PEI Drug Programs Formulary Update Issue 09-01 February 20, 2009 New medications for the treatment of cancer, chronic obstructive pulmonary disease (COPD), osteoporosis, and HIV/AIDS have been approved for coverage by the PEI Drug Programs, effective March 1, 2009. Coverage of all of the new medications have been approved based on recommendations made by the Atlantic Expert Advisory Committee, the Canadian Expert Drug Advisory Committee, or the Joint Oncology Drug Review. The new medications will be covered through a combination of the Family Health Benefit, Financial Assistance, High Cost Drugs, HIV/AIDS, Nursing Home, and Seniors Programs. Most 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 application form may be obtained by contacting the Drug Programs office or online at: www.gov.pe.ca/forms/pdf/1160.pdf. High Cost Cancer Medications The following cancer medications will be covered through the High Cost Drugs Program to patients who meet the established clinical criteria. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients must also submit a completed High Cost Drugs Program application and income verification information to the Drug Programs Office. Dasatinib (Sprycel) 20 mg, 50 mg, and 70 mg Tablets For use as a single agent for the treatment of adults with chronic, accelerated or blast phase chronic myelogenous leukemia (CML) and Philadelphia chromosome acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy including imatinib. Erlotinib (Tarceva) 25 mg, 100 mg, and 150 mg Tablets For use as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen and whose EGFR expression status is positive or unknown. Fludarabine (Fludara) 10 mg Tablets For the treatment of chronic lymphocytic leukemia (CLL) in patients with an ECOG performance status of 0 to 2 when the patient has failed to respond to, or relapsed during/ after previous therapy with an alkylating agent and intravenous administration is not desirable. PEI Drug Programs Update - Issue 09-01- Page 1
Sorafenib (Nexavar) 200 mg Tablets 1. For use as a single agent second line treatment in patients with documented evidence of histologically confirmed advanced or metastatic clear cell renal cell carcinoma, considered to be intermediate or low risk (according to Memorial Sloan-Kettering (MSKCC) prognostic score, see below), have an ECOG performance status of 0 or 1 and progressed after prior cytokine therapy (or intolerance) within the previous 8 months. In any one patient all of the following conditions must be met: Sorafenib may be a second line option only after cytokine therapy. Sorafenib may not be used after another tyrosine kinase inhibitor (i.e., sunitinib) as sequential therapy. In the event of severe toxicity within the first 8 weeks of therapy, a switch to another tyrosine kinase inhibitor (i.e., sunitinib) may be allowed. 2. For use in patients with Child-Pugh Class A advanced hepatocellular carcinoma, who have progressed on trans-arterial chemoembolization (TACE) or are not suitable for the TACE procedure, and have an ECOG performance status of 0 to 2. Renewal of coverage requires no further progression of the patient s disease as evidenced by radiological or scan results. Copies of the results must accompany the Special Authorization. Sunitinib (Sutent) 12.5 mg, 25 mg, and 50 mg Capsules 1. For use as a single agent first line treatment in patients with documented evidence of histologically confirmed advanced or metastatic clear cell renal cell carcinoma who have an ECOG performance status of 0 or 1. In any one patient all of the following conditions must be met: Sunitinib may be a first line option. Sunitinib may not be used after another tyrosine kinase inhibitor (i.e., sorafenib) as sequential therapy. In the event of severe toxicity within the first 8 weeks of therapy, a switch to another tyrosine kinase inhibitor (i.e., sorafenib) may be allowed. 2. For use as a single agent for the treatment of advanced gastrointestinal stromal tumor (GIST) patients after failure of imatinib due to intolerance or resistance. Adjunctive Cancer Medications Coverage of the following adjunctive cancer medications will be provided to patients who meet established clinical criteria and who are eligible for coverage through the Family Health Benefit, Financial Assistance, Seniors, and Nursing Home Programs. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients will be required to pay the normal prescription copays for these programs. Aprepitant (Emend) 80 mg and 125 mg Capsules For use in combination with a 5-HT antagonist and dexamethasone in adult cancer patients treated with 2 chemotherapy that includes cisplatin as a single day therapy greater than or equal to ( ) 70 mg/m to prevent acute and delayed nausea and vomiting. The 5-HT antagonist should only be used on the first day of cisplatin therapy with aprepitant continuing on Days 2 and 3. The dose of dexamethasone may be adjusted due to the increased levels of dexamethasone when combined with aprepitant. Dronabinol (Marinol) 2.5 mg and 5 mg Capsules For the treatment of severe nausea and vomiting associated with cancer chemotherapy in patients who have not been well controlled by standard stepwise antiemetic therapy. PEI Drug Programs Update - Issue 09-01- Page 2
Thyrotropin (Thyrogen) 0.9 mg/ml Injection Solution For use as a single agent in patients who have documented evidence of thyroid cancer, who have undergone appropriate surgical and/or medical management, and require on-going evaluation to monitor for recurrence and metastatic disease. This includes: Primary use in patients with inability to raise an endogenous TSH level ( 25 mu/l) with thyroid hormone withdrawal. Primary use in cases of documented morbidity in patients for whom severe hypothyroidism could be life threatening, such as unstable angina, recent myocardial infarction, class III to IV congestive heart failure, or uncontrolled psychiatric illness. Secondary use in patients with previous thyroid hormone withdrawal resulting in a documented life-threatening event. Medications for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) Coverage of the following medications for the treatment of COPD will be provided to patients who meet established clinical criteria and who are eligible for coverage through the Family Health Benefit, Financial Assistance, Seniors, and Nursing Home Programs. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients will be required to pay the normal prescription copays for these programs. Formoterol Foradil - 12 ug per dose Powder Capsules Oxeze Turbuhaler - 6 ug and 12 ug per dose Powder for Inhalation Formoterol & Budesonide (Symbicort Turbuhaler) 6 ug & 100 ug and 6 ug & 200 ug per dose Powder for Inhalation Salmeterol Servent - 50 ug per dose Aerosol Powder Disk Serevent Diskus 50 ug per dose Powder for Inhalation Salmeterol & Fluticasone Advair 25 ug & 125 ug and 25 ug & 250 ug per dose Inhaler Aerosol Advair Diskus 50 ug & 100 ug, 50 ug & 250 ug, and 50 ug & 500 ug per dose Powder for Inhalation Tiotropium (Spiriva) 18 ug per dose Inhalation Powder Capsule The criteria for coverage of all of the new COPD medications are as follows: 1. For the treatment of mild, moderate, and severe chronic obstructive pulmonary disease (COPD) (i.e. MRC score 2, see below) in patients who continue to be symptomatic after a 3 month trial of ipratropium at a dose of 12 puffs/day and appropriate use of short-acting beta -agonists. 2. For the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) (i.e. MRC score 3 to 5, see below) without a trial of short-acting agents (e.g. ipratropium and beta2-agonists) where spirometry shows moderate to severe airflow obstruction (i.e. FEV1 < 60% predicted and low FEV1/FVC <0.7). A copy of the spirometry report must accompany the Special Authorization. 2 Note: Note: The drug programs will not pay for concurrent use of Tiotropium and Ipratropium. Concurrent use of Tiotropium and Long Acting Beta2-Agonists or Long Acting Beta2-Agonists/Inhaled Corticosteroids will only be considered in patients where FEV1 < 60% predicted and FEV1/FVC <0.7. PEI Drug Programs Update - Issue 09-01- Page 3
Medical Research Council Dyspnea Scale Grade 1 2 3 4 5 Degree of breathlessness related to activities Not troubled by breathlessness except on strenuous exercise Short of breath when hurrying or walking up a slight hill Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace Stops for breath after walking about 100m or after a few minutes on level ground Too breathless to leave the house, or breathless when dressing or undressing Reference: Fletcher C.M. et al. 1959. The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Brit. Med. J. 2:257 66. Medications for the Treatment of Osteoporosis The Special Authorization criteria for the coverage of the Etidronate and Calcium Carbonate (Didrocal and generics) through the Family Health Benefits, Financial Assistance, Nursing Home, and Seniors Programs have been removed. A Special Authorization is no longer needed for the coverage of these products. Patients will be required to pay the normal prescription copays for these programs. Etidronate Disodium & Calcium Carbonate (Didrocal & generics) 400 mg & 1250 mg Tablets (Package) Coverage of Alendronate, Risedronate, and Calcitonin for the treatment of osteoporosis has been approved for patients who meet established clinical criteria and who are eligible for coverage through the Family Health Benefit, Financial Assistance, Nursing Home, and Seniors Programs. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients will be required to pay the normal prescription copays for these programs. Alendronate (Fosamax & generics) 10 mg and 70 mg Tablets 1. For the treatment of osteoporosis in patients with a documented fragility fracture. 2. For use in patients without documented fracture but with a high 10-year fracture risk (see fracture risk tables, see below). A copy of the bone density report, including the T-score, supporting the diagnosis must accompany the Special Authorization. 3. For prophylaxis of corticosteroid induced osteoporosis in patients who will be or have been on systemic corticosteroid therapy for 3 months. Risedronate (Actonel) 5 mg and 35 mg Tablets 1. For the treatment of osteoporosis in patients with a documented fragility fracture. 2. For use in patients without documented fracture but with a high 10-year fracture risk (see fracture risk tables, see below). A copy of the bone density report, including the T-score, supporting the diagnosis must accompany the Special Authorization. 3. For prophylaxis of corticosteroid induced osteoporosis in patients who will be or have been on systemic corticosteroid therapy for 3 months. PEI Drug Programs Update - Issue 09-01- Page 4
Calcitonin (Salmon Synthetic) (Miacalcin & generics) 200 iu per dose Nasal Spray 1. For the treatment of osteoporosis in patients with a documented fragility fracture and when etidronate, alendronate and risedronate are not tolerated or are contraindicated. 2. For use in patients without documented fracture but with a high 10-year fracture risk (see fracture risk tables, see below) and when etidronate, alendronate and risedronate are not tolerated or are contraindicated. A copy of the bone density report, including the T-score, supporting the diagnosis must accompany the Special Authorization. 3. For the short term (up to 3 months) treatment of pain associated with osteoporotic fragility fractures, bone metastases, or pathological fractures. A copy of the radiological or specialist report supporting the diagnosis must accompany the Special Authorization. Fracture Risk Tables Age (years) Low Risk <10% Women 10-Year Risk Moderate Risk 10% - 20% Lowest T-Score Lumbar spine, total hip, femoral neck, trochanter High Risk > 20% 50 > -2.3-2.3 to -3.9 < -3/9 55 > -1.9-1.9 to -3.4 < -3.4 60 > -1.4-1.4 to -3.0 < -3.0 65 > -1.0-1.0 to -2.6 < -2.6 70 > -0.8-0.8 to -2.2 < -2.2 75 > -0.7-0.7 to -2.1 < -2.1 80 > -0.6-0.6 to -2.0 < -2.0 85 > -0.7-0.7 to -2.2 < -2.2 Age (years) Low Risk <10% Men 10-Year Risk Moderate Risk 10% - 20% Lowest T-Score Lumbar spine, total hip, femoral neck, trochanter High Risk > 20% 50 > -3.4 < = -3.4 --- 55 > -3.1 < = -3.1 --- 60 > -3.0 < = 3.0 --- 65 > -2.7 < = -2.7 --- 70 > -2.1-2.1 to -3.9 < -3.9 75 > -1.5-1.5 to -3.2 < -3.2 80 > -1.2-1.2 to -3.0 < -3.0 85 > -1.3-1.3 to -3.3 < -3.3 Reference: Siminoski K. et al. 2005. Recommendations for bone mineral density reporting in Canada. Can. Assoc. Radiol. J. 56:178-88. PEI Drug Programs Update - Issue 09-01- Page 5
Medications for the Treatment of Paget s Disease Coverage of the following medications for the treatment of Paget s Disease have been approved for patients who meet established clinical criteria and who are eligible for coverage through the Family Health Benefit, Financial Assistance, Nursing Home, and Seniors Programs. A completed Special Authorization form must be received by the Drug Programs office before coverage will be considered. Patients will be required to pay the normal prescription copays for these programs. Alendronate (Fosamax & generics) 40 mg Tablets For the treatment of Paget s disease of bone for a maximum 6 month period. A copy of the radiological or specialist report supporting the diagnosis must accompany the Special Authorization. Risedronate (Actonel) 30 mg Tablets For the treatment of Paget s disease of bone for a maximum 2 month period. One additional 2 month course of treatment may be considered after a drug holiday of at least 60 days. A copy of the radiological or specialist report supporting the diagnosis must accompany the Special Authorization. Zoledronic Acid (Aclasta) 5 mg/100 ml Injection Solution For the treatment of Paget s disease of the bone. A copy of the radiological or specialist report supporting the diagnosis must accompany the Special Authorization. HIV/AIDS Medications The following medications have been approved for the coverage through the HIV/AIDS Program. All medications for the HIV/AIDS Program must be filled at the Provincial Pharmacy located in Charlottetown. Dronabinol (Marinol) 2.5 mg and 5 mg Capsules For the treatment of acquired immune deficiency syndrome (AIDS)-related anorexia associated with weight loss. Efavirenz & Embricitabine & Tenofovir (Atripla) Tablets Etravirine (Intelence) 100 mg Tablets Maravirox (Celsentri) 150 mg and 300 mg Tablets Raltegravir (Isentress) 400 mg Tablets The Special Authorization criteria for coverage of Tenofovir and Tenofovir/Embricitabine have been removed. An Special Authorization is no longer needed for the coverage of these products. However, prescription for these medications must be filled at the Provincial Pharmacy. Tenofovir (Viread) 300 mg Tablets Tenofovir & Embricitabine (Truvada) 300 mg & 200 mg Tablets For More Information For more information on PEI Drug Programs or any medications covered by the programs, please contact the Drug Programs office at: Phone: 368-4947 in the Charlottetown area 1-877-577-3737 toll free in PEI Fax: 368-4905 PEI Drug Programs Update - Issue 09-01- Page 6