Pharmacoeconomic review report : (Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.) : indication : indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PEX) and immunosuppressive therapy. Caplacizumab (Cablivi) / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

Canadian Agency for Drugs and Technologies in Health, author, issuing body.

Language:

English

Subjects (All):

Immunosuppressive agents.

Immunosuppression.

Plasma exchange (Therapeutics).

Physical Description:

1 online resource (36 pages)

Edition:

Version: final (with redactions).

Place of Publication:

[Ottawa] : Canadian Agency for Drugs and Technologies in Health, 2020.

Summary:

Caplacizumab (Cablivi) is a selective bivalent anti -von Willebrand factor nanobody indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PEX) and immunosuppressive therapy. Caplacizumab is available in single or multi-pack kits (seven administrations) containing an 11 mg vial of Caplacizumab powder, a pre-filled syringe of sterile water for injection, a vial adaptor, a needle, and two alcohol swabs. The recommended loading dose for caplacizumab is11 mg by IV injection at least 15 minutes prior to PEX, followed by an 11 mg subcutaneous injection after completion of PEX on that day. Subsequently, 11 mg of caplacizumab should be administered as a daily maintenance dose by subcutaneous injection following PEX administration for the duration of daily PEX therapy, then once daily for 30 days following the last daily PEX treatment. If, after the initial treatment course, signs of persistent underlying disease such as suppressed a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) activity levels remain present, treatment may be extended for a maximum of 28 days. No data on re-treatment with caplacizumab are available.

Contents:

Abbreviations

Executive Summary

Background

Summary of Identified Limitations and Key Results

Conclusions

Information on the Pharmacoeconomic Submission

Summary of the Sponsor's Pharmacoeconomic Submission

Sponsor's Base Case

Summary of Sponsor's Sensitivity Analyses

Limitations of Sponsor's Submission

CADTH CDR Reanalyses

Issues for Consideration

Patient Input

Appendix 1. Cost Comparison

Appendix 2. Summary of Key Outcomes

Appendix 3. Additional Information

Appendix 4. Summary of Other HTA Reviews of Drug

Appendix 5. Reviewer Worksheets

References.

Notes:

Description based on publisher supplied metadata and other sources.