Medical Policy: 06.01.15
Original Effective Date: July 2016
Reviewed: November 2020
Revised: November 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Stereotactic radiosurgery (SRS) , also referred to as stereotactic ablative surgery, is a method of delivering high doses of precisely targeted ionizing radiation to intracranial lesions. SRS, when used extra cranially, it is called stereotactic body radiation therapy (SBRT) or stereotactic ablative radiotherapy (SABR). Like other forms of radiation, stereotactic radiosurgery works by damaging the DNA of the targeted cells. The affected cells then lose the ability to reproduce, which causes tumors to shrink.
Delivery systems for SRS and SBRT include, but may not be limited to:
- Linear accelerator (eg. CyberKnife and TrueBeam) is a radiation delivery system that consists of a lightweight linear accelerator device (LINAC) that is mounted to a multi-jointed robotic arm. This device reportedly utilizes a proprietary real-time image-guidance system to deliver stereotactic radiosurgery or radiotherapy. It was designed to enable access hard to reach or complex shaped tumors that may not be accessible by surgery and other radiosurgical technologies.
- Gamma Knife (eg, Perfexion SRS system, Target System) is s radiosurgery technology, which by design is restricted to treating brain tumors. The device utilizes ionizing radiation (gamma rays) produced by 201 radioactive colbalt-60 sources to ablate intracranial targets via a fixed stereotactic frame.
- GammaPod is a stereotactic radiotherapy system that is designed to deliver SBRT by purportedly using thousands of individual focused beams from 36 rotating radioactive Cobalt-60 sources. It is intended for use in the noninvasive stereotactic delivery of radiation to a portion of the breast in conjunction with breast conserving treatment. The individual will lie prone on a table with the breast immobilized in a vacuum-assisted cup, which supposedly provides increased accuracy in the delivery of the radiation.
Key issues regarding the role for SRS in treating metastatic disease are the size and number of lesions that can be treated and whether or not SRS should be combined with whole brain irradiation to address lesions that are undetectable with imaging techniques. As part of the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, and Joint Tumor Section Multidisciplinary Evidence Based Clinical Practice Parameter Guidelines on Metastatic Brain Tumors, a guideline was developed addressing this role, which offered the following recommendation:
- The local control advantage of single-dose SRS for patients with greater than or equal to 4 metastatic brain tumors and a KPS [Karnofsky performance score] greater than or equal to 70% warrants further investigation in the form of an RCT.
Alternatives to SRS and SBRT include, but may not be limited to, the following:
- Deep brain stimulation
- Endovascular embolization
- Intensity modulated radiation therapy (IMRT)
- Prescription drug therapy
- Proton beam radiation
- Surgical removal
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
National Comprehensive Cancer Network guidelines version 2.2020 for the treatment of prostate cancer notes: SBRT can be considered cautiously as an alternative to conventionally fractionated regimes at clinics with appropriate technology and clinical expertise. Longer follow-up and prospective multi-institutional data are required to evaluate longer-term results, especially because late toxicity theoretically could be worse in hypofractionated regimens compared to conventional fractionation. It is noted that during oligometastatic disease SBRT may be considered in clinical trials.
National Comprehensive Cancer Network guidelines version 6.2020 for the treatment of small cell lung cancer (SCLC) notes: A few reports have suggested that stereotactic ablative ratiotherapy (SBRT) might be useful for select patients with limited-stage SCLC; however, there are insufficient data to make a recommendation.
National Comprehensive Cancer Network (NCCN) Guidelines version 1.2020 for pancreatic adenocarcinoma note that one regime is not necessarily more effective than another and that recommendations for radiation therapy is typically based on several scenarios. Specifically, stereotactic body radiotherapy (SBRT) “should be avoided if direct invasion of the bowel or stomach is observed on CT, MRI, or endoscopy”.
The American Society for Radiation Oncology (ASTRO)
In May, 2013, ASTRO updated its Model Policy for SBRT and states "It is ASTRO's opinion that data supporting the use of SBRT for prostate cancer have matured to a point where SBRT could be considered an appropriate alternative for select patients with low to intermediate risk disease."
In 2013, the American Society for Radiation Oncology (ASTRO) published a Model Policy that addressed the role of SBRT in the treatment of spinal metastases, stating SBRT has been demonstrated to achieve durable tumor control when treating lesions in vertebral bodies or the paraspinous region, where extra care must be taken to avoid excess irradiation of the spinal cord when tumor-ablative doses are administered. However, the document also notes that when palliation is the primary treatment goal "it is generally appropriate to use a less technically complex form of palliative radiotherapy rather than SBRT."
In general ASTRO recommends: SBRT may be used as an alternative to surgery for treating various lesions and may be an effective and safer alternative than conventional radiation therapy for certain presentations of cancers and other non-cancer targets. Direct physician involvement, image guidance and immobilization are integral to stereotactic treatment for these diverse body sites. SBRT is indicated for primary tumors and tumors metastatic to the lung, liver, kidney, adrenal gland or pancreas.
The Agency for Healthcare Research and Quality (AHRQ)
Stereotactic Body Radiation Therapy Structured Abstract Objectives. Conducted a systematic literature scan for published data for the treatment of stereotactic body radiation therapy (SBRT) and provided a broad overview of the current state of SBRT for solid malignant tumors.
SBRT’s most important features and theoretical advantages compared to other forms of EBRT are the high degree of dose conformality, the use of high-dose radiation, the delivery of a single or very few fractions (thus decreasing the overall length of treatment), and an improved treatment response. However, SBRT can also be difficult to administer because of the high level of accuracy required, interfraction or intrafraction movements within the body (e.g., respiratory movements) and movements of the body. Similar to other forms of EBRT, SBRT can be used in combination with chemotherapy, and sometimes after other radiation therapy (RT) interventions. As with other radiation treatments, geographic misses of the targeted tumor causes damage to surrounding healthy tissues. However, because each SBRT radiation fraction is a higher dose compared to other forms of EBRT, there is greater potential for radiation injury.
American College of Radiology
The Expert Panel on Radiation Oncology-Gynecology/American College of Radiology‘s Appropriateness Criteria on “Definitive therapy for early stage cervical cancer” stated that “Stereotactic body RT (SBRT) has been shown to be a useful treatment option in other tumor sites, especially in early stage lung cancer. There are preliminary data on its use in treating cervical cancer, but, given target definition, tumor motion, and the proven track record of brachytherapy, SBRT should not be considered a substitute for brachytherapy”.
American Academy of Ophthalmology
In 2015, the American Academy of Ophthalmology updated its evidence-based preferred practice pattern on age-related macular degeneration. For extrafoveal choroidal neovascularization, radiotherapy was not recommended (SIGN grade: III; GRADE assessment: moderate level of evidence, strong recommendation).
In their 2019 Preferred Practice Pattern for age-related macular degeneration, they state that current data is insufficient “to demonstrate clinical efficacy” for extrafoveal choroidal neovascularization.
SRS has also been studied in a wide variety of other cranial applications including the treatment of epilepsy, chronic pain, Parkinson's disease and other movement disorders. For these applications, there is a lack of studies regarding the safety and effectiveness of radiosurgery in comparison with standard therapies.
Stereotactic Radiosurgery (SRS)/Stereotactic Body Radiotherapy (SBRT)
Stereotactic radiosurgery (SRS) using a gamma ray or linear accelerator or Stereotactic Body Radiotherapy (SBRT) may be considered medically necessary for the following indications:
- Arteriovenous malformations;
- Acoustic neuromas;
- Pituitary adenomas;
- Nonresectable, residual, or recurrent meningiomas;
- Uveal melanoma
- Glomus tumors;
- Solitary or multiple brain metastases in patients having good performance status (see Karnofsky Performance Status in Policy Guidelines) and no active systemic disease (defined as extracranial disease that is stable or in remission);
- Primary malignancies of the central nervous system (CNS), including, but not limited to, high-grade gliomas (initial treatment or treatment of recurrence);
- Trigeminal neuralgia refractory to medical management;
- Base of skull chordomas and chondrosarcomas;
- Oligometastases involving lung, adrenal glands and/or, bone
- Patients with stage T1 or T2a small cell lung cancer and non-small-cell lung cancer (not >5 cm) showing no mediastinal nodal or distant disease and who are not candidates for surgical resection;
- Spinal or vertebral body tumors (metastatic or primary) in patients who have received prior radiotherapy.
- Spinal or vertebral metastases that are radioresistant (eg, renal cell carcinoma, melanoma, sarcoma).
- Primary head and neck stage IV tumor (Any N1, M0, M1 and G) with limited tumor bulk amenable to local therapy
- Hepatocellular Carcinoma,and secondary metastasis to the liver that is considered unresectable
- Pancreatic Cancer without invasion of bowel or stomach
- Kidney Cancer in the following clinical scenario:
- Relapse or Stage IV and
- Unresectable and
- Symptomatic Metastases
- Cervical cancer in isolated metastatic sites only
- For Prostate Cancer without metastasis in low and favorable, intermediate risk defined by the following:
- Gleason score (GS) less than or = to 8 AND
- Prostate specific antigen (PSA) less than 20 ng/ml
Stereotactic body radiotherapy (SBRT) is considered Investigational if failing to meet the above medical necessity criteria including for very low-risk prostate cancer, very high-risk prostate cancer, and high-volume metastatic disease.
Very Low risk Prostate Cancer
- PSA less than or = to 6 ng/mL
- Fewer than 3 prostate biopsy fragments/cores positive
- PSA density <0.15 ng/mL/g
Very High-Risk Prostate Cancer
- Stage greater than or equal to T3a
- Gleason Score (GS) greater than 8
- PSA greater than 20 ng/mL
High-Volume Metastatic Disease
High volume disease is defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.
Stereotactic radiosurgery/Stereotactic body radiotherapy (SBRT) is considered Investigational for the following including, but not limited to:
- The treatment of seizures, including epilepsy
- Functional disorders (other than trigeminal neuralgia), including chronic pain, headaches, and tremor
- Parkinson’s disease and other movement disorders
- Mammographic microcalcification
- Behavior Health Disorders
- Cancer of the liver when tumor resection is an option
- Pancreatic Cancer when invasion of the bowel or stomach is observed on CT, MRI, or endoscopy
- Kidney Cancer outside of above indications
- Cancer of the adrenal glands
- Breast Cancer
- Cervical Cancer outside of the above indications
- Thyroid Cancer
- Cardiac Arrhythmia (including but not limited to ventricular tachycardia)
- Extrahepatic bile duct cancer (cholangiocarcinoma), gall bladder cancer
- Cardiac radio-ablation
- Choroidal neovascularization
The evidence is insufficient to determine the effects of the technology effects on health outcomes in patients who have solid tumors, primary or metastatic, of the liver, pancreas, kidney, adrenal glands, and oligo metastases, except with metastases to the spine and as noted above. There is a lack of studies that show the use of SRS/SBRT has the expectation of a long-term benefit that could not have been attained with conventional therapy. Locally ablative therapies such as chemoembolization or radiofrequency ablation are established therapies for the treatment of inoperable primary liver cancer or metastatic disease.
The patient’s record must support the necessity and frequency of treatment. Medical records should include not only the standard history and physical but also:
- Patient’s functional status and
- A description of current performance status. See Karnofsky Performance Status under Policy Guidelines and
- Progression or remission status of systemic disease
Karnofsky Performance Status Scale
- 100 Normal; no complaints, no evidence of disease.
- 90 Able to carry on normal activity; minor signs or symptoms of disease.
- 80 Normal activity with effort; some signs or symptoms of disease.
- 70 Cares for self; unable to carry on normal activity or to do active work.
- 60 Requires occasional assistance but is able to care for most needs.
- 50 Requires considerable assistance and frequent medical care.
- 40 Disabled; requires special care and assistance.
- 30 Severely disabled; hospitalization is indicated although death not imminent.
- 20 Very sick; hospitalization necessary; active supportive treatment is necessary.
- 10 Moribund, fatal processes progressing rapidly.
- 0 Dead.
Patients should be categorized into “poor risk” and “good risk” groups. The poor-risk group includes patients with KPS below 60; multiple, serious, major neurologic deficits; extensive systemic disease with few treatment options; bulky CNS disease; and neoplastic meningitis related to encephalopathy. The good risk group includes patients with KPS greater than or equal to 60, no major neurologic deficits, minimal systemic disease, and reasonable systemic treatment options.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
- 32701 Thoracic target(s) delineation for stereotactic body radiation therapy (SRS/SBRT), (photon or particle beam), entire course of treatment
- 61796 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 simple cranial lesion
- 61797 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator) each additional cranial lesion, simple (List separately in addition to code for primary procedure)
- 61798 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator); 1 complex cranial lesion
- 61799 Stereotactic radiosurgery (particle beam, gamma ray or linear accelerator) each additional cranial lesion, complex (List separately in addition to code for primary procedure)
- 61800 Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure)
- 63620 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 spinal lesion
- 63621 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each additional spinal lesion (List separately in addition to code for primary procedure)
- 77371 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source Cobalt 60 based
- 77372 Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based
- 77373 Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
- 77432 Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session)
- 77435 Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions
- G0339 Image guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session, or first session of fractionated treatment
- G0340 Image guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum 5 sessions per course of treatment
- Buyyounouski M, Miller R, Schefter T, et al. Stereotactic body radiotherapy (SBRT) for primary management of early-stage, low-intermediate risk prostate cancer. Report of the ASTRO Emerging Technology Committee (ETC). Fairfax, VA: American Society for Therapeutic Radiation Oncology (ASTRO); September 19, 2008.
- Buyyounouski MK, Balter P, D'Ambrosio DJ, et al. Stereotactic body radiotherapy for early-stage non-small-cell lung cancer: Report of the ASTRO Emerging Technology Committee. Full Report. Fairfax, VA: American Society for Therapeutic Radiation Oncology (ASTRO); January 12, 2010.
- Yamada Y, Laufer I, Cox BW, et al. Preliminary results of high-dose single-fraction radiotherapy for the management of chordomas of the spine and sacrum. Neurosurgery. 2013;73(4):673-680; discussion 680.
- Shah A, Hahn SM, Stetson RL, et al. Cost-effectiveness of stereotactic body radiation therapy versus surgical resection for stage I non-small cell lung cancer. Cancer. 2013;119(17):3123-3132.
- Small W Jr, Strauss JB, Jhingran A, et al, Expert Panel on Radiation Oncology-Gynecology. ACR Appropriateness Criteria® definitive therapy for early stage cervical cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2012.
- Howington JA, Blum MG, Chang AC, et al. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e278S-e313S.
- Zhang B, Zhu F, Ma X, et al. Matched-pair comparisons of stereotactic body radiotherapy (SBRT) versus surgery for the treatment of early stage non-small cell lung cancer: A systematic review and meta-analysis. Radiother Oncol. 2014;112(2):250-255.
- Chang JY, Senan S, Paul MA, et al. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: A pooled analysis of two randomised trials. Lancet Oncol. 2015;16(6):630-637.
- Hernandez-Duran S, Hanft S, Komotar RJ, Manzano GR. The role of stereotactic radiosurgery in the treatment of intramedullary spinal cord neoplasms: A systematic literature review. Neurosurg Rev. 2015 Jul 30 [Epub ahead of print].
- Tipton KN, Sullivan N, Bruening W, et al. Stereotactic body radiation therapy. Effective Healthcare Program Technical Brief.No. 6 Prepared by the ECRI Institute Evidence-Based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. 290-02-0019. AHRQ Publication No. 10(11)-EHC058-EF. Rockville, MD: AHRQ; May 2, 2011.
- National Comprehensive Cancer Network. Clinical practice guideline: Hepatobiliary Cancers. Version 4.2020 NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Pancreatic Adenocarcinoma. Version 1.2020 NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Kidney Cancer. Version 1.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Cutaneous Melanoma. Version 3.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Breast cancers. Version 5.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Cervical cancers. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Bone cancers. Version 1.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Small Cell Lung Cancer. Version 4.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Non-Small Cell Lung Cancer. Version 6.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline Head and Neck Cancers. Version .2.2020. NCCN: Fort Washington, PA
- National Comprehensive Cancer Network. Clinical practice guideline: Prostate Cancer. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Neuroendocrine and Adrenal Tumors. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Central Nervous System Cancers. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Anal Carcinoma. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Soft Tissue Sarcoma. Version 2.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Colon Cancer. Version 4.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline: Rectal Cancer. Version 6.2020. NCCN: Fort Washington, PA.
- National Comprehensive Cancer Network. Clinical practice guideline Thyroid Carcinoma. Version 2.2020. NCCN: Fort Washington, PA
- American College of Radiology (ACR). ACR Appropriateness Criteria. Management of recurrent endometrial cancer.
- Régis, J., Tuleasca, C., Resseguier, N., Carron, R., Donnet, A., Gaudart, J., & Levivier, M. (2016). Long-term safety and efficacy of gamma knife surgery in classical trigeminal neuralgia: A 497-patient historical cohort study. Journal of Neurosurgery, 124(4), 1079–1087. doi:10.3171/2015.2.jns142144
- Herman, J., Chang, D., Goodman, K., et. al. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma. Cancer 2015; 121(7):1128-1137.
- Wahl, D., Stenmark, M., Tao, Y., et. al. Outcomes after stereotactic body radiotherapy or radiofrequency ablation for hepoatocellular carcinoma. J Clin Oncology 2016; 34:452-9.
- ECRI Institute. Technology News. FDA approves GammaPod radiotherapy system for breast cancer. Published February 12, 2018.
- Nguyen T, Chung LK, Sheppard JP, et al. Surgery versus stereotactic radiosurgery for the treatment of multiple meningiomas in neurofibromatosis type 2: Illustrative case and systematic review. Neurosurg Rev. 2017 Sep 13
- Bui TT, Lagman C, Chung LK, et al. Systematic analysis of clinical outcomes following stereotactic radiosurgery for central neurocytoma. Brain Tumor Res Treat. 2017;5(1):10-15.
- Zhong J, Patel K, Switchenko J, et al. Outcomes for patients with locally advanced pancreatic adenocarcinoma treated with stereotactic body radiation therapy versus conventionally fractionated radiation. Cancer. 2017;123(18):3486-3493
- Hintenlang LL, Miller DH, Kaleem T, et al. Treatment of a glioblastoma multiforme dural metastasis with stereotactic radiosurgery: A case report and select review of the literature. J Clin Neurosci. 2018;48:118-121
- Pan J, Jabarkheel R, Huang Y, et al. Stereotactic radiosurgery for central nervous system hemangioblastoma: Systematic review and meta-analysis. J Neurooncol. 2018;137(1):11-22.
- Chen L, Douglass J, Kleinberg L, et al. Concurrent immune checkpoint inhibitors and stereotactic radiosurgery for brain metastases in non-small cell lung cancer, melanoma, and renal cell carcinoma. Int J Radiat Oncol Biol Phys. 2018;100(4):916-925.
- Kobiela J, Spychalski P, Marvaso G, et al. Ablative stereotactic radiotherapy for oligometastatic colorectal cancer: Systematic review. Crit Rev Oncol Hematol. 2018;129:91-101.
- Lehrer EJ, Peterson J, Brown PD, et al. Treatment of brain metastases with stereotactic radiosurgery and immune checkpoint inhibitors: An international meta-analysis of individual patient data. Radiother Oncol. 2018 Sep 18 [Epub ahead of print].
- Lydiard S, Caillet V, Ipsen S, et al. Investigating multi-leaf collimator tracking in stereotactic arrhythmic radioablation (STAR) treatments for atrial fibrillation. Phys Med Biol. 2018;63(19):195008.
- Zei PC, Wong D, Gardner E, et al. Safety and efficacy of stereotactic radioablation targeting pulmonary vein tissues in an experimental model. Heart Rhythm. 2018;15(9):1420-1427.
- American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern: Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019.
- Karnofsky DA, Burchenal JH. (1949). “The Clinical Evaluation of Chemotherapeutic Agents in Cancer.” In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. pp 196.
- Coverage with Evidence Development Requirements Position Statement. American Society for Radiation Oncology Web site
- Brand DH, Tree AC, Ostler P, et al. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet, Sept. 17, 2019.
- November 2020 - Interim Review, Policy Revised
- July 2020- Annual Review, Policy Revised
- October 2019 - Interim Review, Policy Revised
- July 2019 - Annual Review, Policy Revised
- November 2018 - Interim Review, Policy Revised
- July 2018 - Annual Review, Policy Revised
- July 2017 - Annual Review, Policy Revised
- July 2016 - New policy
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