Nova Scotia Formulary Updates · PDF fileNova Scotia Formulary Updates ... The following is a list of ATC codes for which claims for drugs and products must ... Agents Acting on the

FEBRUARY 2014 • VOLUME 14-01 PHYSICIANS’ EDITION

Nova Scotia Formulary Updates New Benefit Status Non-Insured Products New Diabetic Products

Nova Scotia Pharmacare Programs Updates Minimum Days' Supply

Nova Scotia Formulary Updates New Benefit Status With upcoming changes to the pricing within the proton pump inhibitor (PPI) category, the following PPI categories will become full benefits effective April 1, 2014 at regular dosing levels (up to 425 tablets per year). Beneficiaries who require higher doses will continue to need to go through the Exception Status Process.

Please note: rabeprazole is the most cost effective PPI available on the Formulary. It is a full benefit without a quantity maximum.

PRODUCT PRESCRIBER BENEFIT STATUS

Pantoprazole 20mg EC Tab DNP SFC* Pantoprazole 40mg EC Tab DNP SFC* *Full benefit at standard dosing (maximum 425 tablets per year)

Effective April 1, 2014, the following category will become a full benefit.

PRODUCT PRESCRIBER BENEFIT STATUS

Rosuvastatin 5mg Tab DNP SF

PAGE 2 OF 4 PHYSICIANS’ EDITION

VOLUME 14-01

Non-Insured Products The following products were reviewed by the Canadian Drug Expert Committee (CDEC) and were not recommended to be listed as benefits under the Nova Scotia Pharmacare Programs.

PRODUCT STRENGTH DIN PRESCRIBER BENEFIT STATUS MFR

Byetta® (exenatide) 1.2mL Prefilled Pen 2.4mL Prefilled Pen

02361809 02361817

N/A N/A

Not Insured Not Insured

LIL LIL

Decision Highlights • Exenatide, at the recommended doses, is more expensive than currently available alternatives, such as sulfonylureas, biphasic insulin apart and insulin NPH, for glycemic control in patients with type 2 diabetes mellitus who are inadequately controlled with only metformin.

PRODUCT STRENGTH DIN PRESCRIBER BENEFIT

STATUS MFR

Bystolic® (nebivolol) 2.5mg Tab 5mg Tab 10mg Tab 20mg Tab

02398990 02399008 02399016 02399024

N/A N/A N/A N/A

Not Insured Not Insured Not Insured Not Insured

FLC FLC FLC FLC

Decision Highlights • Nebivolol has not shown greater efficacy or safety than less expensive alternatives for the treatment of mild to moderate essential hypertension.

PRODUCT STRENGTH DIN PRESCRIBER BENEFIT

STATUS MFR

Edarbi® (azilsartan medoxomil)

40mg Tab 80mg Tab

02381389 02381397

N/A N/A

Not Insured Not Insured

TAK TAK

Edarbyclor® (azilsartan medoxomil plus chlorthalidone)

40/12.5mg Tab 40/25mg Tab 80/12.5mg Tab

02397749 02397765 02397757

N/A N/A N/A

Not Insured Not Insured Not Insured

TAK TAK TAK

Decision Highlights • Azilsartan medoxomil single product (Edarbi®) and the combination product with chlorthalidone (Edarbyclor®) are more costly than currently funded angiotensin II receptor blockers (ARBs) single products and combination products with a diuretic.


VOLUME 14-01

New Diabetic Products The following products are new listings to the Nova Scotia Formulary, effective February 3, 2014. The benefit status within the Nova Scotia Pharmacare Programs is indicated.

PRODUCT DIN/PIN PRESCRIBER BENEFIT STATUS MFR

GE200 Glucose Test Strip (50) 97799372 DNP SFD BNM GE200 Glucose Test Strip (100) 97799373 DNP SFD BNM Novofine Plus 32g x 4mm 97799386 DNP SFD NNO

Legend

PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES

D N P

- Physician / Dentist - Nurse Practitioner - Pharmacist

S F

C D E

- Seniors’ Pharmacare - Community Services Pharmacare - Under 65-Long Term Care Pharmacare - Family Pharmacare - Drug Assistance for Cancer Patients - Diabetes Assistance Program - Exception status applies

BNM FLC LIL NNO TAK

- Bionime USA Corp - Forest Laboratories Canada Inc. - Eli Lilly Canada Inc. - Novo Nordisk Canada Inc. - Takeda Canada Inc.


VOLUME 14-01

Nova Scotia Pharmacare Programs Updates

Minimum Days' Supply The following is a list of ATC codes for which claims for drugs and products must be a minimum of 28 days' supply. These drugs can be prescribed in any quantity that is appropriate, however Pharmacare will only reimburse one dispensing fee every 28 days. Note: Injectables and compounded oral liquids that have been approved for an individual beneficiary within these ATC codes are exempt from the 28 day minimum supply policy.

ATC CODE DESCRIPTOR ATC CODE DESCRIPTOR A02A Antacids M01A Anti-Inflammatory/Anti-Rheumatic Prod.,

Non-steroids, except M01AB01 Indomethacin A02B Drugs for Peptic Ulcer and

Gastroesophageal Reflex Disease (GERD) A06 Laxatives M05 Drugs for Treatment of Bone Diseases A07E Intestinal Anti-Inflammatory Agents N02BA01 Acetylsalicylic Acid A09 Digestives, Including Enzymes N02BA11 Diflunisal A10 Drugs Used for Diabetes N02BG04 Floctafenine A11 Vitamins N03AD Succinimide Derivatives B01AC Platelet Aggregation Inhibitors Excl. Heparin N03AF Carboxamide Derivatives B03 Anti-Anaemic Preparations N03AG Fatty Acid Derivatives C01 Cardiac Therapy N03AX09 Lamotrigine C02 Anti-Hypertensives N03AX11 Topiramate C03 Diuretics N03AX14 Levetiracetam C04 Peripheral Vasodilators N03AX18 Lacosamide C07 Beta Blocking Agents N04 Anti-Parkinson Drugs C08 Calcium Channel Blockers N06D Anti-Dementia Drugs C09 Agents Acting on the Renin-Angiotensin

System N07C Anti-Vertigo Preparations

C10 Lipid Modifying Agents S01X Other Opthalmologicals G04BD Urinary Anti-Spasmotics V07AY04 Insulin Syringes B04CA Alpha-Adrenoreceptor Antagonists V07AY05 Insulin Pen Needles H03 Thyroid Therapy V07AY06 Diabetic Lancets

MAY 2014 • VOLUME 14-02 PHYSICIANS’ EDITION

Nova Scotia Formulary Updates New Exception Status Benefits • Xtandi® (enzalutamide) • Effient® (prasugrel

hydrochloride) • Fycompa® (perampanel) • Latuda® (lurasidone)

Criteria Updates • Eliquis® (apixaban) • Humira® (adalimumab) • Votrient® (pazopanib)

New Products New Diabetic Products Pharmacare Reminders Smaller Quantities Nova Scotia Pharmacare Programs Contact Information Included with this Bulletin Proton Pump Inhibitor (PPI) Form

Nova Scotia Formulary Updates

New Exception Status Benefits The following product has been reviewed by the pCODR Expert Review Committee (pERC) and will be listed as an exception status benefit, with the following criteria effective May 20, 2014.


Xtandi® (enzalutamide)

40mg Cap 02407329 DNP E ASL

Criteria • For the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel therapy with the following criteria:

o As a single agent treatment option for metastatic CRPC patients with ECOG PS 0-2, no risk for seizures and progression after previous treatment with docetaxel.

o Enzalutamide would be an alternative to abiraterone for patients in the post-docetaxel setting and not a sequential therapy.


VOLUME 14-02

New Exception Status Benefits Continued…

The following products have been reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed as exception status benefits, with the following criteria effective May 20, 2014.


Effient® (prasugrel hydrochloride)

10mg Tab 02349124 DNP E LIL

Criteria • In combination with ASA for patients with: o ST-elevated myocardial infarction (STEMI) undergoing primary percutaneous

coronary intervention (PCI) who have not received antiplatelet therapy prior to arrival in the catheterization lab.

o Treatment must be initiated in hospital. o Approval period 12 months (up to 3 months for patients with bare metal stents).

• Notes: 1. Criteria Code 30 may be used for the initial 30 day coverage period, however a

written request submitted to the Pharmacare office is required to allow coverage for the remaining duration of treatment.

2. As per the product monograph, prasugrel is contraindicated in patients with a known history of transient ischemic attack or stroke; those with active pathological bleeding such as gastrointestinal bleeding or intracranial hemorrhage; and those with severe hepatic impairment (Child-Pugh Class C).

3. As per the product monograph, prasugrel is not recommended in patients ≥ 75 years of age because of the increase risk of fatal and intracranial bleeding; or those with body weight < 60k kg because of increased risk of major bleeding due to an increase in exposure to the active metabolite of prasugrel.


VOLUME 14-02



Fycompa® (perampanel)

2mg Tab 4mg Tab 6mg Tab 8mg Tab 10mg Tab 12mg Tab

02404516 02404524 02404532 02404540 02404559 02404567

DNP DNP DNP DNP DNP DNP

E E E E E E

EIS EIS EIS EIS EIS EIS

Criteria • As an adjunctive therapy in the management of partial-onset seizures, in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy who meet all of the following criteria:

o Are under the care of a physician experienced in the treatment of epilepsy; o Are currently receiving two or more antiepileptic drugs; and o In whom all other antiepileptic drugs are ineffective or not appropriate.

Decision Highlights • Perampanel is cost neutral when used in adult patients with partial-onset seizures compared to other adjunct therapies, such as lacosamide. The Committee noted, however, that the combination of perampanel and lacosamide has not been studied and this combination would be more costly than other combinations of antiepileptic drugs.


Latuda® (lurasidone)

40mg Tab 80mg Tab 120mg Tab

02387751 02387778 02387786

DNP DNP DNP

E E E

SNV SNV SNV

Criteria • For the treatment of schizophrenia or schizoaffective disorder in patients who have a contraindication to quetiapine and risperidone, or have failed a trial of quetiapine and risperidone due to intolerance or lack of response.


VOLUME 14-02

Criteria Update: Eliquis® The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed with the following new criteria and applicable criteria codes, effective May 20, 2014.


Eliquis® (apixaban)

2.5mg Tab 02377233 DNP E BRI

Criteria • For the prophylaxis of venous thromboembolism following total knee replacement surgery for up to 14 days, as an alternative to low molecular weight heparins. [Criteria Code 14]

• For the prophylaxis of venous thromboembolism following total hip replacement surgery for up to 35 days, as an alternative to low molecular weight heparins. [Criteria Code 35]

• Notes: 1. The total duration of therapy includes the period during which doses are

administered post-operatively in an acute care (hospital) setting, and the approval period is for the balance of the total duration after discharge.

2. The first dose is typically administered 12 to 24 hours after surgery, assuming adequate hemostasis has been achieved.

3. The ADVANCE clinical trial program did not evaluate the efficacy or safety of sequential use of molecular weight heparin followed by apixaban for the prophylaxis of VTE. Due to the current lack of evidence for sequential use, coverage is not intended for this practice.

4. Clinical judgment is warranted to assess the increased risk for VTE and/or adverse effects in patients with a history of previous VTE, myocardial infarction, transient ischemic attack or ischemic stroke; a history of intraocular or intracerebral bleeding; a history of gastrointestinal disease with gastrointestinal bleeding; moderate or severe renal insufficiency (estimated creatinine clearance <30 mL/min); severe liver disease; concurrent use of other anticoagulants; or age greater than 75 years.

5. Apixaban has not been studied in clinical trials in patients undergoing hip fracture surgery, and is not recommended in these patients.

Decision Highlights • Apixaban (2.5mg twice daily) compared with enoxaparin (40mg daily) following total knee or hip replacement surgeries was associated with a statistically significant lower incidence of the primary composite end point (deep vein thrombosis, pulmonary embolism, and death from any cause).


VOLUME 14-02

Criteria Update: Humira® The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed with the following new criteria May 20, 2014.


Humira® (adalimumab)

50mg/mL 02258595 DNP E ABV

Criteria • For the treatment of polyarticular juvenile idiopathic arthritis (pJIA)with the following criteria:

o For patients aged 4-17 years with moderately or severe pJIA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs); and

• Treatment must be initiated by a rheumatologist who is familiar with the use of DMARDs and/or biologic DMARDs in children.

Decision Highlights • Adalimumab, with or without methotrexate, has been shown to be superior to placebo for reducing the proportion of polyarticular juvenile idiopathic arthritis (pJIA) patients with experiencing a disease flare. Adalimumab with methotrexate in pJIA patients has also been shown to be superior to placebo with methotrexate for achieving an American College of Rheumatology (ACR) pediatric (Pedi) 30 and ACR Pedi 70 response.

Criteria Update: Votrient® The following product was reviewed by the pCODR Expert Review Committee (pERC) and will be listed with the following new criteria effective May 20, 2014.


Votrient® (pazopanib)

200mg Tab 02352303 D E GSK

Criteria • As a single agent first-line treatment option for patients with documented evidence of histologically confirmed advanced or metastatic clear cell renal cell carcinoma (RCC) who have an ECOG PS of 0 or 1. In any one patient, all the following conditions must be met:

o Pazopanib may be a first line option. o Pazopanib may not be used after another VEGF tyrosine kinase inhibitor as

sequential therapy. o In the event of significant toxicity, a switch to another VEGF tyrosine kinase

inhibitor may be allowed.


VOLUME 14-02

New Products The following products are new listings to the Nova Scotia Formulary, effective May 20, 2014. The benefit status within the Nova Scotia Pharmacare Programs is indicated.


Epuris® (isotretinoin)

10mg Tab 20mg Tab 30mg Tab 40mg Tab

02396971 02396998 02397005 02397013

DNP DNP DNP DNP

F F F F

CIP CIP CIP CIP

Januvia® (sitagliptin)

25mg Tab 50mg Tab

02388839 02388847

DNP DNP

E E

FRS FRS

New Diabetic Products The following products are a new listing to the Nova Scotia Formulary, effective June 9, 2014. The benefit status and reimbursement price within the Nova Scotia Pharmacare Programs is indicated.

PRODUCT DIN/PIN MRP PRESCRIBER BENEFIT STATUS MFR

BD Ultra-Fine II Syringes, 0.5cc, 31g 97799385 0.3555 DNP SFD BTD

BD Ultra-Fine II Syringes, 1cc, 31g 97799384 0.3555 DNP SFD BTD

Legend

PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES D N P

- Physician / Dentist - Nurse Practitioner - Pharmacist

S F C D E

- Seniors’ Pharmacare - Community Services Pharmacare - Family Pharmacare - Drug Assistance for Cancer Patients - Diabetes Assistance Program - Exception status applies

ABV ASL BRI BTD CIP EIS FRS GSK LIL SNV

- AbbVie Corporation - Astellas Pharma Canada Inc. - Bristol-Myers Squibb Canada Inc. - Becton Dickinson Canada Inc. - Cipher Pharmaceuticals Inc. - Eisai Limited - Merck Canada Ltd. - GlaxoSmithKline Inc. - Eli Lilly Canada Inc. - Sunovion Pharmaceuticals Inc.


VOLUME 14-02

Pharmacare Reminders

Smaller Quantities In order to minimize calls from pharmacies relating to smaller quantities, please refer to the statement below which was included in the Pharmacare News Pharmacists’ Edition:

“The Pharmacare Programs will not pay multiple dispensing fees where the pharmacist dispenses a quantity less than the quantity prescribed. Therefore, more than one dispensing fee cannot be charged on a prescription when the original quantity is reduced and refills are generated, (even at the beneficiary’s request) unless the prescriber is contacted and the reduced quantity plus refills are authorized”.

Nova Scotia Pharmacare Programs Contact Information To ensure accurate and prompt responses, please select the following automated options when phoning Nova Scotia Pharmacare Programs.

496-7001 or 1-800-305-5026

Option 1: Seniors Pharmacare Inquires

Option 2: Nova Scotia Family Pharmacare Inquires

Option 3: Claim Inquires/ Information regarding other Pharmacare Programs/ General Inquires

Option 4: Physicians/ Criteria/ Specific Exception Status Drug (ESD) Inquires

Option 5: Audit

JULY 2014 • VOLUME 14-03 PHYSICIANS’ EDITION

Nova Scotia Formulary Updates New Policy Regarding Vacation Supply for Pharmacare Recipients New Exception Status Benefits • Modafinil • Genotropin® GoQuick®

(somatropin) • Genotropin® MiniQuick®

(somatropin) • Tecfidera® (dimethyl fumarate)

Criteria Update • Suboxone®

(buprenorphine/naloxone) • Topiramate

New Products


New Policy Regarding Vacation Supply for Pharmacare Recipients The Department of Health and Wellness will be extending the length of time Nova Scotia residents are eligible for Medical Services Insurance (MSI) while out of the province for vacation. As of August 1, 2014, Nova Scotians will be eligible for MSI benefits for an additional month while on vacation outside of the province for a maximum of 7 months in each calendar year. Vacationers are required to inform MSI of their absence by telephoning 902-496-7008 (local) or 1-800-563-8880 (toll-free) or submitting an email to [email protected].

In order to allow vacationers an adequate supply of medications while travelling outside the province for more than 100 days, the Nova Scotia Family and Senior’s Pharmacare Programs will allow pharmacies to dispense up to three 90 day refills, billed on three consecutive days, to allow for a 270 day maximum supply of medication for beneficiaries to bring with them as vacation supply.

New Exception Status Benefits The following products have been reviewed by the Atlantic Common Drug Review (ACDR) and were listed as an exception status benefit, with the following criteria effective July 23, 2014.


Modafinil 100mg Tab 100mg Tab

02285398 02239665

DNP DNP

E E

AAP SHI

Criteria • for the treatment of narcolepsy confirmed by sleep study

mailto:[email protected]


VOLUME 14-03


The following products have been reviewed by the Canadian Drug Expert Committee (CDEC) and were listed as an exception status benefit, with the following criteria effective July 23, 2014.


Genotropin® GoQuick® (somatropin)

5.3mg Pen 12mg Pen

02401703 02401711

DNP DNP

E E

PFI PFI

Genotropin® MiniQuick® (somatropin)

0.6mg Syringe 0.8mg Syringe 1mg Syringe 1.2mg Syringe 1.4mg Syringe 1.6mg Syringe 1.8mg Syringe 2mg Syringe

02401762 02401770 02401789 02401797 02401800 02401819 02401827 02401835

DNP DNP DNP DNP DNP DNP DNP DNP

E E E E E E E E

PFI PFI PFI PFI PFI PFI PFI PFI

Criteria • for treatment of growth hormone deficiency in patients with Turner Syndrome, upon the request of an endocrinologist or prescriber with a specialty in endocrinology


VOLUME 14-03



Tecfidera® (dimethyl fumarate)

120mg DR Cap 240mg DR Cap

02404508 02420201

DNP DNP

E E

BIG BIG

Criteria • for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) who meet all of the following criteria:

o requested and followed by a neurologist experienced in the management of RRMS, and

o recent expanded disability status scale (EDSS) score of 5.5 or less (i.e. patients must be able to ambulate at least 100 metres without assistance.)

Exclusion: • not funded in combination with other disease modifying therapies • not funded in patients with an EDSS > 5.5 • not funded in patients < 18 years of age

Renewals: • EDSS score < 5.5 (i.e. patients must be able to ambulate at least 100 metres

without assistance). Date and details of the most recent neurological examination and EDSS score must be provided (exam must have occurred within the last 90 days), and

• patients must be stable or have experienced no more than 1 disabling attack/relapse in the past year

Decision Highlights • Two placebo-controlled randomized controlled trials demonstrated that dimethyl fumarate decreases relapses in RRMS and may be effective in delaying disability progression.


VOLUME 14-03

Criteria Update: Suboxone® Suboxone® was listed with the following new criteria July 23, 2014.


Suboxone® (buprenorphine/naloxone)

2mg/0.5mg SL Tab 8mg/2mg SL Tab

02295695 02295709

D D

E E

RBH RBH

Criteria • for the treatment of opioid dependence for patients in whom methadone is contraindicated (e.g., patients at high risk of, or with, QT prolongation, or hypersensitivity to methadone)

• for the treatment of opioid dependence for appropriate patients ages 18-24 years • must be prescribed by a physician licensed to prescribe methadone for opioid

dependence

Notes • Practicioners are encouraged to review the clinical practice guideline “Buprenorphine/Naloxone for Opioid Dependence” available through the Centre for Addictions and Mental Health (CAMH) at the following link: http://knowledgex.camh.net/primary_care/guidelines_materials/Documents/buprenorphine_naloxone_gdlns2012.pdf

• Information regarding the CAMH Opioid Dependence Treatment Core Course can be found at the following link: http://www.camh.ca/en/education/about/AZCourses/Pages/odtcore_odt.aspx

Criteria Update: Topamax® The following product was reviewed by the Atlantic Common Drug Review (ACDR) and were listed with the following new criteria July 23, 2014.


Topiramate 25mg Tab

50mg Tab

100mg Tab

200mg Tab

Multiple DINs for product please see Nova Scotia Formulary

DNP

DNP

DNP

DNP

E

E

E

E

VAR

VAR

VAR

VAR

Criteria • for adjunctive management of epilepsy not satisfactorily controlled by conventional therapy

• for management of migraine headaches in adult patients who have failed an adequate trial of, or have contraindications to, beta blockers, AND tricyclic antidepressants for prophylaxis

http://knowledgex.camh.net/primary_care/guidelines_materials/Documents/buprenorphine_naloxone_gdlns2012.pdf

http://knowledgex.camh.net/primary_care/guidelines_materials/Documents/buprenorphine_naloxone_gdlns2012.pdf

http://www.camh.ca/en/education/about/AZCourses/Pages/odtcore_odt.aspx


VOLUME 14-03

New Products The following products are new listings to the Nova Scotia Formulary, effective July 23, 2014. The benefit status and reimbursement price within the Nova Scotia Pharmacare Programs is indicated.

PRODUCT DIN MRP PRESCRIBER BENEFIT STATUS MFR

Ran-Atenolol 25mg Tab 02373963 0.0946 DNP SF RAN Jamp-Atenolol 25mg Tab 02367556 0.0946 DNP SF JPC Jamp-Folic Acid 5mg Tab 02366061 0.0363 DNPM SFC JPC Jamp-Dicyclomine 10mg Tab 02391619 0.1128 DNP SFC JPC Jamp-Dicyclomine 20mg Tab 02366088 0.2207 DNP SFC JPC Jamp-Colchicine 0.6mg Tab 02373823 0.2565 DNP SF JPC Acuvail 0.45% Oph Sol 02369362 1.5417 DNPO SF ALL Janumet ® XR 50/1000mg Tab 02416794 1.6015 DNP E FRS

Pegasys Proclick Autoinjector 180mcg/0.5mL Inj

02248077 791.6800 DNP E HLR

Pegasys RBV Proclick Autoinjector 180mcg/0.5mL Inj

02253429 395.8400 DNP E HLR

Legend

PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES D N P M O

- Physician / Dentist - Nurse Practitioner - Pharmacist - Midwife - Optometrist

S F C D E


AAP ALL BIG FRS HLR JPC PFI RAN RBH SHI VAR

AA Pharma Inc. Allergan Inc. Biogen Idec Canada Inc. Merck Canada Inc. Hoffmann-LaRoche Limited Jamp Pharma Corporation Pfizer Canada Inc. Ranbaxy Pharmaceuticals Canada Inc. Reckitt Benckiser Healthcare Ltd Shire Canada Inc. various manufacturers

SEPTEMBER 2014 • VOLUME 14-04 PHYSICIANS’ EDITION

Nova Scotia Formulary Updates New Exception Status Benefits

• Kalydeco® (ivacaftor) • Jakavi® (ruxolitinib) • Inlyta® (axitinib)

Criteria Update

• Afinitor® (everolimus)


New Exception Status Benefits The following product has been reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed as an exception status benefit, with the following criteria effective October 1, 2014.

PRODUCT STRENGTH DIN PRESCRIBER BENEFIT STATUS

MFR

Kalydeco® (ivacaftor)

150mg Tab 02397412 DNP E VTX

Criteria For the treatment of cystic fibrosis in patients who meet the following criteria: • Age 6 years and older; AND • Patient has documented G551D mutation in the Cystic

Fibrosis Transmembrane Conductance Regulator (CFTR) gene.

Initial renewal criteria1: Renewals will be considered in patients with documented response to treatment (after at least 6 months of therapy), as evidenced by the following: In cases where the patient’s sweat chloride levels prior to commencing therapy were above 60 mmol/litre: • the patient’s sweat chloride level fell below 60 mmol/litre;

OR • the patient’s sweat chloride level is 30% lower than the

level reported in a previous test; _______________ 1 It should be noted that, while baseline sweat chloride levels and FEV1 are

not required to meet initial approval criteria for ivacaftor, these parameters may be used to evaluate the effect of ivacaftor upon renewal of the request. It is important that the physician measures baseline sweat chloride levels and FEV1 and provides this information upon renewal to avoid delays in the assessment of the renewal funding decision as these measurements may be required to evaluate renewal requests.


VOLUME 14-04

New Exception Status Benefits continued…


MFR

Kalydeco® (ivacaftor)

150mg Tab 02397412 DNP E VTX

Criteria In cases where the patient’s sweat chloride levels prior to commencing therapy were below 60 mmol/litre: • the patient’s sweat chloride level is 30% lower than the level reported in a

previous test; OR • the patient demonstrates a sustained absolute improvement in FEV1 of at least

5% when compared to the FEV1 test conducted prior to the commencement of therapy.

Subsequent renewal criteria after the patient has met the initial renewal criteria: • The patient is continuing to benefit from therapy with Kalydeco.

Decision Highlights • Approval of funding of ivacaftor is for patients with the G551D genetic mutation only who meet the listed criteria.

The following products were reviewed by the pCODR Expert Advisory Committee (pERC) and will be listed with the following criteria effective October 1, 2014.


MFR

Jakavi® (ruxolitinib)

5mg Tab 15mg Tab 20mg Tab

02388006 02388014 02388022

DNP DNP DNP

E E E

NVR NVR NVR

Criteria • As a single agent in patients with intermediate or high risk symptomatic myelofibrosis (using the Dynamic International Prognostic Scoring System (DIPSS) Plus or symptomatic splenomegaly) with an ECOG performance status (PS) ≤ 3 as first line therapy or refractory to other treatments. Ongoing monitoring and follow up of therapy will be required.

Decision Highlights • The pCODR Expert Review Committee concluded ruxolitinib was an effective treatment for myelofibrosis based on improvements in myelofibrosis symptoms and quality of life.


VOLUME 14-04

New Exception Status Benefits continued…


MFR

Inlyta® (axitinib)

1mg Tab 5mg Tab

02389630 02389649

DNP DNP

E E

PFI PFI

Criteria • As a single second line agent for the treatment of patients (ECOG PS 0 or 1) with advanced or metastatic clear cell renal cell carcinoma (RCC) who are unable to tolerate ongoing use of an effective dose of everolimus or who have a contraindication to everolimus.

• Sequential use of axitinib and everolimus is not permitted except in the case of intolerability or contraindication

Decision Highlights • Axitinib provides an alternative second line therapy for metastatic renal cell carcinoma for patients who are unable to use everolimus.

Criteria Update: Afinitor® The following product was reviewed by the pCODR Expert Advisory Committee (pERC) and will be listed with the following new criteria effective October 1, 2014. PRODUCT STRENGTH DIN PRESCRIBER BENEFIT

STATUS MFR

Afinitor® (everolimus)

2.5mg Tab 5mg Tab 10mg Tab

02369257 02339501 02339528

DNP DNP DNP

E E E

NVR NVR NVR

Criteria • In combination with exemestane for postmenopausal patients (ECOG PS ≤2) with documented hormone receptor positive, HER2 negative-advanced breast cancer after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI).

Note: It may be clinically reasonable to use the combination in patients with treated and stable brain metastasis. • For the treatment of patients with progressive, unresectable, well or moderately

differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (pNET) with good performance status (ECOG 0-2), until disease progression.

Note: Patients whose disease progresses on sunitinib are not eligible for funded treatment with everolimus for pNET


VOLUME 14-04

Legend



S F C D E


NVR PFI VTX

- Novartis Pharmaceuticals Canada Inc. - Pfizer Canada Inc. - Vertex Pharmaceuticals Canada Inc.

OCTOBER 2014 • VOLUME 14-05 PHYSICIANS’ EDITION

Nova Scotia Formulary Updates New Exception Status Benefits • Esbriet® (pirfenidone) • Mozobil® (plerixafor) • Tudorza® Genuair®

(aclidinium bromide) New Product Criteria Update • Xarelto® (rivaroxaban)


New Exception Status Benefits The following products will be listed with the following criteria effective October 31, 2014.


MFR

Esbriet® (pirfenidone)

267mg Cap 02393751 DNP E ITM

Criteria Initial approval criteria: • Adult patients who have a diagnosis of mild to moderate

idiopathic pulmonary fibrosis (IPF) 1 confirmed by a respirologist and a high-resolution CT scan within the previous 24 months.

• Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests)

Initial renewal criteria: • Patients must NOT demonstrate progression of disease

defined as an absolute decline in percent predicted FVC of ≥10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

• Approval period: 6 months _______________ 1 Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted.


VOLUME 14-05



MFR

Esbriet® (pirfenidone)

267mg Cap 02393751 DNP E ITM

Criteria Second renewal criteria (12 months after initiation of therapy): • Patients must NOT demonstrate progression of disease defined as an absolute decline

in percent predicted FVC of ≥10% since initiation of therapy (baseline). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later

• Approval period: 12 months

Decision Highlights • The Canadian Drug Expert Committee will be reviewing new clinical evidence available for the use of pirfenidone which may result in a change in benefit status.


MFR

Mozobil® (plerixafor)

24mg/1.2mL (20mg/mL) Single Use Vial

02377225 DNP E SAV

Criteria • For use in combination with filgrastim to mobilize hematopoietic stem cells for subsequent autologous transplantation in patients with Non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM) if one of the following criteria are met:

o a PBCD34+ count of < 10cells/uL after 4 days of filgrastim; OR o less than 50% of the target CD34 yield is achieved on the 1st day of apheresis

(after being mobilized with filgrastim alone or following chemotherapy); OR o if a patient has failed a previous stem cell mobilization with filgrastim alone or

following chemotherapy.

Notes: • Reimbursement is limited to a maximum of 4 doses (0.24mg/kg given daily) for a single

mobilization attempt and to prescriptions written by an oncologist or hematologist.


VOLUME 14-05


The following product has been reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed as an exception status benefit, with the following criteria effective October 31, 2014.


MFR

Tudorza® Genuair® (aclidinium bromide)

400mcg Powder for Inhalation 02409720 DNP E ALM

Criteria • For the treatment of chronic obstructive pulmonary disease (COPD), if symptoms persist after 2-3 months of short-acting bronchodilator therapy (i.e., salbutamol at a maximum dose of 8 puffs/day or ipratropium at maximum dose of 12 puffs/day)

• Coverage can be provided without a trial of short-acting agent if: o there is spirometric evidence of at least moderate to severe airflow obstruction

(i.e., postbronchodilator values FEV1 < 60% and FEV1/FVC ratio < 0.7), and significant symptoms (i.e., MRC score pf 3-51)

• Combination therapy with aclidinium bromide and a long-acting beta2 agonist/inhaled corticosteroid will only be considered if:

o there is spirometric evidence of at least moderate to severe airflow obstruction (postbronchodilator values FEV1 < 60% and FEV1/FVC ratio < 0.7), and significant symptoms (i.e., MRC score of 3-51); AND

o there is evidence of one or more moderate-to-severe exacerbations per year, on average, for 2 consecutive years requiring antibiotics and/or systemic (oral or intravenous) corticosteroids

_______________ 1 Canadian Thoracic Society COPD Classification By Symptom/Disability:

Moderate - (MRC 3-4) Shortness of breath from COPD causing the patient to stop after walking about 100 meters (or after a few minutes) on the level.

Severe - (MRC 5) Shortness of breath from COPD resulting in the patient being too breathless to leave the house or breathless after undressing, or the presence of chronic respiratory failure or clinical signs of right heart failure.

MRC= Medical Research Council Dyspnea Scale

New Product The following product is a new listing to the Nova Scotia Formulary, effective October 31, 2014. The benefit status within the Nova Scotia Pharmacare Programs is indicated.


MFR

Lodalis® (colesevelam) 625mg Tab 02373955 DNP SF VLN


VOLUME 14-05

Criteria Update The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed with the following new criteria effective October 31, 2014. PRODUCT STRENGTH DIN PRESCRIBER BENEFIT

STATUS MFR

Xarelto® (rivaroxaban)

15mg Tab 20mg Tab

02378604 02378612

DNP DNP

E E

BAY BAY

Criteria • For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) • Approval Period: Up to six (6) months • Criteria Code 42 will be used to allow the 15mg strength to pay (max 42 tablets), which

will allow patients to start therapy while awaiting ESD approval for the six months of therapy

Notes: • The recommended dose of rivaroxaban for patients initiating DVT or PE treatment is

15mg twice daily for 3 weeks, followed by 20mg once daily • Drug Plan coverage for rivaroxaban is an alternative to heparin/warfarin for up to six

months. When used for greater than 6 months, rivaroxaban is more costly than heparin/warfarin. As such, patients with an intended duration of therapy greater than 6 months should be considered for initiation on heparin/warfarin

• Since renal impairment can increase bleeding risk, it is important to monitor renal function regularly. Other factors that increase bleeding risk should be assessed and monitored (see product monograph).

Decision Highlights • In the EINSTEIN PE trial, rivaroxaban was reported to be non-inferior to a regimen of enoxaparin plus warfarin. Based on a cost minimization analysis, rivaroxaban is less costly than enoxaparin plus warfarin when treating patients for up to six months. Therefore coverage criteria for the treatment of venous thrombotic events has been expanded to include patients with pulmonary embolism. Note that coverage is limited to six months, therefore, patients who have a likely treatment duration of greater than six months should be considered for initiation of heparin/warfarin.

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ALM BAY ITM SAV VLN

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