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An article in this issue by Srikanthan, Gill, and Chan1 considers the possible “politicization” of cancer drug funding announcements in Canada. Specifically, the authors examine the number of cancer-drug funding announcements in the weeks before a provincial election, hypothesizing that incumbent political parties might use such announcements for political gain. Reassuringly, they found no evidence of such behaviour. However, the fact that they thought it worthwhile to look for such evidence suggests that concerns about the inappropriate influence not only of politicians, but also the pharmaceutical industry, patient advocacy groups, and even the media in the drug approval process are pervasive. Such concerns are supported by a recent study that reported a statistically anomalous number of provinces announcing the funding of cholinesterase inhibitors in the days immediately preceding a provincial election2. Other studies show that greater media attention to some drugs appears also to be associated with more rapid review and approval processes and that the coverage might have influenced the decisions3,4. There is also evidence of potential conflicts of interest between pharmaceutical companies and patient advocacy groups5,6 and anecdotal concerns about “astroturfing” or organized marketing campaigns disguised as grassroots advocacy7.
At the root of the concerns is a suspicion that some groups are co-opting the drug review process for their own political, economic, or personal benefit, to the detriment of the larger society. To understand the legitimacy of that suspicion, it is useful to briefly review the purpose and aims of the cancer drug review process in Canada, focusing on the pan-Canadian Oncology Drug Review (pcodr). Currently, pcodr is administered within the Canadian Agency for Drugs and Technologies in Health, alongside the Common Drug Review (cdr). Where pcodr is responsible for cancer drugs, the cdr is responsible for reviewing non-cancer treatments8,9. After Health Canada has approved a drug for safety and efficacy10, the cdr and pcodr both make reimbursement recommendations to provincial and territorial drug plans; however, those recommendations are nonbinding, and each jurisdiction makes its own final reimbursement decision. Notably, many of the provincial decisions are made after strictly nondisclosable price negotiations with the pharmaceutical manufacturer11.
The stated objective of the pcodr review process is “to bring consistency and clarity to the assessment of cancer drugs.” The pcodr deliberative process and recommendations emphasize four key elements: clinical benefit, economic evaluation (value for money), patient-based values, and adoption feasibility12. There is, however, no weighting scheme for those criteria and no quantitative threshold that must be met for any single element of the review. The pcodr assessment process also emphasizes transparency in the reporting of all decisions and the evidence on which those decisions were based. A key challenge in that process is that, in many cases, the criteria can be at odds: drugs might be cost-effective, but have a substantial budget impact that limits adoptability; or drugs might have marginal clinical benefit and significant adverse effects, but represent the only treatment available for patients with a rare disease.
To arrive at a final recommendation, the pcodr Expert Review Committee relies on the judgment of a panel of clinical experts, health economists, and patient representatives who consider the evidence and reach a consensus recommendation. That consensus can be to recommend funding, to recommend not funding, or to recommend funding conditional on (most often) a lower drug price13. Conflicts are resolved through discussion, without reference to any explicit decision weights; there is no guidance to indicate what constitutes clinical benefit or good value for money. Committee members therefore apply their own implicit weights to arrive at their consensus. A challenge posed by this sort of approach is the maintenance of consistency: it is possible that a different committee, with different members relying on a different set of implicit weights, could reach a different decision about the same drug. To a large degree, pcodr relies on an “institutional memory” to maintain consistency: Have we reviewed similar drugs in the past, and how did we decide then?
Decision frameworks that guide drug funding recommendations often rely on a predetermined set of criteria involving subjective decision rules rather than explicit thresholds. Proponents of this sort of approach argue that some ambiguity, and even opacity, in the review process is necessary in the face of the inherent complexities of priority-setting, particularly in emotive areas such as cancer care11,14,15. Part of the argument is that cancer, more so than many other diseases, has a strong political component that must be recognized and accommodated11,13. Indeed, there are precedents in oncology in which health care policymakers at the provincial level have chosen to override recommendations set forward by drug funding review committees. In that sense, a political element has been designed into the process: it is a feature, not a bug11.
In many ways, however, it is the possibility of recommendations based on political rather than clinical or economic factors that drives public suspicion and distrust. Political involvement in priority-setting implies a proverbial “thumb on the scale,” and suggests that drug funding decisions are being made on the basis of factors outside those considered important in the review—particularly the characteristics of the patient rather than the drug. Such political involvement would seem most often to be detrimental to marginalized or otherwise “less worthy” groups and diseases in society. For example, Hoffman-Goetz and MacDonald16 observed that the coverage of lung cancer in Canadian women’s magazines is much lower than coverage of breast cancer, and disproportionately lower than its contribution to women’s cancer mortality. Conversely, coverage of breast cancer is much higher than its relative contribution to women’s cancer mortality. The relatively lower profile of lung cancer relative to breast cancer might be driven in part by the perception that lung cancer is a self-inflicted illness because of smoking habits. In contrast, breast cancer has a large and well-organized survivorship network and is perceived as affecting otherwise healthy women3.
In that context, it is difficult to accept that political involvement in priority-setting is likely to be advantageous to marginalized groups. Rather, there would seem to be substantial political advantage associated with being seen to favour higher-profile causes. More broadly, political involvement in the cancer drug review process implies that other disease areas could be marginalized relative to cancer17. Indeed, critics argue that ambiguous decision rules can be exploited to the advantage of special-interest groups or, just as damagingly, can be perceived by the public as being exploited by those groups18,19. Such a perception can lead to a breakdown in the implicit social contract by which individuals with lesser need are willing to stand aside for those deemed to have greater need, on the presumption that others will stand aside for them when they have greater need. If the public does not trust the process by which need and priority are determined, they are less willing to stand aside for others, and the system begins to break down20.
The pcodr undoubtedly provides a uniform and consistent review process for oncology drugs that critically examines clinical benefit, economic value, adoption feasibility, and patient values. However, the ultimate objective of the assessment is not clearly defined in terms of maximizing health outcomes within a constrained budget17, restraining growth in drug expenditures, facilitating greater and more timely access to innovative cancer drugs, or addressing aspects of equity such as unmet needs and patient values. It is indeed likely that the final objective comprises a bit of them all, even though many of the objectives can be in conflict. For example, it is difficult to address unmet needs while also seeking to restrain spending on drugs. In that sense, it is not just the process but the objective itself that is politicized, as decision-makers try to promote and balance outcomes that are unstated and, to varying degrees, mutually incompatible.
As Hoch et al.11 observe, the current pcodr review process was designed by the provinces to exist outside of, but in parallel to, the cdr, strongly suggesting that it was at least initially intended to serve a distinct and implicitly political purpose. Indeed, as McDonald et al.17 conclude, there is no economic rationale for a separate cancer drug review process alongside the cdr. Given that Hoch and Sabharwal13 are correct in observing that cancer is a politically charged issue, a political purpose is therefore not unexpected. Furthermore, those authors note that pcodr makes only recommendations; the final funding decision is the responsibility of political decision-makers at the provincial level, and therefore a political element in the final decisions is inevitable. In that sense, the public’s suspicions of creeping political influence over the cancer drug review process is inaccurate because the current process—that is, pcodr—has had a strong political element from its inception. In the absence of the counterfactual, we might never know how such political involvement has affected the fair and efficient allocation of resources in cancer, and whether, if present, it has caused more harm than good.
CS has served as health economics reviewer for the pan-Canadian Oncology Drug Review (pcodr), and TY has served as a member of the pcodr’s Expert Review Committee. The views presented here are of the authors and not those of either pcodr or the Canadian Agency for Drugs and Technologies in Health.