Achieving launch excellence in oncology: adapting to new market realities

Dr. Simone Seiter and Maneesh Gupta

IMS Consulting Group

Biotechnology and pharmaceutical companies are paying a high price as the oncology market matures and access is increasingly restricted. Ironically, the scientific advances that are transforming the treatment of cancers and the prognosis for patients are presenting new and complex commercial challenges for marketers.

Achieving commercial success for an oncology launch is becoming increasingly more difficult. However, success can be realized provided you understand the new strategies and “rules of the game.”

A pressing need for answers

IMS Health expects that oncology will remain the top therapy area by share value in the world’s leading geographic markets through 2020. The industry’s collective pipeline is brimming with significant innovation, yet potential won’t materialize as easily as before. In many tumor areas, the market has evolved from one of high unmet need to one in which payers have several choices and are therefore imposing access restrictions. It’s clear the growth rate for oncology products is slowing.

Figure 1 Global Oncology Sales and Growth

Considering this moderating growth, IMS conducted an Oncology Launch Excellence Study to identify how excellent oncology launch preparations differ from preparations in other therapeutic areas. IMS found four drivers in oncology which marketers need to consider in a different way when thinking about launch excellence.

"It’s clear the growth rate for oncology products is slowing."

Driver #1: pursue an optimal indication sequencing strategy

Reaching “blockbuster” status ($1 billion in annual sales) with an oncology launch is becoming more difficult than ever before. Today, the first step to success is having the right indication sequencing strategy for optimal investment and maximum return. After Phase I, the available indication choices become clearer, as defined by the mode of action. Upon entering Phase II, companies need to start forming their sequencing strategy, which includes determining:

• How broad a therapeutic footprint they wish to pursue.

• Whether to go for market niche or more comprehensive approach.

• The sequence of indications that will work best over the full life-cycle of the drug.

• How the product can be differentiated and what clinical endpoints will be required.

• The level of financial commitment needed in each scenario and which risk needs to be hedged.

This must be evaluated within the context of the forecasted competitive intensity of the market and the size of the available population. Once a sequencing decision is made, companies can determine what tumor indications are worthy of advancing into Phase III. While large patient populations, historically, were the first area for investment, today companies must consider the payers' view of unmet need before selecting a path. IMS has found that this changes the “attractiveness” of a number of tumor types.

Optimizing clinical trials

The next hurdle is to ensure that the right endpoints are built into the clinical trial plan. The clinical trial endpoints that will hold sway with payers depend upon payer perceptions of the unmet need and the number of targeted therapies available to treat a tumor type.

Overall Survival

Measures of patients’ Overall Survival (OS) time gives payers the best grasp of a product’s value. Increasingly, payers require a demonstration of increased OS time. It may be difficult to present a compelling health economic argument without it, although the rise of additional and targeted therapies makes it harder to statistically prove this particular medical benefit.

"Reaching “blockbuster” status ($1 billion in annual sales) with an oncology launch is becoming more difficult than ever before."

Progression-free survival

Progression-Free Survival (PFS) statistics depend on the environment. In the European Union and Japan, products supported by PFS data alone may face access barriers. While in the United States, they will likely be covered.

Driver #2: make the right segmentation trade-offs

Given how restrictive the market is for some tumor types, one viable strategy is to limit a market to a sub-group of patients for whom the product produces a greater response rate and, hopefully, a higher OS rate. Using biomarkers to segment the patient pool means sacrificing a larger patient population for the sake of a stronger value proposition, which can translate into easier market access and potentially premium pricing. Additionally, aiming for a larger population could fail to produce the necessary clinical endpoints and preclude market access.

In addition to facilitating market access, a strong value proposition greatly enhances further indication approvals, with possible premium price reimbursement. Positive acceptance among the medical community will rebalance the initial limitation of economic potential due to patient stratification.

In some tumor types, developing a biomarker early in the development cycle is a desirable priority. However, the process of developing a biomarker is complex and adds considerable development costs. Best practices in determining the desirability of biomarker development must:

• Examine the trends in physicians’ use of biomarkers in the selected market.

• Ensure correct use of the biomarker, including its practicality and ease of adoption for physicians.

• Consider the cost of the biomarker and who will pay for it.

• Decide who will develop the biomarker.

• Aim to have a biomarker as a competitive advantage against an existing “gold standard” treatment.

• Consider foregoing a biomarker, if the unmet need is high.

Driver #3: employ novel approaches to gain payer acceptance

Even with successful lifecycle and segmentation strategies, companies can meet resistance from payers for their oncology products. Payers are struggling to find balance between their aim to maintain access for patients and their need to control costs, especially in Europe. They face political sensitivity and public pressure to make oncology treatments available, while their budgets are constrained and must cover other therapy areas as well.

"Once a sequencing decision is made, companies can determine what tumor indications are worthy of advancing into Phase III."

The cost pressure is mounting for several reasons: the incidence of cancer is increasing, targeted therapies are expensive, and in some tumors, treatment is shifting from acute to more chronic care settings.

Payers are employing a variety of tools to control pricing and market access and shift risk to manufacturers. European payers have become pioneers in this arena, as the EU today is one of the harshest payer environments for oncology.

Figure 2: Evolving Access Barriers in EU

Consequently, a product that’s systematically reviewed across Europe can easily receive different outcomes from the clinical data analysis. Furthermore, the outcomes of the economic reviews by the assessors can be even more disparate. Companies clearly need to prepare their dossiers to address the requirements and perspectives of individual countries.

Trends in risk sharing

Clearing the hurdles that payers have constructed has meant further sacrifice through risk-sharing agreements. Manufacturers are now making concessions if certain performance levels are not met and are limiting payers’ financial exposure. Risk-sharing agreements will continue to gain momentum, particularly in Europe, where the trend is to follow the lead of Italy and the UK, the region’s most restrictive markets.

The U.S. payer landscape

U.S. companies are faced with different challenges, as the payer landscape is driven predominantly by private insurers. Commercial payer reviews have become more cumbersome and private doctors’ offices are faced with highly bureaucratic processes, especially around the submission of prior authorizations (PAs) for the use of oncologics in an on- or off-label setting.

Nonetheless, the U.S. payer landscape is slowly following in the footsteps of Europe. Payer management is likely to become more restrictive for oncologics, with an increased emphasis on comparative effectiveness and cost-shifting to patients. For pharmaceutical companies, this translates into more head-to-head trials and an increasing focus on biomarkers and demonstrating overall cost-effectiveness.

"Using biomarkers to segment the patient pool means sacrificing a larger patient population for the sake of a stronger value proposition..."

Driver #4: build a strong oncology franchise

Another commonality among successful oncology launches is the sponsor companies' investment in achieving prominence in the therapy area and establishing a durable oncology franchise. These companies have:

• Demonstrated a long-term commitment to oncology.

• Pursued ambitious goals.

• Developed treatments across tumor types via multiple products/indications.

• Established a reputation as a leading player in the field.

These actions provided enviable access to key opinion leaders (KOLs), prescribers and patients for clinical trials. Today, companies entering the oncology market face formidable competition from the market leaders and must aim to achieve their own “critical mass.” Companies can establish a leading franchise by being mindful of certain conditions:

• KOLs are customers and engaging thought leaders in clinical trial design and expanded access programs is critical.

• Payer influence over prescribing decisions in oncology has not overshadowed the physicians.

• Gaining access to physicians requires the right mix of medical and business skills.

• Raising public awareness and inspiring brand advocacy is crucially important. The future of oncology lies at a conceptual rather than at a “pill” level.

Conclusion

Companies with a strategic focus on oncology must accept that the market has changed, with many tumors maturing and payers using new criteria to evaluate treatments. Success in oncology requires greater clinical leadership and commercial savvy. To realize the benefits of the four drivers of success profiled, companies need to appreciate the unique timelines of preparation – both pre- and post-launch. A successful oncology launch requires companies to make major investment decisions earlier – in a highly-fluid, uncertain environment. A highly-effective scenario evaluation and risk management strategy is essential. Companies also need to be more attuned to an individual country’s oncology stakeholders than ever before, and have a customer-facing organization with strong cross-functional integration to ensure a completely holistic approach to stakeholder management. Over time, mastering these areas will help companies develop a public image as a leader in oncology.

About the authors:

Dr. Simone Seiter is Senior Principal, Global Lead, Launch Excellence of IMS Consulting Group. She helps brand teams excel at product launches through the continuum of launch diagnostics, planning and tracking. With IMS since 2006, Dr. Seiter has deep healthcare and pharma knowledge and understanding of management and process consulting. Prior to joining IMS, she worked with Capgemini´s Life Sciences/Healthcare Sector for six years, focusing on marketing and sales projects, as well as product launch support. Before completing a postdoctoral fellowship at the NCI/National Institute of Health in the USA, she worked as a clinical dermatologist at the University of Heidelberg and Homburg/Saar Germany.

Maneesh Gupta is principal, Commercial Effectiveness of IMS Consulting Group. He also co-leads the Launch Excellence practice and in this capacity works with clients on launch strategy, planning, tracking and capability development. Gupta has over 13 years of experience in consulting, strategy, marketing and product management. He earned an MBA, with a concentration in Marketing, from the University of North Carolina, where he was invited to join Beta Gamma Sigma Honor society. Gupta also holds a BSc in Chemical Engineering.

Dr. Wolfram Lux and Nikolaos Kontos, formerly of IMS, contributed to this article.

What do you consider to be drivers of oncology launch success?