Summary of Sponsor’s Budget Impact Analysis

The submitted budget impact analysis (BIA) assessed the introduction of vedolizumab SC as treatment for adult patients with moderately to severely active CD. The analysis was undertaken from a drug plan perspective using a claims-based approach. A 3-year time horizon was used, from 2021 to 2023, with 2020 as a base year. Claims were forecasted over the time horizon based on 4 years of historical public claims data. The relevant comparators for this analysis included intravenous (IV) vedolizumab, adalimumab, infliximab, and ustekinumab. The base case included drug acquisition costs, dispensing fees, and mark-up, with a scenario analysis performed from the health care payer perspective that also included administration costs.

In the reference scenario, the sponsor only considered vedolizumab available as an IV formulation and included the comparators adalimumab and infliximab, with a proportion of market shares for ustekinumab projected in jurisdictions where funding has yet to be received. Vedolizumab SC was introduced in the new drug scenario and was only assumed to capture market share from ▬: ▬% of the total vedolizumab share in year 1, ▬% in year 2, and ▬% by year 3. The market shares of ▬▬▬▬▬ remained unchanged. Key inputs to the BIA are documented in Table .

Summary of the Sponsor’s Budget Impact Analysis Results

Results of the sponsor’s base case suggested the introduction of vedolizumab SC would be cost-neutral (i.e., annual budget impact of $0) over the total 3-year time horizon. This was based on ▬▬▬▬▬ according to the recommended dosing and market share uptake ▬▬▬▬▬. As part of scenario analyses when adopting a health care payer perspective, vedolizumab SC was associated with a cost savings of $5,224,410 over the 3-year time horizon.

CADTH Appraisal of the Sponsor’s Budget Impact Analysis

CADTH identified the following key limitations to the sponsor’s analysis that have notable implications on the results of the BIA:

• Inappropriate uptake of ustekinumab: Ustekinumab for the treatment of CD is currently only reimbursed by the province of Saskatchewan; however, the sponsor’s assumed uptake of ustekinumab in other jurisdictions over the 3-year time horizon was not supported by historical claims data. Specifically, in jurisdictions other than Saskatchewan the sponsor assumed market shares of ▬%, ▬%, and ▬% in years 1, 2, and 3, respectively. Based on the lack of historical data suggesting use of ustekinumab for CD in Canada, CADTH considered the assumptions regarding market share uptake for ustekinumab to be inappropriate. In addition, pCPA negotiations for ustekinumab for CD were concluded without agreement in March 2019, indicating there may be limited uptake of this treatment in CD by the public drug plans.²²

  • CADTH removed all market uptake by ustekinumab in the new and reference scenarios (except for Saskatchewan) as part of the CADTH base case. As CADTH retained the sponsor’s estimates for market share uptake, ▬▬▬▬▬
• Vedolizumab SC only captures market share from ▬: The sponsor assumed that vedolizumab SC would ▬ capture market share from ▬ as part of the base case. In some cases, however, it may be reasonable to assume vedolizumab SC would capture market share from ▬▬▬▬▬ due to the convenience of self-administering an SC treatment rather than travelling to a clinic for IV infusion.
  As a scenario analysis, the sponsor assumed that vedolizumab SC would capture market share from ▬▬▬▬▬. CADTH assessed the effect of this market share ▬▬▬▬▬ assumption without consideration of ustekinumab as a comparator given the limitation above.

  • CADTH assumed that vedolizumab SC would capture market share from ▬▬▬▬▬, as part of a scenario analysis.
• Consideration of induction costs: The sponsor did not include costs associated with the induction phase of both SC and IV therapies in their analysis. As noted in the Issues for Consideration section, first-year induction therapy costs were more than those of subsequent maintenance years. Therefore, the sponsor’s consideration of only maintenance treatment likely underestimates the budget impact for vedolizumab SC if market share is expected to be captured from ▬▬▬▬▬. As the sponsor’s BIA does not separate incident versus prevalent patients and implicitly assumes all patients are initiated and continued according to the maintenance dosing regimen, CADTH was unable to explore the impact of including induction treatment costs on the budget impact.

  • Due to structural limitations, CADTH was unable to assess the inclusion of induction treatment costs.
• Price reduction of vedolizumab SC: In 2016, CADTH previously reviewed vedolizumab IV and recommended a price reduction (of approximately 40%) to that of the least-costly alternative biologic treatment option, infliximab (Renflexis).²³ Where participating drug plans were able to negotiate this price reduction for vedolizumab IV, a similar price reduction would need to be included for vedolizumab SC to be considered cost-neutral.

  • CADTH assumed a price reduction of 40% of vedolizumab IV as part of a scenario analysis.

CADTH Reanalyses of the Budget Impact Analysis

Based on the limitations identified by CADTH, the market share uptake of ustekinumab was adjusted as part of CADTH’s base-case analysis (Table ). However, as vedolizumab SC captured market share only from ▬ in the sponsor’s model and there were limited data to inform the potential uptake from ▬ ▬, the CADTH results do not change: vedolizumab SC remains cost-neutral (Table ).

CADTH explored the potential uptake of market share from ▬in a scenario analysis using the estimates provided by the sponsor, with an overview of the included market shares presented in Table . When including market share uptake from ▬, the 3-year budget impact was $1,929,135 (Table ).

CADTH explored a scenario in which participating drug plans were assumed to have successfully negotiated a 40% price reduction for vedolizumab IV (based on the expected price reduction to match the costs of SEB infliximab [Renflexis]). The 3-year budget impact was $31,986,913 and participating drug plans would be required to negotiate a similar price reduction for vedolizumab SC to remain cost-neutral.