The Times They Are a Changin'

Raoul S. Concepcion, MD

It is only fitting that arguably one of the all-time great troubadours, Bob Dylan, was awarded the Nobel Prize for Literature in 2016 (although his trip to Stockholm to deliver his acceptance lecture will be delayed until 2017). The events of 2016 will certainly lay the framework for an interesting year to come. As a result of the most recent presidential election, it is a big unknown what the new administration will bring as it relates to the future of healthcare in the US. The likelihood of a complete repeal of Affordable Care Act (ACA) is unlikely. Given his lack of expertise in the area, President-Elect Trump will need to work closely with Speaker Ryan to craft a plan that has more transparency, less government regulations, and eliminates individual and employer mandates. This would be a good start, and we hope the incoming President will surround himself, and more importantly, take heed and act, with those who understand the complexities of the health care industry.

As a side note, we will be fortunate to have a urologist in Congress! My good friend, Neal Dunn, MD (R), won the 2nd congressional district in Florida. For those of you who do not know Neal, he was instrumental in getting an amendment stripped from a Florida health care bill back in 2012. Had he not led the charge at the 23rd hour, it would have set precedent for many states to follow that would have made ownership of free-standing radiation centers difficult for urology groups. Along with others, he also led the discussion to integrate groups from the panhandle of the state to the east coast. Dunn will represent us well, and we should continue to support his efforts over the next couple of years so that he can maintain presence on the Hill.

For those who attended the annual Large Urology Group Practice Association (LUGPA) meeting this past November, a major concern that was voiced repeatedly by many of the speakers was the runaway costs of prescriptions drugs in the US. This is of great concern for those readers who manage genitourinary malignancies, where the constant wave of new therapies, especially the immuno-oncology (IO) agents, are being approved in waves. There is no question that our more thorough understanding of the molecular drivers of cancer progression, regardless of the organ of origin, has led to better targeted-boutique drugs that will slow the disease progression and prolong survival without sacrificing quality of life. The cost to develop these drugs is in the billions of dollars. As many of you are fully aware, outside the United States, the reimbursement is from a single payer in most countries, namely the government. Thus, the US is the only market where pharma can recoup some of the research and development costs. As providers, we and our patients, for the most part, have access to most of these agents once they get fast-tracked by the FDA. However, in this age of budget neutrality, the trajectory is unsustainable.

Compounding on the rising costs of the drugs is the lack of financial assistance available to our patients, as well as drug shortages. Taken together, this represents a serious threat to our cancer patients. As we are all aware, the Office of the Inspector General (OIG) this past year has been looking into the legality of patient assistance foundations and the funds once available to help our patients are now quite limited. With the exorbitant costs of therapies, regardless of the mode of delivery, in patients often on fixed income, many are now going without treatment. Unfortunately, there appears to be no relief in the immediate future.

This past week, Sanofi has just announced that it will no longer be manufacturing BCG. For the thousands of patients with high-grade non-muscle invasive bladder cancer (NMIBC), this can only result in worsening outcomes for our patients, and many will progress to muscle invasive disease (MIBC), given the lack of therapeutic options with proven efficacy. There are other companies that produce BCG. However, the ability to meet worldwide demands is dubious. We remain hopeful that newer agents and delivery systems, especially IOs, can come to market quickly and be more efficacious.

With all due respect to the Nobel Laureate Bob Dylan, I am offering my adaptation of his words:

Come senators, congressmen Please heed the callDon’t stand in the doorway Don’t block up the hallFor he that gets hurtWill be he who has stalledThere’s the battle outside ragingIt’ll soon shake your windows and rattle your walls For the times they are a-changing