The sponsor assessed the cost of vedolizumab as an SC injection for the maintenance treatment of adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant of immunomodulators or a TNF alpha antagonist, or have had an inadequate response or intolerance to, or demonstrated dependence on, corticosteroids.16 Vedolizumab SC is a new formulation of vedolizumab that can be self-administered in an at-home setting, removing the need to travel to a hospital or clinic for maintenance therapy, compared with vedolizumab IV infusion, which requires administration in a hospital or infusion clinic. The cost comparison was undertaken from the public drug plan perspective and included drug acquisition costs, with a scenario analysis conducted from the health care payer perspective that included administration costs for IV treatments.
The drug acquisition cost of vedolizumab SC is $822.50 per 108 mg pre-filled pen, while the cost per 300 mg vial of vedolizumab IV is $3,290.00. The recommended maintenance dose for vedolizumab SC is 108 mg every 2 weeks and 300 mg every 8 weeks for vedolizumab IV; an IV induction phase is required for both IV and SC vedolizumab. The average annual maintenance cost of both vedolizumab SC and vedolizumab IV is $21,458 after year 1, suggesting cost-neutrality if vedolizumab SC is reimbursed. Other relevant comparators included in this comparison were adalimumab (Humira), infliximab (Inflectra, Remicade, and Renflexis), and ustekinumab (Stelara). The average annual maintenance costs for the comparators ranged from $11,910 to $29,958 (); however, the sponsor noted that, while ustekinumab is indicated for the treatment of CD, it is currently only reimbursed in Saskatchewan.
Sponsor’s Submitted Cost Comparison.
From a health care payer perspective, the sponsor estimated a total cost of $288.36 per IV administration ($200.06 chair time; $75.00 complex single or multi-agent therapy; $13.30 monthly telephone supervision of chemotherapy) for vedolizumab IV and infliximab. Based on the assumption that patients would receive vedolizumab IV and infliximab an average of 6.5 times per year, the sponsor estimated annual administration costs of $1,874 for IV treatments in Canada.
Critical Appraisal of Cost Information
Comparative efficacy of vedolizumab SC is uncertain: Due to the lack of direct evidence for comparisons between vedolizumab SC and vedolizumab IV or other comparators, the sponsor submitted an ITC to inform relative clinical efficacy (i.e., clinical remission and enhanced clinical response) and safety.
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Consideration of induction costs: The sponsor did not include costs associated with the induction of IV therapies in its cost comparison. In the 2016 review of vedolizumab IV, CADTH noted that the costs associated with the first year of induction therapy were more than in subsequent maintenance years; therefore, the sponsor’s consideration of maintenance treatment likely underestimates total treatment costs for the introduction of vedolizumab SC.
17 The costs for induction treatment with the comparators included in this review were $26,320 for vedolizumab IV, $23,564 for adalimumab, $31,264 for infliximab (Remicade), $15,776 for subsequent entry biologic (SEB) infliximab (Renflexis), $16,800 for SEB infliximab (Inflectra), and $36,745 for ustekinumab in the first year of treatment ( ).
CADTH Cost Comparison Table – New Formulation of Vedolizumab.
CADTH Reanalyses
Based on the assumption that vedolizumab SC would only replace vedolizumab IV upon reimbursement, funding of vedolizumab SC would likely be cost-neutral from the public drug plan perspective as both formulations result in an average annual drug cost of $21,458 ( ).
When considering the other comparators included by the sponsor, the difference in annual maintenance costs compared to vedolizumab SC range from a savings of $8,499 versus ustekinumab to increased costs of $8,596 versus SEB infliximab (Renflexis). The difference in annual induction costs compared to vedolizumab SC range from a savings of $10,425 versus ustekinumab to increased costs of $10,544 versus SEB infliximab (Renflexis).
If a health care payer perspective is adopted, vedolizumab SC would be associated with a cost savings of approximately $1,874 annually per patient for maintenance therapy when compared with vedolizumab IV due to reduced treatment administration costs.
Issues for Consideration
Use of ustekinumab: In 2017, CADTH reviewed ustekinumab for induction and maintenance treatment of CD, and issued a positive recommendation on the condition that the cost of ustekinumab should not exceed the drug plan cost of the least-costly alternative biologic treatment option.
21 However, negotiations for ustekinumab for CD by the pCPA and the sponsor were concluded without agreement in March 2019, indicating there may be limited uptake of this treatment for CD by the participating public drug plans.
22 Impact of health care resource utilization: The introduction of vedolizumab SC as maintenance treatment will lead to a reduced need for IV infusions. However, there may be additional dispensing fees associated with vedolizumab SC given the frequent dosing regimen (i.e., every 2 weeks) compared to vedolizumab IV (i.e., every 8 weeks).
Price reduction of vedolizumab SC: CADTH reviewed vedolizumab IV in 2016, and recommended vedolizumab with a pricing condition in which the cost of treatment with vedolizumab IV should not exceed the drug plan cost of the least-costly alternative biologic treatment option (infliximab [Inflectra] at the time).
23 Comparing current treatment costs between vedolizumab IV ($21,458 annual costs) and infliximab (Inflectra; $13,697) would suggest a price reduction of 36% for vedolizumab IV to meet this condition. Additionally, following the 2016 review SEB infliximab (Renflexis) was introduced at a lower treatment cost compared to infliximab (Inflectra); therefore, a greater price reduction of 40% is required to achieve cost-neutrality. Where participating drug plans were able to negotiate a price reduction for vedolizumab IV, a similar price reduction would be needed for vedolizumab SC to remain cost-neutral relative to vedolizumab IV.
