EDS Application – Hepatitis C Therapy

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.
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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
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