ASCO: Breakthrough Drugs at Breakthrough Prices

ASCO 2015 may be remembered as the year when the high cost of drugs got nearly as much attention as the major scientific breakthroughs in deadly cancers. Indeed, looking back at the presentations and conversations at this year’s oncology conference, what was clear was the growing tension between the breathtaking progress of scientific advancements in cancer therapies – even a potential cure – and what has been dubbed the “financial toxicity” of these treatments.

On the scientific side, immuno-therapy was center stage. This approach of marshalling the body’s own immune system to fight cancer is an elegant and powerful way to treat patients because of its specificity, memory and adaptability.

While promising immuno-therapy study results have been presented at ASCO for the last several years, this year’s presentations demonstrated positive data for the first time in hepatocellular cancer, and markedly increased survival times for non-small cell lung cancer and melanoma. In the trials presented at ASCO, some patients on treatment were still alive for more than three years.

What was even more exciting was data in melanoma which combined two immunotherapies, nivolumab and ipilimumab.   This trial showed a statistically significantly improved median progression free survival (PFS) benefit compared to either ipilimumab or nivolumab alone. Since Median OS was not reached the results promise to be even more impressive.

These trial results have catapulted immuno-therapies to a new position – with doctors and scientists at ASCO talking about the rarely spoken “C” word in these devastating cancers – CURE.   While the potential of immunotherapies is still in its infancy, the hope at ASCO among patients, doctors, researchers, and pharmaceutical executives was unmistakable. If these new immunotherapy agents stay on their current trajectory, they could very well offer a cure for up-till-now deadly cancers.

While pharma companies continue their quest for a cure – the more immediate question at ASCO this year was whether a biomarker to better select patients for these therapies is on the horizon.

Most of the trials presented at this year’s ASCO measured the biomarker PD-L1, but the results are far from definitive as even PD-L1 negative patients responded to therapy. Further confusing the issue is that every company uses its own PD-L1 test with different cut-offs and the tests are sometimes done on archival tissue rather than fresh tissue. Selecting the right patients based on a biomarker is not only important for medical reasons, but for cost implications.

In fact, the buzz around these very exciting clinical trial results, and the promise of a cure, was tempered by a new topic that has been increasingly getting attention at ASCO – yet another “C” word – Cost. Or more accurately price and affordability. The high price of drugs and concern over limited access of these important drugs for patients was a major topic.

In his key note address, ASCO President Peter Paul Yu, MD, talked about ASCO’s Value Framework – an initial version of the framework for public comment can be found here through August 21, 2015. The framework and overview is available here.

According to Dr. Yu, “Patients need to have accurate information about expected benefit, toxicity and cost as well as a context for comparing new and typically more expensive, treatments to standard alternatives.”

Roundtable interviews with patients and physicians urged more dialogue between these two groups specifically “the open, transparent conversations that include real goals and real assessments of the cost.”

The goal in all of this is to help patients make an informed decision about the right therapy choice for them – and consider the treatment’s cost and affordability as one of the prime determinants in that decision.

While pharma was front and center at this year’s ASCO talking about the impressive study results of these important therapies, their voice was largely missing on the pricing conversation and the value these drugs bring to patients and society. Maybe their perspective will better communicated at ASCO 2016.

 

ABOUT THE AUTHORS

Cindy DiBiasi has built a reputation as a leading health care communications consultant by working with top executives at some of the world’s largest companies. Cindy helps clients identify their communications strategy and develop messages on controversial healthcare issues. Her FDA consulting work includes leading clients through high-stakes FDA and Advisory Committee meetings. Cindy also leads 3D’s Market Access/Reimbursement communications work. Connect with Cindy on LinkedIn.

Bert Regeer, MD, has 20 years of experience in clinical development strategy, working at some of the largest pharmaceutical companies in the world. Bert uses his expertise in clinical program design, development, and implementation to help clients prepare for FDA interactions and Advisory Committee meetings. His expertise spans both small molecules and biologics in the areas of oncology, cardiology, infectious diseases, and supportive care. Connect with Bert on LinkedIn.