Medical Policy Title: Extracorporeal Shock ARBenefits Approval: 10/12/11

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1 Medical Policy Title: Extracorporeal Shock ARBenefits Approval: 10/12/11 Wave Lithotripsy for Gallstones Effective Date: 01/01/2012 Document: ARB0155 Revision Date: Code(s): Endoscopic retrograde cholangiopancreatography (ERCP); with endoscopic retrograde destruction, lithotripsy of calculus/calculi, any method S9034 Extracorporeal shockwave lithotripsy for gall stones (if performed with ERCP, use 43265) Public Statement: Administered by: Extracorporeal shock wave lithotripsy (ESWL) for gallstones is a non-invasive procedure for disintegrating gallstones. High-intensity shock waves ( shocks over minutes) are focused sonographically on the gallstones. This procedure is covered for patients with symptomatic single gallstones 20mm or less in diameter who are not surgical candidates. Medical Policy Statement: Extracorporeal shock wave lithotripsy (ESWL) for gallstones, in conjunction with ursodiol therapy, is considered medically necessary and is covered for patients: 1. With symptomatic non-calcified single gallstones measuring 20 mm or less AND 2. Who are either not considered candidates for either open or laparoscopic cholecystectomy due to comorbidities, OR 3. Who actively refuse a surgical option. Background: Enthusiasm for ESWL treatment of gallstones was initially prompted by successful ESWL treatment of kidney stones. Fragmented renal stones could be flushed out relatively easily through the urinary flow. However, in the dependent gallbladder, the fragmented gallstones were often retained and could lead to recurrent biliary colic. In Page 1 of 6

2 the early 1990s interest in ESWL of gallstones waned as laparoscopic cholecystectomy emerged as the treatment of choice for symptomatic cholelithiasis. Research on ESWL treatment of gallstones refocused on its use as an adjunct to ursodiol treatment. In this setting, ESWL was used as a treatment to increase the effectiveness of ursodiol therapy by fragmenting the stones thus increasing their surface area. In fact the clinical studies presented to the FDA as part of the approval process focused on the ability of ESWL to enhance the effectiveness of ursodiol alone. The labeled indication for ESWL for gallstones suggests that the drug be given 2 weeks prior to ESWL and then continued up to 20 months after ESWL or until a stone-free state is achieved. The FDA approval was based on several different studies performed in the 1980s. The data from these studies were reanalyzed to permit a comparison between the outcomes of ursodiol treatment alone and ursodiol treatment combined with ESWL treatment. This complex statistical analysis is difficult to follow in the available FDA advisory committee minutes. However, the data suggest that the clearance rate of gallstones was 60% better in those receiving the combined therapy compared to those receiving ursodiol alone. The best results were seen in those with a single non-calcified gallstone measuring less than 20 mm in diameter. However, it is clear that cholecystectomy still represents the treatment of choice, due to the prompt resolution of symptoms in appropriately selected patients and the absence of stone recurrence, which may recur at a rate of 10% per year in the absence of cholecystectomy. Approximately 500,000 patients per year undergo cholecystectomy. Of these, perhaps 150,000 would be considered candidates on the basis of stone number and size alone. Only a small percentage of these patients would not be considered surgical candidates. A 10-year prospective study on 192 patients who were followed following complete eradication of stone (n = 159) or stones (n = 33) identified 108 patients without recurrence (median of 6.7 years). By acuarial analysis, the cumulative recurrence rates for these 192 stone-free patients were 27% at 3 years, 41% at 5 years, and 54% at 10 years. The authors concluded, "The long-term results are unsatifactory and ESWL of gallbladder stones should be offered only in special cases. ESWL for pancreatic stones was reported in a retrospective study from Japan: 117 patients were treated. 70 patients were followed up after 3 years (evaluated retrospectively) Immediate pain relief was achieved in 97% and complete removal of stones achieved in 56%. In follow-up, 49 of the 70 continued to be asymptomatic. A case report from Japan described a 16 y.o. patient who had undergone excision of excision of a choledochal cyst at age 3, but developed symptomatic stones at the proximal end of the hepatico-jejunostomy anastamosis was treated with ESWL (6 sessions) with complete elimination of the stones. Based on this one case the authors concluded that ESWL "could be a treatment of choice for bile duct stone formation after choledochal cyst excision." A Cochrane Review of Effectiveness done by the Swedish Council on Technology Assessment in Health Care concluded, "Treatment of the gallbladder with lithotripsy Page 2 of 6

3 must be tested further in Randomized Controlled Trial study before introducing the method in clinical practice." References: Adamek HE, Jakobs R, Buttman A, et al.(1999) Long term follow up of patients with chronic pancreatitis and pancreatic stones treated with extracorporeal shock wave lithotripsy. Gut 1999; 45: Adamek HE, Maier M, Jakobs R, et al.(1996) Management of retained bile duct stones: a prospective open trial comparing extracorporeal and intracorporeal lithotripsy. Gastrointest Endosc 1996; 44: Amplatz S, Piazzi L, Felder M, et al.(2007) Extracorporeal shock wave lithotripsy for clearance of refractory bile duct stones. Dig Liver Dis, 2007; 39: Barkun AN, Barkun JS, Sampalis JS, et al.(1997) Costs and effectiveness of extracorporeal gallbladder stone shock wave lithotripsy versus laparoscopic cholecystectomy: a randomized clinical trial. Int J Tech Assess Health Care 1997; 13: Blind PJ, Lundmark M.(1998) Management of bile duct stones: lithotripsy by laser, electrohydraulic, and ultrasonic techniques. Report of a series and clinical review. Eur J Surg 1998; 164: Borch K, Jonsson KA, Lindstrom E, et al.(1996) Extracorporeal shock-wave lithotripsy of gallbladder stones: an alternative for the selected few. Eur J Surg 1996; 162: Carlsson P, Ihse I, Petterson S, et al.(2007) Lithotripsy of kidney stones and gallstones. The Swedish Council on Technology Assessment in Health Care. Cochrane Health Technology Assessment Database, 2007, Issue 4. Carrilho-Ribeiro L, Pinto-Correla A, Velosa J, et al.(2006) A ten-year prospective study on gallbladder stone recurrence after successful extracorporeal shock-wave lithotripsy. Scand J Gastroenterol, 2006; 41: Carroccio A, Iovanna JL, Iacono G, et al.(1997) Pancreatitis-associated protein in patients with celiac disease: serum levels and immunocytochemical localization in small intestine. Digestion 1997; 58: Costamagna G, Gabbrieli A, Mutignani M, et al.(1997) Extracorporeal shock wave lithotripsy of pancreatic stones in chronic pancreatitis: immediate and medium-term results. Gastrointest Endosc 1997; 46: Coverage Issues Manual Page 3 of 6

4 Delhaye M, Vandermeeren A, Baize M, et al.(1992) Extracorporeal shock wave lithotripsy of pancreatic calculi. Gastro 1992; 102: Dig Dis Sci 1993; 38: Dion YM, Morin J.(1995) The role of extracorporeal shock-wave lithotripsy in the treatment of symptomatic cholelithiasis. Can J Surg 1995; 38: Elewart A, Crape A, Afschrift M, et al.(1993) Results of extracorporeal shock wave lithotripsy of gall bladder stones in 693 patients: a plea for restriction to solitary radiolucent stones. Gut 1993; 34: FDA Advisory Committee Minutes FDA.(1999) Gastroenterology and urological devices; reclassification of the extracorporeal shockwave lithotripter. Federal Register. February 8, 1999; 64: Gallstones and Laparoscopic Cholecystectomy. NIH Consensus Statement. September 14-16, 1992; 10:1-26http://odp.od.nih.gov/consensus/cons/090/090_statement.pdf. Gilchrist AM, Ross B, Thomas WE.(1997) Extracorporeal shockwave lithotripsy for common bile duct stones. Br J Surg 1997; 84: Hochberger J, Bayer J, May A, et al.(1998) Laser lithotripsy of difficult bile duct stones: results in 60 patients using a rhodamine 6G dye laser with optical stone tissue detection system. Gut 1998; 43: Howard DE, Fromm H.(1999) Nonsurgical management of gallstone disease. Gastroenterol Clin North Am 1999; 28(1): Int J Tech Assess Health Care 1994; 10:713. Jakobs R, Adamek HE, Maier M, et al.(1997) Fluoroscopically guided laser lithotripsy versus extracorporeal shock wave lithotripsy for retained bile duct stones: a prospective randomized study. Gut 1997; 40: Lindstrom E, Borch K, Kullman EP, et al.(1992) Extracorporeal shock wave lithotripsy of bile duct stones: a single institution experience. Gut 1992; 33: Med J Aust 1993; 158: Neuhaus H, Zillinger C, Bom P, et al.(1998) Randomized study of intracorporeal laser lithotripsy versus extracorporeal shock-wave lithotripsy for difficult bile duct stones. Page 4 of 6

5 Gastro Endosc 1998; 47: Nicholl JP, Brazier JE, Milner PC, et al.(1992) Randomized controlled trial of costeffectiveness of lithotripsy and open cholecystectomy as treatments for gallbladder stones. Lancet 1992; 340: NIDDK.(1998) Gallstones Ohara H, Hoshino M, Hayakawa T, et al.(1996) Single application extracorporeal shockwave lithotripsy is the first choice for patients with pancreatic duct stones. Am J Gastro 1996; 91: Okada Y, Miyamoto M, Yamazaki T, et al.(2007) Piezoelectric extracorporeal shockwave lithotripsy for bile duct stone formation after choledochal cyst excision. Pediatric Surg Int, 2007; 23: Sackmann M, Niller H, Klueppelberg U, et al.(1994) Gallstone recurrence after shockwave therapy. Gastro 1994; 106: Sauerbruch T, Holl J, Sackmann M, et al.(1992) Extracorporeal lithotripsy of pancreatic stones in patients with chronic pancreatitis and pain: a prospective follow-up study. Gut 1992; 33: Sauerbruch T, Holl J, Sackmann M, et al.(1992) Fragmentation of bile duct stones by extracorporeal shock-wave lithotripsy: a five-year experience. Hepatologya 1992; 15: Soehendra N, Nam VC, Binmoeller KF, et al.(1994) Pulverization of calcified and noncalcified gall bladder stones: extracorporeal shock wave lithotripsy used alone. Gut 1994; 35: Tadenuma H, Ishihara T, Yamguchi T, et al.(2005) Long-term results of extracorporeal shockwave lithotripsy and endoscopic therapy for pancreatic stones. Clin Gastroenterol Hepatol, 2005; 3: White DM, Correa RJ, Gibbons RP, et al.(1998) Extracorporeal shock-wave lithotripsy for bile duct calculi. Am J Surg 1998; 175: Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 5 of 6

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Long-term Results of Extracorporeal Shockwave Lithotripsy and Endoscopic Therapy for Pancreatic Stones

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2005;3:1128 1135 Long-term Results of Extracorporeal Shockwave Lithotripsy and Endoscopic Therapy for Pancreatic Stones HIROSHI TADENUMA, TAKESHI ISHIHARA, TAKETO