Objectives: To review clinical guidelines, recent HTA decisions, and the influence of economic analyses in HTA decisions related to biologic therapies in UC.
Methods: A literature review and targeted research provided information on clinical treatment guidelines (US and Europe) and HTAs (Europe) related to biologics in UC. Economic models in UC were identified and reviewed to determine how these affected HTA decisions.
Results: Since several biologics were approved after the last version of the US treatment guidelines, the US guidelines only address the use of infliximab for the treatment of moderate or severe UC. In the UK, NICE has recommended infliximab, adalimumab, and golimumab as possible treatments for adults with moderate to severe UC in whom conventional therapy hasn’t worked or isn’t suitable. A recent NICE HTA recommends vedolizumab as an option for treating moderately to severely active UC in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme. The Scottish Medicines Consortium (SMC) recommends vedolizumab for the treatment of adult patients with moderate-to-severe UC and an inadequate response, lost response, or intolerance to conventional therapy or a TNF α antagonist; this advice is "contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower." Earlier SMC advice did not recommend adalimumab, golimumab or infliximab for use within NHS Scotland due to lack of robust economic analyses. The SMC advice is superseded by the NICE HTA decisions.
Conclusions: In the UK and Scotland, more than 9 HTA have been performed in the 10 years since biologics have become available for the treatment of moderate-to-severe UC. Differential cost-effectiveness among specific indications, lines of treatment, and countries have resulted in a variety of recommendations as to their use which supplement clinical guidelines in UC.
