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CPPA Interactive Case Studies
Certified Pharmacy Policy Analyst (CPPA)
The Scenario: Creating Policy for a New High-Cost Drug
"PulmoVate," a new oral therapy for Idiopathic Pulmonary Fibrosis (IPF), has just been FDA-approved. It offers a new mechanism of action but has an annual cost of over $100,000. As the lead CPPA for a health plan, you must develop the initial Prior Authorization (PA) policy to ensure its use is restricted to the appropriate patient population, aligns with clinical evidence, and fits within the existing formulary strategy.
Clinical Evidence & Plan Context
FDA Label & Trial Data
- Indication: To slow the rate of decline in pulmonary function in adults with Idiopathic Pulmonary Fibrosis (IPF).
- Pivotal Trial Inclusion Criteria: Age > 40; diagnosis of IPF confirmed by HRCT scan; FVC between 50%-90% predicted.
- Exclusion Criteria: Evidence of other interstitial lung diseases (e.g., COPD).
Health Plan Formulary
- Current Formulary Agents for IPF: Nintedanib and Pirfenidone are both currently on formulary as preferred agents.
- Goal: Establish PulmoVate's place in therapy relative to the existing preferred agents.
Your Task
1. Based on the pivotal trial's inclusion criteria, what are the three most critical, objective clinical criteria you must include for an initial approval?
Answer:
- Confirmed Diagnosis: The patient must have a confirmed diagnosis of IPF, documented by a pulmonologist and supported by a copy of the high-resolution computed tomography (HRCT) report.
- Pulmonary Function: The patient must have a recent Pulmonary Function Test (PFT) report demonstrating a Forced Vital Capacity (FVC) between 50% and 90% of the predicted value.
- Exclusion of Other Diseases: The clinical documentation must rule out other potential causes of interstitial lung disease, such as COPD or drug-induced lung disease.
2. To manage costs and ensure a logical progression of therapy, what "place-in-therapy" or "step-edit" requirement should be a core component of this policy?
Answer:
The policy must require the patient to have had a trial and failure of, or a documented intolerance or contraindication to, both of the existing preferred formulary agents (nintedanib and pirfenidone). This establishes PulmoVate as a third-line agent, ensuring that the plan's established, cost-effective therapies are used first, and reserving the new, expensive agent for patients who have exhausted other options.
3. What specific reauthorization criteria should be developed to justify continued coverage after 6 months of therapy?
Answer:
Reauthorization criteria should be based on an objective measure of treatment effect. The policy should state:
"For reauthorization at 6 months, the patient must submit an updated PFT report. Continued approval requires evidence that the drug is slowing the rate of pulmonary function decline, as demonstrated by one of the following: 1) A stable FVC, or 2) A rate of FVC decline that is slower than the rate observed in the pre-treatment period. A decline of >10% in FVC may be considered treatment failure."
The Scenario: Translating a New Guideline into Policy
The American Heart Association (AHA) has just released a landmark update to its guidelines for Heart Failure with Preserved Ejection Fraction (HFpEF). The new guideline gives a Class 1A (strongest) recommendation for using SGLT2 inhibitors in all HFpEF patients, based on new evidence. Your health plan's current policy severely restricts access to SGLT2 inhibitors, covering them only for Type 2 Diabetes. As the CPPA, you must analyze the new guideline's impact and recommend necessary changes to your plan's formulary and utilization management policies.
Guideline vs. Current Policy
New 2025 AHA Guideline (Excerpt)
"For patients with Heart Failure with Preserved Ejection Fraction (HFpEF), treatment with an SGLT2 inhibitor is recommended to reduce the risk of heart failure hospitalizations and cardiovascular mortality (Class of Recommendation: 1, Level of Evidence: A)."
Health Plan's Current Policy (ST-DIAB-05)
"SGLT2 inhibitors are non-preferred. A prior authorization is required. Approval requires: 1) A diagnosis of Type 2 Diabetes Mellitus, AND 2) A documented trial and failure of metformin."
Supporting Evidence: The guideline change was driven by trials showing SGLT2 inhibitors reduce HF hospitalizations by over 20% in HFpEF patients, regardless of their diabetes status.
Your Task
1. What is the most significant conflict between the new AHA guideline and your health plan's current policy?
Answer:
The most significant conflict is that the current policy restricts SGLT2 inhibitors to only patients with Type 2 Diabetes. The new guideline, with the highest possible level of evidence, recommends them for all patients with HFpEF, including the large population of patients who do not have diabetes. This means the plan's current policy is now outdated, misaligned with the national standard of care, and potentially denying members access to a life-saving therapy.
2. The finance department is concerned about the budget impact of expanding access. How do you justify the necessary policy change from a "total cost of care" perspective?
Answer:
You must frame the increased pharmacy spend as a strategic investment to prevent much larger medical expenses. The argument is:
"While expanding access to SGLT2 inhibitors will increase our pharmacy budget, the clinical evidence is unequivocal (Level A) that these drugs significantly reduce heart failure hospitalizations. A single HF hospitalization can cost our plan over $20,000. By investing a few thousand dollars per year in this drug, we can prevent these highly expensive medical events. The expected savings on the medical benefit from avoided hospitalizations will far outweigh the increased spend on the pharmacy benefit, leading to a net reduction in the total cost of care for this population."
3. What is your final, actionable recommendation to the P&T Committee regarding the formulary status and PA criteria for SGLT2 inhibitors?
Answer:
The recommendation is twofold:
- Change Formulary Status: Move the entire SGLT2 inhibitor class from "Non-Preferred" to "Preferred" status.
- Update PA Criteria: Rescind the old policy. Create a new, simpler policy that allows approval for patients with a documented diagnosis of EITHER Type 2 Diabetes Mellitus OR Heart Failure (with supporting documentation like an echocardiogram for HFpEF). The metformin step-edit should be removed for the heart failure indication.
This aligns the plan's policy with the current, evidence-based standard of care, improves patient access to a life-saving therapy, and is projected to reduce the plan's total cost of care.
The Scenario: Analyzing a New Step-Therapy Policy
You are a Pharmacy Policy Analyst for a regional health plan. Six months ago, the P&T Committee implemented a new step-therapy policy for GLP-1 agonists used in Type 2 Diabetes. The policy requires patients to first try and fail a lower-cost preferred agent ("Glucotrol") before being approved for more expensive, non-preferred agents ("Ozempic," "Trulicity"). The goal was to reduce pharmacy spend. The committee has now tasked you with analyzing post-policy data to determine if the policy was successful and to assess any unintended consequences on patient outcomes and total cost of care.
Data Sets
Table 1: Patient Cohort Data (6-Month Period)
| Time Period | Avg. Medication Adherence (PDC) | Avg. Monthly Pharmacy Cost per Patient | Avg. Monthly Medical Cost per Patient (ER/Urgent Care) |
|---|---|---|---|
| Pre-Policy | 85% | $850 | $150 |
| Post-Policy | 60% | $500 | $550 |
Table 2: Excerpt from P&T Committee Meeting Minutes
Objective for Policy #ST-GLP1:
"The primary objective of this step-therapy policy is to achieve a reduction in overall pharmacy expenditures for the GLP-1 agonist class. Success will be measured by a decrease in the per-member-per-month (PMPM) pharmacy cost. Clinical outcomes, including medication adherence, will be monitored to ensure patient care is not adversely affected."
Your Task
1. Looking at total cost of care (pharmacy + medical), what was the true financial impact of this policy?
Answer:
The policy was financially detrimental, leading to a $50 increase in the total cost of care per patient per month.
Methodology:
- Calculate Pre-Policy Total Cost: $$\$850 \text{ (Pharm)} + \$150 \text{ (Med)} = \$1,000$$
- Calculate Post-Policy Total Cost: $$\$500 \text{ (Pharm)} + \$550 \text{ (Med)} = \$1,050$$
- Find the difference: $$\$1,050 - \$1,000 = \$50 \text{ increase}$$
2. Based on your complete analysis, what is your recommendation to the P&T Committee regarding Policy #ST-GLP1?
Answer:
My recommendation is to rescind or significantly modify Policy #ST-GLP1. While it met the primary goal of reducing pharmacy spend, it failed its secondary objective by adversely affecting patient care (25% drop in adherence) and ultimately increasing the total cost of care for the health plan.
Justification:
The analysis demonstrates that the $350 saved on the pharmacy benefit was more than offset by a $400 increase in the medical benefit, leading to a net loss. The policy represents "false savings" and is not aligned with the health plan's goal of providing cost-effective, high-quality care.
