The IBM report on the pCPA

Editor's Notes

• #4: 1. pCPA overview: what it is and where it fits into the great scheme of things 2. the IBM report:   - background on governance issues with pCPA and why the report was likely sought —> this should set the stage for why it matters to patients   - comments received  - timelines from NOC to CDR/pCODR  - options considered   - recommendations made (general, model of governance, and pCPA process) 3. Update since the IBM report was received by Canada’s Premiers (since March 2014, including name change, Ontario as location of secretariat, etc.) 4. Impacts on patient access: what is hoped for and what are key areas of engagement for patients as Canada’s Premiers move forward in implementing recommendations of the report.
• #7: Negotiations information current to December 31, 2014. pCPA reform process: There are also lead jurisdictions for managing the pCPA process (internally) on behalf of their counterparts - lead jurisdictions for innovative medications are NS / ON - lead jurisdictions for generic medications are NS / SK pCPA recommends that its participating jurisdictions negotiate a PLA with manufacturer: Collectively Individually (each prov / territory), or Not at all Negotiations as of December 31, 2014 – most current on website
• #8: THE INNOVATIVE STREAM WILL BE THE FOCUS OF OUR DISCUSSION FOR THE REST OF TODAY. Main take-away from this process slide: pCPA is an add-on to the existing process: more time, no other changes to existing processes – all existing process continue as they had before. Each negotiation has its own lead jurisdictions responsible for pCPA process on behalf of their counterparts (typically ON and BC). All participating jurisdictions meet every second week to go through list of new products that are coming and get an update on current negotiations. In the meantime, business moves ahead – the lead jurisdictions have responsibility to ensure that negotiations move ahead and letters of intent are signed.
• #9: pCPA has met their objectives in some respects but there are some issues. Some of these issues will be addressed through the IBM recommendations.
• #11: These are the stakeholders that were consulted in the development of the IBM Report
• #14: Guiding principles - based on feedback from stakeholders but unclear how influential they will be in the future development of pCPA Loosely aligned with pCODR’s principles Accountability mechanism for stakeholders (patients)
• #15: No existing model to import – none of the existing Canadian medication review and approval processes could be modified Common themes – from report: • The PCPA goals are acceptable including non-price goals: All stakeholders agreed that the PCPA goals were acceptable but specified that there is an underlying focus on price which should be one of the stated goals. The acronym “PCPA” also suggests the negotiations have been “all about price”. Stakeholders felt that the goals of PCPA needed to be clearly articulated without an undue focus on price. • In principle, a single pan-Canadian negotiation is better than multiple parallel negotiations: Stakeholders did not want duplication and redundancy in processes and hence believed that the premise of having a single pan-Canadian negotiation was better than multiple individual negotiations. • No current government body is seen as a “fit” for PCPA: When asked if there was an existing organization that would be a good “fit” for the PCPA in terms of absorbing the PCPA as part of its governance structure, most stakeholders felt there was no current entity that was appropriately positioned to take on this role without compromising their existing (and distinct) mandates. For example, a body such as CADTH bases its recommendations on independent evidence-based evaluations according to pre-established guidelines and procedures. In contrast, the PCPA process incorporates a wider array of relevant factors, including individual jurisdictional considerations - which are more appropriate to an informed negotiation between various parties. International leading practices reflect a clear separation between evidence-based health technology assessments (HTAs) and complex price negotiations in order to achieve the goals that the PCPA is striving to achieve. Most concerns about existing government organizations included providing sufficient role clarity for the PCPA vis-à-vis an existing organization and mixing negotiation with HTA creating a possible conflict of interest. • Provincial subject matter expertise key to success of the PCPA: The drug program branches and cancer agencies are comprised of true subject matter experts in regards to scientific, technical and policy related matters pertaining to drugs. This includes market access, regulatory affairs, reimbursement, cost effectiveness, drug specific technical details such as efficacy and effectiveness data from clinical trials, etc. Most stakeholders stated that the provincial drug expertise should be strongly considered when evaluating various governance models and leveraged accordingly. • Resource constraints coping with the PCPA volume (now and in the future): The PCPA activities across the country are time consuming and the amount and types of resources available to perform such tasks falls short of what is required given the volume of drugs that will be negotiated through the PCPA. Concerns were raised at how increasing numbers and complexity of drugs negotiated through the PCPA will affect how negotiations can be performed in a timely and effective manner with the existing resources at the P/T level. • The PCPA is evolving and is a young alliance:Many stakeholders agreed that the PCPA is an evolving and young alliance that needed additional structure and consistency in processes. • The PCPA needs to improve their communication and be more transparent: Most stakeholders felt that communications from the PCPA regarding timelines and overall process were minimal. More collaborative, consistent, open and transparent communications were felt to be necessary. • The PCPA process is still informal and requires more consistency: The PCPA stakeholders felt that the PCPA process was informal. A more consistent and transparent process with some additional clarity around average timelines for each stage would be helpful to keep stakeholders, particularly manufacturers, informed about the status of negotiations. The simple analogy of a courier company, where the customer has visibility into the location of their package, can be adopted by the PCPA-by informing its stakeholders where in the process a particular negotiations lie. • Metrics are required to evaluate and benchmark the PCPA performance: All stakeholders would like to see the development and use of metrics to evaluate the PCPA performance going forward and to benchmark its performance. Manufacturers and some drug program branches were open to the idea of “co-creating” certain metrics such that both manufacturers and the government had an incentive and vested interest in achieving such performance measures.
• #16: General recommendations include:  changing the name from "pricing alliance" to "pharmaceutical alliance" to address perceptions that the initiative is solely concerned with reducing costs - note that Canada's Premiers have already implemented this recommendation; enhancing communications by providing: (a) standard templates, information, negotiation status, timelines, benchmarks, and statistics based on past negotiations; (b) annual reports including data compared with benchmarks; and (c) playbook with templates, forms, and other submission information; standardization of templates of, for example, product listing agreements and letters of intent, that incorporate flexibility in contracting practices and identify complicating issues to flag for manufacturers early in the process; common non-disclosure agreement covering manufacturers and provinces; implement a tiered structure that reflects different evidence needed for different products, modelled on one in use in Australia; early in negotiation process, assign a lead and possibly offer pre-negotiation briefings that include PCPA lead province, manufacturer, HTA bodies, and patient group representative; develop metrics to evaluate the functioning of different parts of the process and review the performance and outcomes of the drugs that have already been through the negotiation process, possibly including manufacturers in the development of such metrics.
• #17: The report recommends a secretariat as the optimal governance model of the PCPA.  The consultants provided five governance options: (1) status quo; (2) secretariat; (3) extend an existing body; (4) establish a new entity to undertake all negotiations but each province retains discretion; and (5) establish a new entity to undertake negotiations with the result being binding on all provinces.  The second option was identified as the quickest option with the lowest relative expenditures that will provide a point of contact while offering future flexibility should a decision be made to establish a new entity.  The report notes that establishing a new entity would require extensive legislative and policy changes but provides information on that option as well, at the request of the Steering Committee.  Note that Ontario has been chosen as the location of the Secretariat. In terms of the PCPA process, the report recommends increased standardization and transparency, along with clear timelines for exchanges between jurisdictions and manufacturers.