Updates to the Alberta Drug Benefit List. Effective August 1, 2017

Transcription

1 Updates to the Alberta Drug Benefit List Effective August 1, 2017

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) Website: 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: ( G.S.T.) Contents only: ( G.S.T.) A cheque or money order must accompany the request for copies. ABC 40211/81160 (R2017/08)

3 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Table of Contents Special Authorization... 1 Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorizatiotion... 1 Added Product(s)... 1 Restricted Benefit(s)... 1 New Drug Product(s) Available by Restricted Benefit... 1 Drug Product(s) with Changes to Criteria for Coverage... 1 Least Cost Alternative (LCA) Price Change(s)... 1 Product(s) with a Price Change... 2 Discontinued Listing(s)... 2 Product(s) Removed from the ADBL as Price Policy Requirements Not Satisfied... 3 Part 2 Drug Additions Part 3 Special Authorization EFFECTIVE AUGUST 1, 2017

4 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Special Authorization The following drug product(s) will be considered for coverage by special authorization for patients covered under Alberta government-sponsored drug programs. Criteria for coverage of Alberta Human Services can be found in the August 1, 2017 Alberta Human Services Drug Benefit Supplement. Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorization MAR-MODAFINIL 100 MG TABLET MODAFINIL MAR TEVA-MODAFINIL 100 MG TABLET MODAFINIL TEV Added Product(s) MED-OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL GMP MED-OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL GMP PMS-BETAHISTINE 16 MG TABLET BETAHISTINE DIHYDROCHLORIDE PMS PMS-OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL PMS PMS-OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL PMS Restricted Benefit(s) New Drug Product(s) Available by Restricted Benefit EYLEA 2 MG / VIAL INJECTION AFLIBERCEPT BAI Drug Product(s) with Changes to Criteria for Coverage LUCENTIS 2.3 MG / VIAL INJECTION RANIBIZUMAB NOV 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 Decrease, will be effective September 1, Please review the online Alberta Drug Benefit List at for further information. Generic Description Strength / Form New LCA Price BETAHISTINE DIHYDROCHLORIDE 16 MG TABLET EFFECTIVE AUGUST 1,

5 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Least Cost Alternative (LCA) Price Change(s), continued Generic Description Strength / Form New LCA Price MODAFINIL 100 MG TABLET Product(s) with a Price Change The following product(s) had a Price Decrease. The previous higher price will be recognized until August 31, For products within an established IC Grouping, the LCA price may apply. APO-MODAFINIL 100 MG TABLET MODAFINIL APX ACT BETAHISTINE 16 MG TABLET BETAHISTINE DIHYDROCHLORIDE APH AURO-BETAHISTINE 16 MG TABLET BETAHISTINE DIHYDROCHLORIDE AUR TEVA-BETAHISTINE 16 MG TABLET BETAHISTINE DIHYDROCHLORIDE TEV 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 August 1, 2017, 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 September 1, 2017 claims will no longer pay for these product(s). 292 TABLET CODEINE PHOSPHATE PPH ACT SUMATRIPTAN 50 MG TABLET SUMATRIPTAN SUCCINATE APH CARDIZEM CD 120 MG CONTROLLED-DELIVERY CAPSULE CARDIZEM CD 180 MG CONTROLLED-DELIVERY CAPSULE CARDIZEM CD 240 MG CONTROLLED-DELIVERY CAPSULE CARDIZEM CD 300 MG CONTROLLED-DELIVERY CAPSULE DILTIAZEM HCL VCL DILTIAZEM HCL VCL DILTIAZEM HCL VCL DILTIAZEM HCL VCL 2 EFFECTIVE AUGUST 1, 2017

6 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Product(s) Removed from the ADBL as Price Policy Requirements Not Satisfied The Alberta government-sponsored drug programs previously covered the following drug product(s). Effective August 1, 2017, 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 September 1, 2017 claims will no longer pay for these products. ZAMINE 21 TABLET DROSPIRENONE/ ETHINYL ESTRADIOL APX ZAMINE 28 TABLET DROSPIRENONE/ ETHINYL ESTRADIOL APX EFFECTIVE AUGUST 1,

7 Drug Additions PART 2 Drug Additions

8 ALBERTA DRUG BENEFIT LIST UPDATE AFLIBERCEPT RESTRICTED BENEFIT This Drug Product is a benefit to a member of an Alberta Government Sponsored Drug Plan when the Drug Product is prescribed by a registered prescriber and pursuant to the following criteria: "For the treatment of neovascular (wet) age-related macular degeneration (AMD) if all of the following apply to the eye to be treated: - The best corrected visual acuity (BCVA) is between 6/12 (20/40) and 6/96 (20/320); and - There is active disease activity (choroidal neovascularization) and no permanent structural damage to the central fovea; and - There is evidence of recent (< three (3) months) presumed disease progression (blood vessel growth, as indicated by fluoroscein angiography, optical coherence tomography (OCT) or recent visual acuity changes); and - No concurrent verteporfin PDT treatment; and - The injection will be administered by a qualified ophthalmologist with experience in intravitreal injections. Treatment with anti-vegf agents should be continued only in patients who maintain adequate response to therapy. The anti-vegf agent should be discontinued if any of the following occur: - Reduction in BCVA in the treated eye to less than fifteen (15) letters (absolute) on two (2) consecutive visits in the treated eye, attributed to AMD in the absence of other pathology; or - Reduction in BCVA of thirty (30) letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect or adverse event or both; or - There is evidence of deterioration of the lesion morphology despite optimum treatment over three (3) consecutive visits. The interval between the doses should be no less than 1 month. Coverage will not be provided for patients who have failed to respond to a previous anti- VEGF agent." "For the treatment of diabetic macular edema (DME), in patients with severe visual impairment as defined by: Best-Corrected Visual Acuity (using the Early Treatment Diabetic Retinopathy Study visual acuity test) of seventy-eight (78) to twenty-four (24) letters and a central retinal thickness greater than or equal to three hundred (300) micrometres meeting all of the following criteria: - clinically significant diabetic macular edema for whom laser photocoagulation is also indicated, and - a hemoglobin A1c of less than or equal to 12%. Coverage will not be provided to patients who have failed to respond to a previous anti- VEGF agent." "For the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). Aflibercept is administered by intravitreal injection once every month. The interval between doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Clinical trial experience of a monthly dosing regimen of 2 mg aflibercept beyond 6 months in the CRVO and BRVO indications is limited. The dosing regimen of once every 4 weeks changed, at 24 weeks, to a regimen that allowed for extension of the treatment based on The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 2. 1 EFFECTIVE AUGUST 1, 2017

9 ALBERTA DRUG BENEFIT LIST UPDATE AFLIBERCEPT visual and anatomic outcomes in the CRVO clinical trials and to once every 8 weeks in the BRVO clinical trial. Coverage will not be provided for patients who have failed to respond to a previous anti- VEGF agent." 2 MG / VIAL INJECTION EYLEA BAI BETAHISTINE DIHYDROCHLORIDE 16 MG ORAL TABLET ACT BETAHISTINE AURO-BETAHISTINE PMS-BETAHISTINE TEVA-BETAHISTINE SERC APH AUR PMS TEV BGP OLMESARTAN MEDOXOMIL 20 MG ORAL TABLET ACT OLMESARTAN APO-OLMESARTAN AURO-OLMESARTAN JAMP-OLMESARTAN MED-OLMESARTAN PMS-OLMESARTAN SANDOZ OLMESARTAN OLMETEC 40 MG ORAL TABLET ACT OLMESARTAN APO-OLMESARTAN AURO-OLMESARTAN JAMP-OLMESARTAN MED-OLMESARTAN PMS-OLMESARTAN SANDOZ OLMESARTAN OLMETEC APH APX AUR JPC GMP PMS SDZ MFC APH APX AUR JPC GMP PMS SDZ MFC The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. PRODUCT IS NOT INTERCHANGEABLE 2. 2 EFFECTIVE AUGUST 1, 2017

10 ALBERTA DRUG BENEFIT LIST UPDATE RANIBIZUMAB This Drug Product is a benefit to a member of an Alberta Government Sponsored Drug Plan when the Drug Product is prescribed by a registered prescriber and pursuant to the following criteria: "For the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on ranibizumab treatment. Thereafter patients should be monitored monthly for visual acuity. Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to macular edema secondary to RVO and continued until stable visual acuity is reached again for three consecutive monthly assessments." Coverage will not be provided for patients who have failed to respond to a previous anti- VEGF agent. "For the treatment of diabetic macular edema (DME), in patients with severe visual impairment as defined by: Best-Corrected Visual Acuity (using the Early Treatment Diabetic Retinopathy Study visual acuity test) of seventy-eight (78) to twenty-four (24) letters and a central retinal thickness greater than or equal to three hundred (300) micrometres meeting all of the following criteria: - clinically significant diabetic macular edema for whom laser photocoagulation is also indicated, and - a hemoglobin A1c of less than or equal to 11%." Coverage will not be provided for patients who have failed to respond to a previous anti- VEGF agent. "For the treatment of neovascular (wet) age-related macular degeneration (AMD) in antivascular endothelial growth factor (anti-vegf) treatment naive patients if all of the following apply to the eye to be treated: - The best corrected visual acuity (BCVA) is between 6/12 (20/40) and 6/96 (20/320); and - There is active disease activity (choroidal neovascularization) and no permanent structural damage to the central fovea; and - There is evidence of recent (< three (3) months) presumed disease progression (blood vessel growth, as indicated by fluoroscein angiography, optical coherence tomography (OCT) or recent visual acuity changes); and - No concurrent verteporfin PDT treatment; and - The injection will be administered by a qualified ophthalmologist with experience in intravitreal injections. Treatment with anti-vegf agents should be continued only in patients who maintain adequate response to therapy. The anti-vegf agent should be discontinued if any of the following occur: - Reduction in BCVA in the treated eye to less than fifteen (15) letters (absolute) on two (2) consecutive visits in the treated eye, attributed to AMD in the absence of other pathology; or - Reduction in BCVA of thirty (30) letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect or adverse event or both; or - There is evidence of deterioration of the lesion morphology despite optimum treatment over three (3) consecutive visits." The interval between the doses should be no less than 1 month. The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 2. 3 EFFECTIVE AUGUST 1, 2017

11 ALBERTA DRUG BENEFIT LIST UPDATE RANIBIZUMAB Coverage will not be provided for patients who have failed to respond to a previous anti- VEGF agent. 2.3 MG / VIAL INJECTION LUCENTIS NOV For this product - pricing has been established on a per vial basis. The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. PRODUCT IS NOT INTERCHANGEABLE 2. 4 EFFECTIVE AUGUST 1, 2017

12 Special Authorization PART 3 Special Authorization

13 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS MODAFINIL "For the treatment of documented narcolepsy. This drug product must be prescribed by a specialist in Neurology or Psychiatry, or a sleep specialist affiliated with a recognized level 1 lab. Special authorization may be granted for 6 months." The following product(s) are eligible for auto-renewal. 100 MG ORAL TABLET APO-MODAFINIL MAR-MODAFINIL TEVA-MODAFINIL ALERTEC APX MAR TEV TMP The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 3. 1 EFFECTIVE AUGUST 1, 2017