(The Hill) – Cancer centers are contending with shortages of key chemotherapy drugs, with potentially dire consequences once the scarcity starts hitting patients.
A new survey released this week by the National Comprehensive Cancer Network (NCCN) found that 93% of cancer centers are reporting shortages of carboplatin and 70% are reporting shortages of cisplatin. These two drugs are commonly used together to treat a wide variety of cancers — including breast, lung, prostate and many types of leukemias — often with the aim of curing them.
The survey conducted in May found that cancer centers were still able to treat patients with cisplatin without delays or claim denials, but only 64% of centers were able to keep patients on a regime of carboplatin. A fifth of cancer centers said they were able to continue prescribing carboplatin for some but not all of their patients.
According to Mike Ganio, director of pharmacy practice and quality for the American Society of Health-System Pharmacists (ASHP), the U.S. is seeing “a near-10 year high in active ongoing shortages”
Much of the current shortages stem from a major interruption in manufacturing that occurred when a facility in India, run by Intas Pharmaceuticals, halted production in March after the Food and Drug Administration (FDA) discovered a “cascade of failures” in the plant’s quality control.
The FDA issued an import alert to the facility last week, stating all future shipments originating from the facility would be denied admission into the U.S. except for 24 drugs that are in short supply, including carboplatin and cisplatin.
“These are critical oncology medicines,” Alyssa Schatz, senior director of policy and advocacy for NCCN, said.
“I think the good news is that there are safe alternatives in many cases, but NCCN is concerned that a lack of guidance and clarification from payers on how those drugs will be covered with or without prior authorization can cause harmful delays in care,” she said.
Schatz noted that when cancer care was disrupted during the pandemic, insurance companies responded by providing flexibilities with telehealth and releasing guidance on coverage when it came to oral equivalents of chemotherapy that could be sent through the mail.
To help with the current chemotherapy shortages, she said insurance providers must provide this same type of response, providing clear guidance on waiving prior authorization for chemotherapy alternatives.
The shortages of these critical medications has caught the attention of Congress with Democratic Sens. Dick Durbin (Ill.), Debbie Stabenow (Mich.), Gary Peters (Mich.) and Rep. Elissa Slotkin (D-Mich.) recently calling on the FDA to take immediate action, such as importing chemotherapy drugs and alternative treatments from other countries.
FDA Commissioner Robert Califf appeared to heed these calls when he announced last week that his agency would to allow the “temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities.”
The FDA is working with Qilu Pharmaceuticals in China to increase the availability of cisplatin and Canadian pharmaceutical company Apotex to distribute it.
These short term fixes may improve the situation for the time being, but stakeholders warn that drug shortages are an ever-increasing problem that needs to be addressed at the systemic level.
Schatz cited lower-priced generics as one factor behind drug shortages, albeit in a roundabout way.
“Paradoxically, low drug prices are a key driver of this shortage. We often hear about how the U.S. overpays for drugs, but that conversation is primarily related to brand-name drugs,” said Schatz. “Generics manufacturers operate on a razor thin margin and that can lead to quality and supply issues.”
These margins pressure manufacturers to operate at near-capacity and reduce the number of makers in the market, leaving it vulnerable to shortage when crises occur.
“We’re talking about things that have low profit margins. Therefore there’s little incentive to invest in facilities, there’s little incentive for manufacturers to get into manufacturing those products,” Ganio from ASHP said.
Healthcare organizations continue to urge Congress to advance policies that incentivize manufacturers to invest in critical drug production, for cancer and other diseases, and improve how the Strategic National Stockpile functions and encourage stronger manufacturing quality.
To that end, Reps. Buddy Carter (R-Ga.) and Lisa Blunt Rochester (D-Del.) reintroduced the Essential Medicines Strategic Stockpile Act earlier this year. The bill would direct federal agencies to develop a stockpile of 50 generic drugs at risk of shortage that could supply U.S. patients with their medicines for six months.
While this bill would not address the root cause of shortages, it would provide the market with a supply of drugs while a disruption to the supply chain was addressed, experts told The Hill.
In a letter to Califf and Health and Human Services Secretary Xavier Becerra on Thursday, a bipartisan group of 70 House lawmakers asked the officials how the federal government can improve its oversight and enforcement of pharmaceutical supply chains in light of the chemotherapy shortage.
“Patients, physicians, and pharmacists are often the last to know when an essential drug will no longer be available, yet, are affected by these shortages the most,” they wrote.
“We strive to ensure patients, physicians, and pharmacists never have to experience shortages of essential medications, but when shortages do occur it is vital that these individuals are made aware as quickly as possible so that they can better prepare.”