Plasma Protein Products: Why we do what we do. Peter Saunders Associate Director, National Operations April 24, 2015

Transcription

1 Plasma Protein Products: Why we do what we do Peter Saunders Associate Director, National Operations April 24, 2015

2 Outline Introduction Background and Regulations Business Cycle Product Selection Process Plasma product review / listing process with recent changes Procurement Strategy Current situation of PPP contracts Inputs on procurement strategy Current Reviews and strategy for fractionated and all other products Next steps

3 CBS Background/Overview

4 Background Canadian Blood Services (CBS) is a federally incorporated, not-for-profit corporation with a mandate to deliver safe, reliable and cost-effective blood products and services throughout Canada, except for the province of Québec. We are funded by the provincial and territorial ministries of Health, and operate at arm s length from governments. CBS operates under licences issued by Health Canada, and all CBS sites are centrally managed from both an operating and Quality Assurance perspective, and all undergo regular and intensive internal and external audits.

5 Background (cont d) CBS is responsible for collecting, processing and distributing blood and blood products to approximately 730 health care facilities. Approximately 1 million units of blood are collected and processed annually. CBS is also responsible for procuring and distributing plasma protein products which includes plasma-derived and recombinant therapeutic products. Transparent public tendering processes Bulk buying approach Product becomes available to all jurisdictions Focused stakeholder involvement with shared combined utilization measures Avoids shortages Quality control and quality management of the vendors we do business with Ensuring safe reliable products for the best possible patient outcomes

6 Blood and Plasma Supply System in Canada Regulates Biologics and Genetic Therapies Directorate, Health Canada CBS Custom Fractionators (Grifols, CSL Behring) Regulates Plasma Plasma products Canadian Provincial and Territory Health Ministries (except Québec) Funds Canadian Blood Services Blood collections Québec Health Ministry Funds Héma Québec Blood collections Supplies Supplies Commercial plasma products suppliers Plasma products Hospitals Hospitals Adapted from Review of Australia s Plasma Fractionation Arrangements: Chapter 4: How other countries meet their needs

7 PPP Business Cycle Shipping to CBS Sites Donation Donation at CBS Sites CBS Sites H Processing at CBS Sites CBS Head Office Warehouse in Ottawa Patient Care FROZEN TRANSPORTATION By Truck and /or Ship Warehouses in Toronto REFRIGERATED TRANSPORTATION By Truck and/or Ship Fractionation Plant US or Europe

8 Product Review / Listing Process

9 Plasma product Review / Listing Process When a new plasma protein product is licensed in Canada, it may be considered to add to the CBS portfolio. The decision to add a product is based on Confirmation that the product fits with the portfolio requirements Identified patient need for the product by physicians Established safety and efficacy of the product PT approval if a cost impact If the product is a new brand of an existing product already carried, the review of the product and decision is made by CBS (assuming no incremental cost impact for the PTs). If there is an incremental cost impact for a new brand, the PTs must approve.

10 Plasma product Review / Listing Process If a new licensed plasma protein product represents a new category of product not already carried, it must follow a more formal review process, similar to a common drug review. This includes: A medical/scientific review, to confirm safety and efficacy and patient benefit as a comparison to existing products carried An economic review, and a funding recommendation to the PTs We have recently concluded a redesign of the Product Selection Process: clarifying roles of participants and stakeholders Generating process efficiencies, defining and improving timelines

11 Plasma product Review / Listing Process CBS and CADTH collaborate in the review of new category products to enhance the consistency and quality of the reviews, eliminate duplication, and to maximize the use of limited resources and expertise. CBS medical review, which includes expert external medical reviewers (treating physicians), will be conducted in a way (i.e. systematic review) so that there is no need for a separate clinical review to be performed by CADTH. The responsibilities of CBS include identification of eligible products; identify and involve required experts and stakeholders; and providing additional information relevant for the review but not included in the supplier s submission or available in the published literature. CBS provides listing recommendations to the PTBLC for approval decision.

12 CBS Products Plasma-Derived Albumin Plasbumin 5% & 25% Albumin 25% Alburex 5% & 25% Antithrombin III C1 Esterase Inhibitor Berinert P FVII * Factor VII FVIII Humate-P (FVIII/vWF) Wilate FIX Immunine FXI * Factor XI concentrate FXIII Corifact FEIBA Fibrinogen RiaSTAP Hyperimmune Globulins CytoGam (anti-cmv) GamaSTAN S/D (anti-ha) HepaGamB (anti-hb) HyperHEP B S/D (anti-hb) VariZIG (anti-varicella Zoster) WinRho SDF (anti-d) IGIV and SCIG IGIVnex 10% Gamunex 10% Gammagard Liquid Privigen Gammagard-SD Hizentra Octagam Protein C -* Ceprotin Prothrombin Complex - Octaplex - Beriplex SDP - Octaplas * These products are not licensed by Health Canada and require Special Access Program authorization

13 CBS Products Recombinant rviia Niastase rviii Advate Kogenate Xyntha rix Benefix rxiii Tretten

14 Procurement Strategy

15 Current situation of PPP Contracts RFPs were issued in 2012 which resulted in approximately $600M in savings to be realized over a 5 year period. The contracts were negotiated in 2012/13 and are valid for 5 years, with two one-year extensions possible beyond that. We are entering years 2 & 3 our contracts with our eleven PPP suppliers (covering 45 brands and 90 variants). Entering final year of our recombinant factor VIII contract for a 40% share of the market.

16 Plasma Products Portfolio For procurement decisions, CBS employs competitive invitational bidding processes. Flow chart and relevant operating procedures are shown below. All suppliers must first be qualified before they can be considered. All products carried must be Health Canada licensed. Where possible, CBS attempts to maintain multiple suppliers for physician choice and security of supply.

17 Preparation Develop Selection/Review Committee Member List Advise Supplier audit department if audit is needed Issue RFP with approved Supplier Qualification Issue RFP Obtain approval from Executive YES NO Answer Bidders questions Team develops: Specifications Selection Criteria Decision Matrix Bidder List Is Supplier considered critical to the Business stakeholders and previously approved?

18 Evaluation & Award Process Proposals Submitted Proposals Evaluated (Decision Matrix) Short List Prepared Bidder Audit (as required) Evaluate Goods (as required) Request Supplier SQQ or Presentation (as required) Recommendation Obtain necessary approvals Sign Contract

19 Types of Contracts Where approved products are limited, fixed share contract strategies can be valuable. Provides security of supply in sole source and/or single source scenarios Fixed pricing with budget certainty for both parties Multiple sources of approved products can drive competition and force prices down. Request for Proposals/Quotation are key Will still enter into fixed term supply contracts, but will not necessarily guarantee specific share percentages

20 Stakeholder input on strategy Cost pressures from the PTs continue we need to continue to look for efficiencies and price reductions to achieve lower prices per unit for PPP. At the same time, new products are entering the market and offer additional patient benefits We need to manage brands and or categories intelligently, to offer choice but optimize cost. Longer term, we need to better partner with healthcare professionals to help monitor product utilization and ensure system optimization.

21 Stakeholder input on strategy (cont d) Needs of our stakeholders and the input of patient groups must be weighed carefully in the selection of suppliers and products. Our stakeholders have an important role in providing input and guidance on our product selection and procurement processes. Patient groups provide input into the selection of those products that could be reviewed, participate in the product selection process itself and or the RFP exercises. Physician groups are needed to help determine those products to review and to be active participants in the selection review process.

22 Reviews Currently Underway With current products and new long acting recombinants on the horizon, factor VIII and IX products holds promise for cost reduction. New long acting Factor products recently approved by Health Canada, with dossiers submitted to CBS for consideration to carry. Presently under review with recommendations soon to be released for Factor IX (Alprolix), and Factor VIII (Eloctate) to follow. Initially, looking at cost containment with potential incremental savings to the system via: Less product being administered Lower frequency of dosing resulting in less labour hours

23 Procurement strategy We are formulating a procurement strategy in 2015/2016 contract extensions or RFPs. For our fractionated products: No immediate action required. New contracts were negotiated to get us through the expected market uncertainty due to Ig demand from possible new indications that were evident at the time (e.g. Alzheimer s). Factors VIII and IX worth considering. RFP for factor VIII is likely to happen first We will time RFPs with market availability of new products to maximize choice and cost reduction potential

24 Key Considerations & Next Steps

25 PPP Business Cycle Shipping to CBS Sites Donation Donation at CBS Sites CBS Head Office Warehouse in Ottawa CBS Sites H Patient Care FROZEN TRANSPORTATION Processing at CBS Sites By Truck and /or Ship Warehouses in Toronto REFRIGERATED TRANSPORTATION By Truck and/or Ship Fractionation Plant US or Europe

26 Key Considerations CBS acts as a national partner with the Provinces and Territories in managing this important portfolio of product. More than just SCM expertise. CBS provides expertise in transfusion medicine in managing blood products and products derived from whole blood/plasma and or their recombinants. The acquisition strategies are being prepared for endorsement. Some external and internal stakeholder groups have already been approached to kickoff strategy discussions - include patient, nurse and physician groups. Exact roles dependent upon strategies taken. Total Quality & Value Proposition value is not only in the price Safety and efficacy of the product, security of supply, choice for patients ensuring best possible outcomes

27 Key Considerations (cont d) Total systems cost being considered Acquisition and distribution full supply chain Managing the fractionator and partnering with them to drive down costs, while providing safe reliable product CBS currently has a number of key initiatives to drive costs down, to become more efficient at what we do, while ensuring the right product gets to the right place at the right time Price of Plasma Products makes of nearly half of the CBS operating budget ($500M). Sourcing strategies being developed. National distribution being reviewed (logistics and movement of product) with aggressive targets to reduce cost

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