National Strategy for Drugs for Rare Diseases Initiative, Canada - New Brunswick Funding Agreement

Between: His Majesty the King in Right of Canada, as represented by the Minister of Health (hereinafter referred to as "Canada")

And: His Majesty the King in Right of the Province of New Brunswick as represented by the Minister of Health (hereinafter referred to as "New Brunswick")

Canada and New Brunswick are also referred to as a "Party" or collectively as the "Parties"

Table of contents

Preamble

Whereas, the Parties have agreed to targeted federal funding over three (3) years, beginning in 2024-25, for investments to increase access to, and affordability of, promising and effective drugs for rare diseases (DRD) to improve the health of patients;

Whereas, in Budget 2021, the Government of Canada reaffirmed its announced plan to provide ongoing funding of $500 million per year to help Canadians with rare diseases access the drugs they need;

Whereas, in March 2023, the Government of Canada announced the National Strategy for DRD, which will make available up to $1.4 billion over three (3) years to provinces and territories through bilateral agreements;

Whereas, the Government of Canada authorizes the Minister of Health to enter into agreements with the provinces and territories, for the purpose of supporting activities provinces and territories will undertake to help improve access to New DRD, enhance access to existing DRD, invest in governance and infrastructure, and improve Screening and Diagnostics for rare diseases;

Whereas, the Prescription Drug Payment Act and the Prescription and Catastrophic Drug Insurance Act authorizes the provincial Minister to enter into agreements with the Government of Canada under which Canada undertakes to provide funding toward costs incurred by New Brunswick, to help improve access to New DRD, enhance access to existing DRD, invest in governance and infrastructure, and improve Screening and Diagnostics for rare diseases;

Whereas, Canada respects jurisdictional roles, and recognizes that New Brunswick is responsible for the design and delivery of publicly insured prescription drug coverage to its residents;

Whereas, Canada respects and acknowledges the existing pharmaceutical management systems and the roles of the pan Canadian Pharmaceutical Alliance and New Brunswick. The National Strategy for DRD will operate within the existing systems;

Whereas, New Brunswick acknowledges to meaningfully engage and work with Indigenous organizations and governments responsible for the delivery of drug benefits to further support access to DRD;

Whereas, New Brunswick acknowledges the overall importance of the meaningful support of official languages, including but not limited to the support of official languages minority communities; and

Whereas, New Brunswick acknowledges the overall importance of the meaningful support of the use of Sex and Gender-Based Analysis Plus to address the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion and more.

Therefore, the Parties agree as follows:

1. Definitions

In this Agreement,

2. Objectives

3. Term of agreement and review

4. Financial contribution and obligations

5. Use of funds

6. Performance measurement and reporting

7. Communications

8. Dispute resolution

9. Amendments to the agreement

10. General

11. Terminating the agreement

12. Notice

Communications, including reporting and any notice, information, document, request or other communication, shall be in writing and sent to the coordinates below. Communications that are delivered in person shall be deemed to have been received upon delivery; communications transmitted by facsimile or by e-mail shall be deemed to have been received one (1) business day after having been sent; and communications that are sent by mail shall be deemed to have been received eight (8) business days after being mailed.

Any notice to Canada shall be addressed to:

Associate Assistant Deputy Minister, Health Policy Branch
Health Canada
70 Colombine Driveway, Tunney's Pasture
Building Brooke Claxton Building
Ottawa, OntarioK1A 0K9
Email: michelle.boudreau@hc-sc.gc.ca

Any notice to the New Brunswick shall be addressed to:

Éric Levesque, Associate Deputy Minister, Francophone Affairs, Pharmaceutical Services, Public Health and Medicare & Physician Services Division, Department of Health
Carleton Place
520 King Street
Fredericton, New Brunswick
E3B 6G3
Eric.Levesque2@gnb.ca
Telephone: 506-453-2536
Facsimile: 506-453-5243

13. Signing in counterpart

This Agreement may be signed in counterparts and each counterpart shall constitute an original document; these counterparts taken together shall constitute one and the same Agreement.

In witness whereof, this Agreement is duly executed by authorized representatives of the Parties.

Signed on behalf of Canada by the Minister of Health

The Honourable Mark Holland, Minister of Health

Signed on behalf of New Brunswick by the Minister of Health

The Honourable Dr. John Dornan, MD, FRCP, MBA, Minister of Health

Annex A – Confidential

Not available

Annex B – Evidence collection

Purpose:

This document serves as an Annex to the National Strategy for Drugs for Rare Diseases Initiative Canada-New Brunswick Funding Agreement (the "Agreement") as referenced in section 5.2(b) of that Agreement.

  1. Definitions:

    "Evidence" is Real World Evidence and Real World Data

    "Evidence Collection" means the processes by which Evidence is generated and collected for the further evaluation of drugs in the Common Set and may include, but is not exclusive to, work done by individual PTs, the PT DRD Working Group and other Strategy partners

    "Evidence Collection Work Plan" means the Evidence Collection Work Plan approved each quarter throughout the term of the agreement by the Pharmaceuticals Executive Group

    "Real World Data" are data relating to patient status and/or the delivery of health care routinely collected from a variety of sources

    "Real World Evidence" is evidence on the use, safety, effectiveness, and cost of health technologies that is derived from real-world data.

  2. All other terms are defined as outlined in the Agreement
  3. New Brunswick will support the inclusion of Evidence Collection as part of the pan-Canadian Pharmaceutical Alliance negotiation process, as and where appropriate.
  4. New Brunswick will participate in the development of the Evidence Collection Work Plan, including the development and identification of mechanisms/options to support Evidence Collection in respect of drugs in the Common Set.
  5. New Brunswick will fulfill the duties of a PT in regard to Evidence Collection, as outlined in the Evidence Collection Work Plan, including but not limited to:
    1. New Brunswick will support Evidence Collection Mechanisms in relation to drugs in the Common Set according to the Evidence Collection Work Plan;
    2. New Brunswick will support projects / pilots related to drugs on the Common Set;
    3. New Brunswick will participate in partnerships with identified organizations to support the collection/generation of evidence on Common Set drugs as and where appropriate / as determined by the Evidence Collection Work Plan;
    4. New Brunswick will support data collection and sharing, as outlined in the Evidence Collection Work Plan.
  6. New Brunswick may also participate, at its option, in activities as developed under the Evidence Collection Work Plan, for New DRD not in the Common Set and/or other existing DRD.

Annex C – Reporting requirements for Provinces and Territories under the National Strategy for Drugs for Rare Diseases

To measure the performance of the provincial/territorial component of the National Strategy for Drugs for Rare Diseases (National Strategy) over time, Provinces and Territories (PTs) will be required to report specific data on a yearly basis covering the previous Fiscal Year.

The data will be used to report internally on the progress of the Strategy and may be used to report publicly or communicate on National Strategy implementation pending notification to PTs (pursuant to sections 7.4 and 7.5 of the Agreement, which allow for this).The data will cover New drugs for rare diseases (DRD) (including those in the Common Set), other drugs for rare diseases, and Screening and Diagnostics.

Reporting deadline: October 1 for the period covering April 1 to March 31 of the previous Fiscal Year

Data required from PTs on a yearly basis:

Item Outcome Indicator
1

Improved collaboration across public drug plans related to DRD decision-making

Canadians have improved access to DRDs

Number of drugs in the Common Set for which the PT has made an Election
2

Number of existing DRD not in the Common Set for which the PT makes public funding available

Note: DRD Secretariat compiling a list of DRDs (New and existing) against which PTs would report.

3 Number of New DRD not in the Common Set for which the PT makes public funding available
4

Canadians with rare diseases have better access to Screening and Diagnostic services they need

List of newborn screening tests for rare diseases that are included on PT screening panels
5 Number of publicly-funded clinical settings routinely offering Genome-wide sequencing
6 Canadians have quicker access to DRDs List of drugs in the Common Set for which the PT has made an Election with a corresponding evidence generation plan in the last Fiscal Year
7

Canadians have quicker access to DRDs

Date the PT makes public funding available in the last Fiscal Year for each drug for which the PT has made an Election in the Common Set
8 Date the PT makes public funding available in the last Fiscal Year for each New DRD not in the Common Set
9

Canadians have an understanding of the impact of the National Strategy

A description of improvements made to the coverage of drugs in the Common Set
10 A description of improvements made to the coverage of New DRD not in the Common Set.
11 A description of improvements made to the coverage of existing DRD.
12 A description of improvements in Screening and Diagnostics.
13 A description of how the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion, official language minority communities, and more were addressed.

Definitions:

DRD
a drug for a condition with an orphan designation by the European Medicines Agency or US Food and Drug Administration.
Existing DRD
means a DRD that obtained Health Canada approval prior to 2019.Genome-wide sequencing (GWS) – refers to whole exome sequencing (WES) and whole genome sequencing (genome sequencing refers to sequencing the entire genetic code of a person and exome sequencing refers to sequencing only the parts of the genome that contain protein-coding genes). Genome-wide sequencing technologies: A primer for paediatricians - PMC (nih.gov)
Routinely offering
means offered regularly as a normal part of diagnostic processes (even if testing is completed outside of the PT).

Reporting template for Provinces and Territories under the National Strategy for Drugs for Rare Diseases

Province or territory:

Reporting period: [April 1, YYYY to March 31, YYYY]

Table 1: PT input on indicators
Item Indicator PT input Source of PT data (e.g., name of database(s))
1 Number of drugs in the Common Set for which the PT has made an Election    
2 Number of Existing DRD not in the Common Set for which the PT makes public funding available    
3 Number of New DRD not in the Common Set for which the PT makes public funding available    
4 List of newborn screening tests for rare diseases that are included on PT screening panels Please complete Table 2 below.  
5 Number of publicly-funded clinical settings routinely offering Genome-wide sequencing    
6 List of drugs in the Common Set for which the PT has made an Election with a corresponding evidence generation plan in the last Fiscal Year Please complete Table 3  
7 Date the PT makes public funding available in the last Fiscal Year for each drug for which the PT has made an Election in the Common Set Please complete Table 4 below.  
8 Date the PT makes public funding available in the last Fiscal Year for each New DRD not in the Common Set Please complete Table 5 below.  
9 A description of improvements made to the coverage of drugs in the Common Set Please complete Table 6 below.  
10 A description of improvements made to the coverage of New DRD not in the Common Set. Please complete Table 6 below.  
11 A description of improvements made to the coverage of existing DRD. Please complete Table 6 below.  
12 A description of improvements in Screening and Diagnostics. Please complete Table 6 below.  
13 A description of how the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion, official language minority communities, and more were addressed. Please complete Table 6 below.  

Table 2: Newborn screening tests for rare diseases that are included on PT screening panels

In order to simplify reporting we have provided a list of conditions that are included on newborn screening panels in Canada. The Intergovernmental Newborn Screening Working Group Report Back to Ministers of Health – Provincial-Territorial Health Ministers' Meeting (January 2016) included a list of 22 diseases for the recommended national core panel. These diseases are denoted in Table 2. All of these were also included in a recent document prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH) for discussion purposes at its Newborn Screening Advisory Panel meetings, with the exception of Methylmalonic acidemia (Cbl A, B). The additional conditions were included in CADTH's document.

This list is not exhaustive. Please add rows as needed.

Item Condition Included on PT newborn screening panels (YES or NO)
1 Argininosuccinic acidemia  
2 Biotinidase deficiency  
3 Carnitine palmitoyltransferase 1 deficiency  
4 Carnitine palmitoyltransferase 2 deficiency  
5 Carnitine-acylcarnitine translocase deficiency  
6 Carnitine uptake deficiency  
7 Citrullinemia  
8 Cobalamin A disease  
9 Cobalamin B disease  
10 Congenital adrenal hyperplasia  
11 Congenital hypothyroidism  
12 Cystic fibrosis  
13 Galactosemia  
14 Glutaric acidemia type 1  
15 Guanidinoacetate methyltransferase deficiency  
16 Homocystinuria  
17 Isovaleric acidemia  
18 Long chain L-3-OH acyl-CoA dehydrogenase deficiency  
19 Maple syrup urine disease  
20 Medium chain acyl-CoA dehydrogenase deficiency  
21 Methylmalonic acidemia: mutase deficiency  
22 Methylmalonic acidemia (Cbl A, B)  
23 Mucopolysaccharidosis type 1  
24 Permanent hearing loss risk due to congenital cytomegalovirus infection  
25 Permanent hearing loss risk due to genetic factors  
26 Phenylketonuria  
27 Propionic acidemia  
28 Severe combined immunodeficiency  
29 Sickle cell disease  
30 Spinal muscular atrophy  
31 Trifunctional protein deficiency  
32 Tyrosinemia type 1  
33 Very long chain acyl-CoA dehydrogenase deficiency  
34 X-linked adrenoleukodystrophy  
35 3-hydroxy-3-methylglutaryl-CoA (HMG) CoA lyase deficiency  
Table 3: List of drugs in the Common Set for which the PT has made an Election with a corresponding evidence generation plan (if applicable) from [April 1, YYYY to March 31, YYYY]Please add rows as needed
Item Brand name of drug Description (e.g., outcome-based agreement, registry, other)
1    
2    
3    
Table 4: Date the PT makes public funding available from [April 1, YYYY to March 31, YYYY] for each drug for which the PT has made an Election in the Common Set
Item Brand name of drug Date the PT makes public funding available
1    
2    
3    
Table 5: Date the PT makes public funding available from [April 1, YYYY to March 31, YYYY] for each New DRD not in the Common Set
Item Brand name of drug Date the PT makes public funding available
1    
2    
3    
Table 6: Descriptions of impact of funding under the National Strategy
Item Component

Description

Please provide qualitative details describing the impact funding has had on each identified component. For example, if funding was used to modernize an existing drug plan, please describe the advancements made. Additionally, if funding was used to hire a consultant or additional staff, describe the improvements these staff were able to make to the identified components.

(suggested word count per item is less than 300 words)

1 A description of improvements made to the coverage of drugs in the Common Set  
2 A description of improvements made to the coverage of New DRD not in the Common Set  
3 A description of improvements made to the coverage of existing DRD  
4 A description of improvements in Screening and Diagnostics  
5 A description of how the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion, official language minority communities, and more were addressed  

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