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Important information re the surplus in the Trust Fund for the 1986-1990 Hepatitis C Settlement Agreement

On June 20-22, 2016, Chief Justice Hinkson of the British Columbia Supreme Court, Justice Perell of the Ontario Superior Court and Justice Corriveau of the Superior Court of Québec held joint hearings in Toronto, Ontario, to consider the applications of the Joint Committee and the federal government about the surplus in the 1986 to 1990 Hepatitis C Settlement Agreement Trust Fund which is estimated to be between $207 million and $256 million as at December 31, 2013.

DECISIONS OF THE JUDGES
The decisions of Justice Perell and Justice Corriveau on the applications to allocate excess capital were released on August 15, 2016. The decision of Chief Justice Hinkson on the applications to allocate excess capital was released on August 16, 2016. Each of the courts approved seven of the nine recommendations (with some modifications) made by the Joint Committee. Each of the courts dismissed the application of Canada to have the excess capital paid to Canada. The parties have appeal rights according to the rules of court in each jurisdiction. The Joint Committee is considering these decisions and will provide updates on the 86-90 website on next steps and developments.

Click here for more details on the issue.

WITHDRAWAL

On August 15, Bayer Inc. withdrew nineteen lots of Kogenate FS distributed in Canada. These lots of Kogenate FS currently meet potency requirements, but have been identified as being at risk of falling below potency before their expiry date.  

The lots are as follows:

Product

Lot Number

Expiry

KOGENATE FS 250, BIOSET

270P4P8

11/22/2016

KOGENATE FS 1000, BIOSET

270R46W

8/8/2017

KOGENATE FS 3000 IU VIAL ADAPTER

270RH0N

9/6/2017

KOGENATE FS 2000 IU VIAL ADAPTER

270RH0T

9/26/2017

KOGENATE FS 500 IU VIAL ADAPTER

270RH0V

11/23/2017

KOGENATE FS 500 IU VIAL ADAPTER

270RH13

12/15/2017

KOGENATE FS 500 IU VIAL ADAPTER

270RW6G

12/15/2017

KOGENATE FS 250 IU VIAL ADAPTER

270RH12

12/19/2017

KOGENATE FS 1000 IU VIAL ADAPTER

270T0RC

1/8/2018

KOGENATE FS 500 IU VIAL ADAPTER

270T4KJ

1/25/2018

KOGENATE FS 3000 IU VIAL ADAPTER

270T4G5

2/13/2018

KOGENATE FS 1000 IU VIAL ADAPTER

270T69K

2/18/2018

KOGENATE FS 1000 IU VIAL ADAPTER

270T510

2/18/2018

KOGENATE FS 2000 IU VIAL ADAPTER

270T558

3/3/2018

KOGENATE FS 500 IU VIAL ADAPTER

270TG7P

3/25/2018

KOGENATE FS 3000 IU VIAL ADAPTER

270TKJ1

3/27/2018

KOGENATE FS 3000 IU VIAL ADAPTER

270TGWH

4/9/2018

KOGENATE FS 3000 IU VIAL ADAPTER

270TTR5

6/22/2018

KOGENATE FS 1000 IU VIAL ADAPTER

270TW0P

7/8/2018

The Association of Hemophilia Clinic Directors of Canada is ensuring that personnel in hemophilia treatment centres are aware of the situation and are available to answer any questions you may have.  

Kovaltry, Bayer’s recombinant FVIII product currently being introduced to replace Kogenate FS, is not affected by this withdrawal.

*    NOTE: Kogenate FS is distributed in all provinces except Québec

Recall of two lots of Kogenate FS




On July 27, Bayer Inc. recalled two lots of Kogenate FS distributed in Canada* because of reduced potency. Tests conducted by the company indicate that these lots have fallen or will fall before their expiry date below the guaranteed potency of at least 80% of what is listed on the vial.

This means that a 2000 IU vial may actually contain less than 1600 IUs.
The 2000 IU lots are:
  • 270RH0P
  • 270TN19

The Association of Hemophilia Clinic Directors of Canada has informed the CHS that personnel in hemophilia treatment centres are aware of the situation and are contacting patients to discuss whether or not the vials can be used or should be returned for replacement. This process may be delayed in those parts of the country where distribution records are not easily accessed.

Health Canada is aware of the recall and is in agreement that the risk classification associated with this recall is Type III. A Type III recall is defined as a “situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.”
Kovaltry, Bayer’s recombinant FVIII product currently being introduced to replace Kogenate FS, is not affected by this recall.

It is suggested that those patients who have these lots in their possession contact their hemophilia treatment centre.

Click here to access the Health Canada recall notice.

*  NOTE: Kogenate FS is distributed in all provinces except Québec.



Factor VIII and IX: CBS tender results announced

OTTAWA, April 6, 2016 - Canadian Blood Services (CBS) announced the results of the tender for recombinant factor VIII and IX for the April 1, 2016 – March 31, 2018 period for Canada, excluding Quebec.

It is important to note that the decision surrounding these contracts was a unanimous one by the selection committee, involving experts from CBS, the Association of Hemophilia Clinic Directors of Canada, the Canadian Association of Nurses in Hemophilia Care and the Canadian Hemophilia Society. The evaluation was based on safety, efficacy, quality and cost.

The new contracts for recombinant factor VIII and IX will result in an estimated 40 to 50 million dollars of savings for the health care system annually. These savings are in addition to significant savings realized in the 2013-16 period over previous years.

A large number of patients with hemophilia A will be switching products as Advate, manufactured by Shire (formerly Baxalta) is phased out over the next several months. Following similar tender processes in recent years in countries such as Ireland, the U.K. and Australia, resulting in massive product switching, no negative outcomes were observed. The province of Quebec went through a similar mass switch in rFVIII products (Helixate FS to Xyntha) one year ago, and the process went very smoothly.

In addition, Bayer’s Kogenate FS will be replaced by the company’s new recombinant FVIII product, Kovaltry, also over the next several months.

While supply factors suggest that many patients using Kogenate FS will switch to Bayer’s new product Kovaltry, and that many users of Advate will switch to Pfizer’s Xyntha, such decisions are made jointly by the physician and patient/caregiver, and should not be imposed.

There are now four rFVIII products available for use in provinces served by CBS: Xyntha, manufactured by Pfizer; extended half-life Eloctate, manufactured by Biogen; Kovaltry, manufactured by Bayer; and Nuwiq, manufactured by Octapharma.

With regard to factor IX, Pfizer’s Benefix remains the predominant product. Biogen’s extended half-life Alprolix is also available. The plasma-derived FIX product, Immunine from Shire-Baxalta, while not part of the tender process, remains available.

The product switchovers will take place progressively across the country this summer and fall. Treatment centres will be in touch with their patients at the appropriate moment.

__________________

CLICK HERE to access clotting factor concentrate charts listing all available products.




Impressive advances announced at WFH Congress in Orlando

July 29, 2016, Orlando – Participants in WFH World Congress 2016 left Orlando, Florida last week convinced that this was the meeting when everything suddenly changed. From next-generation clotting factor concentrates to alternative coagulation therapies to gene therapy to Star Trek-inspired diagnostic tools, there were advances like we have never seen before.



CLICK HERE to read all about it.





Hemophilia Today - August 2016









Bayer introduces Kovaltry to replace Kogenate FS in Canada

Kogenate and its successor Kogenate FS have been used in Canada to treat hemophilia A for almost a quarter-century. Their manufacturer, Bayer, is now replacing Kogenate FS with its next generation, Kovaltry, in the Canadian marketplace. First licensed by Health Canada in early 2016, the recombinant factor VIII concentrate has now also been approved by the U.S. FDA and the European Medicines Agency.

Hemophilia Today met with Dr. Mohammed Mahdi, medical and scientific advisor in the Hematology Branch at Bayer Canada, and Dr. Jayson Stoffman, medical director at the Manitoba Bleeding Disorders Program and past-president of the Association of Hemophilia Clinic Directors of Canada, to learn more about Kovaltry.

CLICK HERE for the complete interview.

Montreal awarded WFH World Congress 2022

July 29, 2106, Orlando – The World Federation of Hemophilia (WFH) announced that Montreal had been chosen as the host city for World Congress 2022.

The CHS had presented excellent bids for Montreal for Congress 2016, won by Miami and later moved to Orlando, and Congress 2020, won by Kuala Lumpur, Malaysia. The CHS did not bid for Congress 2022. Bids by Madrid, Amsterdam and Vienna, however, were considered not to be financially viable. As a result, the WFH Board of Directors made the decision to hold the Congress in Montreal, site of WFH headquarters, where the support of the CHS and the medical community, and the very advantageous conditions offered by the Montreal Palais des Congrès promise to make Montreal an ideal venue.

See you in 2022, when many of the amazing advances announced in Orlando will be hitting prime time!


CHS Statement on the SIPPET study

For many years there has been debate in the medical community about which class of products has the lowest risk of inhibitor development in previously untreated patients (PUPs) with hemophilia A: recombinant factor VIII or plasma-derived factor VIII?

Some studies showed a lower rate of inhibitor development with plasma-derived FVIII; other studies did not. The studies, however, were quite small and retrospective or observational in nature, and so they didn’t provide conclusive results.

The SIPPET study is the first prospective, randomized trial to attempt to answer the question.

CLICK HERE to read more about this important topic.

16 MINUTES.








The Canadian Hemophilia Society and the Patient Reported Outcomes Burdens and Experiences (PROBE) study group invite you to participate in a multinational, patient-focused research study to investigate and directly probe patient perspectives on outcomes that affect your own life and care.

Click here for all the details.



CHS support to research and market studies

Several times in the past, the CHS has invited the bleeding disorder community to participate in research and market studies. Once again, we wish to reinforce the importance of these projects and the benefit for our community to participate. Research and market studies are crucial to the advancement of care and treatment. This is your chance to voice your concerns and priorities when it comes time to your care and treatment or those of your child. At many levels, these studies are often one step closer towards a better quality of life.

These studies, however, need our community to gather sufficient data to be relevant.

Please take the time to see what is presently happening with regards to research and market studies and to see if you could take an active part in them.

Click here for more details on the RESEARCH studies currently recruiting participants.

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Click here for more details on the MARKET studies currently recruiting participants.


MyCBDR app now available!

MyCBDR app is now available for free from the Google Play Store (Android version) and the Apple Store (iOS version). If you are already using the MyCBDR website to record your treatments and bleeds, you can log in to the app using your MyCBDR credentials.

If you have not registered for MyCBDR yet, you can submit your request at www.mycbdr.ca/MyCBDR/Account/Register. Remember to select your HTC from the drop-down menu available at registration. The AHCDC and McMaster University are working continually to enrol more HTCs into the CBDR network. In case you belong to an HTC that is not yet using CBDR, you can still request a MyCBDR account by selecting “Holding Center for MyCBDR” as your HTC.

Please feel free to send in your questions, comments and feedback to help@mycbdr.ca.

N.B. The French-language version of the app should soon be available.



E-novella spreading the word on bleeding disorders on Wattpad

One in 100 Canadians carries an inherited bleeding disorder gene, yet so many remain undiagnosed. In an effort to educate a younger audience about the symptoms and risks of bleeding disorders, we’ve developed an e-novella – entitled ‘A Negative’ – to spread the word in an engaging and memorable way.



Playing off the popular Harlequin romance genre, ‘A Negative’ tells the story of a young woman unknowingly living with von Willebrand disease. We’ve published the e-novella on Wattpad – the world’s largest online community of writers and readers – in order to connect with young women across Canada. This unique approach introduces the issue into a different medium, enabling us to speak to and educate an engaged but unsuspecting audience.

CLICK HERE for the press release.

CLICK HERE to read 'A Negative'.

Menstrual Assessment Chart (PBAC)

A bandage is not enough.





HELP SPREAD THE WORD ABOUT INHERITED BLEEDING DISORDERS.


Click here for more information about this important public awareness and outreach campaign or to download promotional material.


You and your family depend on research...






Make a difference - Help save lives


We can stop the suffering of those living with hemophilia and other bleeding disorders. But we can't do it alone. Only with the generous financial support of caring Canadians can we make our dream come true.

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