CPAP Module 23, Section 1: Oncology Case Simulation: PA for Immunotherapy
MODULE 23: SPECIAL TOPICS & CASE SIMULATIONS

Section 1: Oncology Case Simulation: PA for Immunotherapy

Navigating the pinnacle of clinical complexity, where every data point tells a story and every approval is a lifeline.

SECTION 23.1

Oncology Case Simulation: PA for Immunotherapy

From Clinical Detective to Patient Advocate: Assembling the Evidence for a Life-Changing Therapy.

23.1.1 The “Why”: The Highest Stakes on the Board

Welcome to the major leagues. Of all the prior authorizations you will manage in your career, those for oncology—and specifically for novel agents like checkpoint inhibitor immunotherapies—represent the absolute pinnacle of complexity, urgency, and clinical significance. This is not about managing cholesterol or controlling blood pressure. This is about securing access to therapies that can fundamentally alter the course of a terminal disease, often with price tags exceeding hundreds of thousands of dollars per year. The stakes, for both the patient and the healthcare system, could not be higher.

Why is this domain so uniquely challenging? It’s a confluence of several factors. First, the science is exquisitely precise. An immunotherapy agent like pembrolizumab or nivolumab is not a “one-size-fits-all” drug. Its approval hinges on a patient’s specific cancer type, its stage, its genetic mutations, and the expression of particular protein biomarkers like PD-L1. A simple diagnosis of “lung cancer” is woefully insufficient. The payer needs to know it’s non-small cell lung cancer, stage IV, with a PD-L1 Tumor Proportion Score (TPS) of 60%, and confirmed negative for EGFR or ALK mutations. Each of these data points is a non-negotiable prerequisite for approval.

Second, the documentation is fragmented and highly specialized. The proof you need is not on a prescription blank; it’s buried deep within pathology reports, molecular diagnostic summaries, radiation oncology notes, and oncologist progress reports. You must become a master navigator of the Electronic Medical Record (EMR), able to hunt down and interpret these disparate pieces of evidence. Third, the urgency is palpable. A delay of days or weeks in starting therapy is not an inconvenience; it can be a clinically meaningful setback for a patient with rapidly progressing disease. Your efficiency is a clinical intervention.

In this simulation, we will move beyond theory and immerse you in a realistic case. You will take on the role of the prior authorization pharmacist tasked with securing approval for a patient who desperately needs it. You will learn to think like an oncologist, read like a pathologist, and argue like a lawyer, using clinical evidence as your only weapon. Mastering this process is one of the most profound ways a pharmacist can impact a patient’s life. This is where your expertise translates directly into hope.

Retail Pharmacist Analogy: The High-Stakes REMS Coordination

Imagine a patient arrives at your pharmacy with a new prescription for a highly-specialized, limited-distribution drug that costs $15,000 per month. This isn’t just any medication; it’s under a strict FDA Risk Evaluation and Mitigation Strategy (REMS) program due to its potential for severe side effects.

The prescription itself is just the entry ticket. To dispense it, your pharmacy, the prescriber, and the patient must all be separately certified in the REMS program. The patient needs baseline liver function tests, a negative pregnancy test, and a signed patient-physician agreement form acknowledging the risks. These items are the clinical criteria. The test results are the biomarker data, and the signed form is the physician attestation.

You can’t just fill the prescription. You become a project manager. You look in the patient’s profile and see none of this required documentation exists. Your first call is to the specialist’s office. You don’t ask, “Can I fill this?” You say, “I’m the pharmacist coordinating the REMS requirements for Jane Doe’s new therapy. I need you to fax me a copy of the completed patient-physician agreement form, and can you confirm the date of her baseline LFTs and negative pregnancy test? I need the official lab reports.” This is your clinical clarification and document retrieval.

The nurse is busy and faxes you only the agreement form. The labs are missing. You have to call back, politely but firmly escalating the urgency. “I’m sorry to bother you again, but I cannot get the medication shipped from the manufacturer without the source lab reports. The patient’s therapy is on hold until we have them.” This is advocating against an information deficit.

Finally, you have all the pieces: the prescription, the lab reports, and the signed form. You don’t just put them in a folder. You log into the REMS portal and meticulously upload each document, entering the specific dates and lab values into the required fields. You are building the clinical narrative for the manufacturer and the FDA. Only after you have assembled this complete, evidence-based package and it’s been approved by the REMS administrator do you receive the authorization to dispense.

This entire process—acting as a central coordinator, hunting down specific, non-negotiable clinical data points from specialist sources, and assembling them into a formal package to meet strict, predetermined criteria—is the exact workflow of an oncology PA pharmacist. Your retail experience with REMS drugs has already trained you in the core principles of evidence gathering and procedural precision. Now, you’re just applying those skills to a different, even more complex, set of rules.

23.1.2 The Case Presentation: Meet Mr. Harrison

Your task begins when a new prior authorization request appears in your queue. It’s a high-priority, STAT request from the oncology department.

Patient Demographics

  • Name: David Harrison
  • Age: 68 years old
  • Insurance: Aetnalogic Health Commercial PPO (Plan ID: AGP789456)
  • Prescribing Physician: Dr. Eleanor Vance, MD (Oncology)

The Submitted Prescription

  • Drug: Pembrolizumab (Keytruda)
  • Dose: 400 mg
  • Route: Intravenous (IV) Infusion
  • Frequency: Every 6 weeks
  • Diagnosis Code Attached: C34.9 – Malignant neoplasm of unspecified part of bronchus or lung

The only document attached to the initial electronic PA request is a one-page “Letter of Medical Necessity” from Dr. Vance’s office. It is a generic form letter that simply states: “Patient has Stage IV NSCLC and requires treatment with Keytruda. Please approve urgently.”

Immediate Red Flag Analysis

As an experienced PA pharmacist, this initial request immediately raises several critical red flags. It’s a classic example of an “aspirational” submission, lacking virtually all of the required objective evidence.

  • Vague Diagnosis Code: C34.9 is too generic. Payers require the most specific code available, which would detail the location and histology (e.g., C34.11 for adenocarcinoma of the right upper lobe). This signals a lack of detail.
  • No Biomarker Data: The single most important piece of information for approving pembrolizumab in first-line NSCLC—the PD-L1 expression score—is completely missing.
  • No Mutation Status: The letter doesn’t mention the patient’s EGFR, ALK, ROS1, or BRAF mutation status. If the patient had certain activating mutations, immunotherapy would be the wrong choice, and the request would be denied. The absence of this information is a major gap.
  • No Treatment History: The letter doesn’t specify if this is for first-line or second-line treatment. Has the patient received prior chemotherapy? This is a fundamental fork in the decision tree for payers.
  • Non-Standard Dosing: While 400 mg every 6 weeks is an FDA-approved dosing regimen for Keytruda, many institutional protocols and older clinical trials used 200 mg every 3 weeks. The payer’s policy might have specific language about which regimens are considered standard. You need to verify this against the policy.
  • Lack of Objective Evidence: The entire submission rests on a single subjective sentence from the physician. There is no pathology report, no lab data, and no progress notes attached. This request, as it stands, has a 100% chance of being denied.

Your mindset must immediately shift from “processing a request” to “building a case from scratch.” The submitted request is merely the starting signal for your investigation.

23.1.3 The Mission: Deconstructing the Payer’s Policy

Your first action is not to dive into the patient’s chart. It is to pull up the Aetnalogic Health clinical policy for Pembrolizumab (Policy #CL-ONC-247). You cannot win the game if you don’t know the rules. You must read the policy with the focus of a lawyer reviewing a contract, because that is exactly what it is.

After navigating to the section for Non-Small Cell Lung Cancer (NSCLC), you find the criteria for approval as a first-line monotherapy treatment. This is what you must prove.

Aetnalogic Health Policy #CL-ONC-247: Criteria for Pembrolizumab in First-Line NSCLC

Aetnalogic Health considers the use of pembrolizumab medically necessary for the first-line treatment of metastatic NSCLC when ALL of the following criteria are met:

  1. Diagnosis Confirmation: The patient has a histologically confirmed diagnosis of metastatic (Stage IV) non-small cell lung cancer.
    • Required Documentation: Surgical pathology or cytology report.
  2. Biomarker Qualification (PD-L1): The patient’s tumor expresses PD-L1 with a Tumor Proportion Score (TPS) ≥ 50% as determined by an FDA-approved test.
    • Required Documentation: Complete molecular pathology/biomarker report showing the PD-L1 staining result and interpretation.
  3. Biomarker Qualification (Genomic): The patient’s tumor has no EGFR, ALK, ROS1, or BRAF mutations for which an FDA-approved targeted therapy is available.
    • Required Documentation: Next-Generation Sequencing (NGS) report or individual mutation analysis reports.
  4. Performance Status: The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Required Documentation: Most recent oncology progress note where performance status is explicitly documented.
  5. Provider and Dosing: The medication is prescribed by an oncologist and the requested dosing is in accordance with FDA labeling or NCCN guidelines.
    • Required Documentation: The prescription order itself.
From Policy to Personal Checklist

This policy is now your roadmap. You must translate it into a concrete, actionable checklist of documents and data points you need to find for Mr. Harrison. This is the master list for your entire investigation.

  • ITEM 1: Pathology Report. I need the definitive report that says “non-small cell lung cancer” and “metastatic.”
  • ITEM 2: PD-L1 Report. I need the lab report that shows the TPS score. The number must be 50% or greater.
  • ITEM 3: Genomics/NGS Report. I need the report that explicitly states EGFR, ALK, ROS1, and BRAF are negative or “not detected.”
  • ITEM 4: ECOG Status Note. I need a recent clinic note from Dr. Vance that documents the ECOG score as a 0 or a 1.
  • ITEM 5: Dosing Verification. I need to confirm the 400 mg q6wks regimen is standard and appropriate. (A quick check of the Keytruda package insert or NCCN guidelines will confirm this).

Your job is now simple, if not easy: Find these five pieces of evidence.

23.1.4 The Investigation: Mastering the EMR Dive

With your checklist in hand, you now pivot to the patient’s Electronic Medical Record (EMR). This is where your skills as a clinical detective are put to the test. Hospital EMRs are vast, complex systems. Knowing where to look is half the battle.

Masterclass Table: Navigating the EMR for Oncology PA Evidence
Checklist Item Primary EMR Location Secondary Locations & Keywords Pharmacist’s Action & Interpretation
1. Pathology Report “Media” or “Scanned Documents” Tab Chart Search for: “pathology,” “biopsy,” “cytology,” “histology.” Check notes from pulmonology or interventional radiology who may have performed the biopsy. Action: Open the PDF report. Scan for the “Final Diagnosis” section. You are looking for specific keywords: “adenocarcinoma,” “squamous cell carcinoma” (both are types of NSCLC) and phrases like “consistent with metastatic disease.”
For Mr. Harrison: You find a report from two weeks ago. Diagnosis: “Poorly differentiated non-small cell carcinoma, favor adenocarcinoma.” This satisfies the histology part of criterion #1. The report also mentions the biopsy was from a liver lesion, which confirms metastatic disease. CHECK.
2. PD-L1 Report “Labs” -> “Pathology” or “Molecular” sub-tab This is often an “add-on” test to the original pathology. Look for a supplemental report dated a few days after the main pathology report. Search for “PD-L1,” “TPS,” “Tumor Proportion Score,” “22C3 pharmDx” (the assay name). Action: Find the report that explicitly lists the PD-L1 TPS. It’s a number. Don’t accept a physician’s summary in a note; you need the source document from the lab.
For Mr. Harrison: You find an addendum pathology report. It reads: “PD-L1 (22C3) IHC: Tumor Proportion Score (TPS) = 75%.” This is well above the ≥50% threshold. CHECK.
3. Genomics/NGS Report “Labs” -> “Molecular” or “Genomics” Sometimes filed under “Send-out Labs” if an external company like Foundation Medicine or Caris performed the testing. Search for “NGS,” “Foundation,” “Caris,” “EGFR,” “ALK.” Action: Open the multi-page report. You are looking for a summary table or section that lists the key mutations. You must see “Not Detected,” “Negative,” or “Wild Type” next to EGFR, ALK, ROS1, and BRAF.
For Mr. Harrison: You find a 15-page NGS report. On the summary page, you see: EGFR: No alterations detected. ALK: No fusions detected. ROS1: No fusions detected. BRAF: No alterations detected. CHECK.
4. ECOG Status “Notes” -> “Oncology” -> “Progress Notes” Review the most recent clinic visit note from Dr. Vance. Often found in the “Physical Exam” or “Assessment and Plan” section. Use CTRL+F to search the note for “ECOG” or “performance status.” Action: You need to find the specific phrase. An ECOG of 0 means fully active. An ECOG of 1 means restricted in strenuous activity but ambulatory and able to carry out light work.
For Mr. Harrison: You open Dr. Vance’s note from yesterday. Under “Physical Exam,” you find the sentence: “Performance Status: ECOG 1 – Patient is symptomatic but fully ambulatory and able to perform self-care.” CHECK.

23.1.5 Building the Clinical Narrative: Your Submission Package

You have successfully gathered all the required evidence. Your initial request, which contained only a single, vague sentence, is about to be transformed into an undeniable, evidence-based case for approval. Your task now is to assemble these documents and write a clinical summary that functions as a cover letter, guiding the payer’s reviewer through the evidence and proving you meet every single criterion from their policy.

You will upload the four documents you found as separate attachments. Then, in the “Clinical Notes” or “Justification” free-text field of the electronic PA submission, you will write your summary. It should be structured, concise, and directly reference the policy criteria.

The Pharmacist’s PA Submission Framework: A Winning Template

SUBJECT: Prior Authorization Request for Pembrolizumab for David Harrison (ID: AGP789456)

This letter provides the clinical justification for the use of pembrolizumab (Keytruda) for the treatment of Stage IV Non-Small Cell Lung Cancer in this 68-year-old male. The patient meets all criteria for first-line monotherapy as outlined in Aetnalogic Health Policy #CL-ONC-247.

  • 1. Diagnosis Confirmation (Criterion #1): The patient has a histologically confirmed diagnosis of metastatic (Stage IV) poorly differentiated non-small cell adenocarcinoma.
    SEE ATTACHED: Pathology Report (File: Harrison_Pathology_Report.pdf)
  • 2. PD-L1 Biomarker Qualification (Criterion #2): The patient’s tumor is strongly positive for PD-L1 expression.
    – Result: Tumor Proportion Score (TPS) = 75%.
    SEE ATTACHED: PD-L1 Addendum Report (File: Harrison_PDL1_Report.pdf)
  • 3. Genomic Biomarker Qualification (Criterion #3): The patient’s tumor is negative for targetable genomic alterations.
    – Results: EGFR, ALK, ROS1, and BRAF mutations were NOT DETECTED.
    SEE ATTACHED: NGS Report (File: Harrison_NGS_Report.pdf)
  • 4. Performance Status (Criterion #4): The patient is in good functional condition and is an excellent candidate for systemic therapy.
    – Result: ECOG Performance Status is 1.
    SEE ATTACHED: Oncology Progress Note dated [Yesterday’s Date] (File: Harrison_Onc_Note.pdf)
  • 5. Provider and Dosing (Criterion #5): The prescription is from a board-certified oncologist and the requested regimen (400 mg IV every 6 weeks) is an FDA-approved dosing schedule for this indication.

Based on the attached, objective clinical evidence, Mr. Harrison unequivocally meets all medical necessity criteria for treatment with pembrolizumab. We request your urgent approval to allow this life-altering therapy to begin without delay. Thank you for your review.

Sincerely,
[Your Name], PharmD
Prior Authorization Pharmacist

This structured approach is profoundly effective. You have made the reviewer’s job easy. You have anticipated their every question and provided the answer with a corresponding piece of primary source evidence. You have transformed a guaranteed denial into a near-certain approval through your diligent investigation and clear, evidence-based communication.

23.1.6 Denial Traps & Proactive Problem Solving

While the case for Mr. Harrison was straightforward once the evidence was gathered, many oncology PAs are not so simple. An expert PA pharmacist doesn’t just find evidence; they anticipate problems and solve them before they result in a denial.

Common Pitfalls in Oncology PAs
  • The “Indeterminate” PD-L1 Result: Sometimes, the tissue sample is too small or has too few tumor cells for the lab to give a definitive TPS score. The report might say “Indeterminate” or “QNS” (Quantity Not Sufficient). This is a hard stop. The payer will not approve without a number.
    Proactive Solution: You must call the oncologist’s office immediately. “Dr. Vance’s office, this is the pharmacist. I see the PD-L1 result for Mr. Smith is indeterminate due to a small sample. Will a repeat biopsy be performed? We cannot get the immunotherapy approved without a definitive score.” This forces a clinical decision and prevents a dead-end submission.
  • The Missing ECOG Score: Oncologists are busy. Sometimes they forget to document the performance status in their note. You can have every other piece of evidence, but if the note is missing that one data point, the payer can (and often will) deny on a technicality.
    Proactive Solution: Call the clinic. “Hi, this is the PA pharmacist. I’m working on the Keytruda authorization for Mrs. Jones. I have all the labs, but I don’t see an ECOG score documented in yesterday’s visit note. Could Dr. Carter please add an addendum to the note with her current performance status? I need that to complete the submission.” This is far more effective than submitting and waiting for the denial.
  • “Equivocal” Pathology: Sometimes the initial biopsy is not definitive. A pathologist might write, “suspicious for, but not diagnostic of, adenocarcinoma.” An insurer will not approve a $200,000 therapy based on a “suspicious” diagnosis.
    Proactive Solution: Your investigation must look for a follow-up. Is there a second opinion from another pathologist? Was a larger surgical biopsy performed later that gave a definitive diagnosis? You must find the report that solidifies the diagnosis.
  • Policy Lag: Cancer treatment evolves at a blistering pace. A new indication for an immunotherapy might be approved by the FDA and added to the NCCN guidelines, but the payer’s internal clinical policy document hasn’t been updated yet. Your request might be denied because it doesn’t meet the old, outdated criteria listed in their policy.
    Proactive Solution: This is where you elevate your game. In your submission, you proactively address this. “We acknowledge that the patient’s specific indication may not yet be reflected in Policy #CL-ONC-247, last updated in January. However, this use was FDA-approved in May and is now a Category 1 recommendation in the most recent NCCN guidelines. See attached NCCN compendium excerpt. Therefore, this represents the current standard of care and should be approved.” This shows you are an expert and puts the onus on them to justify using an outdated policy.