Download Ga-DOTA-NOC_Fact_Sheet_for Insurance_Pre

Request for Pre-Approval
68Ga-DOTA-NOC
PET/CT for Evaluation of Neuroendocrine Cancer
RE: ___________________________ (Patient Name and Identifier)
Dr. ___________________________, who is treating Mr./Ms. ________________, believes that
management of this patient’s clinical care would be advanced by performance of a 68Ga-DOTA-NOC
PET/CT scan.
The clinical indication for this 68Ga-DOTA-NOC PET/CT study is:
☐ NEN patient, who is a potential candidate for multi-visceral organ transplant (MVOT), to
determine extent of disease.
☐ Patient with biopsy-proven NEN or NESSTR, where there is clinical need to determine extent
of disease or location of unknown primary.
☐ Patient with strong clinical suspicion of NEN or NESSTR, where conventional imaging results
(e.g. 111InOctreoscan) have failed to establish diagnosis and there is concern for false
negative exam results
Prior Octreoscan Study Date: _______________________________________
☐ Patient with NEN or NESSTR who has had disease-specific treatment and where there is
clinical need to establish interim response to therapy or evaluate for disease recurrence.
* Intended for Neuroendocrine Neoplasia (NEN) or other neoplasms expressing somatostatin
receptors (NESSTR), such as astrocytomas and meningiomas in the brain; adrenal
medullary tumors (pheochromocytoma, neuroblastoma, ganglioneuroma), medullary
thyroid cancer, renal cell cancer, pituitary adenomas, paragangliomas, and patients with
primary tumor-induced osteomalacia.
Is patient receiving Octreotide, or another somatostatin-receptor-binding drug, therapeutically?
☐Y ☐ N
If yes, Drug: __________________________________
Dose: ________________________
Date of last administration: _____________________________
Date of next planned administration: ______________________
Scan date should be coordinated to occur just prior to the next planned dose
The Indiana University School of Medicine can produce the 68Ga-DOTA-NOC
radiopharmaceutical for this patient under Physician-Sponsored Expanded Access IND
#117255 (James W. Fletcher, M.D., Sponsor).
The 68Ga-DOTA-NOC radiopharmaceutical is a somatostatin-receptor-targeting peptide, radiolabeled
with gallium-68, that has found widespread clinical use in Europe, and that has proven quite effective in
localizing neuroendocrine tumors with PET/CT [1-10].
While related to the FDA-approved 111In-Octreotide (Octreoscan) agent for gamma and SPECT imaging of
neuroendocrine tumors, the literature shows the 68Ga-PET procedure to deliver images with superior
tumor/non-target contrast, and far better sensitivity for tumor detection [1-10]. Our clinical experience
with 68Ga-DOTA-NOC PET/CT at the Indiana University Hospital is fully consistent with this literature.
The 68Ga-DOTA-NOC PET/CT procedure will be performed in accordance with the published procedure
guidelines of the European Association of Nuclear Medicine and Molecular Imaging [1].
The FDA-authorized charge for this Expanded Access radiopharmaceutical is $3,013. This charge
represents the break-even cost of producing the radiopharmaceutical per patient.
The charges to the patient will be the following:
The patient charge for the dose will be $100.00.
The technical charge for performance of the PET CT scan will be $4,200.00.
The professional fee for interpretation and reporting will be $609.00.
Technical questions about the 68Ga-DOTA-NOC PET/CT procedure can be directed to:
Professor James W Fletcher, M.D.
Director of Nuclear Medicine and PET Imaging
Department of Radiology and Imaging Sciences
Indiana University School of Medicine
Indianapolis, IN 46202
317-944-1800
e-mail: [email protected]
Questions about the clinical need for the 68Ga-DOTA-NOC PET/CT procedure, and how it is expected to
advance this patient’s care, should be directed to:
___________________________, M.D.
Department of __________________________
Indiana University School of Medicine
Indianapolis, IN 46202
317-__________________
e-mail: _________________
The 68Ga-DOTA-NOC PET/CT study cannot be performed for this patient without confirmation that
payment will be made for the procedure.
For reference, Blue Cross of Arkansas has issued a favorable coverage decision for such 68Ga-PET
evaluation of neuroendocrine tumors:
http://www.arkansasbluecross.com/members/report.aspx?policyNumber=2001039&viewIntro=yes
Literature References
1.
I. Virgolini, V. Ambrosini, J.B. Bomanji, R.P. Baum, S. Fanti, M. Gabriel, N.D. Papathanasiou, G.
Pepe, W. Oyen, C. De Cristoforo, A. Chiti. Procedure guidelines for PET/CT tumour imaging
with
68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, Eur J
Nucl Med Mol Imaging (2010) 37:2004–2010.
2.
D. Wild, H.R. Mäcke, B. Waser et al. 68Ga-DOTANOC: A first compound for PET imaging with high
affinity for somatostatin receptor subtypes 2 and 5 Eur J Nucl Med Mol Imaging, 32 (2005), p. 724.
3.
V. Prasad, R.P. Baum Biodistribution of the Ga-68 labeled somatostatin analogue DOTA-NOC in
patients with neuroendocrine tumors: Characterization of uptake in normal organs and tumor
lesions Q J Nucl Med Mol Imaging, 54 (2010), pp. 61–67.
4.
V. Rufini, M.L. Calcagni, R.P. Baum Imaging of neuroendocrine tumors Semin Nucl Med, 36
(2006), pp. 228–247.
5.
V. Prasad, V. Ambrosini, M. Hommann et al. Detection of unknown primary neuroendocrine
tumors(CUP-NET) using (68)Ga-DOTA-NOC receptor PET/CT Eur J Nucl Med Mol Imaging, 37
(2010), pp. 67–77.
6.
Baum R, Niesen A, Leonhardi J, Wortmann R, Mueller D, Roesch F. Receptor PET/CT imaging of
neuroendocrine tumors using the Ga-68 labelled, high affinity somatostatin analogue DOTA-1-Nal3
octreotide (DOTA-NOC): clinical results in 327 patients. Eur J Nucl Med Mol Imaging 2005;32
Suppl 1:S54–5.
7.
Valentina Ambrosini, Davide Campana, Lisa Bodei, Cristina Nanni, Paolo Castellucci, Vincenzo
Allegri, Gian Carlo Montini, Paola Tomassetti, Giovanni Paganelli, and Stefano Fanti. 68GaDOTANOC PET/CT Clinical Impact in Patients with Neuroendocrine Tumors, J Nucl Med 2010;
51:669–673.
8.
Antunes P, Ginj M, Zhang H, Waser B, Baum RP, Reubi JC, et al. Are radiogallium-labelled DOTAconjugated somatostatin analogues superior to those labelled with other radiometals? Eur J Nucl
Med Mol Imaging (2007) 34(7):982–93.
9.
C. Pettinato, A. Sarnelli, M. Di Donna, S. Civollani, C. Nanni, G. Montini, D. Di Pierro, M.
Ferrari,
M. Marengo, C. Bergamini. 68Ga-DOTANOC: biodistribution and dosimetry in patients
affected by neuroendocrine tumors, Eur J Nucl Med Mol Imaging (2008) 51:72–79.
10.
D Wild, JB. Bomanji, P Benkert, H Maecke, PJ. Ell, JC Reubi, ME Caplin. Comparison of 68GaDOTANOC and 68Ga-DOTATATE PET/CT within patients with gastroenteropancreatic
neuroendocrine tumors, J Nucl Med (2013) 54:364–372.