Clinical Policy Title: Radiofrequency ablation of tumors

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Clinical Policy Title: Radiofrequency ablation of tumors Clinical Policy Number: Effective Date: April 1, 2018 Initial Review Date: February 6, 2018 Most Recent Review Date: March 6, 2018 Next
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Clinical Policy Title: Radiofrequency ablation of tumors Clinical Policy Number: Effective Date: April 1, 2018 Initial Review Date: February 6, 2018 Most Recent Review Date: March 6, 2018 Next Review Date: March 2019 Related policies: Policy contains: Radiofrequency ablation. Neoplasms. Osteoid osteomas. Barrett s esophagus. CP# CP# Radioembolization and chemoembolization for liver cancer and other indications Radiofrequency ablation of uterine fibroids ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of radiofrequency ablation to be clinically proven and, therefore, medically necessary in members aged 18 years and older for treatment of tumors that are accessible to the procedure and at least 1 cm from major organs or structures that could be injured by thermal conduction, including: Hepatocellular carcinoma confirmed by biopsy or imaging (National Comprehensive Care Network [NCCN], 2017a; Interqual, 2016; American College of Radiology [ACR], 2015): - Bridge therapy to maintain candidacy for liver transplantation. - When a member is medically inoperable, ineligible for liver transplantation, or refuses resection, and has either: Barcelona Clinic Liver Cancer early-stage (defined as a single tumor 5 cm at its longest axis, or two or three tumors each 3 cm, Child-Pugh A-B, and performance status 0) with no extrahepatic disease. 1 Barcelona Clinic Liver Cancer intermediate stage (defined as a single large tumor or multinodular disease, preserved liver function, and no extrahepatic spread or macrovascular invasion) and tumors have been downsized to a single tumor 5 cm or two to three tumors each 3 cm following transarterial therapy. Liver metastases confirmed by biopsy or imaging when all of the following criteria are met (NCCN, 2017a, b, c, f; ACR, 2015; Interqual, 2016): - Tumors 5 cm. - Ineligible for surgical resection. - For members with colorectal cancer, metastases are confined to the liver. - For members with neuroendocrine tumor involvement, persistent symptoms after medical treatment with somatostatin analogs. Renal cell carcinoma when all of the following criteria are met (NCCN, 2018; Interqual, 2017): - Stage I (T1a). - Confirmed by biopsy. - Single tumor 1 cm and 4 cm. - No metastasis. Symptomatic osteolytic bone metastases in members who have failed, or are poor candidates for, standard pain treatments such as radiation or opioids (Rosian, 2017; Rosenthal, 2012; Warmuth, 2012). Primary or secondary lung cancers (NCCN, 2018; National Institute for Health and Care Excellence [NICE], 2010a): - Early-stage, resectable (stage I-II, N0) non-small cell lung cancer in members who are medically inoperable or refuse surgery (Bi, 2016; Sher, 2011). - For members: who are not candidates for stereotactic ablative radiotherapy, external beam radiation therapy, or sublobar resection; who have failed stereotactic ablative radiotherapy; or for whom local control may not be the highest priority (NCCN, 2018). Primary therapy for: Intestinal metaplasia (Barrett s esophagus) (Almeida, 2016; NICE, 2014; NICE, 2010b). Early-stage esophageal or esophagogastric cancer (ptis, pt1a, ptibn0) with or without endoscopic resection (NCCN, 2017d). After esophageal resection for residual or recurrent high-grade or low-grade esophageal dysplasia (NCCN, 2017d; Evans, 2013). Thyroid cancer for locoregional control when standard therapy (e.g., surgery or local therapies) is contraindicated, has failed, or is refused (NCCN, 2017e; NICE, 2016). Metastatic (synchronous stage IV) soft tissue sarcoma of the trunk, extremity, head, or neck (NCCN, 2018c; Gronchi, 2016): - Primary local therapy when confined to a single organ and limited tumor bulk. - Palliative therapy for symptomatic disseminated disease. 2 AmeriHealth Caritas considers the use of radiofrequency ablation to be clinically proven and, therefore, medically necessary for treatment of osteoid osteomas that cannot be managed successfully with medical treatment, are accessible to the procedure, and at least 1 cm from major organs or structures that could be injured by thermal conduction (Rosenthal, 2012; Warmuth, 2012). Limitations: The effectiveness of radiofrequency ablation for indications other than the ones listed above has not been established. Radiofrequency ablation may be considered on a case-by-case basis for removal of other primary or metastatic malignant neoplasms when either: Removal of the neoplasm may be curative and the member is unable to tolerate or refuses surgical resection or radiation therapy. Palliative debulking or complete removal may relieve symptoms. Relative contraindications include (NCCN, 2017a, b, c; Interqual, 2016): Ablative margins measuring less than 1 cm (i.e., tumors should be located at least 1 cm from critical structures or vessels to achieve complete tumor destruction), except in cases of palliation or debulking. More than three tumors per organ. However, the number of lesions should not be considered an absolute contraindication to radiofrequency ablation if successful treatment of all metastatic deposits can be accomplished. Untreatable or unmanageable coagulopathy is an absolute contraindication to radiofrequency ablation. Alternative covered services: Standard of care specific to each tumor. Background Radiofrequency ablation applies heat using high-frequency alternating current via electrodes placed within the tissue to induce tissue coagulation and cell death (Friedman, 2004). It is one of several types of ablative therapies used to treat a wide range of cardiac, neurologic, vascular, and oncologic conditions. The U.S. Food and Drug Administration (FDA) classifies radiofrequency ablation as an electrosurgical, cutting, and coagulation device with 510(k) marketing submission requirements (FDA, 2017). Radiofrequency ablation can be applied percutaneously, laparoscopically, or at open surgery. The choice of technique will depend on: the patient s condition; tumor size, number, location, and growth pattern; 3 and operator and local practice patterns. It may be performed in outpatient or inpatient settings under general anesthesia, conscious sedation, or deep sedation (Friedman, 2004). Percutaneous radiofrequency ablation is a minimally invasive, repeatable procedure performed under radiologic guidance. The percutaneous approach requires that tumors not lie adjacent to other organs or vessels that could be injured by thermal conduction. Surgical approaches allow a more accurate evaluation of disease in and around the organ and present less risk to adjacent structures. The open approach allows for concurrent combination therapies, such as resection and placement of pumps for regional chemotherapy (Friedman, 2004). This policy will focus on radiofrequency ablation as treatment for tumors and pre-malignant conditions, excluding treatment of uterine fibroids. See Clinical policy # Radiofrequency ablation of uterine fibroids. Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on January 8, Search terms were: Catheter Ablation (MeSH), Neoplasms (MeSH), and the free text terms radiofrequency ablation and RFA. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Radiofrequency ablation was initially indicated as a treatment option for inoperable hepatic tumors. The liver is a common site for metastasis from solid tumors, and many are unsuitable for surgical excision because of their number, distribution, or the presence of extrahepatic spread (NCCN, 2017a). 4 Increasingly, radiofrequency ablation is becoming an attractive treatment option for locoregional control, palliation, and, in some circumstances, cure of other solid tumors, including some operable tumors for which well-established local or systemic treatment alternatives are available. For patients who present with significant surgical risks or who have significant competing comorbidities, radiofrequency ablation balances potential cure, locoregional control, or palliation with treatment toxicity and benefits common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). Existing evidence and clinical experience supports radiofrequency ablation as a safe procedure in the hands of an experience specialist and effective in tumor destruction, which may be associated with higher survival rates for some cancers. The most common complications include post-procedural pain, fever, and burns. An absolute contraindication is uncontrolled coagulopathy. Other relative contraindications primarily relate to tumor location and underlying organ function. To be amenable to ablation, typically a 1 cm margin of tumor-free tissue is needed, except in cases of palliation or debulking, and the tumor must be in an accessible location and away from major organs and vessels. Currently, there is no standard tumor size or number of tumors appropriate for ablation; however, studies have found improved outcomes when tumors 4 cm or smaller are treated (NCCN, 2017a, b, c; Interqual, 2016). Typically, choice of ablative technique is based on tumor size (radiofrequency ablation is most effective for treating tumors 3 cm at their longest axis) and location and underlying organ function (NCCN, 2017a). Except for studies of osteoid osteoma, most studies included patients older than 17 years. Radiofrequency ablation is an established treatment alternative for the following hepatic indications (NCCN, 2017a, b, c; ACR, 2015): Early-stage hepatocellular carcinoma: - Curative therapy for isolated tumors 3 cm (in select cases, up to 5 cm). - Locoregional therapy in medically inoperable patients. Neoadjuvant therapy as a bridge to transplant. Isolated colorectal liver metastasis 3 cm to 5 cm. There is sufficient evidence to support radiofrequency ablation as a locoregional treatment option for the following extrahepatic indications: Early-stage renal cell carcinoma without metastasis (NCCN, 2018a). Symptomatic osteolytic bone metastases in persons who have failed, or are poor candidates for, standard treatments such as radiation or opioids (Rosian, 2017; Rosenthal, 2012; Warmuth, 2012). Osteoid osteomas that cannot be managed successfully with medical treatment (Rosenthal, 2012; Warmuth, 2012). Primary or secondary lung cancers (NCCN, 2018b; NICE, 2010a): 5 - Early-stage, resectable (stage I-II, N0) non-small cell lung cancer in patients who are medically inoperable or refuse surgery (Bi, 2016; Sher, 2011). - For patients who are not candidates for stereotactic ablative radiotherapy, external beam radiation therapy, or sublobar resection; who have failed stereotactic ablative radiotherapy; or for whom local control may not be the highest priority (NCCN, 2018b). Primary therapy for intestinal metaplasia (Barrett s esophagus) (NCCN, 2017d; Almeida, 2016; NICE, 2014; NICE, 2010b). Residual or recurrent high-grade or low-grade esophageal dysplasia after esophageal resection (NCCN, 2017d; Evans, 2013). Thyroid cancer for locoregional control when standard therapy (e.g., surgery or local therapies) is contraindicated, has failed, or is refused (NCCN, 2017e). Metastatic (synchronous stage IV) soft tissue sarcoma of the trunk, extremity, head, or neck (NCCN, 2018c): Primary local therapy when confined to a single organ and limited tumor bulk. Palliative therapy for symptomatic disseminated disease. There is insufficient evidence to support the use of radiofrequency ablation for treatment of any other malignant primary tumor or benign tumor, such as Morton s neuroma (American Orthopaedic Foot and Ankle Society, 2018; Valerio, 2017; Peek, 2016; Association of Extremity Nerve Surgeons, 2014; Fegrachi, 2014; Fischer, 2012b). Policy updates: None. Summary of clinical evidence: Citation Rosian (2017) for the Ludwig Boltzmann Institut für Health Technology Assessment (LBIHTA) Radiofrequency ablation for metastatic spinal lesions Content, Methods, Recommendations Systematic review of four prospective single-arm studies and five retrospective single-arm studies with at least 30 patients. Data on safety and efficacy were evaluated in 471 and 112 patients, respectively. Significant improvement in pain relief (three prospective studies) and health-related quality of life (two studies) after treatment with radiofrequency ablation and vertebroplasty. No recurrence of vertebral metastases during follow-up (one study). No major radiofrequency ablation-related complications were reported. Adverse event rate (procedure-related or not procedure-related) = 18% (105/583 patients); most frequent radiofrequency ablation-related adverse events were increased pain and numbness (7.8%, 6/77 patients); most frequent adverse event reported related to vertebroplasty was cement extravasation (18.7%, 67/358 patients). 6 Citation Valerio (2017) New and established technology in focal ablation of the prostate Almeida (2016, update of Xie, 2009) for the Technology Assessment Unit of McGill University Health Centre Radiofrequency ablation for treatment of Barrett s esophagus Bi (2016) Comparison of the effectiveness of radiofrequency ablation with stereotactic body radiation therapy in inoperable stage I nonsmall cell lung cancer Chen (2016) Radiofrequency ablation for treatment of benign thyroid nodules Peek (2016) Content, Methods, Recommendations Systematic review of 37 studies (3,230 total patients) of focal therapy using seven sources of energy in single-arm retrospective and prospective development studies, including one case series on radiofrequency. Focal therapy seems to have a minor impact on quality of life and genito-urinary function. Oncological effectiveness is yet to be defined against standard of care. Systematic review and cost analysis of two randomized controlled trials (RCTs), eight single arm cohort studies, and one systematic review for high-grade dysplasia, and two RCTs, one single-arm cohort study, and two meta-analyses for low-grade dysplasia. Considered standard of care for treatment of high-grade dysplasia based on good-quality evidence of effectiveness and safety in eliminating dysplastic tissue and higher morbidity associated with esophagectomy. More controversial for low-grade dysplasia based on lower quality evidence of diagnostic accuracy, uncertainty surrounding the progression rates to cancer, and the spontaneous reversion in some patients. Routine use not recommended but may be considered in patients with risk factors suggestive of higher risk of progression to high-grade dysplasia/cancer (e.g., multifocal, long segment, or persistent Barrett s esophagus). Systematic review and pooled analysis of 31 primarily case series of stereotactic body radiation therapy (2,767 patients) and 13 studies of radiofrequency ablation (328 patients). Local tumor control rates (95% confidence interval) at 1, 2, 3, and 5 years: - Radiofrequency ablation = 77% (70% to 85%), 48% (37% to 58%), 55% (47% to 62%), and 42% (30% to 54%), respectively. - Stereotactic body radiation therapy = 97% (96% to 98%), 92% (91% to 94%), 88% (86% to 90%), and 86% (85% to 88%) (P .001). Differences remained significant after correcting for stage IA and age (P .001 at 1 year, 2 years, and 3 years; P =.04 at 5 years). No statistically significant difference in overall survival between modalities (P .05). Most frequent complication of radiofrequency ablation was pneumothorax (31%) and of stereotactic body radiation therapy was (grade 3) radiation pneumonitis (2%) Systematic review and meta-analysis 20 single-arm studies comprising data from 1,090 patients with 1,406 benign thyroid nodules. Overall quality: low with significant publication bias. Radiofrequency ablation significantly decreased nodule volume at 1, 3, 6, 12, and the last follow-up months compared to baseline, including a decline by cold and hot nodules. Radiofrequency ablation decreased the largest diameter, symptom score, cosmetic score, triiodothyronine level, and vascular scale, had no effect in free thyroxine, and increased thyrotropin level. 7 Citation Minimally invasive ablative techniques in the treatment of breast cancer Fegrachi (2014) Radiofrequency ablation for unresectable locally advanced pancreatic cancer Fischer (2012a) for the LBIHTA Radiofrequency ablation for the treatment of benign and malignant nodules of endocrine organs (thyroid gland and adrenal gland) Fischer (2012b) for the LBIHTA Radiofrequency ablation for the treatment of head and neck cancer Rosenthal (2012) Content, Methods, Recommendations Systematic review and meta-analysis of 63 studies, including 1,608 patients with breast tumors treated with radiofrequency ablation, high-intensity focused ultrasound, and cryo-, laser-, or microwave-ablation. Highest rate of complete ablation was achieved with radiofrequency ablation (87.1%, 491/564 patients) and microwave ablation (83.2%, 89/107 patients). Microwave ablation had the highest rate of short-term complications (14.6%, 21/144 patients). Overall recurrence rate = 4.2% (24/570 patients) and most often with laser ablation (10.7%, 11/103 patients). Radiofrequency ablation had the shortest treatment times (15.6 ± 5.6 min) and highintensity focused ultrasound the longest (101.5 ± 46.6 min). Adequately powered and prospectively conducted cohort trials are needed to confirm complete pathological ablation in all patients. Systematic review of five non-comparative studies (158 total patients). Overall quality: low with high risk of bias and heterogeneous study populations and outcomes. Median survival after radiofrequency ablation = three months to 33 months. Procedure-re
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