Eight Ingredients for a Successful Oncology Drug Development Recipe

In light of the risks and challenges inherent in the development of oncologics, some biopharma companies are beginning to question whether oncology remains an attractive therapeutic area in which to invest limited research, development, and commercialization resources.

The simple answer to this is, yes, oncology remains an area of high unmet need and product revenue potential. But organizations hoping to gain regulatory approval, healthy reimbursement rates and a favorable response from practicing oncologists must be sure to bake the right cake. Here are the eight key ingredients to use:

1. Clearly Defined Commercial Pathways

It is important to fully understand the commercial pathway for the product, whether it is based on biomarkers and patient stratification, orphan drug designation, or emerging markets.  The commercial strategy will then need to be customized to local markets.  Different types of local markets require different customer-facing roles and strategies, rather than a national one-size-fits-all approach.  For commercial pathways based on orphan drug designation, having a compendia strategy in place becomes critical, especially for products that have a high potential for off-label utilization.  Many payers-both government and commercial-will only reimburse such a product if the off-label utilization is recommended in Medicare compendia.

2. A Compelling Product Value Proposition

With only so much money to allocate and new oncology agents coming to the market all the time, payers need to be judicious in what they choose to cover.  Drug manufacturers will need to develop both a clinical and an economic value proposition to ensure pathway inclusion.  Manufacturers need to start working with payers early on to form partnerships and gain a better understanding of what payer expectations are as a product is brought to the market.  As the industry evolves, a purely product-centric model may no longer be enough.  Manufacturers should consider a transition to a patient-centric model focused on the use of diagnostics and genetic testing to ensure a more predictable response to medications.

3. Biomarkers and Patient Stratification

The clinical bar can be lowered with the use of biomarkers, patient stratification methods, or companion diagnostics.  Biomarkers offer the potential to increase the probability of success and to reduce the size, length, and cost of clinical trials by identifying patients most likely to benefit from therapy and predict response to therapy before the hard endpoints are reached.

4. Well-Defined Endpoints

Rather than just looking at response rate or progression-free survival, FDA will increasingly want to look at overall survival.  The data has significantly increased in the past two decades, mostly due to the introduction of targeted therapies.  But recent years have introduced few breakthrough treatments, with new products mostly improving upon existing treatment regimens or simply tweaking existing molecules.  As a result, it has become much more complicated to demonstrate a significant improvement.

5. Access to Physicians

In the face of the no-see physician trend, sales forces need to be right-sized and equipped to provide added value beyond pure product information.  To gain access to oncologists, reps need to be able to provide their customers with reimbursement support and wrap-around services that can truly help differentiate a product.

6. A Life Cycle Management Plan

The approach to life cycle management in oncology has to be broadened to focus less on just pure indications and more on other traditional life cycle management options in terms of method of administration, delivery, etc.  In oncology, it is important to take advantage of the fact that the products tend to have multiple shots on goal, with different patient populations and different tumor types.  This is a factor that should be embedded as part of the development program from the beginning.

7. A Holistic Approach to Patient Care and Management

Manufacturers can no longer simply make a product and sell it.  They need to be thinking about providing services and patient support around the individual products.  Potential business opportunities exist throughout the patient journey in oncology, and companies will broaden their focus to improve patient quality of life throughout that journey, from prevention and diagnosis all the way through treatment, supportive services and care, and provider/payer services.

8. An Emerging Market Strategy

China and India show untapped revenue potential as the growth of the disease population far outpaces the treated population in both countries.  China’s oncology market appears poised for growth as the introduction of targeted agents expands the market over the next decade.  Challenges still remain with reimbursement of expensive targeted agents by public insurance schemes.  In India, meanwhile, conditions look promising on paper, but the country may not be a lucrative market due to reimbursement challenges and poor patent protection.

To read the full oncology market report, click here.

Matthew Cook is Vice President, Campbell Alliance. He can be reached at mcook@campbellalliance.com. Sebastien Morisot is Senior Consultant, Campbell Alliance. He can be reached at smorisot@campbellalliance.com.