"The conclusion is that if you look at varicose vein treatments in the same sort of terms that we use to assess something like cancer drugs, then it would appear that varicose vein treatment is actually very cost-effective, and quite a good way to use your money," said lead researcher Jonathan Michaels, a professor of vascular surgery at the University of Sheffield in England.
The review is published in the latest issue of Health Technology Assessment, the international journal series of the Health Technology Assessment program of the National Health Service for the United Kingdom.
The analysis was prompted by the unique problems of the publicly funded U.K. health care system, and uses that country's cost assumptions. But the research may also provide guidance for American medical practice, where sclerotherapy is gaining in popularity as a varicose vein treatment.
Varicose veins are enlarged, sometimes twisted veins just under the skin caused by a faulty valve that allows a backflow of blood. The condition, which often appears in the legs, can be cosmetically troubling for patients or progress to cause symptoms like heaviness, itching or even a breakdown of the skin.
In the United Kingdom, the high demand for varicose vein treatment has led to some "rationing" of therapy and long health-service waiting lists, Michaels said.
"There are a lot of questions about whether minor conditions like varicose veins should really be treated on the NHS when there are competing demands for expensive treatments for more serious diseases, such as cancer," he said.
Those questions have created an ethical debate about how and where to invest health care resources, he added. Michaels' technology cost assessment suggests that varicose vein treatment is a good buy.
The study tested the varicose vein treatments for three different groups patients with mild, moderate and severe varicose veins.
Only the third patient group, of people with severe varicose veins, was large enough show a definitive treatment advantage. Surgery outperformed conservative management, providing the greatest improvements in quality of life, symptoms and patient satisfaction.
Varicose vein surgeries vary, but in a common technique called "ligation and stripping" the defective vein is tied off then removed. Conservative management is a range of measures to care for varicose veins, which can include education and reassurance, advice to elevate the legs or the use of compression stockings.
Once the clinical trial was completed, the research team used both actual data from the study and modeling to compare sclerotherapy versus conservative management, and surgery versus conservative management.
In sclerotherapy, the varicose vein is injected with a chemical that hardens the lining of the vein, which then closes up and dissipates. After injection treatment, pressure is applied to the vein with a stocking or elastic bandages to prevent blood from returning to the treated area.
For sclerotherapy and surgery, Michaels' team calculated an incremental cost effectiveness ratio, or ICER a health-economics concept used to evaluate a medical treatment. An ICER measures the incremental benefit of the treatment compared to the next best thing. The lower the ratio, the more cost-effective a treatment is.
"What we found was a small benefit, but for a relatively small cost to the health service," Michaels said.
For patients with minor varicose veins, the economic modeling for sclerotherapy resulted in an ICER of about 3,500 British pounds (roughly $6,450 in U.S. dollars) per unit of improved health status, measured in quality-adjusted life years (QALY).
For patients with moderate varicose veins, the ICER was 3,388 British pounds per QALY for sclerotherapy, 2,083 British pounds per QALY for surgery.
Sclerotherapy is not appropriate for patients with severe varicose veins, so surgery or conservative management were the only treatments assessed for that group. For surgery, costs culled from the actual trial, resulted in an ICER of 7,175 British pounds per QALY. The team's modeling, which factors in continued benefit beyond the study period, resulted in an ICER of 1,941 British pounds per QALY
In all cases, the ICER for sclerotherapy and surgery fell far below the threshold normally considered appropriate for funding by the NHS. The U.K.'s National Institute for Health and Clinical Excellence, which provides national guidance on promoting good health and preventing and treating ill health, suggests a loose upper, acceptable limit of 20,000 British pounds to 30,000 British pounds. (In the U.S. the generally accepted upper limit for an ICER is $50,000 per QALY.)
"So varicose vein treatment is very cost-effective in British health service terms," Michaels said.
With that finding, Michaels makes the case against the rationing of varicose vein therapy in the United Kingdom. Wait-listing delays the benefit patients can gain from relatively inexpensive treatment, he said.
A U.K. health-economics analysis does not have great relevance for U.S. physicians, said Frank T. Padberg, Jr., a professor of surgery with the New Jersey Medical School, University of Medicine.
"I think perhaps in the United States, cost-effectiveness takes a second seat than it would in an NHS hospital," he said. "Almost all standard varicose vein treatments are covered by Medicare and most private insurance."