Updates to the Alberta Human Services Drug Benefit Supplement

Transcription

1 Updates to the Alberta Human Services Drug Benefit Supplement Effective December 9, 2013

2 Inquiries should be directed to: Pharmacy Services Alberta Blue Cross Street NW Edmonton AB T5J 3C5 Telephone Number: (780) (Edmonton) (403) (Calgary) (Toll Free) FAX Number: (780) (Toll Free) 109BWebsite: Hhttp:// Administered by Alberta Blue Cross on behalf of Alberta Health. The Drug Benefit List (DBL) is a list of drugs for which coverage may be provided to program participants. The DBL is not intended to be, and must not be used as a diagnostic or prescribing tool. Inclusion of a drug on the DBL does not mean or imply that the drug is fit or effective for any specific purpose. Prescribing professionals must always use their professional judgment and should refer to product monographs and any applicable practice guidelines when prescribing drugs. The product monograph contains information that may be required for the safe and effective use of the product. Copies of the Alberta Drug Benefit List Publication are available from Pharmacy Services, Alberta Blue Cross at the address shown above. Binder and contents: $42.00 ($ $2.00 G.S.T.) Contents only: $36.75 ($ $1.75 G.S.T.) A cheque or money order must accompany the request for copies. ABC 40211/81160 (R2013/12)

3 UPDATES TO THE ALBERTA HUMAN SERVICES DRUG BENEFIT SUPPLEMENT Table of Contents Special Authorization... 1 Drug Product(s) with Changes to Criteria for Coverage... 1 Part 3 Special Authorization EFFECTIVE DECEMBER 9, 2013

4 UPDATES TO THE ALBERTA HUMAN SERVICES DRUG BENEFIT SUPPLEMENT Special Authorization The following drug product(s) may be considered for coverage by special authorization for Alberta Human Services. Drug Product(s) with Changes to Criteria for Coverage Trade Name / Strength / Form Generic Description DIN MFR AVONEX PS/PEN (30 MCG/0.5 ML) 6 MIU / SYR INJECTION SYRINGE BETASERON (0.3 MG) 9.6 MIU / VIAL INJECTION COPAXONE 20 MG / SYR INJECTION SYRINGE EXTAVIA (0.3 MG) 9.6 MIU / VIAL INJECTION INTERFERON BETA-1A BIO INTERFERON BETA-1B BHP GLATIRAMER ACETATE TMP INTERFERON BETA-1B NOV GILENYA 0.5 MG CAPSULE FINGOLIMOD HYDROCHLORIDE NOV REBIF (1.5 ML CARTRIDGE) 44 MCG / ML INJECTION CARTRIDGE REBIF (1.5 ML CARTRIDGE) 88 MCG / ML INJECTION CARTRIDGE REBIF (0.5 ML SYRINGE) 22 MCG / SYR INJECTION SYRINGE REBIF (0.5 ML SYRINGE) 44 MCG / SYR INJECTION SYRINGE INTERFERON BETA-1A SRO INTERFERON BETA-1A SRO INTERFERON BETA-1A SRO INTERFERON BETA-1A SRO TYSABRI 20 MG / ML INJECTION NATALIZUMAB BIO EFFECTIVE DECEMBER 9,

5 Special Authorization PART 3 Special Authorization

6 FINGOLIMOD HYDROCHLORIDE Relapsing Remitting Multiple Sclerosis (RRMS): Special authorization coverage may be provided for the treatment of relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability in adult patients (18 years of age or older) who are refractory or intolerant to either interferon beta or glatiramer acetate. Definition of 'intolerant' Demonstrating serious adverse effects or contraindications to treatments as defined in the product monograph, or a persisting adverse event that is unresponsive to recommended management techniques and which is incompatible with further use of that class of MS disease modifying therapy (DMT). Definition of 'refractory' -Development of neutralizing antibodies to interferon beta. -When the above MS DMTs (interferon beta, glatiramer) are taken at the recommended doses for a full and adequate course of treatment, within a consecutive 12-month period while the patient was on the MS DMT, the patient has: 1) Been adherent to the MS DMT (greater than 80% of approved doses have been administered); 2) Experienced at least two relapses* of MS confirmed by the presence of neurologic deficits on examination. i. The first qualifying clinical relapse must have begun at least one month after treatment initiation. ii. Both qualifying relapses must be classified with a relapse severity of moderate, severe or very severe**. * A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. **Relapse Severity: with moderate relapses modification or more time is required to carry out activities of daily living; with severe relapses there is inability to carry out some activities of daily living; with very severe relapses activities of daily living must be completed by others. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS DMT. In most cases this will be satisfied by the refractory to treatment criterion but if a patient failed interferon beta or glatiramer acetate more than one year earlier, ongoing active disease must be confirmed. UNIT OF ISSUE - REFER TO PRICE POLICY 3. 1 EFFECTIVE DECEMBER 9, 2013

7 FINGOLIMOD HYDROCHLORIDE 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage will not be approved when any MS DMT or other immunosuppressive therapy is to be used in combination with fingolimod. Coverage of fingolimod will not be approved if the patient was deemed to be refractory to fingolimod in the past, i.e., has not met the 'responder' criteria below in 'Continued Coverage'. Following assessment of the request, coverage may be approved for up to 12 months. Patients will be limited to receiving a one-month supply of fingolimod per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more; Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. 4) The registered MS Neurologist must confirm in writing that the patient is a 'responder' who has experienced no more than one inflammatory event in the last year (defined as either a clinical relapse or gadolinium-enhancing lesion). In instances where a patient has had four or more clinical relapses in the year prior to starting treatment, there must be at least a 50% reduction in relapse rate over the entire treatment period. Following assessment of the request, continued coverage may be approved for maintenance therapy for up to 12 months. Patients may receive up to 100 days supply of fingolimod per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months In order to be eligible for coverage, after an interruption of therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for fingolimod must be completed using the Fingolimod Hydrochloride Special Authorization Request Form (ABC 60000). 0.5 MG ORAL CAPSULE GILENYA NOV $ PRODUCT IS NOT INTERCHANGEABLE 3. 2 EFFECTIVE DECEMBER 9, 2013

8 GLATIRAMER ACETATE Relapsing Remitting Multiple Sclerosis (RRMS): Special authorization coverage may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory patients with relapsing remitting multiple sclerosis. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage may be approved for up to 12 months. Patients will be limited to receiving a onemonth supply of glatiramer acetate per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 12 months. Patients may receive up to 100 days' supply of glatiramer acetate per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months UNIT OF ISSUE - REFER TO PRICE POLICY 3. 3 EFFECTIVE DECEMBER 9, 2013

9 GLATIRAMER ACETATE In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for glatiramer acetate must be completed using the Glatiramer Acetate/ Interferon Beta-1a/ Interferon Beta-1b Special Authorization Request Form (ABC 60001). 20 MG / SYR INJECTION SYRINGE COPAXONE TMP $ PRODUCT IS NOT INTERCHANGEABLE 3. 4 EFFECTIVE DECEMBER 9, 2013

10 INTERFERON BETA-1A Relapsing Remitting Multiple Sclerosis (RRMS): Special authorization coverage may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory patients with relapsing remitting multiple sclerosis. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage may be approved for up to 12 months. Patients will be limited to receiving a onemonth supply of interferon beta-1a per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 12 months. Patients may receive up to 100 days' supply of interferon beta-1a per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months UNIT OF ISSUE - REFER TO PRICE POLICY 3. 5 EFFECTIVE DECEMBER 9, 2013

11 INTERFERON BETA-1A In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for interferon beta-1a must be completed using the Glatiramer Acetate/ Interferon Beta-1a/ Interferon Beta-1b Special Authorization Request Form (ABC 60001). 44 MCG / ML INJECTION CARTRIDGE REBIF (1.5 ML CARTRIDGE) 88 MCG / ML INJECTION CARTRIDGE REBIF (1.5 ML CARTRIDGE) 6 MIU / SYR INJECTION SYRINGE AVONEX PS/PEN (30 MCG/0.5 ML) 22 MCG / SYR INJECTION SYRINGE REBIF (0.5 ML SYRINGE) 44 MCG / SYR INJECTION SYRINGE REBIF (0.5 ML SYRINGE) SRO SRO BIO SRO SRO $ $ $ $ $ PRODUCT IS NOT INTERCHANGEABLE 3. 6 EFFECTIVE DECEMBER 9, 2013

12 INTERFERON BETA-1B Relapsing Remitting Multiple Sclerosis (RRMS): Special authorization coverage may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory patients with relapsing remitting multiple sclerosis. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage may be approved for up to 12 months. Patients will be limited to receiving a onemonth supply of interferon beta-1b per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 12 months. Patients may receive up to 100 days' supply of interferon beta-1b per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months UNIT OF ISSUE - REFER TO PRICE POLICY 3. 7 EFFECTIVE DECEMBER 9, 2013

13 INTERFERON BETA-1B In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for interferon beta-1b must be completed using the Glatiramer Acetate/ Interferon Beta-1a/ Interferon Beta-1b Special Authorization Request Form (ABC 60001). Secondary Progressive Multiple Sclerosis with Relapses (SPMS with relapses): Special authorization coverage may be provided for the slowing of progression in disability and the reduction of the frequency of clinical relapses in patients with secondary progressive multiple sclerosis with relapses. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of SPMS with relapses; 2) The patient must have active disease which is defined as two relapses* of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms (documented by a physician), lasting at least 72 hours in the absence of fever, not associated with withdrawal from steroids, and preceded by stability for at least one month. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadoliniumenhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) The patient must be ambulatory to 100m without an aid (The registered MS Neurologist must provide an updated Expanded Disability Status Scale (EDSS) score of less than or equal to 5.5). Coverage may be approved for up to 12 months. Patients will be limited to receiving a onemonth supply of interferon beta-1b per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of SPMS with relapses; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or PRODUCT IS NOT INTERCHANGEABLE 3. 8 EFFECTIVE DECEMBER 9, 2013

14 INTERFERON BETA-1B above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 12 months. Patients may receive up to 100 days' supply of interferon beta-1b per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for interferon beta-1b must be completed using the Glatiramer Acetate/ Interferon Beta-1a/ Interferon Beta-1b Special Authorization Request Form (ABC 60001). 9.6 MIU / VIAL INJECTION BETASERON (0.3 MG) EXTAVIA (0.3 MG) BHP NOV $ $ UNIT OF ISSUE - REFER TO PRICE POLICY 3. 9 EFFECTIVE DECEMBER 9, 2013

15 NATALIZUMAB Relapsing Remitting Multiple Sclerosis (RRMS): Special authorization coverage may be provided for the treatment of relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability, in adult patients (18 years of age or older) who are refractory or intolerant to both interferon beta and glatiramer acetate. Definition of 'intolerant' Demonstrating serious adverse effects or contraindications to treatments as defined in the product monograph, or a persisting adverse event that is unresponsive to recommended management techniques and which is incompatible with further use of that class of MS disease modifying therapy (DMT). Definition of 'refractory' -Development of neutralizing antibodies to interferon beta. -When the above MS DMTs (interferon beta, glatiramer) are taken at the recommended doses for a full and adequate course of treatment, within a consecutive 12-month period while the patient was on the MS DMT, the patient has: 1) Been adherent to the MS DMT (greater than 80% of approved doses have been administered); 2) Experienced at least two relapses* of MS confirmed by the presence of neurologic deficits on examination. i. The first qualifying clinical relapse must have begun at least one month after treatment initiation. ii. Both qualifying relapses must be classified with a relapse severity of moderate, severe or very severe**. *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. **Relapse severity: with moderate relapses modification or more time is required to carry out activities of daily living; with severe relapses there is inability to carry out some activities of daily living; with very severe relapses activities of daily living must be completed by others. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS DMT. In most cases this will be satisfied by the 'refractory' to treatment criterion but if a patient failed interferon beta and PRODUCT IS NOT INTERCHANGEABLE EFFECTIVE DECEMBER 9, 2013

16 NATALIZUMAB glatiramer acetate more than one year earlier, ongoing active disease must be confirmed. 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage will not be approved when any MS DMT or other immunosuppressive therapy is to be used in combination with natalizumab. Coverage of natalizumab will not be approved if the patient was deemed to be refractory to natalizumab in the past, i.e., has not met the 'responder' criteria below in 'Continued Coverage'. Following assessment of the request, coverage may be approved for up to 13 doses of 300 mg (i.e., one dose administered every 4 weeks for a period up to 12 months). Patients will be limited to receiving one dose (4 weeks supply) of natalizumab per prescription at their pharmacy. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more; Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. 4) At the first renewal there must be evidence that neutralizing antibodies to natalizumab are absent. 5) The registered MS Neurologist must confirm in writing that the patient is a 'responder' who has experienced no more than one inflammatory event in the last year (defined as either a clinical relapse or gadolinium-enhancing lesion). In instances where a patient has had four or more clinical relapses in the year prior to starting treatment, there must be at least a 50% reduction in relapse rate over the entire treatment period. Following assessment of the request, continued coverage may be approved for maintenance therapy of 300 mg every 4 weeks for a period up to 12 months. Patients will be limited to receiving one dose of natalizumab per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period. All requests (including renewal requests) for natalizumab must be completed using the Natalizumab Special Authorization Request Form (ABC 60003). 20 MG / ML INJECTION UNIT OF ISSUE - REFER TO PRICE POLICY EFFECTIVE DECEMBER 9, 2013

17 NATALIZUMAB 20 MG / ML INJECTION TYSABRI BIO $ PRODUCT IS NOT INTERCHANGEABLE EFFECTIVE DECEMBER 9, 2013

18 ALBERTA GOVERNMENT SPONSORED DRUG BENEFIT PROGRAMS REGISTRATION FOR MS NEUROLOGIST STATUS for Alberta Drug Benefit List Special Authorization Coverage Eligible MS Disease Modifying Therapies (e.g., fingolimod hydrochloride, glatiramer acetate, interferon beta-1a, interferon beta-1b, natalizumab) Requests for special authorization coverage of eligible MS Disease Modifying Therapies is restricted to those neurologists who have registered with Alberta Blue Cross as an MS Neurologist. Approval of patient coverage may or may not be granted based on the information provided on the Special Authorization Request Form. Responsibilities of a registered MS Neurologist : Maintain adequate knowledge regarding multiple sclerosis (MS) and its treatment. Maintain expertise in treating/managing patients with MS. Provide adequate follow-up for their patients. This includes assessment of adverse events including discussion of concerns brought by the patient to the MS Special Therapies Nurse. It also includes assessment of tolerance, effectiveness, indications for continuation (on at least a yearly basis) and completion of the renewal request for continued coverage. Neurologists who choose not to apply to be a registered MS Neurologist may also prescribe MS Disease Modifying Therapies, but patients will not be eligible for coverage under the program for such prescriptions. The patient may choose to receive the product at their own expense. Please complete all sections of this form and return it by fax to Alberta Blue Cross Registrations will be accepted on an ongoing basis NEUROLOGIST LAST NAME FIRST NAME INITIAL OFFICE PHONE: FAX: OFFICE ADDRESS CITY PROVINCE POSTAL CODE COLLEGE OF PHYSICIANS AND SURGEONS REGISTRATION NO. OR PROFESSIONAL REGISTRATION NO. I agree to abide by the responsibilities of a registered MS Neurologist and submit special authorization requests for eligible MS Disease Modifying Therapies in accordance with policies and criteria as updated from time to time in the Special Authorization section of the Alberta Drug Benefit List. SIGNATURE OF PRESCRIBER (required): DATE: The information on this form is being collected and 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 purposes 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 or use of this information, please contact an Alberta Blue Cross privacy matters representative toll-free at or write to Privacy Matters, Alberta Blue Cross, Street, Edmonton AB T5J 3C5. PLEASE RETURN YOUR COMPLETED REGISTRATION BY FAX TO ABC Reg Form (2013/12)

19 Please complete all required sections to allow your request to be processed. PATIENT INFORMATION PATIENT LAST NAME FIRST NAME INITIAL DATE OF BIRTH: Year / Month / Day ALBERTA PERSONAL HEALTH NUMBER FINGOLIMOD HYDROCHLORIDE SPECIAL AUTHORIZATION REQUEST FORM Patients may or may not meet eligibility requirements as established by Alberta Government sponsored drug programs. COVERAGE TYPE: Alberta Blue Cross Alberta Human Services Other STREET ADDRESS CITY PROV POSTAL CODE IDENTIFICATION/CLIENT/COVERAGE No: PRESCRIBER INFORMATION PRESCRIBER LAST NAME FIRST NAME INITIAL PRESCRIBER PROFESSIONAL ASSOCIATION REGISTRATION STREET ADDRESS CITY, PROVINCE CPSA CARNA ACP PHONE: ACO ADA+C Other REGISTRATION NO. FAX: POSTAL CODE Please provide the following information for ALL requests: FAX NUMBER MUST BE PROVIDED WITH EACH REQUEST SUBMITTED NEW request (i.e. new to fingolimod and/or coverage). If patient is already on fingolimod, specify date started: RENEWAL request RESTART request MS disease modifying therapy (DMT) Switch Diagnosis Relapsing-remitting multiple sclerosis Other (please specify): Current *EDSS:. Date: *If the current EDSS is 7.0 or above, has the EDSS score been sustained at 7.0 or above for one year or more? Yes No Please provide the following information for all NEW requests and for RESTART after treatment interruption: Qualifying Relapses: Provide the dates of 2 relapses within the last 2 years, OR the 2 years prior to starting MS DMT Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Clinical relapse a) Has the patient been on MS DMT since the relapse(s)? No Yes MRI relapse (T1 gadolinium-enhancing lesion(s)) b) Indicate if there have been any interruptions in therapy since starting MS DMT: No Yes If yes, indicate: i) Reason for the interruption in therapy: ii) Specify time period of interruption: From (YYYY/MM/DD) iii) How many relapses did the patient experience while off therapy? To (YYYY/MM/DD) NEW requests: Previous medication utilized (Check ONE only): INTERFERON BETA OR GLATIRAMER ACETATE Specify response to the previous medication identified AND date of treatment initiation (YYYY/MM/DD): INTOLERANCE despite the use of symptom management techniques; OR REFRACTORY a) Does the patient have clinically significant titres of neutralizing antibodies to interferon beta? Yes No b) Within a consecutive 12-month period while on the MS DMT, did the patient experience at least two relapses of MS? No Yes Provide the dates of either 2 clinical relapses OR 1 clinical relapse and 1 MRI relapse Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Please provide the following information for all RENEWAL requests and NEW requests when patient is already on fingolimod: a) Has the patient experienced more than one relapse event per year since starting fingolimod? Yes No b) If yes and the patient experienced 4 or more relapses in the year prior to starting treatment, has the patient demonstrated a 50% reduction in relapse events since starting treatment? Yes No PRESCRIBER 'S SIGNATURE DATE Please forward this request to: Alberta Blue Cross, Clinical Drug Services Street NW, Edmonton, Alberta T5J 3C5 FAX: in Edmonton toll free all other areas ONCE YOUR REQUEST HAS SUCCESSFULLY TRANSMITTED, PLEASE DO NOT MAIL OR RE-FAX YOUR REQUEST. The information on this form is being collected and 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 purposes 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 or use of this information, please contact an Alberta Blue Cross privacy matters representative toll-free at or write to Privacy Matters, Alberta Blue Cross, Street, Edmonton AB T5J 3C5. ABC (2013/12) 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

20 Please complete all required sections to allow your request to be processed. PATIENT INFORMATION PATIENT LAST NAME FIRST NAME INITIAL DATE OF BIRTH: Year / Month / Day GLATIRAMER ACETATE/INTERFERON BETA-1A/INTERFERON BETA-1B SPECIAL AUTHORIZATION REQUEST FORM Patients may or may not meet eligibility requirements as established by Alberta Government sponsored drug programs. ALBERTA PERSONAL HEALTH NUMBER COVERAGE TYPE: Alberta Blue Cross Alberta Human Services Other STREET ADDRESS CITY PROV POSTAL CODE IDENTIFICATION/CLIENT/COVERAGE No: PRESCRIBER INFORMATION PRESCRIBER LAST NAME FIRST NAME INITIAL PRESCRIBER PROFESSIONAL ASSOCIATION REGISTRATION STREET ADDRESS CITY, PROVINCE CPSA CARNA ACP PHONE: ACO ADA+C Other REGISTRATION NO. FAX: POSTAL CODE Please provide the following information for ALL requests Indicate which MS disease modifying therapy (DMT) is requested (check one box): Avonex PS (interferon beta-1a) (e.g.) Betaseron / Extavia (interferon beta-1b) Copaxone (glatiramer acetate) FAX NUMBER MUST BE PROVIDED WITH EACH REQUEST SUBMITTED Rebif (interferon beta-1a) NEW request (i.e. new to MS DMT and/or coverage). If patient is already on MS DMT, specify date started: RENEWAL request RESTART request MS DMT Switch Diagnosis Current *EDSS:. Date: Relapsing-remitting multiple sclerosis Secondary-progressive multiple sclerosis with *If the current EDSS is 7.0 or above, has the relapses EDSS score been sustained at 7.0 or above for one Yes Other (please specify): year or more? Please provide the following information for all NEW requests and for RESTART after treatment interruption: Qualifying Relapses: Provide dates of 2 relapses within the last 2 years, OR the 2 years prior to starting MS DMT Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Clinical relapse Clinical relapse a) Has the patient been on MS DMT since the relapse(s)? No Yes MRI relapse (T1 gadolinium-enhancing lesion(s)) MRI relapse (T1 gadolinium-enhancing lesion(s)) b) Indicate if there have been any interruptions in therapy since starting MS DMT: No Yes If yes, indicate: i) Reason for the interruption in therapy: ii) Specify time period of interruption: From (YYYY/MM/DD) To (YYYY/MM/DD) iii) How many relapses did the patient experience while off therapy? PRESCRIBER 'S SIGNATURE DATE Please forward this request to: Alberta Blue Cross, Clinical Drug Services Street NW, Edmonton, Alberta T5J 3C5 FAX: in Edmonton toll free all other areas ONCE YOUR REQUEST HAS SUCCESSFULLY TRANSMITTED, PLEASE DO NOT MAIL OR RE-FAX YOUR REQUEST. The information on this form is being collected and 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 purposes 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 or use of this information, please contact an Alberta Blue Cross privacy matters representative toll-free at or write to Privacy Matters, Alberta Blue Cross, Street, Edmonton AB T5J 3C5. ABC (2013/12) 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 No

21 Please complete all required sections to allow your request to be processed. PATIENT INFORMATION PATIENT LAST NAME FIRST NAME INITIAL DATE OF BIRTH: Year / Month / Day ALBERTA PERSONAL HEALTH NUMBER NATALIZUMAB SPECIAL AUTHORIZATION REQUEST FORM Patients may or may not meet eligibility requirements as established by Alberta Government sponsored drug programs. COVERAGE TYPE: Alberta Blue Cross Alberta Human Services Other STREET ADDRESS CITY PROV POSTAL CODE IDENTIFICATION/CLIENT/COVERAGE No: PRESCRIBER INFORMATION PRESCRIBER LAST NAME FIRST NAME INITIAL PRESCRIBER PROFESSIONAL ASSOCIATION REGISTRATION STREET ADDRESS CITY, PROVINCE CPSA CARNA ACP PHONE: ACO ADA+C Other REGISTRATION NO. FAX: POSTAL CODE Please provide the following information for ALL requests: FAX NUMBER MUST BE PROVIDED WITH EACH REQUEST SUBMITTED NEW request (i.e. new to natalizumab and/or coverage). If patient is already on natalizumab, specify date started: RENEWAL request RESTART request MS disease modifying therapy (DMT) Switch Diagnosis Relapsing-remitting multiple sclerosis Other (please specify): Current *EDSS:. Date: *If the current EDSS is 7.0 or above, has the EDSS score been sustained at 7.0 or above for one year or more? Yes No Please provide the following information for all NEW requests and for RESTART after treatment interruption: Qualifying Relapses: Provide the dates of 2 relapses within the last 2 years, OR the 2 years prior to starting MS DMT Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) a) Has the patient been on MS DMT since the relapse(s)? No Yes b) Indicate if there have been any interruptions in therapy since starting MS DMT: No Yes If yes, indicate: i) Reason for the interruption in therapy: ii) Specify time period of interruption: From (YYYY/MM/DD) To (YYYY/MM/DD) iii) How many relapses did the patient experience while off therapy? NEW requests: Previous medication utilized: Please fill out response to BOTH interferon beta AND glatiramer acetate Specify response to INTEFERON BETA and date of treatment initiation (YYYY/MM/DD): INTOLERANCE despite the use of symptom management techniques; OR REFRACTORY a) Does the patient have clinically significant titres of neutralizing antibodies to interferon beta? Yes No b) Within a consecutive 12-month period while on the MS DMT, did the patient experience at least two relapses of MS? No Yes Provide the dates of either 2 clinical relapses OR 1 clinical relapse and 1 MRI relapse Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Specify response to GLATIRAMER ACETATE and date of treatment initiation (YYYY/MM/DD): INTOLERANCE despite the use of symptom management techniques; OR REFRACTORY Within a consecutive 12-month period while on the MS DMT, did the patient experience at least two relapses of MS? No Yes Provide the dates of either 2 clinical relapses OR 1 clinical relapse and 1 MRI relapse Date of Relapse (YYYY/MM/DD) Type of Relapse (One MRI relapse may substitute for one clinical relapse) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Moderate to very severe clinical relapse MRI relapse (T1 gadolinium-enhancing lesion(s)) Please provide the following information for all RENEWAL requests and NEW requests when patient is already on natalizumab: a) Has the patient experienced more than one relapse event per year since starting natalizumab? Yes No b) If yes and the patient experienced 4 or more relapses in the year prior to starting treatment, has the patient demonstrated a 50% reduction in relapse events since starting treatment? Yes No Please provide the following information for the first RENEWAL request only Natalizumab neutralizing antibody test result: Negative for natalizumab antibodies Positive for natalizumab antibodies Date of the test: PRESCRIBER 'S SIGNATURE DATE Please forward this request to: Alberta Blue Cross, Clinical Drug Services Street NW, Edmonton, Alberta T5J 3C5 FAX: in Edmonton toll free all other areas ONCE YOUR REQUEST HAS SUCCESSFULLY TRANSMITTED, PLEASE DO NOT MAIL OR RE-FAX YOUR REQUEST. The information on this form is being collected and 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 purposes 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 or use of this information, please contact an Alberta Blue Cross privacy matters representative toll-free at or write to Privacy Matters, Alberta Blue Cross, Street, Edmonton AB T5J 3C5. ABC (2013/12) 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