Managed Care - August 2012 - (Page 13)

EVIDENCE REVIEW The results of two low-quality studies suggest that adding MelaFind to standard practice is unlikely to decrease the number of unnecessary biopsies to a clinically relevant degree. 3. What adverse events (AEs) are reported in studies of the MelaFind system? A small number of false-negative results (0.17 percent) were reported in two studies of the MelaFind system, which could delay diagnosis and treatment. In the study conducted for the premarket approval application submission, one melanoma in situ, one invasive melanoma, and one high-grade lesion were not detected. In the smaller Friedman et al. study, one melanoma in situ was missed. If clinicians rely heavily on the “negative” findings of the MelaFind device to recommend against biopsies, some melanomas may be missed. Diffusion MELA Sciences planned to launch MelaFind to about 200 selected “high-volume,” integrated dermatology and skin cancer specialists’ practices. As of June 2012, MELA Sciences has distributed four systems in the United States and two systems in Germany. Physician practices pay a one-time fee of about $7,500 to lease MelaFind and undergo company training. There is a fee of $50 per procedure to unlock the system for each use. Diffusion is likely to be slow given the competition from numerous available dermoscopic devices and lack of reimbursement at the time of the product launch. Dermatologists may be reluctant to adopt this technology given the added expense and the fact that most third-party payers currently reimburse all or part of the expense of performing biopsies for clinically atypical lesions. Coverage In the United States, the Centers for Medicare & Medicaid Services (CMS) does not have a national coverage policy for multispectral analysis of skin. Thus, coverage for use of the MelaFind device to assess suspected skin lesions is at the discretion of local Medicare contractors. ECRI Institute routinely searches 11 major private, third-party payers that publish their policies online (i.e., Aetna, Anthem, Blue Cross/Blue Shield Alabama, Blue Cross/Blue Shield Massachusetts, CIGNA, HealthPartners, Humana, Medica, Regence, Wellmark, UnitedHealthcare). Many private payers have not updated their coverage policies since FDA approval of the MelaFind device in November 2011. However, coverage determination for multispectral analysis using this device will likely be included in policies that describe dermoscopy STATE OF EVIDENCE BASE Quantity of evidence: Low. The evidence base for this technology consists of two studies: a prospective, blinded trial that enrolled 1,383 patients with 1,831 pigmented lesions that had one or more clinical or historical characteristics of melanoma. The findings of MelaFind and dermatologists’ clinical judgment were compared to histopathology results and a blinded, comparison trial that evaluated the performance of 10 specialized clinicians in diagnosing 99 small pigmented skin lesions (diameter ≤6 mm) compared with using the MelaFind system. Quality of evidence: Low. Weaknesses of the evidence base include the following: results may not be applicable to standard practice; the case-control study may overestimate the test’s accuracy; a considerable number of lesions in the study prepared for the U.S. Food and Drug Administration premarket approval submission were ineligible for analysis or not evaluable due to operator error. Also, as with many new technologies, potential conflict of interest exists as the MelaFind manufacturer funded all studies available for analysis. Consistency of evidence: Low. Too few studies are available to evaluate the consistency of patient-oriented outcomes of interest among different studies. in general. Payers that decide to reimburse for this test are likely to restrict coverage to exams performed only by dermatologists. Our searches found two major payers with policies that describe coverage for dermoscopy in general (i.e., Aetna, CIGNA), five payers with policies that deny coverage for dermoscopy (i.e., Anthem, BCBS Alabama, BCBS Massachusetts, Humana, Wellmark) and four payers without a specific policy (i.e., HealthPartners, Medica, Regence, UnitedHealthcare). Excerpted with permission from ECRI Institute’s database of Emerging Technology Evidence Reports. To download the full report, visit www.ecri.org/managedcare. For inquiries about this report or membership in ECRI Institute’s Health Technology Assessment Information Service, send an e-mail to htais@ecri.org. AUGUST 2012 / MANAGED CARE 13 http://www.ecri.org/managedcare

Table of Contents for the Digital Edition of Managed Care - August 2012

Managed Care - August 2012
Editor’s Memo
Contents
Legislation & Regulation
News & Commentary
Medication Management
Evidence Review
Compensation Monitor
Private Exchanges: Practice Makes Perfect
Hospitals and Providers Ganging Up on Plans?
Q&A: Kaiser Permanente’s Sharon Levine, MD
God Save the Health Care System!
Future Points to Greater PBM/Plan Cooperation
Formulary Files
Plan Watch
Tomorrow’s Medicine
Outlook

Managed Care - August 2012