City,State,Zipcode Re: Patient Sname Policyno.: XXXXXXXX

[Alternatesiteofcare’sname]Attn:[ASOCcontactname][ASOCaddress:

Streetname

City,State,Zipcode]Re:[Patient’sname]PolicyNo.:[XXXXXXXX]

Dear[Infusioncenter]:

IamwritingtorecommendKRYSTEXXA® (pegloticase)injection,8mg/mL,forintravenousinfusionfor[Patient’sname].

[MM/DD/YYYY]

KRYSTEXXAisaPEGylateduricacid–specificenzymeindicatedforthetreatmentofchronicgoutinadultpatientswhohavefailedtonormalizeserumuricacid(sUA)levelandwhosesignsandsymptomsareinadequatelycontrolledwithxanthineoxidaseinhibitors(XOIs)atthemaximummedicallyappropriatedoseorforwhomthesedrugsarecontraindicated.KRYSTEXXAisnotrecommendedforthetreatmentofasymptomatichyperuricemia.

Inmyclinicalopinion,KRYSTEXXAismedicallynecessaryandappropriatetotreat[Patient’sname]atthispointin[hisorher]courseofcare.

[Patient’sname],[age],hashadgoutfor[numberofmonthsoryears]andhasbeenonthemaximummedicallyappropriatedoseof[xanthineoxidaseinhibitordrugname]for[numberofmonthsoryears].However,[hisorher]sUAlevelisstillat[sUAlevel],and[heorshe]isstillexperiencing[numberofflares]flaresperyearorhasvisibletophi.

•Labresults:G6PDcanbefoundonpageX

•DatesanddurationoftreatmentwithXOIs(allopurinolorfebuxostat)

•Ifapplicable,datesanddurationoftreatmentwithuricosurics(probenecid,lesinurad)canbefoundonpageX

•Labresults:sUAlevelsthroughoutprevioustreatmentscanbefoundonpageX

•TenderandswollenjointcountscanbefoundonpageX

•Numberofflaresinthelast18monthscanbefoundonpageX

•Numberofvisibletophi,specificlocation,size,severity,andimagingcanbefoundonpageX

•Anyadditionalnotesonseverityofsignsandsymptoms,suchashospitaladmissionsordaysmissedfromwork,canbefoundonpageX

•Chartnotesindicatingallergytourate-loweringtherapycanbefoundonpageX

•PrimarydiagnosiscodeforrenalimpairmentandsecondarydiagnosiscodeforgoutduetorenalimpairmentcanbefoundonpageX

Basedonallthesefactors,Ibelievethat[Patient’sname]isnotrespondingto[hisorher]currenttreatment(s)andthatKRYSTEXXAmayhelprelieve[hisorher]signsandsymptomsofgout.

IamenclosingdocumentationsupportingthemedicalnecessityofKRYSTEXXAforthispatient.Pleasecontactmeat[officecontactinformation]ifyourequireadditionalinformationorwouldliketodiscussthecaseingreaterdetail.

Thankyou.[Signature][Physician’sname]

[PhoneNo.]

[Streetname]

[City,State,Zipcode]

Enclosures

P-KRY-00264