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AN OPEN LETTER TO CANADA’S hEALTh MINISTERS REGARDING RARE DISEASE DRUGS
An Open Letter tO CAnAdA’s HeALtH Ministers re: rAre diseAse drugs
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This is an open letter to all of the Heath Ministers in Canada from the Canadian Organization for Rare Disorders, presenting a simple and elegant solution to providing appropriate, timely, and sustainable access to therapies for rare disease patients and other targeted patient subgroups living with more common conditions.
Innovative therapies, including drugs for rare diseases, have been much maligned as threats to affordable drug coverage, but they may actually provide the solution to the ultimate goal of “the right drug to the right patient at the right time and at the right scribe the right medicine and correct dosage would make their best guess (based on clinical guidelines), observe the outcomes, and adjust accordingly, or change therapies. This is not a “common” pattern for rare diseases drugs, in part because knowledge about the disease, the therapy, and patient outcomes may be very limited, and there are few, if any, alternative therapies. In other cases, a “trial-and-error” approach (such as the “double-blind randomized controlled clinical trial”) is neither appropriate nor likely to yield illuminating results, since the therapy is designed specifically to address the “cause” of the condition, often a genetic abnormality, and the treatment (replacing a missing enzyme or blocking gene expression) almost always works. This latter scenario also defines “targeted” therapies (aka precision or personalized medicines) that are developed for subtypes of common conditions, often defined by specific genetic abnormalities (for example, gene mutations, changes in the DNA, and over-expression or under-expression of a gene). Again, once the patient is correctly diagnosed through the appropriate genetic and/or other tests, the therapy should work.
What may not be certain is whether all patients with the genetic abnormality require therapy, the optimal time for starting therapy, the potential complications of comorbidities, and the patient preference in considering the benefits versus risks.
A key barrier to optimizing appropriate and timely access is the lack of certainty around “real world” effectiveness, safety and patient timing due, in large part, to small and often short clinical trials. These are, after all, small patient populations often
price.” In order to use these “small patient population” therapies effectively and costeffectively, we need to evolve responsive and responsible pathways to manage their use. It is given that not all drugs work for all individuals. It is equally true that some drugs, albeit listed as “open access” on formularies, have demonstrated “more benefits than harms for only slightly more than 50 per cent of the persons tested.” So, for many common conditions, nearly half of patients may be prescribed a therapy that is individually suboptimal. Which, of course, is also not cost-effective.
Traditionally, clinicians wishing to pre-
with life-threatening or serious conditions and no other viable treatments where the goal has been to make therapies available, to the broader patient community, as soon as possible. Unfortunately, the short clinical trials, often using surrogate markers and a very narrowly defined sample to optimize results, is often the bane of the health technology assessors and payers, who are looking for certainty in clinical outcomes, changes in disease status, and/or additional “life years”, preferably high-quality ones. This conundrum is a universal challenge, and various jurisdictions, including Canada, have evolved a variety of solutions. So what is the elegant solution that CORD proposes? In 2014, CORD called for a “managed access” approach to drugs for rare diseases that would address both the urgent unmet needs of patients and the uncertainty of effectiveness and safety of drugs tested with small patient populations. In reality, managed access schemes, defined as “an approach to providing access to drugs by setting criteria (based on evidence) for starting (such as, disease status, symptoms, previous treatments, co-morbidities, or age), how patients should be monitored while on therapy, and criteria that would indicate the therapy needs to be changed or the patient transitioned to something else” have been used to introduce rare and targeted therapies for a number of years. For example, managed access schemes (aka as managed entry agreements, coverage with evidence development, or risk sharing schemes) underlie the Canadian Fabry Disease Initiative, Ontario’s Drugs for Rare Diseases framework, Cancer Care Ontario’s Evidence Building Program, and the first Federal/Provincial/Territorial “Expensive Drugs for Rare Diseases” proposal in 2008 as part of the National Pharmaceutical Strategy. Currently, a limiting factor to MAS is the “disconnect” between the regulatory review (Health Canada) and all of the review processes (Common Drug Review, panCanadian Oncology Drug Review, Institut national d’excellence en santé et en services sociaux (INESSS), provincial drug reviews, and panCanadian Pharmaceutical Alliance) used to reach a decision whether to reimburse, or not. Similarly, the requirements for data and patient monitoring prior to allowing drugs on the market are mostly nonexistent once the drugs are in general use. The disconnect is driven partly by divergent aspirations: for patients and clinicians, the desire to access therapies matched to individual profiles, offering better efficacy and safety; for developers, managing the complexities and cost of proving targeted therapies for small patient populations; for payers, deciding value for money when drugs are very expensive and evidence highly uncertainly against traditional assessment methods. But that pattern is changing.
Canada’s imminent implementation of the Orphan Drug Regulatory Framework, premised on a lifecycle approach to drug approval, offers the opportunity to adopt a continuous evaluation approach that engages all stakeholders, including patients, reviewers, and payers, from the very beginning to define the “value proposition.” The collective goal is to define the desired outcomes from the each stakeholder’s perspective, set up mechanisms to assure the evidence is collected and analyzed, and to make evolving decisions accordingly (for example, update the guidelines, increase monitoring, liberalize access, or call for changes to the price).
In Europe, countries like Italy and Spain have been using managed access schemes, not exclusively for rare disease drugs, for many years. There have also been pilots in the UK and the Netherlands. In 2014, the European Medicines Agency announced the first set of drugs to be considered under its pilot “adaptive licensing” project, seeking “to examine whether iterative, ‘adaptive’ approaches to medicine development and authorisation offer advantages in terms of achieving the best balance between the need for timely patient access with the importance of providing adequate, evolving information on a medicine’s benefits and risks.” As importantly, the project calls for early engagement of the HTA bodies (under the umbrella of the European Network of HTA, or EUNetHTA), the payers, and the patient organizations to determine the evidence that needs to be generated as well as the “hurdles” to data collection.
Even in the U.S., where access and pricing have traditionally been negotiated through market forces, policy makers, publicly administered drug plans, and insurers are looking at a managed “health economics and outcomes research” (HEOR) approach to the reimbursement of precision medicines “when the clinical and/or economic value proposition for the broader patient populations is unfavorable, unclear, or unexceptional” as they seek to “limit coverage of such therapies to subpopulations most likely to benefit.”
In Canada, the challenges of implementing managed access schemes have been (successfully) addressed with many of the rare disease drugs currently in use. Rare disease clinics and specialty pharmacies have established patient registries (collecting natural history data along with drug utilization and other patient outcomes) and providing on-going monitoring and assessment, often updating clinical practice guidelines in the process. While recognizing the need for internationally linked MAS and patient registries, as well as international evaluation of outcomes, we suggest that Canada, at this time, take a bold step in implementing MAS as a standard strategy for “innovative targeted therapies.” The opportunity comes from Canada’s Orphan Drug Regulatory Framework (developed and soon to be implemented) and the recently announced Provincial and Territorial Health Ministers’ working group on “evidence-based approaches” to managing rare disease drug therapies. We urge the Working Group to set up pilot MAS projects with rare disease therapies currently seeking reimbursement to develop recommendations based on experience with real drugs and real patients. The Canadian Organization for Rare Diseases has asked that CORD be invited as a member of the working group to ensure the pilots and deliberations are directly informed by patient perspectives. We definitely can afford rare disease drugs. We cannot afford not to make them available. We just need to do right.
To see this story online visit http://biotechnologyfocus.ca/ open-letter-canadas-healthministers-regarding-rare-disease-drugs
By Noel Courage,
Bereskin & Parr LLP
ExpErimEnting Without infringing patEnts
Canada’s patent laws have a “safe harbour” exemption from patent infringement (s. 55.2(1) of the Canadian Patent Act). The safe harbour applies to activities reasonably related to generation of information for a regulatory agency, such as Health Canada or the U.S. FDA. The Canadian safe harbour is based on a similar provision in U.S. law, but the Canadian law’s wording is broader -- it is not limited to drug approval but could also apply to other types of regulatory approvals. There is also a common law exception to patent infringement which is created in court decisions, not statutes passed by the government. The common law exception is narrow, for example permitting testing of an invention merely to see if it works. The narrow scope of this common law exemption was part of the reason for enacting the broader safe harbor.
Most of the recent court decisions were in the pharmaceutical industry. A leading Canadian decision, Merck et al. v. Apotex ([2006] FCA 323, Federal Court of Appeal), was made in the context of generic drug development. In the Merck case, the Canadian Court held that Apotex prepared and tested the patented Lisinopril drug for the purposes of filing abbreviated new drug submissions necessary to sell lisinopril in Canada and the United States. Not all lisinopril data was referenced in Apotex’s submissions, but all data was directed to that purpose. Apotex also had stored samples in the event that they were required for future reference by the government. The Court concluded that the safe harbor was sufficiently broad to exempt these generic drug development activities from infringement. The safe-harbour can protect activities reasonably related to development and submission of information required by law, either before or after market approval. The Court also found that Apotex’s use of lisinopril in ongoing research and development of alternate formulations and alternate techniques for tablet-making fell within the common law exemption to infringement. This was because Apotex did not proceed beyond an experimental (testing) phase and were not take as steps to manufacture, promote and sell the product. The safe harbour may not apply if the drug samples used for regulatory purposes are commercialized subsequent to their use for regulatory purposes. It is important to carefully keep records evidencing the regulatory purpose. In Apotex Inc. v. Sanofi-Aventis, 2013 FCA 186, since the generic company could not produce records showing the destruction of the disputed lots of drug clopidogrel, it was concluded that it had not demonstrated that the experimental and regulatory use exemption applied to those lots. Therefore, as a best practice, unused drug originally obtained for regulatory purposes should later be either producible or destroyed in a documented manner. This better practice was shown in a subsequent case, Teva Canada Ltd. and Apotex v. Novartis AG, 2013 FC 141. Apotex had carefully prepared evidence to account for all its test imatinib, and provided an undertaking to the Court that whatever is left over after the regulatory process is completed will be destroyed. In that case, the leftover material was not covered by the safe harbour, but could nonetheless be retained subject to the undertaking that it will be destroyed after reaching its expiry date. There has not yet been a Canadian case in the context of innovative drug development (competing innovative companies), or use of a patented research tool, so there is still some uncertainty as to how the safe harbor applies in those situations. The safe harbor should have some applicability to the innovative drug development context because it was recently considered to be potentially available in the context of a mechanical device case involving two innovative competitors developing helicopter landing gear (Eurocopter v. Bell Helicopter Textron Canada Ltée, 2012 FC 113, aff’d 2013 FCA 219).
The Canadian safe harbour provides a useful tool for companies intending to do development for regulatory-related purposes in Canada. The boundaries of the infringement exception must be kept in mind, since any non-regulatory development, or change in character to commercial use risks infringement.
Searching for PROOF of
By Bruce McManus
Are diseases burdens or opportunities?
We are all too aware of the immense global burden of heart, lung and kidney failure, and the challenges they pose to communities, health systems, care providers, and patients and families. The impact of ischemic heart disease alone outstrips all other socioeconomic burdens in health, while not including diseases of the valves, cardiomyopathies, and developmental abnormalities. Chronic obstructive pulmonary disease, third in the world as a cause of death, is now second in the U.S. Other common conditions like asthma, pneumonias and various forms of environmental lung disease still plague people of our planet. The epidemic of dysmetabolism and obesity that now enwraps almost all societies is associated with a progressive frequency of renal disease and failure. Old-age associated dementias, ischemic brain diseases and cognitive impairment evoke fear for patients and great concern by architects of health care for the emerging 21st century.
Many of the risks and illnesses we face are termed “chronic” diseases. They do cast a shadow on health for years and in many instances for nearly a lifetime. Indeed, the roots of these “organ-based” conditions reside in the prenatal and perinatal periods and then evolve under the influence of environments, behaviours and genes over a lifetime. Yet, these chronic diseases are punctuated by episodes of acuteness and precipitant decline which lead to urgent care utilization and to cost-centre incursions underlying our painfully bloated healthcare budgets.
The enormity of the challenges in healthcare delivery cannot be overstated, but neither can the opportunities to make changes that alter the cost curve while improving quality of care and patient experiences. Tools to identify people at risk with early disease, susceptible to rapid decline or unresponsiveness to various therapies are emerging. Better predictive, diagnostic and prognostic tests are now possible through the alignment and interrogation of multi-marker data sets that can represent the “system of health, risk or disease.” The PROOF Centre of Excellence resides at the eye of the storm in enabling a new era of laboratory medicine that supports better care for the many patients suffering from chronic diseases.
Can medicine really be more personal?
Personalized medicine shines before us like the Holy Grail. The term (or a poor variant like precision medicine) is used more and more – the right drug, for the right patient,
Person-sPecific Prevention and
care at the right time, in the right dose, at the right frequency – in a very pharmacotherapyconstrained context. However, there is much speculation on the promise of the molecular genetic approach alone to render widespread, person-specific prevention and care. The essential inclusion of high quality data and information regarding environmental influences (physical, ethnic, social, economic, educational, therapeutic, etc.) and behaviours (diet, physical activity, stress reduction, substance abuse, medication compliance, etc.) is often taken for granted or ignored in the rush to think about genes. Humans are not locked in cages, do not have standardized light-dark cycles, did not come from the same genetic stock, and have widely variant journeys that modify their gene expression, their regulatory systems and their responses to stimulation or injury. With these caveats, and while truly personalized medicine is currently less rather than more common, even in the most advanced societies, we are seeing great strides, especially in areas such as Dr. Dan Holmes and Grace van der Gugten of the St. Paul’s Hospital Clinical Laboratory work hand-inhand with the PROOF Centre team to validate new blood tests for clinical care.
biomarker development, pharmacogenomics, and oncogenomics—inching towards a more tailored approach to health care.
Personalized medicine will not be achieved in a basic laboratory, by a government, through a private corporation or as individuals alone. If there is anything we have learned on this first leg of the journey, it is that we must build on the potential of diverse teams, knowledge and resources to truly achieve anything of pervasive and lasting value. Humans and their societies are complex, so we know that the solutions will not be immediately simple in production or implementation. Tapping the value that resides in a full range of sectors has become a maxim for success. Others like Drs. Federica Raia and Mario Deng would say that we need to consider the entire interface between new technologies and human beings, what they define as Relational Medicine in order to be truly effective in an era when technology appears to dominate our lives as patients or caregivers.
What has the PROOF Centre learned that we bring to the table?
In the Centre of Excellence for Prevention of Organ Failure (PROOF Centre), teams are developing high-value biomarker-based blood tests for improved patient management, especially those with heart, lung or kidney failure. A world-leading analytics team in the PROOF Centre is harnessing the power of clinical, molecular and computational data and nuances to move laboratory medicine into a new dimension of impact for patients and their caregivers. Health economists are providing essential and rigorous guidance on questions of value and in the development of decision support tools that can help to assure better tests and make them more useful. Similarly, outcome collaborators are poised to assess the impact of new tests along the life cycle of organ failure on patients, their families, caregiving and the healthcare system itself.
PROOF Centre’s core strengths relate to critical guidance by expert clinicians regarding unmet needs in clinical management that could be addressed by a new generation of sensitive and specific blood tests. The multimarker tests are reflective molecular science of human biology and its systems, are generated by a layered data analytics strategy, and draw scientists, practitioners, and trainees to the challenge that extends across all disciplines, sectors and geographies. Together this team harnesses all relevant perspectives necessary to mature and implement new blood tests. Such tests are driven by the desire to prevent disease or catch it early in an accurate fashion, and to enable physicians and their teams, whether they practice in primary or quaternary care settings. Such a thrust is also influenced greatly by patient needs and comforts. Tools to accelerate and make drug discovery programs of the pharmaceutical industry more efficient are also front and centre. Thus, the development of companion diagnostics or providing support for more efficient drug development pipelines, including cohort enrichment and patient population stratification, are among our day-to-day objectives.
By brief examples, the team, in strong collaboration with physicians and scientists of Alberta Heart and Dr. Ignaszewski locally, is working on new tests to correctly and more quickly identify patients as having chronic heart failure than possible now without imaging at regional or quaternary centres. Such blood tests, as well as those to identify different subtypes of chronic heart failure and to monitor patients for recovery of heart function from drug therapy, will improve care. For acute heart failure patients, teams including Dr. Anson Cheung have identified biomarkers that predict outcomes such as survival and response to mechanical circulatory assist device therapy. These tools are expected to lead to better patient care through appropriate targeted therapies. With many collaborators, especially Dr. Don Sin, the PROOF Centre is also committed to develop new blood tests to manage COPD patients, hopefully reducing their need to access urgent care through early recognition of their individual risks of acute exacerbation (lung attacks). We are similarly intent on helping to forecast the rate of decline in lung function in COPD patients, which will improve patient management directly and in hastening drug development by industry.
In another example, the most advanced, the decade-mature Biomarkers in Transplantation program will render tests to be implemented at the St. Paul’s Hospital clinical laboratory for validation and real-time studies this year. This critical implementation step occurs through the expertise of Drs. Dan Holmes and Mari DeMarco, and with the collaboration of HTG Molecular Diagnostics, Inc. A majority of heart transplant patients could thereby ultimately forego the need from so many invasive heart biopsies during the first year post-transplant.
The PROOF Centre currently has developed blood test content for more than 15 indications in acute and chronic heart failure, chronic obstructive lung disease, asthma, chronic kidney disease, and heart and kidney transplantation. They also have major biomarker collaborations related to spinal cord injury and muscular dystrophy.
It is worth emphasizing once again that each biomarker program begins with understanding patients and their pressing clinical needs. The team works to develop clinically relevant diagnostic, prognostic and monitoring tests for earlier diagnosis and more effective and patient-friendly care of patients as well as guidance tools for the pharmaceutical industry. Blood tests are
Dr. Raymond Ng, Chief Informatics Officer, PROOF Centre, and computational team use systems science tools and data analytics to develop new biomarker signatures as blood tests
tailored to maximize patient benefit while reducing healthcare costs. The diversity and depth of the team mirrors the degree of difficulty in getting across the goal line with products. It is easy to get to the “red zone” with partially validated biomarker solutions, but it requires everyone on the field to score the touchdown.
Why is the future all about systems?
From molecule to population, biomarker development, for whatever end purpose, demands a systems attitude. In fact, it is a systems within systems within systems within systems philosophy that is required. From DNA to protein, to metabolite, to cell, to tissue, to organ, to whole organism, to community, to health system – all must be under consideration. Then, the fine art is taking that complexity and reducing it to signatures that define or relate to patient phenotypes and physiology in precise and accurate ways for given risks and diseases. To achieve this complete view, we need to embrace new tools and technologies; we need to not only think of the gene for example, but also the epigene; we need to think about biological networks, social networks, linkages among medical disciplines, policy networks, engineering innovation, community designs, and as Dr. Mark FitzGerald would remind us, about “humanomics”, the artful core of health care. We need a truly systems approach to developing new, powerful solutions to improve health and meet, face on, the towering shadow of chronic diseases.
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led by those who achieve on the fly linkage of data sets in an ethics-enabling fashion. Whether the scale of personalized medicine initiatives underway in jurisdictions like the United Kingdom can be matched here will depend on whether we can master data, locally, nationally and internew card:Layout 1 1/31/2013 9:09 AM Page 1nationally. Fortunately, patients are well on their way to generating and immediately acting on their own data, recorded on wearable, mobile devices. Many will soon have their genomes and what such at their electronic fingertips. As data is democratized, we must be nimble or innovation will pass by bureaucratically hampered health sciences innovators like a roadrunner passes a stone.
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Bruce M. McManus MD, PhD, FRSC, FCAHS is a Professor, Department of Pathology and Laboratory Medicine, UBC, Co-Director, Institute for Heart + Lung Health, CEO, Centre of Excellence for Prevention of Organ Failure (PROOF Centre) and Board Member, Personalized Medicine Initiative (British Columbia). Email: bruce.mcmanus@hli.ubc.ca To see this story online visit www.biotechnologyfocus.ca/ searching-proof-person-specificprevention-care
Can BC and Canada harvest their great opportunity in personalization of care?
Personalized medicine requires collaboration. It especially requires enabling frameworks for data management. While there is understandable emphasis on “Big Data”, since there is SO much data within various resources, generated from such platforms as “Next Generation” sequencing technologies, yet there is simply a need to share data of all types and sizes in order for value to be realized in a timely fashion. We are fortunate in Canada to have many data resources of direct pertinence to the efforts to improve health care. A number of these resources are national in scope. In BC alone, we host expert clusters and rich data sources. The Ministries are home to immense and potentially useful resources. While there are tools like Privacy by Design, a made-in-Canada solution for the challenges of data access and linkage, these are cumbersome, slow and still shrouded in fear. The future of healthcare innovation will be
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FEBruarY 2015
February 25
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Bloom Burton & Co. Healthcare Investor Conference Venue: Toronto, ON Tel: 416-640-7580 Email: bbloom@bloomburton.com Web: www.bloomburton.com/conference
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Company & advertiser index
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6............................................................................................. www.merck.ca Mettler Toledo ............................................................................................ 28...................................................................................................ca.mt.com National Research Council of Canada .......................................................... 8..................................................................................... www.nrc-cnrc.gc.ca OncoGenex Pharmaceuticals Inc................................................................. 10.................................................................................www.oncogenex.com Panasonic ............................................................................................................5 ................................................. us.panasonic-healthcare.com/celliqseries POI Business Interiors 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