Octber 23, 2016 evicre Healthcare Attn: Dr Greg Allen 400 Buckwalter Place Bulevard Blufftn, SC 29910 RE: evicre Draft Onclgy Imaging Guidelines, v 19.0 Gentlepersns: Prstate Cancer Internatinal is a nt-fr-prfit 501(c)(3) funded in 2008. The missin f the rganizatin is t transfrm glbal understanding f the risks assciated with prstate cancer and the strategies t manage thse risks until preventin is pssible and a cure can be fund. We are primarily fcused n prviding high-quality infrmatinal and educatinal services fr prstate cancer patients and their family members thrugh The New Prstate Cancer InfLink (see www.prstatecancerinflink.net) and thrugh an nline scial netwrk with ver 6,000 members. Hwever, we als act as advcates fr relevant research and fr prgress in the diagnsis and management f prstate cancer. It has cme t ur attentin that evicre s current draft Onclgy Imaging Guidelines, tentatively scheduled fr implementatin n Nvember 1, 2016, cntain statements specific t the use f certain imaging agents and prcesses currently being used in the evaluatin and wrk-up f patients suspected f having prgressive r recurrent frms f prstate cancer which may nt be identifiable with traditinal imaging methds such as technectium-based bne scans. They als cntain assciated statements related t the management f prstate cancer itemized belw. Specifically, n page 12 f the current evicre draft, we find the statement: PET imaging using istpes ther than 18 F-FDG, including 18 F NaF (PET bne scan), 11 C- Chline, 68 Ga-DOTATATE, and Fluciclvine F 18 is cnsidered investigatinal at this time. Furthermre, n page 124 we find the fllwing: Active surveillance describes the mnitring f disease prgressin in an individual with knwn diagnsis f prstate cancer. Current guidelines suggest the fllwing prtcl: PSA every 6 mnths;
Digital Rectal Exam every 12 mnths and; Repeat prstate bipsy every 12 mnths. PET imaging (including 18 F-FDG, 18 F-NaF, and 11 C-Chline ) is cnsidered investigatinal and experimental fr all indicatins fr prstate cancer at this time. Laser prstate ablatin is cnsidered investigatinal and experimental at this time, and advanced imaging fr treatment planning and/r surveillance f laser prstate is nt indicated. High intensity fcused ultrasund prstate ablatin is cnsidered investigatinal and experimental at this time, and advanced imaging fr treatment planning and/r surveillance f high intensity fcused ultrasund prstate ablatin is nt indicated. MR Spectrscpy (CPT 76390) is cnsidered investigatinal and experimental in the evaluatin f prstate cancer at this time. Prstate Cancer Internatinal is, frankly, puzzled and disturbed by sme f these statements, which (in the pinin f this rganizatin and thers) clearly appear t be inaccurate, and we have grave cncerns that the evicre draft guidance, if implemented as currently written, will deprive numerus men wh have been diagnsed with prstate cancer as well as men wh are suspected f being at high risk fr prstate cancer despite a prir negative bipsy f frms f care acknwledged by experts t be f high quality and f frms f imaging that are clearly nt investigatinal because they have been apprved by the U.S. Fd and Drug Administratin (FDA) fr use in the management f prstate cancer. We nte that n page 30 f the draft guidelines nce can find the fllwing definitin: "An experimental r investigatinal prcedure is generally defined as the use f a service, supply, drug r device that is nt recgnized as standard medical care fr the cnditin, disease, illness r injury being treated as determined by the health plan based n independent review f peer reviewed literature and scientific data." This definitin is, in and f itself, disturbing. It carefully and deliberately blurs the lines between a truly experimental technique, an investigatinal prcedure (which has gne beynd the experimental level t be tested in significant numbers f patients), and an accepted and apprved technique r prcedure that has already been validated and endrsed by regulatrs and/r many pinin-leaders in the diagnsis and management f a specific disrder but that has nly recently becme widely available utside the centers in which it was riginally develped and prven. The use f such a definitin actually guarantees the delay f access fr patients t well-prven diagnstic and therapeutic prcedures and techniques n grunds that have nthing t d with the
quality f the methdlgy. We understand that when such prcedures and techniques are cstly, it is reasnable fr payers and health care insurance prviders t ensure (thrugh prir apprval prcesses) that such prcedures and techniques are ging t be apprpriately used amng wellcharacterized patients wh are likely t be benefit frm their use. Hwever, we wuld categrically disagree with yur use f the definitin as written. We certainly wuld nt agree that An experimental r investigatinal prcedure is generally defined in the abve manner, and we suspect that the majrity f the health care cmmunity wuld als dispute that definitin. Specifically, we wuld draw yur attentin t the items belw. (1) On September 12, 2012, prductin f [ 11 C]chline was apprved by the FDA at the May Clinic as a Psitrn Emissin Tmgraphy (PET) imaging agent used t help detect recurrent prstate cancer. In making this apprval public, Charles Ganley, MD, then the directr f the Office f Drug Evaluatin IV in FDA s Center fr Drug Evaluatin and Research, is quted as saying, Chline C 11 Injectin prvides an imprtant imaging methd t help detect the lcatin f prstate cancer in patients whse bld tests suggest recurrent cancer when ther imaging tests are negative and The FDA s apprval f Chline C 11 Injectin at the May Clinic prvides assurance t patients and health care prfessinals they are using a prduct that is safe, effective, and prduced accrding t current gd manufacturing practices. The use f [ 11 C]chline in this indicatin is therefre clearly nt investigatinal by any reasnable definitin f that term, and we respectfully request apprpriate mdificatin f yur draft guideline t include this frm f imaging as an apprved practice. We acknwledge, hwever, that a payer may wish t put in place plicies that require pre-apprval fr the use f this type f imaging test s that its use is limited t well-identified and apprpriate patients. (2) On May 27, 2016, [ 18 F]fluclvine (als knwn as Axumin) was apprved by the FDA fr psitrn emissin tmgraphy (PET) imaging in men with suspected prstate cancer recurrence based n elevated prstate specific antigen (PSA) levels fllwing prir treatment. In making this apprval public, Liber Marzella, MD, PhD, then the directr f the Divisin f Medical Imaging Prducts in the FDA s Center fr Drug Evaluatin and Research, is quted as saying that previusly available imaging methds are nt able t determine the lcatin f the recurrent prstate cancer when the PSA is at very lw levels, and that Axumin is shwn t prvide anther accurate imaging apprach fr these patients. Again, the use f [ 18 F]fluclvine in this indicatin is therefre clearly nt investigatinal by any reasnable definitin f that term, and we respectfully request apprpriate mdificatin f yur draft guideline t include this frm f imaging as an apprved practice. We acknwledge, again, that a payer may wish t put in place plicies that require pre-apprval fr the use f this type f imaging test s that its use is limited t well-identified and apprpriate patients. (3) It is unclear t us frm what surce yu drew the statement abut management f patients n active surveillance. We wuld bring t yur attentin that n February 16, 2016, the American Sciety f Clinical Onclgy (ASCO) issued a set f frmal guidelines abut the management f
patients n active surveillance (see Chen et al. di: 10.1200/JCO.2015.65.7759). In that set f guidelines, ASCO stated that 3. The AS prtcl shuld include the fllwing tests: A PSA test every 3 t 6 mnths DRE at least every year At least a 12-cre cnfirmatry transrectal ultrasund guided bipsy (including anterir directed cres) within 6 t 12 mnths, and then serial bipsy every 2 t 5 years thereafter r mre frequently if clinically warranted. Men with limited life expectancy may transitin t watchful waiting and avid further bipsies. These guidelines als nted that the use f ther tests, including the use f multiparametric MRI testing, was still cnsidered t be under investigatin at that time. We wuld request that evicre amend its guidance abut the management f patients n active surveillance t cnfrm, at a minimum, t the guidance issued by ASCO. Hwever, we wuld als advise yu that Prstate Cancer Internatinal is highly supprtive f the apprpriate use f multiparametric MRI scans in the evaluatin and management f men n active surveillance when used in cnfrmity with the PI-RADs versin 2 assessment and evaluatin f such scans. (4) We wuld als nte that there is nw extensive evidence f the value f multiparametric MRI scanning in the diagnsis and wrk-up f a brad range f men with early stage prstate cancer -- either pst-diagnsis, in the determinatin f risk fr spread f prstate cancer utside the prstate capsule (which can be f cnsiderable value in the determinatin f the extent f extracapsular disease and therefre the planning f treatment) r in cmbinatin with transrectal ultrasund (TRUS) t ensure the accurate bipsying f areas f risk within the prstate. While it was arguable that this use f MRI scanning might have been investigatinal 2 t 3 years ag, we wuld argue strngly that this is n lnger the case and that a large percentage f the urlgy cmmunity nw carries ut MRI/TRUS fusin bipsies with regularity in rder t ensure the accurate bipsy f many men wh have multiple signals risk fr prstate cancer despite a negative systematic 12-cre bipsy. Indeed, ne review article published mre than a year ag cncluded as fllws: the benefits f targeted bipsy have been repeatedly shwn in several studies. There is munting evidence alng with the recent literature suggesting that effectiveness f mp-mri when used alng with PSA, fllwed by targeted bipsy f the MRI-visible lesin, is a better alternative t systematic TRUS bipsy in the diagnstic pathway fr prstate cancer detectin and therefre benefits the diagnsis f cancer. The largest benefit may cme frm reductin f unnecessary bipsies (NPV f mp-mri fr clinically significant cancer), which culd in turn prevent verdiagnsis and vertreatment. It als has the ptential t decrease the number f missed clinically significant cancers and imprves risk stratificatin; therefre, it prvides a mre accurate therapeutic ptin t
the patient. As we mve tward persnalized medicine, use f MRI t bipsy each man's prstate differently rather than based n a pre-defined 12 cre seems t be supprted in the recent literature. We wuld therefre disagree categrically with the statement in the draft guidelines that, MR Spectrscpy (CPT 76390) is cnsidered investigatinal and experimental in the evaluatin f prstate cancer at this time. We wish, respectfully, t suggest that evicre Healthcare carefully recnsiders and amends its current draft guidelines n imaging in nclgy with respect t the items abve-listed. We believe that such amendments will lead t significant reductins in the csts f lengthy, expensive, and ften inapprpriate and unnecessary treatments fr many patients with prstate cancer while simultaneusly ensuring greater safety and accuracy f treatments fr thse men mst in need f treatment. Prstate Cancer Internatinal and the patients it represents appreciate yur time and care in assessing the matters we have brught t yur attentin in this letter (which we will be sharing with ther members f the prstate cancer advcacy cmmunity). We wuld be pleased t discuss these cmments with yu further shuld this be f value. Finally, as advcates fr members f the prstate cancer cmmunity, it is nly right and prper that we infrm yu that we can be expected t advise patients t appeal clinical decisins made by payers and health insurance cmpanies that are based n several f the prpsed evicre guidelines as currently written, shuld these be finalized in their current frm. Sincerely Mike Sctt Jan Manarite E. Michael D. Sctt Jan Manarite President and C-Funder Executive Vice President mike@pcainternatinal.rg jmanarite@htmail.cm Tel: 215 446 8080 Tel: 239 208 4400