Best Practices: Pharmaceutical Market Access, Commercialization Canada, EU, US

The Path to Success

This article explores successful strategies for entering and accessing markets. I am focusing on notions which involve:

1). The alignment of clinical development plans with global value dossiers and planning for driving market excellence.

2). Market positioning, pricing strategies with market sequencing.

3). The distinct challenges associated with launching different types of pharmaceuticals across different markets when market pricing is changing.

Global positioning and a thorough framework for establishing price value is required to effectively choose and sequence markets before launch.

The pharmaceutical industry is a complicated space. The rules for market entry and getting a drug reimbursed through government reimbursement, 3rd party payers & insurance companies differs wildly between regions, nations, payers and markets.

If you're a pharmaceutical company executive, knowing the best practices in Canada, the European Union (EU), and the United States (US) is key to a successful product launch and ensuring the drug is reimbursed and market access is optimized through sales. If you don't get market access, you will not be doing any marketing except in the private payer market. The process of strategy and planning cannot be oversimplified or misaligned across functions.

Current changes in the industry and drug pricing norms with sanctions will determine how markets are sequenced. This will alter planning requirements around positioning the pharmaceutical drug for selective markets. Price value thresholds determine planning and sequencing of markets for launch excellence.

When launch excellence is not planned for effectively and the submission is not prepared with a systems thinking approach the pharmaceutical company risks being cornered into a bargaining position to negotiate price. This bargaining position and checkmate affects all global markets and patient access.

Nothing can be taken for granted in planning the launch of a new pharmaceutical drug whether it is a brand, a biosimilar or a generic. Understanding the difference between bargaining and negotiating is key for strategy, planning and execution in market access and driving commercial excellence.

Understanding Market Entry & Reimbursement

Entering the pharmaceutical market means navigating through regulations, clinical development plans, and reimbursement procedures. According to the National Institutes of Health (NIH), CADTH, GBA, INESSS it is essential for companies to align their clinical development plans with cost-effectiveness, clinical value & affordability. This up-front planning helps ensure new drugs meet not only safety and efficacy standards but also deliver tangible value to healthcare systems.

Failures in market access and commercialization barriers arise due to the lack of an integrated pathway that aligns all functions. Much of the work is carried out as separate tasks with deliverables without a systems thinking approach, leading to isolated value outputs. When the reimbursement dossier for market access is completed, it is often seen in fragmented parts that may not effectively convey a story enhancing the value proposition. Market positioning must be aligned. The entire dossier should be developed and understood with a systems thinking perspective to deliver the best package for market access and commercialization.

Optimum market access, pricing to drive revenue & healthcare value

"Begin with the end in mind."

Stephen Covey

The timeline for market entry is especially important in areas like oncology and rare diseases. These sectors can be time-consuming due to detailed clinical trials and safety evaluations. For example, oncology drugs may take up to 10 to 15 years to develop and gain approval, with costs often exceeding $2.6 billion. This reflects the extensive data required to prove their clinical benefits.

Regulatory Frameworks: Canada, EU, and US

In Canada, Health Canada is the body that regulates new pharmaceuticals. The Patented Medicine Prices Review Board (PMPRB), established in 1987, monitors drug prices to ensure they are not excessive. For example, a recent review found that a new cancer drug could not be priced above $5,000 monthly in order to maintain patient accessibility.

The Canadian Agency for Drugs and Technologies in Health (CADTH) assesses the clinical and cost-effectiveness of new medicines. This means that their recommendations influence negotiation strategies between pharmaceutical companies and provincial health authorities. Early access requires alignment between all bodies of decision-making pre-regulatory approval. If you lose 2-3 years of market access due to misaligned planning across functions, you are losing 3 or more years of revenue and patent life.

In the EU, the European Medicines Agency (EMA) oversees drug safety evaluations. However, each EU member state has its own pricing mechanisms. For instance, in Germany, new medications undergo an assessment process called the "AMNOG" that can delay market entry by an average of 6 to 12 months. Discrepancies can cause added hurdles for companies seeking to reach patients quickly.

In the US, the Food and Drug Administration (FDA) manages drug approvals, while the Centers for Medicare & Medicaid Services (CMS) handle reimbursement. With a landscape of numerous private insurers, reimbursement strategies can be quite fragmented, often resulting in pricing negotiations that take several months to conclude.

Launch Excellence Practices

Different types of pharmaceuticals have unique launch practices. For instance, biologics usually require extensive clinical data to show efficacy and safety. Their launch must include strong health economic outcomes research to justify their high prices, often ranging from $10,000 to over $100,000 annually per patient.

Premium-priced pharmaceuticals, especially in oncology and rare diseases, are also scrutinized. To illustrate, a recent drug that treats a rare genetic disorder was priced at $370,000 per year, requiring the companies to present solid justifications for the cost.

Biosimilars, which are more affordable alternatives to biologics, are gaining traction in Canada, showing an increase in market share of nearly 30% since their introduction. Companies looking to enter this market must understand not just the regulatory intricacies but also the competitive landscape. This includes developing an economics for the common good model in sales/negotiations, demonstrating bioequivalence and assessing gaps for patient support programs.

A modern pharmaceutical laboratory equipped with advanced technology.

Time to Reimbursement by Therapeutic Area

The timeline for reimbursement widely differs across therapeutic areas. For oncology drugs, it can take between 12 to 24 months for full reimbursement due to the need for in-depth clinical data and extensive cost-effectiveness analyses. Similarly, rare diseases are often complicated by their small patient populations, which can lead to difficulties in pricing negotiations. It has been my experience that when the strategy, positioning and planning for reimbursement is not done in the most effective ways there can be no access for up to 3-6 years or limited access.

In Canada, the decentralized system means each provincial health authority negotiates pricing individually in confidential agreements after the PMPRB determines the list price or maximum allowable price. For example, a recent cancer treatment was available in British Columbia after 9 months but took 14 months for approval in Ontario. Companies must engage proactively with provincial authorities to streamline the reimbursement process.

In the US, the landscape involves multiple negotiations, leading to varied timelines for reimbursement from private insurers versus government-funded programs. Understanding these nuances is vital for companies seeking efficient market entry. The private insurance market submission process is similar to the U.S. managed care approvals with different deliverables.

Future Planning for Biologics & Biosimilars

With the growing acceptance of biosimilars, pharmaceutical companies need to think strategically about their future pipelines. Recent studies indicate that biosimilar uptake could save the healthcare system up to $54 billion over the next decade in the US alone.

For premium-priced rare disease drugs and oncology medicines, companies should focus on developing solutions tailored to patient needs while demonstrating measurable value to healthcare systems. This can involve pilot programs or partnerships with patient advocacy organizations to better understand treatment requirements, burden of illness & patient support requirements.

A pharmaceutical research facility focused on innovative drug development.

Key Takeaways

Navigating the pharmaceutical industry's challenges in market entry, reimbursement, and commercialization requires understanding global best practices. Companies must align their clinical development plans with cost-effectiveness and affordability needs while addressing the specific obstacles posed by different therapeutic areas. The new U.S. drug pricing rules affect launch & market sequencing.

In Canada, PMPRB and CADTH play significant roles in ensuring accessibility and affordability of new drugs. In both the EU and US, grasping the regulatory and reimbursement frameworks is crucial for successful market entry. Canada has been very organized since the late '80's and serves as a benchmark for establishing the value of a price.

As the market evolves, pharmaceutical companies need to stay agile and responsive to change. By implementing best practices focused on demonstrating value, companies can enhance their market access strategies and contribute to better patient outcomes.

For additional insights on best practices in market entry and access, consider exploring the following resources:

• CADTH

• Institute for Clinical and Economic Review (ICER)

• GBA

• US Medicaid

• NICE U.K.

• NIH

References:

• Boylan, R.M. (2006-2009). Conflicts and considerations comparing Abraham Maslow's hierarchy of needs to Jane Loevinger's model of ego development for assessing the level of development of a leader. M.A. Leadership Studies (Master's)

• Brunsson, N. (2007). The consequences of decision-making. Oxford University Press.

• Cialdini, R.B. (1993). Influence: The Psychology of Persuasion. Harpers Collins

  Publishers.

• Cooper, D. F., & Chapman, C. B. (2005). Risk Management: A Project Management Approach. Taylor & Francis.

• Covey, S. The 7 Habits of Highly Effective People. (1989). Stephen Covey.

• Deutsch, M., Coleman, P.T. (2000). The Handbook of Conflict Resolution: Theory and Practice. Jossey-Bass Publishers.

• Fisher, R., Ury, W., & Patton, B. (2011). Getting to Yes: Negotiating Agreement Without Giving In. Penguin Books.

• French, J. R. P., & Raven, B. (1959). The bases of social power. In D. Cartwright

   (Ed.), Studies in Social Power (pp. 150-167). Ann Arbor: University of Michigan Press.

• Harvard Business Review. (2019). On Negotiation. Harvard Business Review Press

• Harvard Negotiation Project https://www.pon.harvard.edu/tag/the-harvard-negotiation-project/

• Hofstede, Geert. (2017). Culture’s Consequences: Comparing values, behaviours, institutions and organizations across nations. A MASCAT Analysis.

• Jung, C.G. (2002). Psychology of the Unconscious. Dodd, Mead & Company.

• Kruglanski, A. W., & Webster, D. M. (1996). Motivated closing of the mind: "Seizing" and "freezing." Psychological Review, 103(2), 263-283.

• Lewicki, R. J., Barry, B., & Saunders, D. M. (2015). Negotiation (7th ed.). McGraw-Hill Education.

• O’Connor, J. & Prior, R. (1995). Successful selling with NLP: Neuro-linguistic programming the way forward in the new bazaar. Harper Collins Publisher.

• Pritchard, C.L. (2001). Risk Management: Concepts and guidance Second edition. ESI International.

• Rackham, N. (1988). SPIN Selling. Situation, Problem, Implication, Need-Payoff. McGraw-Hill  Book Company.

• Raiffa, H. (2002). Negotiation Analysis: The Science and Art of Collaborative Decision Making. Harvard University Press.

• Raiffa, H. (1982). "The Art and Science of Negotiation." Harvard University Press.

• Raine, A. (2002). "Biosocial Studies of Antisocial and Violent Behavior." Journal of Abnormal Psychology, 111(1), 1-10.

• Ries, A. Trout, J. (1981). Positioning : The Battle for your mind. Werner Books.

• Salacuse, J.W. (2008). Seven secrets for negotiating with government: How to deal with local, state, national, or foreign governments and come out ahead. AMACOM

• Thompson, L. (2014). The Mind and Heart of the Negotiator (6th ed.). Pearson.

• Ury, W. (1993). Getting Past No: Negotiating Your Way from Confrontation to Cooperation. New York: Bantam Books.

• Weiss, J. (2016). Harvard Business Review Guide to. Negotiating: Take the Lead Manage Conflict Get to Yes. Harvard Business Review Press

• Bass, B. M., & Riggio, R. E. (2006). Transformational Leadership. Mahwah, NJ: Lawrence Erlbaum Associates.

• Dweck, C. S. (2006). Mindset: The New Psychology of Success. New York: Random House.

• Phelps, E. A. (2006). Emotion and cognition: Insights from studies of the human amygdala. Annual Review of Psychology, 57, 27-53.

• Prochaska, J. O., Norcross, J. C., & DiClemente, C. C. (1992). Changing for Good. New York: HarperCollins.

• Rackham, N. (1989). Major Account Sales Strategy. McGraw-Hill Inc.

• Cialdini, R.B. (2007). Influence: The Psychology of Persuasion. Collins Business.

• Trout, J. Ries, A. (1993). Positioning: The Battle for your mind. Marketing Warfare. Warner Books.

• Rackham, N. (1988). SPIN Selling: The best-validated sales method available today. Mcgraw-Hill Book Company.

• Fournies, F.F. (2000). Coaching for improved work performance. R. R. Donnely & Sons Company.

• Manz, C. C., & Sims, H. P. (1980). Self-Leadership: Toward an Expanded Theory of Leadership. The Academy of Management Review.

• Bass, B. M. (1985). Leadership and Performance Beyond Expectations. Free Press.

• Goleman, D. (1995). Emotional Intelligence: Why It Can Matter More Than IQ. Bantam Books.

• Northouse, P. G. (2018). Leadership: Theory and Practice (8th ed.). SAGE Publications.

• Robinson, S. P., & Judge, T. A. (2019). Organizational Behavior (18th ed.). Pearson.