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Health Newsflash — a Quarterly Publication New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings 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 Colesevelam (colesevelam) Dosage Form Oral tablet DIN & Strength 02373955 – 625mg Manufacturer Genzyme Canada Inc distributed by Valeant Canada AHFS Class 26:06.04 – Bile acid sequestrant Indication(s) *Canadian Product Monograph not available, information from US Prescribing Information for WelChol ® and Valeant Canada press release* Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia either alone or combination therapy with a statin. Dose The recommended adult dose of colesevelam hydrochloride is 1875 mg twice daily or 3750 mg once daily. Therapeutic Alternatives Colestid (colestipol tablets and granules); cholestyramine (powder, generics) Clinical Notes Colesevelam is a bile acid sequestrant used for the treatment of high blood cholesterol. Following oral administration, colesevelam binds bile acids in the intestine, preventing their absorption and resulting in reduction in blood LDL-C levels. Place in Therapy In general, statins (e.g., atorvastatin, simvastatin) are the agents of choice for most patients with high blood cholesterol. Bile acid sequestrants (e.g., colestipol, cholestyramine) are commonly added in resistant patients, or are used alone in patients intolerant of statins. Indirect comparisons suggest that the efficacy of colesevelam monotherapy is similar to or slightly less than that of colestipol or cholestyramine in lowering LDL-C; greater benefit is achieved with all agents when combined with a statin. Adverse effects have been minimal with colesevelam in available studies, suggesting an advantage over colestipol or cholestyramine; however, direct comparisons will ultimately be needed. All prices listed are Ontario prices, unless otherwise indicated. All Express Scripts Canada Book of Business (BOB) data cited is for all of Canada, excluding Québec. Volume14 Issue 1 Jan. 27, 2012

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Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

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

Colesevelam (colesevelam)

Dosage Form Oral tablet

DIN & Strength 02373955 – 625mg

Manufacturer Genzyme Canada Inc distributed by Valeant Canada

AHFS Class 26:06.04 – Bile acid sequestrant

Indication(s) *Canadian Product Monograph not available, information from US Prescribing Information for WelChol® and Valeant Canada press release* Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia either alone or combination therapy with a statin. Dose The recommended adult dose of colesevelam hydrochloride is 1875 mg twice daily or 3750 mg once daily. Therapeutic Alternatives Colestid (colestipol tablets and granules); cholestyramine (powder, generics) Clinical Notes Colesevelam is a bile acid sequestrant used for the treatment of high blood cholesterol. Following oral administration, colesevelam binds bile acids in the intestine, preventing their absorption and resulting in reduction in blood LDL-C levels. Place in Therapy In general, statins (e.g., atorvastatin, simvastatin) are the agents of choice for most patients with high blood cholesterol. Bile acid sequestrants (e.g., colestipol, cholestyramine) are commonly added in resistant patients, or are used alone in patients intolerant of statins. Indirect comparisons suggest that the efficacy of colesevelam monotherapy is similar to or slightly less than that of colestipol or cholestyramine in lowering LDL-C; greater benefit is achieved with all agents when combined with a statin. Adverse effects have been minimal with colesevelam in available studies, suggesting an advantage over colestipol or cholestyramine; however, direct comparisons will ultimately be needed. All prices listed are Ontario prices, unless otherwise indicated. All Express Scripts Canada Book of Business (BOB) data cited is for all of Canada, excluding Québec.

Volume14 I ssue 1

Jan. 27,

2012

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

Jan. 27,

2012

Comparative Pricing

Colesevelam 625mg Tablets Colestid 1g Tablets

Estimated monthly cost Price not available $18 - $144

Impact Impact not determined. Plan Management Suggestions None at this time.

Saphris (asenapine)

Dosage Form Sublingual tablet

DIN & Strength 02374803 – 5mg 02374811 – 10mg

Manufacturer Merck Canada Inc.

AHFS Class 28:16.08 - Antipsychotics

Indication(s) Saphris (asenapine) sublingual tablet is indicated for the treatment of schizophrenia, for the acute treatment of manic or mixed episodes associated with bipolar I disorder. For bipolar disorder, Saphris may be used as alone or in combination with lithium or divalproex sodium. Dose The recommended dose of Saphris is 5 to 10mg twice daily. Therapeutic Alternatives For both schizophrenia and bipolar mania or mixed states: chlorpromazine, fluphenazine, haloperidol, loxapine, perphenazine,;aripiprazole (Abilify), clozapine, olanzapine, paliperidone (Invega), quetiapine, risperidone, ziprasidone (Zeldox). Clinical Notes Saphris (asenapine) is an atypical antipsychotic with mixed serotonin-dopamine antagonist activity. The addition of serotonin antagonism to dopamine antagonism is thought to improve negative symptoms of psychoses and reduce the incidence of extrapyramidal side effects as compared to other antipsychotics. There are indications that asenapine may lower risk of weight gain compared to other atypical antipsychotics. Place in Therapy Saphris is an atypical antipsychotic agent that has demonstrated efficacy for the acute treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Some commonly used atypical antipsychotics (e.g. olanzapine, quetiapine, risperidone) are available in generics, and there is a small number of clinical studies evaluating the comparative efficacy and safety of asenapine vs. olanzapine or haloperidol.

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Comparative Pricing

Saphris Abilify Invega Zeldox

olanzapine (generic)

Estimated monthly cost

$120 $125 - $200 $160 - $320 $107 - $336 $38 - $223

Impact/Plan Management Suggestions Minimal impact – priced in line with other branded atypical antipsychotics. Recommend listing similar to other atypical antipsychotics.

Samsca (tolvaptan)

Dosage Form Oral tablet

DIN & Strength 02370468 – 15mg 02370476 – 30mg 02370484 – 60mg*

Manufacturer Otsuka Pharmaceutical Co. Ltd.

AHFS Class 40:28.00 - Diuretics

* Strength not marketed Indication(s) Samsca (tolvaptan) is indicated for the treatment of clinically important, non-hypovolemic hyponatremia, e.g., serum sodium < 130 mEq/L, or symptomatic hyponatremia. Dose The usual starting dose for Samsca is 15 mg administered once daily and maximum dose is 60mg once daily. Treatment initiation requires observation and monitoring by a physician and is recommended to take place in a hospital. Dose is individualized depending on results and blood sodium levels. Therapeutic Alternatives No available alternative drug therapies in Canada. Clinical Notes Samsca (tolvaptan) is an orally administered, nonpeptide, selective arginine vasopressin V2 receptor antagonist that increases free water clearance, thereby correcting low serum sodium levels. Activation of V2 receptors in the distal nephron increases water permeability in the collecting duct, resulting in passive reabsorption of water due to the high osmolarity in the interstitium of the renal medulla. Antagonism of arginine vasopressin at the V2 receptor increases urinary excretion of free water (aquaresis). Place in Therapy Samsca provides an additional treatment option for individuals with clinically significant hypervolemic or euvolemic hyponatremia, including patients with Syndrome of Inappropriate Antidiuretic Hormone, heart failure, or cirrhosis which can be used in the outpatient setting. Comparative Pricing No drug comparators available in Canada

Volume14 I ssue 1

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Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Page 3

Samsca

Dose 15 – 60mg/day

Estimated cost per day $263.75 - $527.50

Estimated annual cost $96,269 - $192,538

Impact/Plan Management Suggestions Intermediate impact – high estimated yearly cost with low disease prevalence. Recommend that drug be managed with use of Prior Authorization to insure cost effective use of drug to labeled indication.

Visanne (dienogest)

Dosage Form Tablet

DIN & Strength 02374900 – 2mg

Manufacturer Bayer Inc.

AHFS Class 68:32.00 - Progestins

Indication(s) Visanne (dienogest) is indicated for the management of pelvic pain associated with endometriosis. Dose The dosage of Visanne is one 2mg tablet taken once daily. Therapeutic Alternatives GnRH agonists: Zoladex; Lupron; Synarel (GnRH agonists officially indicated for endometriosis); Combination oral contraceptives (various types, off-label); Mirena (levonorgestrel intrauterine system, off-label) Clinical Notes Endometriosis is defined as the occurrence of endometrial tissue outside the uterus, which induces a chronic inflammation. Typical symptoms include pelvic pain, painful menstruation, painful sexual intercourse, bladder and bowel symptoms, and infertility. Endometriosis is a relatively common disorder estimated to be experienced by one in ten women during their reproductive years. Visanne (dienogest) is a synthetic oral progestogen with unique pharmacological properties, it is highly selective for the progesterone receptor. Place in Therapy Dienogest, in a daily dose of 2 mg, has been shown to be significantly better than placebo in relieving pelvic pain and dysmenorrhea related to endometriosis and as effective as GnRH agonist therapy in relieving pain associated with endometriosis. Dienogest appeared to have fewer adverse effects such as hot flashes, insomnia, and vaginal dryness than the GnRH agonists, and, in particular, did not produce clinically significant reductions in bone mineral density significant androgenic effects. Comparative Pricing

Visanne Zoladex LA Lupron Depot

Synarel Nasal Spray

Estimated 6-month cost

$348 $2,300 $2,206 $228

Volume14

I ssue 1

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Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

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Impact/Plan Management Suggestions 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.

NEW FORMULATION

OxyNEO (oxycodone)

Dosage Form Controlled release tablets

DIN & Strength 02372525 – 10mg 02372533 – 15mg 02372797 – 20mg 02372541 – 30mg 02372568 – 40mg 02372576 – 60mg 02372584 – 80mg

Manufacturer Purdue Pharma

AHFS Class 28:08.08 – Opiate agonists

Indication(s) OxyNEO™ (oxycodone hydrochloride controlled release tablets) is indicated for the relief of moderate to severe pain requiring the continuous use of an opioid analgesic preparation for several days or more. Dose Individual dosing requirements vary considerably based on each patient's age, weight, severity and cause of pain, and medical and analgesic history. For patients who have not previously received opioid analgesics the starting dose is 10 or 20 mg every 12 hours. Therapeutic Alternatives OxyContin; Kadian, M-Eslon, MS Contin; Hydromorph Contin; Jurnista Clinical Notes Oxycodone (dihydrohydroxycodeine) is a semi-synthetic opioid analgesic with pharmacologic properties similar to those of morphine. Oxycodone, like other opioids, can relieve pain and produce other effects such as anxiolysis, euphoria, feelings of relaxation, respiratory depression, and constipation. OxyNEO is a reformulated version of OxyContin, designed to reduce intentional abuse or misuse of the product. Studies have shown OxyNEO to be bioequivalent to equivalent doses of OxyContin. OxyNEO tablets have been hardened through heat-treatment recrystallization technology to reduce the risk of being broken, crushed or chewed. The drug is contained within a matrix of polyethylene oxide polymer which forms a viscous gel upon contact with water preventing its extraction with alcohol and also preventing its abuse through injection or snorting. Even when crushed, tablet fragments have been shown to retain controlled-release properties. Place in Therapy This new formulation of controlled-release oxycodone is intended to replace OxyContin, while reducing the

likelihood of abuse or accidental misuse. Patent expiry of OxyContin is expected to occur around the end of 2012.

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

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Comparative Pricing

OxyNEO OxyContin

Estimated daily cost $1.88 to $9.00 $1.32 to $9.00

Estimated monthly cost $55.40 - $270 $40.00 - $270

Impact/Plan Management Suggestions Minimal impact – cost shift from OxyContin which has similar pricing. Recommend listing similar to OxyContin.

Durela (tramadol)

Dosage Form Extended-release capsule

DIN & Strength 02373017 – 100mg 02373025 – 200mg 02373033 – 300mg

Manufacturer Cipher Pharmaceutical

AHFS Class 28:08.08 – Opiate agonists

Indication(s) *Canadian Product Monograph not available, information from US Prescribing Information* Durela™ (tramadol hydrochloride extended-release capsules) is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the clock treatment of their pain for an extended period of time.

Dose Durela is an extended-release formulation and is taken 100 to 300mg once a day

Therapeutic Alternatives Ralivia, Tridural, Zytram XL – tramadol extended release tablets

Clinical Notes Durela is a once-daily capsule formulation of tramadol, which has both immediate-release and extended-release components. Tramadol is a centrally acting synthetic opioid analgesic.

Place in Therapy Durela is an alternative to other extended release tramadol products for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of pain for an extended period of time.

Comparative Pricing

Strength Durela Ralivia Tridural Zytram XL

75mg $0.88

100mg Price not available $1.26 $1.21 $1.15

150mg $1.69

200mg Price not available $2.30 $2.22 $2.22

300mg Price not available $3.34 $3.22 $3.22

400mg $4.22

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Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

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Impact/Plan Management Suggestions Indeterminate impact. Plan management recommendations not currently available.

NEW DRUG COMBINATION

Complera (rilpivirine/emtricitabine/tenofovir)

Dosage Form Tablet

DIN & Strength 02374129 – 25/200/300mg

Manufacturer Gilead Sciences Canada, Inc.

AHFS Class 08:18.08 - Antiretrovirals

Indication(s) Complera™ (emtricitabine/rilpivirine/tenofovir) is indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naive adults. Dose The recommended dose of Complera is one tablet taken once daily Therapeutic Alternatives Atripla (efavirenz/emtricitabine/tenofovir) Clinical Notes Rilpivirine is a non-nucleoside reverse transcriptase inhibitor, emtricitabine, is a nucleotide reverse transcriptase inhibitor and tenofovir, is a nucleotide reverse-transcriptase inhibitor. This combination of three drugs is used to prevent the replication of the HIV-1 virus. Place in Therapy The combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (Emtricitabine and tenofovir) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine) is indicated as a complete regimen to treat HIV-1 infection in antiretroviral treatment-naive adults. Comparative Pricing

Complera Atripla

Unit Price $41.78/tablet $42.40/tablet

Monthly Cost $1,254 $1,300

Impact/Plan Management Suggestions Minimal impact – cost shift from similarly priced alternative. List similar to other HIV medications (e.g., Atripla).

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

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Page 7

NEW INDICATION

Lucentis (ranibizumab)

Dosage Form Solution for intravitreal injection

DIN & Strength 02296810 – 10mg/ml

Manufacturer Novartis Pharmaceuticals Canada Inc.

AHFS Class 52:92.00 – EENT Drugs, Miscellaneous

Indication(s) For - the treatment of visual impairment due to diabetic macular edema (DME). - the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). [Original indication unchanged: For the treatment of neovascular (wet) age-related macular degeneration (AMD).] Dose The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses should not be shorter than 1 month. Treatment is continued until maximum visual acuity is achieved. Therapeutic Alternatives Diabetic macular edema: laser focal photocoagulation (preferred); intravitreal triamcinolone injection (off-label generic im injection or Triesence®); off-label Avastin Retinal vein occlusion: laser photocoagulation (preferred for branch RVO, 2nd line for central RVO); intravitreal triamcinolone injection (off-label generic im injection; Triesence®); Ozurdex intravitreal implant; off-label Avastin Clinical Notes Each new indication was approved on the basis of two clinical trials each. Treatment of visual impairment due to DME: This indication was based on results of the RESOLVE and RESTORE trials. These trials showed positive improvement in visual acuity and central retinal thickness with ranibizumab over both sham intravitreal injections and laser treatments. Treatment of visual impairment due to macular edema secondary to RVO: This indication was approved based on the results of the BRAVO (for branch RVO) and CRUISE (for central RVO) trials. Both showed significant improvements in visual acuity with the use of ranibizumab over sham intravitreal injections. Place in Therapy Anti-VEGF agents such as Lucentis (ranibizumab) are developing into potential mainstays in the medical treatment of ophthalmic conditions involving neovascularization such as neovascular (wet) AMD, DME, and macular edema due to central and branch RVO.

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

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Comparative Pricing

Lucentis Triesence Ozurdex Intravitreal Implant*

Generic Triamcinolone Acetonide injection†

Unit cost $360/dose Price not available

$1,366/implant $0.50/dose

Cost of one course of treatment

$1,100 (3 injections)

Price not available

$1,366 §

* indicated for CRVO only † off-label use and administration § effect is transient, continuous treatment may be required Impact Minimal impact.

Botox (botulinum toxin A, onabotulinumtoxin A)

Dosage Form Intramuscular injection

DIN & Strength 01981501 – 100unit/vial

Manufacturer Allergan

AHFS Class 92:00.00 – Miscellaneous therapeutic agents

Indication(s)

1. Prophylaxis of headaches in adults with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

2. For the treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury in adults who had an inadequate response to or are intolerant of anticholinergic medications.

Dose 1. The recommended dose for chronic migraine prophylaxis is 155 units total as 5 units (0.1 mL) IM into

specific head/neck muscle areas. Retreatment is recommended every 12 weeks. 2. Neurogenic detrusor overactivity: The recommended dose is 200 Units of Botox.

Therapeutic Alternatives 1. Topiramate, beta-blockers (propranolol, metoprolol, timolol); amitriptyline; valproic acid 2. None

Clinical Notes Onabotulinumtoxin A blocks neuromuscular conduction by binding to receptor sites on motor nerve terminals. When injected intramuscularly at therapeutic doses, Botox produces partial chemical denervation of the muscle resulting in localized muscle paralysis.

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

Jan. 27,

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Page 9

Place in Therapy 1. Patient selection appears to be a key to the successful use of the toxin in headache management.

Patients who do not use concurrent preventive medications, and those who have had relatively short disease duration, may benefit the most from the drug. Botox’s long duration of action and favorable adverse effect profile make it particularly suitable for patients who are not compliant with the daily intake of oral headache preventive drugs. Using Botox for suitable headache patients earlier in the course of their disease, rather than as a last resort, may result in better treatment outcomes.

2. Intradetrusor injection of Botox improves symptoms of urinary incontinence and quality of life scores in patients with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis with long lasting benefit (average 42 weeks).

Comparative Pricing

Botox Topiramate

Cost per treatment/cost per day $700/treatment $0.83/day

Estimated cost per Year $3,000 $305

Impact/Plan Management Suggestions Minimal impact. Manage with use of Prior Authorization to insure appropriate utilization of drug.

NEW BRAND/STRENGTH/INDICATION

Certican (everolimus)

Dosage Form Tablet

DIN & Strength 02375907 – 0.25mg 02375915 – 0.5mg 02375923 – 0.75mg

Manufacturer Novartis Pharmaceuticals Canada Inc.

AHFS Class 92:44.00 – Immunosuppressants

Indication(s) *Canadian Product Monograph not available at time or writing, information from US Prescribing Information for Zortress®* Prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant.

Dose An initial everolimus dose of 0.75 mg orally twice daily is recommended for adult kidney transplant patients with dose adjustments based on everolimus blood concentrations achieved, tolerability, individual response, change in concomitant medications and the clinical situation.

Therapeutic Alternatives Rapamune (sirolimus)

Clinical Notes Certican (everolimus) is a macrolide immunosuppressant. Everolimus inhibits the activation and proliferation of T and B lymphocytes and forms an immunosuppressive complex in cells.

Volume14 I ssue 1

Jan. 27,

2012

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Page 10

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

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2012

Place in Therapy Similar to sirolimus (rapamycin), everolimus is indicated primarily for use with cyclosporine/steroids to prevent acute rejection episodes in renal transplant recipients. Everolimus offers an advantage over sirolimus for oral administration due to less variation of pharmacokinetic parameters, and it is easier to administer. Despite these advantages, studies comparing everolimus to sirolimus are lacking. Efficacy in available studies has been determined by comparing different doses of the drug to mycophenolate mofetil. Note: Everolimus is currently available as Afinitor (2.5, 5, 10mg), indicated for the treatment of metastatic renal cell carcinoma. Comparative Pricing

Certican Rapamune

Unit cost Price not available $8

Estimated annual cost Price not available $6,000

Impact/Plan Management Suggestions Indeterminate impact. Plan management recommendations not currently available.

Efracea (doxycycline)

Dosage form Extended Release Capsule

DIN & Strength 02375885 – 40mg

Manufacturer Galderma Canada Inc

AHFS Class 08:12.24 - Tetracyclines

Indication(s) *Canadian Product Monograph not available, information from US Prescribing Information for Oracea®* Efracea (doxycycline) is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Dose 40mg once daily. Therapeutic Alternatives tetracycline; Minocin (minocycline) Clinical Notes Efracea contains doxycycline, which is a member of the tetracycline class of antibiotic drugs. Since no definitive microbial cause of rosacea has been identified, the efficacy of oral antibiotics in rosacea is often attributed to their anti-inflammatory properties. The plasma concentrations of doxycycline achieved with Efracea administration are less than the concentrations required to treat bacterial diseases. Efracea should not be used for treating bacterial infections or providing antibacterial prophylaxis. Subantimicrobial doses have shown a roughly equivalent reduction in inflammatory lesions as full microbial doses but with fewer side effects such as gastrointestinal upset.

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Place in Therapy Efracea may be a reasonable option to initiate treatment for papulopustular rosacea and may be a preferred option for long-term oral therapy due to a lower risk of the development of microbial resistance and fewer adverse effects. Comparative Pricing

Efracea Generic doxycycline Generic minocycline

Unit cost Price not available 100mg: $0.60 100mg: $1.00

Monthly cost Price not available $18 - $36 $30 - $60

Impact Insufficient information – pricing not available Plan Management Suggestions To be determined based on pricing.

FIRST-TIME GENERICS

First-Time Generic Drugs (Notices of Compliance from Aug 31, 2011– Nov 29, 2011)

Generic Name Reference Drug (Brand)

Rank by ingredient cost

in 2010

Manufacturer Route of Administration

Approved Indications

Latanoprost/ Timolol

Xalacom 674 Genmed, a division of Pfizer Canada

Ophthalmic Glaucoma

Montelukast Singulair 17 Various Oral Asthma, Seasonal allergic rhinitis

Sirolimus Rapamune 579 Genmed, a division of Pfizer Canada

Oral Prevention of renal transplant rejection

Clopidogrel Plavix 10 Various Oral Prevention of atherothrom-botic or thromboem-bolic events

Authors: Aaron Aoki, RPh, BScPhm, MBA, CRE, CDE Moe Abdallah, B.Sc., B.Sc.Phm

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

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Quebec – Pharmacist expanded practice rights On December 9, 2011, Bill 41, An Act to Amend the Pharmacy Act was assented. Under the Act, a pharmacist will now be able (i) to renew prescriptions for a specified period, (ii) adjust a physician’s prescription by modifying the form, dosage, quantity or directions of the prescribed medication, (iii) substitute another medication from the same therapeutic subclass in the case of a complete disruption in the supply of the prescribed medication in Québec, (iv) administer medications to demonstrate proper usage, (v) prescribe and interpret laboratory analyses (for pharmacists practising in a centre operated by a health or social services institution), and, (vi) prescribe certain medications when no diagnosis is required. A pharmacist will only be able to engage in the professional activities described above in items (i), (ii), (iii) and (vi), once a training certificate has been issued to the pharmacist by the Ordre des pharmaciens du Québec. The provisions of the Act come into force on the date or dates to be set by the Government. Sources http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=5&file=2011C37F.PDF http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=5&file=2011C37A.PDF Quebec- Insulin Pumps Type 1 diabetes On April 16, 2011, Health Minister Yves Bolduc announced a plan to provide universal access to insulin pumps to children under 18 that have type 1 diabetes, through a new government program. At that time, no date was given for the effective date of the program. Since then, the government has decided to backdate the program to April 16, 2011. As confirmed by CHLIA in November, information was received that for Quebec residents covered by a private insurance, the program would be second payer and reimburse any non-insured amount. Source CLHIA, « DU NOUVEAU DANS LE DOMAINE DE LA SANTÉ - Québec – Programme universel d'accès aux pompes à insuline pour les enfants atteints de diabète de type 1 », 22 novembre 2011. http://www.msss.gouv.qc.ca/sujets/prob_sante/diabete/index.php?Programme-pompes-a-insuline&augmenterTailleTexte=normal Quebec – Smoking Cessation Program Just a reminder that as of January 1, 2012, private carriers can interpret the indications regarding the smoking cessation aids in the Liste de Médicaments to a maximum of $665 for 2012. Ontario - ODB – Pharmacy Smoking Cessation Program On September 1, 2011, the Ministry of Health and Long-Term Care launched a pharmacist-directed smoking cessation program to support Ontario Drug Benefit recipients in their attempts to stop smoking. As such, the pharmacist has the opportunity to support ODB recipients seeking smoking cessation counselling support, to provide quit smoking materials and linkages to other community supports as appropriate. In order to do so, the program requires that pharmacists complete a smoking cessation training program.

Health Newsflash — a Quarterly Publication

Policies and Legislation (PAL) Committee Update — 2011 Quarter 4

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The program web page indicates that based on the experiences and outcomes of the program, future consideration could be given to expand the program eligibility to non-ODB patients. Source http://www.health.gov.on.ca/en/pro/programs/drugs/smoking/ Ontario –Pharmaceutical Opinion Program On September 1, 2011, the new Ontario Drug Benefit Pharmaceutical Opinion Program was launched in Ontario. The program refers to the identification by a pharmacist of a potential drug-related problem during (1) the course of dispensing a new or repeat prescription or (2) when conducting a MedsCheck medication review. As a result of a pharmaceutical opinion, the prescription therapy may not be dispensed, may be dispensed as prescribed or may be adjusted. To be eligible for a professional intervention fee, the pharmacist must document and make a recommendation to the prescriber regarding the medication therapy. The reimbursement amount paid to a community pharmacy for a pharmaceutical opinion is $15 per prescription and is available only to ODB recipients. Source http://health.gov.on.ca/en/pro/programs/drugs/pharmaopinion/ (English) http://health.gov.on.ca/fr/pro/programs/drugs/pharmaopinion/ (French) New Brunswick - Pediatric Insulin Pump Program On November 18, 2011, the New Brunswick Health Minister announced the establishment of a pediatric insulin pump program with applications being accepted starting in mid-January. Parents of children 18 or younger with type 1 diabetes are eligible to apply. All approved applicants will be expected to fund a portion of the device, with the remainder being covered by the provincial government. Source http://www2.gnb.ca/content/gnb/en/news/news_release.2011.11.1264.html (English) http://www2.gnb.ca/content/gnb/fr/nouvelles/communique.2011.11.1264.html (French) British Columbia- Smoking Cessation Program Since September 30, 2011, BC PharmaCare now covers bupropion (brand name Zyban®) and varenicline (brand name Champix®) as part of the B.C. Smoking Cessation Program. Each calendar year, eligible residents of the province can receive up to 84 continuous days of coverage for either one prescription smoking cessation drug, or one nicotine replacement therapy product (gum or patch). Source http://www.health.gov.bc.ca/pharmacare/stop-smoking/patient-intro.html

Health Newsflash — a Quarterly Publication

New Drugs and Pipeline News Reviewed at the October to December 2011 DEC Meetings

Volume14 I ssue 1

Jan. 27,

2012

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