layers of information

Cancer is one of greatest healthcare challenges of our time. Despite years of research, every year 8.2 million people die from cancer worldwide, and that number is expected to jump to 11.5 million by 2025. In addition, the cost of both clinical research and cancer treatment continues to rise.

However for every sad statistic, there are also success stories to celebrate. As recently reported, the death rate from cancer has decreased 23% in the past 21 years, representing more than 1.7 million deaths prevented due to improvements in prevention and care (Cancer Statistics, 2016, American Cancer Society). The past few years have seen incredible innovations in oncology research. The US Food and Drug Admiration (FDA) approved 21 oncology drugs and therapies in 2015, and 11 more in 2016, with many more drugs in the development pipeline. These innovative treatments are giving patients hope, and in some cases providing cures for once terminal diseases.

As acknowledge World Cancer Day on February 4, I think it is important to acknowledge these great accomplishments, and to explore the trends that are shaping current and future oncology research.

The empowered patient

Today’s healthcare patients are often not passive recipients of diagnoses and treatments. They are educated and informed consumers who have enough data at their disposal to effectively research their condition, ask pointed questions, and to actively participate in their care. This is especially true in the oncology community where patient advocacy groups and knowledge sharing platforms have empowered patients and their families, in some cases leading them to be more informed than their doctors about the latest treatment innovations.

This trend provides both opportunities and challenges for the biopharma industry. While these patients will not blindly accept treatment plans suggested by their physicians, they may be more likely to seek out new sources of guidance as well as clinical trials on their own to take advantage of cutting edge research. This offers an exciting opportunity for biopharma companies to address recruiting challenges by crafting more direct-to-patient engagement strategies that address patients’ desires to take charge of their care. These patients also offer the opportunity for biopharma companies to develop long term relationships, important in the rare disease marketplace.

However, to accomplish these goals, developers will need to engage these patients, address their concerns in trial designs, and develop new ways to communicate using the most relevant language and platforms. It also means considering new avenues for recruitment, including digital recruiting platforms like TrialReach, Cure Forward, HealthUnion and AutoCruitment that use data analytics natural language communication and educational tools and interactive, patient/biopharma exchanges  to make clinical trials more understandable and accessible.

Activist cancer patients will benefit the community and biopharma. They are the new key stakeholder in the oncology treatment equation, and biopharma companies need to listen to their concerns and accommodate their demands if they want to win their support and improve the feasibility of cancer clinical research

Shifting standards of care

New therapies and diagnostics to address specific tumor types or patient subgroups are emerging so rapidly that it has become nearly impossible to define clear standards of care in some cancer indications. As soon as one new therapy and standard of care is deemed effective, another treatment strategy emerges putting into question which is the best to follow. It is a growing problem that is placing a greater burden on the physicians and clouding our ability to plan clinical research and commercial strategies in biopharma.

Many of the choices we make in clinical research, trial design and future product profiles are based on standards of care, and the constant evolution of this space is making it difficult for developers to establish guidelines for tracking safety and efficacy, assessing evidence, and comparing the value of new therapies. Right now, the best approach we have is to understand of what is going on in the field is based upon primary research with physicians and other stakeholders. However, over time we will need to identify a better long-term strategy. If medical guidelines and established standards of care are no longer applicable, what tools can we use to chart the care path and measure value against other treatment options?

Increased complexity is always a challenge, but I hope it will act as a catalyst for new conversations and collaborations between industry stakeholders who need to work together to identify new ways for setting guidelines and aligning best practices with the rapid advances in the field.

The rising cost of cancer care

For decades, the primary concern for oncology drug developers was whether they would be able to gain regulatory approval for new treatments. While these continue to be important steps in the development lifecycle, the primary focus today is all about cost. Over the past several years, oncology drug prices have skyrocketed while attracting considerable public attention and concern.

The total cost of cancer therapeutics and supportive medicines reached $107 billion in 2015, representing an increase of 11.5% over the prior year, according to a recent QuintilesIMS Institute report. A 2016 report from JAMA shows the average monthly amount insurers and patients paid for a new cancer drug soared from $2,000 in 2000 to $11,325 in 2014. Combination therapies are even more expensive. For example, a combination of nivolumab and ipilimumab, which was approved for melanoma in October 2015, has an annual cost of more than $250,000 per patient.

With reimbursement decisions for innovations such as novel diagnostics lagging for lack of demonstrated clinical value, we currently don’t have all the tools and the models to handle the rising cost of oncology care.. High unit cost and uncertain reimbursement hinder adoption of novel diagnostics and drugs and will negatively impact patient access to effective treatments.

Not surprisingly, payers are seeking assurance of the value that result from their expenditure on these drugs and the associated services required for their appropriate use. This tension can be expected to be amplified over the next five years as a strong pipeline of targeted or immune therapies and diagnostics increasingly, transforming oncology into a multitude of rare diseases, reaches a growing number of patients around the world.In response, industry leaders need to participate in efforts to identify high-value treatments, and explore new payment and delivery models to equitably share value and risk.

All three of these trends suggest a need for the biopharma industry to continually rethink and update its approach to the drug development process and requirements for clinical research. The rapid pace of innovation means we may one day soon view cancer as a treatable illness, but unless we manage the cost issues and perception of value among all stakeholders, we cannot fully achieve this goal for all patients around the world.