OHTAC Recommendation

Transcription

1 OHTAC Recommendation Radiofrequency Ablation for hepatocellular carcinoma or primary June 17,

2 The Ontario Health Technology Advisory Committee (OHTAC) met on June 17, 2003 and reviewed a recommendation to increase availability of radiofrequency ablation (RFA) for primary or hepatocellular carcinoma (HCC). RFA is one of several ablative techniques used for patients. A generator that provides high levels of impedance provides intense heat through an electrode probe that is inserted through the abdomen, into the liver and directly into the centre of the tumour. This applied intense heat kills the tumour. RFA is indicated primarily for patients who are not eligible for liver resection or transplant and who have a few (less than 3 or 4), small (< 4 cm) liver nodules. The incidence of in Ontario is relatively low, affecting approximately 455 people in Ontario each year. Alcohol cirrhosis and underlying hepatitis infection are the prime risk factors. The first line of treatment for HCC patients is surgical resection or transplant, which may provide 50% survival or more at 5 years. However, only 15-25% of patients with HCC are eligible for surgery, based on patient clinical characteristics. Fewer still will receive a transplant. For patients who are not eligible for resection, treatment options are limited. Systemic chemotherapy has no cited benefit. Ablative techniques, however, have been shown to be effective for patients who cannot undergo surgery. These procedures are typically outpatient procedures performed by an interventional radiologist. Aside from RFA, percutaneous ethanol injection (PEI) is the most commonly cited ablative technique whereby an injection of ethanol is applied into each liver nodule. Complete tumour ablation may be observed with one RFA session, but in several PEI sessions. Transcatheter arterial chemoembolization [TACE] is another therapeutic procedure whereby a chemotherapeutic agent is directly applied into the liver through a catheter that is placed in the hepatic artery. This is an inpatient procedure, requiring 2 to 3 days of hospital stay. Outcomes are worse than ablation, up to 50% at 2 years. Several international health technology assessments have evaluated RFA from 2002 to Despite the reviews being heterogeneous in their 2

3 focus and literature review inclusion criteria, there was agreement that RFA is a safe and effective procedure for unresectable HCC patients with a few, small nodules and without extrahepatic disease. The results of one small clinical trial, that randomized 100 unresectable HCC patients into RFA and PEI arms, was the main evidence cited in the international HTAs. This study showed that complete ablation was observed in 91% of tumours treated with RFA in one session, compared with 82% of tumours treated with PEI in about six sessions. A significant difference in 2-year local recurrence free survival was observed after RFA treatment (96%) versus PEI (62%). There was no significant difference in overall survival between the two groups because the overall sample size was small and there were few deaths observed in either treatment arm. Nevertheless, the 2-year survival rates were 98% for RFA and 88% for PEI. There was also no difference in the risk of developing new nodules in the two groups because the underlying disease course was similar in the patients in both arms. A few, small case series studies also observed a survival benefit of RFA, with a 70-90% 3-year survival for patients with a few, small liver tumours who were treated with this procedure. This outcome is favourable when compared to patients who receive no treatment for whom 3-year survival is 0-36%. However, no clinical trials have compared ablative treatment with no treatment. The Ontario budget impact of RFA is relatively low, projected to be below $500,000 per year. This includes the amortized costs of the generator, the costs of disposable electrodes, proposed physician fee and day procedure costs for an estimated 80 to 130 patients who may be eligible for RFA in Ontario (20-30% of 455 possible patients). An Ontario economic decision analysis conducted by MAS shows that RFA and PEI are dominant over TACE as a therapy of choice for nonresectable, as TACE is much more costly and far less costeffective. RFA is marginally more costly than PEI, but is much more cost effective (approximately $3,000 per life year gained). 3

4 There is consensus among the international HTAs that there is currently no evidence of effectiveness of RFA in the treatment of liver metastases or other primary cancer sites. Despite this dearth of evidence, RFA is currently being used for patients with these indications, both in Ontario and in other jurisdictions. Based on the above discussion, OHTAC concluded that: RFA is an important technology in the management of unresectable HCC. There is Level 2 evidence that RFA is as safe and more effective than PEI in the treatment of HCC in terms of disease-free survival. RFA and PEI are more effective and more cost-effective than TACE in the treatment of HCC. RFA is marginally more costly yet more costeffective than PEI. Although complications are few, RFA should be performed by an experienced interventional radiologist. The use of RFA for liver metastases or other primary cancer sites is not encouraged at this time. However, RFA may benefit some patients in these disease areas according to patient clinical presentation. OHTAC recommends: 1. RFA be considered as one treatment option for patients with small unresectable HCC. Use of RFA for indications other than primary liver cancer is considered experimental and should not be encouraged at this time. 2. TACE be considered as a treatment option for patients with unresectable HCC only when RFA and PEI ablative techniques fail. 3. Clinical and utilization guidelines for treatment of unresectable HCC be developed through Cancer Care Ontario. 4

5 4. RFA be made available on a regional basis in multi-disciplinary units with expertise in this area at not more than 3 or 4 hospitals in the province. 5. A fee code application for RFA for primary hepatocellular carcinoma (HCC) () be considered by the Physician Services Committee. 5