We continue our efforts to advocate for Oregon Varicose Vein Treatments. After our August 8th meeting with the HERC in Wilsonville, Oregon we have continued to communicate with them as questions have come up. The issue is that currently most insurance companies and Medicare provide coverage for patients with symptomatic varicose veins that are impacting their activities of daily living and quality of life. The Oregon Health Plan, which provides medicaid health insurance to those in Oregon only covers the most advanced stages of venous insufficiency (those with end stage venous ulcers). This means many OHP patients must wait until the end stages of the disease to qualify for treatment. A public hearing was held August 8, 2019 by the Oregon Health Evidence Review Commission (HERC) considering pubic comment on this subject. Since then there have been several questions and back and forth by e-mail. It is our understanding they will be meeting again on November 14, 2019 to include another public meeting. What follows is a summary of Dr. Boyle’s written reply to their specific questions about the medically necessary indications for treatment of varicose veins.
HERC Question #1: Is conservative treatment (such as compression hose) significantly less effective than any type of invasive procedure (sclerotherapy, vein stripping, etc.) for non-ulcerated varicose veins?
Dr. Boyle REPLY: YES, superficial vein treatment interventions are known to be more effective than conservative therapy. In randomized trials by JA Michaels (https://www.ncbi.nlm.nih.gov/pubmed/16432825 ) and colleagues they compared outcomes between a cohort randomized to conservative measures only and those that had a procedure to treat saphenous vein reflux. In these high quality published clinical trials there was clear evidence that surgical treatment of superficial venous insufficiency is superior in providing symptoms relief and quality of life improvement compared to conservative therapy (for example leg elevation, exercise and compression hose). Surgical treatment also showed a significant economic benefit over conservative therapy. It’s important to note that these studies were done using the most invasive and more expensive form of treatment (surgical vein ligation and stripping in an operating room). Despite this, interventions were still superior to conservative therapy. Since these clinical trials were completed there are now newer less invasive forms of treatment that have been developed such as endovenous ablation using thermal and non thermal treatment that accomplish the same goal in a less invasive manner. These newer techniques have been extensively compared to the old standard of vein stripping for symptom relief, improvement in quality of life, and cost effectiveness. In these studies the newer techniques are have distinct benefits. One prominent example is the 2019 Brittenden trial published in the New England Journal of Medicine (https://www.nejm.org/doi/10.1056/NEJMoa1805186 ) which was a randomized 5 year outcomes study of endovenous ablation vs vein stripping for reduction in symptoms and costs. In this trial, as in many others, the outcomes data favor newer less invasive, less expensive endovenous ablation technique over the older technique of vein ligation and stripping.
HERC Question #2: Do lower grades of varicose veins progress to higher grades? Specifically address that NICE comments that this is an area with low to very low level evidence, and they also comment that there is no high quality evidence that lower grades of varicose veins will progress to higher grades.
Dr. Boyle REPLY: It is important to make the distinction that the question “is venous disease progressive” is different from the question “should prevention of progression be an indication for varicose veins procedures?” I address these questions separately below:
- Chronic venous insufficiency is progressive: We know from epidemiological studies like the Bonn studies, Edinburgh studies and others that venous insufficiency generally does progress over time. However, it does not progress at the same speed in all patients. And there are some patients that have little or no progression. There are others that have rapid progression. And there are some patient factors more correlated with progression. For example it is likely that there are individual genetic features that impact progression. Also women who have been pregnant appear to progress more. Patients years after leg injuries or prior deep vein clots progress faster. This fact that venous disease is progressive over time is well established with high quality research.
- Is there evidence that superficial vein treatment with surgery prevents progression?:
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- No…not enough. Thus we concur that prevention of progression is not an indication for surgical intervention. The indications should be to reduce current symptoms….not prevention of future symptoms.
- As you referenced, according to NICE cg168 (https://www.nice.org.uk/guidance/cg168/resources/varicose-veins-diagnosis-and-management-pdf-35109698485957) section 2.1 on Natural History of Varicose Veins: “the understanding of factors leading to progression are an “area of low evidence.” What they specifically say is: “The results of future studies should help to more accurately identify which patients are at risk of developing more serious disease so that interventions can be offered at an early stage to those who will benefit most.” This is to say that in the future, if the evidence supports this, maybe prevention of progression will be an indication for treatment. But it is not now. We agree. Since prevention of progression is not an indication for treatment, my opinion is the natural history discussion is less relevant to your consideration in revising the coverage policy. Rather, using the coverage policy we are advocating for therapy will be reserved only for those that have moderate to severe venous symptoms NOW, negatively impacting their life NOW, that have not responded to a trial of conservative therapy NOW. In other words, the indications to treat is to reduce symptoms now not prevent symptoms in the future. This focus on treating patients to reduce symptoms now is consistent with these same NICE guidelines that say:
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- 1.1: Patients with varicose veins should be evaluated and educated about the disease and ways to treat it conservatively
- 1.2: Patients with significant symptoms should be referred to a vascular service immediately. This includes skin changes, phlebitis, symptoms like pain and swelling and wounds or healed wounds
- 1.32: Those with confirmed truncal reflux on ultrasound should be be offered ablation. If that is not possible (due to anatomy), they should be offered sclerotherapy. If that is not possible, they should be offered surgery. The branch veins should be treated at the same time.
- 1.34: Do not offer compression hosiery to treat varicose veins unless interventional treatment is unsuitable.
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SUMMARY:
Its clear venous disease is a progressive problem. The NICE guidelines reference the Edinburgh and Bonn studies that demonstrate this. However the specific comment in the NICE guidelines cited by the HERC about “low evidence” is addressing that there is not enough evidence that prevention of progression should be an indication for surgery. We concur that prevention of progression is not an indication for a procedure based on current evidence. The indications that are supported by class I evidence are to reduce current symptoms (such as refractory dependent edema, stasis dermatitis, recurrent thrombophlebitis or pain impacting activities of daily living) not prevent future symptoms. The policy we advocate for accomplishes this goal from a payer policy perspective.