Print | Need Larger Text? | Share

Updates to the Drug Benefit List - Fall 2008

• Additions to the Drug Benefit List
  • Open Benefits
  • New Limited Use Benefits
  • Special Formulary for Chronic Renal Failure
• Changes in Benefit Status
  • Changes in Benefit Status
  • Changes in Benefit Criteria
• Not Added to Formulary
• Drug Discontinued by the Manufacturer
• Manufacturer Changes

The Non-Insured Health Benefits (NIHB) Program provides supplementary health benefits, including prescription and non-prescription drugs, for registered First Nations and recognized Inuit throughout Canada. Visit our Web Site at: www.healthcanada.gc.ca/nihb

Benefit Definitions

Open Benefits

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

Limited Use Benefits

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

Not Added To Formulary

Drugs not added to formulary are those which are not listed in the NIHB DBL after review by the national Common Drug Review (CDR) process and/or the Federal Pharmacy and Therapeutics Committee (FP&T). These drugs will not be added to the NIHB drug list because published evidence does not support the clinical value or cost of the drug relative to existing therapies. Coverage may be considered in special circumstances upon receipt of a completed "Exception Drugs Request Form". These requests are reviewed on a case by case basis.

Exclusions

Certain drug therapies for particular conditions fall outside of the NIHB mandate and will not be provided as benefits under the NIHB Program (e.g., cosmetic and anti-obesity drugs). As well, certain drugs will be excluded from the NIHB Program as recommended by the CDR and the FP&T because published evidence does not support the clinical value, safety or cost of the drug relative to existing therapies, or there is insufficient clinical evidence to support coverage.

Note: The appeal process and the emergency supply policy will not apply to excluded drugs.

Additions to the Drug Benefits List

Open Benefits

Top of Page

New Limited Use Benefits

Prior approval required.
For the treatment of chronic hepatitis B infection when used in combination with lamivudine in patients who have developed failure to lamivudine, as defined by an increase in HBV DNA of ≥ 1 log10 IU/mL above the nadir, measured on two separate occasions within an interval of at least one month, after the first three months of lamivudine therapy, and when failure to lamivudine is not due to poor adherence to therapy.

Prior approval required.
For patients with severe, debilitating psoriasis who meet all of the following criteria:

1. Body surface area (BSA) involvement of >10% and/or significant involvement of the face, hands, feet or genital region;
2. Failure to respond to, contraindications to, or intolerant of methotrexate and cyclosporine;
3. Failure to respond to, intolerant to or unable to access phototherapy.

Coverage will be approved initially for 12 weeks. Continued coverage can be approved in patients who have responded to therapy. A response is defined as patients who have achieved a ≥ 75% reduction in Psoriasis Area Severity Index, or a ≥ 50% reduction in PASI with a ≥ 5 point improvement in the Dermatology Life Quality Index (DLQI) or a quantitative reduction in BSA affected with qualitative consideration of specific regions such as face, hands, feet or genital region.

Note: Patients should be encouraged to have their information entered into the manufacturer's drug registry program (RESTORE) to collect effectiveness and harm outcome information. The collection of information and process will be managed between the client, physician and manufacturer. Enrolment in this registry is NOT a requirement for approval of Raptiva.

Prior approval required.
For the treatment of chronic hepatitis B infection in patients with cirrhosis documented on radiologic or histologic grounds and a HBV DNA concentration above 2000IU/mL.

Prior approval required.
For the treatment of HIV infection in patients who are antiretroviral experienced and have virologic failure due to resistance to at least one agent from each of the three major classes of antiretroviral agents, nucleoside/tide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors.

Prior approval required.
For the management of chronic pain in patients who are unresponsive or intolerant to at least one long-acting oral sustained released product, such as morphine, hydromorphone and oxycodone, despite appropriate dose titration and adjunctive therapy including laxatives and antiemetics.

Prior approval required.
Coverage will be provided:

• as part of multi-drug therapy (maximum 7-14 day coverage) for eradication of Helicobacter pylori in individuals with peptic ulcer disease (diagnosed by urea breath test, serology or endoscopically).

Coverage will also be provided if the following prerequisites are met:

• patient has tried at least 30 days of Omeprazole(Losec^®) and
• patient has tried at least 30 days of Rabeprazole sodium (Pariet^®).

Total trial of 60 days will be confirmed against medication history:

• for treatment of confirmed gastric and duodenal ulcers. Or
• for mild to moderate gastroesophageal reflux disease (GERD) in patients who have failed on or not tolerated and 4-week trial of histamine-2 receptor antagonists. Or
• for severe gastroesophageal reflux disease (GERD) and complications as first-line therapy for a maximum period of 3 months.

Patients should be reassessed endoscopically or with step-down therapy using a histamine-2 receptor antagonist. Or

• for treatment of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers where the NSAID must be continued. Or
• for prevention of NSAID-induced ulcers in patients who have a history of ulcer complications, are over the age of 65 years, have comorbid disease such as cardiovascular disease or coagulopathies or are on concomitant medications which increase risk of ulcers or bleeding. Or
• Zollinger-Ellison Syndrome*. Or
• Barrett's Esophagus*. Or
• esophagitis associated with connective tissue disease. Or
• other exceptional circumstances, evaluated on an individual basis.
• Diagnosis must be confirmed by a specialist qualified to diagnose and treat condition.
  

Top of Page

Special Formulary for Chronic Renal Failure

Changes in Benefit Status

Changes in Benefit Status

The Federal Pharmacy and Therapeutics Committee recently reviewed the evidence for the use of biphasic insulin lispro (Humalog Mix 25 and Humalog Mix 50) in the treatment of diabetes mellitus. Due to a lack of high-quality evidence demonstrating a clinical advantage over currently listed therapies, it was recommended that Humalog Mix 25 be removed from the formulary and that Humalog Mix 50 not be added to the formulary. As a result, effective December 1, 2008, Humalog Mix 25 will be removed from the NIHB Drug Benefit List and Humalog Mix 50 will not be added. Clients who have received funding for either of these therapies since June 1, 2008 will be grandfathered.

Effective Sept 1, 2008, the above Losec products will change benefit status from limited use benefits to open benefits.

Changes in Benefit Criteria

Effective December 1, 2008 the limited use criteria for Prevacid and Pantoloc will change. Coverage for Prevacid or Pantoloc will be provided if a patient has tried at least 30 days of Omeprazole (Losec^®) and 30 days of Rabeprazole sodium (Pariet^®).

Prior approval required.
Coverage will be provided:

• as part of multi-drug therapy (maximum 7-14 day coverage) for eradication of Helicobacter pylori in individuals with peptic ulcer disease (diagnosed by urea breath test, serology or endoscopically).

Coverage will also be provided if the following prerequisites are met:

• patient has tried at least 30 days of Omeprazole(Losec^®) and
• patient has tried at least 30 days of Rabeprazole sodium (Pariet^®).

Total trial of 60 days will be confirmed against medication history:

• for treatment of confirmed gastric and duodenal ulcers. Or
• for mild to moderate gastroesophageal reflux disease (GERD) in patients who have failed on or not tolerated and 4-week trial of histamine-2 receptor antagonists. Or
• for severe gastroesophageal reflux disease (GERD) and complications as first-line therapy for a maximum period of 3 months. Patients should be reassessed endoscopically or with step-down therapy using a histamine-2 receptor antagonist. Or
• for treatment of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers where the NSAID must be continued. Or
• for prevention of NSAID-induced ulcers in patients who have a history of ulcer complications, are over the age of 65 years, have comorbid disease such as cardiovascular disease or coagulopathies or are on concomitant medications which increase risk of ulcers or bleeding. Or
• Zollinger-Ellison Syndrome*. Or
• Barrett's Esophagus*. Or
• esophagitis associated with connective tissue disease. Or
• other exceptional circumstances, evaluated on an individual basis.
• Diagnosis must be confirmed by a specialist qualified to diagnose and treat condition.

Not Added to Formulary

Drugs Discontinued by the Manufacturer

Manufacturer Changes