Form HLTH5490 "Special Authority Request - Obeticholic Acid" - British Columbia, Canada

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Download Form HLTH5490 "Special Authority Request - Obeticholic Acid" - British Columbia, Canada

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SPECIAL AUTHORITY REQUEST
OBETICHOLIC ACID
HLTH 5490 2019/02/07
For up to date criteria and forms, please check: www.gov.bc.ca/pharmacarespecialauthority
Fax requests to 1 800 609-4884 (toll free) OR mail requests to: PharmaCare, Box 9652 Stn Prov Govt, Victoria, BC V8W 9P4
This facsimile is Doctor-Patient privileged and contains confidential information intended only for PharmaCare. Any other distribution, copying or disclosure is strictly prohibited. If you have
received this fax in error, please write “MIS-DIRECTED” across the front of the form and fax toll-free to 1 800 609-4884, then destroy the pages received in error.
If PharmaCare approves this Special Authority request, approval is granted solely for the purpose of covering prescription costs. PharmaCare approval does not indicate that the requested
medication is, or is not, suitable for any specific patient or condition.
Forms with information missing will be returned for completion. If no prescriber fax or mailing address is provided, PharmaCare will be unable to return a response.
SECTION 1 – PRESCRIBER INFORMATION
SECTION 2 – PATIENT INFORMATION
NAME AND MAILING ADDRESS
PATIENT (FAMILY) NAME
MAIL CONFIRMATION
PATIENT (GIVEN) NAME(S)
PHONE NUMBER (INCLUDE AREA CODE)
DATE OF BIRTH (YYYY / MM / DD)
DATE OF APPLICATION (YYYY / MM / DD)
COLLEGE ID OR
MSP NUMBER
PRESCRIBER’S FAX NUMBER
PERSONAL HEALTH NUMBER (PHN)
CRITICAL FOR A
CRITICAL FOR
TIMELY RESPONSE
PROCESSING
9901-0310
OBETICHOLIC ACID:
SECTION 3 – INITIAL COVERAGE (duration of coverage: 1 year)
Prescribed by a gastroenterologist
For treatment of adult patient with confirmed diagnosis of primary biliary cholangitis (PBC) defined as:
· Positive antimitochondrial antibodies (AMA) OR
· Liver biopsy results consistent with PBC
AND
Obeticholic acid will be used in combination with ursodeoxycholic acid (UDCA) in patient who has experienced an inadequate response to
UDCA after a minimum of 12 months treatment
Indicate UDCA treatment start date (DD/MM/YYYY):
Provide current clinical laboratory values as evidence of inadequate response:
DATE (DD/MM/YYYY)
VALUE
ULN**
ALP* ≥ 1.67 x ULN**
(U/L)
(U/L)
AND/OR
Total Bilirubin > ULN** and < 2 x ULN**
(umol/L)
(umol/L)
AND/OR
Compensated cirrhosis and supporting evidence of cirrhosis is attached (eg fibroscan, biopsy, ultrasound, and/or other clinical evidence of cirrhosis)
*ALP: Alkaline Phosphatase
**ULN: Upper Limit of Normal
OR
Obeticholic acid will be used as monotherapy in patient who has experienced documented and unmanageable intolerance to
ursodeoxycholic acid (UDCA). Provide clinical details of intolerance:
SPECIAL AUTHORITY REQUEST
OBETICHOLIC ACID
HLTH 5490 2019/02/07
For up to date criteria and forms, please check: www.gov.bc.ca/pharmacarespecialauthority
Fax requests to 1 800 609-4884 (toll free) OR mail requests to: PharmaCare, Box 9652 Stn Prov Govt, Victoria, BC V8W 9P4
This facsimile is Doctor-Patient privileged and contains confidential information intended only for PharmaCare. Any other distribution, copying or disclosure is strictly prohibited. If you have
received this fax in error, please write “MIS-DIRECTED” across the front of the form and fax toll-free to 1 800 609-4884, then destroy the pages received in error.
If PharmaCare approves this Special Authority request, approval is granted solely for the purpose of covering prescription costs. PharmaCare approval does not indicate that the requested
medication is, or is not, suitable for any specific patient or condition.
Forms with information missing will be returned for completion. If no prescriber fax or mailing address is provided, PharmaCare will be unable to return a response.
SECTION 1 – PRESCRIBER INFORMATION
SECTION 2 – PATIENT INFORMATION
NAME AND MAILING ADDRESS
PATIENT (FAMILY) NAME
MAIL CONFIRMATION
PATIENT (GIVEN) NAME(S)
PHONE NUMBER (INCLUDE AREA CODE)
DATE OF BIRTH (YYYY / MM / DD)
DATE OF APPLICATION (YYYY / MM / DD)
COLLEGE ID OR
MSP NUMBER
PRESCRIBER’S FAX NUMBER
PERSONAL HEALTH NUMBER (PHN)
CRITICAL FOR A
CRITICAL FOR
TIMELY RESPONSE
PROCESSING
9901-0310
OBETICHOLIC ACID:
SECTION 3 – INITIAL COVERAGE (duration of coverage: 1 year)
Prescribed by a gastroenterologist
For treatment of adult patient with confirmed diagnosis of primary biliary cholangitis (PBC) defined as:
· Positive antimitochondrial antibodies (AMA) OR
· Liver biopsy results consistent with PBC
AND
Obeticholic acid will be used in combination with ursodeoxycholic acid (UDCA) in patient who has experienced an inadequate response to
UDCA after a minimum of 12 months treatment
Indicate UDCA treatment start date (DD/MM/YYYY):
Provide current clinical laboratory values as evidence of inadequate response:
DATE (DD/MM/YYYY)
VALUE
ULN**
ALP* ≥ 1.67 x ULN**
(U/L)
(U/L)
AND/OR
Total Bilirubin > ULN** and < 2 x ULN**
(umol/L)
(umol/L)
AND/OR
Compensated cirrhosis and supporting evidence of cirrhosis is attached (eg fibroscan, biopsy, ultrasound, and/or other clinical evidence of cirrhosis)
*ALP: Alkaline Phosphatase
**ULN: Upper Limit of Normal
OR
Obeticholic acid will be used as monotherapy in patient who has experienced documented and unmanageable intolerance to
ursodeoxycholic acid (UDCA). Provide clinical details of intolerance:
OBETICHOLIC ACID
Patient (Family) Name
Patient (Given) Name(s)
Personal Health Number (PHN)
SECTION 4 – RENEWAL OF COVERAGE (duration of coverage: 1year)
Patient continues to benefit from treatment with obeticholic acid as evidenced by:
VALUE PRIOR TO OBETICHOLIC ACID (U/L)
CURRENT VALUE (U/L)
A reduction in ALP level to < 1.67 x ULN
OR
A 15% reduction in ALP level compared to baseline
OR
If the above criteria are not met, please provide supplemental information to demonstrate that patient has responded to, or will continue to benefit from, obeticholic acid.
Please provide details, as applicable:
SECTION 5 – ADDITIONAL COMMENTS
Personal information on this form is collected, used and disclosed under the authority of,
I have discussed with the patient that the purpose of releasing their
and in accordance with, the British Columbia Pharmaceutical Services Act and Freedom of
information to PharmaCare is to obtain Special Authority for prescription
Information and Protection of Privacy Act. It will not be disclosed to any persons without
coverage and for the purposes set out here.
the patient’s consent.The information you provide will be relevant to and used solely to (a)
provide PharmaCare benefits for the medication requested, (b) to implement, monitor and
evaluate this and other Ministry programs, and (c) to manage and plan for the health system
generally. If you have any questions about the collection or use of this information,
call Health Insurance BC from Vancouver at 1-604-683-7151 or from elsewhere in BC toll free at
1-800-663-7100 and ask to consult a pharmacist concerning the Special Authority process.
Prescriber’s Signature (Mandatory)
PharmaCare may request additional documentation to support this Special Authority request.
Actual reimbursement is subject to the rules of a patient's PharmaCare plan, including any annual deductible requirement, and to any other applicable PharmaCare pricing policy.
PHARMACARE USE ONLY
STATUS
EFFECTIVE DATE (YYYY / MM / DD)
DURATION OF APPROVAL
PRINT
CLEAR FORM
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