioning policy. While these tumour necrosis factor (TNF) inhibitors are effective, the patient expressed concern over the need for intravenous infusions, owing to the risk of serious infections or systemic adverse effects (i.e. infliximab), and reported significant needle phobia, raising potential adherence issues with subcutaneous therapies (i.e. adalimumab). Oral therapies were also considered; however, the patient declared that she has issues with adherence to oral agents and did not want to take medication every day. After discussing all the options, the patient showed a strong preference for vedolizumab, which has a more gut-specific mechanism and a potentially more favourable side-effect profile​3–5​. However, according to the locally agreed pathway, vedolizumab is only approved for patients who have failed or are intolerant to anti-TNF agents. Although national guidance indicates similar clinical efficacy, anti-TNF therapies remain the first-line option owing to their greater cost-effectiveness​6​. This created a dilemma: should the prescriber initiate an anti-TNF therapy per formulary guidance and locally agreed pathways, knowing the patient may struggle with adherence and administration, or support an application for vedolizumab based on individual patient factors? Consultation During the consultation, the mechanisms of action, routes of administration, potential side effects and monitoring requirements for anti-TNF agents versus vedolizumab were discussed. The patient explained her needle phobia and the psychological impact it had on her past healthcare experiences. She also raised practical concerns about infusion centre access and time off work for treatment. Importantly, she expressed a willingness to attend infusions if they were less frequent, as with vedolizumab’s longer maintenance interval of every eight weeks, according to NICE guidance​3​. A shared decision-making approach was used, and the patient was encouraged to ask questions and express concerns. Although she acknowledged that infliximab may be a faster-acting agent in some patients, her personal priorities were minimising psychological stress, ensuring treatment adherence and limiting disruption to her career. She was also concerned about infection risk with systemic immunosuppressants and was reassured by the gut-selective action of vedolizumab​3–5​. The pharmacist prescriber consulted the IBD multidisciplinary team (MDT) and the local formulary advisor to discuss an individual funding request (IFR). The IFR process ensures that patients with exceptional clinical circumstances can access treatments not routinely commissioned. The typical IFR workflow can be seen in Box 1​7​. Appropriate monitoring and additional actions agreed Baseline investigations, including TB screening, hepatitis B/C serology and varicella status, were completed. In parallel, the patient was referred to the IBD nurse specialist for biologic counselling, while psychological support services were signposted to help manage treatment-related anxiety. Sick-day rules, infection risk precautions and vaccine advice, including influenza and pneumococcal immunisation, were discussed. The patient was advised on signs of infection, infusion reactions and when to seek medical advice. Follow-up Within two weeks, the IFR was approved. Vedolizumab was initiated with support from the hospital day case team. The patient tolerated induction infusions well, reported significant symptom improvement after the second dose, and returned to full-time work without further absences. Her calprotectin reduced to <150μg/g, and she reported only 2–3 formed stools per day without blood. She also experienced no infusion reactions or infections. The patient reported improved quality of life and satisfaction with her care plan. If the IFR had not been approved, the MDT would have needed to consider alternative therapies that are routinely commissioned, such as anti-TNF agents, alongside additional support for adherence and psychological wellbeing. Further options could include appealing the decision with additional clinical justification or exploring trial enrolment if appropriate. Reflective practice This case illustrates the complexity of prescribing high-cost drugs in the context of patient-centred care, commissioning frameworks and clinical efficacy. It raised an important question: how do we balance guideline adherence, formulary restrictions and patient-centred care when prescribing high-cost biologics? The decision to pursue vedolizumab — despite it being more expensive than anti-TNF therapy — reflected prioritisation of the patient’s individual needs, minimising psychological stress, supporting adherence and allowing continued employment alongside evidence of comparable efficacy. While infliximab or adalimumab may have been appropriate from a cost and guideline perspective, the patient’s preferences and lifestyle circumstances justified a deviation from the default pathway. IFRs exist to enable clinicians to advocate for treatments that are clinically appropriate in exceptional circumstances, even when not routinely commissioned. By collaborating with the MDT and advocating for the patient, we ensured she received a treatment she could engage with long term, reducing the risk of non-adherence, disease flares and hospitalisation. Reflectively, this highlights the importance of balancing policy with personalised care. While cost-effective prescribing is essential, patient engagement, treatment sustainability and functional outcomes are equally critical in real-world decision-making.