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When pCODR Says "No", Then What?


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The pCODR process is designed to bring consistency and clarity to the assessment of cancer drugs by reviewing clinical evidence, cost-effectiveness, and patient perspectives, and using this information to make recommendations to Canada's provinces and territories (except Quebec) in guiding their drug funding decisions. Interested in learning more?

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When pCODR Says "No", Then What?

  1. 1. When pCODR says “no,” then what? Thursday, April 30th, 2020 13:00-14:00 Presented by Ryan Clarke, founder of Advocacy Solutions
  2. 2. When pCODR says “no,” then what? Ryan Clarke, LL.B. (416) 919-9532
  3. 3. Overview • Broad overview of drug approval and reimbursement processes • Closer look at the pCODR process • Closer look at the pCPA process • Patterns between pCODR recommendations and pCPA outcomes – Methodology, findings and conclusions of CCSN research into pCODR recommendations from 2019 • What can you do if pCODR says “no” • What should you do if pCODR says “yes” (given COVID-19) • Q&A
  4. 4. Canadian Drug Approval & Reimbursement Processes
  5. 5. Regulatory Review & Reimbursement Processes • Public drug formularies are impacted by federal, provincial and national policies • Manufacturer submits to Health Canada for approval • The Canadian Agency for Drugs and Technologies in Health (CADTH) operates two pan-Canadian drug review processes: – Common Drug Review (CDR) reviews new drugs (non-oncology) and makes reimbursement recommendations (with the exception of Quebec) – pan-Canadian Oncology Drug Review (pCODR), which deals specifically with cancer drugs and makes reimbursement recommendations (with the exception of Quebec) • The pan-Canadian Pharmaceutical Alliance (pCPA) conducts joint federal/provincial/territorial negotiations for brand name drugs in Canada • Provinces also review new drugs and make the final reimbursement decisions through product listing agreements
  6. 6. pan-Canadian Oncology Drug Review • As the review process within CADTH specifically for oncology drugs, pCODR issues positive or negative funding recommendations • Recommendations are made by the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) based on: – clinical evidence – cost-effectiveness – patient perspectives • Information is then used to make recommendations to Canada's provinces and territories (except Quebec) in guiding their cancer drug funding decisions • pCODR takes into account evidence from a number of sources, including patient groups, drug manufacturers, clinician-based tumour groups, and the pCODR Provincial Advisory Group • Patient/clinician input processes for pCODR allows for written input at two points: prior to pERC review and after pERC initial recommendation is issued 6
  7. 7. • Established in August 2010, the pan-Canadian Pharmaceutical Alliance (pCPA) conducts joint provincial/territorial negotiations for brand name drugs in Canada • The pCPA member jurisdictions include public drug plan and/or cancer agency participation from: British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Québec, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland & Labrador, Yukon, Northwest Territories, Nunavut, Non-Insured Health Benefits (NIHB), Correctional Services of Canada (CSC) and Veterans Affairs Canada (VAC) • All brand name drugs coming forward for funding through pCODR and CDR are considered for negotiation through the pCPA
  8. 8. • The pCPA’s mandate is to enhance patient access to clinically relevant and cost-effective drug treatment options • It serves this mandate by conducting collective, expert-informed, negotiations for drugs • Through the combined negotiating power of drug plans across multiple provinces and territories, the pCPA objectives are to: – increase access to clinically effective and cost-effective drug treatment options – achieve consistent and lower drug costs for participating jurisdictions – reduce duplication of effort and improve use of resources – improve consistency of decisions among participating jurisdictions
  9. 9. pCPA – Negotiation Process Divided into four distinct phases: • Initiation - once a recommendation is published by CADTH and/or INESSS for a new drug, pCPA issues an acknowledgment letter to the manufacturer advising them that the drug is now under consideration for negotiation by pCPA • Consideration - pCPA considers whether it will enter into a negotiation for a drug while also gathering additional information or clarification as required - once this phase is completed, pCPA will issue a letter to the manufacturer identifying whether pCPA will engage in negotiations (Engagement Letter), place a hold on the consideration phase, or close the file and not negotiate
  10. 10. pCPA – Negotiation Process Divided into four distinct phases (continued) • Negotiation – lead jurisdiction(s) is assigned and aims to finalize negotiations within 90 business days from the Engagement Letter • Completion - pCPA process is considered complete once the negotiation has resulted in mutually agreed upon terms and a fully executed letter of agreement (LOI), or, if mutually agreed upon terms are not reached, pCPA has issued a close letter to the manufacturer, indicating that the negotiation is closed
  11. 11. pCPA Status Lists* Under consideration for negotiation (16 – 9 oncology) Active negotiations (20 – 5 oncology) Negotiations that were not pursued (75) • With LOI (316) • With no LOI (53) Completed negotiations (369) Product currently on hold (0) *Status lists maintained by pCPA (as May 5th)
  12. 12. Research - Overview • With a number of medications coming out of CADTH in which negotiations were not pursued or, if initiated, were not successfully concluded, CCSN engaged Eastlake Research Group to examine whether the rate of positive pCODR recommendations changed recently and, if so, to evaluate any potential reasons • All pCODR recommendations for 2019 were reviewed and a comparison drawn between those issued before July 1, 2019 and those issued after that date • Overall finding – 88% of recommendations before July 1, 2019 were positive; only 50% of recommendations post that date were positive
  13. 13. Research - Methods All pCODR final recommendations issued in 2019 were reviewed and the following information abstracted: • Name of drug • Dates of submission to pCODR and issuance of final recommendation, and whether the submission preceded Health Canada’s Notice of Compliance • Recommendation and any conditions • The indication, i.e. the type of cancer for which the drug is indicated • Whether the cancer is a solid tumour or not • How the drug is to be used: advanced or metastatic cancer, relapsed or refractory cancer, adjuvant therapy, after prior treatments or surgery, in combination with other therapies (a drug could fit into more than one of these categories) • The phase of clinical trial(s) whose evidence was reviewed by pCODR • Provincial funding status for the drug available from the pCODR website (since pCODR does not review oncology drugs for Quebec, this information excluded the funding status in that province) pCPA negotiation status relating to the pCODR recommendations were also recorded
  14. 14. 29% 71% All pCODR Recommendations in 2019 Negative Recommendations (9) Positive Recommendations (22) 12% 88% Recommendations Issued Prior to July 1, 2019 Negative Recommendations (2) Positive Recommendations (15) 50%50% Recommendations Issued After July 1, 2019 Negative Recommendations (7) Positive Recommendations (7)
  15. 15. Positive Recommendations (Timeline) 22 Negative Recommendations (Timeline) 9
  16. 16. 16 66 3 0 2 4 6 8 10 12 14 16 18 Solid Tumors Non-Solid Tumors Recommendations Recommendations by Tumor Type Positive Negative
  17. 17. 10 3 2 9 10 5 1 0 1 4 0 2 4 6 8 10 12 Metastatic Cancers Relapsed or Refractory Cancers Adjuvant Therapy Combination Therapy Prior Therapy or Surgery Reccomendations Recommendations by Cancer Type* Positive Negative *Drugs may be in more than one category
  18. 18. 33% 87% 0% 0% 67% 13% 100% 100% 0% 20% 40% 60% 80% 100% Phase I/II Phase III Phase IV Undefined Recommendations by Trial Phase Positive Negative
  19. 19. Research - Conditions/Reasons
  20. 20. 15 1 6 1 7 1 0 2 4 6 8 10 12 14 16 Complete with LOI Complete without LOI Active Not pursued Unknown Recomendations pCPA Status Positive Negative
  21. 21. Provincial Funding Status • Highlights (as of March 31st) – None of the 22 drugs that received a positive recommendation have been funded in every province – Only one of the 9 drugs that received a negative recommendation has been funded in one province – Adcetris (NHL) in BC – Of the positive drugs: • SK has funded the most (8), followed by BC (7), MB (4) and ON (3) • Three provinces have funded only one (NS/NB/NL) • Two provinces have funded none (AB/PE) • Imfinzi (NSCLC) has been funded in the most provinces (5)
  22. 22. What Does the Research Tell Us? • While there is a good probability that a medication that receives a “yes” from pCODR will ultimately be issued an LOI (68% based on the 2019 analysis to date), the review shows that the percentage of positive recommendations dropped significantly in the latter half of the year • When a medication receives a “no” from pCODR, there will be issues regarding the product’s clinical benefit • It is also highly unlikely that such a drug will even be invited into pCPA, let alone be issued an LOI • And even if the product does receive an LOI, there is even less likelihood that any province will ever fund it (1/81) • But there are avenues that can be pursued
  23. 23. When pCODR Says “no”? • Start early – build relationships and deliver messaging to other stakeholders, national review bodies and provincial officials beginning as early on as possible (i.e. well before the drug is even submitted to Health Canada for approval) to set the tone for a sustained advocacy effort • Encourage the manufacturer to wait to submit with Phase III trials • Encourage the manufacturer to resubmit to pCODR if additional data may be forthcoming • Engage pCPA directly to request that the medication not be unilaterally put on the “negotiations that were not pursued” list • If negotiations with pCPA do commence, engage both the manufacturer and pCPA directly to encourage them to actively seek a path towards a LOI
  24. 24. When pCODR Says “no”? • Gather patient/caregiver stories • Host advocacy training sessions with supporters • Establish e-Advocacy hub to facilitate grassroots engagement at the provincial level • Hold virtual advocacy day/week in key provinces (i.e. meetings) • Engage in sustained traditional/social media campaign to amplify e-Advocacy efforts • Consider employing other advocacy tools – i.e. petitions, postcards, pledges, etc.
  25. 25. When pCODR Says “yes” During COVID-19? • On March 23rd, pCPA issued the following to manufacturers:
  26. 26. When pCODR Says “yes” During COVID-19? But again, there are avenues that can be pursued: • Continue to build relationships and deliver messaging to other stakeholders, pCPA and provincial officials around the importance of timely access to medications (i.e. teleconferences, virtual meetings) • Gather patient/caregiver stories • Host advocacy training sessions with supporters • Engage in sustained social media campaign, ideally framing your need within the context of COVID-19 • Consider launching a sustained e-Advocacy campaign targeting pCPA and/or the provinces (when appropriate) • Consider planning a virtual advocacy day targeting one or more of the key provinces So even a “yes” recommendation during this pandemic will mean delay, which is never in the best interests of patients
  27. 27. Canadian Cancer Survivor Network Contact Info 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail: or Website: Twitter: @survivornetca Facebook: Instagram: @survivornet_ca Pinterest: