A new type of cancer treatment is slowly gaining traction, and its supporters say turf wars and referral patterns are the reasons why the acceptance is moving at glacial speed.
The technology in question is ablation therapy, a minimally invasive way to kill cancer cells by heat or cold. Analysts say RITA Medical Systems, Fremont, Calif., founded in 1994, is the industry leader in the production equipment for radiofrequency ablation, which generates heat to destroy cells. However, the market is small, with RITA's roughly $20 million in annual revenue from RFA sales making up about 50% of equipment sales, according to David Turkaly, analyst with financial services company WR Hambrecht & Co.
"It hasn't grown as quickly as a lot of people would have hoped," Turkaly says.
Joseph DeVivo, president and chief executive officer of RITA, says ablation is held back because medical oncologists are afraid of recommending the treatment--they think they'll lose business to those who perform ablation, who are either surgical oncologists or interventional radiologists. It's also more profitable for medical oncologists to start patients on drug therapies, which leaves DeVivo's small device company competing with large pharmaceutical companies for the attention of medical oncologists, he says.
Pros and cons
Steve Paulson, a medical oncologist and chairman of physician group Texas Oncology, Dallas, disagrees with the view that physicians are slow to refer patients to ablation and says the treatment can be beneficial for some patients. He says the treatment's acceptance is growing at the proper rate and the referrals are being made when necessary.
"It's not a silver bullet, but it's not a blank either," says Paulson about ablation therapy.
Ablation works by inserting a probe into a tumor, and once inside the tumor, the probe opens like a flower and heats or freezes the tumor until the cells are killed. The heating ablation uses radiofrequency, and the cooling ablation, or cryoablation, uses liquid nitrogen or argon gas.
Reduced risk of bleeding
The cryoablation is mostly used to fight prostate cancer but is also used to kill liver tumors. However, the preference currently is to use radiofrequency for liver tumors because the heating seals blood vessels, leading to a reduced risk of bleeding.
Paulson says that once patients hear about ablation and its benefits they have a strong desire to undergo the treatment. "I tell patients it's like pulling weeds out of the yard individually as opposed to spreading weed killer," Paulson says. "Both have their advantages and disadvantages."
Paulson says that medical oncologists are educated about the treatment and disagrees that they dismiss it. But he adds that medical oncologists may not recommend the treatment if they don't know of experts in their community who are experienced in performing it.
"In a small community, you may have a more difficult time to make the referral," he says.
Therein is the problem, according to RITA. Ablation treatments are commonly known and performed in large cancer centers, but not in community hospitals. DeVivo says patients--and a hospital's bottom line--would benefit from community hospitals opening an ablation center. "The reimbursement is there," he says.
DeVivo points to the CMS' payment update in the 2006 physician fee schedule; in November, the CMS raised outpatient reimbursement rates to $2,356 for the percutaneous procedure--which is done without making an incision--and $3,790 for open radiofrequency ablation liver treatment starting Jan. 1, compared with $1,753 and $2,436, respectively, in 2005.
In its final regulations published in November, the CMS indicated that it would also evaluate payments for bone radiofrequency ablation after it had more for data. The bone treatment code was new in 2004, and a code for kidney treatments will be used for the first time in 2006.
"The coverage is generally increasing," says Michael Mabry, an assistant executive director for the Society of Interventional Radiology Foundation.
He added that he expects to see codes for lung ablation in 2007 and that would be followed by codes for the ablation of breast cancer. Radiologists are increasingly learning to perform the ablation treatments.
The ablation procedures are most routinely done on an outpatient basis by surgical oncologists who make an incision before inserting the probe. Interventional radiologists are performing the closed or percutaneous procedure, which offers the benefit of patients being able to recover more quickly. However, a benefit of the open procedure is that surgeons can look inside and see if other tumors exist. If others are detected, the ablation of those could be done while the incision is still open.
A disadvantage of ablation is the treatment doesn't remove the tumor and there's no way to be sure all the cancer cells were killed. "To prove that all the cells are dead can be difficult," says Edgar Staren, a surgical oncologist and vice president of medical affairs for Cancer Treatment Centers of America.
Staren says the best way to ensure all cancer cells were killed is through monitoring. If the ablated area shows signs of growth, it's unlikely that all of the cancer cells were killed; if it doesn't continue to grow, it's likely all of the cancer cells were killed.
Still, he says he performs radiofrequency ablation treatments for liver tumors regularly, and ablation, which has had Food and Drug Administration approval for liver tumors since 1996, is a good technique for that type of cancer because about 80% of liver tumors can't be removed with surgery.
Also, chemotherapy can destroy the liver.
Staren says three considerations should be made before recommending ablation: the training of the physician performing the procedure; the type of equipment being used; and the location of the tumor. He says the farther the tumor is from other organs the better; the closer the tumor is to adjacent organs the greater risk those organs could be damaged.
Staren prefers radiofrequency over cryoablation because there is less bleeding, the probe and other equipment are smaller, and there have been some reports--although rare--of patients experiencing inflammation of organs after undergoing cryoablation.
Cryoablation is behind radiofrequency ablation when it comes to lung, liver and bone treatments, but cryoablation has been an accepted practice for prostate and kidney cancer, says Craig Davenport, chairman and CEO of cryoablation devicemaker Endocare, Irvine, Calif. Davenport isn't as adamant as DeVivo when talking about the lack of patients who are referred to ablation treatments. But he understands DeVivo's point that there could be a turf war and says there is potential that some, mainly interventional radiologists, could be left out of the referral loop because they don't have their own patient population.
"Medical oncologists are at the top of the food chain," he says.
What's working against the treatment is that ablation medical device companies don't have the clout and resources pharmaceutical companies have, DeVivo says. He calls the physician education process "an upstream battle" because it's difficult to fund studies that can more conclusively show ablation's effectiveness.
To help "spread the gospel" of ablation, DeVivo hired Jelle Kylstra, an oncologist, to serve as vice president and medical director of RITA. Kylstra spends about half of his working hours educating physicians and the other half on research.
DeVivo's for-profit publicly traded company has a significant interest in the success of radiofrequency ablation. Companies such as Tyco International and Boston Scientific bought companies that offer the RFA cancer equipment, but Tyco and Boston Scientific are much larger and more diversified, while RITA relies mostly on the success of the selling of its radiofrequency ablation devices.
For the first nine months of 2005, radiofrequency ablation sales made up $14.4 million of the company's $34.4 million in total sales. The company reported a net loss of $3.8 million through the first three quarters of 2005, but that's down from a loss of $7.4 million in the first nine months of 2004. RITA is getting closer to profitability with its 2005 third quarter posting a $705,000 loss, compared with a $3.3 million loss in the third quarter of 2004.
That improvement is likely an indication of the greater acceptance of ablation. Studies on liver tumor ablation are the most prevalent because that procedure has been around the longest. The mounting evidence has helped change perception, Kylstra says. "RFA is coming of age," he says.
But there's a long way to go in DeVivo's eyes. He says ablation could be an early line of defense against cancer and now the treatment is too often being used as a last-ditch effort to help patients. He says there's no reason that medical oncologists should fear losing business to ablation because the treatment is not going to replace the other cancer treatments.
DeVivo envisions a world where ablation is the fourth pillar in cancer treatment working in conjunction with chemotherapy, radiation and surgery. He and Paulson say ablation, which doesn't have the toxicities of chemotherapy, can give patients' body a much needed break from that treatment.
"It's not a threat," DeVivo says. "We're trying to give them another option."