How to Get Tysabri (Natalizumab) Covered by UnitedHealthcare in Virginia: Complete Appeals Guide with Forms and Timelines
Answer Box: Getting Tysabri Covered by UnitedHealthcare in Virginia
UnitedHealthcare requires prior authorization for Tysabri (natalizumab) through OptumRx, with mandatory TOUCH program enrollment and documentation of failed prior therapies. In Virginia, after internal appeals, you can request external review through the State Corporation Commission Bureau of Insurance within 120 days. First step today: Have your neurologist gather your complete DMT history, recent MRI results, and JCV antibody status, then submit the PA through the UnitedHealthcare Provider Portal.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Process in Virginia
- Medical Necessity Letter Essentials
- Virginia External Review Process
- Cost Support and Financial Assistance
- FAQ: UnitedHealthcare Tysabri Coverage
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Prior Authorization | Required for all UHC plans via OptumRx | UHC PA Requirements |
| TOUCH Enrollment | Mandatory FDA REMS program | TOUCH Program Portal |
| Step Therapy | Trial/failure of preferred DMTs required | UHC Step Therapy Policies |
| Formulary Status | Specialty tier with PA | Plan-specific formulary |
| Diagnosis Code | G35 (Multiple Sclerosis) | ICD-10 coding |
| Appeals Deadline | 180 days from denial | Denial letter instructions |
Step-by-Step: Fastest Path to Approval
1. Confirm Coverage and Requirements
Who: Patient or clinic staff
Timeline: Same day
Check your specific UnitedHealthcare plan's formulary status for Tysabri through the UHC Provider Portal or member portal.
2. Enroll in TOUCH Program
Who: Prescriber and patient
Timeline: 1-2 business days
Complete enrollment at the TOUCH Program portal or call 1-800-456-2255. Both prescriber and patient must be enrolled before PA approval.
3. Gather Clinical Documentation
Who: Neurologist's office
Timeline: 2-3 days
Collect:
- Recent brain MRI (within 6 months showing disease activity)
- JCV antibody test results
- Complete DMT history with dates and failure reasons
- Current EDSS score or functional assessment
- Documentation of relapses in past 12-24 months
4. Submit Prior Authorization
Who: Prescriber
Timeline: Same day via portal
Submit through UHC Provider Portal PA tool, which routes to OptumRx. Include comprehensive medical necessity letter addressing step therapy requirements.
5. Track Status and Respond Quickly
Who: Clinic staff
Timeline: Check within 72 hours
OptumRx typically responds within 24-72 hours. If additional information is requested, respond immediately to avoid delays.
6. Coordinate Specialty Pharmacy (If Approved)
Who: Patient and clinic
Timeline: 3-5 business days
Work with UHC-contracted specialty pharmacy (typically AllianceRx Walgreens or Optum Specialty) to arrange delivery to infusion center.
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Fix It |
|---|---|
| "Prior authorization required" | Ensure PA was submitted through correct portal (UHC Provider Portal → OptumRx) |
| "Step therapy not met" | Document trial/failure of interferons, glatiramer acetate, dimethyl fumarate, or other preferred DMTs with specific dates and reasons for discontinuation |
| "Not medically necessary" | Strengthen medical necessity letter with recent MRI findings, relapse history, EDSS progression, and impact on daily function |
| "TOUCH enrollment missing" | Provide TOUCH confirmation numbers for both prescriber and patient enrollment |
| "Insufficient documentation" | Submit complete clinical notes, MRI reports, lab results, and detailed prior therapy history |
Appeals Process in Virginia
Internal Appeals with UnitedHealthcare
Level 1 Internal Appeal
- Deadline: 180 days from denial date
- Submit via: UHC Provider Portal or fax as directed in denial letter
- Timeline: 30 days for standard, 72 hours for urgent
- Include: Point-by-point rebuttal to denial reasons, additional clinical evidence
Peer-to-Peer Review Request within 24 hours of denial. UHC medical director will discuss case directly with prescribing neurologist.
Virginia External Review Process
If UnitedHealthcare upholds the denial after internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance.
Eligibility: Final denial from UHC on medical necessity, appropriateness, or effectiveness
Deadline: 120 days from final denial notice
Required Forms:
- Form 216-A - External Review Request
- Form 216-B (if using authorized representative)
- Form 216-C (for expedited review with physician certification)
Submit to: State Corporation Commission
Bureau of Insurance – External Review
P.O. Box 1157
Richmond, VA 23218
Fax: (804) 371-9915
Email: [email protected]
Timeline:
- Standard review: 45 days
- Expedited review: 72 hours (if delay would jeopardize health)
Consumer Help: 1-877-310-6560 (Bureau of Insurance)
From our advocates: We've seen Virginia external reviews succeed when the neurologist provides a detailed letter explaining why Tysabri is uniquely necessary for that patient's aggressive MS phenotype, especially when standard DMTs failed due to documented breakthrough activity on MRI. The independent medical reviewers appreciate specific clinical details over general statements.
Medical Necessity Letter Essentials
Your neurologist's letter should address these key points:
Patient Profile
- MS diagnosis date and phenotype (RRMS, SPMS with relapses)
- Current functional status and EDSS score
- Impact on work, mobility, and daily activities
Disease Activity Evidence
- Relapse frequency and severity over past 2 years
- Recent MRI findings (new/enlarging T2 lesions, gadolinium enhancement)
- Objective measures of disease progression
Prior Therapy Documentation
For each previous DMT, include:
- Medication name, dose, and treatment duration
- Specific reason for discontinuation (lack of efficacy, adverse effects, contraindication)
- Clinical evidence of failure (breakthrough relapses, MRI progression)
Tysabri Justification
- Why high-efficacy therapy is required for this patient
- Clinical rationale for natalizumab over other monoclonal antibodies
- Safety considerations and monitoring plan
- Expected clinical outcomes
Cost Support and Financial Assistance
Manufacturer Support
Biogen Above MS Program
- Copay assistance up to $12,000 annually
- Free drug program for eligible uninsured patients
- Above MS website or 1-800-456-2255
Foundation Grants
- National MS Society: Financial assistance programs
- HealthWell Foundation: MS-specific grants
- Patient Access Network (PAN): Specialty drug assistance
UnitedHealthcare Programs
Check if your plan offers specialty drug cost-sharing caps or patient assistance program partnerships through OptumRx.
FAQ: UnitedHealthcare Tysabri Coverage
How long does UnitedHealthcare PA take for Tysabri? OptumRx typically processes PAs within 24-72 hours. Complex cases requiring clinical review may take up to 5 business days.
What if Tysabri isn't on my formulary? Even non-formulary drugs can be covered with strong medical necessity documentation. Request a formulary exception through the standard PA process.
Can I get expedited review? Yes, if your neurologist certifies that delay would seriously jeopardize your health. Mark "urgent" on PA forms and provide clinical justification.
Do I need to try other high-efficacy DMTs first? UnitedHealthcare's step therapy typically requires trial of platform injectables and oral DMTs before high-efficacy agents, unless contraindicated or clinically inappropriate.
What happens if my appeal is denied? Virginia residents can request external review through the State Corporation Commission within 120 days of the final denial.
How often do I need reauthorization? Most Tysabri PAs are approved for 6-12 months. OptumRx has eliminated some reauthorization requirements in 2025, but verify with your specific plan.
Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by creating targeted, evidence-backed appeals that address payer-specific criteria. Our platform analyzes denial reasons and generates point-by-point rebuttals aligned to each plan's policies, significantly improving approval rates for specialty medications like Tysabri.
When to Contact Virginia Regulators
If UnitedHealthcare fails to follow proper procedures, delays responses beyond required timeframes, or doesn't comply with an external review decision, contact:
Virginia State Corporation Commission
Bureau of Insurance
1-877-310-6560
SCC Consumer Services
Virginia Office of the Managed Care Ombudsman
Assists with HMO and managed care plan issues
Same contact number: 1-877-310-6560
Sources & Further Reading
- UnitedHealthcare Prior Authorization Requirements
- TOUCH Prescribing Program
- Virginia External Review Process
- OptumRx Prior Authorization Guidelines
- UnitedHealthcare Provider Portal
- Tysabri Prescribing Information (FDA)
Understanding your rights and the appeals process empowers you to advocate effectively for necessary treatments. With proper documentation and persistence, many patients successfully obtain Tysabri coverage through Counterforce Health's systematic approach to prior authorization and appeals.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance plan for specific coverage details and requirements.
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