PATIENT INFORMATION: Patient Surname First Name Middle Initial Sex Date of Birth Alberta Personal Health Number M / F Year Month Day

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Sharyl Conley
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1 Applicant must be covered on an Alberta Government sponsored drug program. Page 1 of 6 PATIENT INFORMATION: Patient Surname First Name Middle Initial Sex Date of Birth Alberta Personal Health Number M / F Year Month Day Street Address City Province Postal Code Telephone Number Coverage Type: Alberta Blue Cross Alberta Children and Youth Services Identification/Client/Coverage No: Alberta Employment and Immigration Alberta Seniors and Community Supports Other Contact Person Name: (If applicable) Telephone Number: MS NEUROLOGIST INFORMATION: MS Neurologist Surname First Name Middle Initial College of Physicians and Surgeons Registration No Street Address City Province Postal Code Telephone Number Fax Number Last Consult Date Date Form Completed MS Neurologist s Signature MS NURSE INFORMATION: MS Nurse Surname First Name MS Nurse Signature Telephone Number Fax Number FOR INTERNAL USE ONLY - to be completed by Alberta Blue Cross MS PANEL DECISION SIGNATURE & DATE: NOTE: Section 1 (Pages 1-3) of this form must be submitted for all requests. Section 2 (Pages 4, 5) of this form is submitted in addition to section 1 for Tysabri new requests*. Section 3 (Page 6) of this form is submitted in addition to section 1 for Tysabri renewals. *For patients new to the program but already on Tysabri, additional information is required; see section 3. Please Mail this request to: Alberta Blue Cross, Clinical Drug Services & Evaluation Street NW, Edmonton, Alberta T5J 3C5 Or Fax to: Alberta Blue Cross, Clinical Drug Services & Evaluation in Edmonton toll-free all other areas Notice to Applicant: The information collected by this form is collected pursuant to sections 20, 21 and 22 of the Health Information Act, and sections 33 and 34 of the Freedom of Information and Protection of Privacy Act, for the purpose of determining or verifying eligibility to participate in a program or receive a benefit, product or health service. If you have any questions regarding the collection of this information, please contact the Co-chairs of the Alberta Blue Cross Privacy Steering Committee at or , Street, Edmonton AB, T5J 3C5.

2 Section 1: Complete for ALL MS Drug applications Page 2 of 6 TREATMENT REQUESTED 1 (Check only one box and indicate dosage - must be completed for each request) Avonex/Avonex PS (Interferon beta-1a) Betaseron (Interferon beta-1b) Copaxone (Glatiramer Acetate) Rebif (Interferon beta-1a) Tysabri (natalizumab) Dosage and Frequency Requested: Planned Start Date New to Program: start upon approval/bridging New to Program: on drug already Drug change Renewal PREVIOUS MS DISEASE MODIFYING TREATMENT (must be completed for each request) DRUG DATE STARTED DATE STOPPED REASON DRUG STOPPED* * Examples of reasons drug may be stopped: lack of efficacy, intolerability, non-compliance, pregnancy, financial reasons, interferon antibody positive ELIGIBILITY CRITERIA (complete if new to program or if off all disease modifying therapy more than 6 months and must requalify) Approval may be granted to patients who are assessed by an MS Neurologist and (1) meet the following criteria and (2) do not have the following contraindications to treatment: 1. Have a diagnosis of definite relapsing multiple sclerosis (RRMS or SPMS) (McDonald 2 diagnostic criteria must be met. MRI reports must be enclosed to confirm MRI criteria are met.) Have had at least two attacks/exacerbations of MS during the last two years, or in the two years prior to starting MS disease modifying therapy 3. A gadolinium enhancing MRI lesion at least 3 months before or after an attack may substitute for one attack Ambulatory Status: a. Able to walk with or without aid if relapsing-remitting MS; or... b. Able to walk 100 m without an aid (EDSS < 5.5) if secondary progressive MS with relapses... Contraindications (does the patient have any of the following?): 1. Significant illness likely to alter compliance or substantially reduce life expectancy... No 2. Planned or current pregnancy, or nursing... No 3. a. Active, severe depression; or... No b. Active, severe depression; waiver from a psychologist or psychiatrist attached Progression without relapse No OTHER CLINICAL DATA (must be completed for each request) Age: Gender Male Female Date of onset: / (Year/Month) 6 Current Prescribed Medications: Allergies: 1. Only Betaseron is funded for patients with SPMS starting therapy. 2. McDonald Criteria (Ann Neurol 2001; 50: ) Summary: patients must meet one of the following conditions: a) 2 attacks confirmed by objective findings and evidence of 2 clinically objective lesions. b) 2 attacks confirmed by objective findings, and 1 clinically objective lesion, and either dissemination in space by MRI as below or at least 2 MRI lesions and CSF oligoclonal bands or increased IgG index. c) 1 attack confirmed by objective findings, and 2 clinically objective lesion sites, and dissemination in time by MRI. d) 1 attack confirmed by objective findings, and 1 clinically objective lesion, and dissemination in space by MRI [or 2 MRI lesions and + CSF] and dissemination in time by MRI. Dissemination in space by MRI: (3 of 4 of the following): 1) 1 gd+ lesion or 9 T2 hyperintense lesions (cord or brain); 2) 1 infratentorial lesion; 3) 1 juxtacortical lesion; 4) 3 periventricular lesions Dissemination in time by MRI: Either 1) a gd+ lesion on an MRI at least 3 (or more) months after an attack, at a different site; or, 2) a new T2 lesion at least 3 months after scan that was completed at least 3 months after the initial documented attack, at a different site. 3. In RRMS an attack is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, and not associated with withdrawal from steroids. In SPMS it is more difficult to differentiate attacks from disease fluctuation; therefore, attacks must meet these criteria, must have lasted at least 72 hours, and new neurologic deficits must have been documented by a physician. Attacks must be separated by a period of at least one month. 4. Required prior to approval for all patients who have not been on treatment for at least 6 months. 5. Progression is worsening neurologic impairment not due to residual deficits from attacks. 6. Consider onset as the time of first convincing MS symptoms. This would include episodes such as transverse myelitis or optic neuritis, but not (in most cases) non-specific symptoms such as dizziness, visual blurring or fatigue.

3 Section 1: Complete for ALL MS Drug applications Page 3 of 6 QUALIFYING ATTACKS (complete if new to program or if off disease modifying therapy more than 6 months and must requalify) DATE OF ATTACK ONSET (Year/Month/Day) Most recent attack: Year Month Day Previous attack: Year Month Day MRI ATTACK EQUIVALENT No No (Y/N) SEVERITY 1 RECOVERY FUNCTIONAL SYSTEMS INVOLVED OBJECTIVE CHANGES (SPMS ONLY) Mild Moderate Severe Very Severe Mild Moderate Severe Very Severe None Incomplete Complete None Incomplete Complete Pyramidal Cerebellar Bowel/bladder Cognitive/cerebral Pyramidal Cerebellar Bowel/bladder Cognitive/cerebral Sensory Brain Stem Visual Sensory Brain Stem Visual No No BASELINE AND FOLLOW-UP DATA (must be completed for each request) PRE DRUG CURRENT if on drug YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 Date 2 (Year / Month / Day) EDSS Pyramidal Cerebellar Brain Stem Visual Score Sensory Bowel/Bladder Cognitive # of attacks during 2 yrs prior to baseline assessment # of attacks since last form completed (renewals) Relapse at time of assessment ( or No) Progressive course ( or No) Interferon antibodies (, No, Not applicable, or Unknown) 1. Severity: Mild - symptoms present but no change in function; Moderate - requires modification or more time to carry out activity; Severe - unable to carry out usual activity; Very Severe - requires others to provide personal care for them. 2. Date of examination must be 0-6 months preceding this request, or if already on drug, from the most recent annual assessment. ABC (R04/2010) The Blue Cross symbol and name are registered marks of the Canadian Association of Blue Cross Plans, an association of independent Blue Cross plans. Licensed to ABC Benefits Corporation for use in operating the Alberta Blue Cross Plan

4 Section 2: Complete for NEW Tysabri requests Page 4 of 6 Patient has previously been demonstrated to have at least nine T2 hyperintense lesions on brain MRI. If this application is submitted more than 6 months after the last 12 month treatment failure window, please complete the following to confirm ongoing inflammatory disease: Since the last treatment failure window ended, the applicant has continued to have active inflammatory MS defined as an average of one or more relapses or one gadolinium enhancing T1 lesion on MRI per year (number of years is rounded to the nearest whole number). At least 50% of inflammatory events must have been relapses. (Append supporting brain MRI reports) Date of year onset: Relapse date: MRI date: Patient has demonstrated EITHER: I. Intolerance to interferon-beta (Avonex, Rebif, or Betaseron): 'Intolerance' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs, or a persisting adverse event that is unresponsive to recommended management techniques and which is incompatible with further use of that class of DMT. Describe the intolerance in detail below (or attach letter): OR II. Failure to respond to interferon-beta (Avonex, Rebif, or Betaseron): Within the 12 month treatment period from to the following statements are true: a. The patient reported adherence to the interferon-beta at the standard dose defined as receiving 80% of prescribed dosing b. The patient experienced onset of one or more on-treatment clinical relapses at least 3 months after initiating full dose interferonbeta and this relapse was accompanied by new neurologic deficits that persisted for at least 3 months: Date of relapse onset: Residual deficit (detected at least 3 months after onset of the relapse): c. Evidence of ongoing inflammatory MS disease activity as demonstrated by either: The occurrence of at least one additional clinical relapse at least 1 month after initiating full dose interferon-beta and this relapse was accompanied by new neurologic deficits that persisted for at least one month: Date of relapse onset: Residual deficit (detected at least 1 month after onset of the relapse): Or Evidence of active inflammatory MS disease activity on brain or spine MRI that clearly started/ occurred during treatment with DMT and that was not associated with the qualifying clinical relapse. This may include one of the following: A gadolinium enhancing T1 lesion on MRI at least 3 months after initiating full dose interferon beta and not within 3 months of the relapse described in b or c (above) (append MRI report) The appearance of 2 or more new, or newly enlarging, T2 hyperintense lesions, greater than 3 mm in size* (append MRI report) *This requires comparison of 2 brain MRI scans completed within the 12-month treatment failure window. The baseline scan must have been undertaken at least 1 month after starting DMT. No clinical relapses may occur during the interval between the 2 comparison scans if that relapse is being used to confirm treatment failure. The second MRI report must include evidence that the 2 scans were directly compared, the dates of both scans, and a clear statement indicating that 2 or more new, or newly enlarging, T2 lesions at least 3 mm in size are present on the second scan.

5 Section 2: Complete for NEW Tysabri requests Page 5 of 6 Patient has demonstrated EITHER: I. Intolerance to glatiramer acetate (Copaxone): 'Intolerance' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs, or a persisting adverse event that is unresponsive to recommended management techniques and which is incompatible with further use of that class of DMT. Describe the intolerance in detail below (or attach letter): OR II. Failure to respond to glatiramer acetate (Copaxone): Within the 12 month treatment period from to the following statements are true: d. The patient reported adherence to the glatiramer acetate at the standard dose defined as receiving 80% of prescribed dosing e. The patient experienced onset of one or more on-treatment clinical relapses at least 3 months after initiating full dose glatiramer acetate and this relapse was accompanied by new neurologic deficits that persisted for at least 3 months Date of relapse onset: Residual deficit (detected at least 3 months after onset of the relapse): f. Evidence of ongoing inflammatory MS disease activity as demonstrated by either: The occurrence of at least one additional clinical relapse at least 1 month after initiating full dose glatiramer acetate and this relapse was accompanied by new neurologic deficits that persisted for at least one month Date of relapse onset: Or Residual deficit (detected at least 1 month after onset of the relapse): Evidence of active inflammatory MS disease activity on brain or spine MRI that clearly started/ occurred during treatment with DMT and that was not associated with the qualifying clinical relapse. This may include one of the following: A gadolinium enhancing T1 lesion on MRI at least 3 months after initiating full dose glatiramer acetate and not within 3 months of the relapse described in e or f (above) (append MRI report) The appearance of 2 or more new, or newly enlarging, T2 hyperintense lesions, greater than 3 mm in size* (append MRI report) Contraindications (does the patient have any of the following?): 1. Any evidence of disease progression independent of relapses.. 2. Immune compromise due to immunosuppressant or anti-neoplastic therapy or due to immunodeficiency (HIV, leukemia, lymphoma, etc) 3. History of progressive multifocal leukoencephalopathy (PML) 4. Concurrent malignancy.. 5. Pregnancy or anticipated pregnancy within the next year *This requires comparison of 2 brain MRI scans completed within the 12-month treatment failure window. The baseline scan must have been undertaken at least 1 month after starting DMT. No clinical relapses may occur during the interval between the 2 comparison scans if that relapse is being used to confirm treatment failure. The second MRI report must include evidence that the 2 scans were directly compared, the dates of both scans, and a clear statement indicating that 2 or more new, or newly enlarging, T2 lesions at least 3 mm in size are present on the second scan. No

6 Section 3: Complete for Tysabri RENEWAL requests Page 6 of 6 For patients new to the program who are already on Tysabri: Complete the * questions in addition to section 1 and 2 For continued coverage beyond the initial 6 doses: Complete the following with every renewal The patient must be assessed by an MS Neurologist after the initial 5 or 6 doses to determine response, then at 12 months, then annually. The MS Neurologist must confirm that the patient is a 'responder' according to the following criteria: The patient initiated treatment within 2 months of approval (complete only at first 6 month assessment) The patient has not missed any doses, or delayed any doses by more than 1 week with the exception of medically authorized delays (Rationale for such delays must be justified in a narrative. Only serious medical conditions are acceptable) *There has been at least a 50% reduction in the relapse rate over the entire Tysabri treatment period compared with the 2 years prior to treatment: *Dates of onset of each relapse that occurred during the 2 years prior to initiation of Tysabri: *Dates of onset of each relapse that occurred during each year of Tysabri treatment: 1) 2) 3) 4) 5) 6) 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) If a clinical relapse occurred 3 or more months earlier, brain MRI after 5 or 6 doses shows no evidence of gadolinium enhancing disease activity (unless the patient experienced 5 or more relapses over the 2 years prior to initiation of Tysabri). (Complete this question only at first 6 month assessment) (Append MRI report) N/A Brain MRI scans with gadolinium were completed every 6 months to monitor disease activity and safety. There was no evidence of gadolinium enhancing disease activity on 2 consecutive scans, or on 2 out of any 3 consecutive scans, or on any scan completed within 9 to 12 months of a relapse. (append all MRI reports, in chronological order, completed since Tysabri initiated) At the first 12-month renewal (required at 6 months if already on Tysabri for 6 months at the time of the application). There must be evidence that neutralizing antibodies to Tysabri are absent. This requires an initial test be completed between 6 to 8 months: Are neutralizing antibodies absent at 6 to 8 months? If : no further testing is required No If No: Are neutralizing antibodies absent on repeat testing after an additional 3 months? No Contraindications (does the patient have any of the following?): 1. Any evidence of disease progression independent of relapses. 2. Immune compromise due to immunosuppressant or anti-neoplastic therapy or due to immunodeficiency (HIV, leukemia, lymphoma, etc.) 3. History of progressive multifocal leukoencephalopathy (PML) 4. Concurrent malignancy.. 5. Pregnancy or anticipated pregnancy within the next year No

Updates to the Alberta Human Services Drug Benefit Supplement

Updates to the Alberta Human Services Drug Benefit Supplement Effective December 9, 2013 Inquiries should be directed to: Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5 Telephone