Drug Bulletin - July 2001

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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.

Additions to the Drug Benefit List(Full Benefits)
(Effective July 1, 2001)

1. Valsartan/ hydrochlorothiazide, tablet, 80mg/ 12.5mg, 160mg/ 12.5mg (Diovan-HCT-Novartis)
   
   This fixed combination of an angiotensin II antagonist and a diuretic is indicated for the treatment of essential hypertension in patients for whom this combination is appropriate. It is not indicated for initial therapy.
   
   
2. Granisetron, tablet, 1mg (Kytril-Hoffman-La Roche)
   
   Granisetron is indicated for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and with total body irradiation and fractionated abdominal radiation.
   
   
3. Betahistine, tablet, 8mg (Serc-Solvay Pharma)
   
   Betahistine is indicated for reducing the episodes of recurrent vertigo associated with Menière's disease.
   
   
4. Calcium carbonate, tablet, 500mg (various brands) and calcium carbonate/ Vitamin D, tablet, 500mg/ 125units (various brands)

New Limited use Benefits
(Effective July 1, 2001)

1. Codeine, controlled release tablet, 50mg, 100mg, 150mg, 200mg (Codeine Contin - PFR)
   
   Criteria for coverage include:
   • treatment of chronic pain and palliative care patients as an alternative to products containing codeine in combination with acetaminophen or ASA with or without caffeine
   • treatment of chronic pain and palliative care patients as an alternative to regular release codeine tablets when large doses are required.
     
     
2. Ciprofloxacin/ hydrocortisone ear drops, 2mg/ 10mg per ml (Cipro HC Otic-Alcon)
   
   This topical combination product is indicated for the treatment of acute diffuse bacterial external otitis. Criteria for coverage include:
   • failure to respond to other listed antibiotics
   • contraindications to other listed antibiotics
     
     
3. Risedronate, tablet, 5mg, 30mg (Actonel-Procter & Gamble) Risedronate is another bisphosphonate.
   
   Coverage will be provided for the treatment of:
   • osteoporosis in patients who have documented hip, vertebral or other fractures osteoporosis in patients who are intolerant of or do not respond to etidronate or etidronate/calcium
   • Paget's disease
     
     
4. Tizanidine, tablet, 4mg (Zanaflex-Elan)
   
   Zanaflex is a short-acting drug for the management of spasticity. Coverage will be provided for treatment of spasticity in patients with multiple sclerosis, who have failed therapy with or are intolerant to baclofen.
   
   
5. Cabergoline, tablet, 0.5mg (Dostinex-Pharmacia)
   
   Cabergoline is used for treatment of hyperprolactinemia. It is well tolerated and is administered according to a weekly dosing regimen. Coverage will be provided for treatment of hyperprolactinemia in patients who have failed therapy with or are intolerant to bromocriptine
   
   
6. Verteporfin, powder for intravenous solution, 15mg (Visudyne-QLT)
   
   Verteporfin is indicated for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. A course of therapy is a 2-step process requiring intravenous administration of verteporfin and irradiation of the macula with non-thermal laser red light. Coverage will be provided for the treatment of age-related macular degeneration for patients who are being treated by a certified ophthalmologist.
   
   
7. l-Carnitine, tablet, 330mg; oral liquid, 100mg/ ml; intravenous liquid, 200mg/ ml (Carnitor-Sigma-Tau)
   
   Coverage will be provided for patients with identified carnitine deficiency.
   
   
8. Zinc supplements
   
   Selected zinc supplements will be added to the Special Formulary for Chronic Renal Failure Patients for the treatment of zinc deficiency.

Maximum Allowable Quantities for Codeine-containing Analgesics

Effective July 1, 2001, a quantity limitation will be implemented for products, containing codeine 30mg in combination with either acetaminophen or acetylsalicylic acid and with or without caffeine. A total of 1080 tablets will be allowed in a 90-day period. All paid claims for any codeine 30mg combination analgesic product will be counted towards the maximum allowable quantity.

Process

1. The threshold is 1080 tablets of codeine 30mg combination products in a 90-day period. (This threshold is based on published material and consultation with pain specialists.)
2. The date of service of the first prescription initiates the 90-day period.
3. After 90 days from the date of the first prescription, the client is eligible for another 1080 tablets in a 90-day period.
4. The date of service of the next prescription after the initial 90-day period has expired will initiate this period. The new period can commence immediately or be delayed until the client requires the next prescription.
5. Clients will receive these drugs without any restrictions until the threshold is reached.
6. Once the threshold is reached the claim will be rejected.
7. If the client has medical need for continuing the codeine-containing analgesic, the pharmacist can initiate a request for special authorization (prior approval) for the drug. The Drug Exception Centre will contact the prescriber of the rejected prescription for clinical information about the client to determine if special authorization should be granted.
8. If special authorization is approved, the client can continue to receive the drug without restriction up to the quantity prescribed by the physician.
9. If the threshold level has been reached and timely access to the Drug Exception Centre is not possible (e. g., statutory holidays), a pharmacist may dispense an emergency supply (maximum of a 4-day supply or 48 tablets, whichever is the lesser quantity). The pharmacist must contact the Exception Centre as soon as possible for approval to be back-dated to cover the emergency supply.
10. Pharmacists need to contact the Drug Exception Centre only upon receipt of the following messages:

Addition of Codeine, Controlled Release Tablets (Codeine Contin) as a Limited Use Benefit

To assist in chronic pain management codeine, controlled release tablets, will be available as a limited use benefit, effective July 1,2001.

Rationale for Implementation

Codeine-containing analgesics, such as Tylenol No. 3 and generic products, are amongst the most frequently claimed products in the NIHB Program. A review of NIHB utilization data for codeine 30mg combination products indicates that the majority of claimants receive only one claim per year; however, a small number of claimants receive large quantities. NIHB recognizes that some of these people may require large quantities for chronic pain; some may be addicted; and some may be diverting these drugs. Implementation of maximum allowable quantities is a means to identify unnecessary excess use. Clients who require quantities of these drugs in excess of the threshold level will be able to obtain coverage through the exception process.

Monitoring of Utilization Patterns

Utilization patterns of other narcotics will be closely monitored following the implementation of maximum allowable quantities for the codeine-containing analgesics. Maximum allowable quantities may need to be implemented for other narcotics if excessive utilization is detected.