Fractionation Services and Recombinant Plasma Protein Products: Product Supply and Transitioning

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1 Frequently sked uestions and Recombinant Plasma Supply and Transitioning Summary of product changes Red (underlined): not continuing Blue (bold): new Today s Product Mix Future Product Mix Product Size Product Size Intravenous Immune Globulin Intravenous Immune Globulin Gamunex, Grifols 2.5g, 5g, 10g, 20g Gamunex, Grifols 2.5g, 5g, 10g, 20g IVIGnex, Grifols 20g IVIGnex Grifols 20g Privigen,CSL Behring 2.5g, 5g, 10g, 20g, 40g Privigen CSL Behring 10g, 20g Gammagard Liquid, Shire 5g, 10g Gammagard Liquid, Shire 2.5g, 5g, 10g, 20g, 30g Panzyga, Octapharma 2.5g, 5g, 10g, 20g, 30g Subcutaneous Immune Globulin Subcutaneous Immune Globulin Hizentra, CSL Behring Commercial/Toll* 1g, 2g, 4g, 10g Cuvitru, Shire 1g, 2g, 4g, 8g lbumin lbumin Plasbumin, Grifols Commercial 5% 50 ml, 250 ml 25% 100 ml Plasbumin, Grifols Commercial 5% 50 ml lbumin, Grifols Toll* 25% 100 ml lbumin, Grifols Toll* 25% 100 ml lburex, CSL Behring Commercial/Toll* 5% 250 ml, 500 ml 25% 50 ml, 100 ml lburex, CSL Behring Commercial/Toll* 5% 250 ml, 500 ml 25% 50 ml, 100 ml 1

2 Frequently sked uestions Today s Product Mix Future Product Mix Product Size Product Size Recombinant factor VIII Recombinant factor VIII Xyntha, Pfizer 2,000 IU, 3000 IU Xyntha, Pfizer, 3000 IU Nuwiq, Octapharma Nuwiq, Octapharma Kovaltry, Bayer Kovaltry, Bayer Eloctate, Bioverativ (long-acting) 250 IU, 500 IU, 750 IU, 1000 IU, 1500 IU,, 3000 IU dynovate, Shire (long-acting) Recombinant factor IX Recombinant factor IX Benefix, Pfizer 500 IU, 1000 IU,, 3000 IU Benefix, Pfizer 500 IU, 1000 IU,, 3000 IU lprolix, Bioverativ (long-acting) 500 IU, 1000 IU,, 3000 IU Rebinyn, Novo Nordisk (long-acting) 500 IU, 1000 IU, *Note: Toll Plasma supplied by Canadian Blood Services 2

3 Frequently sked uestions Frequently asked questions When will the changes take effect and how will you manage the transition period? re all changes required to be completed by pril? The expected timing of changes will depend on the rate at which patients are transitioned from one product to another, and will vary from province to province. Our planned timelines are included in the table below. We will carefully monitor these transitions as well as the feedback we receive from hospitals. Product category Intravenous Immune Globulin Product Size Target for introduction Gammagard Liquid 5g, 10g Currently available 2.5g, 20g, 30g vailable March 2018 Target for phase-out Panzyga 2.5g, 5g, 10g, 20g, 30g ugust-september 2018 Commercial Privigen 2.5g, 5g, 40g July 2018 IGIVnex Privigen 20g 10g, 20g Subcutaneous Immune Globulin Cuvitru 1g, 2g January g, 8g March 2018 Hizentra 1g vials December g vials January g, 2g pre-filled syringes December 2017 September - October g, 10g July - ugust 2018 lbumin Plasbumin 5% 250 ml September % 100 ml Phased out no stock Long-acting recombinant factor VIII (note 1) dynovate 250 IU, 500 IU,1000 IU, March 2018 Eloctate* 250 IU March IU, 750 IU,1000 IU, 1500 IU,, 3000 IU September - December 2018 Long-acting recombinant factor IX Rebinyn 500 IU,1000 IU, pril 2018 lprolix* 500 IU March IU,, 3000 IU ugust - September 2018 *Note: uantities of product to remain available for special needs cases on a named patient basis (i.e., patients receiving inhibitor tolerance induction [ITI] treatment and patients in their initial exposure days) are not mentioned in the above table. 3

4 Frequently sked uestions Immune globulin How are the new immune globulin products different? The following table summarizes key differences between products that are used subcutaneously. Please refer to product monographs for more information available on the manufacturer s website. Brand name IGIVnex and Gamunex Hizentra Cuvitru Concentration 10% 20% 20% Ig content Not more than mg/ml No more than 50 mg/l vg. 80 mcg/ml. No more than 280 mcg/ml Sugar content Not indicated in product monograph None Not indicated in product monograph Storage temperature +2 C to +8 C +2 C to +25 C +2 C to +8 C (see note) Recommended infusion rate 20 ml/hr per infusion site 15 ml/hr per site 60 ml/hr/site Note: Cuvitru can be stored at room temperature, but this storage method reduces its shelf life to 12 months. What support will there be to assist clinics, hospitals and patients with the transition and when will it start? Shire will provide transition support for both Cuvitru and dynovate as part of its OnePath Support Program. Shire will share details on the resources and programs that will be provided. This support will consist of: Training for health-care professionals on the clinical features of the products. Patient education materials. comprehensive Patient Support Program for patients receiving subcutaneous immune globulin treatment, including the provision of ancillary supplies, reimbursement support, and nurse training. Novo Nordisk recently received its Notice of Compliance and licence for Rebinyn, and will provide details on its transition support for this product in the new year. Does limiting the number of available products introduce any risks to the supply? For example, if there were a recall of one product, would there be enough of the alternate product to meet patient needs? The security of the supply of plasma protein products was evaluated as part of the request for proposal (RFP) process. For example, there is minimal risk of disruption to the supply of immune globulin given Shire s size and diversity of immune globulin operations, as well as its business continuity plans. Further, most vendors have multiple production sites and are able to move manufacturing if issues arise. Our contracts also protect us from disruptions to supply and reduce the risks of supply interruptions. 4

5 Frequently sked uestions How will the change to Cuvitru impact the subcutaneous immune globulin clinics currently funded through CSL Behring? Is their cessation of funding a direct result of the RFP? Funding by CSL Behring for the Hizentra Care Program varies by province and clinic, particularly as it relates to in-hospital support. Canadian Blood Services is not involved with this program. Shire has confirmed it will continue with all aspects of the patient support program, except for the in-hospital support program. Programs for home care support, patient product ancillaries, in-home nursing support and educational support will continue. The change in funding is not a direct result of the RFP; provincial health ministries were already being asked to fund this program. Why will some provinces fund clinics while others will not? Health care falls under the jurisdiction of the provinces and territories, and services may vary among them. Provinces and territories have their own financial and resource realities. Funding to support subcutaneous immune globulin programs come directly from hospital budgets and, ultimately, from the ministries of health. Is there something Canadian Blood Services can do to address the challenges of bringing patients receiving subcutaneous immune globulin into the hospital for the administration of a new product, given the expected impacts on outpatient day clinics? Some clinics may decide to bring patients into the hospital for the initial injection. We assessed the impact of transitioning patients on immunology, neurology, and hemophilia clinic schedules and recognized that it would require additional efforts. We are committed to working with the provinces and territories to determine the additional resources that may be required. Ultimately, interim funding would need to come through traditional funding mechanisms. Will we run out of Hizentra before the transition is completed? No. We will work with clinics to support the transition over the next six to nine months. We will purchase additional Hizentra as required to ensure a seamless transition. How can hospitals manage the percentages of products required for intravenous immune globulin products? s we have done previously, Canadian Blood Services will continue to communicate the targeted share percentages and the volume of brands available. Where necessary, we may substitute brands to fulfil hospital orders, as we do today. Shire s Gammagard Liquid will constitute the majority of the available supply. Do hospitals now have to stop converting patients receiving immune globulin to Hizentra? We recommend that the timing of new patient switches to subcutaneous immune globulin be considered given the timing of Cuvitru s availability as noted above. While the choice of product is made between patients and prescribers, patients who begin taking Hizentra will need to transition to Cuvitru. 5

6 Frequently sked uestions Why can t there be a variety of choice of subcutaneous immune globulin products? Canadian Blood Services does not manage an open formulary, which means that not all licensed products will automatically be made available. We weigh patient benefits with product choice and budget considerations. In some cases, multiple product brands are available, while in others, a single brand is available. Canadian Blood Services has carried only one subcutaneous immune globulin product (Hizentra) since this type of product has been available. Does Cuvitru come in pre-filled syringes? Will we still have to use pre-filled syringes before Cuvitru is available? Cuvitru is currently only available in vials. Some sites will need to change to Hizentra pre-filled syringes since the number of vials available from CSL Behring is limited. We are working to limit the impact to patients and clinics by introducing pre-filled syringes to select sites only. The use of prefilled syringes is not a result of the RFP. CSL Behring has been responsible for providing training to patients moving to Hizentra and for 24/7 support. What does Shire offer in terms of training and support in the subcutaneous immune globulin program? Shire will support Cuvitru as part of their OnePath Support Program. Details on their resources and programs will come from Shire directly. These will include: Training for health-care professionals on the clinical features of the product. Patient education materials. comprehensive Patient Support Program for patients receiving subcutaneous immune globulin treatment, including the provision of ancillary supplies, reimbursement support, and nurse training. Factor concentrate products Was the cost of chromogenic testing (required for Rebinyn) considered in the decision-making process? We recognized that some newer products could require different assays than those currently used in some hospital laboratories. The savings achieved through this process far outweigh any investment that may be required to support transition-related changes. The suppliers are also ensuring that any new testing required is supported. How can we obtain information from Canadian Blood Services regarding the safety and long-term effects of PEGylation, especially in children? pproved PEGylated protein drugs have been used to treat patients since More than a dozen approved PEGylated drugs are in clinical use around the world, and at least 20 more in advanced clinical development. No safety concerns related to PEGylation have been raised for these drugs in clinical investigation or clinical experience. There have been some concerns with microscopic cellular changes in some subjects during testing where very large doses have been used. Even when these effects were noted, no adverse effects or measurable toxicity was observed in the subjects. 6

7 Frequently sked uestions Is Canadian Blood Services committed to patient choice? Much like other publicly funded formularies or private drug plans in Canada, Canadian Blood Services does not manage an open formulary, which means that not all licensed products are automatically available. We weigh patient benefits with product choice and budget considerations. In some cases, multiple product brands are available, while in others, a single brand is available. Canadian Blood Services has carried only one recombinant factor VIII extended half-life (EHL) product and one recombinant factor IX EHL product to date. In the case of recombinant factor VIII, Eloctate will also be available for children under 12 years of age as required, until dynovate is approved for this age group. Following this, Eloctate will only be available for patients receiving immune tolerance induction (ITI) treatment and for patients within their initial exposure days. Similarly, lprolix will be available for children under 18 years of age as required, until Rebinyn is approved for this age group. Following that, it will no longer be available. Does Canadian Blood Services value cost savings more than potential benefits for patients with hemophilia? Patient care and patient safety are our priorities. Cost is only one of the factors considered in this process. Canadian Blood Services carries more products on its formulary than are carried in many other jurisdictions. New products and therapies not yet available will be considered for Canadian patients in the future. Request for proposal Who was on the RFP panel? Several internal and external stakeholder groups were engaged in both RFP processes. These include patient groups (the Canadian Immunodeficiencies Patient Organization, Immunodeficiency Canada, the Guillain-Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy Foundation of Canada, the Canadian Hemophilia Society) and physician and nursing groups (National dvisory Committee on Blood and Blood Products, ssociation of Hemophilia Clinic Directors of Canada, and Canadian ssociation of Nurses in Hemophilia Care). How will hospitals/clinics receive the funding support required to cover patient transition, testing costs, updates to hospital systems and other impacts the RFP changes? The need for support for this transition, while known, was not fully determined prior to the RFP announcements. Discussions continue to determine how to proceed, and this consideration will be included in all future RFP exercises. Canadian Blood Services contracts are renewed every couple of years and significant changes are required when a new vendor is chosen. Why can t longer-term contracts be used? Contract terms are designed to balance the need for long-term contracts and the emergence of new products. Where possible, measures are put in place to minimize disruption. For example, our current 7

8 Frequently sked uestions contract for recombinant coagulation therapies is for two years, but includes two additional one-year options for renewal (total of four years). In the case of plasma-derived products, contracts are for three years with two additional one-year options for renewal (total of five years). How can the procurement process ensure that value for patients is prioritized over cost containment? Patient care and patient safety are our priorities. Cost is only one of the factors considered in this process. Stakeholder input ensures various perspectives are reflected in the final decisions. The selected products are not necessarily the cheapest options. We continue to look at our procurement processes to improve them. For more information Canadian Blood Services Day-to-day operations and additional information on products and inventory: Contact your local Canadian Blood Services site or Jennifer Davis, Plasma Protein Products and Services team, Shire New products and product support: or Novo Nordisk New products and product support: or