As the year comes to a close, shortages of key cancer drugs have no end in sight. Joining the effort to push legislators to respond, the American Cancer Society Cancer Action Network (ACS CAN) illustrated the impact of shortages on patients and laid out potential solutions in a letter to congressional leaders.
Many of the 16 oncology meds that are currently in short supply serve as the “core backbone” for treatment regimens, the group points out. As it stands, doctors are regularly forced into deciding which cancer patients receive the critical medicines and which don't, as stretching the supply across many patients has become the only option when there are no other reasonable alternatives, ACS CAN wrote in its letter.
In fact, of the 10% of adult patients in active treatment who have been impacted by a shortage in the last year, 68% have faced difficulties finding substitute medicines and 59% have reported treatment delays, according to surveys that ACS CAN conducted.
On the pediatric side, a whopping nearly 53% of children with cancer have been affected by a shortage over the course of their treatment, according to the data cited by the group. Over 80% of pediatric cancer providers noted that their institution was experiencing shortages, the surveys found.
Aside from current patients, the shortage is also having a “chilling effect on research,” ACS CAN says. Often, the comparator treatment arm required in clinical trials is difficult to attain, stopping studies short in many cases.
As ASC CAN sees it, the root cause of these shortages are the economic conditions in the generic sterile injectable market. With little profit margin on the meds, there isn’t much incentive for companies to increase capacity or even remain on the market, in some cases.
More specifically, these shortages happen due to low investment in facilities that make the meds or quality shortfalls that force an FDA production shutdown. When one manufacturer stops production of the med or its active ingredients, others often can’t pick up the slack to meet demand.
Resolving these issues will require legislation that is “comprehensive and will result in systemic changes” that address both the short term and the long term, the action network said.
One approach is providing the tools and knowledge necessary to respond to shortages as they happen, such as data-driven risk assessment tools and increased FDA resources.
But to address the root cause of these shortages, the market must be “transformed” to reward reliability and quality in production and delivery capacities. That includes tweaks to certain government policies that hinder prince increases on low-cost generics and financial support for facility upgrades.
Also this week, the American Society of Clinical Oncologists (ASCO) is delivering similar testimony to the Senate Finance Committee. The group is urging policymakers to respond to the “urgent crisis” with incentives and reimbursements and emphasizing the grueling impact of shortages on providers and patients.