MSAC and PASC ....................................................................................................................... 3
Purpose of this document ........................................................................................................... 3
Items for which PASC wishes to consult more widely on ....................................................... 4
Purpose of application ............................................................................................................. 5
Background .............................................................................................................................. 5
Current arrangements for public reimbursement .......................................................................... 5
Regulatory status ....................................................................................................................... 5
Intervention ............................................................................................................................ 6
Description of the medical condition ............................................................................................ 6
Description of current treatment ................................................................................................. 6
Description and delivery of proposed new intervention ................................................................. 8
Prerequisites ............................................................................................................................. 8
Co-administered and associated interventions ............................................................................. 9
Listing proposed and options for MSAC consideration ............................................................ 9
Proposed MBS listing .................................................................................................................. 9
Clinical place for proposed intervention ......................................................................................11
Comparator ..............................................................................................................................11
Clinical claim .......................................................................................................................... 14
Potential benefits of proposed technology ..................................................................................14
Uncertainties within the economic model ............................................................................. 14
Structure of the economic model ...............................................................................................14
Lack of data to populate an economic model ..............................................................................15
Consideration of the capital costs ...............................................................................................15
Outcomes and health care resources affected by introduction of proposed intervention .............................................................................................................. 16
Proposed structure of economic evaluation (decision-analytic) .....................................................16
Health care resources ...............................................................................................................17
Estimate of utilisation ................................................................................................................18
References ............................................................................................................................. 20

The Medical Services Advisory Committee (MSAC) is an independent expert committee appointed by the Minister for Health and Ageing (the Minister) to strengthen the role of evidence in health financing decisions in Australia. MSAC advises the Minister on the evidence relating to the safety, effectiveness, and cost-effectiveness of new and existing medical technologies and procedures and under what circumstances public funding should be supported.
The Protocol Advisory Sub-Committee (PASC) is a standing sub-committee of MSAC. Its primary objective is the determination of protocols to guide clinical and economic assessments of medical interventions proposed for public funding.
Purpose of this document
This document is intended to provide a draft decision analytic protocol that will be used to guide the assessment of an intervention for a particular population of patients. The draft protocol will be finalised after inviting relevant stakeholders to provide input to the protocol. The final protocol will provide the basis for the assessment of the intervention.
The protocol guiding the assessment of the health intervention has been developed using the widely accepted “PICO” approach. The PICO approach involves a clear articulation of the following aspects of the research question that the assessment is intended to answer:
Patients – specification of the characteristics of the patients in whom the intervention is to be considered for use
Intervention – specification of the proposed intervention and how it is delivered
Comparator – specification of the therapy most likely to be replaced by the proposed intervention
Outcomes – specification of the health outcomes and the healthcare resources likely to be affected by the introduction of the proposed intervention

VMAT is one of several related radiation therapy items currently being considered by PASC. Others include proposals for applications in relation to intensity modulated radiotherapy (IMRT - 1182) and
IGRT (application 1319). PASC determined that there are common issues across all three applications under which specific policy advice from the Department of Health and Ageing would be required in order to guide the assessments. These include:
 The proposed intervention in application 1182 relates to dynamic and static gantry IMRT, and the proposed item descriptor also refers to these positions. VMAT is however a dynamic gantry delivery method for IMRT. Applications 1182 and 1211 therefore have significant overlaps.
 PASC noted that the technologies could be assessed separately rather than combined into a single assessment. It was also noted however that the Department would discuss the situation with both applicants to confirm this approach or whether a single assessment could be considered.

Applications 1182 (IMRT) and 1211 (VMAT) propose significantly different MBS item descriptors, fees, and manner in which MBS claims for these items would be made. Consistency across these issues would be required if the applications are progressed separately. The requirement for IGRT in any new descriptor for IMRT or VMAT may need to be considered.
In relation to VMAT specifically:
 The comparator proposed by the applicant is 3DCRT. This is consistent with the comparator proposed in application 1182 (IMRT). PSAC agreed with this comparator. The consultation DAP also lists IMRT (fixed gantry) as a comparator to VMAT. PSAC considered that this may be required if superiority over fixed gantry IMRT was being claimed during the course of the assessment.
In relation to radiotherapy as a treatment option:
 What information about the selection of radiotherapy as a treatment option for cancer as well as the different radiation treatment techniques that may be employed is given to patients at the planning stage? Is written information on the benefits as well as the short- and longer-term risks involved provided such that a patient or their carers would understand their options?

A proposal for an application requesting MBS listing of volumetric modulated arc therapy (VMAT) was received from Varian Medical Systems Australasia by the Department of Health and Ageing in January
2012. This proposal relates to VMAT, a form of intensity modulated radiotherapy given as a rotational or arc method which could be used in the treatment of cancer. VMATenables increased flexibility of dose delivery through the use of gantry rotation along with continuous modulation of beam aperture and dose rate. It thus has potential for improved dosimetry, including target coverage, dose to normal tissues and dose homogeneity compared with other forms of external beam radiotherapy (IMRT and
3D conformal radiotherapy). VMAT is not currently reimbursed as a separate item number under the
Medicare Benefits Schedule (MBS) but is partially reimbursed under the existent MBS structure.
The NHMRC CTC, as part of its contract with the Department of Health and Ageing, drafted this decision analytical protocol to guide the assessment of the safety, effectiveness and cost-effectiveness of VMAT in order to inform MSAC’s decision-making regarding public funding of the intervention.
Current arrangements for public reimbursement
Radiation oncology services are provided through both public and private sectors. Radiotherapy delivered as either external beam radiotherapy, stereotactic radiosurgery or brachytherapy is reimbursed through the MBS along with the simulation, dosimetry and verification steps involved in the planning and delivery of such treatment.
VMAT is not currently reimbursed as a separate item number under the MBS. It is being used in some radiotherapy centres in Australia. The existing megavoltage numbers (up to 3 additional fields) apply to the delivery of VMAT and are currently being used. These older items are not considered sufficient to encompass the complexities of new treatment approaches such as VMAT.
Regulatory status
The delivery of VMAT requires a linear accelerator with single or multi arc capacity (rotational therapy). Several linear accelerators are listed on the ARTG. The applicant (Varian Medical Systems) in their submission refers to an ARTG approved linear accelerator capable of delivering VMAT (ARTG
#116839). Other equipment is also listed in the application as required to deliver VMAT and is manufacturer specific. These are:
117950 Varian Medical Systems Australasia Pty Ltd - Digital imager, radiation therapy
117951 Varian Medical Systems Australasia Pty Ltd - Patient monitoring system, respiratory, radiation procedure
119980 Varian Medical Systems Australasia Pty Ltd - Radiation therapy treatment system, record/verify
119983 Varian Medical Systems Australasia Pty Ltd - Radiation therapy treatment planning system
119985 Varian Medical Systems Australasia Pty Ltd - Collimator, accelerator system, motorized, automatic aperture control

119986 Varian Medical Systems Australasia Pty Ltd - Port film device, radiation therapy
121225 Varian Medical Systems Australasia Pty Ltd - Accelerator system, stereotactic radiosurgery
It must be noted that others manufacturers have equivalent equipment associated with the delivery of
VMAT which is also listed on the ARTG. These were not included/listed as part of this application.
Description of the medical condition
Cancer describes a diverse group of several hundred diseases in which groups of cells become abnormal and begin to multiply out of control as a result of mutations in the genetic information of the cell. Cancer is a leading cause of death in Australia and is also a major contributor to morbidity in the Australian population (AIHW, 2000). Radiotherapy is one of the main treatment modalities for cancer.
The most commonly diagnosed cancer (excluding non-melanoma skin cancer) is prostate cancer, followed by colorectal or bowel cancer, then breast, melanoma and lung cancer. VMAT has been proposed for use by the applicant in prostate, lung, breast and other extracranial cancers. It is assumed that these clinical indications have been chosen in order to align the proposed item numbers with the current MBS listed treatment sites for 3D-CRT delivery. The application also notes that VMAT is “especially suitable” to malignancies of the head and neck region as well as brain tumours.
Published evidence on the efficacy and safety of VMAT is in patients with prostate cancer, pelvic malignancies, malignancies of the head and neck region, breast and lung cancer as well as central nervous system tumours (Teoh et al 2011). VMAT is considered particularly suited to malignant tumours in sites of complex anatomy, irregularly shaped tumours or tumours adjacent to radiationsensitive structures such as the spinal cord, bowel and intra-abdominal organs (Palma et al 2010).
The Royal Australian and New Zealand College of Radiologists in their position paper on the evidence based for VMAT (Faculty of Radiation Oncology 2011) gave particular attention to the evidence on
VMAT in head and neck malignancies, prostate breast and lung cancers and brain tumours.
MSAC has previously evaluated 3D-conformal radiotherapy for the use in cancer (MSAC 2001). This review was not limited to particular clinical indications at the protocol stage. During the assessment of evidence stage, the availability of good quality evidence narrowed the clinical indications that were reviewed.
Description of current treatment
External-beam radiotherapy (EBRT)
External beam therapy is the most common form of radiotherapy, delivering ionizing radiation (highenergy x-rays, or electrons) with the aim of destroying the cancer cells with the lowest impact on the

surrounding healthy tissue. The process of EBRT can be divided into four stages: simulation, treatment planning, treatment, and treatment verification (imaging).
Conformal radiotherapy (3DCRT) is a form of EBRT (MBS Items 15550-15562) which uses complex software and a multileaf collimator to manipulate the profile of radiation beams allowing them to be shaped to fit the profile of the target tumour, while avoiding the healthy surrounding tissue. By more accurately targeting the tumour it is expected that this will decrease the incidence of late effects and allow for escalation of the radiation dose to the tumour.
The delivery of EBRT (whether conventional or 3DCRT) is currently listed on the MBS and a wide range of items are available depending on a number of factors. These include as examples whether a single or dual photon energy linear accelerator is used, the tumour site of treatment delivery and the number of fields of radiation therapy. Table 1 shows the listings for one field as well as fees payable for additional radiation fields (up to five) for a number of treatment sites on a dual photon energy linear accelerator – separate items are for lung (15245 and 15260), prostate (15248 and 15263), breast (15251 and 15266) and other cancers not covered by tumour sites above (15254 and 15269).
Table 1 Current MBS listing for Radiotherapy treatment based on dual photon linear accelerator
Category [3]– Therapeutic procedures
MBS 15245, 15248,15251,15254
RADIATION ONCOLOGY TREATMENT, using a dual photon energy linear accelerator with a minimum higher energy of at least 10MV photons, with electron facilities - each attendance at which treatment is given - 1 field - treatment delivered to primary site [specific indication listed here]
Fee: $58.55 Benefit: 75% = $43.95 85% = $49.80
Category [3]– Therapeutic procedures
MBS 15260, 15263 or 15266, 15269
RADIATION ONCOLOGY TREATMENT, using a dual photon energy linear accelerator with a minimum higher energy of at least 10MV photons, with electron facilities - each attendance at which treatment is given - 2 or more fields up to a maximum of 5 additional fields (rotational therapy being 3 fields) - treatment delivered to primary site [specific indication listed here]
Fee: The fee for item [relating to one field above] plus for each field in excess of 1, an amount of $37.25
Intensity modulated radiation therapy (IMRT) is a form of external beam radiotherapy which due to advances in radiotherapy planning technology and computer-controlled linear accelerators allows for greater dose complexity. While 3DCRTand IMRT deliver beams that are geometrically shaped, IMRT also modulates the intensities of the beams and can sculpt the radiation to the target area of the tumour more precisely than 3DCRT. IMRT can be delivered by a series of static beams. Usually an odd number of beams are used (3,5,7,9). The more beams that are used, the more closely the irradiated volume conforms to the Planning Target Volume. This complexity however results in an increase in treatment time and an increase in machine monitor units (MUs), a measure of machine radiation output (Enferadi et al 2011). MUs are considered important as a secondary cancer risk in patients treated with radiotherapy is proportional to how many MUs are required per treatment course

(Fogarty et al 2011). Fixed gantry IMRT has a higher number of MUs compared to both 3DCRT and rotational IMRT, also known as Volumetric Modulated Arc Therapy.
IMRT is not currently MBS listed. A proposal for an application requesting MBS listing of IMRT was also considered by PASC at its August meeting (Application 1182). This technology is intended for use in the same population.
Description and delivery of proposed new intervention
VMAT is an extension of intensity-modulated radiation therapy (IMRT) treatment technique that uses the same hardware (i.e. a digital linear accelerator) as used for IMRT or conformal treatment, but delivers the radiotherapy treatment using rotational or arc geometry rather than several static beams.
This can be delivered either via a single rotation around the patient or via multiple arcs. Central to this approach is the use of specialised treatment planning algorithms (treatment planning software).
These planning algorithms improve time efficiency by modifying simultaneously three variables during treatment: These are
 rotation speed of the gantry
 shape and field profile of the multileaf collimator aperture (treatment beam) and
 the strength of the dose being delivered.
The target volume dose does not change when using VMAT and like IMRT dose delivery is still highly conformal. The amount of scatter and leakage radiation dose to the rest of the body however is reduced compared to conventional IMRT (fixed gantry). As such the significant difference between
VMAT and IMRT is the reduction in monitor units (MU) and treatment delivery time (Elith et al 2011).
Treatment with VMAT, as with other radiation therapy methods, requires four stages: simulation, planning, treatment, treatment verification. The exact procedures and dose required in each stage will and should vary depending on what type of cancer is being treated.
Treatment will be given primarily in an outpatient setting and would be carried out in the same specially designed bunkers as other radiation therapy delivery technologies. The duration of individual treatment sessions is dependent on the number of fields that are delivered.
Prerequisites
The delivery of VMAT requires a linear accelerator with a dynamic multileaf collimator with IMRT capability and also capable of delivering rotational therapy. Radiotherapy units that use EBRT or IMRT would already have access to such machines although these would need to be fitted with specialised treatment software. Some of the older linacs do not have the capability for IMRT or rotational IMRT and are considered unlikely to be able to be upgraded. In this instance a new machine would need to be purchased and newer linear accelerators are available that can be fitted with specific VMAT treatment software. The planning computer also requires specific rotational IMRT software. Currently these include: RapidARc TM (Varian), Elektra VMAT TM and Philips SmartArc TM (Philips) and Oncentra
(Nucltron) and Tomotherapy.

A multi-disciplinary range of radiation oncology professionals are also a pre-requisite for the safe and effective utilisation of the proposed new item. It is proposed that VMAT should be delivered under the supervision of radiation oncologists in teams including radiation therapists and medical physicists.
Clinical advice from MESP members indicates that quality assurance requirements are different between 3DCRT and IMRT techniques. Previously QA requirements were machine specific. With VMAT and IMRT a patient specific dosimetric QA is required and may take up to 1.5 hours of physics time.
Co-administered and associated interventions
The same tests are used in the lead up and monitoring of treatment whether a patient receives treatment with the VMAT or alternative EBRT systems. Like other EBRT systems patient simulation and dosimetry are also required for VMAT; resource requirements however are likely to be greater when treatment is provided using VMAT due to the increased complexity of treatment plans. Similarly verification is also required but is more complex for VMAT than both IMRT and 3DCRT. A separate proposal for an application requesting MBS listing of daily and online treatment verification items is to be considered by PASC at its August 2012 meeting. In addition an application for MBS listing of IMRT is also to be considered potentially covering both planning and treatment. The current MBS items for the co-administered procedures are provided in Table 1.
Table 1. MBS item descriptors for lead up and monitoring procedures associated with delivering radiotherapy to prostate cancer patients.
MBS number Procedure Fee
104
105
Specialist consultation (initial)
Specialist consultation (ongoing)
$83.95
$42.20
15550
15556
15559
15562
15705, 15710
Simulation
Dosimetry – Level 1 complexity
Dosimetry – Level 2 complexity
Dosimetry – Level 3 complexity
Verification
$646.30
$652.00
$850.40
$1,099.85
$76.60
Proposed MBS listing
The proposed MBS item for the VMAT system would fall under Category 3 – Therapeutic Procedures, which is the case for currently listed radiotherapy services. Table 2 outlines the proposed descriptor outlined by the applicant in order for VMAT to be reimbursed on the MBS.
Given the applicant states that simulation, dosimetric and verification items are to be the same, the
applicant only proposes a new descriptor in relation to treatment episode. The fee listed below (

Table 2) was provided by the applicant and no details are given as to how this fee was derived
however it would seem to works out to be equivalent to a five field treatment. It is also noted that an additional $55.97 would be sought under the Radiation Oncology Health Program Grant (ROHPG) program.
This proposal is different to the current funding mechanism for radiotherapy treatment. Currently, radiotherapy is funded on the basis of the number of fields delivered during a treatment session. For example, 3DCRT treatment of lung cancer is funded under two MBS item numbers. MBS item number
15245 funds the delivery of a single field in a treatment session. MBS item number 15260 funds additional fields (up to a maximum of maximum of 5 additional fields (3 fields for rotational therapy))
that are delivered in the same treatment session (see Table 1). The overall fee is calculated by
claiming $58.55 under MBS item number 15245 plus $37.25 for each additional field under MBS item
15260.
The funding structure proposed would fund VMAT on a per-treatment basis rather than the delivery of initial and subsequent fields
Table 2: Proposed listing for VMAT (as per applicant)
Category [3]– Therapeutic procedures
MBS 15xxxx
Radiation Oncology Treatment, using a dual photon energy linear accelerator with single or multi arc capacity (rotational therapy) – each attendance at which treatment is given – treatment delivered to primary site
Fee:$207.55
Input from MESP members regarding the item descriptor was that the item should not describe the capability of the machine but rather reflect whether rotational or arc IMRT was given. In addition it was noted that there should be a comment in the proposed item to indicate that a fee for rotational
IMRT can only be reimbursed for one treatment per attendance even if rotational therapy is given as two rotations or arcs. VMAT may also require a higher fee given the greater complexity and requirement for QA.

Table 3 Proposed listing for VMAT (clinical input)
Category [3]– Therapeutic procedures
MBS 15xxxx
Radiation Oncology Treatment, rotational IMRT using a linear accelerator in which treatment was delivered as rotational or arc therapy. – each attendance at which treatment is given.
Fee:
As mentioned above the applicant only proposes a new descriptor in relation to radiation oncology treatment. The applicant does not consider any other items in relation to treatment planning
(dosimetry) or the use of the image guidance both are which are considered to be integral (yet more complex than the existing scope of listed items) to the delivery of IMRT and VMAT. A separate application requesting listing of on-line and daily IGRT items is currently being progressed (application
1319). The descriptors for IGRT in that application potentially may need to incorporate VMAT, and the assessment of it may need to consider VMAT if the latter is to be assessed separately to IMRT.
Clinical place for proposed intervention
Radiotherapy is one of the main treatment modalities for cancer. The type of radiotherapy delivered will depend on the clinical circumstances and the intention of the treatment.
In the context of delivering radiotherapy to patients the use of VMAT would be an
for radiotherapy delivered by existing EBRT systems namely 3DCRT as listed by the applicant. It could however also be an
to fixed gantry IMRT.
Comparator
The applicant lists EBRT as the main comparator. Although not included in the application, IMRT
(fixed gantry) has been added here to facilitate discussion as a potential additional comparator.
External Beam Radiotherapy (3DCRT)
The applicant states that VMAT is suitable for radiation therapy for patient target groups with indications for 3DCRT where VMAT offers a dosimeteric advantage. As such not all patients will require VMAT as the preferred modality of radiotherapy. On the other hand, in any situation where there are normal tissue and adjacent dose-limiting organs, VMAT may be favoured due to the superior dose-distribution that can be achieved to the target tumour while avoiding injury to these normal structures.These clinical indications include but are not limited to the curative treatment of head and neck cancer, prostate and lung cancer
IMRT (fixed gantry)

IMRT is increasingly being used as the treatment of choice for patients with complex-shaped planning target volumes (PTV) targets, especially when the target is close to organs-at risk (Wiezorek et al
2011). While IMRT offers advantages to other forms of EBRT the delivery of plans with traditional
IMRT techniques takes extra time and involves a higher number of monitor units. These higher numbers of MUs result in increased peripheral dose (Wiezorek et al 2011). VMAT offers an alternative to fixed gantry IMRT by allowing treatment plans of similar of better quality delivered in shorter treatment time and reduced MUs (Johnston et al 2011).
.

Figure 1 : Generalised clinical management algorithm for cancer patients undergoing radiotherapy
Patients diagnosed with cancer who are considered eligible for EBRT
Treatmen t decision
Surgery, active surveillance, other forms of radiotherapy
3DCRT Treatment
Simulation
Dosimetric Planning
Quality Assurance
EBRT Treatment and imaging/verficiation: treatment delivered over several sessions
EBRT Radiation therapy
IMRT (fixed gantry)*
Simulation
Dosimetric Planning
(increased complexity
Quality Assurance (pre treatment included in
IMRT)
IMRT fixed gantry treatment and imaging/verification
VMAT (rotational)
Simulation
Dosimetric Planning
Quality Assurance (pre treatment included)
VMAT treatment and imaging/verification
Primary outcomes: Safety, effectiveness such as toxicity, Tumour control, Survival, Quality of Life

Potential benefits of proposed technology
Compared to 3DCRT, radiotherapy delivered by VMAT has the following
benefits:
 Ability to deliver radiotherapy more accurately (dose) which may lead to
 o Reduced toxicity o Improved tumour control
The potential to make treatment more acceptable to patients through its ability to reduce the number of treatment sessions.
Compared to 3DCRT, VMAT has the following
harms:
 Possible increase in low dose radiation to surrounding tissues and a higher number of monitor units (Wagner et al 2009).
On the basis of this, the clinical claim made by the applicant is that VMAT is at least non-inferior to
3DCRT and may be superior in terms of clinical effectiveness with less associated toxicity. While no cost-effectiveness studies have been published comparing VMAT and 3DCRT, there are publications comparing IMRT and 3DCRT in patients with prostate cancer (Centre for Reviews and Dissemination.
& Hummel 2010)(Konski et al 2006).
As part of the application; an unpublished systematic review of the peer reviewed evidence of VMAT compared with current clinical approaches was presented (Dempsey & Findlay 2011). Clinical outcomes of interest were; time to plan and treat; dose evaluation across planning target volumes
(PTV); dose evaluation across organs at risk (OAR) volumes. This review identified 28 studies that were considered relevant and addressed comparison of tumour target doses (PTV) and organ at risk doses (OAR). All studies were level III evidence (case series) and included patients from a range of indications, only three studies had > 15 patients.
A published review of the VMAT literature is also available (Teoh et al 2011). Like the unpublished review, all included studies were level III evidence with few studies including more than 15 patients.
The authors of the review also note that the majority of published studies are on planning and feasibility studies, with few studies reporting on clinical outcomes
Structure of the economic model
The applicant has stated that VMAT is a replacement to 3DCRT and is at least non-inferior to 3DCRT and may be superior in terms of clinical effectiveness with less associated toxicity.This would infer the approach should be a CEA or CUA which may be reduced to a cost-minimisation analysis should the evidence indicate that VMAT is no worse that the comparator (3DCRT).

Table 3: Classification of an intervention for determination of economic evaluation to be presented
Superior
Superior
CEA/CUA
Comparative effectiveness versus comparator
Non-inferior
CEA/CUA
Inferior
Net clinical benefit CEA/CUA
Neutral benefit
Net harms
CEA/CUA*
None^
Non-inferior CEA/CUA CEA/CUA* None^
Net clinical benefit CEA/CUA
Inferior Neutral benefit CEA/CUA* None^ None^
Net harms None^
Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis
* May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service hasbeen indisputably demonstrated to be no worse than its main comparator(s) in termsof both effectiveness and safety, so the difference between the service and theappropriate comparator can be reduced to a comparison of costs. In most cases, therewill be some uncertainty around such a conclusion (i.e., the conclusion is often notindisputable).
Therefore, when an assessment concludes that anintervention was no worse than a comparator, an assessment of the uncertainty aroundthis conclusion should be provided by presentation of cost-effectiveness and/or cost-utility analyses.
^ No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention
.
Lack of data to populate an economic model
There would appear to be limited data on the clinical effectiveness of VMAT in comparison to EBRT.
The literature that is published is primarily planning studies and VMAT is compared to both fixed gantry IMRT and 3DCRT. It is likely that the broader IMRT literature would need to be used to populate a more complex model.
Consideration of the capital costs
Regardless of the economic structure the review will need to outline additional capital costs in respect to the proposed adoption of VMAT in the health system. This will include purchase of additional equipment for planning, delivery and QA of VMAT as well as the staff required to undertake VMAT
(which may require a different skill mix).

This assessment will consider the following outcomes:
Safety:
 Rates and severity of acute and long-term toxicity events associated with IMRT treatment.
Effectiveness:
 Tumour response
 Local control.
 Progression free survival rates
 Overall survival rates.
 Quality of life
Proposed structure of economic evaluation (decision-analytic)
Table 4: Summary of extended PICO to define research question that assessment will investigate
Patients Intervention Comparator Outcomes to be assessed
Healthcare resources to be considered
Patients diagnosed with cancer who are considered eligible for
EBRT
VMAT 3DCRT
IMRT (fixed gantry)
Safety:
Accuracy
Irradiation of adjacent normal tissues
Short term side effects of treatment (incidence and severity)
Site-specific morbidity as a result of acute and long term toxicity eg.gastrointestinal; urological (acute/late)
Effectiveness:
Tumour response
Local control
Progression free survival rates
Overall survival rates.
Quality of life
Resources associated with radiotherapy treatment e.g.
Simulation
Dosimetry
Treatment
Verification
Average treatment planning times
Average treatment times
Resources for treating acute and long-term toxicities of radiation treatment.
What is the safety, effectiveness, and cost-effectiveness of VMAT in comparison to external beam radiotherapy in patients diagnosed with cancer who are considered eligible for EBRT?

Figure 2 Simplified decision tree representing patients treated with VMAT in comparison to EBRT
Please note that the decision trees given here are provided for the purposes of supplementing the information given in the PICO tables and clinical algorithms and may not reflect the cost-effectiveness model required in the final assessment.
Health care resources
The applicant states that there should be no change in resources with the adoption of VMAT as a replacement to 3DCRT. This is true in respect to the utilisation rates of health care resources used to identify eligible patients for treatment using either the VMAT system or conventional EBRT systems.The applicant however does not take into the account the additional expertise and time required for the delivery of VMAT – specifically in relation to treatment planning and verification.
In addition should treatment with the VMAT system result in changes in the rates of acute and longterm toxicities there would also be a corresponding change in the utilisation of the health care resources used to treat or manage these complications. Similar changes in the rates of recurrence would result in a corresponding change in the utilisation of the health care resources used to treat or manage this.
In respect to treatment times, time for VMAT are reduced compared to fixed gantry IMRT. This however depends upon the number of beams and the machine technology. It has been suggested that a reduction in beam-on time may have an impact on the clinical throughput –with the time saved by reducing beam-on time used to implement more online imaging technologies without increasing the total time in the treatment room (Elith et al 2011).

Table 4: List of resources to be considered in the economic analysis (not exhaustive)
Provider of resource
Setting in which resource is provided
Proportion of patients receiving resource
Number of units of resource per relevant time horizon per patient receiving resource
MBS
Safety nets*
Disaggregated unit cost
Other govt budget
Private health insurer
Patient
Total cost
Resources provided to identify eligible population
Specialist Specialist Outpatient
Consultation
-
Resource 2, etc
Resources provided to deliver proposed intervention (VMAT)
Simulation Radiation
Oncologist
Outpatient
-
Dosimetry
Treatment
Radiation
Oncologist
Radiation
Oncologist
Outpatient
Outpatient
-
Verification Radiation
Oncologist
Outpatient
Resources provided in association with proposed intervention (VMAT)
-
Additional imaging
Implantation of fiducial seeds
Specialist Outpatient
Specialist Outpatient
(where relevant)
-
Specialist
Consultation
Specialist Outpatient
Resources provided to deliver comparator (EBRT as above)
-
Resource 1
Resource 2, etc nil
Resources provided in association with comparator 1 (EBRT as above) (e.g., pre-treatments, co-administered interventions, resources used to monitor or in follow-up, resources used in management of adverse events, resources used for treatment of down-stream conditions)
Resource 1
-
Resource 2, etc
* Include costs relating to both the standard and extended safety net.
Estimate of utilisation
Some indication of the expected utilisation of VMAT can be gleaned from looking at the MBS figures
for 3D-CRT dosimetry and treatment simulation (Table 5). These figures reflect usage in the private
hospital system and represent the number of times that they have been claimed rather than the number of patients. Simulation utilisation figures perhaps are more representative of the number of patients who would be eligible – however these are not broken down by clinical indication. As already mentioned the type of radiotherapy delivered depends on the clinical indication and intent of treatment. It would not be expected that VMAT entirely replace 3DCRT; rather be an option for a percentage of patients diagnosed with cancer in whom 3DCRT would normally have been recommended. Similarly it would not replace fixed beam IMRT; rather in some cases fixed beam
IMRT would be appropriate while for others rotational IMRT would be an alternative.

Table 5 MBS utilisation figures for simulation and dosimetry EBRT 2010-2011
MBS Item
Simulation
15550
15553
Dosimetry
15556
15559
15562
Total claims
26,480
1,914
5,360
6,690
15,047
Source: Medicare Item Reports service accessed at https://www.medicareaustralia.gov.au/statistics/mbs_item.shtml
on 26th
June 2012.

1. Centre for Reviews and Dissemination. and Hummel, SSELH 2010. Intensity-modulated radiotherapy for the treatment of prostate cancer: a systematic review and economic evaluation
(Provisional abstract),
2),
2. Dempsey, S.,Findlay, N. 2011.
3. Elith, C, Dempsey, SE et al 2011. An introduction to the intensity-modulated radiation therapy
(IMRT) techniques, tomotherapy, and VMAT,
, 42 (1), 37-43.
4. Enferadi, M, Sadeghi, M et al 2011. Radiation therapy in the early 21st century: Technological advances,
, 7 (4), 303-318.
5. Faculty of Radiation Oncology 2011,
The Royal Australian and New Zealand
College of Radiologists.
6. Fogarty, G, Ng, D et al 2011. Volumetric modulated arc therapy is superior to conventional intensity modulated radiotherapy-a comparison among prostate cancer patients treated in an
Australian centre,
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