Updates to the Alberta Drug Benefit ListThe Drug Benefit List (DBL) is a list of drugs for which...

Updates to the Alberta Drug Benefit List

Effective November 1, 2019

ABC 40211/81160 (R2019/11)

Inquiries should be directed to:

Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5

Telephone Number: (780) 498-8370 (Edmonton) (403) 294-4041 (Calgary) 1-800-361-9632 (Toll Free)

FAX Number: (780) 498-8406 1-877-305-9911 (Toll Free)

109BWebsite: https://www.alberta.ca/drug-benefit-list-and-drug-review-process.aspx

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 are available from Pharmacy Services, Alberta Blue Cross at the address shown above.

Binder and contents: $42.00 ($40.00 + $2.00 G.S.T.) Contents only: $36.75 ($35.00 + $1.75 G.S.T.)

A cheque or money order must accompany the request for copies.

https://www.alberta.ca/drug-benefit-list-and-drug-review-process.aspx

UPDATES TO THE ALBERTA DRUG BENEFIT LIST

EFFECTIVE NOVEMBER 1, 2019

Table of Contents Special Authorization ...................................................................................................................................... 1

Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit / Special Authorization ...................................................................................................................... 1

Added Product(s) ....................................................................................................................................... 1

New Established Interchangeable (IC) Grouping(s) .................................................................................. 1

Least Cost Alternative (LCA) Price Change(s) .......................................................................................... 2

Product(s) with a Price Change ................................................................................................................. 2

Discontinued Listing(s) ............................................................................................................................... 2

Part 2 Drug Additions .............................................................................................................................. 2-1

Part 3 Special Authorization .................................................................................................................... 3-1


EFFECTIVE NOVEMBER 1, 2019 1

Special Authorization The following drug product(s) will be considered for coverage by Special Authorization for patients covered under Alberta government-sponsored drug programs.

Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit / Special Authorization

Trade Name / Strength / Form Generic Description DIN MFR

JAMP ITRACONAZOLE 10 MG / ML ORAL SOLUTION

ITRACONAZOLE 00002484315 JPC

TEVA-ALMOTRIPTAN 12.5 MG TABLET ALMOTRIPTAN MALATE 00002434849 TEV

Added Product(s) Trade Name / Strength / Form Generic Description DIN MFR

ACCEL-ONDANSETRON 4 MG TABLET ONDANSETRON HCL DIHYDRATE 00002478927 ACP

ACCEL-ONDANSETRON 8 MG TABLET ONDANSETRON HCL DIHYDRATE 00002478935 ACP

ATROPINE 1 % OPHTHALMIC SOLUTION ATROPINE SULFATE 00002023695 PSL

JAMP CLINDAMYCIN 150 MG CAPSULE CLINDAMYCIN HCL 00002483734 JPC

JAMP CLINDAMYCIN 300 MG CAPSULE CLINDAMYCIN HCL 00002483742 JPC

JAMP-PREGABALIN 300 MG CAPSULE PREGABALIN 00002436019 JPC

METHADONE HYDROCHLORIDE 10 MG / ML ORAL LIQUID

METHADONE HCL 00002481979 SDZ

MINT-OLANZAPINE 2.5 MG TABLET OLANZAPINE 00002410141 MPI

MINT-OLANZAPINE 5 MG TABLET OLANZAPINE 00002410168 MPI

MINT-OLANZAPINE 7.5 MG TABLET OLANZAPINE 00002410176 MPI



RAN-CEFPROZIL 25 MG / ML ORAL SUSPENSION

CEFPROZIL 00002329204 RAN

RAN-CEFPROZIL 50 MG / ML ORAL SUSPENSION

CEFPROZIL 00002293579 RAN

New Established Interchangeable (IC) Grouping(s) The following IC Grouping(s) have been established and LCA pricing will be applied effective December 1, 2019.

Generic Description Strength / Form New LCA Price ATROPINE SULFATE 1 % OPHTHALMIC SOLUTION 0.5490

ITRACONAZOLE 10 MG / ML ORAL SOLUTION 0.6167

METHADONE HCL 10 MG / ML ORAL LIQUID 0.1125


2 EFFECTIVE NOVEMBER 1, 2019

Least Cost Alternative (LCA) Price Change(s) The following established IC Grouping(s) are affected and a revised LCA price has been established. Groupings affected by a price change, will be effective December 1, 2019.

Please review the online Alberta Drug Benefit List at https://www.ab.bluecross.ca/dbl/idbl_main1.php for further information.

Generic Description Strength / Form New LCA Price BUPRENORPHINE HCL / NALOXONE HYDROCHLORIDE DIHYDRATE

2 MG / 0.5 MG SUBLINGUAL TABLET 1.3350

Product(s) with a Price Change The following product(s) had a Price Change. The previous higher price will be recognized until November 30, 2019. For products within an established IC Grouping, the LCA price may apply.


ACT BUPRENORPHINE / NALOXONE 2 MG / 0.5 MG SUBLINGUAL TABLET

BUPRENORPHINE HCL/ NALOXONE HYDROCHLORIDE DIHYDRATE

00002453908 APH

BRENZYS 50 MG / SYRINGE INJECTION ETANERCEPT 00002455323 SSB

BRENZYS (AUTO INJECTOR) 50 MG / SYRINGE INJECTION

ETANERCEPT 00002455331 SSB

PMS-AZITHROMYCIN 600 MG TABLET AZITHROMYCIN 00002261642 PMS

PMS BUPRENORPHINE / NALOXONE 2 MG / 0.5 MG SUBLINGUAL TABLET


00002424851 PMS

Discontinued Listing(s) Notification of discontinuation has been received from the manufacturer(s). The Alberta government-sponsored drug programs previously covered the following drug product(s). Effective November 1, 2019, the listed product(s) will no longer be a benefit and will not be considered for coverage by Special Authorization. A transition period will be applied and, as of December 1, 2019 claims will no longer pay for these product(s).


APO-NAPROXEN 125 MG TABLET NAPROXEN 00000522678 APX

APO-RABEPRAZOLE 10 MG ENTERIC-COATED TABLET

RABEPRAZOLE SODIUM 00002345579 APX

APO-SOLIFENACIN 10 MG TABLET SOLIFENACIN SUCCINATE 00002423383 APX

ERYTHRO-S 250 MG TABLET ERYTHROMYCIN STEARATE 00000545678 AAP

GD-CELECOXIB 200 MG CAPSULE CELECOXIB 00002291983 TEV

TEVA-ATENOLTHALIDONE 50 MG / 25 MG TABLET

ATENOLOL/ CHLORTHALIDONE 00002302918 TEV

TEVA-ATENOLTHALIDONE 100 MG / 25 MG TABLET

ATENOLOL/ CHLORTHALIDONE 00002302926 TEV

TEVA-LISINOPRIL (TYPE P) 10 MG TABLET LISINOPRIL 00002285088 TEV

TEVA-TRAVOPROST Z 0.004% OPHTHALMIC SOLUTION

TRAVOPROST 00002412063 TEV

https://www.ab.bluecross.ca/dbl/idbl_main1.php

Drug A

dditions

PART 2

Drug Additions

ALBERTA DRUG BENEFIT LIST UPDATE

2 .

ALMOTRIPTAN MALATE

ATROPINE SULFATE

AZITHROMYCIN


CEFPROZIL

CLINDAMYCIN HCL

12.5 MG (BASE) ORAL TABLET

1 % OPHTHALMIC SOLUTION

600 MG ORAL TABLET

2 MG (BASE) * 0.5 MG (BASE) ORAL SUBLINGUAL TABLET

25 MG / ML ORAL SUSPENSION

50 MG / ML ORAL SUSPENSION

150 MG (BASE) ORAL CAPSULE

300 MG (BASE) ORAL CAPSULE

00002466821000023984430000240533400002434849

0000202369500000035017

00002261642

000024539080000242485100002295695

00002329204

00002293579

00002245232000024369060000248373400002241709

00002245233000024369140000248374200002241710

ALMOTRIPTANMYLAN-ALMOTRIPTANSANDOZ ALMOTRIPTANTEVA-ALMOTRIPTAN

ATROPINEISOPTO ATROPINE

PMS-AZITHROMYCIN

ACT BUPRENORPHINE/NALOXONEPMS-BUPRENORPHINE/NALOXONESUBOXONE

RAN-CEFPROZIL

RAN-CEFPROZIL

APO-CLINDAMYCINAURO-CLINDAMYCINJAMP CLINDAMYCINTEVA-CLINDAMYCIN

APO-CLINDAMYCINAURO-CLINDAMYCINJAMP CLINDAMYCINTEVA-CLINDAMYCIN

SNSMYPSDZTEV

PSLALC

PMS

APHPMSIUK

RAN

RAN

APXAURJPCTEV

APXAURJPCTEV

2.3478 2.3478 2.3478 2.3478

0.5490 0.7320

10.6652

1.3350 1.3350 2.7261

0.1649

0.3294

0.2217 0.2217 0.2217 0.2217

0.4434 0.4434 0.4434 0.4434

1 EFFECTIVE NOVEMBER 1, 2019UNIT OF ISSUE - REFER TO PRICE POLICY

$$$$

$$

$

$$$

$

$

$$$$

$$$$

RESTRICTED BENEFIT - This product is a benefit when prescribed by a Specialist in Infectious Diseases or a designated prescriber.

(Refer to Section 3 - Criteria for Special Authorization of Select Drug Products of the Alberta Drug Benefit List for eligibility when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber.)

RESTRICTED BENEFIT - This product is a benefit for patients 18 to 64 years of age inclusive for the treatment of acute migraine attacks in patients where other standard therapy has failed. (Refer to Criteria for Special Authorization of Select Drug Products of the List for eligibility in patients 65 years of age and older, and Criteria for Special Authorization of Select Drug Products in the Alberta Human Services Drug Benefit Supplement for eligibility in Alberta Human Services clients.)

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.


2 .PRODUCT IS NOT INTERCHANGEABLE

ITRACONAZOLE

METHADONE HCL

OLANZAPINE

10 MG / ML ORAL SOLUTION

10 MG / ML ORAL LIQUID




2.5 MG ORAL TABLET

5 MG ORAL TABLET

7.5 MG ORAL TABLET

0000248431500002231347

0000248197900002394596

0000248197900002394618

00002241377

00002244290

000022817910000241724300002410141000023728190000238586400002303116000023103410000227671200002229250

000022818050000241725100002410168000023728270000238587200002303159000023103680000227672000002229269

000022818130000241727800002410176000023728350000238588000002303167000023103760000227673900002229277

JAMP ITRACONAZOLESPORANOX

METHADONE HYDROCHLORIDEMETHADOSE

METHADONE HYDROCHLORIDEMETHADOSE SUGAR FREE

METADOL CONCENTRATE

METADOL-D

APO-OLANZAPINEJAMP OLANZAPINE FCMINT-OLANZAPINEOLANZAPINEOLANZAPINEPMS-OLANZAPINESANDOZ OLANZAPINETEVA-OLANZAPINEZYPREXA



JPCJAI

SDZMAL

SDZMAL

PAL

PAL

APXJPCMPISNSSIVPMSSDZTEVLIL



0.6167 0.8222

0.1125 0.1500

0.1125 0.1500

0.4059

0.1500

0.1772 0.1772 0.1772 0.1772 0.1772 0.1772 0.1772 0.1772 1.8894

0.3544 0.3544 0.3544 0.3544 0.3544 0.3544 0.3544 0.3544 3.7791

0.5316 0.5316 0.5316 0.5316 0.5316 0.5316 0.5316 0.5316 5.6685


$$

$$

$$

$

$

$$$$$$$$$

$$$$$$$$$

$$$$$$$$$

RESTRICTED BENEFIT - This product is a benefit when prescribed by a Specialist in Infectious Diseases or a designated prescriber.

(Refer to Section 3 - Criteria for Special Authorization of Select Drug Products of the Alberta Drug Benefit List for eligibility when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber.)



2 .

OLANZAPINE

ONDANSETRON HCL DIHYDRATE

10 MG (BASE) ORAL TABLET

15 MG ORAL TABLET



000022818210000241728600002410184000023728430000238589900002303175000023103840000227674700002229285

000022818480000241729400002410192000023728510000238590200002303183000023103920000227675500002238850

0000247892700002288184000024588100000229634900002313685000023717310000230525900002297868000024178390000242140200002258188000022743100000237609100002213567

0000247893500002288192000024588020000229635700002313693000023717580000230526700002297876000024178470000242141000002258196000022743290000237610500002213575



ACCEL-ONDANSETRONAPO-ONDANSETRONCCP-ONDANSETRONCO ONDANSETRONJAMP-ONDANSETRONMAR-ONDANSETRONMINT-ONDANSETRONMYLAN-ONDANSETRONNAT-ONDANSETRONONDANSETRONPMS-ONDANSETRONSANDOZ ONDANSETRONSEPTA-ONDANSETRONZOFRAN

ACCEL-ONDANSETRONAPO-ONDANSETRONCCP-ONDANSETRONCO ONDANSETRONJAMP-ONDANSETRONMAR-ONDANSETRONMINT-ONDANSETRONMYLAN-ONDANSETRONNAT-ONDANSETRONONDANSETRONPMS-ONDANSETRONSANDOZ ONDANSETRONSEPTA-ONDANSETRONZOFRAN



ACPAPXCELAPHJPCMARMPIMYPNTPSNSPMSSDZSEPNOV

ACPAPXCELAPHJPCMARMPIMYPNTPSNSPMSSDZSEPNOV

0.7088 0.7088 0.7088 0.7088 0.7088 0.7088 0.7088 0.7088 7.5582

1.0631 1.0631 1.0631 1.0631 1.0631 1.0631 1.0631 1.0631

11.3373

3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720 3.2720

14.5480

4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930 4.9930

22.2030


$$$$$$$$$

$$$$$$$$$

$$$$$$$$$$$$$$

$$$$$$$$$$$$$$



2 .PRODUCT IS NOT INTERCHANGEABLE

PREGABALIN300 MG ORAL CAPSULE

0000239429400002436019000023596420000240373000002405598000023928600000239086800002361248

APO-PREGABALINJAMP-PREGABALINPMS-PREGABALINPREGABALINPREGABALINRAN-PREGABALINSANDOZ PREGABALINTEVA-PREGABALIN

APXJPCPMSSIVSNSRANSDZTEV

0.4145 0.4145 0.4145 0.4145 0.4145 0.4145 0.4145 0.4145


$$$$$$$$


Special Authorization

PART 3

Special Authorization

CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS ALBERTA DRUG BENEFIT LIST UPDATE

ALMOTRIPTAN MALATE

AZITHROMYCIN

12.5 MG (BASE) ORAL TABLET

600 MG ORAL TABLET

00002466821000023984430000240533400002434849

00002261642

ALMOTRIPTANMYLAN-ALMOTRIPTANSANDOZ ALMOTRIPTANTEVA-ALMOTRIPTAN

PMS-AZITHROMYCIN

SNSMYPSDZTEV

PMS

2.3478 2.3478 2.3478 2.3478

10.6652


$$$$

$

.3

(Refer to Section 1 - Restricted Benefits of the Alberta Drug Benefit List for coverage of the product when prescribed by a Specialist in Infectious Diseases or a designated prescriber.)

"For the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection or other immunocompromised conditions.

Special authorization may be granted for 6 months."*

*Special Authorization is only required when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber.

The following product(s) are eligible for auto-renewal.

(Refer to 28:32.28 of the Alberta Drug Benefit List for coverage of patients 18 to 64 years of age inclusive.)

"For the treatment of acute migraine attacks in patients 65 years of age and older where other standard therapy has failed."

"For the treatment of acute migraine attacks in patients 65 years of age and older who have been using almotriptan malate prior to turning 65."

"Special authorization for both criteria may be granted for 24 months."

In order to comply with the first criteria, information is required regarding previous medications utilized and the patient's response to therapy.

The following product(s) are eligible for auto-renewal.



PRODUCT IS NOT INTERCHANGEABLE

ETANERCEPT50 MG / SYR INJECTION SYRINGE

00002455323 BRENZYS SSB 241.0000


$

.3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

Rheumatoid Arthritis

***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.

Additionally, patients will not be permitted to switch between etanercept products, if the patient has been previously trialed on any etanercept product and deemed unresponsive to therapy.***

"Special authorization coverage may be provided for use in combination with methotrexate for the reduction in signs and symptoms of severely active Rheumatoid Arthritis (RA) in adult patients (18 years of age or older) who are refractory or intolerant to:

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4-month trial). [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND- Leflunomide (minimum 10 week trial at 20 mg daily).

Special authorization coverage of this agent may be provided for use as monotherapy in adult patients for whom methotrexate is contraindicated and/or for those patients who have experienced serious adverse effects.

'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above.'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments asdefined in product monographs.

For coverage, this drug must be initiated by a Specialist in Rheumatology ("RA Specialist").

- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 8 weeks, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response.2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;


ETANERCEPT

3 EFFECTIVE NOVEMBER 1, 2019UNIT OF ISSUE - REFER TO PRICE POLICY .3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or - Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Rheumatoid Arthritis must be completedusing the Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027).

Ankylosing Spondylitis



"Special authorization coverage may be provided for the reduction in the signs and symptoms of severely active Ankylosing Spondylitis, as defined by the Modified New York criteria for Ankylosing Spondylitis, in adult patients (18 years of age or older) who have active disease as demonstrated by:

- a BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apart AND- a Spinal Pain VAS of greater than or equal to 4 cm (on a 0-10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND- who are refractory or intolerant to treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses.



- Initial coverage may be approved for 50 mg per week for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed at week 12 by an RA Specialist after the initial twelve weeks of therapy to determine response.2) The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:- Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND - Reduction of the Spinal Pain VAS by 2 cm or more.



ETANERCEPT

00002455331 BRENZYS (AUTO INJECTOR) SSB 241.0000


$


Following this assessment, continued coverage may be approved for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by an RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

All requests (including renewal requests) for etanercept for Ankylosing Spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028).

Rheumatoid Arthritis









For continued coverage beyond 8 weeks, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response.2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place];


ETANERCEPT


AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or - Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."


Ankylosing Spondylitis










ETANERCEPT

00002462869 ERELZI SDZ 241.0000


$





Rheumatoid Arthritis:

***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.

In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.







- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.


ETANERCEPT


- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.




Polyarticular Juvenile Idiopathic Arthritis:




"Special authorization coverage may be provided for the reduction in signs and symptoms of severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 4 years of age and older who:- Have 5 or more active joints (defined by either swelling or limitation of motion plus pain and/or tenderness), AND



ETANERCEPT

8 EFFECTIVE NOVEMBER 1, 2019 .3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

- Are refractory to one or more disease modifying anti-rheumatic agents (DMARDS) conventionally used in children (minimum three month trial).

"Refractory" is defined as one or more of the following: lack of effect, serious adverse effects (e.g., leukopenia, hepatitis) or contraindications to treatments as defined in the product monographs.

For coverage, this drug must be prescribed by a prescriber affiliated with a Pediatric Rheumatology Clinic in Edmonton or Calgary (Pediatric Rheumatology Specialist).

- Coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due toserious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage of this agent beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed by a Pediatric Rheumatology Specialist after 12 weeks, but no longer than 16 weeks after, treatment with this biologic agent to determine response.2) The Pediatric Rheumatology Specialist must confirm in writing that the patient is a responder thatmeets the following criteria (ACR Pedi 30):- 30% improvement from baseline in at least three of the following six response variables, with worsening of 30% or more in no more than one of the six variables. The variables include:i. global assessment of the severity of the disease by the Pediatric Rheumatology Specialist,ii. global assessment of overall well-being by the patient or parent,iii. number of active joints (joints with swelling not due to deformity or joints with limitation of motion with pain tenderness or both),iv. number of joints with limitation of motion,v. functional ability based on CHAQ scores,vi. ESR or CRP3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request

Following this assessment, continued coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly, for a maximum of twelve months. After twelve months, in order to be considered for continued coverage, the patient must be re-assessed every twelve months by a Pediatric Rheumatology Specialist and must meet the following criteria:1) The patient has been assessed by a Pediatric Rheumatology Specialist to determine response, and2) The Pediatric RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by maintenance of the ACR Pedi 30,3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.

Once a child with pJIA has had two disease-free years, it is common clinical practice for drug treatment to be stopped."

All requests (including renewal requests) for etanercept for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011).

Ankylosing Spondylitis:

***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel


ETANERCEPT


and are considered a 'responder' as defined in criteria.











Psoriatic Arthritis

***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment



ETANERCEPT


of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.



"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).




- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy. - Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 8 weeks, the patient must meet the following criteria: 1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response. 2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria: - ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or


ETANERCEPT

00002462850 ERELZI (SENSOREADY AUTO INJECTOR) SDZ 241.0000


UNIT OF ISSUE - REFER TO PRICE POLICY

$


- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).










- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from anakinra to other biologic agents except under



ETANERCEPT


exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.








"Special authorization coverage may be provided for the reduction in signs and symptoms of severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 4 years of age and older who:- Have 5 or more active joints (defined by either swelling or limitation of motion plus pain and/or tenderness), AND- Are refractory to one or more disease modifying anti-rheumatic agents (DMARDS) conventionally used in children (minimum three month trial).


For coverage, this drug must be prescribed by a prescriber affiliated with a Pediatric Rheumatology


ETANERCEPT


Clinic in Edmonton or Calgary (Pediatric Rheumatology Specialist).

- Coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due toserious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.







In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a



ETANERCEPT


'responder' as defined in criteria.










Psoriatic Arthritis


In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be


ETANERCEPT


assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.


"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).






Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."



ETANERCEPT

00002274728 ENBREL AMG 401.5400


$













For continued coverage beyond 8 weeks, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response.


ETANERCEPT


2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.







"Special authorization coverage may be provided for the reduction in signs and symptoms of severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 4 years of age and older who:- Have 5 or more active joints (defined by either swelling or limitation of motion plus pain and/or tenderness), AND- Are refractory to one or more disease modifying anti-rheumatic agents (DMARDS) conventionally used in children (minimum three month trial).


For coverage, this drug must be prescribed by a prescriber affiliated with a Pediatric Rheumatology Clinic in Edmonton or Calgary (Pediatric Rheumatology Specialist).

- Coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to



ETANERCEPT


serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.





Psoriatic Arthritis:




"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis


ETANERCEPT


in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).






Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."



***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel



ETANERCEPT


will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.











Plaque Psoriasis:

***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid


ETANERCEPT


Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.



"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating plaque psoriasis in patients who:- Have a total PASI of 10 or more and a DLQI of more than 10, OR- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND- Who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR- Cyclosporine (6 weeks treatment); AND- Phototherapy (unless restricted by geographic location)

Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage being considered.


For coverage, this drug must be prescribed by a Specialist in Dermatology ("Dermatology Specialist").

-Initial coverage may be approved for up to 100 mg per week for 12 weeks.-Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 12 weeks, the patient must meet all of the following criteria:1) The patient must be assessed by a Dermatology Specialist after the initial 12 weeks of therapy todetermine response.2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:- Greater than or equal to 75% reduction in PASI score, OR- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI

Following this assessment, continued coverage may be considered for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting



ETANERCEPT

ITRACONAZOLE

10 MG / ML ORAL SOLUTION

0000248431500002231347

JAMP ITRACONAZOLESPORANOX

JPCJAI

0.6167 0.8222


$$

.3

(Refer to Section 1 - Restricted Benefits of the Alberta Drug Benefit List for coverage of the product when prescribed by a Specialist in Infectious Diseases or a designated prescriber.)

"For the treatment of oral and/or esophageal candidiasis in immunocompromised patients who are intolerant to fluconazole, or who have failed fluconazole as evidenced by significant clinical deterioration due to the fungal infection during a course of therapy or no resolution after a full course of therapy."*

*Special Authorization is only required when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber.


criteria as outlined in (2) above."

PASI and DLQI scores are required for all requests for Plaque Psoriasis including those requests for patients that have significant involvement of the face, palms, soles of feet or genital region.

All requests (including renewal requests) for etanercept for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).

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