Journal of Medicines Optimisation - Mar 2022

Journal of Medicines Optimisation • Volume 8 • Issue 1 • March 2022 24 improve patient quality of life. 1 Remission can be determined as either clinical or endoscopic. Escalation to biologics occurs when conventional options have failed, or contraindications are present. These biologic agents include tumour necrosis factor-alpha inhibitors adalimumab and infliximab (both licensed for CD and UC), and golimumab (licensed for UC only). Vedolizumab is an anti- integrin antibody (licensed for both UC and CD). Ustekinumab is an antagonist of the p40 subunit of pro-inflammatory cytokines interleukin-12 and interleukin-23, (licensed for CD and UC). Tofacitinib is a Janus kinase inhibitors (licensed for UC). Biologics are superior to placebo to induce and maintain remission in IBD refractory to conventional therapies, including immunomodulators such as glucocorticoids, thiopurines, and methotrexate. 2,3,4 Across England and Wales, guidance from the National Institute for Health and Care Excellence (NICE) assesses the clinical and cost effectiveness of health technologies, including pharmaceuticals. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals (TA). Furthermore, the NHS Constitution, which sets out rights to which patients, public and staff are entitled, and pledges which the NHS is committed to achieve, states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate. 5 NICE guidance on IBD, both CD and UC, describes the various treatment options and identifies the relevant technology appraisals. 6,7 In particular, NICE TA 329 for infliximab, adalimumab and golimumab recommends if more than one treatment is suitable the least expensive should be chosen (taking into account drug administration costs, required dose and product price per dose). 8 As well as NICE guidance, various bodies have also issued guidance. 1,9,10,11 Anti-TNF α biosimilars are often started in the majority of naïve patients who need to start a biological therapy, as they allow significant cost-saving compared with other biologics. 12 If patients fail to respond to these therapies, subsequent treatments are usually considered less effective compared with first-line therapies. 13 The annual biologic medicine acquisition cost to the NHS for treating a patient with IBD can range from approximately just over £1,000 to £18,000. This depends on various factors, including availability of a biosimilar of the biologic (e.g. for infliximab, adalimumab), whether there is a patient access scheme associated with the TA, patient weight, and the dosing regimen used. A patient access scheme or commercial arrangement when associated with NICE guidance is a way in which pharmaceutical companies lower the acquisition cost of a medicine to the NHS to improve its cost-effectiveness, so enabling patients to gain access to high-cost medicine treatments. High-cost medicines are so named as they are expensive prescribed items, representing a disproportionate cost relative to the total NHS cost of the relevant hospital episode in terms of volume and cost. Within England there have been number of ongoing strategies to promote the use of biosimilars in hospitals including educational, 14 setting of targets for the proportion of patients who are prescribed biosimilar choices of biologics, 15 and monitoring the local adoption of biosimilars by regional teams that facilitate implementation of national policy measures. 16 Royal Cornwall Hospitals NHS Trust is a 750-bed acute secondary care hospital in the south-west of England. The Gastroenterology Department developed a simple biologics pathway (Figure 1) which describes use of standard therapy (e.g. 5ASA, thiopurine, methotrexate) prior to the use of biologics. It then defaults to biosimilar adalimumab or infliximab as first choice parenteral treatment. Other biologics may be chosen depending on various patient considerations and whether for UC or CD. This pathway has been approved by the health system-wide prescribing committee (composed of clinicians, pharmacists, and commissioners). Within Gastroenterology, patients considered for starting or switching biologic treatment are discussed at a weekly multi-disciplinary team (MDT) meeting, attended by the specialist hospital pharmacist. The hospital, in conjunction with the local clinical commissioning group (CCG), utilises the Blueteq high-cost drug management system. CCGs are statutory regional NHS bodies that are responsible

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