FDA expands DigniCap approval to all solid tumors

How to launch cancer care transformation

On July 3, 2017, FDA expanded its approval of DigniCap Scalp Cooling System for use in all solid tumor cancer patients. This has the potential to significantly improve both the psychological and physical well-being of many cancer patients. For example, one study found that almost half of female cancer patients consider hair loss to be the most traumatic aspect of chemotherapy, while another found that 8% of female cancer patients were at risk for avoiding treatment for fear of hair loss.

What you need to know about scalp cooling systems

• How they work: Cooling cap systems work by continuously circulating coolant through a specially designed silicone cap that's worn immediately before, during, and after chemotherapy treatment. The theory here is that the near-freezing temperatures reduce blood flow to the scalp so that less chemotherapy reaches the hair cells, making them more likely to survive the chemotherapy treatment. The silicone cap is typically covered by a second cap to hold it in place and provide insulation.
  
  
• Efficacy and side effects: Studies on the two FDA-approved cooling systems have found that 50% to 66% of women who used the caps lost less than half of their hair, while all of the women who didn't use them lost more than half of their hair. However, the efficacy of the cooling systems varies based on chemotherapy regimen. The most common side effects of using cooling caps are cold-induced headaches, neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period.
  
  
• Price and insurance coverage: Typically, hospitals or infusion centers are responsible for leasing and operating the cooling system, and patients are charged a fee each time the system is used. The cost to the patient varies based on the manufacturer and number of treatments, but ranges from $1,500 to $3,000 per patient for use during a complete course of chemotherapy. Insurance coverage for scalp cooling is not yet standard in the United States and varies based on plan, coverage, and location; however, some patients have reported successful reimbursement. Patients and facilities have also reported success paying for scalp cooling by tapping into subsidies for patients with demonstrated financial need provided by non-profits, such as HairToStay, and utilizing funding from medical center foundations, community health funds, and other philanthropic entities.
  
  
• Availability: In the United States, DigniCap Scalp Cooling System is currently offered at 74 centers, while Paxman Scalp Cooling System is offered at 38 centers.

Cancer care providers should be prepared to discuss scalp cooling with their patients

Cancer programs should make sure their providers are educated about scalp cooling and prepared to advise their patients on whether it may be a viable option to reduce their chemotherapy-related hair loss. To help educate providers and patients on scalp cooling and amass a global evidence base on its effectiveness, the makers of Paxman and DigniCap Scalp Cooling Systems partnered to fund the Cancer-related Hair Loss, International Leadership and Linkage (CHILL) Registry.

Depending on your patients' needs, investing in a cooling system may be a great way for your program to improve patient satisfaction.

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