Authored by Ana Lucia Padron, Consultant, The Pangaea Group

In a little over two decades, Patient Assistance Programs (PAPs) have helped patients gain access to medications they otherwise could not obtain or afford. These programs were initiated and paid for by the specialty biologics of the time, which led to the creation of the “Specialty Providers”. They offer a full range of patient services such as:

• Reimbursement Navigation
  • Submitting plan applications to public and private insurers
  • Investigating plan’s specificities
  • Special Authorization submissions
  • Advocacy with employers
• Financial Assistance
  • Full/partial copay and deductible support
• Compassionate Assistance
  • Free drug offered to patients with no access to private or public coverage
  • Post-study commitments
• Bridging Assistance
  • Free drug offered to patients for a specific period of time while they wait for coverage
• Clinical Support
  • Adherence Programs, Nursing Adverse Event Reporting
• 24/7 access to information to support compliance
• Shipment Coordination

PAPs originated in the US in the early 1990s to back up the launch of expensive biologics. Canada followed in 1992 with CARE line, a program that assisted patients navigate the public coverage formulary hurdles, private coverage refusals and special authorizations processes for INTRON A®, a drug manufactured by Schering-Plough Corporation. The success of this program encouraged other manufacturers to follow suit, leading to the proliferation of many companies specializing in these kinds of programs and services. Manufacturers understood that the patient assistance programs were a competitive necessity, as well as a way to facilitate access to drugs for patients.

Today, the market place continues to be challenged in the field of access and utilization. Restrictive formularies, approval delays, special authorization’s administrative processes, insurance plan caps, co-pays, managed care plans, etc., are examples of the hurdles every patient is having to endure from the moment he/she is diagnosed and prescribed a drug. PAPs models change depending on the type of product being marketed, patient demographics, modes of administration and the distribution channels for a given product.

These programs continue to help the patients and at the same time provide the much needed market access to the manufacturers. Yet, the over-coordination of the assistance is causing a great deal of aggravation and confusion to the patients and physicians alike. The present challenge lies within the excess and duplication of assistance and the frequency of the calls and correspondence patients receive from the different parties involved in the service offering. The sources range from doctor’s offices, hospitals, government payers, pharmacies, and service providers. The patients become confused and flustered by the burden of the over coordination within a system that is already inherently complex. Physicians are reporting cases of patients who prefer to drop the prescribed biologic – and perhaps more efficacious therapy – in exchange for tranquility.

Listed are the types of calls patients receive once they enroll in a PAP:

• The first call is to welcome the patient into the program and to confirm all the contact, clinical and reimbursement information
• If reimbursement has not been secured before or at the time of the first call, subsequent calls will follow to guide the patient until coverage – private or public – is secured
• Then another call will follow from the insurance company trying to substitute the expensive medication for a less expensive one
• Once the coverage is secured, other call/calls will follow to arrange shipment of the drug
• In Ontario, for example, the patient will also receive a call from the Ontario Biologic Association. In another province, the call might come from a similar organization

Additionally, should the patient fail the initial therapy, they would be exposed to the same process again to get access to subsequent therapies. It is also very important to note that in addition to these access hurdles, the patients must deal with their disease and all the implications that accompany it.

When looking to put together a PAP, manufacturers need to start shifting their thinking to find solutions to the duplication of these key services by seeking innovative approaches to the design of the programs. The PAP of the future should consider the patient and physician’s experience. Programs must meet the exact needs of the patients with laser light precision in order to take patient support to the next level. The ever-growing redundancy of overlapping initiatives has to be eliminated by taking into account the evolving elements in the world of specialty drugs. Elements like companion diagnostics (CDx) and managed care initiatives need to be integrated in order to avoid such redundancies.

The industry is willfully veering to a patient centric model. So, would a universal application to these PAPs be the solution for patient support? Let’s hope that not too far in the future it will be.

Developed with the Strategic Pathways approach, this recent report (December 2012), features a detailed look at British Columbia, Alberta, Ontario and Quebec’s breakdown of patients, money-flow and current therapeutic strategies in Oncology.

The table-of-contents from the Strategic Pathways Oncology Report, highlights what’s covered, including:

• Key facts about the therapeutic area (epidemiology, clinical research, approval process, etc.)
• Outlining the major health care organizations in the four provinces
• Current funding options for treatments

Download the Table of Contents here.

Supplementing the report is a tailored workshop led by Pangaea Director Christelle Fasano [link] focused on the specifics of your company’s current strategies, allowing for optimization and fine tuning for a more successful offering in the oncology market.

Strategic Pathways for Oncology is the perfect tool for existing companies in the oncology marketplace, as well as as training package for newcomers and market support roles.

Ready to have the Strategic Pathways Oncology report lead you to market success? Contact Christelle to get your copy and set up a workshop for your company.

Cord blood is a safer, less donor-risky alternative to using bone marrow or PBSC for unrelated transplants.

An increasing majority of all unrelated pediatric stem cell transplants in Canada are performed using cord blood, and they are being increasingly used on adult patients.

Currently, all cord blood units suppliced by “Canadian Blood Services::http://www.blood.ca/CentreApps/Internet/UW_V502_MainEngine.nsf/page/Home?OpenDocument for unrelated transplants are imported from international sources.

This is putting a strain on what is already a limited supply and driving import costs higher—currently at $42,000 per unit.

Canadians deserve a safe, consistent supply of cord blood to increase the success and accessibility of unrelated transplants. By centralizing the source of this blood, Canada leverages its ethnic diversity, not just for the benefits of its own citizens, but for the international community.

In turn, with such a source, Canada’s medical and scientific community will be stimulated into contributing to further stem cell research, translating our leading edge reserch into cellular therapies.

For these reasons, Pangaea is proudly supporting The Canadian Blood Services’ OneMatch Public Cord Blood Bank initiiative for the benefit of all Canadians.

Pangaea director Joe Knott is a Volunteer Campaign Cabinet for the Campaign For All Canadians, dedicated to working with Canada’s pharma community to raise money for the bank, both through its own donations, but through building continued awareness and developing fundraising campaings from within the industry.

If your organization would like to get involved, please contact Joe directly at jknott@pangaea-consultants.com.

Authored by Peggy Cleary, Associate Managing Director, The Pangaea Group and Helen Kalra, Associate Managing Director, The Pangaea Group

We’ve all heard of or participated in the development of an excellent strategic plan that has gone no further than the shelf to gather dust. In 1999, Fortune Magazine, published the article “Why CEOs Fail,” which stated that “70% of all strategies fail to achieve their desired results and 30% fail to achieve anything at all.” Things don’t seem to have changed much. Why is that? There are many possibilities from lack of focus, unfortunate market timing, competency gaps, and misaligned operations. A lengthy list could be compiled, but here are the main factors we have identified in our work:

• Lack of alignment and commitment at the senior level and throughout the organization*
• Not integrating strategy with day to day management of the business*
• Not having an explicit process to monitor implementation*

Alignment and Commitment

Alignment is an overused word, but it does capture what’s imperative to the successful implementation of strategy: absolute clarity and common understanding of strategic goals paired with the emotional commitment to make them happen. There are a number of dimensions to this:

1. Ensuring the senior team takes the time and makes the effort to collaboratively develop strategy. This entails meaningful sessions of give and take where all views are heard and considered and the best strategies for the business are developed. It means not leaving the room until there is consensus and commitment. Consensus is not unanimity, but it does mean most agree and the rest can live with it. The result is that everyone feels they can get behind the goals.#
2. Ensuring employees understand the strategic challenges the business faces and its concomitant strategic goals while having an opportunity to consider how they personally can contribute to the company’s achievement. This is the best way to obtain the critical buy-in, which ensures strategies are successfully achieved.#
3. This involves a lot of communication and is why each of our planning sessions includes the development of a communication plan: what will be communicated, to whom, by whom, how, and when.#
4. Inherent in the above is the need to tie function and individual performance objectives and compensation to strategic goals.#

Strategy and Day-to-day Business

There is a real challenge in balancing strategic priorities with the day-to-day demands of managing a business. Too often, we see senior teams so focused on short- term results that it is clear they will never achieve their long-term goals. All too soon, the patent cliff is here, or they’re in a new therapeutic area before the organization is ready, or business development opportunities have been missed, or new competitors are nipping at the heels of the business.

Strategic planning is as much about what you won’t do as it is about what you will do. No company has unlimited resources, and there are always tradeoffs. It is important to make those decisions explicitly and to ensure everyone understands what is being given up.

There is also the need to integrate strategic priorities with ongoing operational demands, which is where many companies get stalled. It requires specific focus, agreement and thoughtful planning, and a mindset that acknowledges that both dimensions are important and, therefore, both must be achieved. The plan needs to be a strategic filter to inform and influence all key decisions and actions. Progress on strategic priorities should be included in organization scorecard measures.

Monitoring Implementation

All of the above illustrate the need for a clear, explicit process for monitoring and reporting progress on strategies and their implementation. A series of monitoring meetings will provide a framework of accountability for strategic plan implementation, and it will ensure excellence in execution. The monitoring meetings should:

• Course correct strategies, if needed, based on shifts in the external environment*
• Keep implementation on track*
• Maintain focus and alignment*
• Facilitate effective communication*
• Address barriers to implementation and coordinate actions to handle them*
• Foster effective attitudes, behaviours, and high levels of commitment*
• Celebrate successes*

Get in touch with us for more information on this topic.

Originally published in Canadian Pharmaceutical Marketing November/ December 2012

How are Medical Science Liaisons (MSLs) being deployed, utilized and trained in Canada?

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About Pangaea

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Authored by Marc Lafoley, Director, The Pangaea Group

Since the first Subsequent Entry Biologic (SEB) was approved in Canada in 2009, developments within this new frontier have been continuous but modest. Several factors converged subsequent to this development, making the circumstances ripe for disruptive change.

Following the financial crisis of 2008, governments around the world have had to face difficult choices to avoid the collapse of financial markets and to stimulate economies. Keynesian theories were exercised around the globe and in Canada. In Canada, the federal and provincial governments executed monetary and fiscal policies to stimulate the economy at large. This entailed running large fiscal deficits that must now be reigned in.

As this occurred, health care spending continued to rise faster than GDP, and it continues to consume a larger portion of government and private sector budgets. This unabated growth is driven by several factors, including a growing and aging population, sedentary lifestyles, and a shift in the therapeutic mix to newer technologies, including more expensive specialty and biotechnology drugs.

In Canada, spending on prescription and nonprescription drugs in 2011 reached an estimated $32 billion, or $929 per person, but the rate of increase has significantly slowed down. It is estimated that $21 billion is spent on prescription medication and 2011 marked the first time in the last 30 years that the prescription dollar drug market had a negative growth rate. The drivers of this negative rate were the reduction in generic drug prices, loss of exclusivity for large molecules, and a slower uptake of new technologies (molecules and proteins). Despite this, the rate of consumption of medication continues to increase. The prescription growth rate has maintained a healthy growth of 4 to 5%. Healthy growth in the biopharmaceutical dollar market is expected to return in 2015.

Today, payers (public and private) are looking at ways to best manage drug spend. Biologics currently represent less than 20% of drug spending, but with more than 300 biotechnology products in late stage developments, biologic drug spending is forecast to represent one third of total drug expenditures. With many patents expired or expiring for the top 15 biologics (by dollar volume) in Canada, the introduction of SEBs may be one way to reign in the burgeoning biotechnology drug costs. With different regulatory governance and requirements surrounding biologics, the potential pathways to savings for biologics that currently exist for small molecules may not be applicable and will need to change.

The evolving regulatory environment

Health Canada, the European Medicines Agency (EMA), and the United States Food and Drug Administration (FDA) have all issued guidelines to provide an approval framework for SEBs. The level of detail from all three agencies differs, but one facet is universal: the requirement for clinical data before a marketing authorization is provided. In addition to clinical data, the route to approval will have challenges based on the principle that the manufacturing “process is the product.” It has been demonstrated that minor changes in the manufacturing process may lead to changes in efficacy, pharmacokinetics, and immunogenicity. Given this, each manufacturing change between the SEB and reference product will cause a “drift” between the products, leading one to ask:

1. How similar will SEBs and reference products be over time?
2. Can you safely switch and/or substitute between SEBs and reference products?
3. Can indications be extrapolated for SEBs?

The manufacturing component of biologics has already played a role in two cases that may define the future of SEBs. A Citizen’s petition filed by Abbott in April, 2012 regarding Humira states that manufacturing processes are proprietary and not all details are out- lined in patents and require a more complex regulatory process. In Canada, Amgen is alleging that one of their registered patents will be infringed if a product submitted by Teva is approved.

The channel and payer influencing choice

Regulations governing different channels (i.e. hospital versus retail) may influence brand choice versus SEB. Drug selection and dispensing at an institutional level will be determined by a different set of rules and regulations than those that impact a biologic dispensed at a retail level or specialty pharmacy. Strategy and tactics within each channel will be paramount to success for brands to maintain their share and for SEBs to gain share.

With the introduction of SEBs, the payer may play an increasingly important role in product choice and dispensing. With discounts estimated to be between 20 and 40%, using SEBs can lead to substantial savings for payers. The data that will be required by payers to support reimbursement decisions remains to be seen. However, the “Norwegian” experience demonstrated that legislative changes at a provincial level may be required to support changes in policy.

The “LUCENTIS/AVASTIN” situation may provide a barometer of how payers will treat the wide-spread introduction of SEBs. As reported On thestar.com, Ontario Health Minister Deb Matthews would be willing to consider listing AVASTIN on the Ontario Drug Benefit Formulary for off-label use. This would materialize in annual savings of $100 million dollars to the province. Such a move by Ontario may signal a willingness to adapt current policies that provide savings to the drug budget. The outcome of this situation may be a harbinger of things to come.

What does the future hold?

Many factors are converging that will influence the introduction and adoption of SEBs in Canada. The continuous changes in the health care landscape require constant monitoring of the environment for changes that may modify current assumptions and require tweaking of strategies and tactics. BioPharma must institute measures to successfully prepare and compete in this new paradigm.

Get in touch with us for more information on this topic.

Originally published in Canadian Pharmaceutical Marketing September/ October 2012

Authored by: Kristen Knott, Director,
 The Pangaea Group

Health care will be seeking new and innovative distribution techniques to deliver the more than 275 specialty products, including close to 100 orphan drugs, that are currently in late-stage development. Health care simply does not have enough resources to fund or deliver these new treatments. Change will have to occur in order to deliver these new treatments effectively and efficiently. Therefore, it should come as no surprise that specialty products will continue to challenge our current patient delivery model. Almost every Canadian pharmaceutical company is adding new therapeutic areas to their pipeline, many of which involve specialty, and in particular, oncology products.

As personalized medicines and ultra orphan drugs move from late stage development to commercial availability in Canada, pressures will dramatically increase from payers, trading partners, and patients. Manufacturers will need to examine current distribution options and devise reliable, sustainable, and consistent solutions that meet the complex needs of their patients. Specialty distributors, third party logistics providers (3PL), and wholesaler/retailers will need to strategically align themselves with industry to create these new services or risk being left behind. Manufacturers need to truly understand the evolving influence of the distribution channel on their future.

So why is it that so many brand leaders’ eyes glaze over when the topic of distribution is raised? Could it be that historically there has not been a pressing need to deeply understand the intricacies of distribution? The same may be said of operational leaders who historically manage a support function but are not strategically tuned in to the commercial business.

Operations will always need to focus on decreasing operational costs and increasing efficiencies in the company’s supply chain, while the commercial group will want to develop revenues and market share. There is no reason why the two functions should not work in a more aligned and integrated fashion to ultimately benefit the patient experience.

Does your company include operations in the corporate or brand strategic planning process? Is product flow discussed on a strategic level?

Ultimately, 2012 and 2013 will be the years when commercial leaders need to roll-up their sleeves and start identifying how distribution and patient delivery models will impact their commercial sales, in both the short- and long-term. Alternatives to current distribution models are rarely discussed within our industry. It isn’t easy to build or partner for solutions that we don’t even know we need. Who better to help with these discussions than operations? As companies continue to evolve, expand into new markets, and manufacture more complex molecules, it will be key for operations to have a more integrated relationship with the commercial group.

Do not worry if you don’t know that “controlled environment logistics” is the new term for cold chain, but do be aware that there appears to be a global trend towards supply chain executives making their way to the corner office. Now, more than ever, it is crucial that members of the executive suite start to strategically explore distribution options for their company’s future pipeline requirements.

Get in touch with us for more information on this topic.

Originally published in Canadian Pharmaceutical Marketing (CPM)/ June 2012

It’s no secret in the industry that Pangaea’s directors bring a wealth of knowledge spanning decades of experience in the Canadian pharmaceutical market place.

What you might not know is, with their individual experienced combined, the Pangaea team has successfully launched over 120 products in Canada.

Products launched were in hospital, primary care and specialty care segments covering a huge range of therapeutic classes including: diabetes, oncology, cardiology, mental health, respiratory, Parkinsons treatment, dermatology to name a few.

Many of the companies that have launched these products in Canada continue to be clients of Pangaea, their testimonials can be found around the site.

Find out how the skills and expertise of Pangaea’s team can help launch your product.

Authored by Bev Herczegh, Director, The Pangaea Group

Funding for cognitive pharmacy services got a welcome boost when Alberta, the first to implement expanded scope, finally announced its funding model effective July 2012.

Noteworthy in the Alberta model is the absence of a funding cap and the focus on payment for patient assessment as opposed to fee for service. Perhaps even more important is the fact that funding of pharmacist services is not dependent on savings from generic pricing savings. We’ll closely watch now to monitor how this change impacts the delivery of patient assessment services by pharmacists in Alberta. In this province, pharmacists may now undertake a comprehensive annual care plan- that’s a tall order with the potential to significantly impact outcomes and costs. Pharmacist will need support in this new work and measurement to illustrate value will be critical.

Therapeutic substitution is also in place in five provinces with funding in three. This is clearly potentially very significant depending on the degree to which pharmacists comfortably undertake professional autonomy and liability. On this particular front, it is possible that payors may become the most influential with pharmacists uniquely positioned between payor and patient at that critical point of decision.

In short order, pharmacists right across Canada will be refilling (continued care) and adapting prescriptions as a way to facilitate patient access to timely care. Injecting is already underway in BC, AB and NB, with BC restricted by the standards of practice to immunizations only. Expect to see Ontario pharmacists authorized to inject flu vaccines for fall 2012 as the regulations have now been posted for public consultation and are expected to pass through cabinet this September. Already approximately 600 Ontario pharmacists are trained to inject and two more training sessions have been added this summer. It is an OPA goal to have an injection trained pharmacist in every pharmacy by Dec 2013.

Of significance to all of these changes is that funding, while different in every province, is now in place in every province except Manitoba (no expanded scope yet) and PEI (expanded scope so far limited to continuing car and emergency supplies). Much of this funding has come into place in the past 12 to 18 months.

What does this mean for you?

• Physician as influencer in prescribing is being diluted
• Depending on your portfolio, you may need to consider how you can ensure appropriate product knowledge and positioning at the patient-facing pharmacist level
• Pharmacists always have been, and with expanded scope will even moreso, be the most trusted and accessible health care provider available to an increasingly engaged patient
• The devil is in the details on these new authorities with standards of practice spelling out the “rules” around who, when, how often, where and under what circumstances. Do your homework before getting too far with any plans to engage at this level

Regardless of how one views pharmacist prescribing and/or expanded scope, delivery of healthcare in the future will require expanded scope practice by pharmacists and other HCPs such as nurse practitioners and physicians assistants.

Other funded services are underway in some provinces such as minor ailment prescribing in SK and NS. More on this next time…

authored by Beverly Herczegh, RPh, BScPhm, Director, the Pangaea Group

Both Ontario and Québec are “catching up” to the rest of Canada with respect to the expanded scope of pharmacy practice. Work is underway in Ontario with the new registrar, Marshall Moleschi from British Columbia, and in Québec with new legislation on pharmacy practice just adopted. It is clear that the pace of change in pharmacy will persist through 2012.

Who is leading this change, and how will pharmacy practice/business look? Dispensing could be fully commoditized: a technical function with razor thin margins performed by regulated technicians and/or automation in community settings and central fill locations. Or traditional community pharmacy may survive supported by regulated technicians/automation for a more robust community-based primary care with the pharmacist at the right end of the counter (i.e., – not at the cash register). Perhaps a hybrid will emerge where some pharmacists assume strictly clinical roles, others are both clinicians and dispensers, and still others oversee dispensing centres. Those most comfortable in dispensing roles will be easily replaced. Some are nervous. Others are forging ahead into innovative clinical roles.

Significant obstacles to practice change remain an issue. These include:

• the established dispensing role of the pharmacist
• lack of standardization in professional process
• lack of perceived value of expanded pharmacist services
• lack of supporting technology
• the need to operationalize cognitive work in community pharmacies
• economics

As long as enough money is to be made dispensing pills, the shift to patient-centric practice is hindered, in other words “put on the back burner.”

In provinces where the business of pharmacy is still relatively healthy (i.e., Québec with 30 day filling and those where professional allowances (PAs) are unregulated) focus on expanded scope is not quite as sharp as in Ontario where the revenue from dispensing requires supplementation by funding for cognitive services. Does the business of pharmacy need to get out of the way of the profession?

While the economics of the business of pharmacy can hinder practice change, the economics of health care in Canada is a major driving force behind it. This is less about pharmacists working to their professional capacity and more about the financial need to provide health care to more patients more affordably. Inadequate revenue for dispensing is a fundamental driver to cognitive work where funding is implemented. The Blueprint for Pharmacy is a strong agent for change in this challenging journey. Professional collaboration is underway, albeit with some challenges, and ever so cautiously funding for cognitive functions is supporting change.

Is industry aware of the significance of these new pharmacy services? How should industry engage?

Should pharmacy seek a “fee for a service” model when other health care sectors are trying to escape that very model?

Should pharmacy seek fees for extending, prescribing, and therapeutic substitution, or should the profession pursue a fee strictly for patient assessment?

So many questions. A few things are certain: the role of the physician as prescriber is being diluted, not only by pharmacy but by nursing, midwifery, optometry, patients, and, most significantly, payers. Pharmacists remain the most accessible and most trusted of health care providers. So far, they are still the last touch point with the patient before they initiate a prescription. Are you engaged with this stakeholder?

Get in touch with us for more information on this topic.

Originally published in Canadian Pharmaceutical Marketing (CPM)/ February 2012