By Counterforce Health Team in Tegsedi (inotersen) — 25 Dec 2025

How to Get Tegsedi (inotersen) Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tegsedi (inotersen) Covered by Cigna in Michigan

Tegsedi (inotersen) for hATTR polyneuropathy requires prior authorization from Cigna through Express Scripts, REMS program enrollment, and specialty pharmacy dispensing via Accredo. Michigan patients have strong appeal rights through DIFS external review (127 days to file after final denial). Start today: 1) Verify Cigna formulary status and PA requirements, 2) Complete REMS enrollment for prescriber and patient, 3) Submit PA with genetic testing, neurologist letter, and lab monitoring plan via CoverMyMeds or Express Scripts portal.

Coverage Requirements Overview
REMS Program and Lab Monitoring
Prior Authorization Process
Medical Necessity Documentation
Appeals Process in Michigan
Common Denial Reasons & Solutions
Cost and Patient Assistance
FAQ

Coverage Requirements Overview

Tegsedi (inotersen) is a specialty medication for hereditary transthyretin-mediated amyloidosis (hATTR) polyneuropathy that requires careful coordination between your neurologist, Cigna's Express Scripts pharmacy benefit manager, and Accredo specialty pharmacy.

Coverage at a Glance

Requirement	Details	Source
Prior Authorization	Required for all Cigna plans	Cigna Formulary
Formulary Tier	Specialty Tier 4/5 with PA indicator	Express Scripts
Specialty Pharmacy	Must use Accredo or approved network	Cigna Specialty Pharmacy
REMS Enrollment	Mandatory for prescriber, patient, pharmacy	FDA REMS Program
Age Requirement	Adults ≥18 years	Payer policies
Diagnosis	hATTR polyneuropathy with genetic confirmation	Cigna Policy

Step-by-Step: Fastest Path to Approval

Verify Coverage (Patient/Clinic): Check formulary status at myCigna.com or call member services. Confirm PA requirement and specialty pharmacy network.
Complete REMS Enrollment (Prescriber): Register at Tegsedi REMS program, complete training, and enroll patient. This is mandatory before prescribing.
Gather Documentation (Clinic): Collect genetic testing results, neurologist consultation, baseline labs (platelets ≥100k, renal function), and monitoring plan.
Submit Prior Authorization (Prescriber): Use CoverMyMeds or Express Scripts portal. Include all required clinical documentation.
Track Status (Patient/Clinic): Monitor via Express Scripts portal or call 800-835-3784. Standard review takes up to 2 business days.
Fill at Accredo (Patient): Once approved, coordinate with Accredo specialty pharmacy for delivery and ongoing refills.
Maintain Monitoring (Patient/Clinic): Weekly platelet counts and quarterly renal monitoring per REMS requirements.

REMS Program and Lab Monitoring

Tegsedi carries FDA black box warnings for thrombocytopenia and glomerulonephritis, requiring enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program.

REMS Enrollment Requirements

Prescriber Responsibilities:

Complete REMS training and certification
Enroll each patient individually
Order baseline and ongoing monitoring labs
Ensure REMS-certified pharmacy dispensing

Patient Responsibilities:

Sign enrollment forms acknowledging risks
Commit to weekly blood draws for platelet monitoring
Report symptoms like bleeding, bruising, or decreased urination immediately

Pharmacy Requirements:

REMS certification for dispensing
Verification of prescriber and patient enrollment before each fill

Required Lab Monitoring Plan

Baseline Labs (before first dose):

Platelet count ≥100 × 10⁹/L
Complete blood count
Serum creatinine and eGFR ≥45 mL/min
Urinalysis (protein, blood)

Ongoing Monitoring:

Weekly platelet counts for duration of therapy
Quarterly renal function (creatinine, eGFR, urinalysis)
More frequent monitoring if abnormal values

Note: Cigna commonly denies applications missing a written lab monitoring protocol. Include specific schedules and hold/stop thresholds per FDA labeling.

Prior Authorization Process

Cigna manages Tegsedi prior authorizations through Express Scripts, with electronic submission strongly preferred for fastest processing.

Submission Methods

Method	Timeline	Best For
CoverMyMeds	Same day to 48 hours	Standard submissions
Express Scripts Portal	24-48 hours	Provider portal users
Phone/Fax	2-5 business days	Urgent cases only

Required Documentation Checklist

Clinical Information:

Diagnosis of hATTR polyneuropathy with ICD-10 code E85.1
Pathogenic TTR mutation confirmed by genetic testing
Disease stage documentation (PND ≤IIIb or NIS 5-130)
Neurologist consultation note

REMS Documentation:

Prescriber REMS certification number
Patient REMS enrollment confirmation
Written lab monitoring protocol

Baseline Assessment:

Laboratory results showing adequate platelets and renal function
Exclusion of other neuropathy causes
Functional assessment and treatment goals

Tip: Submit complete documentation in the initial request. Incomplete submissions are the leading cause of delays and denials.

Medical Necessity Documentation

Your neurologist's letter of medical necessity is crucial for approval. It should address specific criteria Cigna uses to evaluate hATTR polyneuropathy treatments.

Key Elements to Include

Diagnosis Confirmation:

"Patient has confirmed polyneuropathy of hereditary transthyretin-mediated amyloidosis"
Reference genetic testing results showing pathogenic TTR variant
Document exclusion of other neuropathy causes (diabetes, B12 deficiency, etc.)

Disease Staging:

Use validated scales: Polyneuropathy Disability (PND) score or Neuropathy Impairment Score (NIS)
Document ambulatory status and functional limitations
Include autonomic symptoms if present

Treatment Rationale:

Explain why Tegsedi is appropriate for this patient's disease stage
Address any required step therapy or formulary alternatives
Emphasize progressive nature without treatment

Safety Monitoring:

Confirm patient can comply with weekly lab monitoring
Detail clinic's protocol for tracking platelets and renal function
Reference REMS enrollment and ongoing compliance plan

Sample Medical Necessity Language

"This 45-year-old patient has genetically confirmed hATTR polyneuropathy (TTR V30M mutation) with PND Stage II disease causing progressive weakness, sensory loss, and gait impairment. Tegsedi is FDA-approved for this specific indication and represents appropriate disease-modifying therapy. Patient and clinic are enrolled in the REMS program with established weekly platelet monitoring. Without treatment, this progressive condition will lead to wheelchair dependence and significant disability."

Appeals Process in Michigan

Michigan offers strong consumer protections for insurance appeals, with the Department of Insurance and Financial Services (DIFS) providing external review options.

Internal Appeals with Cigna

Timeline: File within 180 days of denial Review Period: 30 days for standard; 72 hours for expedited How to File: Call Cigna member services or submit online through member portal

Required Documents:

Original denial letter
Enhanced medical necessity letter addressing denial reasons
Additional clinical evidence or peer-reviewed studies
Prescriber letter supporting urgency (for expedited appeals)

Michigan External Review

Timeline: File within 127 days of final Cigna denial Review Period: 60 days standard; 72 hours expedited Authority: Michigan Department of Insurance and Financial Services

How to File:

Online at Michigan DIFS website
Phone: 877-999-6442
Submit denial letters, medical records, and physician support letter

Important: Michigan's external review decisions are binding on Cigna. If approved, the insurer must provide coverage as directed.

Common Denial Reasons & Solutions

Denial Reason	Solution	Documentation Needed
Incomplete REMS documentation	Submit enrollment confirmations	Prescriber and patient REMS IDs
Missing lab monitoring plan	Provide detailed protocol	Weekly platelet schedule with thresholds
Insufficient disease staging	Add validated assessment scores	PND or NIS scores from neurologist
Lack of genetic confirmation	Submit genetic testing report	Pathogenic TTR variant documentation
Wrong specialty pharmacy	Transfer to Accredo	Coordinate with approved network pharmacy

When to Request Peer-to-Peer Review

If your initial appeal is denied, request a peer-to-peer review where your neurologist can speak directly with Cigna's medical director. This is particularly effective for rare diseases like hATTR polyneuropathy where general reviewers may lack specialized knowledge.

Script for Requesting Peer-to-Peer: "I'm calling to request a peer-to-peer review for my patient's Tegsedi denial. This is a rare neurogenetic condition requiring specialist expertise. Please schedule a call between the reviewing medical director and our neurologist who specializes in hereditary amyloidosis."

Cost and Patient Assistance

Manufacturer Support

Ionis Pharmaceuticals (Tegsedi's manufacturer) offers patient assistance programs, though the drug was discontinued in 2022. Existing patients may still access support through:

Patient assistance programs for eligible uninsured/underinsured patients
Copay assistance for commercially insured patients
Care coordination support

Alternative Funding Sources

For Michigan Residents:

Michigan Department of Health and Human Services medication assistance programs
Chronic Disease Fund grants for rare diseases
HealthWell Foundation assistance for hATTR patients

Insurance Advocacy Support

For complex cases requiring detailed appeals analysis, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, plan policies, and clinical notes to identify denial basis and draft point-by-point rebuttals aligned to each plan's specific rules.

FAQ

How long does Cigna prior authorization take for Tegsedi in Michigan? Standard electronic submissions through CoverMyMeds or Express Scripts typically receive decisions within 24-48 hours. Phone/fax submissions may take 2-5 business days.

What if Tegsedi is not on my Cigna formulary? Request a formulary exception through Cigna's standard process. Emphasize that Tegsedi is FDA-approved for your specific rare disease indication with limited alternatives.

Can I use expedited appeals in Michigan? Yes, both Cigna internal appeals and Michigan DIFS external reviews offer expedited processes (72 hours) when delays would seriously jeopardize health. Requires physician letter documenting urgency.

Does step therapy apply if I failed treatments outside Michigan? Step therapy requirements follow the patient, not geography. Document previous treatment failures with dates, doses, and reasons for discontinuation regardless of where they occurred.

What happens if my appeal is denied by Cigna? You can file for external review with Michigan DIFS within 127 days. Their independent medical review is binding on Cigna and often overturns denials for rare diseases with proper documentation.

How do I maintain coverage during appeals? Request continuation of benefits during internal appeals if you're already on Tegsedi. For new prescriptions, ask your doctor about emergency supplies while appeals are pending.

Are there alternatives if Tegsedi remains denied? Other FDA-approved hATTR polyneuropathy treatments include Amvuttra (vutrisiran), Onpattro (patisiran), and Wainua (eplontersen). Your neurologist can help determine the best alternative.

What if I can't afford the specialty pharmacy copay? Contact manufacturer patient assistance programs first, then explore foundation grants and state assistance programs. Some patients qualify for $0 copays through these programs.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For official Michigan insurance regulations and consumer rights, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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