Drug Bulletin - January 2004

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The Non-Insured Health Benefits (NIHB) Program provides supplementary
health benefits, including prescription and non-prescription drugs, for
registered Indians, and recognized Inuit and Innu throughout Canada.

Open Benefits

(Effective November 1, 2003)

1. Bimatoprost, ophthalmic solution , 0.03%,(Lumigan®-Allergan Inc.)

Bimatoprost is indicated for the reduction of intraocular pressure in patients with open angle glaucoma or ocular hypertension.

2. Insulin Aspart, injectable, 100 U/ml,(NovoRapid® -NovoNordisk)

This agent is indicated for the treatment of diabetes mellitis.

3. Perindopril erbumine/indapamide, tablet, 4 mg/1.25 mg (Coversyl Plus®-Servier Canada Inc., formerly called Biprel®)

This combination product is indicated for the treatment of mild to moderate hypertension.

4. Rosuvastatin, tablet, 10 mg, 20 mg and 40 mg, (Crestor®-AstraZeneca)

Rosuvastatin is indicated as a lipid lowering agent.

5. Trandolapril, capsules, 1 and 2 mg,(Mavik™-Abbott Laboratories Ltd.)

Trandolapril is indicated for the treatment of mild to moderate hypertension.

New Limited Use Benefits

(Prior approval required)

(Effective December 1, 2003)

1. Ribavarin and peginterferon alfa 2b, injectable,(Pegetron™ - Schering Canada Inc.)

Pegetron™ will be a Limited Use Benefit for the treatment of naive patients with active PCR confirmed Hepatitis C infection, and no documented contraindications.

A. For genotype 1, 4, 5 and 6, an initial 14-week supply will be approved. A maximum further 34- week supply may be approved, if patient has a viral reduction of at least 2 logs or HCV is undetectable at 12 weeks (for a total of 48-weeks treatment).

B. For genotype 2 or 3, initial coverage for a maximum of 24 weeks may be approved. Renewals will not be covered.

2. Tiotropium, capsules for inhalation, 18 mcg,(Spiriva® - Pfizer Canada Inc.)

Spiriva® will be a Limited Use Benefit for the following condition:

For the treatment of moderate* to severe* chronic obstructive pulmonary disease (COPD), in patients who continue to be symptomatic after an adequate trial (2-4 months) of ipatropium, at a dose of 4 puffs 4 times daily.

*Canadian Thoracic Society COPD Classification by Symptoms/Disability:

Moderate: shortness of breath from COPD causing the patient to stop after walking about 100 meters (or after a few minutes) on the level.

Severe: shortness of breath from COPD leaving the patient too breathless to leave the house or breathless after undressing, or in the presence of chronic respiratory failure or clinical signs of right heart failure.

3. Valdecoxib, tablets, 10mg, (Bextra™ -Pharmacia Canada Inc.)

Valdecoxib will be a limited use benefit for the following conditions:

For patients with osteoarthritis who have failed therapy with acetaminophen and who:

A. have failed to achieve adequate response with 2 other listed NSAIDS, or

B. have experienced an adverse event attributable to 2 other listed NSAIDS, or

C. have a history of a serious gastrointestinal complication, such as bleeding or perforation.

For patients with rheumatoid arthritis who:

A. have failed to achieve adequate response with 2 other listed NSAIDS, or

B. have experienced an adverse event attributable to 2 other listed NSAIDS, or

C. have a history of a serious gastrointestinal complication such as bleeding or perforation.

4. Sirolimus, tablets, 1mg, (Rapamune®-WyethPharmaceuticals)

Benefit coverage will be provided as a second line therapy for patients whose treatment using mycophenolate mofetil has failed.

NIHB Decision Not to Add the Following Drugs to the NIHB Drug Benefit List After Review by the Federal Pharmacy and Therapeutics Committee

The following drugs will not be added to the NIHB Drug Benefit List:

1. Desmopressin (Minirin®) 0.1 mg,0.2 mg tablets,(Ferring Pharmaceuticals)

2. Diclofenanc topical (Pennsaid®)1.5% solution,(Dimethaid Health Care Ltd.)

3. Latanoprost/timolol) (Xalacom™) ophthalmic solution,(Pharmacia Canada)

4. Pimecrolimus (Elidel®)1% topical cream,(Novartis Pharmaceuticals Canada Inc.)

5. Rosiglitazone/metformin (Avandamet™) tablets,(GlaxoSmithKline Inc.)

6. Trandolapril/verapamil (Tarka®) tablets, (AbbotLaboratories Limited)

7. Valdecoxib 20 mg (Bextra™) tablets, (PharmaciaCanada Inc.)

Benefits Delisted from the NIHB Drug Benefit List:

Since November 27, 2003 all products containing nefazodone were delisted from the NIHB DBL, following the discontinuation of sales of nefazodone in Canada.

Quantity and Frequency Limits - Blood Glucose Test Strips

Effective February 1, 2004 , a quantity limitation will be implemented for blood glucose test strips. The NIHB Program will reimburse a total number of 5 test strips per day in a 100-day period (500 test strips per 100 days). All paid claims for blood glucose test strips will be counted towards the maximum allowable quantity. No prior approval will be required for the client to obtain the allowable quantity within the specified period. Once the maximum has been exceeded, a prior approval would be required. For coverage details, please refer to the Web site at :

http://www.hc-sc.gc.ca/fnihb/nihb/pharmacy/drugbenefitlist/therapeutic_3600.pdf

Important Drug Safety Information regarding Paxil^®

(The following is taken from the Therapeutics Products Directorate web site, dated2003-07-10).

Until further information is available, PAXIL® (paroxetine hydrochloride) should not be used in children and adolescents under 18 years of age (ie. Pediatric patients), due to a possible increased risk of suicide-related adverse events in this patient population.