P.E.I. Drug Programs Formulary Update Issue 10-01 June 09, 2010 st Effective July 1, 2010, the following medications will be added to the P.E.I. Drug Formulary. New medications for the treatment of ankylosing spondylitis, psoriatic arthritis, severe rheumatoid arthritis, benign prostatic hyperplasia, wet age related macular degeneration and the prevention and treatment of blood clots have been approved for coverage by the P.E.I. Drug Programs, effective July 1, 2010. High Cost Drug Program The following medications will be covered through the High Cost Drugs Program to patients who meet established clinical criteria. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients or their care givers are to complete a High Cost Drugs Program application and to submit it along with income verification information to the Drug Programs office. This information will be used to calculate the patient s share of the prescription cost. Ranibizumab 2.3mg/ 0.23ml vial (Lucentis-Novartis) For the treatment of the better seeing affected eye for patients with neovascular (wet) age-related macular degeneration (AMD) where all of the following apply to the eye to be treated: Criteria For Initial Coverage (loading dose for 3 consecutive months): a) Best Corrected Visual Acuity (BCVA) is between 6/12 and 6/96 AND b) The lesion size is less than or equal to 12 disc areas in greatest linear dimension AND c) There is evidence of recent (< 3 months) presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, optical coherence tomography (OCT), or recent visual acuity changes. The interval between doses should not be shorter than one month. Administration is to be done by a qualified ophthalmologist experienced in intravitreal injections. Criteria For Continued Coverage: Treatment with ranibizumab should be continued only in people who maintain adequate response to therapy. Ranibizumab should be discontinued if any of the following occur: a) Reduction in BCVA in the treated eye to less than 15 letters (absolute) on 2 consecutive visits in the treated eye, attributed to AMD in the absence of other pathology OR b) Reductions in BCVA of 30 letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect, adverse events, or both OR c) There is evidence of deterioration of the lesion morphology despite optimum treatment over 3 P.E.I. Drug Programs Formulary Update Issue 10-1 Page 1
consecutive visits. Coverage will not be approved for patients : a) Receiving concurrent treatment with verteporfin. b) With permanent retinal damage as defined by the Royal College of Ophthalmology guidelines. Coverage is limited to a maximum of one vial in any 30 day period. Coverage must be renewed every 12 months. The request for coverage must be made by an ophthalmologist, using the standard Special Authorization request form available from the Drug Programs office or online at www.gov.pe.ca. Patients must also apply for coverage through the High Cost Drug Program. The patient application is available from the Drug Programs Office or online at www.gov.pe.ca. Ankylosing Spondylitis Adalimumab 40mg/0.8ml kit (Humira-Abbott) Approvals will be for a maximum dose of 40mg every two weeks. Etanercept 50mg/ml; 25mg/kit (Enbrel-Amgen) Approvals will be for a maximum dose of 50mg per week or 25mg twice weekly. Infliximab 100mg/vial (Remicade-Schering) Approvals will be for a maximum dose of 5mg/kg at 0, 2, and 6 weeks then every 6 to 8 weeks. For the treatment of patients with moderate to severe ankylosing spondylitis ( Bath AS Disease Activity Index (BASDAI) score 4 on 10 point scale who: a) have axial symptoms* and who have failed to respond to the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 3 months observation or in whom NSAIDs are contraindicated OR b) have peripheral symptoms and who have failed to respond to, or have contraindications to, the sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 3 months observation and have had an inadequate response to an optimal dose or maximal tolerated dose of a DMARD. *Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication to axial disease, do not require a trial of NSAIDs alone. Approvals for Ankylosing Spondylitis anti-tnf agents will be for a maximum of six months, and will NOT be considered in combination with other biologic agents. Requests for renewal must include information showing the beneficial effects of the treatment, specifically: a) a decrease of at least two points on the BASDAI scale, compared with pre-treatment score OR b) patient and expert opinion of an adequate clinical response as indicated by a significant functional improvement (measured by outcomes such as Health Assessment Questionnaire (HAQ) or ability to return to work). P.E.I. Drug Programs Formulary Update Issue 10-1 Page 2
The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology, using the Ankylosing Spondylitis Special Authorization request form available from the Drug Programs office or online at www.gov.pe.ca. Patients must also apply for coverage through the High Cost Drug Program. The patient application is available from the Drug Programs Office or online at www.gov.pe.ca. Psoriatic Arthritis Adalimumab 40mg/0.8ml kit (Humira-Abbott) Approvals will be for a maximum dose of 40mg every two weeks. Etanercept 50mg/ml; 25mg/kit (Enbrel-Amgen) Approvals will be for a maximum dose of 50mg per week or 25 mg twice weekly. For the treatment of active psoriatic arthritis in patients who meet the following criteria: a) have at least three active and tender joints AND b) have not responded to an adequate trial with two DMARDs or have an intolerance or contraindication to DMARDs. Approvals for initial coverage of Psoriatic Arthritis anti-tnf agents will be 3 months. Coverage will NOT be considered in combination with other biologic agents. Reassessment for coverage is dependent on patient achieving an improvement in symptoms of at least 20% (ACR20) or response using the Psoriatic Arthritis Response Criteria. The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology, using the Psoriatic Arthritis Special Authorization request form available from the Drug Programs office or online at www.gov.pe.ca. Patients must also apply for coverage through the High Cost Drug Program. The patient application is available from the Drug Programs Office or online at www.gov.pe.ca. Rheumatoid Arthritis Agents Abatacept (Orencia-BMS) For patients with severe active rheumatoid arthritis in combination with DMARDs (when these agents are not contraindicated) who have failed to respond to an adequate trial of an anti-tnf agent. Approved dose- 500mg for patients < 60kg 750mg for patients 60 to 100kg 1000mg for patients > 100kg Coverage will be approved for intervals of every 4 weeks after initial coverage. P.E.I. Drug Programs Formulary Update Issue 10-1 Page 3
Initial coverage may be approved for five doses administered at 0, 2, 4, 8 and 12 weeks. For continued coverage beyond five doses, the patient must meet the following criteria: The patient must be assessed by a rheumatologist after the initial five doses to determine response between 12 and 16 weeks of receiving the initial dose. The rheumatologist must confirm in writing that the patient is a 'responder' and has achieved improvement in symptoms of at least 20% (ACR20). Coverage for Abatacept will NOT be considered for use in combination with other biologic agents. The request for coverage must be made by a rheumatologist or prescriber with a specialty in rheumatology, using the Rheumatoid Arthritis Special Authorization form available from the Drug Programs office or online at www.gov.pe.ca. Patients must also apply for coverage through the High Cost Drug Program. The patient application is available from the Drug Programs Office or online at www.gov.pe.ca. Seniors, Nursing Home, Social Assistance and Family Health Benefit Programs The following medications are available to patients who meet the established clinical criteria and are eligible under one of the following programs - Senior s, Nursing Home, Social Assistance or Family Health Benefit. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Low Molecular Weight Heparins Dalteparin (Fragmin-Pfizer) Enoxaparin (Lovenox-Sanofi-Aventis) For the acute treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) for a maximum of 10 days. For prophylaxis in hip replacement and hip fracture surgery, approval is limited to a maximum of 35 days. For prophylaxis in knee replacement surgery, approval is limited to a maximum of 10 days. For prophylaxis in high risk surgery, approval is limited to maximum of 10 days. The request for coverage must be made using the Low Molecular Weight Heparins Special Authorization request form available from the Drug Programs office or online at www.gov.pe.ca. P.E.I. Drug Programs Formulary Update Issue 10-1 Page 4
Dutasteride 0.5mg capsule (Avodart-GSK) Approval will be for 0.5mg daily. For the treatment of symptomatic Benign Prostatic Hyperplasia (BPH): a) when alpha-blockers are contraindicated, not tolerated, or failed AND b) when an adequate trial of finasteride is contraindicated, failed or not tolerated. Initial coverage is limited to 6 months. Continued coverage requires assessment for adequate response and resubmission of a standard Special Authorization request form. Finasteride 5mg tablet (Proscar-Merck Frosst and generics) Approval will be for 5mg daily. For the treatment of symptomatic Benign Prostatic Hyperplasia (BPH): a) when alpha-blockers are contraindicated, not tolerated, or failed OR b) in combination with an alpha-blocker when alpha-blocker therapy has been tried as monotherapy and a partial response has been observed. Initial coverage is limited to 6 months. Continued coverage requires assessment for adequate response and resubmission of a standard Special Authorization request form. All of the new medications will require the patient s medical condition to meet established clinical criteria before coverage will be approved. Physicians must submit a completed Special Authorization (Exceptional Drug) form to the Drug Programs office before coverage will be considered. Medications covered through the High Cost Drugs Program will also require patients or their care givers to complete a High Cost Drugs Program application and to submit it along with income verification information to the Drug Programs office. This information will be used to calculate the patient s share of the prescription cost. Copies of the forms may be obtained by contacting the Drug Programs office or online at.: http://www.gov.pe.ca/health/index.php3?number=1033111&lang=e A copy of the clinical application forms are enclosed with this bulletin. P.E.I. Drug Programs Formulary Update Issue 10-1 Page 5
DINS Added to Formulary Abatacept 250 mg vial 02282097 Orencia Adalimumab 40mg/0.8 ml kit 02258595 Humira Dutasteride 0.5mg capsule 02247813 Avodart Etanercept (Enbrel) 50mg/ml vial 02274728 Enbrel 25mg/kit 02242903 Enbrel Finasteride * 5 mg tablet 02010909 Proscar 02306905 Ratio-Finasteride 02322579 Sansoz-Finasteride 02348500 Novo-Finasteride st *Please note that the above drugs are interchangeable and are listed at a MAC price of 0.9728, effective July 1, 2010. They will appear in the next MAC listing. Infliximab 100mg/vial 02244016 Remicade SCH Ranibizumab 2.3mg/0.23 ml vial 02296810 Lucentis NPC Please refer to the listing below for billing the following drugs. Dalteparin (Fragmin) DIN Billing Volume Fragmin 10,000iu/0.4ml Pre-Filled Syringe 02132648 0.4ml /syringe Fragmin 12,500iu/0.5ml Pre-Filled Syringe 02132648 0.5ml /syringe Fragmin 15,000iu/0.6ml Pre-Filled Syringe 02132648 0.6ml /syringe *Fragmin 18,000iu/0.72ml Pre-Filled Syringe 02132648 0.8ml /syringe Fragmin 5,000iu/0.2ml Pre-Filled Syringe 02132648 0.2ml /syringe Fragmin 7,500iu/0.3ml Pre-Filled Syringe 02132648 0.3ml /syringe Fragmin 10,000iu/1ml Amp (1ml) 02132664 1ml /amp Fragmin 2,500iu/0.2ml Pre-Filled Syringe 02132621 0.2ml /syringe P.E.I. Drug Programs Formulary Update Issue 10-1 Page 6
Fragmin 25,000iu/1ml Multidose Vial (3.8ml) 02231171 3.8ml /vial * Rounded to 0.8ml per syringe due to software limitations. Enoxaparin (Lovenox) Lovenox HP 120mg/0.8ml Pre-Filled Syringe 02242692 0.8ml /syringe SAN Lovenox 100mg/1ml Pre-Filled Syringe 02236883 1ml /syringe Lovenox 150mg/1ml Pre-Filled Syringe 02242692 1ml /syringe Lovenox 40mg/0.4ml Pre-Filled Syringe 02236883 0.4ml /syringe Lovenox 80mg/0.8ml Pre-Filled Syringe 02236883 0.8ml /syringe Lovenox 30mg/0.3ml Pre-Filled Syringe 02012472 0.3ml /syringe Lovenox 60mg/0.6ml Pre-Filled Syringe 02236883 0.6ml /syringe Lovenox 100mg/1ml Vial (3ml) 02236564 3ml /vial P.E.I. Drug Programs Formulary Update Issue 10-1 Page 7