Health Newsflash a Quarterly Publication

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1 The Drug Evaluation Committee (DEC) of ESI Canada conducts monthly reviews of all new drugs receiving their Notice of Compliance from Health Canada, to ascertain their place in therapy and their possible impact on the private payer sector. The prices quoted in this document are approximations for general information purposes only, and are not intended, nor should they be relied upon, for purposes of any actual claims adjudication or reimbursement. This publication, describing new drugs of significance, is provided to our customers on a quarterly basis as a value-added service. We hope that you will find this Health Newsflash informative, timely, and useful. NEW DRUGS Eliquis (apixaban) Oral tablet mg Bristol Myers Squibb Canada 20: Anticoagulants Eliquis (apixaban) is indicated for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective knee or hip replacement surgery. The recommended dose of Eliquis is 2.5 mg taken orally twice daily starting hours after surgery. In patients undergoing hip replacement surgery: The recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery: The recommended duration of treatment is 10 to 14 days. Xarelto (rivaroxaban); Pradax (dabigatran); Low Molecular Weight Heparins (e.g., Fragmin). Eliquis (apixaban) is an activated factor X (FXa) inhibitor (similar to Xarelto [rivaroxaban]). It has been approved in Europe for use in prevention of VTE after total joint (hip and knee) replacement surgery. A recently completed phase III trial in AF patients (ARISTOTLE) showed a significant reduction in risk of stroke compared to warfarin while another (AVERROES) showed a significant reduction in the risk of stroke compared to aspirin in patients unable to take warfarin. With a similar mechanism of action to Xarelto, Eliquis offers an alternative to both traditional treatments using LMWH and newer anticoagulants such as Xarelto and Pradax for prevention of venous thromboembolism following total joint replacement surgery.

2 Page 2 Eliquis Xarelto Pradax Unit price $2.20/2.5mg tablet $9.35/10mg tablet Cost of course of treatment $1.69/75mg capsule $1.69/110mg capsule $1.69/150mg capsule $44 - $167 $130 - $330 $35 - $120 Impact/ Plan Management Suggestions Minimal impact cost shift. Recommend that product be listed similar to other oral anticoagulants. Intravenous injection Halaven (eribulin mesylate) Eisai Limited 0.5mg/ml 10:00.00 Antineoplastic agents Halaven is for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting. The recommended dose of Halaven is 1.4 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. s are adjusted downwards based on liver and kidney function. Preferred single agents (National Comprehensive Cancer Network [NCCN] Guidelines): Anthracyclines (doxorubicin, epirubicin); Taxanes (paclitaxel, docetaxel); Anti-metabolites (capecitabine, gemcitabine); Microtubule inhibitors (vinorelbine). Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai. It attaches to a protein in cells called tubulin, which is important in the formation of the internal skeleton that cells need to assemble when they divide. By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells. The pivotal phase 3 trial of eribulin (EMBRACE) showed a significantly prolonged overall survival (OS) in patients randomized to eribulin of an average of 13.1 months compared to treatment of physicians choice (which included the therapeutic alternatives listed above for the most part) of an average of 10.6 months.

3 This drug represents a new option for heavily pretreated metastatic breast cancer patients and is the only drug so far to show OS benefit in this patient population. Note: closest comparator, vinorelbine, is covered by Cancer Care Ontario s New Drug Funding Program and is on the BC Cancer Agency Benefit Drug List as a Class I benefit. Halaven vinorelbine (generic) Estimated annual cost Price not available $6,000 Indeterminate impact. Health Newsflash a Quarterly Page 3 Intravenous solution mg/ml Feraheme (ferumoxytol) Takeda Canada Inc 20:04.04 Iron preparations Feraheme is indicated for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). The initial recommended dose is 510 mg IV injection followed by a second 510 mg IV injection 2 to 8 days later. Venofer (iron sucrose); Ferrlecit (sodium ferric gluconate). Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the ironcarbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin. Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. It is more effective in increasing hemoglobin levels in patients with all stages of CKD than oral treatment; however, there has been no direct comparison with other parenteral iron preparations.

4 Health Newsflash a Quarterly Feraheme Venofer Ferrlecit Unit cost Price not available $7.91/ml $5.19/ml Minimal impact. Manage as a hospital drug product similar to other intravenous iron preparations. Page 4 Capsule for Inhalation µg Onbrez Breezhaler (indacaterol maleate) Novartis Pharmaceuticals Canada 12:12.08 Beta-adrenergic agonist Onbrez Breezhaler is indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The recommended dosage of Onbrez Breezhaler is the once-daily inhalation of the contents of one 75 mcg Onbrez capsule using the Breezhaler inhaler. Spiriva (tiotropium) Handihaler; SereVent (salmeterol) Diskus; Oxeze (formoterol) Turbuhaler; Foradil (formoterol) Aerolizer. Effective bronchodilation is an important part of the management of patients with chronic obstructive pulmonary disease (COPD) and can improve breathlessness and ability to undertake physical activities. Onbrez (indacaterol) is a new once-daily, long-acting inhaled bronchodilator, which is an ultra-long-acting Beta Agonist (LABA), for COPD. Note that all reported trials used µg per day dosing of indacaterol. At this dose the drug was shown to have a fast onset of bronchodilator effect measurable within 5 minutes of the first dose and provide improvements in lung function and COPD symptoms equivalent or superior to 12-hour LABAs and once daily tiotropium. Onbrez would be a reasonable first choice for maintenance bronchodilator therapy after attempting to use short acting agents and may be particularly useful for those patients who continue to experience breathlessness.

5 Page 5 Onbrez Breezhaler Foradil Aerolizer SereVent Diskus Unit cost $2.25/capsule $0.80/ 12µg capsule $56/60 dose Diskus Monthly cost $67.50 $48 - $96 $56 Minimal impact. List similar to comparable COPD therapies (e.g., LABAs). Tablet mg mg Resotran (prucalopride succinate) Janssen Inc 56:32.00 Prokinetic agents Resotran (prucalopride succinate) is indicated for the treatment of chronic idiopathic constipation in adult female patients in whom laxatives failed to provide adequate relief. The dosage of Resotran is one 2mg tablet taken once daily. Men: The safety and efficacy of Resotran for use in men has not been established in controlled clinical trials therefore Resotran is not recommended for use in men until further data becomes available. Elderly (>65 years): Start with one 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily. Various traditional laxatives available OTC. Resotran (prucalopride) is a highly selective serotonin (5-HT4) receptor agonist. It has a similar mechanism of action to cisapride and tegaserod, which were both withdrawn from the marketplace due to cardiovascular side effects. The 5-HT4 receptor is present in the gastrointestinal tract. Simulation of these receptors produces initiation of peristaltic and secretory reflexes. Studies have shown that prucalopride accelerates gastric emptying, small bowel transit, overall colon transit, and ascending colonic emptying in patients with function constipation. Based on indications and the Rome III diagnostic algorithms, Resotran could be used in patients with confirmed primary functional constipation (ruling out other organic disorders and obstructions) that is refractory to a high-fibre diet and traditional laxatives, who are being considered for further physiological bowel testing (e.g., anorectal manometry, rectal balloon expulsion, colon transit studies).

6 Page 6 Resotran Ratio-Lactulose Lax-A-Day Unit cost $2.27/ 1mg tablet $3.48/2mg tablet $0.0145/ml $0.0533/g Monthly cost $68 - $104 $ $26 $27 Minimal impact. Do not list due to inadequate safety and efficacy data and availability of many less expensive nonprescription alternatives. Tablet mg mg Caprelsa (vandetanib) Astra Zeneca Canada Inc. 10:00.00 Antineoplastic agents Caprelsa (vandetanib) is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. The recommended daily dose of vandetanib is 300 mg daily. No alternative available. Medullary thyroid cancer (MTC) is a tumour of the calcitonin-producing parafollicular or C cells of the thyroid and comprises 2-3% of all thyroid cancers. The incidence of thyroid cancer is 20:100,000. Vandetanib is an oral receptor tyrosine kinase inhibitor that has been shown to provide clinical benefit to patients with metastatic MTC. A phase III RCT in unresectable, locally advanced, or metastatic MTC showed vandetanib to increase progressionfree survival (PFS) when compared to placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69, P<0.001). Overall survival data are not yet available. Health Canada Advisories issued on Feb 13, : Caprelsa can prolong the QTc interval and cases of Torsade de Pointes and sudden deaths were reported in clinical trials. Caprelsa is only available through a Restricted Distribution Program. Only prescribers enrolled in the Caprelsa Restricted Distribution Program can prescribe Caprelsa. In order to prescribe Caprelsa, physicians are required to complete mandatory online training which includes a full description of important safety issues, patient screening and selection criteria, dosage and administration guidelines, ECG and electrolyte monitoring requirements, drug interaction information, and an overview of the patient enrolment process.

7 Caprelsa (vandetanib) is the only pharmacologic agent indicated for use in unresectable locally advanced or metastatic MTC. Pricing not available. No comparators available. Health Newsflash a Quarterly Indeterminate impact. Restricted distribution will minimize risk of inappropriate use. Yervoy (ipilimumab) Page 7 Intravenous injection mg/ml Bristol Myers Squibb Canada 10:00.00 Antineoplastic agents Yervoy (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease. The recommended dose of Yervoy is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of four doses. Proleukin (aldesleukin, interleukin-2, hospital); dacarbazine (off-label, hospital); Temodal (temozolomide, off-label) [all NCCN Category 2A except Yervoy, which is Category 1]. Yervoy (ipilimumab is a monoclonal antibody directed to the immune checkpoint receptor termed cytotoxic T lymphocyte antigen-4 (CTLA-4). A phase III trial showed significantly improved overall survival (OS) with ipilimumab. Another phase III trial showed that ipilimumab was effective in combination with dacarbazine compared to dacarbazine alone in improving OS. Yervoy can cause severe and fatal immune-mediated adverse reactions such as enterocolitis, hepatitis, dermatitis, neuropathy, and endocrinopathy which usually manifest during treatment. Ipilimumab has been demonstrated to improve overall survival in previously-treated (with dacarbazine, temozolomide, fotemustine, carboplatin, or interleukin-2) and untreated patients with unresectable or metastatic melanoma.

8 Page 8 Yervoy Proleukin Unit cost Price not available $515/22Million Unit Vial Estimated cost for one course of treatment Price not available $27,520* * drug must be administered on inpatient basis in hospital Indeterminate impact. Tablet /-; 2/2; 2/3; 1/- Natazia (estradiol valerate/dienogest) Bayer Inc. 68:12.00 Contraceptives Visanne (dienogest) is indicated for the management of pelvic pain associated with endometriosis. One tablet daily. Other combination oral contraceptives. Natazia is a four-phasic combination oral contraceptive (COC). The estrogen in Natazia is estradiol valerate, a synthetic prodrug of 17ß-estradiol. The progestin in Natazia is dienogest (DNG). DNG displays properties of 19- nortestosterone derivatives as well as properties associated with progesterone derivatives. COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. This formulation was shown to produce reduced menstrual (withdrawal) bleeding compared to other forms of contraception, although intracyclic bleeding was the similar. Natazia has been shown to be an effective COC, although it may not be the best choice for younger first time pill users due to the need for consistent pill taking and the more complex missed pill regime. It has an additional benefit of reduction of heavy menstrual bleeding and may be preferable in this population.

9 Page 9 Natazia Ortho 7/7/7 Portia Estimated monthly cost Price not available $18.50 $9.75 Minimal impact. Minimal impact cost shift from more expensive drugs with labeled indication; therefore, it is recommended that this drug be listed similar to other therapies for endometriosis. Extended-release tablet mg Fampyra (fampridine) Biogen Idec Canada Inc. 92:00.00 Miscellaneous therapeutic agents Fampyra (fampridine) sustained release tablets are indicated for the symptomatic improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 3.5-7). The recommended dose of Fampyra sustained release tablets is one 10 mg tablet twice daily. None. In MS, an autoimmune response with an unknown trigger causes inflammation, damaging white matter within the brain and spinal cord. Over the course of the disease, the damaged areas become scarred and hardened. In fact, plaque formation is the hallmark sign of the disease. Plaque forms on the myelin sheath of neurons, causing demyelination and interrupting normal nerve impulses and transmission. The disturbances in nerve conduction lead to the primary symptoms of MS, such as visual complaints, ataxia, and gait instability. The mechanism by which fampridine exerts its therapeutic effect has not been fully elucidated. Fampridine is a broad spectrum potassium channel blocker that decreases the outflow of potassium ions from the potassium channels of demyelinated neurons. This antagonist action allows demyelinated neurons to carry the electrical impulse, increasing neuronal signaling and conduction, which decreases locomotor difficulty In animal tissue preparations, fampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels. Fampyra is indicated only for symptomatic improvement in walking in MS patients affected by gait impairment. Fampyra has no effects on MS disease progression. A u g. 24,

10 Page 10 Fampyra Unit cost 10mg: $9.32 Monthly cost $560 No comparators available Intermediate impact. Manage with Prior Authorization to ensure appropriate drug utilization. Extended-release tablet mg mg Toviaz (fesoterdine) Pfizer Canada Inc 86:12.00 Genitourinary smooth muscle relaxants Toviaz is indicated for the treatment of patients with overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence, or any combination of these symptoms. The recommended starting dose of Toviaz is 4 to 8mg once daily. Oxybutynin; Detrol (tolterodine); Trosec (trospium); Vesicare (solifenacin); Enablex (darifenacin). Toviaz (fesoterodine) is a competitive muscarinic receptor antagonist. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects. Two trials compared 8mg of fesoterodine to 4mg tolterodine ER and found greater efficacy of fesoterodine at the cost of increased side effects such as dry mouth and constipation and higher treatment discontinuations. Toviaz is indicated in adults for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Fesoterodine-treated patients demonstrated significant improvements compared with placebo in the number of micturitions/24 hours, mean number of urgency urinary incontinence, and treatment response, while the 8 mg fesoterodine group had significant improvement over the 4 mg group for urgency urinary incontinence, and treatment response according to pooled data from 2 randomized, fixed-dose, double-blind, phase 3 trials of 1674 adults.

11 Page 11 Toviaz Apo-Oxybutynin Detrol LA Unit cost Price not available $0.14/tablet $1.92/capsule Monthly cost Price not available $ $16.80 $58 Indeterminate impact. Oral tablet mg Zelboraf (vemrafenib) Hoffmann La Roche Limited 10:00.00 Antineoplastic agents Zelboraf (vemurafenib) is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status (e.g., cobas 4800 BRAF V600 Mutation Test). The recommended dose of Zelboraf (vemurafenib) is 960 mg (four 240 mg tablets) twice daily. Yervoy (ipilimumab); Proleukin (aldesleukin, interleukin-2, hospital); dacarbazine (off-label, hospital); Temodal (temozolomide, off-label) [all NCCN Category 2A except Yervoy, Zelboraf are Category 1. Vemurafenib is a low molecular weight, inhibitor of the activated form of the BRAF serine-threonine kinase enzyme. Mutations in the BRAF gene result in constitutive activation of the BRAF kinase, which may promote overactive signalling and cell proliferation in the absence of typical growth factors. As a selective inhibitor of oncogenic BRAF, vemurafenib suppresses downstream signalling through the mitogen-activated protein kinase (MAPK) pathway. The best characterized substrate of BRAF is MEK. BRAF activates MEK by phosphorylation (pmek), which in turn phosphorylates and activates ERK (perk). perk translocates into the nucleus where it activates transcriptional factors responsible for stimulating cell proliferation and cell survival. In vitro preclinical studies demonstrated that vemurafenib inhibits MEK and ERK phosphorylation and activation, and consequently suppresses cellular proliferation in tumour cells expressing mutated BRAF V600 proteins. The phase III trials demonstrated a median progression-free survival of 5.3 months with vemurafenib treatment compared to 1.6 months in the dacarbazine comparator group. Vemurafenib has the potential for significant dermatologic complication including cutaneous squamous cell carcinoma and extreme photosensitivity. Patients should be carefully monitored for the development of other adverse reaction such as joint pain and swelling.

12 Vemurafenib is a BRAF serine-threonine kinase inhibitor with antitumor effects and is indicated for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Vemurafenib is not to be used in patients with wild-type BRAF melanoma. Health Newsflash a Quarterly Zelboraf Yervoy Unit cost $49/240mg tablet Price not available Monthly cost $11,800 Price not available Intermediate impact. Manage with Prior Authorization to ensure appropriate drug utilization. NEW FORMULATION Page 12 Tablet mg mg mg Nucynta (tapendol) Janssen Inc 28:08.08 Opiate agonists Nucynta (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. s above 600 mg a day are not recommended. Tramacet (tramadol/acetaminophen); [immediate release opioid agonists (e.g., Dilaudid, OxyIR, etc.). Tapentadol is a centrally-acting synthetic analgesic believed to exert its analgesic activity by binding to mu-opioid receptors and inhibiting norepinephrine reuptake. It has the potential advantage of reduced gastrointestinal side effects. Tapentadol is recommended to be classified as a narcotic in Canada and can lead to addiction. 1 Nucynta (tapentadol hydrochloride) immediate release is indicated for the treatment of moderate to severe acute pain in adults.

13 Page 13 Nucynta IR Nucynta CR Apo-Tramadol/ Acetaminophen Estimated daily cost $6.00-$9.00 $1.00-$3.60 $5.00 Estimated monthly cost $ $ $ $ $ Minimal Impact. Tablet mg mg Xarelto (rivaroxaban) Bayer Inc 20: Anticoagulants New Indication: prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate. New indication: treatment of deep vein thrombosis (DVT) without symptomatic pulmonary emoblism (PE). Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation: The recommended dose is 20mg once daily. Treatment of deep vein thrombosis (DVT): The recommended dose for patients initiating treatment of DVT is 15 mg of Xarelto twice daily for 3 weeks (one 15 mg tablet in the morning and one in the evening with food), followed by 20 mg of Xarelto once daily for the continued treatment of DVT. warfarin; Pradax (dabigatran). Xarelto (rivaroxaban) is a highly selective, direct, antithrombin independent Factor-Xa inhibitor with high oral bioavailability which is used as an oral anticoagulant. Xarelto 10mg received NOC in September 2008 for prevention of VTE in patients who have undergone elective total joint replacement surgery of the hip or knee. The new indication for prevention of stroke or systemic embolism is based on data from the ROCKET-AF Trial, which showed rivaroxaban to be non-inferior to warfarin for reducing risk of the primary outcome with a lower risk of bleeding. Recommended doses are higher for this new indication. Xarelto is an oral anticoagulant that is indicated for reduction of risk of stroke and systemic embolism in patients with atrial fibrillation and for prevention of venous thromboembolic events in patients who have undergone total hip or knee replacement surgery. Routine laboratory coagulation monitoring is not required with this drug.

14 Page 14 Xarelto Pradax Warfarin Unit Price $2.95/tablet $1.70/tablet $0.11-$0.30/tablet Minimal impact. NEW INDICATION Intravenous injection mg/4ml mg/10ml mg/20ml Actemra (tocilizumab) Hoffmann-La Roche Limited. 92: Disease-Modifying Antirheumatic Agents Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non-steroidal anti-inflammatory drugs and systemic corticosteroids. Systemic Juvenile Idiopathic Arthritis: Actemra can be used alone or in combination with MTX. The recommended dose of Actemra for patients with sjia given once every two weeks as an IV infusion over 1 hour is: 8 mg/kg for patients 30 kilograms (kgs), 12 mg/kg for patients < 30 kilograms (kgs). Enbrel (etanercept) Actemra (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor that binds specifically to both the soluble and membranebound IL-6 receptors. It has been shown to inhibit IL-6 mediated signaling via these receptors. IL-6 is involved in processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts as well as by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. IL-1 (e.g., Kineret (anakinra), Ilaris (canakinumab) which are both investigational for this indication) and IL-6 inhibitors have generally produced better results than TNF-alpha inhibitors (e.g., Enbrel) which seem to deliver variable results.

15 Page 15 Systemic Juvenile Idiopathic Arthritis: Tocilizumab is indicated as monotherapy or in combination with methotrexate for the treatment of active systemic juvenile idiopathic arthritis in children age 2 years and older. Efficacy was established in a 12-week, randomized, double-blind study (n=112). Actemra Enbrel Impact Intermediate impact Unit cost 80mg/4ml: $ mg/10ml: $ mg/20ml: $ mg/ml Vial: $192 Cost for one month $1,200 $500 Intravenous injection mg/ml Avastin (bevacizumab) Hoffmann La Roche Limited 10:00.00 Antineoplastic agents To remove metastatic breast cancer indication. [Other indications remain unchanged: metastatic colorectal cancer; locally advanced, metastatic or recurrent non-small cell lung cancer; glioblastoma] Women who take Avastin for metastatic breast cancer risk potentially life-threatening or serious side effects, such as bleeding and hemorrhaging; heart attack or heart failure; severe blood pressure; and the development of perforations in different parts of the body such as the nose, stomach and intestines. These are the considerable risks of taking Avastin and can be justified only if there is good evidence that the use of the drug will benefit the patient. For some kinds of cancers, Avastin has been shown, by rigorous scientific testing, to provide a benefit that justifies its risks. After reviewing the available studies, however, it is clear that there is no proof of a benefit in breast cancer patients that would justify those risks. Avastin has not been shown to provide a benefit, in terms of delay in tumor growth, that would justify its risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life Avastin is no longer approved for use in metastatic breast cancer. Avastin continues to be indicated for: metastatic colorectal cancer; locally advanced, metastatic or recurrent non-small cell lung cancer; glioblastoma. Potential cost savings for plan sponsors.

16 Page 16 FIRST TIME GENERICS First-Time Generic Drugs (Notices of Compliance from) Generic Name Reference Drug (Brand) Rank by ingredient cost in (2011) Route of Administration Approved Indications bezafibrate Bezalip SR 406 Various Oral High Cholesterol Clopidogrel Plavix 10 Various Oral Prevention of atherothrombotic or thromboembolic events Latanoprost/ Timolol Xalacom 674 Genmed, a division of Ophthalmic Glaucoma losartan/ losartan and hydrochlorothiazide Pfizer Canada Cozaar/Hyzaar 88 Various Oral High Blood pressure meropenem Merrem 619 Various Injection Bacterial Infection Montelukast Singulair 17 Various Oral Asthma, Seasonal allergic rhinitis mycophenolate CellCept 72 Various Oral Prevention of organ rejection after transplant rizatriptan tablets/oral dissolving tablets Maxalt /Maxalt RPD Sirolimus Rapamune 579 Genmed, a division of Pfizer Canada telmisartan/telmisartan and hydrochlorothiazide Micardis /Micardis Plus tolterodine Detrol/Detrol LA 116 Genmed, a division of Pfizer Canada 66 Various Oral Migraines Oral Prevention of renal transplant rejection 65/9 Various Oral High Blood pressure Oral Urinary Incontinence

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