Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review

Figures & data

Figure 1 Fifteen HTA principles.

Note: Copyright © Cambridge University Press 2008. Adapted from Drummond MF, Schwartz JS, Jonsson B, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24(3):244–258.⁷
Abbreviation: HTA, health technology assessment.

Table 1 How does the pCODR meet the process principles

HTA process^Citation14	pCODR Process (as described on their website)^Citation11^–^Citation13
Principle 10: Actively engaging all key stakeholder groups
pCODR formally required to engage stakeholders	• Patients • Manufacturers • Clinical experts (disease site experts involved in the clinical assessment) • Health economics experts • Provincial payer representative (provincial advisory group)
Stakeholders involved in scoping of HTA	There is no scoping process at the pCODR. Manufacturers have the opportunity to engage before submission through presubmission meetings that consist of 1–1.5-hour meetings per submission; maximum of one meeting per manufacturer per 6 months, which needs to be formally requested by the manufacturer. There is no comparable process to the NICE scientific advice consultation service that provides guidance for drug development. There is also nothing comparable to the NICE scoping process. The purpose of the pCODR presubmission meeting is to provide an opportunity for the submitter to introduce the new drug and the approach to the economic evaluation, to help the pCODR to plan its workload, and to help provinces plan demand for new products.
Mechanism for identifying relevant stakeholders	A mechanism is in place to form transitional expert panels if the eleven permanent tumor site panels do not cover a submitted drug.
pCODR encourages or requires submission of evidence from stakeholders	A drug manufacturer and/or a provincially recognized clinician-based tumor group may make a submission. As part of the pCODR deliberative framework, when making a funding recommendation, the pERC must consider patient values and consider the potential impact and feasibility of adopting the recommendation. Patient advocacy group and PAG inputs are solicited for each submission to inform those components. Patient advocacy group input is used by reviewer panels and in pERC deliberations. How patient input contributed to the reason for recommendation is published. Input of manufacturers to clarify clinical and economic information and review nondisclosable information during the review process is done through checkpoint meeting.
pCODR allows stakeholders to comment on reports at the draft stage	Manufacturers can review the clinical and economic guidance reports only, to identify factual errors and confidential information just prior to the pERC meeting. All stakeholders can comment on the pERC initial recommendation within 10 working days. The feedback from manufacturers, patients, and the PAG on the initial recommendation and reasons is posted on the pCODR website.
pCODR allows stakeholders to appeal against recommendations/decisions	The submitter and/or patient advocacy group have 10 working days to make a request for reconsideration after publication of the initial recommendation. No new data can be submitted, only arguments. If the submitter, PAG, and patient advocacy groups approve of the initial recommendation, rapid conversion to a final recommendation occurs. If objections are raised by any of these groups, the dossier will be reassessed at the next pERC meeting. The same reviewers will be involved. The opportunity for rapid conversion is lost.
pCODR committees include stakeholder representation	Clinicians and patients are represented on the pERC. Provincial payers are represented by the PAG. All stakeholder groups are represented except the manufacturers.
Principle 11: Actively seeking all available data
Systematic review of clinical evidence includes gray literature and unpublished data	Yes, but the weight given to the evidence will vary according to the source of information. For example, an unpublished clinical trial available only in abstract or poster format will be given less weight than a clinical trial published in a peer-reviewed journal.
pCODR has a process to handle confidential data from the manufacturer	Confidentiality maintained in the published “Recommendation and reasons” and all other published reports (clinical and economic). Confidential pricing respected at the provincial level. Disclosure guidelines provide clear direction on how confidential information will be managed. Note: incremental cost-effectiveness ratios are not considered to be confidential even if associated with confidential price.
Principle 12: Monitoring of HTA findings
pCODR develops an implementation plan for its recommendations	The pERC recommendation includes advice related to implementation in response to issues raised by PAG in the latter’s assessment of adoption feasibility.
pCODR monitors the impact of its recommendations	The pCODR tracks and reports provincial funding decisions and criteria on its website. There are additional steps between pERC’s recommendation and pCODR’s notification to implement and the ultimate provincial funding decision. These include the negotiations between the manufacturer and the PCPA and any provincial decision-making processes that must be followed.

Notes: Copyright © Cambridge University Press 2008. Adapted from Drummond M, Neumann P, Jonsson B, et al. Can we reliably benchmark health technology assessment organizations? Int J Technol Assess Health Care. 2012;28(2):159–165.¹⁴ Adapted from: CADTH pan-Canadian Oncology Drug Review. How pCODR works. Process in brief [webpage on the Internet]. Ottawa: CADTH; 2015. Available from: https://www.cadth.ca/pcodr/process-in-brief.¹¹ CADTH pan-Canadian Oncology Drug Review. About pCODR. Advisory Bodies [webpage on the Internet]. Ottawa: CADTH; 2015. Available from: https://www.cadth.ca/pcodr/advisory-bodies.¹² CADTH pan-Canadian Oncology Drug Review. Transparency. Find a review [webpage on the Internet]. Ottawa: CADTH; 2015. Available from: https://www.cadth.ca/pcodr/find-a-review.¹³

Abbreviations: PCPA, pan-Canadian Pharmaceutical Alliance; HTA, health technology assessment; pCODR, pan-Canadian Oncology Drug Review; pERC, pCODR Expert Review Committee; PAG, Provincial Advisory Group; NICE, National Institute for Health and Care Excellence.

Figure 2 Recommendations from stakeholder interviews.

Abbreviations: CADTH, Canadian Agency for Drugs and Technologies in Health; HTA, health technology assessment; pCODR, pan-Canadian Oncology Drug Review; pERC, pCODR Expert Review Committee.

DrummondMFSchwartzJSJonssonBKey principles for the improved conduct of health technology assessments for resource allocation decisionsInt J Technol Assess Health Care200824324425818601792

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DrummondMNeumannPJonssonBCan we reliably benchmark health technology assessment organizations?Int J Technol Assess Health Care201228215916522559758

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CADTH pan-Canadian Oncology Drug ReviewHow pCODR works. Process in brief [webpage on the Internet]OttawaCADTH2015 Available from: https://www.cadth.ca/pcodr/process-in-briefAccessed April 16, 2015

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CADTH pan-Canadian Oncology Drug ReviewTransparency. Find a review [webpage on the Internet]OttawaCADTH2015 Available from: https://www.cadth.ca/pcodr/find-a-reviewAccessed April 16, 2015

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CADTH pan-Canadian Oncology Drug ReviewAbout pCODR. Advisory Bodies [webpage on the Internet]OttawaCADTH2015 Available from: https://www.cadth.ca/pcodr/advisory-bodiesAccessed April 16, 2015

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