Saskatchewan Ministry of Health Exception Drug Status Request Hepatitis C Therapy Drug Plan and Extended Benefits Branch Please submit the completed form and required additional information by: • Fax to 306-798-1089; or • Email to [email protected]; or nd • Mail to the Drug Plan and Extended Benefits Branch, 2 floor, 3475 Albert Street, Regina, SK S4S 6X6 If you have any questions, please contact us by phone at 306-787-3317 (in Regina) or toll-free at 1-800-667-7581. Additional documentation to support the request is required. Please ensure that all appropriate information for each section is provided to avoid delays. Section 1 – Prescriber Information First Name Section 2 – Patient Information Last Name First Name Mailing Address Last Name Date of Birth (yyyy/mm/dd) Telephone No. Fax No. Health Services Number Gender □ Male □ Female Section 3 – Requested Drug Regimen (see Appendix A for specific criteria) □ Harvoni* (ledipasvir/sofosbuvir) □ Sovaldi (sofosbuvir) + Ibavyr (ribavirin) □ Sovaldi* (sofosbuvir) + peginterferon alfa-2a or 2b + ribavirin □ 8 weeks Length of therapy required: □ 12 weeks *For patients with HCV genotype 1 that meet eligibility criteria for Harvoni, clinicians will be encouraged to use Harvoni as the preferred therapeutic regimen over other covered therapies (e.g., interferon-based regimens with NS3/4A protease inhibitors or polymerase inhibitors). This recommendation is based on Harvoni’s advantages in some patient populations, including potentially higher SVR rates, improved tolerability, no need for concomitant interferon or ribavirin therapy, shorter course of therapy, and once daily dosing. □ 16 weeks □ 24 weeks Section 4 – Clinical Information Patients must have a confirmed diagnosis of chronic Hepatitis C infection. Lab-confirmed HCV genotype: _________ Sub-type (if available): _________ HIV co-infection: □ Yes □ No Liver disease: □ Compensated □ Decompensated □ Yes □ No Compensated liver cirrhosis: Fibrosis Stage (Metavir scale or equivalent): □ F0 Quantitative HCV RNA: ___________ IU/mL Date (yyyy/mm/dd): ______________ (must be tested within the last six months) Previous HCV treatment history: □ F1 □ F2 □ F3 □ F4 Ensure copy of Fibroscan report (or biopsy, if applicable) is included with request. □ Treatment-naïve; or □ Treatment-experienced (please list previous treatment(s)): __________________________________ Relevant drug intolerances and contraindications: □ None □ Hypersensitivity to peginterferon or interferon alfa-2a or 2b and/or product formulation □ Significant clinical comorbidities: __________________________________________________________ Please be specific and include details to sufficiently explain the patient’s contraindication. Version 1.0 March 2015 Page 1 of 2 Section 5 – Direct Observed Therapy Based on the patient’s individual situation and regular access to a community pharmacy, the prescriber has evaluated the decision for the patient to receive Direct Observed Therapy (DOT). □ Direct Observed Therapy Recommended With DOT, the patient will visit their pharmacy on a daily basis to take their oral Hepatitis C medication doses as a means of encouraging treatment adherence. Pharmacists will follow up with prescribers to discuss patient non-adherence. (leave blank if not recommended) NOTE: Please indicate on the patient’s prescription if DOT is recommended. Section 6 – Patient Consent Patient to check and initial as reviewed. □ ______ I am aware of the requirement for adherence to my prescribed Hepatitis C drug treatment protocol. Missed doses of my Hepatitis C medication will lessen my chances of a successful treatment outcome, and may increase the risk of viral resistance. □ ______ I understand the Saskatchewan Drug Plan will receive data specific to my treatment from my physician for medication effectiveness monitoring purposes. I understand my personal health information will be kept secure and confidential and will not be disclosed for an additional purpose. I also understand my participation is voluntary but required for eligibility of Exception Drug Status coverage from the Saskatchewan Drug Plan. I may withdraw my consent at any time, but once I do, drug coverage for this treatment may also be withdrawn. If you have any questions please contact the Ministry of Health’s Chief Privacy Officer at 787-2137. Patient name (printed): _____________________________________________ Patient signature (required): ______________________________________________ Date (yyyy/mm/dd): _________ Section 7 – Application Requirement Checklist Please ensure all of the following are included with your Exception Drug Status application: □ Both pages 1 and 2 of this application form □ Fibroscan report or liver biopsy report Prescriber’s Signature (Required) Date (yyyy/mm/dd) Once complete, please submit all required materials for review to the Drug Plan by: • Fax to 306-798-1089; or • Email to [email protected]; or nd • Mail to the Drug Plan and Extended Benefits Branch, 2 floor, 3475 Albert Street, Regina, SK S4S 6X6 Version 1.0 March 2015 Page 2 of 2