Benefit Criteria - Drug/Pharmacy

The following criteria are the framework for the Non-Insured Health Benefits Program Drug Benefit List (DBL). All drugs that are to be either considered for listing or currently listed as program benefits must, as a minimum:

1. Be legally available for sale in Canada with a Notice of Compliance;
2. Be sold in Canada (proof may include a copy of the completed notification form issued under the Food and Drug Regulations or listing on a provincial drug benefit formulary);
3. Be administered in a home setting or in other ambulatory care settings;
4. Not be provided in a provincially/territorially funded setting (hospital/institution) or provided through provincially/territorial funded programs or clinics according to provincial/territorial legislation; and
5. Be in accordance with NIHB Program mandate and policies.

This criteria provides the basis for decisions about drugs on the formulary relating to:

1. Drug Benefit Listings;
2. Deletion Criteria;
3. Open Benefits;
4. Limited Use Benefits;
5. Exception Criteria; and
6. Exclusions.

The Non-Insured Health Benefits (NIHB) Program, with assistance from the Federal Pharmacy and Therapeutics Committee, balances a number of factors in making decisions about changes to the Drug Benefit List, such as:

• The needs of First Nations and Inuit recipients;
• Accumulated scientific and clinical research on currently-listed drugs;
• Cost-benefit analysis;
• Availability of alternatives;
• Current health practices; and
• Policies and listings in provincial drug formularies.

A. Drug Benefit Listings

The following criteria guide the decisions about the listing of a drug product on the NIHB Program Drug Benefit List:

1. Demonstrated evidence of therapeutic efficacy;
2. Demonstrated safety;
3. Demonstrated incremental benefit in proportion to incremental cost; and
4. Consistency with NIHB Program mandate and policies.

New formulations and new strengths of listed products may be added or may replace previously approved products.

Generic products are added according to provincial interchangeability lists and other relevant factors.

Combination products are considered for listing if:

• Each component of the combination makes a contribution to the claimed effect;
• A pharmacological or pharmaceutical rationale exists for the combination;
• The dosage of each component (amount, frequency, duration) is safe and effective for a significant proportion of the patient population requiring such concurrent therapy as defined in the labelling of the drug; and
• The cost is reduced, or the scientific evidence indicates that the advantages outweigh any additional cost; or
• An improvement in compliance, resulting in an increase in clinical effectiveness, is demonstrated.

Sustained Release Products may be listed when:

• Clinical studies have demonstrated the safety and efficacy of the active ingredient when administered in the sustained released form; and
• A therapeutic advantage is demonstrated in the treatment of the disease entity for which the product is indicated (therapeutic advantage is defined as: improved efficacy relative to the conventional dosage with no increase in toxicity; or less toxicity with improved or similar efficacy); or
• There is demonstrated improvement in compliance resulting in an increase in clinical effectiveness, or
• There is evidence that the sustained release product is at least as cost-effective as the best price alternative in the conventional form that is currently covered; or
• There is no suitable conventional dosage form(s) of the drug listed that is readily available.

Injectable Drug Products will be considered if they are:

• Self-administered in a home or other ambulatory setting;
• Not part of a physician's standard office supply;
• Not provided in a provincially/territorially funded hospital or institution; or
• Not provided through provincially/territorial funded programs or clinics according to provincial/territorial legislation.

B. Deletion Criteria

The following deletion criteria guide the removal or delisting of a drug product from the NIHB drug benefit list. Drugs are deleted when:

• A product is discontinued from the Canadian market;
• New products possessing clearly demonstrated therapeutic and safety advantages or improvements have been listed;
• New toxicity data shift the risk/benefit ratio to make the continued listing of the product inappropriate;
• New information demonstrates that the product does not have the anticipated therapeutic benefit;
• The purchase cost is disproportionate to the benefits provided; or
• The drug has a high potential for misuse or abuse.

Note: Drugs may also be removed at the discretion of the Director General, NIHB Program when there are undesirable financial, supply or administrative implications to the continued listing of a product.

C. 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.

D. Limited Use Benefits

Certain drug products may be inappropriate for general listing, but have value in specific circumstances. These products may be recommended as "limited use benefits" with specific criteria for provision as a benefit under the NIHB Program. A product will be designated for limited use when:

• It has the potential for widespread use outside the indications for which benefit has been demonstrated;
• It has proven effectiveness, but is associated with predictable severe adverse effects;
• It is usually a second or third line choice for treatment and is required because of allergies, intolerance, treatment failure or noncompliance with a first line alternative; or
• It is very costly and a therapeutically effective alternative is available as a benefit.

There are three types of limited use benefits:

1. Limited use benefits which do not require prior approval. These include:
   • Multivitamins (which are benefits for children up to 6 years of age); and
   • Prenatal and postnatal vitamins (which are benefits for women of childbearing age (12 to 50 years).
     
     
2. Limited use benefits require prior approval. For detailed information, see limited use benefits and the criteria for their coverage.
   
   
3. Benefits which have a quantity and frequency limit. A maximum quantity of drug is allowed within a specified period of time. No prior approval is required for the client to obtain the allowable quantity of drug within the specified period. Drugs with a quantity and frequency limit include the smoking cessation products. Clients are eligible to receive a 3-month supply of smoking cessation products over a one year period which is renewable 12-months from the day the initial prescription was filled.

E. Exception Criteria

Drugs which are not listed in the Drug Benefit List may be approved in special circumstances upon receipt of a completed "Exception Drugs Request Form" from the attending physician or dentist. Requests for exceptions will be considered when:

• The prescription is for a recognized clinical indication and dose which is supported by published evidence or authoritative opinion; and
• There is supporting evidence that available alternatives are ineffective, toxic, or contraindicated (personal preference alone does not justify an exception); or
• There is significant evidence that the requested drug is superior to drugs already listed as program benefits; or
• A patient has experienced an adverse reaction with a best price alternative drug, and a higher cost alternative is requested by the prescriber.

F. Exclusions

Certain drug products are not within the scope of the program. These products will not be reimbursed as benefits under the NIHB Program:

• Anti-obesity drugs;
• Household products (regular soaps and shampoos);
• Cosmetics;
• Alternative therapies, including glucosamine and evening primrose oil;
• Megavitamins;
• Drugs with investigational/experimental status;
• Vaccinations for travel indications;
• Hair growth stimulants;
• Fertility agents and impotence drugs;
• Selected over-the-counter products;
• Codeine containing cough preparations ;
• Darvon® and 642® (propoxyphene) -- effective June 1, 2004;
• Stadol TM NS and generics (b utorphanol tartrate nasal spray) - effective August 1, 2005; and
• Fiorinal®, Fiorinal® C ¼, Fiorinal® C ½ and generics (Butalbital containing analgesics with and without codeine) - effective August 1, 2005.

See Exclusions by the Common Drug Review and the Federal Pharmacy and Therapeutics Committee, found within the Drug Benefit List section, for drugs that are excluded from the NIHB Program as recommended by the Common Drug Review (CDR) and the Federal Pharmacy and Therapeutics Committee (FPT).