The Saskatchewan Formulary lists the drugs, which are covered by the Drug Plan. A prescription is required for all drugs dispensed under the Drug Plan with the exception of insulin, blood-testing agents, urine-testing agents, syringes, needles, lancets and swabs used by diabetic patients.

THE FORMULARY
The Saskatchewan Formulary is a listing of the therapeutically effective drugs of proven high quality that have been approved for coverage under the Drug Plan. It is compiled by the Minister of Health with the advice of the Drug Advisory Committee of Saskatchewan (DACS) and is then prepared, maintained and distributed by the Drug Plan and Extended Benefits Branch.

The members of the DACS are appointed by the Minister of Health and provide independent, specialized advice on drug-related matters. The membership on the DACS is comprised of two public representatives as well as clinical specialists in the areas of medicine, pharmacology, pharmacy and economics.

The Saskatchewan Formulary is published annually in April. Additions to the Formulary are made throughout the year; interchangeable generic drugs are added monthly and other products are added quarterly.

The ongoing work of the DACS includes the evaluation of new drug products, as well as the re-evaluation of listed products as required. The goal is to list a range and variety of drugs that will enable prescribers to select an effective course of therapy for most patients.

For the Drug Review Process, please see Product Submission Process.

EXCEPTION DRUG STATUS (EDS)
Certain drugs are reviewed and recommended by the DACS for coverage under the EDS Program. All recommendations must be approved by the Minister of Health. The drugs usually fall into one of the following categories:
  • The drug is ordinarily administered only to hospital in-patients but is being administered outside of a hospital because of unusual circumstances.
  • The drug is not ordinarily prescribed or administered in Saskatchewan, but is being prescribed because it is required in the diagnosis or treatment of an illness, disability, or condition rarely found in Saskatchewan.
  • The drug is infrequently used because Formulary products are usually effective, but are contraindicated or found to be ineffective due to the clinical condition of the patient.
  • The drug has been deleted from the Formulary but is required by patients previously stabilized on the drug.
  • The drug has potential for use in other than approved indications.
  • The drug has potential for the development of widespread inappropriate use.
  • The drug is more expensive than listed alternatives and offers an advantage in only a limited number of indications.

Drugs approved for EDS coverage are subject to the same deductible and co-payment as the patient's Formulary drugs.

EDS Application Process
  • Physicians, dentists, duly qualified optometrists (or authorized office staff), nurse practitioners and pharmacists may apply for EDS.
  • Requests can be submitted by telephone, by mail or by fax. A toll-free line with an electronic message system is available exclusively for requests on a 24-hour basis. The telephone number to access this line is 1-800-667-2549; the Drug Plan EDS Unit fax number is (306) 798-1089.
  • The following information is required to process all EDS requests: patient name, patient Health Services Number (9 digits), name of drug, diagnosis* relevant to use of drug, prescriber name and phone number.
  • Requests are processed daily on a continuous basis.
  • Patients are notified by letter if coverage has been approved and the time period for which coverage has been approved.
  • If a request has been denied, letters are sent to the patient and prescriber notifying them of the reason for the denial. In most cases, the Drug Plan requires more information to determine the patient's eligibility for coverage, and will reconsider coverage at such time as further information is received.
  • If the drug requested is not a benefit under the Drug Plan, the patient and prescriber are notified. Payment for the medication is the responsibility of the patient in these cases. It is important to note that not all medications currently available on the market in Canada are benefits under the Saskatchewan Drug Plan or under the EDS Program of the Drug Plan.
  • The majority of EDS requests are routinely backdated 30 days from the time the Drug Plan receives the request. Provision can be made for further backdating of EDS coverage on a case-by-case basis by staff in Pharmaceutical Services Division. However, there is no provision or backdating further than one year from the current date.
  • Certain products may be granted EDS for non-approved indications. This is the case only when the DACS has reviewed evidence to demonstrate safety and efficacy and the prescriber is aware the drug is being prescribed for a non-approved indication.
* For pharmacist-initiated EDS requests:
The diagnosis, which must be obtained from the physician or physician's agent, is to be consistently documented within the pharmacy, whether the documentation is on the original prescription, computer file, or EDS fax form.

CRITERIA FOR COVERAGE UNDER EDS
The criteria is established by the Drug Advisory Committee of Saskatchewan and is listed in the Saskatchewan Formulary. See Appendix A, for details regarding EDS criteria.

OVER-THE-COUNTER PRODUCTS
Over-the-counter (OTC) products are generally not included as benefits of the Drug Plan.

Product Interchangeability and Pricing
One function of the Drug Advisory Committee of Saskatchewan is to identify interchangeable drug groups. Interchangeable products are different brands of the same drug with the same strength and dosage form that are equivalent in therapeutic effectiveness and quality.

The Formulary lists two types of interchangeable drug groups; Low Cost Alternative, and Standing Offer Contract.

Low Cost Alternative
In order to ensure price stability for the Formulary period, the Drug Plan and Extended Benefits Branch requires drug manufacturers to provide guaranteed maximum prices for the period. The prices constitute the maximum price that the Drug Plan will allow for those products during the effective Formulary period.

Any drug in a Low Cost Alternative interchangeable group can be used to fill a prescription. The drug cost component in the approved prescription price is the actual acquisition cost of the drug up to the lowest price listed in the Formulary within that interchangeable group.

Standing Offer Contract (SOC)
The Drug Plan tenders the drugs in certain interchangeable groups to obtain the lowest possible price. An accepted tender, called SOC, requires the manufacturer to guarantee delivery of the specific drug to pharmacies through approved distributors at the contracted price. In return, the manufacturer's product will be used almost exclusively. This tender process, in 2010-11 saved Saskatchewan residents and the Drug Plan approximately $17.4M.

Only the accepted tendered drug can be used to fill a prescription in an SOC interchangeable group. If a prescription is ordered as "no substitution" for any brand other than the SOC brand listed, the Drug Plan will cover the actual acquisition cost up to the listed SOC unit price. The difference in acquisition cost between the brand dispensed and the cost covered by the Drug Plan is the responsibility of the consumer.

"No Substitution" Prescription Drug Coverage
It is recognized that extremely rare cases may exist in which a person is not able to use a particular brand of product. In such cases, the physician may request exemption from full payment of incremental cost when a specific brand of drug in an interchangeable category is found to be essential for a particular patient. There is no provision for "blanket" exemptions. Each request must be patient and product specific.

Maximum Allowable Cost (MAC)
Implementation of the MAC policy began on July 1, 2004. Currently this policy applies to one drug class, the proton pump inhibitors, and it may be expanded to other drug classes in the future. Savings achieved with MAC will be available to fund significant new therapies that will be coming in the future and will help to ensure the viability of the Drug Plan.

Under the new policy, the Drug Plan obtains expert advice on which prescription drug products within a group of similar medications are safe and beneficial, and the most cost-effective. The price of the most cost-effective drugs are used as a guide to set the maximum price the Drug Plan will cover for other similar drugs used to treat the same condition. The MAC is not necessarily set at the price of the lowest cost drug.

Physicians can continue to prescribe whichever drug they choose. This new policy only limits the amount that is reimbursed.

See Appendix C for more information regarding MAC.

Product Distribution
Two distribution networks are used to deliver drugs to pharmacies; manufacturers direct to pharmacies, or manufacturers to pharmacies via distributors and Saskatchewan wholesalers.