Drug Bulletin - July 2002

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

Benefit Definitions - Update

Description of drug benefits under the NIHB Program

The following update provides benefit changes and revised drug benefit categories for the Program.

Drugs are placed under the following categories: open benefits, limited use benefits, exceptions and non-benefits. Other drugs which are not within the mandate of the Program are considered exclusions and are not covered under the NIHB Program.

Open Benefits

Open benefits are those drugs listed in the NIHB Drug Benefit List (DBL) and do not have established criteria or prior approval requirements.

Limited use Benefits

Limited use drugs are those that have value in specific circumstances, or which have quantity and frequency limitations. For drugs in this category,specific criteria must be met for these drugs to be eligible for coverage.

Exceptions

Exception drugs are those which are not listed in the NIHB DBL but may be considered for funding in special circumstances where supporting evidence that available alternatives cannot meet the client's need.

Non-Benefits (New Category)

Non-benefit drugs are those which will not be considered for coverage under the NIHB Program, because published evidence does not support the clinical value or cost of the drug relative to existing therapies, or there is insufficient clinical evidence to support coverage.

Exclusions

Certain drug therapies for particular conditions do not fall under the NIHB mandate and will not be provided as benefits under the NIHB Program.

Open Benefits
(Effective May 1, 2002)

1. Travoprost, Ophthalmic Solution, 0.004% (Travatan - Alcon)
   
   This prostaglandin analogue, like latanoprost, should be used as a second line agent for the reduction of Intra-Ocular Pressure such as when topical beta blockers are ineffective or contraindicated.
   
   
2. Estradiol-17ß, transdermal patch, 37.5, 50, 75 and 100 mcg/ day (Estradot - Novartis)
   
   This smaller patch than others (Vivelle7, Estraderm7), may be an option for patients experiencing difficulties with patch tolerability or adherence.
   
   
3. Telmisartan /hydrochlorothiazide, tablet, 80/ 12.5 mg (Micardis Plus - Boehringer Ingelheim)
   
   This fixed combination of an angiotensin II receptor antagonist and a diuretic is indicated for the treatment of essential hypertension. It is not indicated for initial therapy.
   
   
4. Entacapone, tablet, 200 mg (Comtan - Novartis)
   
   This medication may be used as an adjunct to levodopa/ carbidopa or levodopa/ benserazide preparations for patients with idiopathic Parkinson's disease who experience the signs and symptoms of end-of-dose wearing-off.

New Limited Use Benefits
(Effective May 1, 2002)

1. Imatinib mesylate, capsule, 100 mg (Gleevec - Novartis)
   
   Coverage will be provided for the treatment of patients with chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Exception Drugs
(Effective May 1, 2002)

1. Bosentan, tablet, 62.5 and 125 mg (Tracleer - Actelion)
   
   This drug showed modest improvement in the symptomatic management of Pulmonary Arterial Hypertension. This treatment could be considered for patients who have been optimized with conventional therapy.
   
   
2. Moxifloxacin, tablet, 400 mg (Avelox - Bayer)
   
   As a result of concerns regarding increased resistance to quinolones in Canada and no demonstrated economic advantage or efficacy, this will be listed as an exception drug. No other respiratory quinolones are listed on the DBL.
   
   
3. Oxybutynin extended release, tablet, 5 and 10 mg (Ditropan XL - Alza)
   
   This medication does not offer significant advantage to immediate release preparations of oxybutynin or tolterodine, and it is more costly than generic oxybutynin immediate release preparations.

Non-Benefits (New Category)
(Effective May 1, 2002)

1. Mirtazapine, tablet, 30 mg (Remeron - Organon)
   
   The long term efficacy and safety over existing agents are not evident in published trials. No published trials have shown the place of mirtazapine in antidepressant therapy.
   
   
2. Galantamine, tablet, 4, 8 and 12 mg (Reminyl B Janssen-Ortho)
   
   Clinical trials have shown the efficacy of this drug was marginal and long term efficacy could not be demonstrated.
   
   
3. Esomeprazole, tablet, 20 and 40 mg (Nexium - AstraZeneca)
   
   Efficacy over existing agents was not shown in published trials, and it is more costly than lansoprazole and pantoprazole
   
   
4. Fusidic Acid, Ophthalmic Solution, 1% (Fucithalmic B Leo)
   
   Fucithalmic is more costly than gentamycin sulfate or sodium sulfacetamide eye drops, and superior efficacy over these agents was not demonstrated in published trials.
   
   
5. Clindamycin 1%/ Benzoyl Peroxide 5%, Ge l (Clindoxyl B Stiefel)
   
   This product is more costly than either topical benzoyl peroxide or clindamycin. This product is not superior to benzoyl peroxide for non inflammatory lesions, and more trials are needed comparing efficacy and safety with topical erythromycin, an antibiotic with proven efficacy in the management of acne vulgaris.
   
   
6. Doxercalciferol, capsule, 2.5 mcg (Hectorol B Draxis Health)
   
   This drug did not demonstrate any advantage over existing treatments.

Glucose Meters Eligible for Coverage Under the NIHB Program

The following glucose meters and corresponding test strips are currently provided to meet the needs of clients.

Requests for glucose meters other than those listed above may be considered on a case by case basis if a need is demonstrated.

Glucose meters will only be replaced when the meter no longer functions and replacement by the manufacturer is not an option. Replacements will not be provided as a result of misuse, carelessness or client negligence.