Scalp Cooling System for Chemotherapy-Induced Alopecia Approved for Multiple Solid Tumors

The FDA has greenlighted an expanded indication for Paxman’s scalp cooling system in the United States. The medical device company in the United Kingdom announced that its Paxman Scalp Cooling System is now indicated to reduce the likelihood of chemotherapy-induced alopecia in patients with solid tumors, such as ovarian, breast, colorectal, bowel, and prostate cancer.

The system was approved in April 2017 for the reduction and prevention of hair loss associated with chemotherapy treatment in women with breast cancer. Made from lightweight silicone, the cooling cap is soft and flexible, molding to different head shapes and sizes. Liquid coolant passes through the cap, removing heat from the patient’s scalp and ensuring it remains at a constant temperature to minimize hair loss.

According to Paxman, the newly expanded indication will substantially increase the number of new cancer patients per year that can benefit from the system from an estimated 250,000 patients with breast cancer to over 1 million patients with breast cancer or other solid tumors.

“Scalp cooling has been a real game changer for so many of our patients with breast cancer, minimizing the risk of one of the most dreaded side effects of chemotherapy,” said Steven Jay Isakoff, MD, PhD, medical oncologist, Massachusetts General Hospital, in a statement. “That’s to the recent expanded FDA indication for the Paxman Scalp Cooling System, so many more patients with solid tumors in the US can now consider this option as a safe and effective way to keep their hair during chemotherapy.”

Since the system’s original clearance, 225 have been installed with another 65 awaiting delivery and installation.

Highlighting the importance of the affordability of scalp cooling, Richard Paxman, chief executive officer, Paxman, told The American Journal of Managed Care^® in an email: “We are working hard with health plans and payers to ensure that in the future this will be covered. However, at present, the majority of patients are paying out of pocket.”

Paxman added that, “We are seeing positive feedback from a number of commercial payers.”

Currently, the cap kit costs patients $500, cycles 1 through 4 cost $200 per cycle, cycles 5 through 6 cost $150 per cycle, and cycles 7 through 12 cost $100 per cycle. However, the pricing per patient is capped at $2200.

For a chemotherapy treatment of 8 cycles, the total cost comes to $1800. While the cost of a 12-cycle chemotherapy amounts to $2500, the patient would pay the capped amount of $2200.

Although no payer coverage exists for the system yet, the nonprofit HairToStay helps subsidize the cost for eligible patients. Through this, the system’s pricing is discounted by 25% and HairToStay covers 60% of the remaining cost.

“HairToStay has had the privilege of subsidizing a growing number of Paxman scalp cooling users for nearly a year now,” said Bethany Hornthal, founder of HairToStay, in a statement. “This expanded clearance will increase this wonderful option for patients and we expect to see a significant increase in demand for scalp cooling and subsidies.”