How to Get Stelara (ustekinumab) Covered by Aetna (CVS Health) in California: Prior Authorization, Appeals, and Alternative Options
Quick Answer: Getting Stelara Covered by Aetna in California
Aetna (CVS Health) requires prior authorization for Stelara (ustekinumab) with step therapy requirements varying by indication. In California, you have strong appeal rights through the Department of Managed Health Care (DMHC) if denied. First step: Call Aetna at 1-888-632-3862 to confirm your plan's formulary status and PA requirements. Submit documentation of step therapy failures, negative TB screening, and specialist evaluation. If denied, file an internal appeal within 180 days, then request an Independent Medical Review (IMR) through California's DMHC for a binding external review.
Table of Contents
- When Alternatives Make Sense
- Typical Formulary Alternatives
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Exception Strategy for Non-Formulary Status
- Appeals Playbook for California
- Common Denial Reasons & Solutions
- Switching Between Biologics
- Cost Assistance Programs
- FAQ
When Alternatives Make Sense
Aetna's 2024 formularies exclude Stelara for Crohn's disease specifically, with preferred alternatives including AVSOLA, REMICADE, and SKYRIZI IV. For psoriasis and psoriatic arthritis, Stelara isn't explicitly excluded but requires prior authorization after step therapy.
Consider alternatives when:
- Faster approval needed: Preferred agents like infliximab (REMICADE) or adalimumab (Humira) typically get approved more quickly
- Cost concerns: Biosimilars may have lower copays
- Clinical contraindications: If you have conditions that make Stelara less suitable
However, if Stelara is clinically preferred for your specific situation, pursuing an exception or appeal is often worthwhile, especially in California's patient-friendly regulatory environment.
Typical Formulary Alternatives
TNF Inhibitors (Often Preferred)
- Adalimumab (Humira): First-line for most indications
- Infliximab (REMICADE, AVSOLA): IV infusion, often preferred for IBD
- Golimumab (SIMPONI ARIA): Monthly IV option
IL-17 Inhibitors
- Secukinumab (Cosentyx): Strong psoriasis efficacy
- Ixekizumab (Taltz): Rapid onset for psoriasis
Other IL-23 Inhibitors
- Risankizumab (Skyrizi): Similar mechanism to Stelara
- Guselkumab (Tremfya): Another IL-23 option
Stelara Biosimilars (2025-2026)
Multiple biosimilars now available with 80-90% price reductions:
- Wezlana (ustekinumab-auub)
- Pyzchiva (ustekinumab-ttwe)
- Yesintek (ustekinumab)
Note: Most biosimilars carry interchangeability designation, allowing pharmacy-level substitution.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Stelara use | Aetna Specialty Drug List | Aetna |
| Step Therapy | Must try preferred agents first | Plan-specific formulary | Aetna |
| TB Screening | Negative test within 12 months | Stelara Precert Form | Aetna |
| Specialist Evaluation | Required documentation | PA submission | Aetna |
| Appeals Deadline | 180 days from denial | Member handbook | Aetna |
| IMR Timeline | 45 days standard, 7 days expedited | DMHC website | California DMHC |
Step-by-Step: Fastest Path to Approval
1. Verify Coverage Status (Patient/Clinic Staff)
- Action: Call Aetna at 1-888-632-3862
- Ask for: Formulary tier, PA requirements, step therapy protocols
- Timeline: 5-10 minutes
- Document: Plan name, member ID, specific requirements
2. Gather Required Documentation (Clinic)
- Medical records: Previous treatment history with dates and outcomes
- Lab results: TB screening (TST/IGRA), hepatitis B screening
- Disease severity: PASI scores, endoscopy reports, imaging
- Timeline: 1-2 business days
3. Submit Prior Authorization (Provider)
- Method: Aetna Provider Portal or Stelara Precert Form
- Include: All required documentation, ICD-10 codes, treatment rationale
- Timeline: Same day submission possible
4. Follow Up on Decision (Patient/Clinic)
- Standard: 72 hours for non-urgent requests
- Expedited: 24 hours for urgent circumstances
- Auto-approval: If no response within timeframe
5. If Denied, File Internal Appeal (Patient/Provider)
- Timeline: Within 180 days of denial
- Method: Aetna member portal or written request
- Include: Additional clinical evidence, peer-reviewed studies
6. Request California IMR if Still Denied (Patient)
- Contact: DMHC Help Center at 888-466-2219
- Online: healthhelp.ca.gov
- Timeline: No fee; binding decision
Exception Strategy for Non-Formulary Status
When Stelara isn't on your plan's formulary, you can request a formulary exception with these key elements:
Medical Necessity Documentation
- Prior failures: Chart notes showing inadequate response to preferred alternatives
- Clinical rationale: Why Stelara is specifically needed over formulary options
- Contraindications: Medical reasons to avoid preferred agents
Supporting Evidence
- FDA labeling: For approved indications
- Clinical guidelines: From relevant medical societies
- Peer-reviewed studies: Supporting Stelara's efficacy for your condition
From our advocates: We've seen formulary exceptions succeed when providers include specific objective measures (like PASI scores or endoscopy findings) showing disease severity and document precise reasons why preferred alternatives aren't suitable. The key is being specific rather than general about medical necessity.
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to identify the specific basis for denial and craft point-by-point rebuttals aligned to the plan's own rules.
Appeals Playbook for California
Internal Appeal Process
- File within 180 days of denial notification
- Submit via: Aetna member portal or mail
- Include: New clinical evidence, provider letter, relevant studies
- Timeline: 30-60 days for standard review
California Independent Medical Review (IMR)
California offers one of the strongest external review processes in the nation:
- Who can request: Any member with a denial for medical necessity
- When: After internal appeal or if plan doesn't respond in 30 days
- Cost: Free to patients
- Process: Independent physicians review your case
- Timeline: 45 days standard, 7 days expedited
- Success rate: High for well-documented cases
Contact Information
- DMHC Help Center: 888-466-2219
- Online IMR application: healthhelp.ca.gov
- For urgent cases: Request expedited review
Common Denial Reasons & Solutions
| Denial Reason | Solution | Documentation Needed |
|---|---|---|
| Step therapy not met | Document prior failures | Pharmacy records, treatment notes |
| Insufficient disease severity | Provide objective measures | PASI scores, endoscopy reports |
| Missing TB screening | Submit recent results | TST/IGRA within 12 months |
| Not medically necessary | Submit necessity letter | Clinical rationale with guidelines |
| Non-formulary status | Request exception | Medical necessity documentation |
Switching Between Biologics
If you're switching from another biologic to Stelara, Aetna requires documentation of failure on the prior agent:
Failure Criteria
- Inadequate response: Insufficient improvement after adequate trial
- Loss of response: Initial improvement followed by disease flare
- Intolerance: Adverse events requiring discontinuation
Timing Guidelines
- From TNF inhibitors: 2 weeks after last dose
- From IL-23 inhibitors: 4 weeks after last dose
- Loading dose: Required when switching per FDA labeling
Cost Assistance Programs
Manufacturer Support
- Janssen CarePath: Copay assistance and free drug programs
- Eligibility: Most commercial insurance plans
- Savings: Up to significant copay reduction
Foundation Grants
- PAN Foundation: Income-based assistance
- HealthWell Foundation: Disease-specific grants
- Good Days: Chronic disease support
State Programs
California's expanded Medicaid (Medi-Cal) covers Stelara with prior authorization for eligible residents.
FAQ
How long does Aetna prior authorization take in California? Standard requests: 72 hours; expedited: 24 hours. Auto-approval if no response within timeframe.
What if Stelara is non-formulary on my plan? Request a formulary exception with medical necessity documentation. California's IMR process provides strong backup if initially denied.
Can I request an expedited appeal? Yes, for urgent medical situations. Contact Aetna directly and specify the urgent nature of your condition.
Does step therapy apply if I've failed biologics outside California? Previous treatment failures should be documented regardless of location. Include all relevant medical records in your PA submission.
What's the difference between biosimilars and Stelara? Biosimilars are highly similar to Stelara with no clinically meaningful differences in safety or efficacy, often at lower cost.
How do I file an IMR in California? Contact the DMHC Help Center at 888-466-2219 or apply online at healthhelp.ca.gov.
When to Re-try for Stelara Later
If you start on an alternative biologic, document your experience carefully:
- Response rates: Objective measures of improvement
- Side effects: Any adverse events or tolerability issues
- Quality of life: Functional improvements or limitations
- Adherence: Any challenges with dosing or administration
This documentation can support a future request for Stelara if the alternative proves inadequate.
Counterforce Health helps patients, clinicians, and specialty pharmacies navigate these complex approval processes by analyzing denial letters and crafting targeted appeals that address specific payer requirements and clinical evidence standards.
Sources & Further Reading
- Aetna Specialty Drug List 2024 (PDF)
- Stelara Prior Authorization Form - Aetna
- California DMHC Independent Medical Review
- Aetna California 2025 Formulary
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with appeals and coverage issues in California, contact the DMHC Help Center at 888-466-2219.
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