How to Get Keytruda (Pembrolizumab) Covered by Aetna (CVS Health) in Ohio: Complete PA Guide with Forms and Appeal Scripts
Answer Box: Getting Keytruda Covered by Aetna in Ohio
Prior authorization is required for Keytruda (pembrolizumab) on all Aetna CVS Health plans in Ohio. The fastest path to approval: (1) Have your oncologist submit Aetna's Keytruda precertification form with complete biomarker results and prior therapy documentation, (2) Include a medical necessity letter citing FDA labeling and NCCN guidelines, (3) If denied, file internal appeal within 180 days, then external review through Ohio Department of Insurance within 4 months. Most oncology denials are overturned on appeal when proper clinical evidence is provided.
Table of Contents
- Plan Types & Network Requirements
- Formulary Status & Coverage
- Prior Authorization Requirements
- CVS Specialty Pharmacy Process
- Cost-Share Dynamics
- Submission Process & Forms
- Common Approval Patterns
- Appeals Process for Ohio
- Verification & Resources
Plan Types & Network Requirements
Understanding your specific Aetna product type is crucial for Keytruda coverage in Ohio.
HMO Plans
- Referral required: Most Aetna HMO plans require a PCP referral to see an oncologist
- Network restriction: In-network only (except emergencies)
- Referral validity: 90 days for first visit, one year total from issue date
PPO Plans
- No referrals needed: Direct access to specialists
- Network flexibility: In-network and out-of-network coverage (higher costs for out-of-network)
EPO Plans
- Referrals: Usually not required for specialists
- Network restriction: In-network only coverage
- Cost advantage: Lower premiums but no out-of-network benefits
Note: Aetna is ending individual Marketplace plans nationally effective January 1, 2026. Current Ohio Marketplace members will need new coverage.
Formulary Status & Coverage
Keytruda is covered as a medical benefit drug (not pharmacy benefit) on Aetna plans, billed under HCPCS code J9271.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Prior Authorization | Required for all Keytruda prescriptions | Aetna Precertification List |
| Medical Necessity | Must meet FDA-approved indication | Aetna Clinical Policy Bulletin 0890 |
| Biomarker Testing | PD-L1, MSI-H, TMB-H as required by indication | PA forms and clinical policy |
| Network Providers | Oncologist and infusion center must be in-network | Aetna provider directory |
Preferred vs. Non-Preferred Status
For Aetna Medicare plans, Libtayo (cemiplimab) may be preferred over Keytruda for certain indications. Your oncologist may need to document why Keytruda is specifically appropriate.
Prior Authorization Requirements
Required Clinical Documentation
Your oncologist must provide:
- Primary diagnosis with ICD-10 code
- Cancer staging (metastatic, unresectable, recurrent, adjuvant)
- Biomarker results: PD-L1 CPS, MSI-H/dMMR status, TMB-H when relevant
- Prior therapy history: Previous treatments, responses, toxicities
- Treatment plan: Keytruda dosing (200mg q3w or 400mg q6w), combination agents
- Site of care: Infusion center details with NPI/TIN
Medical Necessity Criteria
Aetna's Clinical Policy Bulletin 0890 defines covered indications including:
- Metastatic melanoma (first-line)
- NSCLC with appropriate PD-L1 expression
- MSI-H/dMMR solid tumors
- Urothelial carcinoma
- Head and neck squamous cell carcinoma
CVS Specialty Pharmacy Process
As part of CVS Health, Aetna often routes Keytruda through CVS Specialty for distribution.
Patient Enrollment Steps
- Prescription routing: After PA approval, prescription sent to CVS Specialty
- Patient onboarding: CVS Specialty contacts you for demographics, insurance verification
- Financial review: Copay assistance screening and benefit verification
- Delivery coordination: Drug shipped to infusion center or home (if applicable)
- Ongoing support: Adherence monitoring and side effect education
Tip: Ask your oncologist's office which specialty pharmacy they prefer to work with and confirm it's in your Aetna network.
Cost-Share Dynamics
Typical Cost Structure
- Deductible: May apply to medical benefit drugs
- Coinsurance: Often 10-30% for specialty oncology drugs
- Out-of-pocket maximum: Annual limit protects against catastrophic costs
Financial Assistance Options
- Merck patient assistance: Merck Helps program for eligible patients
- Copay cards: May reduce out-of-pocket costs for commercially insured patients
- Foundation grants: Organizations like CancerCare and Patient Access Network
Note: This is educational information only. Consult your plan documents for specific cost-sharing details.
Submission Process & Forms
Step-by-Step: Fastest Path to Approval
- Confirm plan type (commercial vs. Medicare) - determines which form to use
- Complete appropriate PA form:
- Standard Keytruda form for commercial plans
- Medicare Keytruda form for Medicare Advantage
- Attach clinical documentation - pathology, biomarkers, imaging, treatment history
- Submit via Aetna portal or fax (verify current number with plan)
- Follow up within 5-7 business days if no response
- Prepare for peer-to-peer if initial review is unfavorable
- File appeal immediately if denied
Common Denial Reasons & Fixes
| Denial Reason | How to Overturn |
|---|---|
| Missing biomarker data | Submit PD-L1, MSI-H, or TMB-H test results as required |
| Wrong line of therapy | Document prior treatments and progression with dates |
| Non-formulary status | Request formulary exception with medical necessity letter |
| Experimental/investigational | Cite FDA approval date and indication |
Common Approval Patterns
Strong submissions typically include:
- Clear diagnosis alignment with FDA-approved indications
- Complete biomarker panel appropriate for cancer type
- Detailed treatment history showing progression or intolerance
- Guideline citations from NCCN, ASCO, or other recognized bodies
- Specific dosing rationale and administration plan
From our advocates: We've seen faster approvals when oncology offices include a brief cover letter summarizing why Keytruda is the most appropriate treatment option, referencing both the FDA label and current NCCN guidelines. This composite observation reflects common patterns in successful submissions.
Appeals Process for Ohio
Internal Appeal (Required First Step)
- Timeline: 180 days from denial to file appeal
- Standard review: 30 days for decision
- Expedited review: 72 hours for urgent cases
- Required: Submit additional clinical evidence, medical necessity letter
External Review (Ohio Department of Insurance)
- Eligibility: After completing internal appeal(s) or for urgent cases
- Timeline: 4 months from final denial to request external review
- Process: Ohio Department of Insurance External Review
- Decision timeline: 45 days standard, 72 hours expedited
- Binding: IRO decision is final and binding on Aetna
Getting Help in Ohio
- ODI Consumer Hotline: 800-686-1526
- External review email: [email protected]
- UHCAN Ohio: Nonprofit advocacy for health coverage issues
Verification & Resources
Before Starting Treatment
- Call Aetna member services (number on ID card) to confirm:
- PA approval status and duration
- In-network infusion center coverage
- Your specific copay/coinsurance amount
Key Aetna Resources
- Provider portal for PA status checks
- Clinical policies for coverage criteria
- Member services for benefit verification
Ohio-Specific Resources
- Ohio Department of Insurance for external reviews and complaints
- Ohio cancer resources for Medicaid members
Frequently Asked Questions
How long does Aetna prior authorization take for Keytruda in Ohio? Standard PA decisions typically take 14-30 days. Expedited reviews for urgent cases are completed within 72 hours.
What if Keytruda is denied as non-formulary? Request a formulary exception by submitting clinical evidence showing medical necessity and that preferred alternatives are inappropriate.
Can I get an expedited appeal in Ohio? Yes, if delay would seriously jeopardize your health. Both Aetna and Ohio's external review process offer expedited timelines.
Does step therapy apply to Keytruda? Generally no, but some Medicare plans may prefer Libtayo first. Check your specific plan's PA criteria.
What happens if I'm already on Keytruda and change plans? Document your current treatment to potentially waive step therapy requirements under continuity of care provisions.
About Counterforce Health
Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address each payer's unique requirements. For complex cases like Keytruda coverage, we help navigate the intricate prior authorization process while ensuring all clinical documentation meets Aetna's specific medical necessity standards.
When dealing with Aetna denials, Counterforce Health can help identify which specific coverage criteria weren't met and develop targeted appeals that reference the right clinical guidelines and biomarker requirements for your particular cancer type and treatment setting.
Sources & Further Reading
- Aetna Keytruda Clinical Policy Bulletin 0890
- Keytruda Precertification Form
- Medicare Keytruda Precertification Form
- Ohio Department of Insurance External Review Process
- Aetna Precertification Requirements List
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult your healthcare provider and insurance plan documents for specific guidance. For questions about your coverage, contact Aetna member services directly.
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