What is the most commonly used formulary used in Saskatchewan?
The provincial formulary, SPDP (Saskatchewan Prescription Drug Plan)
What is the formulary process?
The ongoing process through which an organization identifies medications that are most medically appropriate & cost-effective to best serve the health interests of a given patient population
What are the objectives of a drug formulary?
- Optimize appropriate drug therapy
- Reduce drug costs
What are some of the ways the formulary helps manage drug prescribing?
- Inclusion of generics/biosimilars (mandatory generic substitutions)
- Dispensing frquency (100 day drug list/maintenance drug schedule)
- Drug use criteria (EDS, diagnosis, prescriber, failure of other drug therapy, drug specfiic)
- Treatment guidelines (order sets, treatment algorithms, therapeutic approaches)
- Therapeutic substitution/interchange (automatic substitution according to previously established & approved written guidelines, policies, or protocols)
- Others (Maximum allowable cost policy, trial prescription program, SK MS Drugs Program)
What is the role of the Health Technology Assessment?
It is a systematic evaluation of thr properties, effects and/or impacts of a health technology, and aimed mainly at informed decison-making regarding health technologies
Multidisciplinary process to evaluate the social, economic, organizational, and ethical issues of a health interventions or health technology
What is the Canadian Agency for Drugs and Technologies in Health (CADTH)?
An independent organization responsible for performing HTAs for publically funded healthcare providers (improves ability to make evidence-based health policy decisions)
What is the Common Drug Review Program?
A pan-Canadian process for conducting objective, rigourous reviews of thwe clinical, cost effectiveness, and patient eviden ce for drugs (provides formulary listing recommendations to publically-funded drug plans, except for Quebec)
What is the Pan-Canadian Oncology Drug Review (pCODR)?
An evidence-based, cancer drug review process. The pCODR process is intended to bring consistency and clarity to the asessment of cancer drugs by reviewng clinical evidence, cost-effectiveness, and patient perspectives
Review slide 25 for a good review of how drugs/interventionals are included in the reccomendations for formulary inclusion
What is the CDEC (Canadian Drug Expert Committee)?
This committee is composed of pharmacists, physicians, members of the public, ethicist, and an ad hoc blood services expert. They make reccomendations on drugs and therapeutic reviews to the participating jurisdictions
What are the criteria that the Canadian Drug Expert Committee uses to determine whether if a reccomendation is appropriate for formulary inclusion?
- Is there clinical benefit?
- Patient submission
- Is it cost effective
What are some factors that are considered in cost analyses for drug formulary inclusion?
- Frequency of utilization, real world dosing, adherance, dosage creep
- Route of administration (IV, SC, PO)
- Preparation costs
- Requirement of administration equipment
- Additional screening or lab tests required
- Dispensing fees
- Potential genericization of competitors
- Wastage
- Market expanison (are alternatives coming to the market)
What are the levels of Canadian Drug Expert Committee reccomendations for drug/procedure inclusion into drug formularies?
- Reimburse (Include in formulary)
- Reimburse with conditions (Potentially EDS)
- Do not reimburse (do not include in formulary)
What are some types of commonly used reimbursement conditions?
- Initiation criteria (severity of condition, treatment history, comorbidities, subtypes of condition)
- Renewal criteria (minimum treatment response for continuation of therapy)
- Discontinuation criteria (Need for an invasive intervention, initiation of a different therapy, disease progression)
- Prescribing criteria (limiting who can prescribe, restrictions on strength and frequency of administration, restrictions on combination use with other drugs)
- Pricing conditions (cost of drug under review shuld not exceed cost of appropriate comparators)
Review slide 32 for the roles of the different organizations and committies in the inclusion of specific drug/intervention to publically funded formularies
What is the pCPA (pan-Canadian Pharmaceutical Alliance)?
Established in 2010 to acheive greater value for publically funded drug programs and patients through the combined negotiating power of participating jurisdictions. They look at reccomendations from CADTH and will decide whether to enter into negotiations with the manufacturers.
How can potential additions/changes to the formulary be submitted?
- CDR review of new product
- Manufacturer submission
- Request from HCPs
- Request from patient groups
- Ministry or provincial priority
What is the Drug Advisory Committee of Saskatchewan (DACS)?
- Goals: Provide independent specialized advice on drug-related matters
- Duties: Evaluate drug products based on clinincal evidence and cost effectiveness data to provide advice to the minister regarding appropriate drug utilization and drug use optimization
- Members: Pharmacy, Medicine, Public members
What is the Drugs and Therapeutics Committee (DTC)?
Thisgroup adds to hospital (SHA) formulary
Meets 7-9 times per year to manage the formulary. 30 voting members lead by a physician and pharmacist. They have the authority yo approve formulary requests up to a certain dollar amount, as well as a process for non-formulary drugs
What are some reasons for a drug being deleted from the formulary?
- New evidence
- Discontinued by manufacturer and no alternative available
- Safety issues
- Nil to very low usage/need
- Result of a therapeutic class review
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Introduction to EBM13
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Threats to Internal Validity23
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Randomized Controlled Trials31
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Observational Studies29
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Interpreting Study Results29
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Systemic Reviews and Meta-Analyses13
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Clinical Practice Guidelines13
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Direct to Consumer Advertising12
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Humanistic Outcomes19
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Research Ethics25
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Formulary20
