Exceptional Access Program (EAP) Request Form: Chronic Hepatitis C Treatments Section1 – Prescriber Information & Mailing Address Section 2 – Patient Information First Name Initial Last name First Name Initial Last name Street no. Street Name Health Card Number City Postal Code Fax Number Telephone Number Date of Birth (yyyy/mm/dd) Section 3 – Drug(s) Requested Patient’s weight (kg): Expected Start Date (yyyy/mm/dd): PEGETRON: REDIPEN VIAL (Note doses below are per Product VICTRELIS TRIPLE (Combination pack - for Genotype 1 only) Monograph) Treatment Naïve Treatment Experienced Weight Non-G1, Tx Naïve G-1, Tx Experienced Weight G-1, Tx Naïve 40-50 kg: 80mcg/800mg/2400mg 40-50 kg: 80mcg/800mg/2400mg < 40 kg 50mcg/800mg 50mcg/800mg < 40 kg 50mcg/800mg 51-65 kg: 100mcg/800mg/2400mg 51-65 kg:100mcg/800mg/2400mg 40-50 kg 80mcg/800mg 80mcg/800mg 40-50 kg 80mcg/800mg 66-80 kg: 120mcg/1000mg/2400mg 66-85 kg:120mcg/1000mg/2400mg 51-65 kg 100mcg/800mg 100mcg/800mg 51-65 kg 100mcg/800mg 81-105 kg: 150mcg/1200mg/2400mg 86-105 kg:150mcg/1200mg/2400mg 66-85 kg 120mcg/1000mg 120mcg/1000mg 66-80 kg 120mcg/1000mg >105 kg: 150mcg/1400mg/2400mg >105 kg: 150mcg/1400mg/2400mg 86-105 kg 150mcg/1200mg 150mcg/1200mg 81-105 kg 150mcg/1200mg >105 kg 150mcg/1200mg 150mcg/1400mg >105 kg 150mcg/1400mg PEGASYS RBV: VICTRELIS (boceprevir): 180 mcg/0.5 mL PFS + RBV 180 mcg/mL vial + RBV 800 mg tid Section 4 – Clinical Information Genotype: Genotype 1 (only genotype 1 is reimbursed for boceprevir) Genotype 2, 3 Other: ______________________ HCV RNA quantitative value (one level within past 6 months required): Date (yyyy/mm/dd): ___________ Result: _______________ Cirrhosis: No cirrhosis Cirrhosis - provide Child-Pugh score: 5-6 (A) 7-9 (B)* ≥10 (C) * Provide a breakdown of the CP score if the patient has CP score of B: _____________________________________________________ Fibrosis Metavir stage: F1 F2 F3 F4 Fibrosis determined by: Liver biopsy Fibroscan Fibrotest Date: (yyyy/mm/dd):________________________________ Section 5 – Previous Medications Previous treatment: Treatment Naïve – Skip to Section 6 if treatment naïve Peginterferon alfa and ribavirin Peginterferon monotherapy Interferon and ribavirin Interferon monotherapy Start Date of previous treatment (yyyy/mm/dd):___________________ Duration of previous treatment: __________________ Response to previous treatment: Relapser Partial responder or Non-responder Intolerance (Specify/describe: ________________________________ ) Section 6 – Lab values – Must be within past 6 months Lab Date (yyyy/mm/dd) Result If requesting peginterferon alfa and ribavirin dual therapy for a patient with genotype other than 2 or 3 AND the patient does not have fibrosis metavir Hemoglobin stage F2 or higher, please provide 2 ALT results within the previous six WBC months with normal ranges and dates. Any other relevant bloodwork may also be listed below as applicable: Platelets Albumin Lab Date (yyyy/mm/dd) Result ________________ ____________________ _________________ INR ________________ ____________________ _________________ Creatinine ________________ ____________________ _________________ Bilirubin (direct) Section 7 – Additional Information 1. Is the patient a null responder (< 2 log drop in HCV RNA by TW12) to previous treatment with peginterferon alfa/ribavirin? Yes No 2. Does the patient have Hepatitis B co-infection? Yes No 3. Is the patient HIV positive? Yes No 4. Does the patient currently have decompensated liver disease? Yes No 5. Has the patient had an organ transplant (including liver)? Yes (Specify organ) ____________________________________) No 6. Does the patient have any other comorbid conditions? Yes (Specify:___________________________________________) No Prescriber Signature (mandatory) CPSO number Date (yyyy/mm/dd) Fax the completed form and/or any additional/relevant information to (416) 327-7526 or toll-free to 1-866-811-9908; or send your request to the Ontario Public Drug Programs, Exceptional Access Program Branch, 3rd Floor, 5700 Yonge Street, Toronto, ON, M2M 4K5.
Pages to are hidden for
"Section1 � Prescriber Information & Mailing Address"Please download to view full document