Standard of procedures special authorization drugs … Special Authorization Drugs.pdf · 1 UPDATED March 3rd, 2014 Standard of procedures Special Authorization Drugs 1) General Section

1

UPDATED

March 3rd, 2014

Standard of procedures

Special Authorization Drugs

1) General Section For all of the following drugs:

Claims should be coordinate with the Provincial government program when available.

The administration site should be validate for injectable drugs.

For Quebec residents, authorization RAMQ criteria predominate on the criteria of this table.

DRUG DISEASE APPROVAL GUIDELINES FIRST

CLAIM RENEWAL

ABSTRAL (FENTANYL CITRATE)

Sublingal Tablet

DIN : 02364174 (100µg)

DIN : 02364182 (200µg)

DIN : 02364190 (300µg)

DIN: 02364204 (400µg)

DIN: 02364212 (600µg)

DIN: 02364220 (800µg)

Cancer pain

Management of breakthrough pain in patients

with cancer who are already receiving and who

are tolerant to opioid therapy for their

persistent baseline cancer pain

18 years of age or older

3 months

6 months

ACTEMRA (TOCILIZUMAB)

Intravenous Solution

DIN 02350092 (80 MG / 4 ML)

DIN 02350106 (200 MG / 10 ML)

DIN 02350114 (400 MG / 20 ML)

Rheumatoid

Arthritis (RA)

Systemic Juvenile

Idiopathic Arthritis

(JIA)

A confirmed diagnosis of moderate to severe

rheumatoid arthritis with persistent active

disease (8 or more affected joints)

And

Patients who does not respond to methotrexate

adequately at a dose equal to or greater than

15mg per week and to another disease

modifying antirheumatic drugs for a period of

3 months or more

And

One of the following:

○ HAQ > 1

○ Erosion confirmed by X Ray

○ Increase of SRV or CRP

○ Positive rheumatoid factor


5 or more affected joints and failure or

contraindications to methotrexate and to

another disease modifiying antirheumatic drugs

for a period of 3 months or more

Or

1 or more affected joints and at least one

systemic manifestation (fever, rash,

adenomegaly, hepatomegaly, splenomegaly,

serous effusion)

5 months

5 months

1 year

Improvement of 20 % for

affected joints

And


SRV or CRP or HAQ or

return to work

1 year


affected joints

And

Improvement of systemic

manifestations if appropriate

And


SRV or CRP or improvement

of CHAQ or return to school

2


CLAIM RENEWAL

ADCIRCA (TADALAFIL)

Oral Tablet

DIN 02338327 (20 MG)

Pulmonary Arterial

Hypertension

(PAH)

Treatment of primary pulmonary arterial

hypertension (PAH) or PAH associated with

connective tissue disease, congenital heart disease

or anorexigen use:

No response to conventional therapy

WHO functional - Class II or III

Indefinite

N/A

AFINITOR (EVEROLIMUS)

Oral Tablet

DIN 02369257 (2.5 MG)

DIN 02339501 (5 MG)

DIN 02339528 (10 MG)

Metastatic Renal

Cell Carcinoma

(RCC) of clear cell

morphology

Neuroendocrine

tumours of

pancreatic origin

(PNET)

Subependymal giant

cell astrocytoma

(SEGA)

Postmenopausal

women with

advanced breast

cancer

Second-line treatment in metastatic RCC of clear

cell morphology, after failure to VEGF-receptor

thyrosine kinase inhibitor (sunitinib or sorafenib):

ECOG ≤ 2

Treatment of well- or moderately differentiated

neuroendocrine tumours of pancreatic origin

(PNET):

Unresectable, locally advanced or metastatic

disease that has progressed within the last 12

months

ECOG ≤ 2

Treatment of SEGA associated with tuberous

sclerosis complex (TSC) that has demonstrated

serial growth:


Not candidate for surgical resection and for

whom immediate surgical intervention is not

required

ECOG ≤ 2

Treatment of postmenopausal women with

advanced breast cancer:

Hormone receptor-positive

HER2-negative

Associated with aromasin

After failure with letrozole or anastrozole

4 months

4 months

4 months

4 months

4 months

Absence of progression

6 months


4 months


6 months


ALERTEC (MODAFINIL)

Oral Tablet

DIN 02239665 (100 MG)

MODAFINIL (MODAFINIL)

Oral Tablet

DIN 02285398

Symptomatic

excessive sleepiness

Symptomatic treatment of excessive sleepiness:

Hypersomnia with narcolepsy

Hypersomnia associated to sleep apnea despite

the use of a CPAP

Indefinite

N/A

APTIVUS (TIPRANAVIR)

Oral Capsule

DIN 02273322 (250 MG)

HIV infection

Coordinate with HIV/AIDS Provincial

Government Program

In combination with other antiretroviral agents in

treatment-experienced HIV–1 infected adult

patients with evidence of HIV-1 replication and

HIV-1 strains resistant to multiple protease

inhibitors

6 months

1 year

3


CLAIM RENEWAL

ARANESP (DARBEPOETINE ALFA)

Intravenous, Subcutaneous Solution

DIN 02246354 (10 MCG / 0.4 ML)

DIN 02246355 (20 MCG / 0.5 ML)

DIN 02246357 (30 MCG / 0.3 ML)

DIN 02246358 (60 MCG / 0.3 ML)

DIN 02246360 (150 MCG / 0.3 ML)

Anemia

If available, coordinate with the Provincial

Government Program

Treatment of anemia associated with chronic

kidney disease (CKD), including patients on

dialysis and patients not on dialysis

Or

Treatment of Anemia due to Chemotherapy in

Patients with Non-Myeloid Malignancies

Or

AIDS related anemia

Indefinite

N/A

AUBAGIO (TERIFLUNOMIDE)

Oral Tablet

DIN 02416328 (14 MG)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Treatment of relapsing-remitting multiple

Sclerosis (RRMS):


Prescribed by a neurologist

Monotherapy

EDSS ≤ 5.5

Number of disabling clinical relapses in the

last 12 months

MRI

6 months

1 year

AVONEX (INTERFERON BETA-1A)

Prefilled Serynge or Autoinjector

DIN 02269201 (30 MCG / 0.5 ML)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Chronic

Progressive

Multiple Sclerosis

(CPMS)

Single

demyelinating event

with two clinically

silent lesions

typical of MS

(MRI+ )


Government Program

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

If isolated

clinical

syndrome

(ICS): 1

year

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

ICS : 1 year

BANZEL (RUFINAMIDE)

Oral Tablet

DIN 02369613 (100 MG)

DIN 02369621 (200 MG)

DIN 02369648 (400 MG)

Lennox-Gastaut

Syndrome (LGS)

Adjunctive treatment of seizures associated with

Lennox-Gastaut syndrome:


Inadequate response or failure to one or more

other antiepileptic drugs

6 months

1 year

BARACLUDE (ENTECAVIR)

Oral Tablet

DIN 02282224 (0.5 MG)

Hepatitis B virus

infection


Government Program

Treatment of chronic hepatitis B virus infection

with 0.5 mg daily

No resistance to lamivudine and according viral

load

Treatment of chronic hepatitis B virus infection

with 1 mg daily:

Resistance to lamivudine and according viral

load

Failure of treatment with adefovir or being

intolerant to adefovir

Indefinite

N/A

4


CLAIM RENEWAL

BENLYSTA (BELIMUMAB)


DIN 02370050 (120 MG / 5 ML)

DIN 02370069 (400 MG / 20 ML)

Systemic Lupus

Erythematosus

(SLE)

Validate the administration site: if in an hospital

setting, must be free of charge

In addition to standard therapy in patients with

moderate to severe SLE:


Prescribed by a rheumatologist

Autoantibody + (within last 3 months): ANA

or dsDNA+

AND

SELENA-SLEDAI score ≥ 6 and who have not

responded (intolerant or contraindicated) to

corticosteroid and hydroxychloroquine

6 months

6 months:

According to the treatment

response

Achieving and maintaining an

improvement for SELENA-

SLEDAI score (score ≥ 4 vs

initial request)

BETASERON (INTERFERON BETA-1B)

Subcutaneous Solution

DIN 02169649 (0.3 MG)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Chronic

Progressive

Multiple Sclerosis

(CPMS)

Single

demyelinating event

with two clinically

silent lesions

typical of MS

(MRI+ )


Government Program

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

If isolated

clinical

syndrome

(ICS): 1

year

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

ICS : 1 year

5


CLAIM RENEWAL

BOTOX (BOTULINUM TOXIN)

Intramuscular Solution

DIN 01981501 (100 IU)

Blepharospasm /

Strabismus

Cervical dystonia

Hyperhidrosis of

the Axillae

Focal spasticity

Chronic migraine

Neurogenic

detrusor

overactivity

associated with a

neurological

condition




Spasmodic torticollis treatment in adult patients

Excessive sweating (second-line treatment):

Maximum of 200 Units per treatment

In the management of focal spasticity, including

the treatment of upper limb spasticity associated

with stroke in adults

For the prophylaxis of headaches in adults with

chronic migraine:

Headaches lasting 4 hours a day or longer

≥ 15 days / month x ≥ 3 months

Previous medication

Maximum of 200 Units per treatment

Treatment of urinary incontinence due to

neurogenic detrusor overactivity resulting from

neurogenic bladder associated with multiple

sclerosis or subcervical spinal cord injury:

Adults

Inadequate response or intolerant to

anticholinergic agents

1 year

1 year

1 year

1 year

1 year

1 year

Indefinite

Indefinite

Indefinite

Indefinite

1 year

1 year

CAPRELSA (VANDÉTANIB)

Oral Tablet

DIN 02378582 (100 MG)

DIN 02378590 (300 MG)

Medullary thyroid

cancer

Treatment of symptomatic or progressive

medullary thyroid cancer in adult patients with

unresectable locally advanced or metastatic

disease:

Adult

ECOG ≤ 3

3 months

6 months

CIALIS (TADALAFIL)

Oral Tablet

DIN 02296888 (2.5 MG)

DIN 02296896 (5 MG)

Benign Prostatic

Hyperplasia (BPH)

Continuous therapy (2.5 or 5 mg once a day)

Failure to standard treatment

3 months

6 months

CIALIS (TADALAFIL)

Oral Tablet

DIN 02296888 (2.5 MG)

DIN 02296896 (5 MG)

DIN 02248088 (10 MG)

DIN 02248089 (20 MG)

Erectile

Dysfunction (ED)

NOTE:

If no ED clause:

not eligible.

Treatment of erectile dysfunction (ED) in men (18

years of age or older):

Organic erectile dysfunction (e.g. , diabetes

related, vascular related)

Erectile dysfunction with neurological cause

(e.g., spinal cord injury (SCI), nerve damage

as a result of a prostatectomy or TURP)

Drug-induced erectile dysfunction where it

would be inappropriate to alter the dosage or to

discontinue the use of the drug in question

Mixed psychogenic/organic erectile

dysfunction

1 year

Or

Indefinite, if

annual

ceiling

1 year

6


CLAIM RENEWAL

CIMZIA (CERTOLIZUMAB PEGOL)


DIN 02331675 (200 MG / ML)

Rheumatoid

Arthritis

(RA)




And





3 months or more

And


○ HAQ > 1




1 year

1 year


affected joints

And



return to work

COMPLERA

(EMTRICITABINE / TENOFOVIR

DISOPROXIL FUMARATE / RILPIVIRINE)

Oral Tablet

DIN 02374129 (200 MG / 300 MG / 25 MG)

HIV infection


Government Program

In monotherapy for the treatment of HIV-1

infection:

Antiretroviral treatment-naive adults

HIV-1 RNA ≤ 100 000 copies/mL

6 months

1 year

COPAXONE (GLATIRAMER ACETATE)


DIN 02245619 (20 MG / ML)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Chronic

Progressive

Multiple Sclerosis

(CPMS)

Single

demyelinating event

with two clinically

silent lesions

typical of MS

(MRI+ )


Government Program

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

If isolated

clinical

syndrome

(ICS): 1

year

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

ICS : 1 year

DIACOMIT (STIRIPENTOL)

Oral Capsule, Powder for Suspension

DIN 02398958 (250 MG)

DIN 02398966 (500 MG)

DIN 02398974 (250 MG / PCK)

DIN 02398982 (500 MG / PCK)

Refractory

myoclonic epilepsy

Treatment of refractory generalized tonic-clonic

seizures in patients with severe myoclonic

epilepsy in infancy:


In conjunction with clobazam and valproate

After failure with clobazam and valproate

alone

6 months

1 year

7


CLAIM RENEWAL

ENBREL (ETANERCEPT)


DIN 02274728 (50 MG / ML)

DIN 02242903 (25 MG)

Rheumatoid

Arthritis

(RA)

Juvenile Idiopathic

Arthritis (JIA)

Psoriatic Arthritis

(PA)

Ankylosing

Spondylitis (AS)

Chronic moderate

to severe plaque

psoriasis




And





3 months or more

And


○ HAQ > 1





5 or more affected joints and failure or

contraindications to methotrexate and to

another disease modifiying antirheumatic drugs

for a period of 3 months or more

0.8mg/kg (max 50mg) sc every week


psoriatic arthritis with persistent and active

disease (more than 3 affected joints)

Failure or contraindications to methotrexate

and to another disease modifiying

antirheumatic drugs for a period of 3 months

or more

HAQ > 1

No response to NSAIDs

BASDAI score ≥ 4

Treatment of adult patients with chronic

moderate to severe plaque psoriasis who are

candidates for systemic therapy or phototherapy:

No response, contraindications, intolerance or

inaccessibility to phototherapy


Treated by a dermatologist

Failure (or inappropriate) to systemic therapy

by two of the following antipsoriatic agents:

methotrexate, cyclosporine or acitretin

Psoriasis Area Severtiy Index (PASI) ≥10 or

extensive plaques on the face, the palms of the

hands, the soles of the feet or the genital area

And

Dermatology Life Quality Index (DLQI) ≥10

1 year

1 year

1 year

1 year

4 months

2 years


affected joints

And



return to work

2 years


affected joints

And




2 years


affected joints

And


SRV or CRP or a 0.2 point

diminution for the HAQ score

or return to work

2 years

A 2.2 points diminution for

the BASDI score (or 50%) or

return to work

1 year

Improvement of 75% for the

PASI score

Or


PASI score and a 5 points

improvement for DLQI

Or

Significant improvement of

lesions on the face, the palms

of the hands, the soles of the

feet or the genital area

8


CLAIM RENEWAL

EPREX (EPOETINE ALFA)


DIN 02243239 (20000 IU / 0.5 ML)

DIN 02288680 (30000 IU / 0.75 ML)

DIN 02231587 (10000 IU / ML)

DIN 02126591 (10000 IU / ML)

DIN 02231583 (1000 IU / 0.5 ML)

DIN 02231584 (2000 IU / 0.5 ML)

DIN 02126575 (2000 IU / ML)

DIN 02231585 (3000 IU / 0.3 ML)

DIN 02240722 (40000 IU / ML)

DIN 02231586 (4000 IU / 0.4 ML)

DIN 02126583 (4000 IU / ML)

DIN 02243400 (5000 IU / 0.5 ML)

DIN 02243401 (6000 IU / 0.6 ML)

Anemia of Chronic

Renal Failure /

Dialysis

Anemia in HIV-

infected Patients

Anemia due to

chemotherapy

Chronic non-

hemolytic anemia*


Government Program

Treatment of anemia associated with chronic renal

failure, including patients on dialysis and patients

not on dialysis with Hb ˂ 100g/L

Treatment of transfusion-dependent anemia

related to therapy with zidovudine in HIV-

infected patients:

Endogenous serum erythropoietin level is ≤500

mU/mL and when patients are receiving a dose

of zidovudine ≤4200 mg/week

Treatment of anemia due to chemotherapy in

patients with non-myeloid malignancies

Treatment of symptomatic non-hemolytic anemia

not caused by iron deficiency, folic acid or

vitamin B12 for non cancerous persons whose

hemoglobin level is ˂ 100 g//L *

*: Quebec only, according to Quebec Prescription

Drug Plan

Indefinite

Indefinite

Indefinite

Indefinite

N/A

N/A

N/A

N/A

ERIVEDGE (VISMODEGIB)

Oral Capsule

DIN 02409267 (150MG)

Basal cell

carcinoma

Treatment of basal cell carcinoma:


Matastatic

Or

Advanced basal cell carcinoma inappropriate

for surgery

or radiotherapy

Confirmed by biopsy

PPG-E

4 months

6 months

If response to treatment

(decrease of at least 30% of

the size of the tumour and

stabilisation or a subsequent

improvement)

Note: Treatment to follow

until progression of disease or

unacceptable toxic reactions

ESBRIET (PIRFENIDONE)

Oral Capsule

DIN 02393751 (267 MG)

Idiopathic

Pulmonary Fibrosis

(IPF)

Treatment of mild to moderate idiopathic

pulmonary fibrosis (IPF):


Prescribed by a pulmonologist or a specialist

physicians experienced in the diagnosis and

treatment of IFP

Mild to moderate stage

Diagnosis confirmed by bronchoscopy and/or

tomography

6 months

6 months

Well-tolerated medication

Clinical condition of the

patient to be evaluated

(disease evolution)

9


CLAIM RENEWAL

EXTAVIA (INTERFERON BETA-1B)


DIN 02337819 (0.3 MG)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Chronic

Progressive

Multiple Sclerosis

(CPMS)

Single

demyelinating event

with two clinically

silent lesions

typical of MS

(MRI+ )


Government Program

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

If isolated

clinical

syndrome

(ICS): 1

year

4 years if

EDSS < 4

2 years if

EDSS ≥ 4

ICS : 1 year

FAMPYRA (FAMPRIDINE)

Oral Tablet

DIN 02379910 (10 MG)

Multiple Sclerosis

(MS)

Symptomatic improvement of walking in adult

patients with MS:

EDSS ≤ 7

Pre-treatment evaluation:

○ Walking Scale (MSWS-12)

○ Timed 25-Foot Walk (T25FW)

3 months

12 months

If improvement of 20% of

MSWS-12 and T25FW

FORTEO (TERIPARATIDE)


DIN 02254689 (250 MCG / ML)

Severe osteoporosis

Osteoporosis

associated with

sustained systemic

glucocorticoid

therapy in adults

who are at

increased risk for

fracture

Treatment of postmenopausal women with severe

osteoporosis and treatment to increase bone mass

in men with primary or hypogonadal severe

osteoporosis:

Bone mineral density (BMD) T-Score ≤ -2.5

And

New fracture despite antiresorptive treatment

for at least 12 months

Or

Significant reduction in bone mineral density

despite an adequate continuous antiresorptive

treatment for at least 24 months

Treatment of osteoporosis associated with

sustained systemic glucocorticoid therapy in men

and women who are at increased risk for fracture:


(without fractures)


(with fractures or history of fractures)

24 months

Note:

Maximum

treatment

duration =

total of 24

months

24 months

Note:

Maximum

treatment

duration =

total of 24

months

Renewal denied if 24 months

treatment completed

Renewal denied if 24 months

treatment completed

FUZEON (ENFUVIRTIDE)


DIN 02247725 (108 MG)

HIV infection


Government Program



patients with evidence of HIV-1 replication despite

ongoing antiretroviral therapy

6 months

1 year

10


CLAIM RENEWAL

FYCOMPA (PERAMPANEL)

Oral Tablet

DIN 02404516 (2 MG)

DIN 02404524 (4 MG)

DIN 02404532 (6 MG)

DIN 02404540 (8 MG)

DIN 02404559 (10 MG)

DIN 02404567 (12 MG)

Partial seizures

epilepsy

Management of partial-onset seizures:


Failure to at least two conventional treatments

6 months

2 years

Note: Potential for drug abuse

GILENYA (FINGOLIMOD)

Oral Capsule

DIN 02365480 (0.5 MG)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)


Government Program

Generally recommended in MS patients who

have had an inadequate response to, or are

unable to tolerate, one or more therapies for

multiple sclerosis:

Monotherapy


EDSS ≤ 6


6 months

1 year

GLEEVEC (IMATINIB)

Oral Tablet

DIN 02253275 (100 MG)

DIN 02253283 (400 MG)

Including all generic drugs

Chronic Myeloid

Leukemia (CML)

Philadelphia

chromosome-

positive acute

lymphoblastic

leukemia

(Ph+ ALL)

Advanced

Gastrointestinal

Stromal Tumors

(GIST)

Intermediate to high

risk of relapse

following complete

resection of Kit

(CD117) positive

GIST

Treatment of adult and pediatric patients with

newly diagnosed, Ph+ , chronic myeloid

leukemia (CML) in chronic phase

Treatment of adult patients with Ph+ CML in

blast crisis, accelerated phase or chronic phase

(after failure of interferon-alpha therapy)

Treatment of adult patients with Ph+ Acute

lymphoblastic leukemia (Ph+ ALL):

Refractory or recurring and candidate to stem

cell transplantation

Newly diagnosed adult (in the maintenance

stade) after parenteral cancer chemotherapy

Treatment of adult patients with unresectable

and/or metastatic malignant gastrointestinal

stromal tumors (GIST):

Kit (CD117) positive

Adjuvant treatment of adult patients who are at

intermediate to high risk of relapse following

complete resection of Kit (CD117) positive

GIST

1 year

3 months

6 months

6 months

1 year

Indefinite if response to

treatment

3 months

1 year

6 months

1 year

11


CLAIM RENEWAL

HUMATROPE (SOMATROPIN)

Intramuscular, Subcutaneous Solution

DIN 02243077 (6 MG)

DIN 02243078 (12 MG)

DIN 02243079 (24 MG)

DIN 00745626 (1 MG / ML)

Growth hormone

deficiency

Turner syndrome


Government Program

Pediatric patients:

Treatment of pediatric patients who have

growth failure due to an inadequate secretion

of normal endogenous growth hormone or to a

renal failure

Should not be used for treatment of pediatric

patients with closed epiphyses

Treatment covered until 15 years old of bone

age for girls and 16 years old of bone age for

boys and growth rate > 2 cm / year

Adult patients:

For replacement of endogenous growth hormone

in adults with growth hormone deficiency if:

GH Peak ≤ 5 mcg/L

And

Adult Onset: Patients must have GHD, either

alone or associated with multiple hormone

deficiencies (hypopituitarism), as a result of

pituitary disease, hypothalamic disease,

surgery, radiation therapy, or trauma

Or

Childhood-onset: if GHD during childhood and

confirmed as an adult

Long-term treatment of idiopathic short stature

defined by height at least 2.25 standard

deviation scores (SDS) below the mean for age

and sex

Treatment of short stature or growth failure in

children with SHOX deficiency

Long-term treatment of short stature

associated with Turner syndrome



1 year

1 year

1 year

1 year

1 year

1 year

12


CLAIM RENEWAL

HUMIRA (ADALIMUMAB)


DIN 02258595 (40 MG / 0.8 ML)

Rheumatoid

Arthritis

(RA)

Psoriatic Arthritis

(PA)

Ankylosing

Spondylitis (AS)

Crohn' s disease

Chronic moderate

to severe plaque

psoriasis

Juvenile Idiopathic

Arthritis (JIA)




And





3 months or more

And


○ HAQ > 1










or more

HAQ > 1


BASDAI score ≥ 4

Treatment of adult patients who have had an

inadequate response to conventional therapy

(including corticosteroids and/or

immunosuppressants), no response, intolerant or

contraindications














And



5 or more affected joints

Failure to methotrexate as a monotherapy and

to another disease modifiying antirheumatic

drugs for a period of 3 months or more

In combination with methotrexate except if

intolerance or contraindications

24mg/m2 (max 40mg) sc every other week

1 year

1 year

1 year

1 year

4 months

1 year

2 years


affected joints

And



return to work

2 years


affected joints

And




or return to work

2 years



return to work

2 years

1 year


PASI score

Or




Or





2 years


affected joints

And




13


CLAIM RENEWAL

ILARIS (CANAKINUMAB)


DIN 02344939 (150 MG)

Cryopyrin-

Associated Periodic

Syndromes (CAPS)

Neonatal-Onset

Multisystem

Inflammatory

Disease (NOMID)

Chronic Infantile

Neurological,

Cutaneaous

Articular Syndrome

(CINCA)

Indicated for the ongoing management of

Cryopyrin-Associated Periodic Syndromes

(CAPS), in adults and children aged 4 years and

older, including:

Familial Cold Autoinflammatory Syndrome

(FCAS)/Familial Cold Urticaria (FCU)

Muckle-Wells Syndrome (MWS)

May also be used in Neonatal-Onset Multisystem

Inflammatory Disease (NOMID):

4 years of age or orlder

May also be used in Chronic Infantile

Neurological, Cutaneous, Articular Syndrome

(CINCA):


4 months

4 months

4 months

4 months

4 months

4 months

INCIVEK (TELAPREVIR)

Oral Tablet

DIN 02371553 (375 MG)

Chronic Hepatitis C

Treatment of genotype 1 Chronic Hepatitis C in

adult patients with compensated liver disease,

including cirrhosis:


Previously untreated patients or who have

previously failed therapy

In combination with peginterferon alfa (INFα)

and ribavirin (RBV)

HIV-uninfected patients

12 weeks

(TOTAL)

First 12

weeks of the

triple

therapy

treatment

followed by

treatment

with

pegINFα and

RBV only

N/A

INLYTA (AXITINIB)

Oral Tablet

DIN 02389630 (1.0 MG)

DIN 02389649 (5.0 MG)

Metastatic Renal

Cell Carcinoma

(RCC) of clear cell

histology

Treatment of metastatic RCC of clear cell

histology:

After failure of prior systemic therapy

If failure, intolerance or contraindications for

treatment with a tyrosine kinase inhibitor (TKI)

ECOG ≤ 1

4 months

4 months

INTELENCE (ETRAVIRINE)

Oral Tablet

DIN 02306778 (100 MG)

DIN 02375931 (200 MG)

HIV infection


Government Program



patients who have failed prior antiretroviral

therapy and have HIV-1 strains resistant to

multiple antiretroviral agents, including Non-

Nucleoside Reverse Transcriptase Inhibitor

(NNRTIs)

6 months

1 year

IRESSA (GEFITINIB)

Oral Tablet

DIN 02248676 (250 MG)

Advanced or

metastatic non-

small cell lung

cancer (NSCLC)

First-line treatment of patients with locally

advanced or metastatic NSCLC who have

activating mutations of the EGFR-TK:

ECOG ≤ 2

4 months

4 months

14


CLAIM RENEWAL

ISENTRESS (RALTEGRAVIR)

Oral Tablet

DIN 02301881 (400 MG)

DIN 02392429 (25 MG) Chewable

DIN 02392437 (100 MG) Chewable

HIV infection


Government Program

In combination with other antiretroviral agents

for the treatment of HIV–1 infected adult

patients

In combination with other antiretroviral agents

for the treatment of HIV-1 infection in

treatment-experienced children and adolescents

2 years of age and older

6 months

1 year

JAKAVI (RUXOLITINIB PHOSPHATE)

Oral Tablet

DIN 02388006 (5 MG)

DIN 02388014 (15 MG)

DIN 02388022 (20 MG)

Splenomegaly

Treatment of splenomegaly and/or its associated

symptoms:

Primary myelofibrosis

Post-polycythemia vera myelofibrosis

Post-essential thrombocythemia myelofibrosis

Platelet Count

IPSS (International Prostatism Symptom)

Score = 2 or 3

Spleen volume

ECOG ≤ 3

6 months

6 months

JETREA (OCRIPLASMINE)

Intravitreal Solution

DIN 02410818 (2.5 MG/ML)

Symptomatic

vitreomacular

adhesion (VMA)

Treatment of symptomatic vitreomacular

adhesion:


Diagnosis confirmed by optical coherence

tomography

Only one eye at a time

Monotherapy (not authorezed at the same time

as VEGF inhibitors)

Optimum visual acuity of the affected eye

< 20/25 after correction

30 days

N/A

Another treatment for the

second eye is possible

afterwards

KALYDECO (IVACAFTOR)

Oral Tablet

DIN 02397412 (150 MG)

Cystic Fibrosis

(CF)

Treatment of cystic fibrosis:


A G551D mutation in the Cystic Fibrosis

Transmembrane conductance Regulator

(CFTR) gene

Limitation of use: KALYDECO is not

effective in patients with CF who are

homozygous for the F508del mutation in the

CFTR gene

1 year

1 year

If improvement of the

VEMS/FEV1

KINERET (ANAKINRA)


DIN 02245913 (100 MG / 0.67 ML)

Rheumatoid arthritis

(RA)




And





3 months or more

And


○ HAQ > 1




1 year

2 years


affected joints

And



return to work

15


CLAIM RENEWAL

KUVAN (SAPROPTERIN)

Oral Tablet

DIN 02350580 (100 MG)

Hyperphenylalani-

nemia (HPA)

Indicated to reduce blood phenylalanine (Phe)

levels in patients with HPA due to

tetrahydrobiopterin-(BH4)-responsive

Phenylketonuria (PKU)

In conjunction with a Phe-restricted diet


3 months

3 months

LEVITRA (VARDENAFIL)

Oral Tablet

DIN 02250462 (5 MG)

DIN 02250470 (10 MG)

DIN 02250489 (20 MG)

Erectile

Dysfunction (ED)

NOTE:

If no ED

clause: not

eligible.












dysfunction

1 year

Or

Indefinite, if

annual

ceiling

1 year

LEVULAN (AMINOLEVULINIC ACID)

Topical Solution

DIN 02243933 (20%)

Actinic keratoses

History of basocellular carcinoma confirmed

by biopsy


In combination with photodynamic therapy

(PDT)

Sold by a licensed pharmacist

3 months

3 months

LUCENTIS ( RANIBIZUMAB)

Intravitreal Solution

DIN 02296810 (10 MG / ML)

Neovascular (wet)

age-related macular

degeneration

(AMD)

Macular edema

secondary to retinal

vein occlusion

(RVO)

Diabetic Macular

Edema (DME)


Government Program



For all disease:


Maximum one injection per month per eye

Treatment of neovascular (wet) AMD

Treatment of visual impairment due to macular

edema secondary to retinal vein occlusion (RVO)

Treatment of visual impairment due to diabetic

macular edema (DME)

1 year

6 months

6 months

Renewal is permitted if

demonstrated by clinical

beneficial effect (stabilisation

or improvement of the

medical condition confirmed

by a medical examination)

1 year

1 year

1 year

MEKINIST

(TRAMETINIB)

Oral Tablet

DIN 02409623 (0.5 MG)

DIN 02409658 (2.0 MG)

Unresectable or

metastatic

melanoma

Treatment of unresectable or metastatic

melanoma:

Stage

BRAF V600 mutation-positive confirmed by

a validated BRAF V600 test

Monotherapy

ECOG ≤ 1

* Not covered if failure with Zelboraf

4 months

4 months

16


CLAIM RENEWAL

METVIX

(METHYL AMINOLEVULINATE)

Topical Cream

DIN 02323273 (168 MG / G)

Primary superficial

basal cell

carcinoma

Treatment of primary superficial basal cell

carcinoma:

Confirmed by biopsy

In combination with photodynamic therapy

(PDT)



4 months

N/A

NEULASTA (PEGFILGRASTIM)


DIN 02249790 (10 MG / ML)

Neutropenia


Government Program

Indicated to decrease the incidence of

infection, as manifested by febrile neutropenia,

in patients with non-myeloid malignancies

receiving myelosuppressive anti-neoplastic

drugs

1 year

1 year

NEUPOGEN (FILGRASTIM)


DIN 01968017 (300 MCG/ ML)

Neutropenia


Government Program

Indicated for the treatment of the following:

Cancer patients receiving myelosuppressive

chemotherapy

Patients with acute myeloid leukemia

Cancer patients receiving myeloablative

chemotherapy followed by bone marrow

transplantation

Cancer patients undergoing peripheral blood

progenitor cell (PBPC) collection and therapy

Patients with severe chronic neutropenia

(SCN): congenital, cyclic or idiopathic

Patients with HIV Infection: to maintain a

normal absolute neutrophil count (ANC) (e.g.,

between 2× 109 and 10× 109/L)

Note: Not a pre-authorization drug for Quebec

residents.

1 year

1 year

NEXAVAR (SORAFENIB)

Oral Tablet

DIN 02284227 (200 MG)

Renal Cell

Carcinoma (RCC)

(clear cell)

Hepatocellular

Carcinoma (HCC)

Second-line treatment for locally advanced /

metastatic RCC (clear cell):

After failure of cytokine-based therapy or

unsuitable for cytokine-based therapy

ECOG ≤1

Treatment of patients with unresectable

hepatocellular carcinoma (HCC):

ECOG ≤ 2

Child-Pugh score “A”

5 months

5 months

5 months

5 months

NPLATE (ROMIPLOSTIM)


DIN 02322854 (250 MCG / 0.5 ML)

DIN 02322862 (500 MCG / ML)

Chronic Immune

(idiopathic)

Thrombocytopenic

Purpura (ITP)

Indicated to increase the platelet levels in adult

patients with ITP:

Who are non-splenectomized and have had an

inadequate response or are intolerant to

corticosteroids and/or immunoglobulins

Or

Who are splenectomized and have had an

inadequate response to splenectomy

6 months

1 year

17


CLAIM RENEWAL

NUTROPIN / NUTROPIN AQ PEN

(SOMATROPIN)


DIN 02216191 (10 MG)

DIN 02376393 (10 MG / 2 ML)

DIN 02249002 (10 MG / 2 ML)

Growth hormnone

deficiency

Turner’s syndrome


Government Program

Pediatric patients:




renal failure






Adult patients:



GH Peak ≤ 5 mcg/L

And






Or






and sex







1 year

1 year

1 year

1 year

1 year

1 year

18


CLAIM RENEWAL

OMNITROPE (SOMATROPIN)


DIN 02325063 (5 MG / 1.5 ML)

DIN 02325071 (10 MG / 1.5 ML)

Growth hormone

deficiency


Government Program

Pediatric patients:




renal failure






Adult patients:



GH Peak ≤ 5 mcg/L

And






Or






and sex



1 year

1 year

1 year

1 year

19


CLAIM RENEWAL

ORENCIA (ABATACEPT)


DIN 02282097 (250 MG)


DIN 02402475 (125 MG)

Rheumatoid

Arthritis

(RA)

Juvenile Arthritis

(JA)

DIN 02282097

only

Validate the administration site: if in a hospital


(DIN 02282097 only)




And





3 months or more or an Anti-TNF.

And


○ HAQ > 1





5 or more affected joints

Failure to methotrexate as a monotherapy and



< 75kg : 10mg/kg/dose

1 year

1 year

2 years


affected joints

And



return to work

2 years


affected joints

And




OZURDEX (DEXAMETHASONE)

Intravitreal Implant

DIN 02363445 (0.7 MG)

Macular edema

following central

retinal vein

occlusion (CRVO)

Non-infectious

uveitis

Treatment of macular edema following central

retinal vein occlusion (CRVO):



No simultaneous bilateral treatment

Maximum of two injections and an interval of

6 months between the two

Prescribed by an ophthalmologist

Treatment of non-infectious uveitis affecting the

posterior segment of the eye:



No simultaneous bilateral treatment

Maximum of two injections and an interval of

6 months between the two


1 year

(max 2

implants /

year / eye)

1 year

(max 2

implants /

year / eye)

N/A

N/A

20


CLAIM RENEWAL

PEGASYS (PEGINTERFERON ALFA-2A)


DIN 02248077 (180 MCG / 0.5 ML)

DIN 02248078 (180 MCG / ML)

Chronic Hepatitis C

Chronic Hepatitis B

Treatment of chronic hepatitis C:

Genotype 2 or 3

Genotype other than 2 or 3

HIV Co-infection all genotypes

Treatment of both HBeAg-positive and HBeAg-

negative chronic hepatitis B

24 weeks

24 weeks

24 weeks

48 weeks

N/A

Up to a maximum of 48

weeks

Achieved viral clearance or

an HCV-RNA reduction from

baseline of at least 1.8 log by

week 12


weeks




week 12

N/A

PEGASYS RBV

(PEGINTERFERON ALFA-2A / RIBAVIRIN)

Subcutaneous Solution, Oral Tablet

DIN 02253410 (180 MCG/ML, 200 MG/TAB)

DIN 02253429

(180MCG/0.5ML,200MG/TAB)

Chronic Hepatitis C


Genotype 2 or 3



24 weeks

24 weeks

24 weeks

N/A


weeks




week 12


weeks




week 12

PEGETRON / PEGETRON CLEARCLICK

(RIBAVIRIN-PEGINTERFERON ALFA-2B)

Oral Capsule, Subcutaneous Solution

DIN 02246026 (200MG/CAP,

50MCG/0.5ML)

DIN 02246030

(200MG/CAP,150MCG/0.5ML)

DIN 02254581 (200MG/CAP,

80MCG/0.5ML)

DIN 02254603


DIN 02254638


DIN 02254646


Chronic Hepatitis C


Genotype 2 or 3



24 weeks

24 weeks

24 weeks

N/A


weeks




week 12


weeks




week 12

21


CLAIM RENEWAL

PULMOZYME (DORNASE ALFA)

Inhalation Solution

DIN 02046733 (1 MG / ML)

Cystic Fibrosis (CF)


Government Program

Indicated in the management of cystic fibrosis

patients to reduce the frequency of respiratory

infections requiring parenteral antibiotics and to

improve pulmonary function:


Forced vital lung capacity more than 40%

1 year

1 year

PREZISTA (DARUNAVIR)

Oral Tablet

DIN 02338432 (75 MG)

DIN 02369753 (150 MG)

DIN 02324016 (400 MG)

DIN 02324024 (600 MG)

DIN 02393050 (800 MG)

HIV infection


Government Program



patients with evidence of HIV-1 replication who

have failed prior antiretroviral therapy

6 months

1 year

REBIF (INTERFERON BETA-1A)


DIN 02237319 (22 MCG / 0.5 ML)

DIN 02237320 (44 MCG / 0.5 ML)

DIN 02277492 (8.8 MCG / 0.2 ML)

DIN 02281708 (8.8 MCG / 0.2 ML)

DIN 02318253 (66 MCG / 1.5 ML)

DIN 02318261 (132 MCG / 1.5 ML)

Multiple sclerosis

(MS)


Government Program

Treatment of Relapsing-Remitting Multiple

Sclerosis (RRMS)

Or

Treatment of Secondary Progressive Multiple

Sclerosis (SPMS) for patients which still

experience recurrent attacks

And

EDSS < 7

Single demyelinating event with two clinically

silent lesions typical of MS (MRI + )

4 years

If EDSS < 4

2 years

If EDSS ≥ 4

If isolated

clinical

syndrome

(ICS): 1

year

4 years

If EDSS < 4

2 years

If EDSS ≥ 4

ICS: 1 year

22


CLAIM RENEWAL

REMICADE (INFLIXIMAB)


DIN 02244016 (100 MG)

Please see the following page for more

information about Remicade

Crohn’s disease

Ulcerative colitis

Rheumatoid

Arthritis (RA)



Treatment of moderate to severe Crohn’s disease:


Inadequate response to conventional therapy

(including aminosaliyilates and/or

corticosteroids and/or immunosuppressants),

no response, intolerant or contraindications

Induction dosage: 5 mg/kg at 0, 2 and 6 weeks

Adult maintenance dosage: 5 to 10 mg/kg

every 8 weeks

Pediatric maintenance dosage: 5 mg/kg every

8 weeks

Treatment of moderately to severely active

ulcerative colitis:


Inadequate response to conventional therapy

(including aminosaliyilates and/or

corticosteroids and/or immunosuppressants),

no response, intolerant or contraindications


Adult maintenance dosage: 5 to 10 mg/kg

every 8 weeks

Pediatric maintenance dosage: 5 mg/kg every

8 weeks




And





3 months or more

And


○ HAQ > 1





Maintenance dosage: 3 to 10 mg/kg every 4 to

8 weeks

Please see the following page for more

information about Remicade

1 year

1 year

1 year

2 years

2 years

2 years


affected joints

And




or return to work

23


CLAIM RENEWAL

REMICADE (INFLIXIMAB)


DIN 02244016 (100 MG)

Psoriatic Arthritis

(PA)

Ankylosing

Spondylitis (AS)

Chronic moderate

to severe plaque

psoriasis









or more

HAQ > 1


Maintenance dosage: 5 mg/kg every 8 weeks


BASDAI score ≥ 4


Maintenance dosage: 5 mg/kg every 6 to 8

weeks














And


1 year

1 year

4 months

2 years


affected joints

And




or return to work

2 years



return to work

1 year


PASI score

Or




Or





REMODULIN (TREPROSTINIL)


DIN 02246552 (1 MG / ML)

DIN 02246553 (2.5 MG / ML)

DIN 02246554 (5 MG / ML)

DIN 02246555 (10 MG / ML)

Pulmonary Arterial

Hypertension

(PAH)


Government Program

Treatment of primary pulmonary hypertension or

treatment of pulmonary hypertension secondary to

scleroderma:


WHO functional - Class III or IV

Indefinite

N/A

RESOTRAN

(PRUCALOPRIDE SUCCINATE)

Oral Tablet

DIN 02377012 (1 MG)

DIN 02377020 (2 MG)

Chronic idiopathic

constipation in

adult female

Treatment of chronic idiopathic constipation in

adult female after failure of laxatives:

Women


Patients in whom laxatives failed to provide

adequate relief

Symptoms since at least 6 months and not

induced by secondary causes of constipation

6 months

2 years

24


CLAIM RENEWAL

RESTASIS (CICLOSPORIN)

Ophtalmic Emulsion

DIN 02355655 (0.05%)

Aqueous Deficient

Dry Eye Disease

Treatment of moderate to moderately severe

aqueous deficient dry eye disease:



Severity Level 2 or 3 according to DEWS

Guidelines

Indefinite

N/A

RETISERT

(FLUOCINOLONE ACETONIDE)

Intravitreal Implant

DIN 02306980 (0.59 MG)

Non-infectious

uveitis

Treatment of chronic non-infectious uveitis

affecting the posterior segment of the eye:




Administered in a private clinic


One implant / eye / 36 months

1 month

N/A

REVATIO (SILDENAFIL)

Oral Tablet

DIN 02279401 (20 MG)

RATIO-SILDENAFIL R (SILDENAFIL)

Oral Tablet

DIN 02319500 (20 MG)

APO-SILDENAFIL R (SILDENAFIL)

Oral Tablet

DIN 02418118 (20 MG)

Pulmonary Arterial

Hypertension

(PAH)


hypertension (PAH) or treatment of pulmonary

hypertension secondary to connective tissue

disease:



Indefinite

N/A

REVLIMID (LENALIDOMIDE)

Oral Capsule

DIN 02304899 (5 MG)

DIN 02304902 (10 MG)

DIN 02317699 (15 MG)

DIN 02317710 (25 MG)

Myelodysplastic

Syndrome (MDS)

Multiple myeloma

Treatement of transfusion – dependent anemia

due to low or intermediate-1 risk myelodysplastic

syndromes (MDS) associated with a deletion 5q

cytogenetic abnormality:

Hg ≤ 90g/L

Max 10 mg / day

In combination with dexamethasone

Failure to at least one prior therapy

ECOG ≤ 2

6 months

6 months

6 months

12 months

REVOLADE (ELTROMBOPAG)

Oral Tablet

DIN 02361825 (25 MG)

DIN 02361833 (50 MG)

Chronic Immune

(idiopathic)

Thrombocytopenic

Purpura (ITP)

Indicated to increase platelet counts in adult

patients with ITP:

Who are splenectomized and refractory to


Who are non-splenectomized (if surgery is

contraindicated) and inadequate response to


Platelet counts < 30 x 109/L

Child-Pugh Score < 10

4 months

8 months

Platelet counts ≥ 50 x 109 /L

without Ig

REVOLADE therapy should

not exceed 1 year of

continuous treatment. After 1

year of continuous treatment,

therapeutic options should be

reassessed.

If prolonged treatment, the

authorization may be 1 year.

25


CLAIM RENEWAL

RITUXAN (RITUXIMAB)


DIN 02241927 (10 MG / ML)

Rheumatoid

Arthritis (RA)

Granulomatosis

with Polyangiitis

(GPA, also known

as Wegener' s

Granulomatosis) or

Microscopic

Polyangiitis (MPA)






And

In combination with methotrexate (unless

intolerance or contraindications) after

inadequate response or intolerance to TNF

inhibitor therapies

And


○ HAQ > 1




1000 mg IV infusion followed two weeks later

by the second 1000 mg IV infusion

(Retreatment 24 weeks later if needed)

In combination with glucocorticoids

375 mg/m2 body surface area, administered

as an IV infusion once weekly for 4 weeks

1 year

1 month

2 years


affected joints

And




or return to work

N/A

26


CLAIM RENEWAL

SAIZEN (SOMATROPIN)


DIN 02237971 (5 MG)

DIN 02272083 (8.8 MG)

DIN 02350122 (5.83 MG / ML)

DIN 02350130 (8 MG / ML)

DIN 02350149 (8 MG / ML)

DIN 02215136 (10 IU / KIT)

Growth hormnone

deficiency

Turner syndrome


Government Program

Pediatric patients:




renal failure






Adult patients:



GH Peak ≤ 5 mcg/L

And






Or







1 year

1 year

1 year

1 year

1 year

1 year

SAMSCA (TOLVAPTAN)

Oral Tablet

DIN 02370468 (15 MG)

DIN 02370476 (30 MG)

Non-hypovolemic

hyponatremia

Treatment of non-hypovolemic hyponatremia:


Serum sodium < 130mEq/L or symptomatic

hyponatremia

3 months

3 months

SATIVEX

(CANNABIDIOL / DELTA-9-

TETRAHYDROCANNABINOL)

Buccal Spray

DIN 02266121 (25 MG + 27 MG / ML)

Multiple Sclerosis

(MS)

Cancer pain

Treatment for the symptomatic relief of

neuropathic pain in adult patients with multiple

sclerosis (MS)

Treatment of spastic hypertonia associated with

MS in patients unresponsive to prior therapies and

showing an improvement following a first trial

Treatment of moderate to severe cancer pain:


Failure to the highest tolerated dose of strong

opioid therapy

1 year

1 year

1 year

1 year

1 year

1 year

27


CLAIM RENEWAL

SENSIPAR (CINACALCET)

Oral Tablet

DIN 02257130 (30 MG)

DIN 02257149 (60 MG)

DIN 02257157 (90 MG)

Chronic Kidney

Disease (CKD)

Parathyroid

carcinoma

Primary

Hyperparathyroidis

m

(HPT)


Government Program

Treatment of secondary hyperparathyroidism

(HPT) in patients with Chronic Kidney Disease

(CKD) receiving dialysis

Or

Controls parathyroid hormone levels, calcium and

phosphorous levels, and the serum calcium-

phosphorous product (Ca× P), in patients with

CKD receiving dialysis

Indicated for the reduction of hypercalcemia in

patients with parathyroid carcinoma

Indicated for the reduction of clinically significant

hypercalcemia if parathyroidectomy is not

clinically appropriate or is contraindicated

Indefinite

1 year

1 year

N/A

1 year

1 year

SEROSTIM (SOMATROPIN)


DIN 02239046 (5 MG)

DIN 02239047 (6 MG)

Cachexia - AIDS

Treatment of HIV wasting associated with

catabolism, weight loss or cachexia:


3 months

3 months

(only one renewal, up to a

maximum of 6 months for

treatment)

28


CLAIM RENEWAL

SIMPONI (GOLIMUMAB)


DIN 02324776 (50 MG / 0.5 ML)

DIN 02324784 (50 MG / 0.5 ML)

(Ulcerative colitis only)

DIN 02413175 (100 MG / 1.0 ML)

DIN 02413183 (100 MG / 1.0 ML)

Rheumatoid

Arthritis (RA)

Psoriatic Arthritis

(PA)

Ankylosing

Spondylitis (AS)

Ulcerative colitis

In combination with methotrexate (unless

intolerance or contraindications)




And





3 months or more

And


○ HAQ > 1







Failure or contraindications to methotrexate an



HAQ > 1


BASDAI score ≥ 4

Treatment of ulcerative colitis:


Failure to conventional therapy

(aminosaliyilates, corticosteroids, azathioprine

or 6-mercaptopurine)

5 months

5 months

5 months

5 months

1 year


affected joints

And




or return to work

1 year


affected joints

And




or return to work

1 year



return to work

1 year

Response to induction dosage

and maintenance of the

reduction of signs and

symptoms

SOMAVERT (PEGVISOMANT)


DIN 02272199 (10 MG)

DIN 02272202 (15 MG)

DIN 02272210 (20 MG)

Acromegaly

Treatment of acromegaly:


Inadequate response to surgery, and/or

radiation therapy or for whom these therapies

are not appropriate

Symptoms

Serum IGF-I levels

6 months

1 year

If improvement of symptoms

and clinical signs and

normalization of serum IGF-I

levels

29


CLAIM RENEWAL

SPRYCEL (DASATINIB)

Oral Tablet

DIN 02293129 (20 MG)

DIN 02293137 (50 MG)

DIN 02293145 (70 MG)

DIN 02360810 (80 MG)

DIN 02320193 (100 MG)

DIN 02360829 (140 MG)

Chronic Myeloid

Leukemia (CML)

Acute

Lymphoblastic

Leukemia (ALL)

Treatment of adult patients with Ph+ chronic,

accelerated, or blast phase CML with resistance

or intolerance to prior therapy including imatinib

Or

Treatment of adult patients with newly diagnosed

Ph+ CML in chronic phase

ALL in adult patients with Ph+ if resistance or

intolerance to prior therapy

6 months

6 months

6 months

6 months

STAXYN (VARDENAFIL)

Oral Tablet

DIN 02372436 (10 MG)

Erectile

Dysfunction (ED)

NOTE:

If no ED clause:

not eligible.












dysfunction

1 year

Or

Indefinite, if

annual

ceiling

1 year

STELARA (USTEKINUMAB)


DIN 02320673 (45 MG / 0.5 ML)

DIN 02320681 (90 MG / 1.0 ML)

Chronic moderate

to severe plaque

psoriasis

Treatment of adult patients with chronic moderate

to severe plaque psoriasis who are candidates for

systemic therapy or phototherapy:











And


5 months

1 year


PASI score

Or




Or





STIVARGA (REGORAFENIB)

Oral tablets

DIN 02403390 (40mg)

Metastatic

Colorectal Cancer

(CRC)

Treatment of patients with metastatic CRC who

have been previously treated with

fluoropyrimidine-based chemotherapy, oxaliplatin,

irinotecan, an anti-VEGF therapy (bevacizumab),

and, if KRAS wild type, an anti-EGFR therapy

(cetuximab, panitumumab):

ECOG ≤ 1

3 months

3 months

30


CLAIM RENEWAL

SUTENT (SUNITINIB)

Oral Capsule

DIN 02280795 (12.5 MG)

DIN 02280809 (25 MG)

DIN 02280817 (50 MG)

Metastatic renal cell

carcinoma (MRCC)

of clear cell

histology

Gastrointestinal

Stromal Tumours

(GIST)

Pancreatic

neuroendocrine

tumors (PNET)

First-line treatment in MRCC of clear cell

histology:

ECOG ≤ 1

Second-line treatment of GIST:

Inoperable recurrent GIST or metastatic

Resistance or intolerance to Gleevec

Presence of c-kit (cd117)

ECOG ≤ 2

Treatment of progressive PNET disease:

Unresectable, locally advanced or metastatic

disease

ECOG ≤ 1

5 months

6 months

4 months

5 months

6 months

6 months

TAFINLAR (DABRAFENIB)

Oral Capsule

DIN 02409607 (50MG)

DIN 02409615 (75MG)

Unresectable or

metastatic

melanoma

Treatment of unresectable or metastatic melanoma

with or without brain metastases:




Monotherapy (first-line treatment)

ECOG ≤ 1

4 months

4 months

TARCEVA (ERLOTINIB)

Oral Tablet

DIN 02269007 (25 MG)

DIN 02269015 (100 MG)

DIN 02269023 (150 MG)

Advanced or

metastatic non-

small cell lung

cancer (NSCLC)

First-line treatment of patients with locally

advanced or metastatic NSCLC:

EGFR +

ECOG ≤ 3

Second-line treatment of patients with locally

advanced or metastatic NSCLC:

Failure of prior chemotherapy regimen

ECOG ≤ 3

Maintenance treatment:

Stable disease after 4 cycles of standard

platinum-based 1st line chemotherapy

ECOG ≤ 3

3 months

3 months

3 months

6 months

3 months

6 months

TASIGNA (NILOTINIB)

Oral Capsule

DIN 02368250 (150 MG)

DIN 02315874 (200 MG)

Chronic Myeloid

Leukemia (CML)

Treatment of chronic phase and accelerated phase

Philadelphia chromosome positive chronic

myeloid leukemia (Ph+ CML):

Adults

Resistant to or intolerant of at least one prior

therapy, including imatinib

Treatment of patients with newly diagnosed

Philadelphia chromosome positive chronic

myeloid leukemia (Ph+ CML):

Adults

Chronic phase

6 months

6 months

1 year

1 year

TECFIDERA (DIMETHYL FUMARATE)

Oral Capsule

DIN 02404508 (120 MG)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)

Treatment of relapsing-remitting multiple

Sclerosis (RRMS):



Monotherapy

EDSS ≤ 5

6 months

1 year

31


CLAIM RENEWAL

TEMODAL (TEMOZOLOMIDE)

Oral Capsule, Intravenous Solution

DIN 02241093 (5 MG)

DIN 02241094 ( 20 MG)

DIN 02241095 (100 MG)

DIN 02312794 (140 MG)

DIN 02241096 (250 MG)

DIN 02321262 (100 MG / VIAL)

* Including all generic drugs

Brain Tumors

Treatment of adult patients with newly

diagnosed glioblastoma multiforme

concomitantly with radiotherapy and then as

maintenance treatment

Treatment of adult patients with glioblastoma

multiforme or anaplastic astrocytoma and

documented evidence of recurrence or

progression after standard therapy

Indefinite

N/A

THALOMID (THALIDOMIDE)

Oral Capsule

DIN 02355191 (50 MG)

DIN 02355205 (100 MG)

DIN 02355221 (200 MG)

Multiple myeloma

Treatment of patients with previously untreated

multiple myeloma:


First-line therapy

In combination with melphalan and prednisone

ECOG ≤ 2

6 months

1 year

Max = 18 months

(12 cycles of 6 weeks)

THYROGEN (THYROTROPIN ALFA)


DIN 02246016 (0.9 MG / ML)

Thyroid cancer

testing



Indefinite

N/A

TOBI / TOBI PODHALER

(TOBRAMYCIN)

Inhalation Solution, Inhalation Capsule

DIN 02239630 (300 MG / 5 ML)

DIN 02365154 (28 MG)

Cystic Fibrosis

(CF)


Government Program

Treatment of chronic pulmonary P. aeruginosa

infections in cystic fibrosis patients:


After failure or allergy to standard therapy

FEV1 > 25% or < 75%

6 months

3 months

TOCTINO (ALITRETINOIN)

Oral Capsule

DIN 02337630 (10 MG)

DIN 02337649 (30 MG)

Severe chronic hand

eczema

Treatment of severe chronic hand eczema:


Refractory to high potency topical

corticosteroids for at least 8 weeks

Symptoms severity

Treatment course for 12 to 24 weeks

depending on response

4 months

Response to

therapy

should be

evaluated

after 12

weeks of

treatment

Up to 6 months total if

response to therapy

In the event of relapse,

patients may benefit from

further treatment courses of

TOCTINO

TRACLEER (BOSENTAN)

Oral Tablet

DIN 02244981 (62.5 MG)

DIN 02244982 (125 MG)

*Including all generic drugs

Pulmonary Arterial

Hypertension

(PAH)


Government Program

Treatment of primary pulmonary hypertension or

treatment of pulmonary hypertension secondary to

scleroderma:


WHO functional - Class III or IV

Indefinite

N/A

TYKERB (LAPATINIB)

Oral Tablet

DIN 02326442 (250 MG)

Advanced or

metastatic breast

cancer

First-line therapy:

ECOG ≤ 2

In combination with letrozole

Post-menopausal patients

ErB2 (HER2) +

Hormone receptor +

Advanced or metastatic breast cancer:

ECOG ≤ 1

ErB2 (HER2) +

No response to taxanes, anthracycline

No response or contraindications to

trastuzumab in the metastatic stage

In combination with capecitabine

4 months

4 months

4 months

4 months

32


CLAIM RENEWAL

TYSABRI (NATALIZUMAB)


DIN 02286386 (300 MG / 15 ML)

Relapsing-

Remitting Multiple

Sclerosis (RRMS)


Government Program



No response or intolerance to interferons or

glatiramere in highly active disease

Monotherapy


EDSS ≤ 6


1 year

1 year

VIAGRA (SILDENAFIL)

Oral Tablet

DIN 02239766 (25 MG)

DIN 02239767 (50 MG)

DIN 02239768 (100 MG)

* Including all generic drugs

Erectile

Dysfunction (ED)

NOTE:

If no ED clause:

not eligible.












dysfunction

1 year

Or

Indefinite if

annual

ceiling

1 year

VICTRELIS (BOCEPREVIR)

Oral Capsule

DIN 02370816 (200 MG)

VICTRELISVICTRELIS TRIPLE

(BOCEPREVIR / RIBAVIRIN /

PEGINTERFERON ALFA-2B)

Oral Capsule, Subcutaneous Solution

DIN 02371448 (200 MG, 80 MCG / 0.5 ML)

DIN 02371456 (200 MG, 100 MCG / 0.5 ML)

DIN 02371464 (200 MG, 120 MCG / 0.5 ML)

DIN 02371472 (200 MG, 150 MCG / 0.5 ML)

Chronic Hepatitis C

Treatment of genotype 1 Chronic Hepatitis C in

adult patients with compensated liver disease,

including cirrhosis:


Previously untreated patients or who have

previously failed therapy

In combination with peginterferon alfa (INFα)

and ribavirin (RBV) for Victrelis (included in

Victrelis triple package)

Starts 4 weeks after pegINFα/RBV

First authorization: 24 weeks

The authorization will be renewed for an

additional 8 to 16 weeks depending on

response to treatment, previous treatment or

the patient' s medical condition

24 weeks

Up to a maximum of 32 to 44

weeks

If confirmed undetectable

HCV-RNA levels at week 24

VIDAZA (AZACITIDINE)

Subcutaneous Suspension

DIN 02336707 (100 MG)

Myelodysplastic

Syndrome (MDS)

Acute Myeloid

Leukemia (AML)

Treatment of adult patients who are not eligible

for hematopoietic stem cell transplantation with:

Intermediate-2 and High-risk Myelodysplastic

Syndrome (MDS) according to the

International Prognostic Scoring System (IPSS)

AML with 20-30 % blasts and multi-lineage

dysplasia according to WHO classification

ECOG ≤ 2

6 months

6 months

VOLIBRIS (AMBRISENTAN)

Oral Tablet

DIN 02307065 (5 MG)

DIN 02307073 (10 MG)

Pulmonary Arterial

Hypertension

(PAH)


Government Program


hypertension (PAH) or associated with connective

tissue disease:



Indefinite

N/A

33


CLAIM RENEWAL

VOTRIENT (PAZOPANIB)

Oral Tablet

DIN 02352303 (200 MG)

Metastatic Renal

Cell Carcinoma

(RCC) of clear cell

morphology

Soft Tissue

Sarcoma (STS)

Treatment of metastatic renal cell (clear cell)

carcinoma (mRCC):

First-line therapy

Or

Failure or intolerance to cytokines for

metastatic disease

ECOG ≤ 1

Treatment of Soft Tissue Sarcoma (STS):

Advanced metastatic stage

Selected tumour types including:

o Fibroblastic

o so-called fibrohistiocytic

o leiomyosarcoma

o malignant glomus tumours

o skeletal muscles

o vascular

o uncertain differentiation (excluding

chondrosarcoma, Ewing tumours /

primitive neuroectodermal tumours)

o malignant peripheral nerve sheath

tumours

o undifferentiated soft tissue sarcomas

not otherwise specified

o Not indicated for patients with

adipocytic STS (liposarcoma) and

gastrointestinal stromal tumours

(GIST)

After failure of chemotherapy for metastatic

disease

Or

Progression in the 12 months following an

adjuvant or a neoadjuvant treatment

ECOG ≤ 1

Absence of brain metastases

5 months

4 months

5 months

4 months


XALKORI (CRIZOTINIB)

Oral Capsule

DIN 02384256 (200 MG)

DIN 02384264 (250 MG)

Advanced or

metastatic non-

small cell lung

cancer (NSCLC)

Anaplastic lymphoma kinase (ALK)+

Not amenable to curative therapy

Monotherapy

ECOG ≤ 3

3 months

3 months

XEOMIN (BOTULINUM TOXIN)


DIN 02371081 (50 IU)

DIN 02324032 (100 IU)

Blepharospasm

Cervical dystonia

Post-stroke

spasticity of the

upper limb



18 years of age or older for all indications

Maximum: 70 units / eye

Maximum: 300 units / treatement

Maximum: 400 units / treatment

1 year

2 years

XIAFLEX

(COLLAGENASE CLOSTRIDIUM

HISTOLYTICUM)

Intralesional Solution

DIN 02388316 (0.9 MG)

Dupuytren’s

contracture

Treatment of Dupuytren' s contracture:


Patients with a palpable cord

Administered in a private clinic

Maximum of 3 injections 4 weeks apart

Ineligible or inappropriate for surgical

intervention

3 months

N/A

34


CLAIM RENEWAL

XOLAIR (OMALIZUMAB)


DIN 02260565 (150 MG)

Severe allergic

asthma

Treatment of servere allergic asthma:

Prescribed by a specialist


Persistent symptoms despite high dose

inhaled corticosteroid

Positive skin test or in vitro reactivity to a

perennial aeroallergen

IgE (30 – 800 IU/mL)

1 year

1 year

XTANDI (ENZALUTAMIDE)

Oral Capsule

DIN 02407329

Metastatic

castration-resistant

prostate cancer

Treatment of metastatic prostate cancer:

Resistant to medical or surgical castration

Failure to docetaxel

With ou without GnRH analogue

ECOG ≤ 2

6 months

6 months

XYREM (SODIUM OXYBATE)

Oral Solution

DIN 02268272 (50 MG)

Cataplexy in patients

with narcolepsy

Treatment of cataplexy in patients with

narcolepsy:

Prescribed by a physician who has followed the

Xyrem Physician Success Program

6 months

6 months

ZELBORAF (VEMURAFENIB)

Oral Tablet

DIN 02380242 (240 MG)

Unresectable or

metastatic

melanoma

Treatment of unresectable or metastatic

melanoma:

Stage



Monotherapy

ECOG ≤ 1

4 months

4 months

ZOLINZA (VORINOSTAT)

Oral Capsule

DIN 02327619 (100 MG)

Advanced

cutaneous T-cell

lymphoma (CTCL)

Treatment of advanced cutaneous T-cell

lymphoma (CTCL):

Progressive, persistent or recurrent disease

subsequent to prior systemic therapies

3 months

6 months

ZYTIGA (ABIRATERONE ACETATE)

Oral Tablet

DIN 02371065 (250 MG)

Metastatic

castration resistant

prostate cancer

Treatment of metastatic prostate cancer:

Resistant to castration

Failure to docetaxel

With ou without GnRH analogue

In combination with prednisone

ECOG ≤ 2

6 months

6 months

35

2) Cancer drugs / Injectables Section Important Notice:

Intravenous (IV) or intravesical (into the bladder) drugs are generally administered in an hospital setting (H code)

and should therefore be declined : DIN not covered.

o Exceptional situations should be evaluated on a case by case basis with all the clinical information available

using an appropriate drug evaluation form filled and signed by a physician (information required: patient’s

name, certificate number, date of birth, patient’s weight, if available, diagnosis, previous medications used,

drug required, dosage, quantity provided and duration of drug treatment). The drug would need to be

purchased in pharmacy and administered outside the hospital.

All intravenous chemotherapy are usually covered by the various provincial programs and administered in specialist

oncology hospitals. So all claims for payment for intravenous chemotherapy, including chemotherapy not included

in this list should usually be denied. Do not hesitate to contact the SSQ pharmaceutical team for any question about

eligibility or not of a drug.

The following intramuscular (IM), subcutaneous (SC) or implant cancer drugs, purchased in pharmacy and

administered outside the hospital, would require prior authorization according to the diagnosis and usual adult

dose provided.

Drug

Name Active Ingredient DIN Diagnosis Usual Adult Dose

First

Claim Renewal

ALIMTA

PEMETREXED

02253437

First line therapy in

combination with cisplatin for

Malignant pleural

mesothelioma, in patients

whose disease is unresectable

disease or who are not

candidates for curative surgery

Second line therapy for locally

advanced or metastatic Non-

small cell lung cancer

IV infusion 500mg/m2 body surface area

on day 1 of each 21 day cycle

6 months

Only if

clinical

benefit

AMSA PD

AMSACRINE

00582212

Second line therapy for Acute

lymphocytic leukemia

Up to 125mg/m2 body surface area per

day IV infusion for 5 days, repeated

every 3 to 4 weeks

Maintenance: half the starting dose every

4 to 8 weeks

1 year

2 years

AVASTIN

BEVACIZUMAB

02270994

First line therapy in

combination with 5FU

chemotherapy for Metastatic

colorectal cancer

In combination with

carboplatin / paclitaxel

chemotherapy for unresectable

advanced, metastatic or

recurrent non-sqamous non-

small cell lung cancer

As a single agent for the

treatment of patients with

malignant glioma (WHO

Grade IV) – glioblastoma after

relapse or disease progression,

following prior therapy

IV infusion 5mg/kg body weight once

every 14 days

IV infusion 15mg/kg of body weight once

every 3 weeks

IV infusion 10mg/kg body weight once

every 14 days

1 year

6 months

(in

combination

with

chemotherapy

for up 6

cycles)

3 months

2 years

As a single

agent, if

clinical

benefit

6 months

BEXXAR*

TOSITUMOMAB 131I-TOSITUMOMAB

02270471

Second line therapy for Non

Hodgkin’s lymphoma

IV infusion 450mg tositumomab

followed by 185MBq 131I-tositumomab

(35 mg) day 0; 450mg tositumomab

followed by variable mCi (65-75 cGy

TBD) 131I-tositumomab between day 7 to

14 following the first dose

1 month

N/A

* If treatment administered as an outpatient: It should be with the appropriate license conditions as granted by the Canadian Nuclear Safety

36

Commission

N/A = Not applicable

37

Drug


First

Claim Renewal

ERBITUX

CETUXIMAB

02271249

Second line therapy for

EGFR expressing Metastatic

Colorectal Cancer

In combination with radiation

therapy for the initial

treatment of locally or

regionally advanced Squamous

Cell Carcinoma of the Head &

Neck

Loading dose : IV infusion 400mg/m2

body surface area

Maintenance Doses : IV infusion

250mg/ m2 body surface area every

week

Loading dose : IV infusion 400mg/m2

body surface area one week prior to

initiation of a course of radiation therapy

Maintenance Doses : IV infusion

250mg/ m2 body surface area every

week for the duration of radiation therapy

(6-7 weeks). Complete Erbitux

administration 1 hour prior to radiation

therapy

1 year

2 years

FLOLAN

EPOPROSTENOL

02230845

02230848

02230857

Treatment of primary

pulmonary hypertension

(PPH) and secondary

pulmonary hypertension

(SPH) due to scleroderma

spectrum of diseases (SSD) in

NYHA functional Class III

and Class IV patients who did

not respond adequately to

conventional therapy

Only indicated for continuous intravenous

infusion

Chronic infusion of FLOLAN should be

initiated at 2 ng/kg/min and increased

until dose-limiting pharmacological

effects are elicited or until a tolerance

limit to the drug is established and further

increases in the infusion rate are not

clinically warranted

Indefenite

N/A

IMMUCYST

ONCOTICE

BCG STRAIN CONNAUGHT

BCG STRAIN TICE

02153424

02153416

02194376

02153513

Carcinoma (in situ) Bladder

(prophylaxis and treatment)

Prophylaxis following

transurethral resection (TUR)

of primary or recurrent stage

Ta and/or T1 papillary tumors

(Numerous dosing schedules exist &

depend on disease, response &

concomitant therapy)

Initial treatment : 1 vial into the bladder

once a week for 6 weeks, stop 6 weeks,

then weekly for 1-3 weeks

Maintenance dose : weekly for 1 to 3

weeks intravesical instillations per

treatment every 6 months

1 year

2 years

ERWINASE

KIDROLASE

ERWINIA

L-ASPARAGINASE

02237815

01926438

Second line therapy for Acute

lymphocytic leukemia

(Numerous dosing schedules exist &

depend on disease, response &

concomitant therapy)

IM 400 IU/kg body weight Monday &

Wednesday with 600 IU/kg body weight

on Friday for 28 days; may continue

additional 14 days if remission not

achieved

IM/ IV 200 - 1000IU per kg body

weight per day for 28 days; may continue

additional 14 days if remission not

achieved

1 year

N/A

MYOZYME

ALGLUCOSIDASE ALFA

02284863

Coordinate with provincial

government program if

available

Pompe’s Disease (GAA

deficiency)

IV infusion 20mg/kg body weight every

2 weeks

6 months

6 months

PERJETA

PERTUZUMAB

02405016

02405024

In combination with

HERCEPTIN (trastuzumab)

and docetaxel for the

treatment of patients with

HER2-positive metastatic

breast cancer who have not

received prior anti-HER2

therapy or chemotherapy for

metastatic disease

The recommended initial dose of

PERJETA is 840 mg administered as a

60 minute intravenous infusion, followed

every 3 weeks thereafter by a dose of 420

mg administered over 30 to 60 minutes

4 months

4 to 6 months

38

PROLEUKIN

INTERLEUKIN

02130181

Metastatic renal cancer

Metastatic malignant

melanoma

600 000 IU/kg body weight IV infusion

every 8 hours for a max of 14 doses.

Stop 9 days; repeat for another 14 doses

(max 28 doses per course)

1 year

N/A

39

Drug


First

Claim Renewal

REVATIO

SILDENAFIL

02341611

Treatment of primary

pulmonary arterial

hypertension (PAH) or

treatment of pulmonary

hypertension secondary to

connective tissue disease

The recommended dose of REVATIO

intravenous administration is 10 mg

(corresponding to 12.5 mL) three times a

day administered as an intravenous bolus

injection

Indefinite

N/A

SANDOSTATIN

SANDOSTATIN

LAR

OCTREOTIDE

02248639

00839191

02248640

00839205

02248642

02049392

02248641

00839213

02299437

02299445

02299453

02239323

02239324

02239325

Symptomatic metastatic

carcinoid syndrome

Symptomatic vasoactive

intestinal peptide-secreting

tumor (VIPoma)

Acromegaly

Usual adult dose

Immediate release dosage form :

50-1500 μg SC or IV per day

Long acting dosage form (LAR):

30 mg IM every 4 weeks; after 2 months,

may be ↓ to 10 mg or ↑ to 30 mg

depending on response

1 year

2 years

TREANDA

BENDAMUSTINE

02392569

02392550

Relapsed indolent B-cell non-

Hodgking lymphoma (NHL)

who did not respond to or

progressed during or shortly

following treatment with a

rituximab regimen

Symptomatic chronic

lymphocytocytic leukemia

(CCL) who have received no

prior treatment

In monotherapy: 120mg/m2 IV Days 1

and 2 of a 21-day cycle up to 8 cycles

In monotherapy: 100mg/m2 IV on Days 1

and 2 of a 28-day cycle, up to 6 cycles

6 months

6 months

N/A

N/A

VALTAXIN

VALRUBICIN

02242466

Second line therapy for BCG

refractory Bladder cancer

(carcinoma in situ)

800 mg intravesical instillation once a

week for 6 weeks

6 weeks

N/A

40

Drug


First

Claim Renewal

VANTAS

HISTRELIN

02278383

Advanced prostate cancer

One implant SC once yearly

1 year

1 year

VECTIBIX

PANITUMUMAB

02308487


metastatic colorectal cancer

with non-mutated or “wild

type” KRAS gene:

After failure of

fluoropyrimidine,

oxaliplatin and irinotecan-

containing chemotherapy

regimens

IV infusion 6 mg/kg body weight once

every 2 weeks

6 months

1 year

VELCADE

BORTEZOMIB

02262452

As part of combination

therapy for previously

untreated multiple myeloma in

patients unsuitable for stem

cell transplantation


multiple myeloma

IV 1.3 mg/m2 body surface area for nine

6-week treatment cycles: Cycles 1-4:

twice weekly; Cycles 5-9: once weekly

(in combination with oral melphalan &

oral prednisone)

Starting dose : 1.3 mg/m2 body surface

area IV twice a week for 2 weeks (days

1,4,8,11) then 10 days rest period

(days12-21); then repeat for a maximum

of 8 cycles

54 weeks

8 months

Only if clinical

benefit

Up to 2 cycles

in patients

with

complete

response (CR)

N/A = Not applicable

Documents

Standard of procedures special authorization drugs … Special Authorization Drugs.pdf · 1 UPDATED March 3rd, 2014 Standard of procedures Special Authorization Drugs 1) General Section