abbreviations - cadth web viewplease indicate if there are safety advisories and warnings from...

pCODR Submission for (BRAND NAME AND INDICATION)

Template for Biosimilar Submission

Instructions for ManufacturersPlease read the instructions below and consult the recommended documentation before completing the template. If you have any questions regarding the pCODR submission filing process or requirements, please email [email protected] with the complete details of your question(s).

Before Completing the Template: Please review the following documents to ensure an understanding of the pCODR procedures and

submission guidelines: pCODR Procedures (March 201 7 ) pCODR Submission Guidelines (March 201 7 ) pCODR Updates (webpage) for any applicable information.

Note: CADTH is committed to providing an open and transparent cancer drug review process and to the need to be accountable for its recommendations to patients and the public. To ensure that the pCODR review process is transparent and accountable, CADTH considers it essential that the evidence upon which pCODR Expert Review Committee’s recommendations are based be publicly available. Information provided in this template may be publicly disclosed as per the pCODR Disclosure of Information Guidelines.

Completing the Template: Complete all sections of the Biosimilar Submission Template with the exception of sections 3, 5, 6.4,

8, 9 and Appendix 3, 4 and 5, which will be completed by the pCODR Review Team.

Do not exceed the page limitations in sections 4.4, 4.5, 4.6 and 6.

Do not write in sections labelled “To be completed by the pCODR Review Team.”

Use 11-point Calibri font for text outside tables and 10-point Calibri font for text inside tables.

References must be provided in the following format: In-text citations must be numbered in order of appearance. A numbered reference list must be provided in the Citing Medicine format at the end of the

document in the References section.

Save the completed template as a Word document format using the following file name structure:BrandName_Indication_Biosimilar_Template

Submitting the Template to pCODR: Incorporate the completed biosimilar submission template saved as a Word document format into a

complete package of category 1 requirements and may file the Submission through the secure collaborative workspaces.

Please consult the pCODR Submission Guidelines for details on how to file the submission package.

https://www.cadth.ca/sites/default/files/pcodr/pCODR's%20Drug%20Review%20Process/pcodr-submission-guidelines.pdf

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https://www.cadth.ca/sites/default/files/pcodr/pCODR's%20Drug%20Review%20Process/pcodr-procedures.pdf

mailto:[email protected]


TABLE OF CONTENTS

ABBREVIATIONS...........................................................................................................................................4

1. PRODUCT INFORMATION........................................................................................................................5

1.1 Requested Reimbursement Criteria..................................................................................................5

1.2 Rationale for Requested Reimbursement Criteria.............................................................................5

1.3 Health Canada Safety Advisories and Warnings................................................................................5

1.4 Summary of the Biosimilar Product...................................................................................................5

1.5 Summary of the Reference Product...................................................................................................6

2. INDICATIONS...........................................................................................................................................7

2.1 Health Canada-Approved Indications................................................................................................7

2.2 Proposed Indications under Review by Health Canada.....................................................................7

3. Clinical information and highlights of stakeholder input evidence..........................................................8

4. BIOSIMILARITY.........................................................................................................................................9

4.1 Methods............................................................................................................................................9

4.1.1 Literature Search Methods........................................................................................................................9

4.1.2 Study Selection..........................................................................................................................................9

4.1.3 Quality Assessment.................................................................................................................................10

4.2 Literature Search Results.................................................................................................................10

4.3 Pivotal Clinical Studies.....................................................................................................................10

4.3.1 Name of Clinical Study 1..........................................................................................................................11

4.3.2 Name of Clinical Study 2..........................................................................................................................13

4.4 Other Important Safety Information about the Biosimilar..............................................................17

4.5 Immunogenicity...............................................................................................................................17

4.6 Overall Results and Conclusion on Efficacy and Safety....................................................................17

5. CRITICAL APPRAISAL OF CLINICAL STUDIES...........................................................................................18

5.1 Internal Validity...............................................................................................................................18

5.2 External Validity...............................................................................................................................18

6. AUTHORIZATION OF INDICATIONS........................................................................................................19

6.1 Manufacturer’s Rationale for Authorization of Indication(s)...........................................................19

6.2 Health Canada’s Conclusion on Authorization of Indication(s)........................................................19

6.3 International Regulatory Conclusions on Indication(s) Authorized by Health Canada.....................19

6.4 pCODR Comments on Authorization of Indication...........................................................................20

7. COST COMPARISON...............................................................................................................................21


8. DISCUSSION...........................................................................................................................................22

9. CONCLUSION.........................................................................................................................................22

APPENDIX 1: ADDITIONAL DATA................................................................................................................23

APPENDIX 2: PUBLIC DRUG PROGRAM FUNDING STATUS FOR REFERENCE PRODUCT AND OTHER FUNDED BIOSIMILARS...............................................................................................................................24

APPENDIX 3: SUMMARY OF PATIENT GROUP INPUT.................................................................................26

APPENDIX 4: SUMMARY OF REGISTERED CLINICIAN INPUT......................................................................27

APPENDIX 5: SUMMARY OF PROVINCIAL ADVISORY GROUP INPUT..........................................................28

REFERENCES..............................................................................................................................................29


ABBREVIATIONS

Please provide a list of abbreviations used in your completed template. The list should be in alphabetical order and should use the two-column table format shown in the example below.

AE adverse eventAUC area under the curveCI confidence intervalCmax maximum concentrationCSR Clinical Study ReportCTD Common Technical DocumentDB double-blindEMA European Medicines AgencyFDA Food and Drug AdministrationpCODR pan-Canadian Oncology Drug ReviewpERC pCODR Expert Review CommitteeRCT randomized controlled trialSAE serious adverse eventWDAE withdrawal due to adverse event


1. PRODUCT INFORMATION

1.1 Requested Reimbursement CriteriaPlease state the requested reimbursement criteria in the table below; using separate rows for each indication (add additional rows as necessary).

Requested Reimbursement CriteriaState the requested reimbursement criteria for indication 1

State the requested reimbursement criteria for indication 2



1.2 Rationale for Requested Reimbursement CriteriaProvide a clear rationale for all of the requested reimbursement criteria noted in section 1.1 with references where appropriate.

1.3 Health Canada Safety Advisories and WarningsPlease indicate if there are safety advisories and warnings from Health Canada that may relate to the requested reimbursement criteria.

1.4 Summary of the Biosimilar Product

Please complete all sections of the following table

Characteristics

Manufacturer-Provided DetailsBiosimilara Reference Producta Other Biosimilar(s) a

approved for sale in Canada (if available)

Brand name:Non-proprietary name:Manufacturer:Strength(s):Dosage form:Route of administration:Drug Identification Number(s):Therapeutic classification:

a Please rename these column headings with brand names of the Biosimilar and the reference product.

Please provide a brief summary of the similarities and differences between the biosimilar and the reference product, particularly with respect to the following:

pharmaceutical form and composition the dosage form, strength, and route of administration


1.5 Summary of the Reference Product

Please provide a brief description of the reference product that was used to apply for market authorization in Canada. Clearly state if the reference biologic drug is authorized for sale and marketed in Canada. If a non-Canadian reference biologic drug was used, briefly explain the rationale for this choice.


2. INDICATIONS

2.1 Health Canada-Approved IndicationsPlease complete the table (add rows as necessary) with the following information:

Indications ‒ State the exact wording of each indication in a separate row. Authorization of Indication ‒ Indicate if the indication was approved by Health Canada for the

indication(s) held by the biologic drug authorized in Canada to which a reference is made.

Indication(s) Authorization of Indication

State exact wording of indication Yes / NoState exact wording of indication Yes / NoState exact wording of indication Yes / No

2.2 Proposed Indications under Review by Health CanadaPlease complete the table (add rows as necessary) with the following information:

Proposed Indications ‒ State the exact wording of each proposed indication in a separate row. Anticipated date of NOC – Provide the day, month and year for the anticipated date NOC.

Proposed Indication(s) Anticipated Date of NOCState proposed indication Day, Month, YearState proposed indication Day, Month, YearState proposed indication Day, Month, Year


3. CLINICAL INFORMATION AND HIGHLIGHTS OF STAKEHOLDER INPUT EVIDENCE

To be completed by pCODR Review Team


4. BIOSIMILARITY

In section 4 of the template, the manufacturer will summarize the key data submitted for the Health Canada review. The required information or evidence must be succinct and entered directly into the template.

References must be provided in the following format:• In-text citations must be numbered in order of appearance.• A numbered reference list must be provided using the Citing Medicine format in the References

section located at the end of the template.

4.1 Methods

4.1.1 Literature Search MethodsProvide details on the literature search strategy including search terms used and databases searched as well as the dates searched. If methodological filters were applied, please include details. Please also include any details of limits used in the search (e.g., limits by language).

If grey literature was searched, please provide details, including the sources and the dates searched.

Example:

Published literature was identified by searching the following bibliographic databases: MEDLINE (YEAR-MONTH-DAY, YEAR) with in-process records & daily updates via Ovid; EMBASE (YEAR-MONTH-DAY, YEAR) via Ovid; and PubMed (searched MONTH-DAY, YEAR). The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were BIOSIMILAR and metastatic breast cancer. Methodological filters were applied to limit retrieval to randomized controlled trials and controlled clinical trials. Retrieval was limited to the human population and to English language publications.

Grey literature (literature that is not commercially published) was identified by searching the websites of regulatory agencies (US FDA, EMA) and clinical trial registries (ClinicalTrials.gov).

4.1.2 Study SelectionProvide details of how studies were selected, including the number of reviewers and the role of each. Please also provide the study selection criteria for the systematic review (i.e., inclusion and exclusion criteria) in a table format.

Example:

One reviewer selected studies for inclusion in the review according to a predetermined protocol. All articles considered potentially relevant were acquired from library sources. Two reviewers independently made the final selection of studies to be included in the review and differences were resolved through discussion.

Example Table of Selection Criteria for the Systematic Review


Clinical Trial Design Patient Population Intervention Comparators OutcomesProvide details on the designs of clinical trials included in systematic review.

Provide details on the patient population to be included in the systematic review.

Provide details on the intervention to be included in the systematic review, including dosage and administration

Provide details on the comparators to be included in the systematic review, including dosage and administration.

Provide details on the outcomes of interest for the systematic review.

Notes:

4.1.3 Quality Assessment Provide details on how the assessment of study bias was performed, including details on the number of reviewers who conducted the assessment as well as any checklists that may have been used to assess limitations and sources of bias.

Example: Assessment of study bias was performed by one reviewer with input provided by a clinical expert. The Cochrane Risk of Bias tool was used to assess potential sources of bias in included studies.

4.2 Literature Search Results

Summarize the total number of citations identified and the number of studies included and excluded (with reasons) throughout the screening process.

4.3 Pivotal Clinical Studies

Please provide a brief introduction to the pivotal clinical studies by completing the table below. Please clearly identify all pivotal trials, including any switching study trials (if available).

Study Name Design Objectives Population State the study name

Provide a brief description of the study design

State the study objectives Therapeutic area and key characteristics

Example:BIOSIMILAR study

Non-inferiority RCT To determine if BIOSIMILAR has non-inferior clinical effectiveness and safety compared to REFERENCE DRUG

Second-line treatment of locally advanced or metastatic breast cancer

4.3.1 Name of Clinical Study 1Using the format provided below, please provide details of each clinical trial conducted to establish the efficacy of the biosimilar relative to the reference product. Add additional tables and sections as needed.


a) Study Characteristics Provide a brief description of the study (one paragraph). Complete the table below with all of the requested information regarding the study design.

Characteristics Details for (provide study name)

Study Name State the study name i.e., BIOSIMILAR study

STU

DYDE

SIGN

Objective State the study objective, e.g., pivotal pharmacokinetic study, pivotal efficacy and safety study.Example:To determine if BIOSIMILAR has non-inferior clinical effectiveness and safety compared to REFERENCE DRUG

Blinding Blinding of investigators and/or patients (e.g., double-blind, open-label) Study period State the beginning and end dates of the study (YYYY-MM to YYYY-MM)Study centres List the number of centres and the countries involvedDesign Provide a brief description of the study design, e.g., equivalence or non-

inferiority.

STU

DY P

OPU

LATI

ON Population Therapeutic area and key characteristics i.e., “Second-line treatment of locally

advanced or metastatic breast cancer”Randomized (N) #Inclusion criteria Major criteria onlyExclusion criteria List only major/select criteria

DRU

GS

Intervention Drug, dose, route of administration, frequency of administration

Comparator(s) Drug, dose, route of administration, and frequency of administration, for each comparator

DURA

TIO

N Run-in Specify the durationTreatment Specify the durationFollow-up Specify the duration

OU

TCO

ME

S

Primary End Point(s) Define the end point

Other End Points List and define other end points. Specify, for each, whether it was a secondary or exploratory end point.

NO

TES

Publications Provide references for all publications related to this study. Provide the clinicaltrials.gov identification code (e.g., NCTXXXXXXXX). Example:

Smith J. Study of BIOSIMILAR to REFERENCE in metastatic breast cancer. Journal of Biosimilar Research. 2017. 1(1):1-10.

Doe J. Long-term follow-up of BIOSIMILAR trial. Journal of Biosimilar Research. 2017. 1(2):1-10.


Intervention and Comparators Briefly describe the interventions employed in the trial, including dose, route and frequency of

administration, duration, etc. Please clearly state if a non-Canadian reference product was used in the trial. If the trial is blinded, indicate the use of matched placebos, double-dummy controls, etc. Describe any concomitant medications required or permitted during the study.

Outcomes Describe the key efficacy and safety outcomes for the study (definitions and measurement).

Statistical Analyses Briefly describe the statistics protocol for equivalence and/or non-inferiority testing. Briefly describe the rationale for the equivalence and/or non-inferiority margins used. Briefly define analysis sets (e.g., intention to treat or per-protocol). Please provide references for where the complete details can be located (e.g., sections of the

Common Technical Document and/or Clinical Study Report).

b) Results

Baseline Characteristics Summarize major/relevant demographic and baseline characteristics using a table. Comment on similarity/differences among groups. Comment on concomitant conditions, medications, and other relevant issues.

Patient Disposition Provide a brief paragraph summarizing the patient disposition for the study. Summarize the patient disposition for the study in the table below.

Summary of Patient Disposition for (insert study name)

DispositionProvide Study Name

Biosimilara Reference Producta

Screened, N N NRandomized, N N NDiscontinued, N (%) N (%) N (%)


WDAEs, N (%) N (%) N (%)Withdrawal due to SAEs, N (%) N (%) N (%)Lost to follow-up, N (%) N (%) N (%)Other, N (%)b

Intention to treat, N N NPer-protocol, N N NSafety, N N N

a Please rename these column headings with brand names of the biosimilar and the reference product.b Please detail all reasons for treatment discontinuation.SAE = serious adverse event; WDAE = withdrawal due to adverse event.

Efficacy ResultsSummarize the key efficacy end points of the study, including, but not limited to, patient reported outcomes (e.g. health related quality of life, including information on completion rates, baseline values, changes from baseline over the treatment period, details on minimally important differences, etc.), overall survival, progression-free survival, and response rates. A table in this section may be provided for the outcomes.

Safety ResultsSummarize the key safety end points of the study. Harms data should be presented based on the number of patients with an event, not the total number of events, e.g. the proportion of patients with ≥ 1 SAE; specific types of SAEs per patient; number of patients with ≥ 1 AE; frequency of selected AEs relevant to review drug per patient; proportion of patients with any Grade 3 or higher AEs, proportion of patients with specific Grade 3 or higher AEs. Adverse event data may be provided in a table, if appropriate.

4.3.2 Name of Clinical Study 2Using the format provided below, please provide details of each clinical trial conducted to establish the efficacy of the biosimilar relative to the reference product. Add additional tables and sections as needed.

a) Study Characteristics Provide a brief description of the study (one paragraph). Complete the table below with all of the requested information regarding the study design.


Study Name State the study name i.e., BIOSIMILAR study

STU

DYDE

SIGN

Objective State the study objective, e.g., pivotal pharmacokinetic study, pivotal efficacy and safety study.Example:To determine if BIOSIMILAR has non-inferior clinical effectiveness and safety compared to REFERENCE DRUG



Blinding Blinding of investigators and/or patients (e.g., double-blind, open-label) Study period State the beginning and end dates of the study (YYYY-MM to YYYY-MM)Study centres List the number of centres and the countries involvedDesign e.g., equivalence or non-inferiority

STU

DY P

OPU

LATI

ON Population Therapeutic area and key characteristics i.e., “Second-line treatment of locally

advanced or metastatic breast cancer”Randomized (N) #Inclusion criteria Major criteria onlyExclusion criteria List only major/select criteria

DRU

GS

Intervention Drug, dose, route of administration, frequency of administration

Comparator(s) Drug, dose, route of administration, and frequency of administration, for each comparator

DURA

TIO

N Run-in Specify the durationTreatment Specify the durationFollow-up Specify the duration

OU

TCO

ME

S

Primary End Point(s) Define the end point

Other End Points List and define other end points. Specify, for each, whether it was a secondary or exploratory end point.

NO

TES

Publications Provide references for all publications related to this study. Provide the clinicaltrials.gov identification code (e.g., NCTXXXXXXXX). Example:

Smith J. Study of BIOSIMILAR to REFERENCE in metastatic breast cancer. Journal of Biosimilar Research. 2017. 1(1):1-10.

Doe J. Long-term follow-up of BIOSIMILAR trial. Journal of Biosimilar Research. 2017. 1(2):1-10.

Intervention and Comparators Briefly describe the interventions employed in the trial, including dose, route and frequency of

administration, duration, etc. Please clearly state if a non-Canadian reference product was used in the trial. If the trial is blinded, indicate the use of matched placebos, double-dummy controls, etc. Describe any concomitant medications required or permitted during the study.

Outcomes Describe the key efficacy and safety outcomes for the study (definitions and measurement).

Statistical Analyses Briefly describe the statistics protocol for equivalence and/or non-inferiority testing. Briefly describe the rationale for the equivalence and/or non-inferiority margins used. Briefly define analysis sets (e.g., intention to treat or per-protocol).


Please provide references for where the complete details can be located (e.g., sections of the Common Technical Document and/or Clinical Study Report).

b) Results

Baseline Characteristics Summarize major/relevant demographic and baseline characteristics using a table. Comment on similarity/differences among groups. Comment on concomitant conditions, medications, and other relevant issues.

Patient Disposition Provide a brief paragraph summarizing the patient disposition for the study. Summarize the patient disposition for the study in the table below.

Summary of Patient Disposition for (insert study name)

Disposition Provide Study NameBiosimilara Reference Producta

Screened, N N NRandomized, N N NDiscontinued, N (%) N (%) N (%)

WDAEs, N (%) N (%) N (%)Withdrawal due to SAEs, N (%) N (%) N (%)Lost to follow-up, N (%) N (%) N (%)Other, N (%)b

Intention to treat, N N NPer-protocol, N N NSafety, N N N

a Please rename these column headings with brand names of the biosimilar and the reference product.b Please detail all reasons for treatment discontinuation.SAE = serious adverse event; WDAE = withdrawal due to adverse event.

Efficacy ResultsSummarize the key efficacy end points of the study, including, but not limited to, patient reported outcomes (e.g. health related quality of life, including information on completion rates, baseline values, changes from baseline over the treatment period, details on minimally important differences, etc.), overall survival, progression-free survival, and response rates. A table in this section may be provided for the outcomes.

Safety ResultsSummarize the key safety end points of the study. Harms data should be presented based on the number of patients with an event, not the total number of events, e.g. the proportion of patients with ≥ 1 SAE; specific types of SAEs per patient; number of patients with ≥ 1 AE; frequency of selected AEs relevant to review drug per patient; proportion of patients with any Grade 3 or higher AEs, proportion of patients with specific Grade 3 or higher AEs. Adverse event data may be provided in a table, if appropriate.


4.4 Other Important Safety Information about the Biosimilar

Section 4.4 must not exceed one page.

Provide a brief overview of any additional safety information relevant to the biosimilar under request, with references to documents where the complete details can be located (e.g., module 2.7.4 of the Common Technical Document).

4.5 Immunogenicity

Section 4.5 must not exceed one page.

Summarize the key methods and results of immunogenicity assays performed in the study, and Health Canada’s comments on any clinically meaningful differences in immunogenicity between the biosimilar and the reference biologic drug. Include a summary table displaying key data if appropriate.

4.6 Overall Results and Conclusion on Efficacy and Safety

Section 4.6 must not exceed half a page.

Please provide a summary and conclusion of the overall results from the key clinical trials.


5. CRITICAL APPRAISAL OF CLINICAL STUDIES

5.1 Internal Validity


5.2 External Validity



6. AUTHORIZATION OF INDICATIONS

Section 6 must not exceed five pages.

If the biosimilar has been authorized by Health Canada for the requested indication(s) held by the reference biologic drug, please complete both sections 6.1 and 6.2. If the biosimilar has not been authorized by Health Canada for any indications held by the reference biologic drug, please indicate “Not applicable” for each of the sections below.

6.1 Manufacturer’s Rationale for Authorization of Indication(s)Please provide the rationale that justifies authorization of the biosimilar in each indication to the reference biologic drug with references to the sections in the Common Technical Document where complete details are located.

6.2 Health Canada’s Conclusion on Authorization of Indication(s) Please provide Health Canada’s conclusions regarding the authorization of indication to the reference biologic drug using the exact wording that is stated in the official documentation (e.g., Health Canada’s Biologics Safety and Efficacy Assessment Report [BSEAR] and/or Clarifaxes). Please ensure that the statements are appropriately referenced to allow the reader to locate the source of the statements.

6.3 International Regulatory Conclusions on Indication(s) Authorized by Health CanadaPlease limit the information in this section to the requested indication(s) that was approved by Health Canada for the biosimilar under review (or those that are likely to be approved, in the case of a submission filed on a pre-NOC basis). CADTH considers foreign regulator discussions regarding other indications that are not approved in Canada to be beyond the scope of the pCODR review.

Please provide a brief overview of the following (if applicable): European Medicines Agency’s conclusions regarding the authorization of indication to the

reference biologic drug. US Food and Drug Administration’s conclusions regarding the authorization of indication to the

reference biologic drug. Australian Therapeutic Goods Administration’s conclusions regarding the authorization of

indication to the reference biologic drug.


Please ensure that all statements are appropriately referenced.

6.4 pCODR Comments on Authorization of Indication

To be completed by pCODR Review Team.


7. COST COMPARISON

Summarize the cost differential between the biosimilar compared with the reference product in a brief paragraph.

Provide the following information in a table (an example is provided below): price of the biosimilar under review for all strengths per smallest unit to four decimal places; price of the reference product per smallest unit to four decimal places; price of other biosimilars approved for sale in Canada for the same requested indication (if

available); sources of price information must be provided as footnotes below the table.

Clearly identify the name of the biosimilar, name of the reference product, and the indication(s) in the title of the table.

If the recommended dosage for the biosimilar and/or reference product varies across different indications, please provide a separate cost for each indication.

TABLE: COST COMPARISON OF BIOSIMILAR AND THE REFERENCE PRODUCT FOR INDICATION

Drug / Comparator Strength Dosage Form Price ($)b RecommendedDosec

Average Drug Cost ($)

Biosimilar under reviewa $X.XXXX

Reference producta $X.XXXXOther marketed biosimilars (if applicable)

$X.XXXX

a Please rename these row headings with brand names of the biosimilar and the reference product.b Provide sources for price information.c Provide sources for the dosage information.

pCODR Review Team’s Comments Regarding Cost Information



8. DISCUSSION


9. CONCLUSION



APPENDIX 1: ADDITIONAL DATA

Please include any supplemental topics (e.g., companion diagnostics) that may be relevant to the requested reimbursement criteria.

Please include any large tables or figures in this section of the template. Please ensure the following is included:

All items in this section must be well-labelled (e.g., Table 6: Adverse Events from Study X). All items in this section must be clearly referenced in the main body of the template. For

example, “please see Table 6 in Appendix 1 for complete details regarding the adverse events reported in the Study X.”


APPENDIX 2: PUBLIC DRUG PROGRAM FUNDING STATUS FOR REFERENCE PRODUCT AND OTHER FUNDED BIOSIMILARS

For each indication that is approved by Health Canada for the biosimilar (or likely to be approved, in the case of a submission filed on a pre-NOC basis), please provide the publicly available listing status and criteria for the reference product and other funded biosimilars, if applicable. CADTH may update the information provided by the manufacturer with new information provided by the participating jurisdictions, as required.

Step 1: Use the following abbreviations to complete the table. Use a separate row for each indication and add more rows if necessary.

Abbreviation DescriptionEX Exception item for which coverage is determined on a case-by-case basisFB Full benefitNB Not a benefitRES Restricted benefit with specified criteria (e.g., special authorization, exception drug status, limited use benefit)UR Under review ‒ Information not available

Funding Status for (name of reference product)

Indication(s)Participating Jurisdictions

BC AB SK MB ON NB NS PE NL YK NT NIHB DND VACIndication 1Indication 2Indication 3Indication 4

AB = Alberta, BC = British Columbia, DND = Department of National Defence; MN = Manitoba; NIHB = Non-Insured Health Benefits Program; NL = Newfoundland and Labrador; NS = Nova Scotia; ON = Ontario; PE = Prince Edward Island; SK = Saskatchewan; VAC =Veterans Affairs Canada.

Step 2: For all restricted benefit entries (RES), please state the criteria used by each public drug plan. Use a separate table for each indication and add or delete rows as necessary.


Restricted Benefit Criteria for (name of reference product) for the treatment of (state the indication)Drug Plan Criteria for Restricted BenefitAdd name State the exact criteria Add name State the exact criteria Add name State the exact criteria


APPENDIX 3: SUMMARY OF PATIENT GROUP INPUT

To be completed by the CADTH staff based on input received from patient groups.


APPENDIX 4: SUMMARY OF REGISTERED CLINICIAN INPUT

To be completed by the CADTH staff based on input received from registered clinician(s).


APPENDIX 5: SUMMARY OF PROVINCIAL ADVISORY GROUP INPUT

To be completed by the CADTH staff based on input received from Provincial Advisory Group.


REFERENCES

Please provide a numbered list of references using the Citing Medicine format. Each number in the reference list must correspond to the in-text citation for that reference.

abbreviations - cadth web viewplease indicate if there are safety advisories and warnings from...

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