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Putting NICE guidance into practice Costing statement: Ulcerative colitis Implementing the NICE guidance on vedolizumab for treating moderately to severely active ulcerative colitis (TA342) Published: June 2015 1 Introduction 1.1 The guidance on ‘vedolizumab for treating moderately to severely active ulcerative colitis’ (NICE technology appraisal 342) offers an additional treatment option for treating moderately to severely active ulcerative colitis in adults. 1.2 There is variation in current clinical practice across the country and a lack of data on treatment outcomes. Therefore, we encourage organisations to evaluate their own practices against the recommendations in the guidance and assess costs and savings locally. Some of the resource effects to be considered locally are discussed in this statement. 1.3 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. 1.4 This technology is commissioned by Clinical Commissioning Groups (CCGs). Providers of services for ulcerative colitis are NHS hospital trusts. 2 Guidance 2.1 The guidance states that: Vedolizumab is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme. National costing statement: vedolizumab for ulcerative colitis (June 2015) 2 of 10 Vedolizumab should be given until it stops working or surgery is needed. At 12 months after the start of treatment, people should be reassessed to see whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to see whether continued treatment is justified. 3 Background 3.1 Ulcerative colitis is a chronic condition in which inflammation develops in the large intestine. Symptoms may include bloody diarrhoea, abdominal pain, weight loss, fatigue, anaemia and an urgent need to defaecate. 3.2 Ulcerative colitis has a prevalence of 0.24%, which amounts to approximately 106,000 adults in England. About 52% of the people affected have moderate to severe disease. 3.3 Symptoms can flare up then disappear for months or even years, but about 50% of people with ulcerative colitis will relapse at least once a year. Ulcerative colitis can cause complications such as primary sclerosing cholangitis (inflamed and damaged bile ducts), bowel cancer, osteoporosis and toxic megacolon (swelling of the colon caused by trapped gases, which can be life-threatening). 3.4 Ulcerative colitis is defined by the modified Truelove and Witts severity index as being mild if there are fewer than 4 bowel movements daily; moderate ulcerative colitis if there are more than 4 daily bowel movements but the person is not systemically ill; and severe ulcerative colitis if there are more than 6 bowel movements daily and the person is also systemically ill. Severe ulcerative colitis is potentially life threatening and normally needs hospitalisation and emergency care. National costing statement: vedolizumab for ulcerative colitis (June 2015) 3 of 10 3.5 This costing statement considers people with moderately to severely active ulcerative colitis; it does not include acute severe ulcerative colitis (that is, severe ulcerative colitis according to the Truelove and Witts severity index) that is a medical emergency. Recommendations for managing acute severe ulcerative colitis can be found in the NICE clinical guideline Ulcerative colitis: Management in adults, children and young people and the technology appraisal Infliximab for acute exacerbations of ulcerative colitis. 3.6 Conventional treatment options for moderately to severely active ulcerative colitis include oral or topical aminosalicylates (sulfasalazine, mesalazine, balsalazide or olsalazine), or treatment with corticosteroids if aminosalicylates are contraindicated or not tolerated. 3.7 Some people may also be offered a TNF-alpha inhibitor if conventional therapy fails. Recommendations for infliximab, adalimumab or golimumab can be found in the NICE technology appraisal infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. 3.8 If the TNF-alpha inhibitors fail the treatment options are limited to a return to conventional therapy, or surgery. Surgery would be considered a final treatment option (if symptoms are inadequately controlled or if the person has a poor quality of life on conventional therapy). 4 Resource impact Population 4.1 Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis that has had an National costing statement: vedolizumab for ulcerative colitis (June 2015) 4 of 10 inadequate response or lost response to, or who were intolerant to either conventional therapy or a TNF–alpha inhibitor. 4.2 Table 1 shows that 5 people per 100,000 population could potentially be treated with vedolizumab. Table 1 Number of people per 100,000 population potentially eligible for treatment Population Percentage Per 100,000 population Number of adultsa Prevalence of ulcerative colitisb Prevalence of moderate to severe diseaseb,c 79,234 0.24% 190 52.33% 99 16.20% 16 30% 5 Proportion of people whose condition fails conventional therapy and who are treated with a biologicb Estimated uptake for treatment with vedolizumabb a GP registered population 2012: Public Health England - patients registered with GP practices, by age and sex. b Based on the manufacturer’s submission. c Ulcerative colitis is defined by the modified Truelove and Witts severity index as being moderate ulcerative colitis if there are more than 4 daily bowel movements but the person is not systemically ill; and severe ulcerative colitis if there are more than 6 bowel movements daily and the person is also systemically ill. Severe ulcerative colitis is potentially life threatening and normally needs hospitalisation and emergency care. Costs 4.3 The average annual drug cost of vedolizumab is shown in table 2. The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence. The NHS list price is £2050 per 300 mg vial of National costing statement: vedolizumab for ulcerative colitis (June 2015) 5 of 10 vedolizumab. This gives an annual cost of £16,913 in the first year and £13,325 in subsequent years. Details on the drug and administration costs of vedolizumab are available in Appendix A. 4.4 It is anticipated that, as with the other biologics, vedolizumab would be added-on to existing treatments. The manufacturer’s model assumes that while patients are receiving biologic therapies, the costs associated with conventional non-biologic therapies will be half of those incurred by patients who are receiving conventional therapies only. Table 2 shows the full costs of conventional therapies. National costing statement: vedolizumab for ulcerative colitis (June 2015) 6 of 10 Table 2 Comparative annual costs of treatment options Annual treatment cost per patient per drug Treatment Cost (£) Vedolizumab (based on the NHS list price)a Infliximab proprietaryb Infliximab biosimilarb Adalimumabb Golimumabb 5-ASAs, tablets (Ipocol)c 5-ASAs, enemas (Asacol)c 5-ASAs, suppositories (Asacol)c Azathioprined 6-mercaptapurinee Prednisoloned 1st year Induction (£) Maintenance (£) Biologics 6,150 10,250 Subsequent years Maintenance (£) 13,325 5,035 8,392 10,910 4,532 7,553 9,819 2,817 8,867 3,052 8,393 Conventional treatments 10,611 9,919 49.50 111.83 161.33 106.88 589.75 696.63 40.49 223.41 263.90 13.40 261.15 76.70 73.93 1,441.00 - 87.33 1,702.15 - a The NHS list price is £2050 per 300 mg vial of vedolizumab. The company has agreed a patient access scheme with the Department of Health. The level of the discount is commercial in confidence. Induction doses at 0,2 and 6 weeks. Maintenance doses every 8 weeks thereafter. NHS list price from eMC Dictionary of Medicines May 2015. The SPC for vedolizumab states that dose escalation is possible, but this has not been included in the calculation. b The drug costs for the TNF-alpha inhibitor biologic drugs are based on the calculations used for the costing statement on TA329 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. Please refer to that document for the detail behind the calculations. Dose escalation was taken into account for adalimumab from week 12 (D Wolf et al. (2014) Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis). There is a patient access scheme for golimumab in which the company agrees to provide the 100 mg dose of golimumab at the same cost as the 50 mg dose. There are no patient access schemes for infliximab or adalimumab. c 8 week induction. Daily maintenance thereafter. Drug costs from Chemist and Druggist May 2015. d 8 week induction. Drug costs from eMC Dictionary of Medicines May 2015. e 8 week induction. Daily maintenance thereafter. Drug costs from eMC Dictionary of Medicines May 2015. National costing statement: vedolizumab for ulcerative colitis (June 2015) 7 of 10 Savings 4.5 The manufacturer suggests that there could be a reduction in the number of drug-related adverse events compared with other biologic drugs. Based on the estimates in the manufacturer’s submission, there could be 189 less adverse events such as skin reactions and serious infections. With a weighted average adverse event cost of £1,581, this gives potential savings of around £300k in England per year. Users are encouraged to estimate any potential savings locally. 5 Conclusion 5.1 The guidance offers an additional treatment option for treating moderately to severely active ulcerative colitis in adults. We encourage organisations to evaluate their own practices against the recommendations in the NICE guidance and assess costs and savings locally. 5.2 There is variation in current clinical practice across the country and a lack of data on treatment outcomes. It is anticipated that there will be increased drug costs for clinical commissioning groups. 5.3 There may be some savings associated with a reduction in drugrelated adverse events compared with other biologic drugs. National costing statement: vedolizumab for ulcerative colitis (June 2015) 8 of 10 Appendix A Drug and administration costs per treatment cycle - vedolizumab a Units per year Product Vedolizumab Mg 300 Cost per unit £2,050 Induction Maintenance Subsequent years Maintenance 3 5 6.5 First year b Drug cost per year Induction Maintenance Subsequent years Maintenance £6,150 £10,250 £13,325 First year a Administration cost per year First year Induction £395 Maintenance £535 Subsequent years Maintenance £696 The number of units per cycle refers to the total number of vials, pens or syringes required. This does not reflect the number of administrations. b It is assumed that administration of vedolizumab will require an outpatient attendance for intravenous infusion. It is estimated that 3 attendances would be required during induction in the first year, 5 during maintenance in the first year and 6.5 during maintenance in subsequent years, at a cost of £181 for the first attendance and £107 per subsequent attendance (Payment by results 2015-16 enhanced tariff option, 301 Gastroenterology outpatient appointment). Commissioners and providers may need to agree a payment as the cost of administration may fall between an outpatient appointment and a day case. National costing statement: vedolizumab for ulcerative colitis (June 2015) 9 of 10 National costing statement: vedolizumab for ulcerative colitis (June 2015) 10 of 10