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  • 1

    September 2015

    Allergen Immunotherapy

    FINAL ENVIRONMENTAL SCAN REPORT

  • FINAL REPORT

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    September 30 th , 2015 odprn.ca Ontario Drug Policy Research Network

    Conflict of Interest Statement

    No study members report any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that may present a potential conflict of interest in the Allergen Immunotherapy Drug Class Review.

    Acknowledgments

    The Ontario Drug Policy Research Network (ODPRN) is funded by grants from the Ontario Ministry of Health and Long-term Care (MOHLTC) Health System Research Fund. The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources and supporting organizations.

    A special thank you to all of the provincial and territorial representatives in Canada from the respective Ministries of Health as well as the representative from the Non-Insured Health Benefits for First Nations and Inuit (NIHB) who participated in the telephone survey.

    Study Team

    Environmental Scan: Sandra Knowles

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    September 30 th , 2015 odprn.ca Ontario Drug Policy Research Network

    Executive Summary

    Part A: Pharmacy Benefit Programs in Ontario, across Canada and internationally In Canada, allergen immunotherapy is available either for sublingual administration (SLIT) or for subcutaneous administration (SCIT). There are three commercialized products available for SLIT administration: Oralair, Ragwitek and Grastek. Most SCIT products are formulated specifically for the allergic patient (one exception is Pollinex R, which is available as a commercially formulated product). The compounding of patient-specific serums is done by commercial laboratories, pharmacies or in the physician’s office. The cost of these compounded products is not standardized nor is it publically available.

    In Ontario, Oralair and Ragwitek are listed as Limited Use products on the Ontario Drug Benefit formulary. Allergenic extracts for SCIT are available for ODB eligible patients under the special “Allergy Product” program. Across Canada, most public drug programs (with the exception of Yukon Territories) provide coverage for allergen immunotherapy, in particular the SCIT products. SLIT products are listed on five public drug plans. Only one jurisdiction (Nova Scotia) has developed clinical criteria for SCIT and SLIT products in Canada. In the US, most drug plans reviewed provide coverage for SCIT for patients with specific conditions. Australia and New Zealand provide coverage through the public plan programs only for subcutaneous venom immunotherapy.

    Part B: Guidelines for the use of allergen immunotherapy There have been several guidelines and consensus statement published by various organizations on allergen immunotherapy including the American Academy of Allergy, Asthma and Immunology (AAAAI), Canadian Society of Allergy and Clinical Immunology (CSACI), British Society for Allergy and Clinical Immunology and the German, Austrian and Swiss professional associations (S2K group). Recommendations for allergenic extract preparation, use of diluents, dosing and compatibility for allergy immunotherapy were reviewed.

    Part C: Impact of different drug reimbursement schemes for allergen immunotherapy There is a lack of literature investigating various reimbursement schemes for allergen

    immunotherapy.

    Part D: Rapid review of selected topics  Venom immunotherapy: Venom immunotherapy is an effective therapy for prevention of

    future allergic reactions to Hymenoptera stings, and also improves quality of life. However, venom immunotherapy is not without risk, and patients may develop local reactions or more rarely, systemic reactions.

     Duration of therapy: Although the optimal duration of immunotherapy is unknown, three to five years duration for SCIT has been recommended. Patients receiving venom immunotherapy may require life-long administration. For SLIT, three years of therapy (pre- and co-seasonal) is recommended.

     Sublingual immunotherapy (drop formulation): In meta-analyses that have compared SLIT tablets and drops, SLIT tablets are more effective than drops in terms of symptom improvement. The use of multiallergen SLIT administration has not been well studied and may not be as effective as single-allergen SLIT.

     Immunotherapy for food allergies: Use of subcutaneous allergen immunotherapy for food

    allergies is not recommended due to safety concerns. Although sublingual allergen

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    September 30 th , 2015 odprn.ca Ontario Drug Policy Research Network

    immunotherapy has been studied for some food allergies, the evidence for its efficacy and

    safety is still limited and cannot be recommended for routine use at this time.

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    September 30 th , 2015 odprn.ca Ontario Drug Policy Research Network

    Table of Contents September 2015 ..................................................................................................................... 1

    Conflict of Interest Statement ................................................................................................. 2

    Acknowledgments ................................................................................................................... 2

    Study Team ............................................................................................................................. 2

    Note ......................................................................................... Error! Bookmark not defined.

    Executive Summary .................................................................................................................... 3

    Introduction ................................................................................................................................. 7

    Part A: Pharmacy Benefit Programs in Ontario, across Canada and internationally ............... 8

    Availability of Allergen Immunotherapy in Canada ................................................................. 8

    Common Drug Review .......................................................................................................... 10

    Product listing in Ontario ....................................................................................................... 10

    Public Plan Listings in Canada ............................................................................................. 12

    Restriction Criteria ............................................................................................................. 12

    Selected International Jurisdictions ...................................................................................... 14

    Part B: Guidelines for the use of allergen immunotherapy ...................................................... 17

    Part C: Impact of different drug reimbursement schemes for allergen immunotherapy .......... 22

    Part D: Rapid Review of Selected Topics ............................................................................... 23

    Duration of immunotherapy treatment .............................................................................. 23

    Venom Immunotherapy ..................................................................................................... 24

    Sublingual immunotherapy: focus on oral drop administration ......................................... 26

    Immunotherapy for food allergies...................................................................................... 27

    Health Canada Warnings .................................................................................................. 28

    Discussion ................................................................................................................................ 28

    Part A: Pharmacy Benefit Programs in Ontario, across Canada and internationally .......... 28

    Availability in Canada ........................................................................................................ 28

    Public Plan Listing in Ontario ............................................................................................ 29

    Public Plan Listing in Canada ........................................................................................... 29

    Selected International Jurisdictions .................................................................................. 29

    Part B: Guidelines for the use of allergen immunotherapy .................................................. 29

    Part C: Impact of different drug reimbursement schemes for allergen immunotherapy ...... 29

    Part D: Rapid Reviews of Selected Topics .......................................................................... 29

    Health Equity ............................................................................................................................ 30

    Conclusion ................................................................................................................................ 30

    Reference List ........................................................................................................................... 31

    Appendix A: Marketed pr

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