Category: Uncategorized
- Published: 29 November -0001
Chalfont St Giles, UK – September 4th, 2008 – Photodynamic Diagnosis of Bladder Cancer (PDD) has been selected by The NHS Technology Adoption Centre (NTAC), from over 50 applications, as a “Technology implementation project”.
The aim of these projects is to enable effective uptake of new technologies as standard care within the NHS, by gaining an understanding of implementation issues and how to overcome potential barriers to the adoption of the latest technology. The selection was based on those technologies which are clinically proven, have improved patient outcomes or system efficiencies, support NHS policy and clinical focus – but have still had minimal adoption by the NHS.
Margaret Parton, NHS Technology Hub Adoption Centre Chief Executive says: “The photodynamic diagnosis of bladder cancer is an exciting technology with the potential to deliver excellent benefits to patients. We are delighted that it has passed the very stringent criteria applied by the NHS Technology Centre to become part of the implementation programme”.
To date, GE Healthcare’s HexvixÒ (hexaminolevulinate) is the only approved product in the UK market to perform a PDD or fluorescence cystoscopy. “The company is delighted that HexvixÒ cystoscopy has been selected as one of the NHS projects- GE Healthcare’s vision of early health is embodied by HexvixÒ as it helps detect more bladder cancer lesions in more patients. It is fantastic to see this technique selected for the implementation project in order to make it available to more patients’”, said Nigel Mason, GE Healthcare’s Country Manager in the UK.
Bladder cancer is one of the most expensive cancers to treat because of its combination of long survival and intensive and costly routine monitoring and treatment due to the recurrent nature of the disease[1]. In the UK, the total cost for diagnosis, treatment and five-year follow-up of patients diagnosed with bladder cancer was 55 million GBP (2001-2002), with the majority of the cost borne by the NHS. The mean cost per patient with bladder cancer was 8349 GBP over the five years[2].
Bladder cancer is the fourth most commonly diagnosed malignancy in men and tenth among women in the UK[3]. GE Healthcare\'s Hexvix cystoscopy might prove to be a cost effective technique and it is hoped it can have a significant impact in the patient\'s quality of life. Recent analytic modeling has suggested that the use of Hexvix might reduce the economic impact of this disease.
“I have been using HexvixÒ for a period of time, and with it I can find and resect more bladder lesions compared to white light cystoscopy alone which can be a significant benefit to a patient and their long term prognosis” said Mr. Hugh Mustafid, Consultant Urological Surgeon to the North Hampshire Hospital.
The economic benefits of Hexvix were recently assessed in a decision analytic model reflecting practice patterns and costs in the UK. The model predicted a possible reduction of 18% in the number of cystectomies and 4.3% reduction in TURBs when Hexvix cystoscopy was compared to white light cystoscopy (WLC). Using the same modeling an increase of 211.106 disease free days (DFD) was predicted for Hexvix over a two year time horizon for more than 9.000 patients in comparison with WLC, improving quality of life for patients[4]. Whilst these data are still to be proven by clinical trials the modelling , based on expert input, is encouraging.
References:
[1]. Botteman M et al. (2003) The health economics of bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics 21: 1315–1330 [2]. Sanger VK, Ragavan N, Matanhelia SS, et al. The economic consequences of prostate and bladder cancer in the UK. BJU Inter 2005;95:59–63.
[3]. Http://info.cancerresearchuk.org/cancerstats/types/bladder/incidence/#source1 (29/08/08) [4]. Hexvix Fluorescente Cystoscopy for non-invasive bladder cancer management: an economic model on the impact on healthcare cost in the UK. T. Zyckynski et al.
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PRESCRIBING INFORMATION HEXVIX (hexaminolevulinate) Please refer to full national Summary of Product Characteristics (SPC) before prescribing. Indications and approvals may vary in different countries. Further information available on request.
Hexvix 85 mg, powder and solvent for solution for intravesical use. PRESENTATION Pack of one 10ml glass vial containing 85mg of hexaminolevulinate as 100mg hexa-minolevulinate hydrochloride as a powder and one 50ml polypropylene or glass vial containing sol-vent. After reconstitution in 50ml of solvent, 1ml of the solution contains 1.7mg hexaminolevulinate which corresponds to a 8mmol/l solution of hexaminolevulinate.
INDICATIONS This medicinal product is for diagnostic use only. Detection of bladder cancer, such as carcinoma in situ, in patients with known bladder cancer or high suspicion of bladder cancer, based on e.g. screening cystoscopy or positive urine cytology. Blue light fluorescence cystoscopy should be used as an adjunct to standard white light cystoscopy, as a guide for taking biopsies.
DOSAGE AND METHOD OF ADMINISTRATION Hexvix cystoscopy should only be performed by health care professionals trained specifically in Hexvix cystoscopy. The bladder should be drained before the instillation. Adults (including the elderly): 50ml of 8mmol/l reconstituted solutionis instilled into the bladder through a catheter. The patient should retain the fluid for approximately 60 minutes. Following evacuation of the bladder, the cystoscopic examination in blue light should start within approximately 60 minutes. Patients should be examined with both white and blue light to obtain a map of all lesions in the bladder. Biopsies of all mapped lesions should normally be taken under white light. Only CE marked cystoscopic equipment should be used, equipped with necessary filters to allow both standard white light cystoscopy and blue light (wavelength 380–450nm) fluorescence cystoscopy Children and adolescents: There is no experience of treating patients below the age of 18 years.
CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients of the solvent. Porphyria. Women of child-bearing potential.
WARNINGS AND PRECAUTIONS Repeated use of Hexvix as part of follow-up in patients with bladder cancer has not been studied. Hexaminolevulinate should not be used in patients at high risk of bladder inflammation, e.g. after BCG therapy, or in moderate to severe leucocyturia. Widespread inflammation of the bladder should be excluded by cystoscopy before the product is administered. Inflammation may lead to increased porphyrin build up and increased risk of local toxicity upon illumination, and false fluorescence. If a wide-spread inflammation in the bladder becomes evident during white light inspection, the blue light inspection should be avoided. There is an increased risk of false fluorescence in the resection area in patients who recently have undergone surgical procedures of the bladder.
INTERACTIONS No specific interaction studies have been performed with hexaminolevulinate.
PREGNANCY AND LACTATION No clinical data on exposed pregnancies are available. Reproductive toxicity studies in animals have not been performed.
UNDESIRABLE EFFECTS Most of the reported adverse reactions were transient and mild or moderate in intensity. The most frequently reported adverse reactions were bladder spasm, reported by 3.8% of the patients, bladder pain, reported by 3.3% of the patients and dysuria, reported by 2.7% of the patients. Other commonly reported adverse reactions are: headache, nausea, vomiting, constipation, urinary retention, haematuria, pollakuria and pyrexia. Uncommonly reported adverse reactions are cystitis, sepsis, urinary tract infection, insomnia, urethral pain, incontinence, white blood cell count increase, bilirubin and hepatic enzyme increase, post-procedural pain, anaemia, gout and rash. The adverse reactions that were observed were expected, based on previous experience with standard cystoscopy and transurethral resection of the bladder (TURB) procedures.
OVERDOSE No case of overdose has been reported. No adverse events have been reported with prolonged instillation times exceeding 180 minutes (3 times the recommended instillation time), in one case 343 minutes. No adverse events have been reported in the dose-finding studies using twice the recommended concentration of hexaminolevulinate. There is no experience of higher light intensity than recommended or prolonged light exposure.
INSTRUCTIONS FOR USE AND HANDLING Hexaminolevulinate may cause sensitisation by skin contact. The product should be reconstituted under aseptic conditions using sterile equipment.
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CLASSIFICATION FOR SUPPLY Subject to medical prescription (POM). UK MARKETING AUTHORISATION NUMBER PL 00637/0064. PRICE £286.
DATE OF REVISION OF TEXT 14 April 2008.
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.
Adverse events should also be reported to GE Healthcare © 2008
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