Timeliness of the oncology drug review process for public funding in Canada

Editorial

Timeliness of the oncology drug review process for public funding in Canada


T. Younis, MBBCh*, C. Skedgel, MA PhD§

doi: https://doi.org/10.3747/co.24.3825

The oncology drug review process for public funding in Canada (Figure 1) encompasses both

  • ■ regulatory reviews by the Health Products and Food Branch of Health Canada, which examines the drug’s efficacy and safety to assess its potential benefits and risks; and

  • ■ public funding reviews by relevant interprovincial and provincial agencies, involving health technology assessments, price negotiations, and final funding decisions.

 


 

FIGURE 1 Oncology drug review process in Canada. aInstitut national d’excellence en santé et en services sociaux (INESSS) in Quebec. bMinistries of health or provincial cancer agencies. TTA = time to approval; TTL = time to listing; CADTH = Canadian Agency for Drugs and Technologies in Health; pCODR = pan-Canadian Oncology Drug Review; pCPA = pan-Canadian Pharmaceutical Alliance; CAPCA = Canadian Association of Provincial Cancer Agencies; CDIAC = Cancer Drug Implementation Advisory Committee.

The evolution of the latter component (that is, the public funding reviews) has been defined by a number of milestones since 2006 (Figure 2). The interim Joint Oncology Drug Review and its successor, the pan-Canadian Oncology Drug Review (pcodr), were established in 2007 and 2011 respectively to provide greater consistency and transparency in oncology drug reviews1. In April 2014, the pcodr was transferred to the Canadian Agency for Drugs and Technologies in Health to “consolidate policy direction across Canada’s drug review programs, and to strengthen the pcodr governance structure for long-term viability and sustainability”2.

 


 

FIGURE 2 Oncology drug review process milestones in Canada. iJODR = Interim Joint Oncology Drug Review; pCODR = pan-Canadian Oncology Drug Review; CPAC = Canadian Partnership Against Cancer; CADTH = Canadian Agency for Drugs and Technologies in Health; pCPA = pan-Canadian Pharmaceutical Alliance; CDIAC = Cancer Drug Implementation Advisory Committee.

Concurrently, the pan-Canadian Pharmaceutical Alliance (pcpa), formerly the Pan-Canadian Pricing Alliance, was established in August 20103. The pcpa is currently tasked with conducting joint provincial–territorial price negotiations to combine provincial negotiating power and to achieve greater value for publicly funded drug programs. More recently, the Cancer Drug Implementation Advisory Committee, a cornerstone of the Pan-Canadian Cancer Drug Funding Sustainability Initiative, was established in late 2016 to “provide advice, ideally before pcpa negotiations, about how new drugs can be integrated into existing treatment pathways and to achieve greater consistency in drug funding decisions across Canada”4.

The creation of those new bodies—that is, the pcodr, the pcpa, and the Cancer Drug Implementation Advisory Committee—provide an interprovincial platform to address various aspects of the cancer drug approvals process in Canada, including health technology assessments, price negotiations, and the effective integration of cancer drugs within existing treatment pathways. However, their creation also comes with uncertainties, including concerns about whether the multiple processes delay access to new, potentially life-saving, treatments.

Overall, the timeliness of the oncology drug review process for public funding could be affected by either or both of the time to approval (tta) at Health Canada [that is, the time between manufacturer submission and a Notice of Compliance (noc) being issued], and the time to listing (ttl) by provincial public plans [that is, the time from the Health Canada noc being issued to public formulary listing for each province, which includes the pcodr review, the pcpa negotiations, and provincial deliberations (Figure 1)].

In an earlier issue of Current Oncology, Samuel and Verma5 compared the ttas for 37 antineoplastic agents between the U.S. Food and Drug Administration (fda), the European Medicines Agency, and Health Canada. The tta was significantly shorter for the fda (6.9 months ± 2.8 months) than for the European Medicines Agency (14.2 months ± 3.6 months, p < 0.001) or for Health Canada (14.0 months ± 7.5 months, p < 0.001). The ttas for Health Canada and the European Medicines Agency were not significantly different (difference of 0.65 months, p = 0.89). Most notably, the primary reason for the speedier tta at the fda appeared to be their use of accelerated approval mechanisms, such as “rolling reviews” which permit data to be submitted for the review process as it is accumulated by the sponsor. However, the fda has a higher-than-expected rate of label revision, wherein guidance must be revised after drug approval, suggesting that the accelerated fda approval process might also come with greater risks.

In an article appearing in this issue of Current Oncology, Srikanthan et al.6 examine the effect of the pcodr on ttl (that is, the time from a noc being issued to drug funding) and provincial decision concordance. Using the Health Canada Drug Product Database, the investigators identified 88 new indications for cancer drugs (representing 51 unique cancer drugs) between January 2003 and May 2014, and they researched relevant drug funding dates and decisions in provincial formulary listings. They observed a significant overall decline in the ttl after implementation of the pcodr (median: 393 days vs. 522 days, p < 0.001) and an accompanying significant increase in interprovincial concordance for drug funding decisions (p = 0.002). Overall, those findings suggest a positive impact of the pcodr on both the timeliness of public funding and equitable access across Canada.

The timeliness of the oncology drug review process for public funding is a recognized priority. Indeed, pcodr works with stakeholders to ensure that initial recommendations are issued within 180 calendar days of the manufacturer’s submission being deemed complete7. Of 75 submissions to the pcodr since its inception (July 2011 to 31 March 2016), the median timeline for a pcodr review was 144 business days. Over its years of existence, the pcodr has implemented a number of mechanisms—including priority review, pre-noc reviews, and early conversion—to improve the timeliness of reviews.

The priority review (10 of 16 requests granted so far), which is based on specific clinical criteria, helps to advance consideration of the specific submission, but not the overall pcodr timeliness (that is, it affects only the order of reviews). The pre-noc option, which allows submissions to go to the pcodr before Health Canada’s noc is issued (approximately 63% of pcodr’s submissions are pre-noc), has been associated with fewer median business days elapsing from the noc to the notification to implement (86 days pre-noc vs. 201 days post-noc). The early conversion to final decision (with 17 submissions so far having benefited from early conversion) is a step in the pcodr process that allows for a review of the feedback on an initial recommendation to determine whether that recommendation is eligible for conversion to a final recommendation without reconsideration by the full committee.

The effect of the pcpa on the timeliness of drug reviews in Canada appears thus far to be favourable8; the effect of the most recently introduced Cancer Drug Implementation Advisory Committee is not yet fully appreciated. An abstract presentation by Millson and Zhang8 recently reported an overall net reduction in median national ttl since the initiation of pcpa (to 502 days from 706 days for oncology and non-oncology drugs combined, p < 0.0001). Most interestingly, the reduction was mostly attributable to reductions in historically “slow” provinces, suggesting that those provinces have preferentially benefited most from the collaborative negotiation. Conversely, pcpa negotiations have not resulted in the anticipated increase in listings, and differences in drug coverage continue to exist from province to province.

The timeliness of the oncology drug review process for public funding is a contentious issue9. Indeed, the foregoing findings highlight the tension between speedier access to potentially life-saving drugs and confidence that the drugs are effective, safe, and cost-effective. Delays in approval and funding can lead to loss of life for patients awaiting access to new treatments, but hasty approval can also lead to loss of life through unanticipated adverse effects or, indirectly, through an inefficient use of scarce health care resources. If a hasty review approves an ineffective or inefficient treatment, or a hasty negotiation arrives at a higher price than could otherwise have been achieved, potential health benefits will be lost. Striking that balance is challenging but essential for Canada’s independent drug funding processes.

CONFLICT OF INTEREST DISCLOSURES

We have read and understood Current Oncology’s policy on disclosing conflicts of interest, and we declare the following interests: TY has served as a member of the pcodr’s Expert Review Committee, and CS has served as a health economics reviewer for the pcodr. TY has participated in a number of pharmaceutical firm– sponsored advisory boards and consultant meetings involving health technology assessments. The views presented here are those of the authors and not those of either the pcodr or the Canadian Agency for Drugs and Technologies in Health.

AUTHOR AFFILIATIONS

*Department of Medicine, qeii Health Sciences Centre, and,
Faculty of Medicine, Dalhousie University, Halifax, NS;,
Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, U.K.;,
§School of Pharmacy, Dalhousie University, Halifax, NS..

REFERENCES

1. Hoch JS, Sabharwal M. Informing Canada’s cancer drug funding decisions with scientific evidence and patient perspectives: the pan-Canadian Oncology Drug Review. Curr Oncol 2013;20:121–4.
cross-ref  pubmed  pmc  

2. Canadian Agency for Drugs and Technologies in Health (cadth). About the pan-Canadian Oncology Drug Review (pCODR) [Web page]. Ottawa, ON: cadth; 2017. [Available at: https://www.cadth.ca/pcodr/about-pcodr; cited 14 July 2017]

3. Canada’s Premiers. Scope of pan-Canadian Pharmaceutical Alliance. Ottawa, ON: Council of the Federation Secretariat; n.d. [Available online at: http://www.pmprovincesterritoires.ca/phocadownload/pcpa/scope_of_pcpa_process_dec_2014.pdf; cited 14 July 2017]

4. Canadian Association of Provincial Cancer Agencies (capca). The Pan-Canadian Cancer Drug Funding Sustainability Initiative [Web page]. Toronto, ON: capca; 2017. [Available at: https://www.capca.ca/current-issues/the-pan-canadian-cancer-drug-funding-sustainability-initiative; cited 14 July 2017]

5. Samuel N, Verma S. Cross-comparison of cancer drug approvals at three international regulatory agencies. Curr Oncol 2016;23:e454–60.
cross-ref  pubmed  pmc  

6. Srikanthan A, Mai H, Penner N, et al. Impact of the pan-Canadian Oncology Drug Review on provincial concordance with respect to cancer drug funding decisions and time to funding. Curr Oncol 2017;24:295–301.

7. Canadian Agency for Drugs and Technologies in Health (cadth). CADTH pCODR Operational and Performance Metrics Report. Ottawa, ON: cadth; 2016. [Available online at: https://www.cadth.ca/sites/default/files/pcodr/pCODR-Performance-Metrics-Report-2016.pdf; cited 14 July 2017]

8. Millson B, Zhang Y. pcpa/cdr/pcodr changes and impact to market access in Canada [abstract]. Value Health 2016;19:A280.
cross-ref  

9. Skedgel C, Younis T. The politicization of oncology drug funding reviews in Canada. Curr Oncol 2016;23:139–43.
cross-ref  pubmed  pmc  


Correspondence to: Tallal Younis, QEII Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia B3H 2Y9. E-mail: tallal.younis@nshealth.ca

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Current Oncology, VOLUME 24, NUMBER 5, October 2017








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ISSN: 1198-0052 (Print) ISSN: 1718-7729 (Online)