TELUS Talks Health. The drug pipeline paradigm shift Game-changing therapies: who pays? The new therapeutic paradigm. March 2016 Edition

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1 TELUS Talks Health The drug pipeline paradigm shift Game-changing therapies: who pays? March 2016 Edition Author, Luc Vilandré, Vice-President and General Manager, Health Benefits and Payment Solutions Scientific breakthroughs with pharmaceutical technologies are creating a new therapeutic paradigm that is as inspiring as it is disruptive to drug coverage sustainability. New speciality drugs can cure serious disease, reduce or eliminate very challenging symptoms or even extend life; but they come with a high price tag. This article examines the impact of this new therapeutic paradigm and underscores how a small and ever-shrinking proportion of claims is becoming responsible for an increase in benefit plan costs. This dynamic is placing urgent pressure on plan sponsors and, indeed, on the very sustainability of drug coverage in Canada overall. The new therapeutic paradigm Specialty drugs, including biologics and biosimilars, are fundamentally changing health outcomes for patients. For example, today s therapies for Hepatitis C can completely eradicate the condition in up to 95% of cases. Only a few short years ago, in 2012, this was true for only two-thirds of patients and prior to that for only 21%, leaving many exposed to severe liver complications, the need for a liver transplant, or even death. Equally inspiring is the promise of personalized medicine, which targets therapies based on an individual s genome and unique way of metabolizing certain drugs. As an illustrative example, a 67-year- old woman battling colon cancer learns that her tumor recurred and that conventional treatments will no longer be effective. Her condition is terminal. At the same time, the cancer research team sequences her tumor and discovers that it is over-producing a specific protein that can be controlled with an existing medication for high blood pressure. When the medication is prescribed, the cancer disappears. 1 Specialty drug approvals surpassing traditional drugs This is the beginning of a new era. For the first time, specialty drug approvals have surpassed traditional drugs and this trend will continue. In 2015, 22% of all drug approvals by Health Canada were for specialty drugs, including biologics and biosimilars. Today, 45-50% of drugs under Health Canada review over the next three years are biologic and more than 60% of the FDA s new drug approvals are expected to be for speciality drugs. 2 In addition, some of the new drugs in the pipeline now treat chronic conditions, such as high cholesterol, asthma, heart failure and migraines that are common to working-age Canadians. Yet, this new therapeutic paradigm comes with a high price-tag. Currently, this price is being shouldered squarely by employers who ultimately pay for their employees drug benefit coverage. The pipeline of high-cost speciality drugs is coming to market at a rapid pace and has redefined the economics so dramatically that the current business model underlying Canada s drug benefit ecosystem has no way to respond. As a result, the sustainability of drug benefit plans is at serious risk and Canadians are being denied access to life-saving therapies. One of the most pivotal questions to be answered is: Who pays? and it must be addressed in concert by government, private payors and plan sponsors. The sustainability of drug benefit plans is at serious risk and Canadians are being denied access to life-saving therapies.

2 Drug economy redefined In 2014, private sector expenditure on prescribed drugs was $16.7 billion, with $10.3 billion financed by private drug plans offered by employers and $6.4 billion out of pocket by Canadians. 3 Fast-forward to 2015 and the primary concern of private drug plan managers is the growing cost of specialty drugs. In 2015, a scant 0.55% of the claims represented a full 23% of plan costs. Only five years ago, in 2010, these drugs represented a somewhat smaller portion of claims submitted (0.37%) but only 13% of the costs. 4 The introduction of new therapies for Hepatitis C had a major, unplanned impact on many private drug plans and is seen as heralding what s to come. Since 2013, some reported that claims for all Hepatitis C drugs combined increased by 189% and spend increased by 424%. 5 The following diagram uses Hepatitis C treatments as an example demonstrating the cost impact faced by payors over the last six years. Hepatitis C monthly treatment time horizon 2,000 1,800 1,600 1,400 1,200 1, Distinct Claimants $ 14,000 $ 12,000 $ 10,000 $ 8,000 $ 6, JAN 2010 MAY 2010 SEP 2010 JAN 2011 MAY 2011 SEP 2011 JAN 2012 MAY 2012 SEP 2012 JAN 2013 $ 4,000 $ 2,000 Average cost per Claimants $ MAY 2013 SEP 2013 JAN 2014 MAY 2014 SEP 2014 JAN 2015 MAY 2015 SEP 2015 JAN 2016 [Source: TELUS data warehouse, March 2016] As the demand for specialty drugs continues to rise, employers are forced to make tough choices in what they will cover and to what extent. As a result, many Canadians will be faced with the choice of going without treatment or facing increased out-of-pocket expenses to obtain new and more effective drugs. Untapped economic trickle-down effect Another intriguing effect of the new drug economy is the removal of costs out of the public system. This happens in two ways. First, some treatments that were previously administered in hospital, and therefore paid for by public payors, now have new drug alternatives that can be taken at home. As a result, costs are shifting over to private payors. For example, malignant melanoma was traditionally treated in hospital using a chemotherapy drug called Dacarbazine. Today, a newer class of therapies, BRAF inhibitors, can be administered at home and extend survival from under 2 months to more than a year. 6 telushealth.com 2

3 Lack of access to life-changing therapies, whether due to drug coverage or drug availability, is a bitter pill to swallow, particularly in Canada, where access to healthcare is predominantly viewed as a universal right. Secondly, these new therapies are changing the resources needed to treat conditions. For example, new Hepatitis C specialty drugs cost approximately $80,000 per patient. While that price tag may seem high, consider the reduction in the number of liver transplants, hospital stays and ongoing medical care that would have been required for these patients before these new therapies were available. This trickle-down effect is very real, but remains unaccounted for within the fragmented health system. Because of our siloed approach to costs in the Canadian healthcare payor system, we are not calculating how much new therapies can save in hospitalization fees, medical professional fees, surgery. To illustrate, there are close to 400 liver transplants performed in Canada each year, many of them related to a Hepatitis diagnosis. Each transplant, according to a 2014 study, costs the Canadian healthcare system $89,000 and does not include the treatments and the cost of drugs prior to reaching the transplant decision. 7 Status quo creates unacceptable risk At the same time that an era of game-changing treatments is building momentum, the inability of the current system to forge new ways forward and adapt quickly is creating an era of haves and have nots. Those who can afford specialty drugs win, and those who cannot, sadly, will lose. 8 Haves and have-nots As observed recently in the Globe and Mail, this is placing many Canadians in a high-stakes game of hot potato with governments, drug makers, insurers and employers for the costly medications they need. The situation is expected to worsen as a growing number of Canadians seek promising new treatments not only for rare diseases, but also for late-stage cancers and chronic conditions, such as rheumatoid arthritis and high cholesterol. For those who cannot afford specialty drugs, or who are seeking treatments that are not available in Canada, the use of crowdfunding to cover medical expenses is a popular option. In 2015, GoFundMe raised $147 million across North America in its Medical, Illness & Healing section, making it one of the site s most popular categories. 9 Plan sponsors hesitant to disrupt plan members experience Plan sponsors need to find new ways to respond to the impact of specialty drugs on their plan costs. Yet, despite rising drug plan costs, many plan sponsors are hesitant to make drug plan changes as they do not wish to introduce pressure on their employees or create turmoil within their plan members experience. A recent TELUS Health survey revealed that in 2014, 70% of plan sponsors made no changes to their plan design. And the Sanofi Canada 2015 Healthcare Survey reports that less than 42% of employers plan to make changes to their plan design in the next 2 years, despite rising costs and 33% of plan sponsors do not have a program in place to respond to claims for higher-cost pharmaceuticals. Why is this? In some cases there are historical reasons to stay with an existing plan. After all, benefit plans play a key role in attracting and retaining employees and are an important part of overall compensation packages. Understandably, employers wish to avoid disrupting their plan members experience particularly without access to data-driven insights that can give them confidence that the changes they are making will have the impact they anticipate. Political and business courage Without question, big science is presenting equally significant requirements to recast the health benefit sector in a way that allows Canadians to fully leverage the therapeutic advances that are here today and that are soon to be introduced through the near-term drug pipeline. This needs to happen in a way that takes charge of the economic trickle-down effect and fairly distributes the cost impact across public and private systems. This is not an easy fix and will demand the political and business courage to do things differently and to do different things. What s needed is a better coordinated effort throughout the ecosystem informed by data, supported by technology and led by stakeholders What s needed is a better coordinated effort throughout the ecosystem informed by data, supported by technology and led by stakeholders from across the drug ecosystem. What are the game-changing innovations that will lead there? No single player holds the answer. Rather, different participants hold different pieces of the puzzle that will, in time, adjust business models to respond sustainably to the redefined drug economy. telushealth.com 3

4 Private payors are taking steps Many insurers are already innovating and leveraging approaches to better manage risk associated with rising drug costs. For example, existing mechanisms such as Preferred Pharmacy Networks (PPNs), Product Listing Agreements (PLAs) or drug insurance pooling are areas of increased focus that can help better manage costs. Some are providing incentives for clients that tailor their drug benefits to cover medication with proven treatment value as judged by data from independent physicians and pharmacists. Sun Life launched such a program in Others are using data analysis to launch programs to promote wellness. La Capitale s VIVA program goes one step further. Through data analysis the VIVA program allows the implementation of targeted wellness activities that have been identified as being of specific need within a given employer s workforce. La Capitale makes its program available to any Quebec-based company, regardless of whether they are La Capitale group insurance clients or not. 11 Green Shield Canada has taken another approach and re-envisioned its concept of wellness under the Change4Life initiative that uses advanced analytics based on the insights drawn from millions of extended health and drug claims to search out, find and offer help to plan members diagnosed with chronic disease. The program also reaches out proactively to plan members at the highest risk of developing one. 12 Others still are introducing more complex mechanisms. For example, Manulife s new DrugWatch assessment program evaluates new high-cost and high-volume medications, and applies a rigorous process to ensure they meet clinical effectiveness standards in relation to their expense. Repatha, a high-cholesterol medication approved by Health Canada in 2015, is the first new medication Manulife will evaluate. 13 Plan sponsors a return to basics and actionable information More and more employers will need to assess their plans with a holistic view that is based on business intelligence (BI). BI allows employers to make decisions based on data analysis that can help them understand the ROI implications of where to invest or scale back their plans. Harnessing analytics can also enable them to achieve new plan designs that evolve beyond generic drug plans and proactively target their top cost drivers chronic disease management and absenteeism. In the near-term, employers can return to basics and more aggressively leverage programs that are readily available. Step therapy, generic substitution, maximum allowable cost (MAC) pricing, pharmacy dispensing fee caps and prior authorization for specialty drugs are all examples proven to reduce drug plan costs with minimal disruption to plan member experience. Harnessing analytics can enable plan sponsors to achieve new plan designs that evolve beyond generic drug plans and proactively target their top cost drivers chronic disease management and absenteeism. telushealth.com 4

5 Furthermore, there is opportunity for employers to stem costs by investing in wellness and prevention. If 23% of plan costs are driven by less than 1% of claims, there is potential to impact the remaining 77% of costs that account for the vast majority of claims many of which are consumed by chronic disease, like type 2 diabetes. Prevention-related plan designs, combined with the ability to look at data and correlate disability and absenteeism to drug costs is a necessary shift that plan sponsors will need to embrace moving forward. Greater cooperation between public and private sectors The payor ecosystem is siloed not only among payors, providers and patients; but also across public and private sectors. While there is little clarity at a system level as to how to bridge these siloes, there are movements within the sector that indicate either a willingness to cooperate or a desire to work more closely together. For example, integration of private payor drug plans with provincial drug plans is becoming more commonplace and helps manage the increase in overall drug claims as well as ensuring plan members receive as much coverage as possible. In addition, with Canadians paying some of the highest prices in the world for prescription drugs, the provinces and territories have formed the Pan-Canadian Pharmaceutical Alliance, with the goal of negotiating better prices on both brand name and generic prescription drugs. To-date, the initiative has not been extended to include employer plans and individuals. New world; new mindset There is no question that the drug paradigm shift, and all of its implications, has created the need for a new way of thinking. Public and private stakeholders alike need to acknowledge the material change in the landscape that goes far beyond sustainability of the existing public healthcare system. Rather, it is also about preventing a society of healthcare haves and have nots and instead finding a collective way to ensure equitable access to the best of care for all Canadians. References 1 TELUS Talks Health, Personalization paradigm: what molecularly tailored medicine means, Dr. Brendan Byrne, October Medical Cost Trend: Behind the Numbers 2016, Health Research Institute, June 2015, PwC 3 CIHI Drug Spending (April 2015) 4 TELUS block of business 5 Green Shield. Follow The Script. Fall Roche media release, Roche receives EU approval of Cotellic for use in combination with Zelboraf in advanced melanoma, 25 November Mark C. Taylor, MD, MSc et al, Factors associated with the high cost of liver transplantation in adults; Can J Surg, vol. 45, no. 6, December Jacqueline Nelson, The high-stakes battle of medications, insurers and the government, Globe and Mail, July Helaine Olen, The DIY Safety Net, Slate, January Jacqueline Nelson, Sun Life to offer discount to companies that streamline drug benefits, Globe and Mail, October Richard Cloutier, Finance et investissement, March Green Shields Canada website 13 Benefits Canada, Manulife may deny reimbursement for some pricey drugs, September 25, 2016 telushealth.com 5