STAGING OF PROSTATE CANCER. Approved 1/8/2015. HERC Coverage Guidance

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1 (HERC) COVERAGE GUIDANCE: ADVANCED IMAGING FOR STAGING OF PROSTATE CANCER HERC Coverge Gudnce To determne rsk sttus nd tretment optons, prostte cncer clncl stgng tht ncludes PSA level nd prostte opsy wth Gleson score s ed for coverge. MRI s ed for coverge for men wth hstologclly proven prostte cncer f knowledge of the T or N stge could ffect mngement. (wek ton) CT of the pelvs s not ed for coverge n men wth low- to ntermedte-rsk prostte cncer (strong ton), unless MRI s contrndcted. Rdonuclde one scnnng s not ed for routne coverge n men wth low-rsk prostte cncer. (wek ton) Rdonuclde one scnnng s ed for coverge when hormone therpy s eng deferred (through wtchful wtng) n symptomtc men who hve hgh or ntermedte rsk prostte cncer. (wek ton) Rsk levels re defned n Tle 1. PET mgng s not ed for coverge n prostte cncer. (strong ton) te: Defntons for strength of ton re provded n Appendx B GRADE Element Descrpton Rtonle for gudnce development The HERC selects topcs for gudelne development or technology ssessment sed on the followng prncples: Represents sgnfcnt urden of dsese Represents mportnt uncertnty wth regrd to effccy or hrms Represents mportnt vrton or controversy n clncl cre Represents hgh costs, sgnfcnt economc mpct Topc s of hgh pulc nterest Coverge gudnce development follows to trnslte the evdence revew to polcy decson. Coverge gudnce my e sed on n evdence-sed gudelne developed y the Evdencesed Gudelne Sucommttee or helth technology ssessment developed y the Heth Technology Assessment Sucommttee. In ddton, coverge gudnce my utlze n exstng evdence report produced y one of HERC s trusted sources, generlly wthn the lst three yers. 1

2 EVIDENCE SOURCES Trusted sources Ntonl Insttute for Helth nd Clncl Excellence. (2014). Prostte Cncer: dgnoss nd tretment. London: Ntonl Insttute for Helth nd Clncl Excellence. Retreved from Addtonl sources Medcre Ntonl Coverge Determntons Mnul: Chpter 1, Prt 4 (Sectons ). Retreved from Gudnce/Gudnce/Mnuls/Downlods/ncd103c1_Prt4.pdf on 11/11/14. NCCN Clncl Prctce Gudelnes n Oncology: Prostte Cncer. Verson Retreved from on 11/11/14. The summry of evdence n ths document s derved drectly from ths evdence source, nd portons re extrcted vertm. EVIDENCE OVERVIEW Clncl ckground Prostte cncer s the most common cncer n men nd mkes up 26% of ll mle cncer dgnoses n the Unted Kngdom. It s predomnntly dsese of older men (ged yers) ut round 25% of cses occur n men younger thn 65. There s lso hgher ncdence of nd mortlty from prostte cncer n men of lck Afrcn-Cren fmly orgn compred wth whte Cucsn men. Prostte cncer s usully dgnosed fter lood test n prmry cre hs shown elevted prostte-specfc ntgen (PSA) levels. The ntroducton of PSA testng hs sgnfcntly reduced the numer of men presentng wth metsttc cncer snce the 1980s. Most prostte cncers re now ether loclzed or loclly dvnced t dgnoss, wth no evdence of spred eyond the pelvs. A numer of tretments re vlle for loclzed dsese, ncludng: ctve survellnce, rdcl prosttectomy, externl em rdotherpy nd rchytherpy. Hormone therpy (ndrogen deprvton or nt-ndrogens) s the usul prmry tretment for metsttc prostte cncer, ut s lso ncresngly eng used for men wth loclly dvnced, non-metsttc dsese. The TNM clssfcton s used to stge prostte cncer (see Appendx A). It descres the extent of the prmry tumor (T stge), the sence or presence of spred to nery lymph nodes (N stge) nd the sence or presence of dstnt spred, or metstss (M stge). The clncl stge s determned from nformton tht s vlle wthout surgery. The pthologc stge s sed on the surgcl removl nd hstologcl exmnton of the entre prostte glnd, the semnl vescles nd surroundng structures nd, f relevnt, pelvc lymph nodes. The mngement of prostte cncer wll depend on the TNM stge of the dsese s well s oth 2 Coverge gudnce: Advnced mgng for stgng of prostte cncer

3 ochemcl nformton (e.g. PSA) nd pthologcl nformton (e.g. Gleson score), whch hve prognostc vlue. The optmum tretment for mn wth prostte cncer requres n ssessment of the rsk of metsttc spred s well s the rsk of locl recurrence. For ths, the results of mgng cn e ssessed n the lght of nformton from clncl nomogrms. EVIDENCE REVIEW Men newly dgnosed wth prostte cncer cn ntlly e strtfed nto those for whom rdcl tretment s posslty nd those for whom t s not pproprte. The decson out tretment ntent wll e sed on the mn s lfe expectncy, hs vlues, nd the ntcpted clncl course of the prostte cncer. tons: Determne the provsonl tretment ntent (rdcl or non-rdcl) efore decsons on mgng re mde. routnely offer mgng to men who re not cnddtes for rdcl tretment. Qulfyng sttement: There ws gudelne development group (GDG) consensus, n the sence of ny reserch evdence, tht ths wll reduce the mount of npproprte nvestgton. The cost effectveness of routne mgnetc resonnce mgng MRI could not e concluded. Both the clncl presentton nd the tretment ntent nfluence the decson out when nd how to mge the ndvdul. The rsk of recurrence of prostte cncer fter defntve locl tretment s the ss for the strtfcton of men wth loclzed prostte cncer nto rsk groups: low, ntermedte nd hgh (see Tle 1). The tons for mgng of loclzed dsese re smlrly sed on these prognostc groups. Tle 1 Level of rsk PSA Gleson Score Clncl stge Low < 10 ng/ml And 6 And T1-T2 Intermedte ng/ml Or 7 Or T2 Hgh >20 ng/ml Or 8-10 Or T2c Imgng my nform the choce etween dfferent rdcl tretments (for exmple y determnng whether the cncer hs extended eyond the prosttc cpsule). It lso sssts n the dentfcton of metsttc dsese therey ledng to more pproprte tretment optons. Imgng for T-stgng nd N-stgng The T-stge nvolves the ssessment of the locl extent of the prmry tumor n the prostte nd ts reltonshp to surroundng structures. Usng mgng to dstngush etween T1 nd T2 cncers does not usully ffect tretment. But f rdcl tretment s eng consdered, t s mportnt to decde whether tumor s T2 (confned wthn the prostte) or T3/T4 (spred 3 Coverge gudnce: Advnced mgng for stgng of prostte cncer

4 outsde the prostte). MRI s now the commonly used mgng technque for T-stgng men wth prostte cncer. Mny of the orgnl pulctons used now-outdted MRI technology, nd the ccurcy reported for MRI s mprovng. After trnsrectl prostte opsy, ntr-prosttc hemtom cn ffect mge nterpretton for t lest four weeks. It s mportnt to know the nodl sttus of men wth loclzed dsese, s the spred of cncer to the pelvc lymph nodes wll ffect the choce of tretment. Prtn's Tles (Prtn et l. 2001) re the most commonly used clncl nomogrms for determnng the rsk of nodl spred. Currently, mgng s of some vlue for N-stgng ecuse computed tomogrphy (CT) nd conventonl MRI rely on sze crter to ssess the lkelhood of metsttc spred to the lymph nodes. CT cnnot chrcterze the nternl rchtecture of n enlrged node nd MRI s only le to provde prtl nformton. Newer MRI contrst gents such s superprmgnetc ron oxde (SPIO) my mprove the overll specfcty of MRI for evlutng lymph nodes ut re not yet routnely vlle. ton: offer CT of the pelvs to men wth low- or ntermedte-rsk loclzed prostte cncer (see Tle 1). Qulfyng sttement: There s not enough evdence to support the routne use of CT n men wth ntermedte-rsk dsese nd t s consdered nferor to MRI n ths clncl stuton. studes mesurng the mpct of dgnostc mgng on ptent outcomes were found; nsted most studes were of dgnostc test ccurcy. Two studes showed etter stgng ccurcy wth MRI thn wth CT. Other systemtc revews hve consdered the stgng ccurcy of MRI nd CT seprtely. There ws contrdctory evdence, from smll oservtonl studes, out the eneft of ddng of mgnetc resonnce spectroscopy (MRS) to MRI. There ws consstent evdence, from oservtonl studes, tht MRI tumor stge ws prognostc fctor for PSA relpse. One of the studes, however, concluded tht MRI tumor stgng only dded clnclly menngful nformton for men t ntermedte pre-tretment rsk of PSA relpse. MRI tumor stge dd not strtfy PSA flure rsk well enough to gude clncl decson mkng for other ptents. Clncl queston: Does stgng wth MRI mprove outcomes n men wth prostte cncer? Bochemcl recurrence-free survvl One study provded very low qulty evdence of no sgnfcnt dfference n the proporton of ptents experencng ochemcl recurrence etween those whch hd undergone mgng nd those whch hd not (p=0.50). However, the study ws not lmted only to those ptents who underwent MRI (18%) nd ncluded ptents who hd receved computerzed tomogrphy (81%) nd one scns (73%), wth mny ptents recevng more thn one type of mgng. [Very low strength of evdence (SOE).] 4 Coverge gudnce: Advnced mgng for stgng of prostte cncer

5 Overll survvl, tretment-relted mordty, nd helth-relted qulty of lfe studes reported overll survvl, tretment-relted mordty, or helth-relted qulty of lfe. Clncl queston: In whch ptents wth prostte cncer wll MRI stgng lter tretment? Four studes reported chnge n mngement followng MRI, 23 reported chnge n stgng followng MRI, nd eght reported the dgnostc ccurcy of oth clncl nd MRI stgng, usng rdcl prosttectomy s reference stndrd. All studes were of low to very low qulty evdence, wth most (96%) consdered unrepresenttve of the ptents who would receve MRI n prctce. Mny (68%) of the studes lso used MRI s the reference stndrd whch my not hve clssfed the trget condton correctly. A numer of pre-specfed su-groups were vlle for nlyses. Chnge n mngement Two studes found chnge n the mngement of rdotherpy strtegy followng MRI n 31% nd 9% of ptents. Two further studes found chnge n surgcl procedure n 44% nd 30% of ptents followng MRI respectvely. (Low SOE.) Chnge n stge All studes found reported MRI to result n up-stgng of proporton of ther ptents, rngng from t lest 5% to 100% of ll ptents. Where reported, MRI lso resulted n down-stgng of etween 5% nd 19% of ptents. Ths ws found for low, ntermedte nd hgh rsk ptents. (Very low SOE.) Dgnostc ccurcy Four studes found tht MRI ws not consstently more senstve, specfc or ccurte thn stgng y DRE or TRUS. Sx studes found MRI to e more senstve thn clncl stgng n dentfyng ptents wth extrcpsulr extenson (stge T3), ut not consstently more specfc or ccurte. MRI ws not consstently more senstve, specfc or ccurte thn clncl stgng n dentfyng ptents wth semnl vescle nvson (stge T3). Three studes of ptents wth clnclly loclzed dsese found MRI to e more senstve thn clncl stgng when dentfyng extrcpsulr extenson or semnl vescle nvson, ut not consstently more specfc or ccurte. One study found MRI to hve hgher senstvty ut lower specfcty thn DRE or TRUS for overll stgng of prostte cncer, whle nother found MRI to hve hgher ccurcy. Two studes only ncluded ptents wth PSA < 10 ng/ml; one found the overll ccurcy of stgng to e the sme etween MRI nd TRUS, whle oth found MRI to e more senstve ut less specfc thn TRUS when dentfyng extrcpsulr extenson nd less senstve when dentfyng semnl vescle nvson ut not consstently more specfc. Another study conducted sugroup nlyss y PSA level nd found MRI to e more senstve thn TRUS n dentfyng oth extrcpsulr extenson nd semnl vescle nvson n ptents wth ether PSA > 17 ng/ml or PSA < 10 ng/ml. 5 Coverge gudnce: Advnced mgng for stgng of prostte cncer

6 Two studes only ncluded ptents wth Gleson 6; one found MRI to e more senstve ut less specfc thn TRUS when dentfyng extrcpsulr extenson nd less senstve when dentfyng semnl vescle nvson ut of smlr specfcty. The other found MRI to hve the sme rte of flse postves s clncl stgng when dentfyng stge T3-T4 dsese. Another study only ncluded ntermedte- nd hgh-rsk ptents nd found MRI to e more senstve ut less specfc thn clncl stgng when dentfyng extrcpsulr extenson, nd to e more senstve ut hve the sme specfcty when dentfyng semnl vescle nvson. tons: Consder multprmetrc MRI, or CT f MRI s contrndcted, for men wth hstologclly proven prostte cncer f knowledge of the T or N stge could ffect mngement. Imgng for M-stgng Isotope one scns cn e used to look for one metstses t the tme of presentton. The postvty rte for one scns ncreses wth PSA or Gleson score. ton: routnely offer sotope one scns to men wth low-rsk loclzed prostte cncer. Qulfyng sttement: Ths ton s supported y cse seres evdence nd wll reduce unnecessry nvestgton. Two systemtc revews looked t the role of rdosotope one scns n the stgng of men wth newly dgnosed prostte cncer. One summrzed one scn results y serum PSA level n men wth newly dgnosed prostte cncer. Serum PSA level nd rsk of postve one scn were strongly correlted. The other revew concluded tht PSA level ws the est mens of dentfyng those t rsk of postve one scn nd tht men wth PSA less thn 10 ng/ml were unlkely to hve postve one scn. ton: Offer sotope one scns when hormonl therpy s eng deferred through wtchful wtng to symptomtc men who re t hgh rsk of developng one complctons. Qulfyng sttement: In the sence of ny evdence there ws GDG consensus tht mkng ths ton would reduce the rsk of ptents developng spnl cord compresson. Serches found no drect evdence out the nfluence of mgng on the tmng of systemc tretment or frequency of clncl follow-up n men for whom rdcl tretment s not ntended. Smll cse seres reported outcomes n men wth postve one scns t presentton. Two of these seres found extensve dsese on one scn ws n dverse prognostc fctor for survvl. There s oservtonl evdence tht extensve dsese on one scn s n ndependent rsk fctor for spnl cord compresson n men wthout functonl neurologcl mprment. 6 Coverge gudnce: Advnced mgng for stgng of prostte cncer

7 Role of Postron-emsson tomogrphy (PET) n stgng prostte cncer Postron-emsson tomogrphy mgng usng the rdophrmceutcl gent 18-FDG does not relly show prmry prostte cncer. Ths s ecuse of the reltvely low metolc ctvty n tumors whch re slow-growng nd ecuse the rdophrmceutcl gent ccumultes n the ldder, oscurng the prostte. Newer postron-emttng trcers re under evluton. ton: offer PET mgng for prostte cncer n routne clncl prctce. Qulfyng sttement: There ws lck of evdence to support the use of PET mgng. Mngng relpse fter rdcl tretment Mgnetc resonnce mgng (MRI) scnnng my hve some vlue n those wth ochemcl relpse eng consdered for further locl therpy. It my detect sgnfcnt extrcpsulr dsese, semnl vescle nvolvement or lymphdenopthy whch mght preclude rdcl slvge therpy. The chnce of fndng skeletl metstses n men wth ochemcl relpse s est predcted y the solute PSA level nd the rte of rse. For men wth evdence of ochemcl relpse followng rdcl tretment nd who re consderng rdcl slvge therpy: do not offer routne MRI scnnng pror to slvge rdotherpy n men wth prostte cncer offer n sotope one scn f symptoms or PSA trends re suggestve of metstses. Qulfyng sttement: These tons re sed on cse seres evdence nd GDG consensus. The lterture serch found no studes reportng the mpct of stgng fter ochemcl recurrence on ptent outcomes. Smll cse seres report good senstvty nd specfcty of MRI for the detecton of locl recurrence fter rdcl prosttectomy. The rte of one scns postve for mlgnncy n men wth ochemcl recurrence fter rdcl prosttectomy ws 4 to 14% n four cse seres. The rte of suspcous or ndetermnte (ut ultmtely non-mlgnnt) scns ws lmost s hgh t etween 3 nd 8%, rsng questons out the specfcty of the one scn. Trgger PSA, PSA slope, nd PSA velocty were ll sgnfcnt predctors of one scn result. The rsk of postve one scn for men wth PSA less thn 10ng/ml ws etween 1 nd 3% n two seres, compred wth 75% for PSA greter thn 10 ng/ml. PET scnnng ws not dscussed n the NICE gudelne s n opton for mngng relpse fter rdcl tretment, or n ny other secton other thn dgnoss nd stgng (presented ove). Evdence Summry When determnng when nd how to mge n ndvdul, men wth loclzed prostte cncer should e strtfed nto rsk groups sed on PSA level, Gleson score nd clncl stge. 7 Coverge gudnce: Advnced mgng for stgng of prostte cncer

8 There s nsuffcent evdence to support the routne use of CT of the pelvs n men wth low- or ntermedte-rsk loclzed prostte cncer, nd t s consdered nferor to MRI n ths clncl stuton. The evdence s nsuffcent to determne whether stgng wth MRI mprove outcomes n men wth prostte cncer. There s low SOE tht stgng wth MRI cn result n chnge n mngement, nd very low SOE tht MRI results n up-stgng or down-stgng hghly vrle proporton of ptents. Most studes found stgng wth MRI more senstve thn stgng wth DRE or TRUS, ut not consstently more specfc or ccurte. There s nsuffcent evdence to support the use of PET for ny stge of prostte cncer. 8 Coverge gudnce: Advnced mgng for stgng of prostte cncer

9 GRADE-INFORMED FRAMEWORK The HERC develops tons y usng the concepts of the Grdng of tons Assessment, Development nd Evluton (GRADE) system. GRADE s trnsprent nd structured process for developng nd presentng evdence nd for crryng out the steps nvolved n developng tons. There re four elements tht determne the strength of ton, s lsted n the tle elow. The HERC revews the evdence nd mkes n ssessment of ech element, whch n turn s used to develop the tons presented n the coverge gudnce ox. Blnce etween desrle nd undesrle effects, nd qulty of evdence, re derved from the evdence presented n ths document, whle estmted reltve costs, vlues nd preferences re ssessments of the HERC memers. Indcton/ Interventon Blnce etween desrle nd undesrle effects Qulty of evdence* Resource llocton Vrlty n vlues nd preferences Coverge ton Rtonle CT of pelvs n low- to ntermedte rsk prostte cncer Inferor to MRI Low Low Moderte vrlty (mny would prefer to vod rdton exposure), except when MRI s contrndcted. Insuffcent/mxed evdence, smlr or more rsk thn vlle lterntves. MRI stgng of prostte cncer MRI my result n chnge n mngement, nd possly chnge n stge; my e more senstve thn DRE nd/or TRUS Low to Very Low Low, f other dgnostc testng cn e lmted Low vrlty Suffcent evdence shows more effectve, less rsk nd smlr or less cost thn lterntves. 9 Coverge gudnce: Advnced mgng for stgng of prostte cncer

10 Indcton/ Interventon Blnce etween desrle nd undesrle effects Qulty of evdence* Resource llocton Vrlty n vlues nd preferences Coverge ton Rtonle Bone scn n evluton of newly dgnosed, low rsk prostte cncer Postve one scn hghly correlted wth PSA level; those wth PSA level < 10 unlkely to hve postve one scn.. Low Low Moderte vrlty (vodnce of multple tests vs. perceved vlue from those tests) Suffcent evdence; smlr rsk nd effectveness to lterntves, ut hgher cost. Bone scn n symptomtc hgh-rsk men My result n erler tretment of metsttc dsese, resultng n preventon of spnl cord compresson Very Low Low Low vrlty (vodnce of spnl cord compresson) Insuffcent/mxed evdence, no lterntves vlle, smlr rsk thn no tretment. Tretment s prevlent nd reserch study s not resonle. PET for stgng of prostte cncer Unknown Very Low Moderte Low vrlty Insuffcent/mxed evdence; rsk s smlr or more thn vlle lterntve effectve tretments *The Qulty of Evdence rtng ws ssgned y the prmry evdence source, not the HERC Sucommttee te: GRADE frmework elements re descred n Appendx B 10 Coverge gudnce: Advnced mgng for stgng of prostte cncer

11 POLICY LANDSCAPE Qulty mesures One qulty mesure ws dentfed when serchng the Ntonl Qulty Mesures Clernghouse tht ws pertnent to ths coverge gudnce. It ws formulted y the Amercn Urologcl Assocton, nd s endorsed y the Ntonl Qulty Forum. It sttes the followng: Prostte cncer: percentge of ptents, regrdless of ge, wth dgnoss of prostte cncer, t low rsk of recurrence, recevng ntersttl prostte rchytherpy, OR externl em rdotherpy to the prostte, OR rdcl prosttectomy, OR cryotherpy who dd not hve one scn performed t ny tme snce dgnoss of prostte cncer. Choosng Wsely Choosng Wsely s prt of mult-yer effort of the ABIM Foundton to help physcns e etter stewrds of fnte helth cre resources. Orgnlly conceved nd ploted y the Ntonl Physcns Allnce through Puttng the Chrter nto Prctce grnt, more thn 50 medcl speclty orgnztons, long wth Consumer Reports, hve dentfed numer of tests or procedures commonly used n ther feld, whose necessty should e questoned nd dscussed. Ech prtcptng orgnzton ws free to determne how to crete ts own lst, provded tht t used cler methodology nd dhered to the followng set of shred gudelnes: Ech tem should e wthn the speclty s purvew nd control. The tests nd/or nterventons should e used frequently nd/or crry sgnfcnt cost. Ech ton should e supported y generlly ccepted evdence. The selecton process should e thoroughly documented nd pulcly vlle on request. One of the orgnztons tht chose to prtcpte n the Choosng Wsely cmpgn s the Amercn Socety of Clncl Oncology. The frst lst creted y ths orgnzton sttes the followng: Don t perform PET, CT, nd rdonuclde one scns n the stgng of erly prostte cncer t low rsk for metstss. Imgng wth PET, CT, or rdonuclde one scns cn e useful n the stgng of specfc cncer types. However, these tests re often used n the stgng evluton of low-rsk cncers, despte lck of evdence suggestng they mprove detecton of metsttc dsese or survvl. Evdence does not support the use of these scns for stgng of newly dgnosed low grde crcnom of the prostte (Stge T1c/T2, prostte-specfc ntgen (PSA) <10 ng/ml, Gleson score less thn or equl to 6) wth low rsk of dstnt metstss. Unnecessry mgng cn led to hrm through unnecessry nvsve procedures, overtretment, unnecessry rdton exposure, nd msdgnoss. 11 Coverge gudnce: Advnced mgng for stgng of prostte cncer

12 Medcre Ntonl Coverge Determnton Effectve Septemer 4, 2014, Medcre mkes the followng coverge determnton pertnng to PET scnnng nd prostte cncer: Intl Ant-Tumor Tretment Strtegy Ntonlly n-covered Indctons CMS contnues to ntonlly non-cover ntl nt-tumor tretment strtegy n Medcre enefcres who hve denocrcnom of the prostte. Susequent Ant-Tumor Tretment Strtegy Ntonlly Covered Indctons (ncludes prostte cncer) Three FDG PET scns re ntonlly covered when used to gude susequent mngement of nt-tumor tretment strtegy fter completon of ntl nt-cncer therpy. Coverge of more thn three FDG PET scns to gude susequent mngement of nt-tumor tretment strtegy fter completon of ntl nt-cncer therpy shll e determned y the locl Medcre Admnstrtve Contrctors. Ntonl Comprehensve Cncer Network Gudelne Ths gudelne sttes the followng wth regrd to PET or PET/CT: PET/CT usng cholne trcers my dentfy stes of metsttc dsese n men wth ochemcl recurrence fter prmry tretment flure. Other cholne rdotrcers re under evluton. Further study s needed to determne the est use of cholne PET/CT mgng n men wth prostte cncer. Oncologc PET/CT s performed typclly usng [FDG] In certn clncl settngs, the use of FDG-PET/CT my provde useful nformton, ut FDG-PET/CT should not e used routnely snce dt on the utlty of FDG-PET/CT n ptents wth prostte cncer s lmted. C-11 cholne PET/CT hs een used to detect nd dfferentte prostte cncer from engn tssue. The senstvty nd specfcty of the technque n restgng ptents wth ochemcl flure re 85% nd 88%, respectvely. C-11 cholne PET/CT my e useful to detect dstnt metstses n these ptents. Newer technology usng 18F-NF s the trcer for PET scn cn e used s dgnostc stgng study. Ths test ppers to hve greter senstvty thn 99- technetum one scn. However, there s controversy out how the results of 18F-NF PET one scn would e cted upon snce ll phse 3 clncl trls to dte hve sed 12 Coverge gudnce: Advnced mgng for stgng of prostte cncer

13 progresson crter on the 99-technetum one scns. PET nd hyrd mgng one scns pper more senstve thn conventonl 99-technetum one scns. Coverge gudnce s prepred y the Helth Evdence Revew Commsson (HERC), HERC stff, nd sucommttee memers. The evdence summry s prepred y the Center for Evdence-sed Polcy t Oregon Helth & Scence Unversty (the Center). Ths document s ntended to gude pulc nd prvte purchsers n Oregon n mkng nformed decsons out helth cre servces. The Center s not engged n renderng ny clncl, legl, usness or other professonl dvce. The sttements n ths document do not represent offcl polcy postons of the Center. Reserchers nvolved n preprng ths document hve no ffltons or fnncl nvolvement tht conflct wth mterl presented n ths document. 13 Coverge gudnce: Advnced mgng for stgng of prostte cncer

14 APPENDIX A. TNM STAGING FOR PROSTATE CANCER Stge Su-Stge Defnton Tumor (T) Prmry Tumor TX T0 T1 T2 T3 T4 de (N) Metstss (M) T1 Prmry tumor cnnot e ssessed evdence of prmry tumor Clnclly npprent tumor, nether plple nor vsle y mgng Tumor ncdentl hstologcl fndng n 5% of tssue resected T1 Tumor ncdentl hstologcl fndng n more thn 5% of tssue resected T1c T2 T2 T2c T3 T3 NX N0 N1 M0 M1 M1 M1 M1c Tumor dentfed y needle opsy, e.g., ecuse of elevted prostte-specfc ntgen (PSA) Tumor confned wthn prostte Tumor nvolves one-hlf of one loe Tumor nvolves more thn one-hlf of one loe, ut not oth loes Tumor nvolves oth loes Tumor extends through the prosttc cpsule Extrcpsulr extenson (unlterl or lterl) ncludng mcroscopc ldder neck mprovement Tumor nvdes semnl vescle(s) Tumor s fxed or nvdes djcent structures other thn semnl vescles: externl sphncter, rectum, levtor muscles, nd/or pelvc wll Regonl lymph nodes Regonl lymph nodes cnnot e ssessed regonl lymph nodes metstss Regonl lymph node metstss Dstnt metstss dstnt metstss Dstnt metstss n-regonl lymph node(s) Bone (s) Metstss t other ste(s) 14 Coverge gudnce: Advnced mgng for stgng of prostte cncer

15 APPENDIX B. GRADE ELEMENT DESCRIPTIONS Element Blnce etween desrle nd undesrle effects Qulty of evdence Resource llocton Vlues nd preferences Descrpton The lrger the dfference etween the desrle nd undesrle effects, the hgher the lkelhood tht strong ton s wrrnted. The nrrower the grdent, the hgher the lkelhood tht wek ton s wrrnted The hgher the qulty of evdence, the hgher the lkelhood tht strong ton s wrrnted The hgher the costs of n nterventon tht s, the greter the resources consumed the lower the lkelhood tht strong ton s wrrnted The more vlues nd preferences vry, or the greter the uncertnty n vlues nd preferences, the hgher the lkelhood tht wek ton s wrrnted Strong ton In Fvor: The sucommttee s confdent tht the desrle effects of dherence to ton outwegh the undesrle effects, consderng the qulty of evdence, cost nd resource llocton, nd vlues nd preferences. Agnst: The sucommttee s confdent tht the undesrle effects of dherence to ton outwegh the desrle effects, consderng the qulty of evdence, cost nd resource llocton, nd vlues nd preferences. Wek ton In Fvor: The sucommttee concludes tht the desrle effects of dherence to ton proly outwegh the undesrle effects, consderng the qulty of evdence, cost nd resource llocton, nd vlues nd preferences, ut s not confdent. Agnst: The sucommttee concludes tht the undesrle effects of dherence to ton proly outwegh the desrle effects, consderng the qulty of evdence, cost nd resource llocton, nd vlues nd preferences, ut s not confdent. Qulty or strength of evdence rtng cross studes for the tretment/outcome 1 Hgh: The sucommttee s very confdent tht the true effect les close to tht of the estmte of the effect. Typcl sets of studes re RCTs wth few or no lmttons nd the estmte of effect s lkely stle. Moderte: The sucommttee s modertely confdent n the effect estmte: The true effect s lkely to e close to the estmte of the effect, ut there s posslty tht t s sustntlly dfferent. Typcl sets of studes re RCTs wth some lmttons or well-performed nonrndomzed studes wth ddtonl strengths tht gurd gnst potentl s nd hve lrge estmtes of effects. Low: The sucommttee s confdence n the effect estmte s lmted: The true effect my e sustntlly dfferent from the estmte of the effect. Typcl sets of studes re RCTs wth serous lmttons or nonrndomzed studes wthout specl strengths. Very low: The sucommttee hs very lttle confdence n the effect estmte: The true effect s lkely to e sustntlly dfferent from the estmte of effect. Typcl sets of studes re nonrndomzed studes wth serous lmttons or nconsstent results cross studes. 1 Includes rsk of s, precson, drectness, consstency nd pulcton s 15 Coverge gudnce: Advnced mgng for stgng of prostte cncer

16 APPENDIX C. APPLICABLE CODES CODES DESCRIPTION ICD-9 Dgnoss Codes 185 Mlgnnt neoplsm of prostte Crcnom n stu of prostte ICD-10 Dgnoss Codes C61 Mlgnnt neoplsm of prostte D07.5 Crcnom n stu of prostte ICD-9 Volume 3 (Procedure Codes) Other computerzed xl tomogrphy Mgnetc resonnce mgng of pelvs, prostte, nd ldder Bone scn Scn of other stes CPT Codes Computed tomogrphc, pelvs; wthout contrst mterl Computed tomogrphc, pelvs; wth contrst mterl(s) Computed tomogrphc, pelvs; wthout contrst mterl, followed y contrst mterl(s) nd further sectons Mgnetc resonnce, pelvs; wthout contrst mterl Mgnetc resonnce, pelvs; wth contrst mterl(s) Mgnetc resonnce, pelvs; wthout contrst mterl, followed y contrst mterl(s) nd further sequences Bone nd/or jont mgng; lmted re Bone nd/or jont mgng; multple res Bone nd/or jont mgng; whole ody Bone nd/or jont mgng; 3 phse study Bone nd/or jont mgng; tomogrphc (SPECT) Postron emsson tomogrphy (PET) mgng; lmted re Postron emsson tomogrphy (PET) mgng; skull se to md-thgh Postron emsson tomogrphy (PET) mgng; whole ody Postron emsson tomogrphy (PET) wth concurrently cqured computed tomogrphy (CT) for ttenuton correcton nd ntomcl loclzton mgng; lmted re Postron emsson tomogrphy (PET) wth concurrently cqured computed tomogrphy (CT) for ttenuton correcton nd ntomcl loclzton mgng; HCPCS Level II Codes ne skull se to md-thgh Postron emsson tomogrphy (PET) wth concurrently cqured computed tomogrphy (CT) for ttenuton correcton nd ntomcl loclzton mgng; whole ody te: Incluson on ths lst does not gurntee coverge 16 Coverge gudnce: Advnced mgng for stgng of prostte cncer

17 APPENDIX C. HERC GUIDANCE DEVELOPMENT FRAMEWORK HERC Gudnce Development Frmework Prncples Ths frmework ws developed to ssst wth the decson mkng process for the Oregon polcy-mkng ody, the HERC nd ts sucommttees. It s generl gude, nd must e used n the context of clncl judgment. It s not possle to nclude ll possle scenros nd fctors tht my nfluence polcy decson n grphc formt. Whle ths frmework provdes generl structure, fctors tht my nfluence decsons tht re not cptured on the frmework nclude ut re not lmted to the followng: Estmte of the level of rsk ssocted wth the tretment, or ny lterntves; Whch lterntves the tretment should most pproprtely e compred to; Whether there s dscrete nd cler dgnoss; The defnton of clncl sgnfcnce for prtculr tretment, nd the expected mrgn of eneft compred to lterntves; The reltve lnce of eneft compred to hrm; The degree of eneft compred to cost; e.g., f the eneft s smll nd the cost s lrge, the commttee my mke decson dfferent thn the lgorthm suggests; Specfc ndctons nd contrndctons tht my determne pproprteness; Expected vlues nd preferences of ptents. 17 Coverge gudnce: Advnced mgng for stgng of prostte cncer

18 CT of pelvs; PET for stgng of prostte cncer Center for Evdence-sed Polcy HERC Gudnce Development Frmework Refer to HERC Gudnce Development Frmework Prncples for ddtonl consdertons I Level of Evdence II Decson Pont Prortes 1. Level of evdence 2. Effectveness & lterntve tretments 3. Hrms nd rsk Prevlence of tretment 6. Clncl reserch study s resonle 18 Coverge gudnce: Advnced mgng for stgng of prostte cncer A Effectveness compred to lt. tretment(s) 1 (clnclly sgnfcnt mprovement n outcomes) 1 2 effectve Tretment rsk compred to lt. tretment(s) effectveness Tretment rsk compred to lt. tretment(s) c Suffcent effectve Ineffectve or hrm exceeds eneft 1 For dgnostc testng, dgnostc ccurcy (senstvty, specfcty, predctve vlue) compred to lterntve dgnostc strteges, wth clnclly mportnt mpct on ptent mngement. 2 Clncl reserch study s resonle when flure to perform the procedure n queston s not lkely to result n deth or serous dslty; or n stuton where there s hgh rsk of deth, there s no good clncl evdence to suggest tht the procedure wll chnge tht rsk. 3 Tretment rsk compred to lt. tretment(s) or more Effectve B lt. tretment(s) vlle/ccessle Ineffectve or hrm exceeds eneft or more Insuffcent or mxed Alterntve effectve tretment(s) vlle/ccessle 1 Tretment rsk compred to lt. tretment(s) A or more Tretment rsk compred to no tretment Unknown Tretment s prevlent Clncl reserch study s resonle 2 Revsed 12/05/2013 B Unknown

19 MRI stgng of prostte cncer Center for Evdence-sed Polcy HERC Gudnce Development Frmework Refer to HERC Gudnce Development Frmework Prncples for ddtonl consdertons I Level of Evdence II Decson Pont Prortes 1. Level of evdence 2. Effectveness & lterntve tretments 3. Hrms nd rsk Prevlence of tretment 6. Clncl reserch study s resonle 19 Coverge gudnce: Advnced mgng for stgng of prostte cncer A Effectveness compred to lt. tretment(s) 1 (clnclly sgnfcnt mprovement n outcomes) 1 2 effectve Tretment rsk compred to lt. tretment(s) effectveness Tretment rsk compred to lt. tretment(s) c Suffcent effectve Ineffectve or hrm exceeds eneft 1 For dgnostc testng, dgnostc ccurcy (senstvty, specfcty, predctve vlue) compred to lterntve dgnostc strteges, wth clnclly mportnt mpct on ptent mngement. 2 Clncl reserch study s resonle when flure to perform the procedure n queston s not lkely to result n deth or serous dslty; or n stuton where there s hgh rsk of deth, there s no good clncl evdence to suggest tht the procedure wll chnge tht rsk. 3 Tretment rsk compred to lt. tretment(s) or more Effectve B lt. tretment(s) vlle/ccessle Ineffectve or hrm exceeds eneft or more Insuffcent or mxed Alterntve effectve tretment(s) vlle/ccessle 1 Tretment rsk compred to lt. tretment(s) A or more Tretment rsk compred to no tretment Unknown Tretment s prevlent Clncl reserch study s resonle 2 Revsed 12/05/2013 B Unknown

20 Bone scn n evluton of newly dgnosed, low-rsk prostte cncer Center for Evdence-sed Polcy HERC Gudnce Development Frmework Refer to HERC Gudnce Development Frmework Prncples for ddtonl consdertons I Level of Evdence II Decson Pont Prortes 1. Level of evdence 2. Effectveness & lterntve tretments 3. Hrms nd rsk Prevlence of tretment 6. Clncl reserch study s resonle 20 Coverge gudnce: Advnced mgng for stgng of prostte cncer A Effectveness compred to lt. tretment(s) 1 (clnclly sgnfcnt mprovement n outcomes) 1 2 effectve Tretment rsk compred to lt. tretment(s) effectvene ss Tretment rsk compred to lt. tretment(s) c Suffcent effectve Ineffectve or hrm exceeds eneft 1 For dgnostc testng, dgnostc ccurcy (senstvty, specfcty, predctve vlue) compred to lterntve dgnostc strteges, wth clnclly mportnt mpct on ptent mngement. 2 Clncl reserch study s resonle when flure to perform the procedure n queston s not lkely to result n deth or serous dslty; or n stuton where there s hgh rsk of deth, there s no good clncl evdence to suggest tht the procedure wll chnge tht rsk. 3 Tretment rsk compred to lt. tretment(s) or more Effectve B lt. tretment(s) vlle/ccessle Ineffectve or hrm exceeds eneft or more Insuffcent or mxed Alterntve effectve tretment(s) vlle/ccessle 1 Tretment rsk compred to lt. tretment(s) A or more Tretment rsk compred to no tretment Unknown Tretment s prevlent Clncl reserch study s resonle 2 Revsed 12/05/2013 B Unknown

21 Bone scn n symptomtc hgh-rsk men Center for Evdence-sed Polcy HERC Gudnce Development Frmework Refer to HERC Gudnce Development Frmework Prncples for ddtonl consdertons I Level of Evdence II Decson Pont Prortes 1. Level of evdence 2. Effectveness & lterntve tretments 3. Hrms nd rsk Prevlence of tretment 6. Clncl reserch study s resonle 21 Coverge gudnce: Advnced mgng for stgng of prostte cncer A Effectveness compred to lt. tretment(s) 1 (clnclly sgnfcnt mprovement n outcomes) 1 2 effectve Tretment rsk compred to lt. tretment(s) effectvene ss Tretment rsk compred to lt. tretment(s) c Suffcent effectve Ineffectve or hrm exceeds eneft 1 For dgnostc testng, dgnostc ccurcy (senstvty, specfcty, predctve vlue) compred to lterntve dgnostc strteges, wth clnclly mportnt mpct on ptent mngement. 2 Clncl reserch study s resonle when flure to perform the procedure n queston s not lkely to result n deth or serous dslty; or n stuton where there s hgh rsk of deth, there s no good clncl evdence to suggest tht the procedure wll chnge tht rsk. 3 Tretment rsk compred to lt. tretment(s) or more Effectve B lt. tretment(s) vlle/ccessle Ineffectve or hrm exceeds eneft or more Insuffcent or mxed Alterntve effectve tretment(s) vlle/ccessle 1 Tretment rsk compred to lt. tretment(s) A or more Tretment rsk compred to no tretment Unknown Tretment s prevlent Clncl reserch study s resonle 2 Revsed 12/05/2013 B Unknown

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