Oncology market access challenges in Canada

Innovative cancer drugs reimbursement is a significant issue for Canadian Healthcare professional and their cancer patients. As our market access month comes to a close and our oncology focus begins, Antoine Abugaber discusses how this growing concern will increase in the future, with new personalized treatments options.

The medical need to have new innovative drugs available to patients had Health Canada to facilitate early approval under the Priority Review process from 18–24 months to about 6 months, advantaging patients with new innovative treatments.

"As new and innovative oncology drugs are made available on the market, their cost also becomes significantly higher."

Next to the Hospital cost, drug cost is the next highest of the total Healthcare budget. As new and innovative oncology drugs are made available on the market, their cost also becomes significantly higher. In view of the growing cost containment from Provincial Government Payers, it has become more and more challenging to get reimbursement for these new medications and often delays for reimbursement may take from 6–24 months if not more, thus negating the patient advantage gained in earlier drug approval.

The review of the clinical, and pharmaco-economic evidence are an important component of the market access process, while reimbursement decisions should be made on evidence based medicine (EBM) and cost-effectiveness analysis (CEA), they also have to ensure timely access to urgently required treatments, as delays in initiating therapy have been associated with negative health outcomes. Unfortunately administrators and payers are not made accountable to ensure that appropriate reimbursement is approved in a timely manner.

We still observe some reimbursement restrictions across Provinces, creating inconsistencies of care, inequalities, which can lead to untoward consequences for vulnerable groups (seniors, social assistance recipients, fixed income). These inequities defy the guiding principles, that all Canadians should have similar access to health care benefits. Today, treatment options as a cancer patient in Canada are still better in the west and worst as you head east.

"Today, treatment options as a cancer patient in Canada are still better in the west and worst as you head east."

The Provincial budgets are unlikely to grow, and surely not at the same rate as that of drug cost. These financial restrictions, are forcing Payers to reimburse for priority drugs treatments that have shown a significant longer survival improvement in a certain patient group. The biggest challenge to healthcare providers is access to innovative cancer therapies for their cancer patients. The treating oncologist and healthcare providers are tired of navigating the complex reimbursement system wasting significant time, and resources to provide their patients with best cancer treatment option.

Currently, Payers adjudicate and restrict cancer medications further to cover only patients who met explicit inclusion / exclusion criteria, as defined in the registration trials and not necessarily aligned with Health Canada's approved label indication. These cumbersome processes have driven some Healthcare providers to practice "drug access Medicine" instead of "evidence based Medicine" for some of their vulnerable patients groups. As a consequence, Canada is perceived as part of the worst Countries to reimburse and treat cancer patients with innovative new drugs, when compared to emerging and less rich countries.

By 2020, thanks to DNA sequencing, the potential for significant improvement in cancer treatments will come but at a hefty price tag. As novel therapies will be focusing on targeting abnormalities found in individual patients, we will experience more and more a personalized treatment approach for each cancer patient. The payers will have to plan now, for the future of healthcare delivery systems, equity, and the financial mechanisms that underpin them. It is clear that upcoming innovation will inevitably bring further inequalities to health should current process status quo remains.

"Canada is perceived as part of the worst Countries to reimburse and treat cancer patients with innovative new drugs, when compared to emerging and less rich countries."

Some current options to consider for the Pharma and Payers:

• Pharma will need to plan now, to obtain better access, that their registration Phase III clinical trials includes a broader inclusion criteria and less exclusion criteria for patients. These same criteria are likely the chosen ones to become the ones limiting their drug reimbursement, and impacting their sales forecasts.

• Payers may want to re-distribute drug portfolio allocation for non-essential medications currently paid to the general population and shift those same funds for priority cancer treatments instead.

• Government decisions must be transparent and equitable, with consistency across jurisdictions in terms of which drugs are covered, for which indication(s), and for what duration, and therapies required urgently should be made available.

• Measure the economic, clinical and human impact, data resources utilization through electronic data captures, could facilitate on-going monitoring measuring the impact of decisions and accountability.

• Create / increase a pre-approved list of oncologists that would have access to adjudicate and prescribe certain expensive drug for reimbursement, leaving the decision making within the medical profession.

There are no simple solutions to sort this growing cancer patient access to innovative cancer drugs. Perhaps the implementation of some of these options may allow a greater number of Canadians to receive optimal treatment at an affordable cost, until we find a solution, as personalized cancer treatment will become the treatment of the future.

About the author:

Antoine held several important strategic positions in several Multinational Pharmaceutical companies.

While in the Medical Department in large Pharma he held the positions of; Director of Clinical Operations, International Clinical Research and Development, Medical Research Scientist, and also as VP of an Oncology Division. During his career he directed and contributed to the activities of over 125 Canadian and international multi-center (Phase I-IIIb) clinical trials and pre-clinical projects, resulting in the introduction of several new cancer drugs and indications. He has also contributed to several Investigational New Drug (IND) submissions dossier evaluations to Health Authorities, identifying potential registration issues and developed regulatory submission strategies and obtained early drug approval. He is an affiliate Member of the American Society of Clinical Oncology (ASCO), the European Society of Medical Oncology (ESMO) and has written and co-authored several articles and Abstracts published in Medical/Scientific Journals. His oncology disease sites expertise includes: Breast, Prostate, Colorectal, Leukemia (CML, CLL, NHL, AML), Lung, Liver, Ovarian, Renal and several others.

As Director of the Prescription Drug Program and Medicare at the Department Health & Wellness, at the Government in the Province of New Brunswick (NB), he provided Direction and Guidance to Elected Premier and Minister of Health, on all issues relating to Prescription Drug Program (PDP) / Medicare while ensuring that entitled health services provided by thousands of physicians, pharmacists were accessible to the population.

He can be reached on LinkedIn: http://www.linkedin.com/pub/antoine-abugaber/0/770/284 or by e-mail: antoine.abugaber@sympatico.ca

How can we improve access to innovative cancer treatments in Canada?