Table 1Reimbursement Conditions and Reasons

Reimbursement condition Reason Implementation guidance
Initiation
1. Eligibility for upadacitinib should be based on the criteria used by each of the public drug plans for reimbursement of bDMARDs for the treatment of adults with active AS who have had an inadequate response to a bDMARD, are intolerant, or who have contraindications to bDMARDs.There is no direct evidence that upadacitinib is clinically superior or inferior to biologic treatments currently reimbursed for the treatment of active AS who have had an inadequate response to a bDMARD, are intolerant, or who have contraindications to bDMARDs.—
Renewal
2. Upadacitinib should be renewed in a similar manner to bDMARDs currently reimbursed for the treatment of adult patients with active AS who have had an inadequate response to a bDMARD, are intolerant, or who have contraindications to bDMARDs.There is no evidence that upadacitinib should be held to a different standard than other reimbursed options when considering renewal in adult patients with active AS who have had an inadequate response to a bDMARD, are intolerant, or have contraindications to bDMARDs.Upadacitinib should not be considered a first-line treatment option.
Prescribing
3. Upadacitinib should be prescribed by a rheumatologist or clinicians who have experience treating adult patients with active AS.Accurate diagnosis and follow-up of patients with active AS are important to ensure that upadacitinib is prescribed to the most appropriate patients. In addition, there are several bDMARD and tsDMARD treatment options that may be considered when selecting the most appropriate therapy for patients, which is best determined by a rheumatologist or clinician who is familiar with this complex treatment paradigm.In some rural areas of Canada, patients may be followed by a general internist with special interest in rheumatology.
4. Upadacitinib should not be reimbursed when used in combination with bDMARDs or other JAK inhibitor treatments for active AS.No data were identified to demonstrate a benefit of upadacitinib in combination with bDMARDs.—
Pricing
5. Upadacitinib should be negotiated so that it does not exceed the drug program cost of treatment with the least costly bDMARD reimbursed for the treatment of AS.There is insufficient evidence to justify a cost premium for upadacitinib over the least expensive bDMARD reimbursed for AS.—

AS = ankylosing spondylitis; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; bDMARD = biologic disease-modifying antirheumatic drug; tsDMARD = targeted synthetic disease-modifying antirheumatic drug.

From: Upadacitinib (Rinvoq)

Cover of Upadacitinib (Rinvoq)
Upadacitinib (Rinvoq): CADTH Reimbursement Recommendation: Indication: For the treatment of adults with active ankylosing spondylitis who have had an inadequate response to a biologic disease-modifying antirheumatic drug or when use of those therapies is inadvisable. Upadacitinib may be used as monotherapy or in combination with nonsteroidal anti-inflammatory drugs [Internet].
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