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Certified Formulary Strategy Pharmacist (CFSP)
Official Examination Content Outline
This document provides the official content outline for the Certified Formulary Strategy Pharmacist (CFSP) examination. This advanced certification validates a pharmacist's expertise in evidence-based medicine, pharmacoeconomics, specialty drug management, and population health strategies, which are essential for developing and managing formularies in today's value-driven healthcare landscape.
Examination Specifications
| Name of Credential | Certified Formulary Strategy Pharmacist (CFSP) |
|---|---|
| Certification-Issuing Body | The Council on Pharmacy Standards (CPS) |
| Designation Awarded | CFSP |
| Target Population | Pharmacists specializing in formulary management, pharmacoeconomics, specialty pharmacy, and outcomes research within managed care organizations, PBMs, and health systems. |
| Examination Length | 120 multiple-choice items |
| Administration Time | 3.0 hours |
Examination Content Outline
The CFSP examination is weighted according to the five domains listed below, covering the entire lifecycle of formulary strategy, from evidence assessment and financial modeling to specialty drug management and quality outcomes.
| Domain 1: Clinical & Real-World Evidence Evaluation | 25% |
| Domain 2: Economic Evaluation, Contracting, and Financial Strategy | 25% |
| Domain 3: Specialty Drug and Utilization Management Strategy | 25% |
| Domain 4: P&T Committee Governance and Communication | 15% |
| Domain 5: Population Health, Outcomes, and Quality | 10% |
Domain 1: Clinical & Real-World Evidence Evaluation (25%)
Task 1: Appraise evidence from clinical trials and precision medicine.
- Assess the internal and external validity of clinical trials, identifying potential sources of bias.
- Analyze study design, methodology, and the appropriateness of primary and secondary endpoints.
- Assess the validity and utility of biomarker data and companion diagnostics used in precision medicine trials.
- Interpret key statistical measures (e.g., p-value, confidence intervals, NNT) to determine clinical significance.
- Evaluate the diversity and representation of trial populations to identify potential health equity gaps.
Task 2: Evaluate real-world evidence (RWE) and comparative effectiveness research (CER).
- Differentiate between various RWE study designs (e.g., cohort, case-control) and their limitations.
- Critically appraise observational studies, patient registries, and network meta-analyses.
- Assess the quality and relevance of patient-reported outcomes (PROs) and other real-world data sources.
- Analyze how social determinants of health (SDOH) may impact real-world outcomes and generalizability of evidence.
- Integrate RWE and CER findings with RCT data to inform coverage decisions.
Task 3: Synthesize evidence for biosimilar and interchangeable products.
- Evaluate the totality of evidence supporting biosimilarity, including analytical, clinical, and non-clinical data.
- Differentiate the FDA approval pathways and data requirements for biosimilar versus interchangeable biologics.
- Assess clinical studies designed to demonstrate no clinically meaningful differences between a biosimilar and its reference product.
- Analyze switching studies to determine the safety and efficacy of alternating between reference and biosimilar products.
- Monitor post-marketing surveillance data for biosimilars to assess real-world safety and immunogenicity.
Task 4: Conduct systematic literature reviews.
- Formulate a focused clinical question using a structured framework (e.g., PICO).
- Design and execute a comprehensive search strategy across multiple biomedical databases.
- Apply predefined inclusion and exclusion criteria to screen and select relevant studies.
- Extract and synthesize data from included studies to answer the clinical question.
- Assess the overall strength and quality of the body of evidence using established grading systems (e.g., GRADE).
Task 5: Apply health technology assessment (HTA) and value frameworks.
- Differentiate the methodologies of major value frameworks and HTA bodies (e.g., ICER, NCCN Evidence Blocks, NICE).
- Evaluate the clinical, economic, and patient-centered inputs used in framework assessments.
- Analyze how HTA reports are used to inform value-based pricing and formulary negotiations.
- Critique the methods and assumptions underlying HTA models and conclusions.
- Adapt HTA findings to the specific context of the local health plan or population.
Task 6: Develop evidence-based drug monographs and therapeutic class reviews.
- Integrate all relevant clinical, real-world, and economic evidence into a formal drug monograph.
- Compare and contrast the evidence for all agents within a therapeutic class.
- Formulate objective, evidence-based recommendations on efficacy, safety, and place in therapy.
- Present a balanced summary that addresses both the strengths and weaknesses of the evidence.
- Update monographs and class reviews in response to new, high-impact clinical evidence or digital health data.
Domain 2: Economic Evaluation, Contracting, and Financial Strategy (25%)
Task 1: Develop budget impact models (BIMs).
- Construct a model to forecast the net financial impact of adding a new drug to a formulary.
- Identify and justify all key model inputs, including population size, market share, drug cost, and cost offsets.
- Incorporate the financial effects of rebates and utilization management into the model.
- Conduct one-way and multi-way sensitivity analyses to test the robustness of model results.
- Present BIM results to financial stakeholders to inform budgeting and forecasting.
Task 2: Critically appraise pharmacoeconomic analyses.
- Differentiate between cost-minimization, cost-benefit, cost-effectiveness (CEA), and cost-utility (CUA) analyses.
- Interpret the results of a CEA/CUA, including the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-year (QALY).
- Assess the validity of assumptions, data sources, and modeling techniques used in manufacturer-submitted analyses.
- Evaluate the perspective of the analysis (e.g., payer, societal) and its relevance to the decision.
- Apply best practice guidelines (e.g., CHEERS statement) to evaluate the quality of economic studies.
Task 3: Design traditional and rebate-based contracting strategies.
- Analyze how formulary placement decisions can be leveraged to maximize rebate revenue.
- Model the net cost of competing products after applying potential rebate offers.
- Evaluate contract language to ensure favorable terms and mitigate financial risk.
- Differentiate between flat, tiered, and market-share based rebate structures.
- Monitor drug utilization post-contract to ensure compliance with rebate agreement terms.
Task 4: Structure value-based and risk-based contracts.
- Differentiate value-based contracts from traditional rebate agreements.
- Design outcomes-based agreements that link payment to clinical or economic performance metrics.
- Evaluate risk-sharing arrangements, such as shared savings models or money-back guarantees.
- Identify appropriate, measurable, and auditable outcomes to include in a value-based contract.
- Assess the operational feasibility of tracking and adjudicating outcomes for contracting purposes.
Task 5: Analyze the financial implications of government programs.
- Assess the impact of the 340B Drug Pricing Program on covered entities and contract pharmacies.
- Analyze the financial impact of Medicare Part D/B and Medicaid policies, including CMS rebate rules and inflationary caps.
- Evaluate how Medicaid "best price" regulations influence manufacturer pricing and rebate strategies.
- Assess the financial implications of policies from the Inflation Reduction Act (IRA) on drug pricing.
- Differentiate pricing benchmarks (e.g., WAC, ASP, AWP) and their use in government program reimbursement.
Task 6: Model the financial impact of specialty drugs and novel therapies.
- Analyze the key drivers of spending trends for specialty medications.
- Forecast the budget impact of high-cost pipeline agents, including cell and gene therapies.
- Evaluate innovative payment models (e.g., milestone-based, subscription) for curative therapies.
- Model the potential cost savings associated with the adoption of biosimilars.
- Assess the total cost of care, including medical cost offsets, for specialty drugs.
Domain 3: Specialty Drug and Utilization Management Strategy (25%)
Task 1: Design comprehensive utilization management (UM) programs.
- Develop objective, evidence-based clinical criteria for prior authorization (PA) programs.
- Design step-therapy (ST) protocols that promote the use of first-line, cost-effective agents.
- Establish appropriate quantity limits (QLs) to ensure safety and prevent waste.
- Implement strategies to streamline UM processes, such as electronic prior authorization (ePA).
- Evaluate the clinical and economic performance of existing UM programs.
Task 2: Develop a specialty drug management strategy.
- Design specialty tiers and cost-sharing structures to manage specialty drug spend.
- Differentiate management strategies for drugs covered under the pharmacy versus the medical benefit.
- Evaluate the use of limited or exclusive specialty pharmacy networks to control costs and improve care.
- Develop policies for managing high-cost orphan drugs for rare diseases.
- Integrate clinical pharmacist management programs for patients on specialty medications.
Task 3: Implement site-of-care optimization programs.
- Analyze claims data to identify specialty drugs with significant price differentials across sites (e.g., hospital outpatient, ambulatory infusion center, home infusion).
- Design policies to steer patients to the most clinically appropriate and cost-effective site of care.
- Collaborate with medical management teams to coordinate site-of-care transitions.
- Develop criteria for determining medical necessity for higher-cost sites of care.
- Assess the impact of site-of-care programs on patient access, quality of care, and total cost.
Task 4: Manage Risk Evaluation and Mitigation Strategies (REMS) requirements.
- Differentiate between the various types of REMS requirements (e.g., Medication Guide, Elements to Assure Safe Use).
- Assess the organization's ability to comply with REMS program requirements for specific drugs.
- Implement operational workflows to ensure documentation and fulfillment of REMS elements.
- Train clinical and operational staff on their roles and responsibilities within a REMS program.
- Audit compliance with REMS programs to mitigate organizational risk.
Task 5: Formulate a biosimilar adoption strategy.
- Develop formulary policies to promote the use of preferred biosimilars over reference products.
- Design provider and member incentive programs to drive biosimilar uptake.
- Create communication and education campaigns for providers and patients about biosimilars.
- Establish a process for P&T committee review and approval of new biosimilars.
- Monitor biosimilar utilization rates and financial savings against organizational goals.
Task 6: Manage the high-impact pharmaceutical pipeline.
- Monitor drugs in late-stage clinical development to identify potential high-impact agents.
- Forecast the potential clinical, utilization, and financial impact of new pipeline drugs.
- Develop proactive management and reimbursement strategies for novel agents with high budget impact (e.g., gene and cell therapies).
- Present regular pipeline updates to clinical and financial leadership.
- Engage in pre-launch discussions with manufacturers to inform coverage and contracting strategies.
Domain 4: P&T Committee Governance and Communication (15%)
Task 1: Manage P&T committee governance and ethical considerations.
- Develop and maintain the P&T committee's charter, bylaws, and policies and procedures.
- Plan meeting agendas, prepare meeting materials, and facilitate P&T committee meetings.
- Manage and transparently disclose all potential conflicts of interest, including those related to manufacturer rebates and contracting.
- Ensure that committee membership reflects a diverse range of clinical expertise.
- Document meeting minutes accurately and ensure proper approval and archival.
Task 2: Integrate diverse perspectives into decision-making.
- Develop a formal process for incorporating patient and caregiver perspectives into formulary deliberations.
- Engage external subject matter experts and provider groups for input on complex coverage decisions.
- Analyze the potential impact of formulary policies on health equity and vulnerable populations.
- Incorporate health equity considerations as a standard component of drug reviews.
- Balance clinical, economic, ethical, and patient-centered factors in making recommendations.
Task 3: Present complex evidence to the P&T committee.
- Synthesize and present drug monographs and therapeutic class reviews in a clear and objective manner.
- Communicate complex clinical trial data and statistical concepts to a diverse audience.
- Explain the methods and results of pharmacoeconomic and budget impact models.
- Answer challenging clinical and financial questions from committee members.
- Defend formulary recommendations based on a rigorous evaluation of the total body of evidence.
Task 4: Implement and operationalize P&T committee decisions.
- Translate P&T committee recommendations into specific formulary and UM policy changes.
- Oversee the operational implementation of all committee decisions across claims adjudication and clinical review systems.
- Collaborate with IT and operations teams to ensure accurate system configuration.
- Develop a project plan for implementing significant formulary changes.
- Audit claims data post-implementation to verify that policies are working as intended.
Task 5: Design transparent and digital formulary communication strategies.
- Develop a comprehensive communication plan to notify members and providers of formulary changes.
- Create clear, concise, and accurate communications for provider newsletters, websites, and member notifications.
- Leverage digital tools, such as interactive dashboards and evidence portals, to communicate formulary information to stakeholders.
- Develop and maintain an up-to-date, user-friendly, and searchable online formulary.
- Establish a process for responding to provider and member inquiries about formulary decisions.
Task 6: Manage a drug information service.
- Serve as the organization's leading expert on evidence-based medicine and literature evaluation.
- Respond to complex clinical inquiries from internal stakeholders, such as medical directors and case managers.
- Provide timely, accurate, and fully referenced responses to drug information questions.
- Develop educational materials and training programs for clinical staff on formulary-related topics.
- Stay current with new drug approvals, clinical guidelines, and emerging therapeutic trends.
Domain 5: Population Health, Outcomes, and Quality (10%)
Task 1: Apply population health principles to formulary design.
- Analyze population-level data to identify prevalent conditions and unmet needs.
- Align formulary and benefit design with preventive care and chronic disease management goals.
- Implement value-based insurance design (VBID) to reduce cost-sharing for high-value services.
- Design formularies that support evidence-based clinical practice guidelines across a population.
- Evaluate the population health impact of formulary coverage policies.
Task 2: Integrate formulary strategy with quality improvement programs.
- Integrate formulary strategy with payer/provider quality programs to improve performance on medication-related measures (e.g., HEDIS, STAR Ratings).
- Analyze how formulary access and UM criteria may impact performance on these measures.
- Design formulary strategies to improve medication adherence for key drug classes (e.g., statins, antihypertensives).
- Model the potential impact of formulary changes on quality scores and associated financial incentives.
- Collaborate with quality improvement teams to develop targeted, medication-focused interventions.
Task 3: Design interventions to improve medication adherence and persistence.
- Analyze claims data to identify patient populations with low adherence rates.
- Design and implement targeted programs to address barriers to adherence.
- Evaluate the effectiveness of adherence interventions on clinical and economic outcomes.
- Incorporate adherence-promoting strategies into benefit design and UM programs.
- Leverage digital monitoring tools, pharmacist outreach, and targeted interventions to improve medication adherence and persistence.
Task 4: Analyze data to identify and address health disparities.
- Use claims data and demographic information to identify variations in medication access, use, and outcomes among different populations.
- Assess whether formulary policies or UM criteria may inadvertently exacerbate health disparities.
- Design interventions to mitigate identified disparities and promote health equity.
- Incorporate a health equity impact assessment into the formulary decision-making process.
- Track metrics to measure progress in reducing medication-related health disparities.
Task 5: Manage data analytics and digital health integration.
- Analyze pharmacy and medical claims data to evaluate drug utilization trends and outcomes.
- Integrate data from various sources (e.g., EHRs, claims, patient-reported outcomes) to support decision-making.
- Apply predictive analytics and AI-driven models to forecast utilization and identify at-risk patients.
- Evaluate the clinical and economic value of digital health interventions and applications.
- Ensure data governance and privacy standards are met when using member-level data for analysis.
Task 6: Report on value-based outcomes.
- Define and track key performance indicators (KPIs) for the pharmacy benefit.
- Develop dashboards and reports to communicate clinical and financial outcomes to leadership.
- Measure the real-world performance of drugs under value-based contracts.
- Analyze and report on the total cost of care for specific diseases or populations.
- Demonstrate the value of the pharmacy benefit strategy to internal and external stakeholders.
