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EXAMINING THE IBM REPORT ON THE pCPAPresentation for CCSN

February 5, 2015

Draft v1

December 31, 2013

Draft v2

February 18, 2014

Draft v3

February 24, 2014

Final version

March 22, 2014

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1. pCPA Overview

2. The IBM Report

3. Update

4. Impacts on Patient Access

Outline

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pCPA Overview

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pCPA Overview - DescriptionThe pan-Canadian Pharmaceutical Alliance (pCPA) is an initiative to facilitate the conduct of joint negotiations for pharmaceuticals being considered for reimbursement through participating public drug plans.

PARTICIPANTS

• British Columbia• Alberta• Saskatchewan• Manitoba• Ontario• New Brunswick• Nova Scotia• Prince Edward

Island• Newfoundland

& Labrador• Yukon

• Quebec

Objectives:

• Capitalize on the combined purchasing power of public drug plans across multiple jurisdictions

• Improve the consistency of medication listing decisions across the country

• Achieve consistent pricing and lower costs • Increase access to treatment options, and • Reduce duplication of negotiations and improve how

resources are used

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pCPA Overview – Parallel Processes

Innovative medicines

Negotiate product listing agreements (PLAs)

• Closed / Completed: 49• Underway: 18• No negotiations: 23• P/T negotiaions: 9

Generic medicines

Value Price Initiative caps generic medicines at 18% of innovative medicine

• 2013: six generic medicines (cholesterol, depression, high blood pressure, GI)

• 2014: four additional medicines• 2015: plans to cap additional four• 2016: plans to cap another four

pCPA

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pCPA Overview – Innovative Process

Source: pan-Canadian Drugs Negotiations Report

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pCPA Challenges• Patient concerns

• No seat at the table• Patient voices may help clarify, expedite, provide additional perspectives and

lead to co-creation of metrics

• Outcomes:• Every product should be listed if LOI is signed

• Timeliness:• Clarity around timelines of negotiations needed• Use Special Access Programme while medication under negotiation• Concurrent processes preferred to consecutive processes

• Patient experiences: • Patient submissions should be considered• Consider other aspects of value to patients (e.g., different delivery systems)

• Health system impacts• also important (e.g., fewer doctor visits) – not just price

• Guaranteed supply

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pCPA Challenges

Other stakeholders• Industry:

• Lack of transparency re timelines, pCPA process, and specific criteria

• Overall economic impact should be considered as “value”• pCODR as model of collaboration with industry and patient groups• Provincial implementation after LOI signed inconsistent and unclear• Rare diseases: Consider nominating one province with expertise /

program (Ontario)

• Private payers:Do not have access to the same prices

• Pharmacists:• No transparent pricing

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pCPA Stakeholders • Provincial and Territorial drug program branches • Provincial cancer agencies (CAPCA) • Manufacturers (innovative) • Industry groups (Rx&D, BIOTECanada) • Regulatory bodies (pCODR, CADTH, PMPRB) • Patient groups • Cross Sector Alliance (CGPA, CACDS, CAPDM, CPhA)

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The IBM report

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IBM Report - Mandate• Mandate. Recommend options for:

• Innovative medicines: a permanent model• Generic medicines: achieving better value for money

• Approach. IBM’s approach included: • An environmental scan of best practices• Strategic interviews with key senior stakeholders, and • Targeted survey with provincial drug programs on timelines for

reimbursement of medicines negotiated through PCPA and future expected human resource needs

• The focus was on innovative medicines, but governance and process recommendations could also apply to generic medicines.

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IBM Report – Findings

Canada’s system is unique: no existing model to import

Guiding Principles:• Holistic• Predictable• Consistent• Transparent• Timely• Efficient• Collaborative• Representative• Ethical

Somewhat aligned with pCODR principles

Provide accountability mechanism for stakeholders

Yet to be endorsed

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IBM Report – Findings Common themes

• pCPA goals (incl. non-price goals) are acceptable

• Single negotiation better than multiple parallel processes in principle

• pCPA seen as distinct from existing bodies in access continuum – e.g., CADTH

• Subject matter expertise of provincial drug programs critical to success

• Volume limited by resource constraints• pCPA young and evolving: needs more structure

& more formal / consistent / transparent processes

• Needs more collaborative, consistent, open and transparent communications

• Metrics required to evaluate and benchmark pCPA performance

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IBM Report – General Recommendations

• Name change from “pricing” to “pharmaceutical” • Improve communications:

• Negotiation status• Benchmarks• Timelines • Annual reports on performance

• Standardize LOIs & PLAs: flexible contracting process & ID complex issues early in process

• Use tiered structure: different evidence needed for different products (Australia)

• Possible pre-negotiation briefings: pCPA lead, manufacturer, HTA bodies & patient group representative

• Develop metrics for different parts of the process – possibly include manufacturers

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IBM Report – Governance Recommendations

• Governance model: Five potential options – secretariat recommended• Secretariat: central office providing support function (negotiating

skills, templates, admin services, etc.) instead of reinventing the wheel each time

• Process recommendations: • Increased standardization• Increased transparency• Clear timelines for exchanges between

jurisdictions and manufacturers• Etc.

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Update

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Update• Decision to establish secretariat announced on September 30, 2014.

• Secretariat will be physically located with the Ontario drug plan but administered separately.

• The provinces launched a stakeholder consultation regarding the ongoing development of the new pCPA Office.• Consultations ended December 31, 2014.

• The secretariat is expected to be operational by April 2015

Mandate: support national negotiations with manufacturers. Tasks:

• standardization of templates, • multi-channel communications, • administrative support and tracking of performance metrics.• Capacity building: additional expertise to support

consistency of negotiations across jurisdictions, transparency of process and accountability.

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Impacts onpatient access

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Impacts on patient access• Process longer BUT new medications that would not

otherwise be listed are being reimbursed• More affordable / tailored through negotiation process

• Increase in capacity and timeliness of decisions in smaller jurisdictions (Atlantic provinces and Manitoba)• Generally consistent with CDR / pCODR recommendations• Unclear how consistent they are with signed LOIs

• In some cases, pCPA may represent the end of the road• Implications in other sectors: benefits don’t accrue to

those not covered by public plan

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Thank you!

Gerry Jeffcottgjeffcott@3sixtypublicaffairs.com613.851.1602 (mobile)

Rachael Manionrmanion@3sixtypublicaffairs.com613.805.9552 (mobile)

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