What Is the CADTH Reimbursement Recommendation for Rinvoq?: CADTH recommends that Rinvoq be reimbursed for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic disease-modifying antirheumatic drug (bDMARD) or when use of those therapies is inadvisable only if certain conditions are met.

Which Patients Are Eligible for Coverage?: Eligibility for Rinvoq should be based on the criteria used by each of the public drug plans for reimbursement of bDMARDs for the treatment of adult with active AS who have had an inadequate response to a bDMARD, are intolerant, or who have contraindications to bDMARDs.

What Are the Conditions for Reimbursement?: Rinvoq should only be reimbursed if it is prescribed by a rheumatologist. For patients with other manifestations, an ophthalmologist, gastroenterologist, or dermatologist may be consulted. Rinvoq should not be reimbursed when used in combination with bDMARDs or other Janus kinase (JAK) inhibitor treatments for active AS. The cost of Rinvoq should not exceed the drug program cost of treatment with the least expensive bDMARD reimbursed for the treatment of AS.

Why Did CADTH Make This Recommendation?:

1. Based on evidence from 2 clinical trials in which Rinvoq demonstrated clinically meaningful improvements in clinical response (e.g., Assessment in SpondyloArthritis international Society 40%), AS symptom reduction (e.g., total back pain), function and disability improvement (i.e., Bath Ankylosing Spondylitis Functional Index), and AS disease activity reduction (e.g., Bath Ankylosing Spondylitis Disease Activity Index 50) in adult patients with active AS. Rinvoq also demonstrated clinically meaningful improvements in health-related quality of life (i.e., Ankylosing Spondylitis Quality of Life) in Study 944 and MRI-detected axial inflammation in Study 098.

2. Rinvoq addresses some of the unmet needs identified as important by patients, such as reducing AS symptoms, reducing disease activity, and improving health-related quality of life.

3. Based on CADTH’s assessment of the health economic evidence, Rinvoq does not represent good value to the health care system at the public list price. The committee determined there is not enough evidence to justify a greater cost for Rinvoq compared with bDMARDs.

4. Based on public list prices, Rinvoq is estimated to cost the public drug plans approximately $6 million over the next 3 years.

What Is Ankylosing Spondylitis?: AS (also referred to as radiographic axial spondyloarthritis) is a chronic inflammatory disease primarily involving the spine and the sacroiliac joints. Patients with AS experience back pain and spinal stiffness that negatively affect their quality of life. In 2019, AS was estimated to affect 300,000 people in Canada. The goals of treatment for patients with AS are to maximize long-term health-related quality of life, control symptoms and inflammation, maintain spinal flexibility and normal posture, reduce functional limitations, maintain work ability, decrease disease complications, and prevent progressive structural damage.

Unmet Needs in AS: Not all patients with AS respond to currently available treatments. Patients on AS medications experience various adverse effects with current therapies; report that medications become less effective more frequently, which requires a switch to another medication; and experience the persistence of constant spinal pain and active extra-articular manifestations. Finally, the lack of orally administrated treatment options affects compliance and adherence to the treatment plan.

How Much Does Rinvoq Cost?: Treatment with Rinvoq is expected to cost approximately $17,965 per patient per year.