REVIEW REQUEST FOR Peg-Intron® (Pegylated Interferon alfa-2b)- Interferons Complete form in its entirety and fax to: Anthem Blue Cross 866-408-7195 Provider Data Collection Tool Based on Clinical Guidelines DRUG-07 Policy Last Review Date: 11/17/2011 Request Date: Initial Request Buy and bill / Policy Effective Date: 01/11/2012 Provider Tool Effective Date: 01/11/2012 / Subsequent Request Individual’s Name: Date of Birth: / / Individual’s Phone Number: Insurance Identification Number: Primary Diagnosis: ICD-9 Code(s) (if known): Ordering Provider Name & Specialty: Individual’s Weight (lbs) (kg) Provider Tax ID Number or NPI: Office Address: Contact Name AND Office Phone Number: Office Fax Number: Servicing Provider Name & Specialty (If different than Ordering Provider): Provider Tax ID Number or NPI: Office Address: Contact Name AND Office Phone Number: Office Fax Number: Place of Service: Home Office Dialysis Center Outpatient Hospital Ambulatory Infusion Ambulatory Infusion Center Other: Drug Name/HCPS Code (if known) Dose to be administered: Peg-Intron® S0148 Other: When did the individual first start this drug? Frequency (Days, Wks, Months) / / Duration: Start Date For This Request: (Weeks) / / (units) Please check all that apply to the individual: 1. Use of pegylated interferon alfa 2b for the diagnosis of hepatitis C-Genotype 1,2,3,4, 5, 6. Please complete this section before proceeding to specific therapy regimen : (check a response to each that applies) Individual is age 3 or older Individual does not have uncontrolled depression (for example, suicide risk) Individual does not have autoimmune hepatitis or other condition known to be exacerbated by interferon and ribavirin Individual is not pregnant, nor likely to become pregnant Individual does not have severe concurrent diseases, including, but not limited to, severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes or obstructive pulmonary disease Individual does not have untreated hyperthyroidism Individual does not have known hypersensitivity to drugs used to treat hepatitis C Individual is not a recipient of kidney, heart, or other solid organ transplant except liver transplant Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. ®ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Page 1 of 4 2. Treatment of hepatitis C Virus (HCV) A. Triple Therapy – pegylated interferon in combination with ribavirin and a serine protease inhibitor (boceprevir or telaprevir) Initial triple therapy – Genotype 1 Request is for pegylated interferon as part of a planned triple therapy in an individual with confirmed HCV genotype 1 for up to an initial 12 weeks of therapy Individual has: (Please check all that apply): Detectable HCV ribonucleic acid (RNA) Compensated liver disease Not received previous treatment for HCV with triple therapy Other: Continuation of triple therapy – Genotype 1 Request is for pegylated interferon as part of triple therapy in an individual with HCV genotype 1 currently receiving a 12 week course of triple therapy who require up to an additional 36 weeks of treatment (to complete up to a total of 48 weeks) of therapy Individual has: (Please check all that apply): A decrease in HCV RNA to less than 1000 IU/mL for telaprevir-based triple therapy at week 4 & 12 of initial therapy A decrease in HCV RNA to less than 100 IU/mL for boceprevir-based triple therapy at week 12 of initial therapy Other: B. Dual Therapy – pegylated interferon in combination with ribavirin Initial dual therapy – Genotype 1, 2, 3, 4, 5 or 6 Request is for pegylated interferon as part of dual therapy in an individual with confirmed HCV genotype 1 for up to an initial 12 weeks of therapy Request is for pegylated interferon as part of dual therapy in an individual with confirmed HCV genotype 2 or 3 for an initial course of treatment not to exceed 24 weeks in duration Request is for pegylated interferon as part of dual therapy in an individual with confirmed HCV genotype 4, 5 or 6 for up to an initial 12 weeks of therapy Individual has: (Please check all that apply): Detectable HCV ribonucleic acid (RNA) Compensated liver disease Not received previous treatment with pegylated interferon in combination with ribavirin Significant fibrosis or cirrhosis who received one of the following and demonstrate no response or has relapsed: Previous treatment with non-pegylated interferon monotherapy, or Previous treatment with non-pegylated interferon with ribavirin, or Previous treatment with pegylated monotherapy Other: Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. ®ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Page 2 of 4 Continuation of dual therapy – Genotype 1, 2, 3, 4, 5 or 6 Request is for pegylated interferon as part of dual in an individual with HCV genotype 1 currently receiving a 12 week course of dual therapy who require an additional 36 weeks of treatment (to complete up to a total of 48 weeks) of therapy Request is for pegylated interferon as part of dual therapy in an individual with HCV genotype 2 or 3 for a course of treatment not to exceed 48 weeks in duration Request is for pegylated interferon as part of dual therapy in an individual with HCV genotype 4, 5 or 6 currently receiving a 12 week course of combination pegylated interferon and ribavirin therapy who require an additional 36 weeks of treatment (to complete a total of 48 weeks) of therapy Individual has: (Please check all that apply) Documented early viral response (EVR) (An EVR is defined as a decrease in HCV RNA greater than 2 log from baseline) A decrease in HCV ribonucleic acid (RNA) to undetectable levels at week 12 of initial therapy Detectable HCV ribonucleic acid (RNA) HIV coinfection Demonstrated no response to initial dual therapy or have relapsed after: (Please check all that apply) Previous treatment with non-pegylated interferon monotherapy, or Previous treatment with non-pegylated interferon with ribavirin, or Previous treatment with pegylated monotherapy Other: Slow responders to initial dual therapy – Genotype 1 Request is for pegylated interferon as part of dual therapy (pegylated interferon in combination with ribavirin) in an individual with HCV genotype 1who is a slow responder, defined as HCV RNA test becomes negative between weeks 12 and 24 of initial dual therapy for a maximum treatment duration of 72 weeks Other: C. Monotherapy - treatment in individuals with a contraindication to ribavirin Request is for pegylated interferon monotherapy in an individual with a contraindication to ribavirin and confirmed HCV with compensated liver disease for up to 48 weeks Individual has: (Please check all that apply) Any genotype Detectable HCV ribonucleic acid (RNA) Not received previous treatment with pegylated interferon monotherapy Received previous non-pegylated interferon monotherapy with no response or relapse has occurred Other: 3. Other Other Use(s) (Please submit all supporting documents including labs, progress notes, imaging, etc., for review.) Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. ®ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Page 3 of 4 This request is being submitted: Pre-Claim Post–Claim. If checked, please attach the claim or indicate the claim number I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its designees may perform a routine audit and request the medical documentation to verify the accuracy of the information reported on this form. Name and Title of Provider or Provider Representative Completing Form and Attestation (Please Print)* Date *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted. Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. ®ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Page 4 of 4