Will Reimbursement in the United States Follow a Trial?

After Great Pain, a Cold Cap for Chemo Hair Loss Came

Nick Mulcahy

January 07, 2016

In 1992, at age 14, Claire Paxman accompanied her 36-year-old mother, Sue, who was undergoing chemotherapy for breast cancer, into a bathroom at the family home in Huddersfield, United Kingdom, and cut off all of her mother's hair with common house scissors.

Sue's hair had begun to fall out in clumps, which was emotionally devastating — even more so than the breast cancer diagnosis. "The first time she cried is when her hair started to come out," Claire told Medscape Medical News at the San Antonio Breast Cancer Symposium (SABCS) in December.

Claire and her brother, Richard, staffed a booth for the Paxman Scalp Cooling System in the trade exhibition hall at the symposium.

The sibling pair are part of the family-run Paxman Cooler business that produces the device, which consists of a compact floor-based refrigeration unit that circulates coolant via a tube into a silicone rubber cap that is placed on the head.

Scalp cooling, in various product manifestations — including ice and cryogel packs, such as the Penguin Cap — is applied during chemotherapy infusion and is a clinically tested method for reducing hair loss; in fact, studies date back to the 1970s.

Scalp cooling causes blood vessel vasoconstriction that reduces blood flow and chemotherapy distribution to the chilled area. It is theorized that this will reduce hair follicle cell destruction.

Claire Paxman

Claire, who has thick curly hair like her mother, said that Sue received "old-fashioned" scalp cooling with a "crude" device to limit chemotherapy-induced alopecia, but it did not work.

"It affected us all," said Richard about his mother's hair loss.

Ultimately, Sue died of metastatic breast cancer in 2000. But even before the family's loss, her husband, Glenn, and his brother, Neil, set about to build a better scalp cooling device.

They were uniquely qualified to do so; refrigeration was the family's business. Grandfather Eric Paxman had invented and commercialized a draft beer cooling system for breweries in the 1950s.

Eventually, Eric's two sons installed the first prototype of the Paxman Scalp Cooling System at the Huddersfield Royal Infirmary in 1997. The company has continued to refine the technology and expects to introduce a fourth-generation system this year.

Multiple studies of the Paxman system have been conducted. In one observational study, the cooling system achieved an 89% success rate (grade 0 alopecia; no wig or scarf needed) in breast cancer patients undergoing chemotherapy (Eur J Oncol Nurs. 2004;8:121-130).

Scalp cooling results have improved over time, according to a review of 53 studies the subject (Ann Oncol. 2005;16:352-358). The efficacy in terms of successful hair preservation (no wig or scarf needed) increased from 56% in studies conducted before 1995 to 73% in studies conducted from 1995 to 2005 — an improvement likely related to better scalp cooling systems and techniques.

Trial Design Has Reimbursement in Mind

There are currently about 2500 Paxman systems in use in 32 countries, but none in the United States. However, this situation might change in a few years; the company has begun an American clinical trial.

But Dignitana, a Swedish company, has beaten the Paxman system to market in the United States. Its DigniCap cooling system was approved by the US Food and Drug Administration (FDA) in December, as reported by Medscape Medical News.

The DigniCap prevented significant hair loss in 70.3% of patients with breast cancer receiving adjuvant chemotherapy, according to results presented at the 2015 annual meeting of the American Society of Clinical Oncology, whereas 94.0% of patients in the control group experienced hair loss of more than 75%.

The two cooling systems are technically similar, Claire explained, and clinical trial data suggest that their effectiveness in hair retention is similar. But the Paxman cooling device is significantly smaller, and therefore takes up less space in clinics.

The Paxman clinical trial being conducted at six sites in the United States, and involving 235 breast cancer patients, is unique in a number of ways. It might address what is currently a major problem for American patients — the lack of insurance reimbursement for scalp cooling.

This is the first prospective randomized controlled trial of its kind, said investigator and trial designer Julie Nangia, MD, a medical oncologist at the Baylor College of Medicine in Houston.

Dr Nangia, who presented a poster at the SABCS, explained that various other trials have not been "true" randomized controlled trials. For example, the Dignitana clinical study conducted in the United States was a prospective trial, but there were 101 patients in the treatment group and only 16 in the control group.

The primary end point of the American Paxman study is hair retention graded by blinded observers. Secondary end points include measures of anxiety/depression and body image. "There's really no prospective data with regard to how women do psychologically when they keep their hair," Dr Nangia told Medscape Medical News.

The mental health data are important because, in the United States, insurance companies do not reimburse patients for procedures considered cosmetic, which is often the designation for alopecia and hair retention, Dr Nangia reported.

"It is very important to collect the data about how hair loss can mentally affect a woman," she emphasized, suggesting that insurers might cover the treatment for its psychologic benefit.

"We want everyone to have access to this device, not just women who have money and can afford it," she said.

Dr Nangia pointed out that although postmastectomy breast reconstruction is now covered by insurance, it was not initially. "A lot of data eventually came out that showed that reconstruction is not just cosmetic. I am really hoping to show the same thing is true of alopecia."

Anthracyclines (such as doxorubicin and epirubicin) and taxanes (such as docetaxel and paclitaxel) are the most effective and commonly used chemotherapy regimens for breast cancer, said Dr Nangia. Both chemo types cause complete alopecia, she added.

The adverse effects associated with cooling caps include, in the short-term, cold discomfort, headache, and lightheadedness. There is also a risk for a serious adverse event — scalp metastases. However, in its approval of the Dignitana device, the FDA said that the risk that chemotherapy will miss an isolated grouping of breast cancer cells in the scalp because of the cold cap is extremely rare.

Dr Nangia has disclosed no relevant financial relationships.

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