Drug Bulletin - January 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.

Additions to the Drug Benefit List (Full Benefits)
(effective January 1, 2002)

1. Candesartan cilexetil/ hydrochlorothiazide, tablet, 16 mg/ 12.5 mg (Atacand Plus - AstraZeneca)
   
   This fixed combination of an angiotension II receptor antagonist and a diuretic is indicated for the treatment of essential hypertension. It is not indicated for initial therapy.
   
   
2. Gliclazide modified release, tablet, 30 mg (Diamicron MR - Servier)
   
   The 30 mg modified release tablets offer the advantage of once daily dosing instead of twice daily with the regular release 80 mg tablets.

New Limited use Benefits
(effective January 1, 2002)

1. Meloxicam, tablet, 7.5mg and 15mg (Mobicox - Boehringer Ingelheim)
   
   Meloxicam is indicated for the symptomatic treatment of rheumatoid arthritis and painful osteoarthritis in adults and currently offers the advantage of being priced lower than the two other available COX-2 selective inhibitors. The current criteria are:
   
   For patients with osteoarthritis who have failed therapy with acetaminophen and who:
   
   
   1. have failed to achieve adequate response with 2 other listed NSAIDs;
   2. have experienced an adverse event attributable to 2 other listed NSAIDs; or
   3. have a history of a serious gastrointestinal complication such as bleeding or perforation.
      
      
   For patients with rheumatoid arthritis who:
   
   
   1. have failed to achieve adequate response with 2 other listed NSAIDs;
   2. have experienced an adverse event attributable to 2 other listed NSAIDs; or
   3. have a history of a serious gastrointestinal complication such as bleeding or perforation
   
   
2. Temozolomide, capsule, 5mg, 20mg, 100mg and 250mg (Temodal - Schering)
   
   Coverage will be provided for the treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma, and documented evidence of recurrence or progression after standard therapy (resection, radiotherapy, and chemotherapy).
   
   
3. Amprenavir, capsule, 50mg and 150mg; oral liquid, 15mg/ mL (Agenerase - GlaxoSmithKline)
   
   Coverage will be provided for the management of HIV disease in patients who have failed other protease inhibitor combinations, or for patients who experienced a lack of tolerability to other protease inhibitors.
   
   
4. Lopinavir/ ritonavir, capsule, 133.3mg/ 33.3mg; oral solution, 80mg/ 20mg per mL (Kaletra - Abbott)
   
   Coverage will be provided for the management of HIV disease in patients who have failed other protease inhibitor combinations, or for patients who experienced a lack of tolerability to other protease inhibitors.
   
   
5. Polyethylene glycol - interferon alfa-2b, powder for subcutaneous solution, 74mcg, 118.4mcg, 177.6mcg and 222mcg per vial (PEG-Intron - Schering)
   
   Coverage will be provided for the treatment of patients suffering from chronic hepatitis C who have demonstrated failure or intolerance to combination therapy using interferon alfa-2b and ribavirin, or who have demonstrated intolerance to interferon alfa-2b alone.
   
   
6. Linezolid , tablet, 600mg; Intravenous solution, 2mg/ mL (Zyvoxam - Pharmacia)
   
   Coverage will be provided for the treatment of proven vancomycin-resistant enterococci (VRE) infections when other antibiotics are not available, and for the treatment of proven Methicillin-Resistant Staphylococcus aureus (MRSA) infections in patients who cannot tolerate or who had an idiosyncratic reaction with Vancomycin. The intravenous solution is also available when linezolid cannot be administered orally in the above mentioned situations.
   
   
7. Sirolimus, oral liquid, 1mg/ mL (Rapamune - Wyeth Ayerst)
   
   Coverage will be provided as a second line therapy for patients failing mycophenolate mofetil.

Limited Use Benefits - Change
(effective February 1, 2002)

This product was listed as a full benefit since January 1999. In February 2002, it will revert to a limited use benefit for patients with glaucoma who are intolerant or unresponsive to other listed agents. Repeat prescriptions will be exempted.

Important Safety Reminder for Patients Taking Oral Diabetes Drugs Rosiglitazone (AVANDIA - SKB) and Pioglitazone (ACTOS - LILLY)

Avandia and Actos have been added to the NIHB Drug Benefit List as limited use benefits. Please note: Health Canada has published important drug safety information, that thiazolidinediones can cause fluid retention that can progress to congestive heart failure. Additional information regarding this advisory is located on the Health Canada website:

http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/adviss_ ind_ e.html

New Methadone Formulations for Pain Management and for Opioid Dependancy

Methadone, oral concentrate, 10mg/ mL (Metadol and Metadol-D - Pharma Science)

A special authorization from the Drug Exception Center is required for Methadone prescriptions, whether Methadone is prescribed for pain management or for the treatment of opioid dependency. The special authorization is set up for 3 months at a time.

When prescribed for pain management, Metadol 10 mg/ mL oral concentrate (DIN 02241377) may be used, or if a mixture is being compounded the "normal and customary" extemporaneous mixture code should be be used.

When prescribed for opioid dependency, Metadol-D 10mg/ mL oral concentrate (DIN 02244290) may be used, and if a mixture is being compounded the pseudodin (DIN 0908835) should be used.

In the case of special authorization no number is required for billing purposes.