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1 MP Thyrgen (Thyrtrpin Alfa) Medical Plicy Sectin Prescriptin Drug Issue 12:2013 Original Plicy Date 12:2013 Last Review Status/Date Created with literature search/12:2013 Return t Medical Plicy Index Disclaimer Our medical plicies are designed fr infrmatinal purpses nly and are nt an authrizatin, r an explanatin f benefits, r a cntract. Receipt f benefits is subject t satisfactin f all terms and cnditins f the cverage. Medical technlgy is cnstantly changing, and we reserve the right t review and update ur plicies peridically. Descriptin Surgery is the crnerstne f management f patients with differentiated thyrid cancer. As an adjunct t this treatment, sme high-risk patients may need t underg radiactive idine treatment, further destrying nrmal thyrid tissue. All patients with tumrs arising frm fllicular epithelium require TSH suppressin since differentiated thyrid cancers cntain membrane receptrs respnsive t TSH. Lng-term thyrid hrmne supplements are used t maintain metablism in patients wh have had partial r ttal thyridectmy and/r radiactive idine treatment and t suppress endgenus levels f TSH. Management f patients with a histry f thyrid carcinma requires cntinuing evaluatin t mnitr cancer recurrence and metastatic disease by peridic physical examinatins, thyrglbulin levels, radiidine scans, and assurance f apprpriate TSH suppressin. A high level f TSH in a patient's bldstream is necessary t achieve ptimal sensitivity f serum thyrglbulin testing and in rder fr radiidine imaging t detect remnant thyrid tissue r metastatic disease. In rder t accmplish this, patients must stp taking their hrmne supplements fr tw t six weeks prir t testing. This thyrid hrmne withdrawal causes patients t experience symptms f hypthyridism -- fatigue, weight gain, cnstipatin, mental dullness, lethargy, depressin, and ther adverse reactins. On December 1, 1998, the FDA granted marketing apprval fr Thyrgen (thyrtrpin alfa) fr use as 'an adjunctive diagnstic tl fr serum thyrglbulin testing with r withut radiidine imaging in the fllw-up f patients with well-differentiated thyrid cancer.' Thyrgen, a recmbinant frm f TSH, prvides an external surce f TSH and allws thyrid cancer patients t avid hrmne withdrawal and its debilitating effects while underging diagnstic testing. The FDA made its decisin based n review f tw phase III clinical trials which were cnducted n 358 patients with well-differentiated thyrid cancer t cmpare 48-hur radiidine whle bdy scans btained after Thyrgen t whle bdy scans after thyrid hrmne withdrawal. One f these trials als cmpared thyrglbulin levels btained after Thyrgen t thse n thyrid hrmne suppressin therapy, and t thse after thyrid hrmne withdrawal. Acrss the tw clinical studies, Thyrgen was shwn t significantly enhance the sensitivity f thyrglbulin testing in patients maintained n thyrid hrmne therapy. The cmbinatin f a Thyrgen-stimulated scan and a serum thyrglbulin test did detect all patients with metastatic disease, althugh nt as sensitive as cmbinatin testing perfrmed after patients were 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

2 withdrawn frm thyrid hrmne supplements. The Thyrgen-stimulated scan failed t detect remnant and/r cancer lcalized t the thyrid bed in 16% (20/124) f patients in whm it was detected by a scan after thyrid hrmne withdrawal. In additin, the Thyrgen scan failed t detect metastatic disease in 24% (9/38) f patients in whm it was detected by a scan after thyrid hrmne withdrawal. Based n these studies, ne can cnclude that even when Thyrgen-stimulated thyrglbulin testing is perfrmed in cmbinatin with radiidine imaging, there remains a meaningful risk f missing a diagnsis f thyrid cancer r f underestimating the extent f disease. Recmbinant human thyrtrpin has als been demnstrated t be useful t facilitate radiidine ablatin f remnant thyrid tissue after surgery fr differentiated thyrid carcinma, as an alternative t thyrid hrmne withdrawal. After surgery fr differentiaed thyrid carcinma, many patients are treated with radiidine t ablate remnant thyrid tissue. This prcedure is mst cmmnly perfrmed with the patient in the hypthyrid state t prmte endgenus TSH stimulatin t ptmize radiidine uptake by remnant thyrid tissue. Hwever, thyrid hrmne withdrawal is assciated with hypthyrid symptms and impaired quality f life. Pacini, et al. (2006) reprted the results f a randmized cntrlled clinical trial t cmpare recmbinant human thyrtrpin t prepare patients n thyrid hrmne therapy t ablate remnant thyrid tissue with radiidine, cmpared with cnventinal remnant ablatin prefrmed in the hypthyrid state. The investigatrs fund cmparable remnant ablatin rates by administering recmbinant human thryrtrpin r by withhlding thyrid hrmne. Successful thyrid remnant ablatin was achieved by 23 f 24 patients (96 percent) treated with recmbinant human thyrtrpin, cmpared t 18 f 21 (86 percent) patients treated in the hypthyrid state (p = 0.23). The investigatrs reprted that subjects treated with recmbinant human thyrtrpin had a significantly higher quality f life during treatment than subjects treated in the hypthyrid state. The investigatrs reprted that subjects treated with recmbinant human thyrtrpin als had a significantly lwer radiatin expsure t the bld than patients treated in the hypthyrid state. Plicy Thyrgen (thyrtrpin alfa) is cnsidered medically necessary fr the fllwing patients with a histry f differentiated thyrid carcinma: Fr thyrglbulin (Tg) testing and radiidine imaging in place f thyrid hrmne withdrawal fr any f the fllwing: Patients wh wuld therwise be examined slely with a serum thyrglbulin test withut underging hrmne supplement withdrawal; r Patients with an undetectable Tg n thyrid hrmne suppressive therapy t exclude the diagnsis f residual r recurrent thyrid cancer; r Patients requiring serum Tg testing and radiidine imaging wh are unwilling t underg thyrid hrmne withdrawal testing and whse treating physician believes that use f a less sensitive test is justified; r Patients wh are either unable t munt an adequate endgenus thyrid stimulating hrmne (TSH) respnse t thyrid hrmne withdrawal; r Patients in whm withdrawal frm hrmne supplement is cntraindicated fr medical reasns. 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

3 T facilitate radiidine ablatin f remnant thyrid tissue after surgery fr differentiated thyrid carcinma, as an alternative t thyrid hrmne withdrawal. Thyrgen is cnsidered investigatinal fr all ther indicatins. Nte: Peridic thyrid hrmne withdrawal Tg testing, with r withut radiidine imaging, still remains the standard diagnstic mdality t assess the presence, lcatin and extent f thyrid cancer in persns wh have undergne surgery r radiactive idine treatment. References: 1. USAN Cuncil. List N New names. Thyrtrpin alfa. Clin Pharmacl Ther. 1998;64(1): Hrmann R. Recmbinant TSH and TSH analgs. Therapeutic implicatins? Internist (Berl). 1998;39(6): Utiger RD. Fllw-up f patients with thyrid carcinma. N Engl J Med. 1997;337(13): Ladensn PW, Braverman LE, Mazzaferri EL, et al. Cmparisn f administratin f recmbinant human thyrtrpin with withdrawal f thyrid hrmne fr radiactive idine scanning in patients with thyrid carcinma. N Engl J Med. 1997;337(13): Reynlds JC, Rbbins J. The changing rle f radiidine in the management f differentiated thyrid cancer. Semin Nucl Med. 1997;27(2): Rudavsky AZ, Freeman LM. Treatment f scan-negative, thyrglbulin-psitive metastatic thyrid cancer using radiidine 131I and recmbinant human thyrid stimulating hrmne. J Clin Endcrinl Metab. 1997;82(1): Ribela MT, Bianc AC, Bartlini P. The use f recmbinant human thyrtrpin prduced by Chinese hamster vary cells fr the preparatin f immunassay reagents. J Clin Endcrinl Metab. 1996;81(1): N authrs listed. M.D. Andersn studies drug fr thyrid cancer testing. Onclgy (Huntingt). 1996;10(6):820, David A, Bltta A, Bndanelli M, et al. Serum thyrglbulin cncentratins and (131)I whle-bdy scan results in patients with differentiated thyrid carcinma after administratin f recmbinant human thyrid-stimulating hrmne. J Nucl Med. 2001;42(10): Basaria M, Graf H, Cper DS. The use f recmbinant thyrtrpin in the fllw-up f patients with differentiated thyrid cancer. Am J Med. 2002;112(9): Ladensn PW. Recmbinant thyrtrpin fr detectin f recurrent thyrid cancer. Trans Am Clin Climatl Assc. 2002;113: Emersn CH, Trres MS. Recmbinant human thyrid-stimulating hrmne: Pharmaclgy, clinical applicatins and ptential uses. BiDrugs. 2003;17(1): Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

4 13. Bmbardieri E, Seregni E, Villan C, et al. Recmbinant human thyrtrpin (rhtsh) in the fllw-up and treatment f patients with thyrid cancer. Tumri. 2003;89(5): Bauer DC. Review: Sensitive thyrtrpin testing in unselected inpatients has lw diagnstic accuracy. Evidence Based Med. 2000;5(1): British Thyrid Assciatin, Ryal Cllege f Physicians. Guidelines fr the management f thyrid cancer in adults. Lndn, UK: Ryal Cllege f Physicians; March Medical Services Advisry Cmmittee (MSAC). Recmbinant human thyrid stimulating hrmne (rhtsh). Diagnstic agent fr use in well-differentiated thyrid cancer. Assessment Reprt. MSAC Applicatin Canberra, ACT: AusInf; December Available at: Accessed August 8, Dagan T, Bedrin L, Hrwitz Z, et al. Quality f life f well-differentiated thyrid carcinma patients. J Laryngl Otl. 2004;118(7): Pichn Riviere A, Augustvski F, Cernadas C, et al. Benefits f recmbinant thyrid stimulating hrmne (rhtsh) in thyrid cancer fllw-up. Reprt IRR N. 21. Buens Aires, Argentina: Institute fr Clinical Effectiveness and Health Plicy (IECS); Kls RT. Papillary thyrid cancer: Medical management and fllw-up. Curr Treat Optins Oncl. 2005;6(4): Mernagh P, Campbell S, Dietlein M, et al. Cst-effectiveness f using recmbinant human TSH prir t radiidine ablatin fr thyrid cancer, cmpared with treating patients in a hypthyrid state: The German perspective. Eur J Endcrinl. 2006;155(3): Rbbins RJ, Driedger A, Magner J; U.S. and Canadian Thyrgen Cmpassinate Use Prgram Investigatr Grup. Recmbinant human thyrtrpin-assisted radiidine therapy fr patients with metastatic thyrid cancer wh culd nt elevate endgenus thyrtrpin r be withdrawn frm thyrxine. Thyrid. 2006;16(11): Pacini F, Ladensn PW, Schlumberger M, et al. Radiidine ablatin f thyrid remnants after preparatin with recmbinant human thyrtrpin in differentiated thyrid carcinma: Results f an internatinal, randmized, cntrlled study. J Clin Endcrinl Metab. 2006;91(3): Tuttle RM, Brkhin M, Omry G, et al. Recmbinant human TSH-assisted radiactive idine remnant ablatin achieves shrt-term clinical recurrence rates similar t thse f traditinal thyrid hrmne withdrawal. J Nucl Med. 2008;49(5): Brget I, Remy H, Chevalier J, et al. Length and cst f hspital stay f radiidine ablatin in thyrid cancer patients: Cmparisn between preparatin with thyrid hrmne withdrawal and thyrgen. Eur J Nucl Med Ml Imaging. 2008;35(8): Cdes Number Descriptin HCPCS J3240 Injectin, thyrtrpin alpha, 0.9 mg, prvided in 1.1 mg vial 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)

5 42 Memrial Drive Suite 1 Pinehurst, N.C Phne (910) Fax (910)