Pan-canadian oncology dRug Review

pcodr:changing the conversation about access to cancer drugs

On any given week, media headlines extoll the benefi ts of a new “breakthrough” cancer drug. For governments, they face the diffi cult task of deciding how best to allocate limited public resources and at the same time, ensure the sustainability of the health care system.

Prior to 2011, each province had its own process for evaluating and funding cancer drugs. This “patchwork” and often unpredictable approach made it diffi cult for patients and oncologists to fi nd out if a particular drug was currently under review in their province, or if it had been approved or turned down for coverage, and how the decision had been made.

Two years ago, in an effort to make the process more open, effi cient and consistent, the provinces and territories (except Québec which retains its own system) came together to create the pan-Canadian Oncology Drug Review, or pCODR. Based in Toronto, the pCODR’s mandate is to provide the provinces with the same set of evidence-based recommendations to guide their funding decisions.

Many have been affected by cancer, whether directly or through a loved one, a friend or a colleague. pCODR recognies the importance of its work and the process’s value to patients, governments and clinicians in evaluating cancer drugs using an evidence-based, rigorous and non-emotional approach.

The new process eliminates duplication by individual provinces and introduces a transparent, rigorous, consistent and collaborative approach that involves the input of patient advocacy groups, pharmaceutical companies, economists, ethicists and clinicians, and the provincial advisory group.

The establishment of a pan-Canadian process also provides a single entry point for pharmaceutical companies to have their oncology product evaluated for public funding.

The process begins when a pharmaceutical manufacturer or a group of cancer experts in a particular area of cancer, called a tumour group, submits a new drug for review. The submitter provides required information about the drug including how well it works and its cost-effectiveness.

Once a submission has been accepted, pCODR draws from leading experts from across Canada to conduct the clinical and economic evaluation of the drug. Individuals who serve on the clinical guidance panel bring expertise in the type of cancer targeted by the drug whereas individuals on the economic guidance panel have experience in applied health technology assessment.

Drawing on reports from the two guidance panels, pCODR’s expert review commit-

tee (known as pERC) formulates an initial recommendation. In its deliberations before making a recommendation, the committee applies a deliberative framework that considers the clinical effectiveness of the drug, its costs, patient-based values and adoption feasibility.

An essential part of the process is hearing from those cancer patients who may be directly affected by a pCODR recommendation. Two patient representatives sit on the expert review committee to ensure that the patient voice is heard during its deliberations. Registered patient advocacy groups may also make a submission on a drug undergoing review. As of December 2013, close to 97 per cent of reviews have had patient input.

“By coming forward and stating that certain side effects are acceptable or that patients are willing to trade off uncertainty for a chance at prolonged survival, we have helped the review committee to understand what outcomes patients are looking for and this has infl uenced how they frame their analysis,” said Annette Cyr, chair of Canadian Cancer Action Network’s Drug Review Working Group.

All stakeholders that contributed at the start of the process for a specifi c drug or indication are invited to provide feedback on the initial recommendation before the fi nal recommendation is arrived at. Recommendations include a “green light” to fund the drug or consider to fund it only if certain conditions are met (e.g. dependent on better pricing of the drug) or not to fund it.

In keeping with its commitment to transparency, pCODR posts the status of each review on its website and explains the rationale behind its recommendations. Changes to timelines for a specifi c review (a need to gather additional information, for example) are noted on the site, along with the reason for the change.

“Based on my experiences with pCODR, it’s clear that there’s a real level of respect and a commitment to collaborate openly with pharmaceutical companies throughout the review process, particularly during the ‘check-point’ meetings,” said Farzad Ali, director of Health Economics Outcome Research, Pfi zer Canada. “At the end of the process, we may not always agree with the fi nal recommendation. But we agree with how the decision was reached so there’s strong buy-in on the process.”

The whole process takes about fi ve to eight months but in exceptional cases, it may take longer. To have more timely recommen-

FAST FACTS: as of decemBeR, 2013, PcodR has

Accepted 35 submissions for review. Issued 29 fi nal recommendations,which several provinces and territories have already made their funding decisions.

Received patient input for 97% of reviews.

Reviews are targeted for completion within 99-149 days; review timelines met the 150-day average objective.

pCODR permits a drug manufacturer the option to submit a cancer drug to pCODR while Health Canada is determining whether or not the drug can be sold in Canada (i.e., pre-NOC submission). The option of this parallel process means that the provinces and territories will receive a pCODR recommendation more quickly than if they waited until Health Canada authorized sale of the drug; if Health Canada does not authorize the sale, pCODR will stop the review. As of December 2013, 54% of submissions were made pre-NOC versus 46% for post-market approval

It is important to note that review timelines for pre-NOC submissions are much shorter than post-NOC submissions from the date of receiving the notice of compliance to the date of notifi cation to implement. Submissions made pre-NOC ranged between 49-127 days and submissions made post-market ranged from 143-824 days.

dations, pCODR encourages manufacturers to submit a drug for review before Health Canada approves it for sale; about half of the submissions are made before such approval is granted.

Once pCODR issues a fi nal recommendation on a particular drug, it is up to each province to decide if they should fund it. This funding decision is not taken lightly and provinces must consider several factors aside from pCODR’s recommendations, including its budget, its political priorities and the patient population. Provincial funding decisions are reported monthly on the pCODR site so that patients, patient advocacy groups and others can keep track. pCODR has also produced How Cancer Drug Funding Decisions are Made, a tutorial available for download at www.pcodr.ca and www.cancerview.ca/cancerdrugfunding. A collaboration between pCODR and the Canadian Partnership Against Cancer, the tutorial explains how public funding decisions are made, which groups are involved in the process, how new drugs are evaluated, how health benefi ts, costs and values play into the decision, and how individuals might participate in decision-making panels.

Looking ahead, I hope that pCODR’s review process, which is centered on a commitment to transparency and bringing greater clarity on the cancer drug review process, will serve as a model for other countries. Patients deserve to know why a particular cancer drug was or was not recommended and the rationale behind a funding decision and I believe that pCODR is raising the bar for all agencies that are responsible for reviewing new drugs and technologies.

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