Author Lookman Alli
Position Health Intelligence Officer
Policy Lead Tamara Djuretic
Public Health Consultant
Directorate ...
CONTENTS PAGE
HPP 324 – Policy..............................................................................1
1.Overview ....
1. Overview
NHS Haringey, as an organisation, is committed to improving and protecting the
health of residents, and takes ...
2. Policy Statement
In the absence of very high quality evidence on the effectiveness of gamma-knife
surgery for treating ...
c. Arteriovenous malformations (AVMs)
• Treatment with surgery or embolisation followed by surgery is contraindicated
or c...
2. Introduction
2.1 The procedure
Gamma knife is a complex machine that uses an element known as cobalt 60 as its
energy s...
involves inflating a balloon near the nerve. All of these are minimally invasive surgical
procedures. Another form of trea...
4. Brain (cerebral) metastasis
Metastasis to the brain common occurs from primary cancers in lung, breast and
gastrointest...
4.2 Local cost implications
There were 694 cancers in Haringey in 2007.10
Of those, 15-30% would develop
cerebral metastas...
subsequent hemorrhage has been reported to range from 4.5 to 34.4%; the best
estimate is approximately 6% during the first...
A prospective study of 500 patients followed up for a median of 7.8 years reported the
cure rates for radiosurgery as rang...
Reference source not found Hence, an estimated one patient in two years would
require treatment by gamma knife for AVM in ...
Results from a follow-up study31
of 972 radio-surgically treated patients with 1045
intracranial meningiomas managed durin...
Incidence of brain meningioma is 2.3 per 100,000 population per year. Haringey would
expect approximately five new cases o...
• Treatment with surgery or embolisation followed by surgery is contraindicated
or considered clinically inappropriate;
• ...
10.Appendix
Appendix I
Date of policy: October 2009 (version 1)
Date of review: October 2010
Appendix II
Spetzler-Martin Grading Scale for Arteriovenous Malformation*
Feature Score
Maximum diameter
< 3 cm 1
3-6 cm 2...
Framework of Principles
Haringey TPCT’s vision is to improve the health of the local population and to ensure
that there a...
treatment. Thus, a decision about the treatment of one person or a group of
people can have resource implications beyond t...
 treatment for those whose quality of life is extremely severely affected by
disabling chronic illness,
 special charact...
The approach that we take to determining health and health care priorities should
take account of ethical considerations, ...
 follow technology appraisal guidelines (TAGs) from the National Institute for
Health and Clinical Excellence (NICE)
3
wh...
The individual cases appeal process is described in section 7 of the Individual Cases
Panel Policy.
There should be regula...
11. References
24
1
J.N.W. Lim, L. Ayiku. The clinical efficacy and safety of stereotactic Radio-surgery (gamma knife)
in the treatment of t...
24
Medscape. e-medicine, Meningioma @ http://emedicine.medscape.com/article/1217466-
overview (viewed on 07/01/09)
25
Canc...
Upcoming SlideShare
Loading in …5
×

Gamma Knife Radiosurgery

4,213 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
4,213
On SlideShare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
39
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Gamma Knife Radiosurgery

  1. 1. Author Lookman Alli Position Health Intelligence Officer Policy Lead Tamara Djuretic Public Health Consultant Directorate Public Health Date October 2009 Version 1.1 Approved By NHS Haringey Individual Cases Panel (ICP) 05.10.09 Review Date October 2010 Date of policy: October 2009 (version 1) Date of review: October 2010 COMMISSIONING POLICY FOR GAMMA KNIFE RADIOSURGERY TREATMENT HPP 324 – Policy
  2. 2. CONTENTS PAGE HPP 324 – Policy..............................................................................1 1.Overview ...........................................................................................................3 2. Policy Statement ..............................................................................................4 2. Introduction ......................................................................................................6 3. Trigeminal neuralgia (TN).................................................................................6 4. Brain (cerebral) metastasis...............................................................................8 5. Arteriovenous malformations (AVMs) ..............................................................9 AHA Scientific Statement Recommendations for the Management of Intracranial Arteriovenous Malformations. A Statement for Healthcare Professionals From a Special Writing Group of the Stroke Council, American Stroke Association. Circulation. 2001;103:2644-2657............................................................................25 6. Meningiomas...................................................................................................12 7. Eligibility Criteria for Gamma Knife Radiosurgery Treatment ........................14 8. Exceptionality .................................................................................................15 9. Process...........................................................................................................15 10. Appendix.......................................................................................................16 11. References....................................................................................................24 Date of policy: October 2009 (Version 1) Date of review: October 2010 2
  3. 3. 1. Overview NHS Haringey, as an organisation, is committed to improving and protecting the health of residents, and takes all necessary actions to ensure that the health needs of its population are met. In meeting this need, the organisation uses the best available evidence to commissioning timely treatments and care in reputable units working in partnership with the community. A couple of months ago, the Primary Care Trust commissioned a piece work examining Gamma Knife Radiosurgery technology in order to determine its effectiveness and safety with a view to commissioning the procedure for Haringey residents who might need it to treat their condition. This document provides the guidance for which NHS Haringey will consider requests for treatment Arteriovenous malformations, brain metastasis, meningioma and trigeminal neuralgia. The criteria were developed using the best available evidence for the technology in treating these conditions and, like other commissioning policies of the Primary Care Trust, it is underpinned by a framework of Principles which accompanies this document. The aims of this policy are as follows: • To improve access and effectiveness; service quality and the overall experience of our patients who need treatment with the procedure for arteriovenous malformations, brain metastasis, meningioma and trigeminal neuralgia; • To have a commissioning guidance in place that will ensure a high level of consistency in the care of people who require treatment with the Gamma Knife Radiosurgery; • Make sure that people with arteriovenous malformations, brain metastasis, meningioma and trigeminal neuralgia, and who are most likely to benefit from the procedure have timely access to treatment in order to enhance success. Date of policy: October 2009 (Version 1) Date of review: October 2010 3
  4. 4. 2. Policy Statement In the absence of very high quality evidence on the effectiveness of gamma-knife surgery for treating the following conditions, it is recommended that this service is not routinely commissioned by NHS Haringey. It is therefore proposed that NHS Haringey should fund requests for stereotactic radio-surgery with Gamma Knife where the following criteria are met and in carefully selected patients in whom the procedure will most likely be beneficial: Eligibility Criteria for Gamma Knife Radiosurgery Treatment a. Trigeminal Neuralgia NHS Haringey should fund requests for stereotactic radio-surgery with Gamma Knife for the treatment of trigeminal neuralgia if the following conditions are met: • Pain is very severe affecting the quality of life of the patient; • First line treatment using medications has failed; • Other convectional treatments have also failed or are inappropriate to use. • The clinician should ensure that patients understand the potential complications of the procedure and the uncertainty about its efficacy in the long term. • Arrangements for audit and clinical governance should also be in place. b. Cerebral metastasis • Treatment with conservative surgery is contraindicated or considered clinically inappropriate; • The patient has a Karnofsky Performance Score (KPS) of greater than 70 (Appendix I); • There is no active extracranial cancer; • The patient is clinically fit to undergo the procedure; • There are no more than two cerebral metastatic lesions. • Whole brain radiotherapy (WBRT) has already been tried; • The lesions should be equal to or less than 3 cm in size. • The clinician should ensure that patients understand the potential complications of the procedure and the uncertainty about its efficacy and safety. • Arrangement for audit and clinical governance should also be in place. Date of policy: October 2009 (Version 1) Date of review: October 2010 4
  5. 5. c. Arteriovenous malformations (AVMs) • Treatment with surgery or embolisation followed by surgery is contraindicated or considered clinically inappropriate; • The size of the lesion is equal to or less than 3cm; • Treatment is not aimed to be fractionated; • The lesion is Grade III or less on the Spetzler- Martin Grading Scale; • The lesion is compact (and not a diffuse malformation). d. Meningiomas • If treatment with surgery is contraindicated or considered clinically inappropriate; • The size of the lesion is equal to or less than 3.5 cm; • Treatment is not aimed to be fractionated; • The lesion is benign and typical; • The lesion belongs to World Health Organisation (WHO) Grading I where the histology is known. • There are no more than 2 lesions. Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Those cases may be reviewed at the Individual Cases Panel making sure that the following above conditions are met. Date of policy: October 2009 (Version 1) Date of review: October 2010 5
  6. 6. 2. Introduction 2.1 The procedure Gamma knife is a complex machine that uses an element known as cobalt 60 as its energy source, and is able to focus a precise intersection of beams of gamma rays to perform radio-surgery. Radio-surgery radiation treatment utilizes a precisely focused beam of radiation to treat a small, defined, target lesion while minimizing irradiation of adjacent normal structures. The procedure is at most minimally invasive and, is now being used in the treatment of conditions such as trigeminal neuraligia, primary and secondary brain tumours (metastases), arteriovenous malformations (AVMs), vestibular schwannoma and so on. The target for the radio-surgery is usually clearly defined through prior use of high- resolution computerised tomography (CT) and Magnetic Resonance Imaging (MRI) scans. 2.2 Current providers of stereotactic radiosurgery using Gamma Knife There are a few specialist units across England and Wales and, among them are: - Barts & The London Hospital (where NHS Haringey has a case by case service level agreement (SLA). - Sheffield Teaching Hospital and; - The Cromwell Hospital All treatment requests are currently considered through the Individual Cases Panel (ICP) for decision and the number of requests is increasing. The panel considered a total of 4 requests for funding treatment with Gamma Knife radiosurgery in 2008 and another 4 have been considered in 2009. 3. Trigeminal neuralgia (TN) Trigeminal neuralgia is a condition characterised by sudden bursts of facial pain, which may be triggered by touch; talking; eating, or brushing teeth. The pain occurs in the areas supplied by the trigeminal nerve such as the cheeks, jaw, teeth, gums, lips and, less often, around the eye or forehead. Trigeminal neuralgia is rare in occurrence; the mean annual incidence is 4.7 per 100 000 population.1 Some people with mild symptoms recover without treatment but most people have bursts of severe pain indefinitely. Where treatment is indicated, the first line treatment for trigeminal neuralgia is medication such as Carbamazepine, Phenytoin and Baclofen. Approximately 70% of trigeminal neuralgia patients are well-controlled by non-operative means. Surgery is considered for people who experience severe pain despite medication, or who have side effects from medication. Other treatments for severe trigeminal neuralgia include: glycerol injection into trigeminal nerve under x- ray guidance; radiofrequency radio-surgery, balloon micro-compression, which Date of policy: October 2009 (Version 1) Date of review: October 2010 6
  7. 7. involves inflating a balloon near the nerve. All of these are minimally invasive surgical procedures. Another form of treatment is microvascular decompression, which is a more invasive procedure involving opening the skull.Error: Reference source not found 3.1 Clinical Efficacy & Safety Radio-surgery for the treatment of trigeminal neuralgia was a subject of a systematic review commissioned by the National Institute of Clinical Excellence (NICE) in 2004. The review reported that between 33% and 90% of patients achieved complete initial pain relief after stereotactic radiosurgery using the gamma knife. After a mean follow- up period of 18 months, the proportion of patients with recurrence of pain ranged from 0% to 34%, with an average of 14%.Error: Reference source not found A careful interpretation suggests that in typical trigeminal neuralgia, gamma knife radiosurgery offers similar clinical efficacy, in terms of initial and short –term pain relief as microvascular decompression, percutaneous radiofrequency thermocoagulation rhizotomy, percutaneous glycerol rhizolysis and percutaneous balloon compression.Error: Reference source not found A reported zero rate of operative mortality, a low rate of major complication risk, and only minor complications were reported in review commissioned by NICE.Error: Reference source not found The most common complication reported was facial numbness, affecting 8% (139/1757) of patients. New or worsened trigeminal nerve dysfunction was reported in 4% (66/1757) of patients. Facial paraesthesia occurred in 2% (33/1757) of patients. Less commonly reported complications included troublesome dysaesthesia, loss of taste, corneal numbness and deafness. There is a lack of long-term data and the condition can recur. Although the recurrence rate appears to be higher after stereotactic radiosurgery than after other treatments, the patient groups reported were not comparable. Relapse is most common in patients with multiple sclerosis and atypical neuralgia.Error: Reference source not found 3.2 Local cost implications The mean annual incidence of trigeminal neuralgia is 4.7 per 100 000 population, suggesting that Haringey would expect approximately 11 new cases of trigeminal neuralgia each year. Of this, three to four cases would not respond to medications and would require other modalities of treatment. The cost of treatment of trigeminal neuralgia using Gamma Knife Radio surgery is £7,9902 . If we assume that two patients with TN would eventually need to be treated with Gamma Knife per year that would result in total cost of £15,908. 3.3 Existing guidelines/ positions professional groups NICE Interventional Procedure Guidance (IPG 85) published in 2004 states that the ‘current evidence on the safety and efficacy of stereotactic radiosurgery for trigeminal neuralgia using the gamma knife appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance’3 Date of policy: October 2009 (Version 1) Date of review: October 2010 7
  8. 8. 4. Brain (cerebral) metastasis Metastasis to the brain common occurs from primary cancers in lung, breast and gastrointestinal tract. In general 15-30% of cancer cases develop cerebral metastasis per year. In general terms, once brain metastases are diagnosed, the median survival is less than a year; however, timely therapy could restore neurological function and prevent further neurological complications of cancer for the duration of a patient's survival.5 Treatment modalities for cerebral metastasis include surgery, radiotherapy and, supportive care with drugs like corticosteroids. Surgery provides the best therapy, especially in patients with good prognostic features, but results are still not encouraging because even patients with the best prognostic indicators often die within 18 to 24 months.4 The common agreed factors for poor prognosis in cerebral metastasis include poor performance status on the Karnofsky Performance Scale (KPS) score, old age, and active extracranial disease.5 4.1 Clinical Efficacy & Safety A systematic review of evidence to assess the efficacy of gamma knife radiosurgery in the treatment of brain metastasis (and other conditions such as arteriovenous malformations, acoustic neuroma, cerebral metastases and trigeminal neuralgia) shows there is no benefit for Gamma Knife radiosurgery compared to whole brain radiotherapy (WBRT), when employed as first line radiation treatment. None of the studies considered showed that surgical excision is better than WBRT alone.6 No RCT comparing GKS with surgical resection was found; however a retrospective case- controlled study suggested that there was no statistically significant improvement in median survival between surgery and GKS.7 Evidence from small RCT found that there may be slightly improved local control for patients treated with radiosurgery plus WBRT compared with WBRT alone. There was, however, no survival benefit for these patients. The results of uncontrolled case series generally supported those of the randomised trial.8 Another study evaluated the role of stereotactic radio-surgery (SRS) in 83 patients with multiple brain metastases who underwent SRS between 1991 and 1999 by analyzing prognostic factors that predict survival. All 83 patients were included in the calculation of overall survival. The overall survival was 22% at one year and 13% at two years, and a median survival of 5.4 months (range, 0.3-28.8 months) was demonstrated. Variables that predicted survival were Karnofsky Performance Scale (KPS) score, extracranial disease status, and the number of intracranial metastases. Median survival in patients with a KPS score greater than as compared with less than 70 was 9.1 and 2.7 months, respectively (p = 0.002). Median survival, when comparing absence and presence of extracranial disease, was 9.9 and 4.1 months, respectively (p = 0.02). Median survival in patients harbouring two, three, or four or more lesions was 6.6 months, 5.4 months, and 2.7 months, respectively (p = 0.02). In patients with a KPS score greater than or equal to 70 and with three or fewer lesions, median survival was 7 months or longer.9 Date of policy: October 2009 (Version 1) Date of review: October 2010 8
  9. 9. 4.2 Local cost implications There were 694 cancers in Haringey in 2007.10 Of those, 15-30% would develop cerebral metastasis. Hence, we would expect between 104- 264 new cases of cerebral metastasis per year in Haringey. A proportion of these cases could be considered for Gamma Knife radiosurgery however it is difficult to determine the exact number of cases that would meet the proposed set of criteria . The cost of a Gamma Knife procedure is £7,990 excluding anaesthesia and other materials. 4.3 Existing guidelines/ Positions of Professional groups The Guidance of Cancer Service: Improving Outcomes for People with Brain and Other CNS Tumours published by NICE in June 2006 advise as follows: ‘Complete surgical excision should be considered in patients with single metastases where the risk of unacceptable complications is low. Postoperative radiotherapy following the resection of solitary metastases may reduce the likelihood of intracranial relapse in appropriately selected patients. Stereotactic radiotherapy can be considered as an alternative to surgery in small lesions (< 3 cm) when the histopathological diagnosis is known. Occasionally it may be considered in patients with more than one lesion. The role of further treatment with radiotherapy to the brain following stereotactic radiotherapy is uncertain, although it may prevent intracranial relapse.’ The American Society for Therapeutic Radiology and Oncology (ASTRO) in their review of the role of radiosurgery for brain metastases in 2005 reported that ‘there is insufficient evidence as to the clinical benefit/risks radiosurgery used in the setting of recurrent or progressive brain metastases, although radiographic responses are well- documented’.11 5. Arteriovenous malformations (AVMs) Arteriovenous malformations (AVMs) are tangled web of abnormal arteries and veins connected by abnormal corridors (fistulas). They are generally thought to be present from birth and most commonly occur in the brain. AVM lesions are graded using the Spetzler-Martin Grading Scale, which is based on the lesion’s diameter, location and venous drainage. (see Appendix I) The prevalence of arteriovenous malformation is estimated at approximately 0.01% of the general population, but reported rates range from 0.001% to 0.52%12 . The annual incidence rate is around 1.1 (95%CI 0.9 to 1.4) per 100,000 adults per year.13 Brain arteriovenous malformations (AVMs) are the single most common cause of intracerebral haemorrhage in young adults occurring in 42 to 72% of clinically apparent arteriovenous malformations. After an initial hemorrhage, the annual risk of a Date of policy: October 2009 (Version 1) Date of review: October 2010 9
  10. 10. subsequent hemorrhage has been reported to range from 4.5 to 34.4%; the best estimate is approximately 6% during the first year, with a return to the baseline risk afterward. AVMs can also cause seizure(s) and focal neurological deficits, migraine or an epileptic seizure in the absence of haemorrhage. Several characteristics specific to arteriovenous malformation may also predict an increased risk of hemorrhage such as the presence of aneurysms, drainage into the deep venous sinuses, deep location (i.e., basal ganglia, internal capsule, thalamus, or corpus callosum), a single draining vein, and venous stenosis. Some data also suggest that risk increases with decreasing diameter of the malformation.Error: Reference source not found Treatment options include neurosurgical excision, endovascular, and staged combinations of these interventions can be used to treat brain AVMs.14 Radio-surgery is also an option- it avoids a craniotomy (opening the skull via surgery), but there is a lag period of approximately one to three years from the time of treatment to potentially complete obliteration of the arteriovenous malformation, during which time there continues to be a risk of hemorrhage.Error: Reference source not found Trials directly comparing these approaches with one another or with observation are lacking, and information on outcomes derives largely from case series. A randomised trial of unruptured brain AVMs (ARUBA) is currently underway to evaluate long-term outcome of best possible standard interventional therapy as compared to the natural history risk in a prospective multidisciplinary international study (www.arubastudy.org). 5.1 Clinical Efficacy & Safety A systematic review to assess the effects of stereotactic radiosurgery compared with conventional neurosurgery or whole brain radiotherapy on functional outcomes and survival in people with secondary brain tumours, acoustic neuromas or arteriovenous malformations found no level 1 studies. The studies identified suggest that stereotactic radiosurgery may be beneficial in the treatment of brain metastases, AVMs and acoustic neuromas. 15 The conclusion from another systematic review to assess the effectiveness of stereotactic radiosurgery (SRS) treatment in a range of conditions was that SRS should be regarded as a complementary option, with surgery being preferred if the lesion could be excised safely.16 A follow- up study to investigate cure rate after gamma knife radiosurgery treatment performed on 300 patients with AVMs with size ranging from 0.15 to 28.6 cm (median, 3.9 cm) found that obliteration was achieved in 222 (74%) patients after the first round of radiosurgery and in 47 (69%) after the second. The overall chance of cure was 92% (269 patients). Final angiography verified complete obliteration by 12 to 96 months (median, 25 months) after initial radiosurgery. Smaller volume AVMs and the application of a higher radiation dose resulted in a higher chance of obliteration. The risk of rebleeding after radiosurgery was 2.1% annually until full obliteration and the overall mortality from rebleeding was 1%. The risk of permanent morbidity after the first and second radiosurgery treatments were 2.7 and 2.9%, respectively. The cumulative risk of morbidity in both groups of patients was 3.4%.17 Date of policy: October 2009 (Version 1) Date of review: October 2010 10
  11. 11. A prospective study of 500 patients followed up for a median of 7.8 years reported the cure rates for radiosurgery as ranging from 81 to 90% for lesions less than 3 cm in diameter, with lower cure rates for larger lesions. The risk of hemorrhage was reduced by 88% after obliteration by radio- surgery. 18 In general, there is a 5% to 7% risk of treatment-related complications with radiosurgery. Over a 3-year period, the patient has a 14% to 19% risk of complication or hemorrhage in addition to possible incomplete obliteration.19 Early complications include seizures, nausea, vomiting, and headaches, most of which are self-limited. Delayed complications, which can occur weeks to years after treatment, include seizures, hemorrhage, radionecrosis, progressive edema, and venous congestion; in rare cases, these can be life-threatening.Error: Reference source not found 5.2 Cost Effectiveness An economic study comparing surgical resection with GKS for small an operable brain AVMs notes that surgical resection confers a larger clinical benefit over GKS by protecting patients earlier from haemorrhage. Surgical resection was found to confer a 0.98 quality-adjusted life year (QALY) advantage over GKS. The incremental cost- effectiveness ratio is $7100 per QALY for a patient treated surgically. The result was also found to be sensitive to surgical morbidity and surgical mortality only. The preferred treatment strategy favouring GKS only at the extreme high end of the possible range for these variables, when the rate of permanent neurological morbidity resulting from surgery exceeds 12% or the surgical mortality rate exceeds 4%.20 5.3 Existing guidelines/ Positions of Professional bodies - A report on Gamma Knife radiosurgery by the Society for British Neurological Surgeons in 2001 noted that it is ‘less suitable for larger (> 3cm) targets’ and also ‘not suited to fractionated treatments’.21 - Stroke Council of the American Stroke Association recommends ‘Strong consideration of surgery is recommended for lesions of Spetzler-Martin grade I and grade II, and consideration of endovascular embolization followed by microsurgery is recommended for grade III lesions. Consideration of radiosurgery is recommended for lesions that may be associated with an increased rate of surgical complications, owing to their anatomical location or feeding-vessel anatomy, in particular for lesions in eloquent tissue. Because of the risks of treatment, grade IV and grade V lesions are generally not treated.’Error: Reference source not found 5.4 Local cost implications The in- patient cost for stereostatic radiology treatment for AVMs is £6,16822 (excluding other costs) An estimated three patients would develop AVMs in Haringey per year; of those an estimated 23% would potentially be treated by stereostatic radiology per year.Error: Date of policy: October 2009 (Version 1) Date of review: October 2010 11
  12. 12. Reference source not found Hence, an estimated one patient in two years would require treatment by gamma knife for AVM in Haringey. 6. Meningiomas Meningiomas are primary intracranial tumours arising from the Arachnoid, the fibrous covering of the brain and the spinal cord. They are the second most common primary tumor of the brain accounting for about one-fifth of all primary intracranial tumors.23 Population-based studies in the USA indicate an overall incidence of 2.3 cases per 100,000.24 An estimated 1200 new cases develop in the United Kingdom per year.Error: Reference source not found Meningiomas are generally benign and usually slow growing; as they grow, they compress the normal brain. Eighty percent (80%) of people with slow- growing meningiomas will live more than 5 years. For those with high grade, malignant meningiomas, less that 6 out of 10 will live for 5 years.25 Seizures occur in approximately 50% of cases. Increased intracranial pressure (headache, blurred vision) are common.26 Where feasible, craniotomy and complete removal of the tumours and its dural base has been the preferred treatment.Error: Reference source not found In large single- institution series, gross-total resection has been reported to achieve 5-, 10-, and 15- year recurrence-free survival rates of approximately 90, 80, and 70%, respectively.27 Stereotactic radiosurgery is an option to surgery for meningiomas in locations, such as the skull base, where operative manipulation may be particularly difficult.28 Other options include radiotherapy and chemotherapy. 6.1 Clinical Efficacy & Safety A systematic review of consecutive series of 309 meningiomas treated with gamma knife stereotactic radiosurgery by Malik I et al29 over a 6- year period found that the 5- year control rates was 87% for typical meningiomas, 49% for atypical tumours and 0% for malignant lesions. It was also found that tumour type (histology) was the main determinant of growth control (p < 0.001). In this study, there was an extreme selection bias towards lesions unfavourable for surgery, which was determined by the patients referred for treatment. Complications were reported in 3% of tumours, and were most frequently trigeminal and eye movement disturbances.Error: Reference source not found Another review of the literature on benign adult brain tumors using evidence-based standards and focusing on meningiomas and a few other benign primary brain tumours found that there is a level 3 evidence that radiosurgery is effective as an alternative to surgery in small to medium-sized meningiomas. The efficacy of drugs in therapy of meningiomas recurring after surgery was difficult to interpret due to lack of uniform criteria in the studies.30 Date of policy: October 2009 (Version 1) Date of review: October 2010 12
  13. 13. Results from a follow-up study31 of 972 radio-surgically treated patients with 1045 intracranial meningiomas managed during an 18-year period showed that the overall control rate (described as tumour regression or size unchanged) for patients with benign meningiomas (World Health Organization Grade I) was 93%. Control rate for patients with World Health Organization Grade II and III tumors, tumor control was 50 and 17%, respectively. After 10 years, Grade 1 tumors were controlled in 91% (n = 53); in those without histology, 95% (n = 22) were controlled. In those without previous histological confirmation (primary radiosurgery) and, receiving radio-surgery as the primary treatment (n = 482), tumor control rate was 97% at a median of 4 years. Of those whose neurological examination results were available, 93% either improved neurologically (n=87) or remained unchanged (n = 380). Past 10 years, 16 patients were stable, three were improved and, three were worse. Follow- up imaging past 8 and 10 years were obtained for 49 ad 22 tumours with control rates of 94 and 95% respectively. Delayed resection after radio-surgery was necessary in 51 patients (5%) at a mean of 35 months due to local tumour growth or increased symptoms. Additional radiotherapy was performed in 2.9% at an average of 32 months. Further radio-surgery was performed in 41 (4%) at 49 months due to new tumours. Eight of the patients later received chemotherapy (0.8%). Further analysis showed that worse overall survival significantly correlated with increasing age, increasing WHO grade from 0-III (0 for no tissue diagnosis) and increasing tumour volume. Worse disease survival was found to be significantly associated with WHO grade from 0-III, increasing age, and multiple tumours. In this study the overall morbidity rate attributable to radio-surgery was 7.7% at an average time of 11 months. 6.2 Existing guidelines/ Positions of Professional bodies NICE, in their Guidance of Cancer Service: Improving Outcomes for People with Brain and Other CNS Tumours published in June 2006 advise as follows32 : ’Resection may be appropriate for patients with skull vault meningiomas. It can prevent further disease progression and the associated deterioration in neurological function although recurrence may occur. Radiotherapy may be considered following histopathological confirmation of the diagnosis in patients with the following features: • a WHO histopathological grade 2/3 tumour • invasion by tumour of adjacent brain or extensive invasion of other tissues • a second or subsequent relapse • a contraindication to surgery. Stereotactic radiotherapy and radiosurgery may be useful in selected patients although the value of these approaches is still uncertain. There is no clearly established role for chemotherapy, hormonal therapy and radiolabelled treatments in the management of these patients.’ 6.3 Local cost implications Date of policy: October 2009 (Version 1) Date of review: October 2010 13
  14. 14. Incidence of brain meningioma is 2.3 per 100,000 population per year. Haringey would expect approximately five new cases of meningioma per year; an estimated 33.3% of these cases would potentially require treatment with radiosurgery. Hence, potentially two patients from Haringey would require the treatment per year at cost of £15,980. 7. Eligibility Criteria for Gamma Knife Radiosurgery Treatment In the absence of very high quality evidence on the effectiveness of gamma-knife surgery for treating the following conditions, it is recommended that this service is not routinely commissioned by NHS Haringey. It is therefore proposed that NHS Haringey should fund requests for stereotactic radio-surgery with Gamma Knife where the following criteria are met and in carefully selected patients in whom the procedure will most likely be beneficial: a. Trigeminal Neuralgia NHS Haringey should fund requests for stereotactic radio-surgery with Gamma Knife for the treatment of trigeminal neuralgia if the following conditions are met: • Pain is very severe affecting the quality of life of the patient; • First line treatment using medications has failed; • Other convectional treatments have also failed or are inappropriate to use. • The clinician should ensure that patients understand the potential complications of the procedure and the uncertainty about its efficacy in the long term. • Arrangements for audit and clinical governance should also be in place. b. Cerebral metastasis • Treatment with conservative surgery is contraindicated or considered clinically inappropriate; • The patient has a Karnofsky Performance Score (KPS) of greater than 70 (Appendix I); • There is no active extracranial cancer; • The patient is clinically fit to undergo the procedure; • There are no more than two cerebral metastatic lesions. • Whole brain radiotherapy (WBRT) has already been tried; • The lesions should be equal to or less than 3 cm in size. • The clinician should ensure that patients understand the potential complications of the procedure and the uncertainty about its efficacy and safety. • Arrangement for audit and clinical governance should also be in place. c. Arteriovenous malformations (AVMs) Date of policy: October 2009 (Version 1) Date of review: October 2010 14
  15. 15. • Treatment with surgery or embolisation followed by surgery is contraindicated or considered clinically inappropriate; • The size of the lesion is equal to or less than 3cm; • Treatment is not aimed to be fractionated; • The lesion is Grade III or less on the Spetzler- Martin Grading Scale; • The lesion is compact (and not a diffuse malformation). d. Meningiomas • If treatment with surgery is contraindicated or considered clinically inappropriate; • The size of the lesion is equal to or less than 3.5 cm; • Treatment is not aimed to be fractionated; • The lesion is benign and typical; • The lesion belongs to World Health Organisation (WHO) Grading I where the histology is known. • There are no more than 2 lesions. 8. Exceptionality Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Those cases may be reviewed at the Individual Cases Panel making sure that the following above conditions are met. 9. Process 9.1 Approval & Ratification Process The policy was approved by the NHS Haringey Individual Cases Panel on 5th October 2009. The policy is planned to be reviewed in October 2010 in the light of new evidence. 9.2 Dissemination Eligibility for access to fertility services will be disseminated all GPs, secondary and tertiary care providers and will be placed on NHS Haringey external website and Intranet. NHS Haringey Board will also be made aware of the existence of this policy. Date of policy: October 2009 (Version 1) Date of review: October 2010 15
  16. 16. 10.Appendix Appendix I Date of policy: October 2009 (version 1) Date of review: October 2010
  17. 17. Appendix II Spetzler-Martin Grading Scale for Arteriovenous Malformation* Feature Score Maximum diameter < 3 cm 1 3-6 cm 2 > 6 cm 3 Location Non eloquent cortex tissue 0 In or adjacent to eloquent cortex tissue 1 Venous drainage Superficial only 0 Deep 1 The sum of the scores is equal to the grade* APPENDIX III – NHS HARINGEY POLICY SETTING Date of policy: October 2009 (version 1) Date of review: October 2010
  18. 18. Framework of Principles Haringey TPCT’s vision is to improve the health of the local population and to ensure that there are good quality, appropriate health services for those people that need them. We want to ensure that people receive 21st century health services – that is the right treatment at the right time in the right place, provided by appropriately skilled staff. The experience of the NHS from its inception is that demand has always outstripped supply. There is no evidence that this is changing and thus we must sometimes choose between providing one type of service or treatment over another. Haringey TPCT is committed to focusing its resources where they are needed most. Haringey TPCT will apply a number of principles, and balance these against each other, when determining what are the most appropriate services and most appropriate treatments for both the population of Haringey and for individuals that it will give priority to. These principles are listed in the following sections. 1.0 Clinical Effectiveness Our resources should be used in the most clinically effective way –  clinical effectiveness is the extent to which specific clinical interventions, when deployed in the field for a particular patient or population, do what they are intended to do – that is, maintain or improve health, and secure the greatest possible health gain from available resources;  we recognise a distinction between ‘evidence of lack of effectiveness’ and ‘lack of evidence of effectiveness’, and we will seek to avoid supporting the use of interventions for which evidence of clinical effectiveness is either absent, or too weak for reasonable conclusions to be reached; and  As well as strength of evidence for a particular intervention, we will also take into account the likely magnitude of benefit and of safety, as well as the number of people who can reasonably be expected to benefit from that intervention. 2.0 Cost Effectiveness Our resources should be used in the most cost effective way –  the NHS is required to keep within its budget, so to maximize the care that can be given we must extract the maximum value from the money we spend and from the way in which all other types of resources are used,  the cost of treatment is relevant because every activity has opportunity costs – if resources are used in one area they cannot be used in another, so we must seek to use all resources in the most appropriate way if the greatest number of people possible are to benefit in the greatest possible ways; and  All decisions set precedents – if one person or a group of people are given treatment then others in similar circumstances should receive the same 18
  19. 19. treatment. Thus, a decision about the treatment of one person or a group of people can have resource implications beyond that individual or group. 3.0 Affordability We should only provide, contract for, or commission the services that we consider are appropriate if we have sufficient money or other resources to do so –  we are statutorily required to keep within the resources made available to us, that is, we are legally bound not to spend more money than we have been allocated; and  if we spend money or use other resources on one thing, then we cannot use those same resources for another, so we have to recognise that even if something is clinically effective and it is, compared to other interventions for the same condition, also cost-effective, this does not necessarily mean that we will be able to support its use because we may not always have enough money or other resources available. 4.0 Equity Our resources should be used in an equitable way –  within the requirements of legislation and NHS regulations, and other than where there is good evidence that a particular characteristic (e.g. age) or lifestyle (e.g. smoking) adversely impacts the clinical and/or cost-effectiveness of treatment, we will seek not to directly or indirectly discriminate between people on grounds of 1 – − age − place of abode 2 − gender − employment − ethnicity − financial status − physical, sensory or learning disability − personal lifestyle − family or other personal circumstances − religious beliefs − sexual orientation − social position;  health care should be allocated justly and fairly on the basis of need, and we will seek to maximise the welfare of people within the resources available to us, but without taking a rigid approach , i.e. we will allow flexibility so that variations from this approach may (but will not necessarily always) be made in certain circumstances, such as (but not limited to) –  urgent need, e.g. immediate life-saving treatment, 1 This list is not exhaustive, but is intended to provide examples of the types of differences between people that the we will not use as grounds for determining whether one person or group of people should or should not receive a particular treatment, other than where there is good evidence that a characteristic is associated with poorer clinical or cost-effectiveness 2 Other than the fact that PCTs are only responsible for the health care needs of the residents of their boroughs, for people registered with their general medical practitioners, for the provision of a range of school nursing services to children attending their local schools, and for visitors to their areas who develop a need of emergency health care whilst there 19
  20. 20.  treatment for those whose quality of life is extremely severely affected by disabling chronic illness,  special characteristics of an individual patient justifying treatment of higher cost than normal, e.g. where an intervention may be less cost-effective for a particular person because of a disability or other characteristic but is otherwise freely available to others who do not have that disability; and  whilst we consider that people have equal rights of access to health and health care services on the basis of equal need, we note that –  there may be occasions or circumstances when some categories of care are given priority in order to address health inequalities in the community,  Health and health care services should be allocated justly and fairly on the basis of both need and capacity to benefit, in order to maximise benefits to the population within the resources available. In the absence of evidence of health need or reasonable capacity to benefit, treatment will not generally be given solely because a person or a group of people request it. Similarly, a treatment of likely limited benefit will not necessarily be provided simply because it is the only treatment available;  Sometimes the needs of the wider population conflict with the needs of individuals, especially when an expensive treatment may possibly produce some clinical benefit and possibly quite a lot of benefit, but only for a relatively limited time. For example, such a treatment may do something to improve a patient’s (or group of patients’) condition to some extent or slow the progression of disease but not change the ultimate outcome, i.e. it will not ‘cure’. However, more people may gain greater benefit if the same money or other resources were used for other purposes, even if that may not be in the best interests of an individual or smaller group of people. 5.0 Quality & Safety The services we provide, contract for and commission should be safe and of high quality to minimise risk to people and to minimise waste–  high quality care can be thought of in terms of doing the right thing, in the right way, to the right person, at the right time and doing it right first time; and  Failing to do this risks harming people and wasting limited resources (and thus harming other people by denying them access to services that can no longer be afforded). We will therefore need to be satisfied that any service provider has adequate quality and safety mechanisms in place. Generally, these will have to be equivalent to NHS clinical governance mechanisms, and we will expect all standards set by the Healthcare Commission and Care Standards Authority to be met. 6.0 Ethics 20
  21. 21. The approach that we take to determining health and health care priorities should take account of ethical considerations, specifically 33 –  respect for patient autonomy – which requires that we help people to make their own decisions (e.g. by providing important information), and respect those decisions (even when we may believe that a patient’s or a group of people’s decision may be inappropriate, noting that this does not require us to provide a specific treatment just because someone wants it, but only if it satisfactorily meets the other criteria in this framework) and only requires us to provide a treatment in a particular place of their choice if that meets the requirements of the national ‘Patient Choice’ initiative or other NHS regulations; we also recognise that some treatments may enable a patient to maintain their independence and/or dignity, e.g. prolonging the time that they can continue to perform everyday living activities with relative independence, and we consider that this is a desirable objective, although it will not necessarily take precedence over other considerations;  beneficence – which emphasises the moral importance of ‘doing good’ to others, entailing doing what is ‘best’ for the patient or group of people (the question of who should be the judge of what is ‘best’ is often interpreted as focusing on what an objective assessment by a relevant health professional would determine as in the patient’s best interests, with the patient’s own views being considered through the principle of respect for patient autonomy, the two only conflicting when a competent patient chooses a course of action that might be thought of as not in their best interests);  non-maleficence – which requires that we should not harm patients, and, because most treatments carry some risk of doing some harm as well as good, the potential goods and harms and their probabilities must be weighed up to decide what, overall, is in the patient’s or group of patients’ best interests (but it must also be noted that we have a duty of non-maleficence to others – we could indirectly harm others because a decision to provide treatment to one person or group of people could prevent others from receiving other care of proven clinical and cost-effectiveness; and  Distributive justice – which recognises that time and resources do not allow every patient to have the ‘best possible’ treatment and that decisions must be made about which treatments can be offered within a health care system. This principle of justice emphasises two points:  people in similar situations should normally have access to similar health care, and  When determining what level of health care should be available for one group, we must take into account the effect of such a use of resources on others (i.e. the opportunity costs). 7.0 General Principles In determining which treatment priorities to focus on, we will use mechanisms that – 21
  22. 22.  follow technology appraisal guidelines (TAGs) from the National Institute for Health and Clinical Excellence (NICE) 3 where they exist and where the circumstances of patients meet NICE criteria precisely and in full;  are based on evidence – using both local data (to enable effective targeting) and the results of high-quality research, including literature reviews, that are published in peer-reviewed publications, and including clinical guidance from national health-professional bodies and non-TAG clinical guidance from NICE (to enable us to support care that is appropriate for the largest number of people possible);  are transparent, i.e. the reasoning behind our decisions made should be clear and available to anyone who wishes to see them (as long as patient confidentiality is preserved);  are ethical, i.e. that meet principles of fairness and appropriateness and that seek to provide the greatest good for the greatest number of people whilst not discriminating against people who, because of their personal circumstances (e.g. a disability) would benefit from treatment provided in a less cost-effective way than were their circumstances otherwise to be similar to those of the general population; and  Are managerially robust, i.e. that follow due process and can be seen to have done so. 8.0 Accountability We will be accountable for our decisions, through –  publicity – decisions and their rationale will be publicly accessible, i.e. the processes and the principles behind them will be ‘transparent’,  reasonableness – our decisions and their rationale should reflect an ‘even- handed’ and ‘sensible’ interpretation of how we should ensure both value for money and equitable access to the services that we provide, contract for or commission for the varied health needs of the population, within the resources available to us;  an appeal process for population-based decisions – there may be objections from individuals or from groups to decisions made by Commissioning Division Directors on recommendations made to change services and in the first instance these should be dealt with through the normal complaints process with a response from the chief executive, although it may be necessary to seek the views of the Commissioning Division Directors and/or the group making the recommendation (e.g. Individual Cases Panel) if new information or evidence is made available by the referring clinician;  an appeal process for individual cases decisions – there should be a separate mechanism for challenge and dispute resolution, including an opportunity for us to change previous decisions in the light of new information or evidence, or if there is a prime facie case that we have failed to follow our declared process appropriately. 3 These are also referred to as ‘final appraisal determinations (FADs) 22
  23. 23. The individual cases appeal process is described in section 7 of the Individual Cases Panel Policy. There should be regulation of these processes by the PCT to ensure that the four conditions above are met. 9.0 Ensuring Probity People involved in making decisions using this framework will be bound by the ‘Seven Principles of Public Life’ defined by the Nolan Committee. These are:  Selflessness – holders of public office should act solely in terms of the public interest. They should not do so in order to gain financial or other benefits for themselves, their family or their friends;  integrity – holders of public office should not place themselves under any financial or other obligation to outside individuals or organisations that might seek to influence them in the performance of their official duties.;  objectivity – In carrying out public business, including making public appointments, awarding contracts, or recommending individuals for rewards and benefits, holders of public office should make choices on merit.;  accountability – holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office;  Openness – holders of public office should be as open as possible about all the decisions and actions that they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands;  honesty – holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest; and  Leadership – holders of public office should promote and support these principles by leadership and example. 10.0 Developing this Framework The principles described will be developed:  in the light of our own experience and that of other organisations, especially to ensure a fair and ethical approach;  in response to new scientific evidence coming to light concerning the effectiveness of health and health care interventions;  As public values and perceptions changes; and in response to changes in legislation and regulatory requirements. 23
  24. 24. 11. References 24
  25. 25. 1 J.N.W. Lim, L. Ayiku. The clinical efficacy and safety of stereotactic Radio-surgery (gamma knife) in the treatment of trigeminal neuralgia. January 2004 (on behalf of NICE) 2 Source: Cromwell Hospital 3 NICE. Stereotactic radiosurgery for trigeminal neuralgia using the gamma knife. Interventional Procedure Guidance 85. August 2004 4 Alexander E 3rd, Loeffler JS. The case for radiosurgery. Clin Neurosurg. 1999;45:32-40 5 Gaspar L, Scott C, Rotman M, et al. Recursive partitioning analysis (RPA) of prognostic factors in three Radiation Therapy Oncology Group (RTOG) brain metastasis trials. Int J Radiat Oncol Biol Phys 1997;37:745-751 6 Ontario Ministry of Health and Long-Term Care. Health Technology Assessment Database 2008 Issue 3 7 P. Charles Garell1 , Patrick W. Hitchon1 , B. Chen Wen2 , David E. Mellenberg2 and James Torner3 Stereotactic Radiosurgery Versus Microsurgical Resection for the Initial Treatment of Metastatic Cancer to the Brain. Journal of Radiosurgery.Volume 2, Number 1 / March, 1999. 8 Centre for Reviews and Dissemination. Database of Abstracts of Reviews of Effects 2008 Issue 3. 2008 University of York. Published by John Wiley & Sons, Ltd 9 Cho KH, Hall WA, Gerbi BJ, Higgins PD. The role of radiosurgery for multiple brain metastases. Neurosurg Focus. 2000 Aug 15;9(2):e2 10 Thames Cancer Registry January 2007. 11 Mehta MP, Tsao MN, Whelan TJ, Morris DE, et al. The American Society for Therapeutic Radiology and Oncology (ASTRO) evidence-based review of the role of radiosurgery for brain metastases. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):37-46. 12 Robert M. Friedlander. Arteriovenous Malformations of the Brain. The New England Journal of Medicine. Boston: Jun 28, 2007. Vol. 356, Iss. 26; pg. 2704 13 Source: Scottish Intracranial Vascular Malformation Study (SIVMS) 14 Al-Shahi R, Warlow CP. Interventions for treating brain arteriovenous malformations in adults. Cochrane Database of Systematic Reviews: Reviews. DOI: 10.1002/14651858.CD003436.pub2. John Wiley & Sons, Ltd. 2006 Issue 1 15 Michell A W. Stereotactic radiosurgery for brain tumours and arteriovenous malformations. London: Bazian Ltd (Editors), Wessex Institute for Health Research and Development, University of Southampton. 2001, 11. STEER: Succint and Timely Evaluated Evidence Reviews 1(13) 16 Hailey D. Stereotactic radiosurgery: an update. Edmonton, AB, Canada: Alberta Heritage Foundation for Medical Research. 2002, 102 ISBN 1896956564 17 Liscák R, Vladyka V, Simonová G, Urgosík D, Novotný J, Janousková L, Vymazal J.Arteriovenous malformations after Leksell gamma knife radiosurgery: rate of obliteration and complications. Neurosurgery 2007 Jun;60(6):1005-14; discussion 1015-6. 18 Maruyama K, Kawahara N, Shin M, et al. The risk of hemorrhage after radiosurgery for cerebral arteriovenous malformations. N Engl J Med 2005;352:146-53. 19 AHA Scientific Statement Recommendations for the Management of Intracranial Arteriovenous Malformations. A Statement for Healthcare Professionals From a Special Writing Group of the Stroke Council, American Stroke Association. Circulation. 2001;103:2644-2657 20 Porter, PJ. MD et al. Surgery versus Stereotactic Radiosurgery for Small, Operable Cerebral Arteriovenous Malformations: A Clinical and Cost Comparison. Neurosurgery: October 1997 - Volume 41 - Issue 4 - pp 757-766 21 Society for British Neurological Surgeons. Report on Stereotactic Radiosurgery/ Radiotherapy Workshop. April 2001. 22 Source: National Centre for Streotactic Radiology, Sheffield 23 International Radiosurgery Association. Meningioma. http://www.irsa.org/meningioma.html (viewed on 07/01/09)
  26. 26. 24 Medscape. e-medicine, Meningioma @ http://emedicine.medscape.com/article/1217466- overview (viewed on 07/01/09) 25 CancerResearch United Kingdom . Statistics and outlook for brain tumours @ http://www.cancerhelp.org.uk/help/default.asp?page=5296#mening1 (viewed on 07/01/09) 26 Johns Hopkins University. Johns Hopkins Medicine Radiostatic Surgery (http://www.radonc.jhmi.edu/radiosurgery/disorders/meningioma.asp) viewed on 07/01/09 27 Rogers L,Mehta M. Role of radiation therapy in treating intracranial meningiomas.Neurosurgical Focus, 2007, vol./is. 23/4(E4), 1092-0684 (Abstract). 28 Elia AE,Shih HA,Loeffler JS. Stereotactic radiation treatment for benign meningiomas. Neurosurgical Focus, 2007, vol./is. 23/4(E5), 1092-0684. 29 Malik I,Rowe JG,Walton L,Radatz MW,Kemeny AA.The use of stereotactic radiosurgery in the management of meningiomas.British Journal of Neurosurgery, Feb 2005, vol./is. 19/1(13-20), 0268-8697.(Abstract) 30 Aghi M,Barker FG. Benign adult brain tumors: an evidence-based medicine review. Progress in Neurological Surgery, 2006, vol./is. 19/(80-96), 0079-6492. 31 Kondziolka D,Mathieu D,Lunsford LD,Martin JJ,Madhok R,Niranjan A,Flickinger JC.Radiosurgery as definitive management of intracranial meningiomas. Neurosurgery, Jan 2008, vol./is. 62/1(53-8; discussion 58-60), 1524-4040. 32 NICE. Guidance of Cancer Service: Improving Outcomes for People with Brain and Other CNS Tumours. June 2006. 33

×