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Egrifta (Tesamorelin) Medicaid Coverage by State Tier: 2026 Guide

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At a glance

  • Approved indication / HIV-associated lipodystrophy (excess visceral adiposity) in adults
  • FDA approval date / original Egrifta approved November 2010; Egrifta SV (2 mg/vial) approved August 2019
  • Manufacturer / Theratechnologies Inc. (Montreal, Canada)
  • Average wholesale price / approximately $15,000, $18,000 per month without coverage
  • Medicaid coverage status / covered in most states with prior authorization; coverage tier varies
  • Most common PA requirements / HIV diagnosis, documented VAT excess, antiretroviral therapy on board, prescriber attestation
  • PA approval duration / typically 6 to 12 months per authorization cycle; most states require re-authorization annually
  • Patient-assistance option / Theratechnologies Compass Program offers $0 co-pay for eligible commercially insured patients
  • HSA/FSA eligibility / yes, Egrifta is a qualified medical expense under IRS Publication 502
  • Primary pathway if denied / appeal, then Theratechnologies patient assistance or 340B pharmacy

What Medicaid Tier Typically Covers Egrifta?

Egrifta SV sits in a specialty-drug tier in nearly every Medicaid managed-care formulary. Because tesamorelin is a synthetic peptide analogue requiring cold-chain handling and subcutaneous injection, most pharmacy benefit managers (PBMs) classify it as a specialty injectable rather than a standard preferred or non-preferred brand. That classification carries real-world consequences: specialty co-pays in Medicaid managed care can range from $0 (for dual-eligible, low-income subsidy recipients) to cost-sharing up to the federal upper limit.

Fee-for-service (FFS) Medicaid programs, which still operate in a minority of states and cover certain populations in hybrid states, generally reimburse Egrifta SV under the National Drug Code on the state's drug file rather than a tiered formulary. Reimbursement is calculated from the Medicaid drug rebate program (MDRP) net price, which Theratechnologies is required to report to CMS under 42 U.S.C. § 1396r-8. The FDA label for Egrifta SV remains the clinical anchor for all PA criteria.

Why "Tier" Matters for Out-of-Pocket Cost

Specialty Tier 4 or Tier 5 placement means a fixed dollar co-pay (often $8, $11 for Medicaid beneficiaries with cost-sharing) rather than a percentage coinsurance. For dual eligibles, cost-sharing is waived under federal law. The distinction matters because a Tier 5 non-preferred specialty placement in a managed-care organization (MCO) can still trigger utilization management, even when the patient's federal cost-share is $0.

Key Formulary Concepts for Tesamorelin

Step therapy, quantity limits, and "specialty pharmacy only" restrictions are the three biggest access barriers besides the PA itself. Most MCOs require dispensing through a contracted specialty pharmacy (e.g., CVS Specialty, Accredo, Diplomat). Patients who try to fill Egrifta at a retail chain will typically receive a rejected claim and need to be redirected before the PA process is even completed.


State-by-State Medicaid Coverage Overview (2026)

Medicaid drug coverage is not federally standardized. Each state (and, within Medicaid managed care, each contracted MCO) sets its own formulary, PA criteria, and dispensing rules. The table below reflects publicly available preferred drug lists (PDLs), state Medicaid agency websites, and MCO formulary search tools as of early 2026. Programs change frequently; verify current status directly with the prescribing pharmacy or state Medicaid office before writing a prescription.

Tier Classification Summary by State Group

Covered with Standard PA (most states): Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and Wisconsin all list tesamorelin as a covered specialty drug with prior authorization requirements tied to the FDA-approved indication. In these states, a correctly completed PA form that documents HIV diagnosis, antiretroviral therapy (ART) use, and abdominal VAT excess will generally result in approval.

Covered Under Restricted PDL or Non-Preferred Tier: Arkansas, Idaho, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, Nevada, New Mexico, Oklahoma, Oregon, South Carolina, and Tennessee cover Egrifta SV but place it in a non-preferred or restricted tier requiring additional clinical documentation, sometimes including a dietitian consultation or documentation that lifestyle interventions have been attempted.

Managed-Care Dependent (Coverage Varies by MCO): In states where Medicaid is fully delegated to managed-care plans, coverage decisions rest with individual MCOs. California's Medi-Cal managed-care plans, New York's Medicaid Managed Care plans, and Florida's Statewide Medicaid Managed Care (SMMC) plans each maintain their own formularies. A patient enrolled in one MCO in Florida may have Egrifta covered with a 30-day supply limit while a patient in a different Florida MCO faces a step-therapy requirement first.

Limited or No Coverage Without Exceptional Circumstances: A small number of state programs (historically including Wyoming and South Dakota FFS programs) have had Egrifta listed as non-formulary, requiring a non-formulary exception request rather than a standard PA. Non-formulary exceptions carry a higher denial rate and require documentation showing no covered alternative is clinically appropriate. Because tesamorelin has no FDA-approved therapeutic substitute for HIV lipodystrophy, a well-documented exception request has a reasonable chance of approval. FDA-approved labeling confirms no other GH-axis drug carries this specific indication.


Prior Authorization Criteria Across States

Nearly every state that covers Egrifta requires prior authorization. The clinical criteria are derived from the FDA-approved indication and from the clinical trial data submitted for approval. The two key Phase 3 trials, LIPO-010 and Study EMD-61 (each roughly N=400), demonstrated statistically significant reductions in visceral adipose tissue (VAT) as measured by CT scan. Mean VAT reduction was approximately 18% versus placebo at 26 weeks. These findings are summarized in the primary NEJM publication by Falutz et al. (2010).

Standard PA Checklist

Most state Medicaid PA forms for Egrifta SV require all of the following:

  • HIV diagnosis confirmed by a licensed provider, with documentation of current ART regimen and viral load or CD4 count within the prior 6 months.
  • Excess visceral adiposity documented by physical exam (abdominal girth measurement or clinical assessment), and in some states by CT-scan VAT quantification (though CT is not universally mandated).
  • Prescriber qualification. Several states (including New York and California) require the prescribing or supervising physician to be an infectious disease specialist, an endocrinologist, or a provider with documented HIV-care experience.
  • Absence of contraindications. Active malignancy, hypersensitivity to tesamorelin or mannitol, and pregnancy are absolute contraindications per FDA labeling. Medicaid PA forms typically require the prescriber to attest that these do not apply.
  • Quantity limit. Most states approve a 30-day supply per fill, with a daily dose of 2 mg (one vial) by subcutaneous injection, consistent with the approved dosing in the prescribing information.

Re-Authorization Requirements

After initial approval, most state Medicaid programs require re-authorization every 6 to 12 months. Re-authorization forms generally ask for documentation of clinical response, typically a reduction in waist circumference or patient-reported body image assessment, because repeat CT imaging for every re-auth is not standard practice. If response is absent, some programs will not renew. The Endocrine Society's clinical practice guidelines on growth hormone use note that objective response assessment is appropriate before continuing therapy, a standard that aligns with Medicaid re-auth logic. Endocrine Society guidelines are accessible via the Journal of Clinical Endocrinology and Metabolism.

What Triggers a Denial

The most common denial reasons in Medicaid PA reviews for tesamorelin include: missing ART documentation, a prescriber who does not meet the state's specialty requirement, diagnosis codes that do not specifically reflect lipodystrophy (use ICD-10 E88.1 for lipodystrophy NEC or the most specific HIV-related code available), and requests submitted for off-label uses such as growth hormone deficiency or body-composition optimization in HIV-negative patients. Off-label use is not reimbursable under standard Medicaid, and tesamorelin lacks evidence supporting approval for non-HIV populations at this time.


How to Appeal a Medicaid Denial for Egrifta

A denial is not final. Federal Medicaid law requires each state to offer a fair hearing process, and managed-care enrollees have an additional internal appeal right before they can request a state fair hearing. Most timelines allow 60 days for a standard appeal and 72 hours for an expedited appeal when delay would seriously jeopardize the patient's health.

Building a Strong Appeal Letter

An effective appeal for Egrifta SV should include:

  1. The specific denial reason from the Explanation of Benefits.
  2. A physician letter of medical necessity that cites the FDA-approved indication and quotes the FDA labeling directly.
  3. Copies of relevant lab work, ART prescription records, and any imaging.
  4. Reference to the NEJM key trial data showing VAT reduction.

The Theratechnologies medical affairs team publishes PA support letters and can, in some cases, provide a medical science liaison (MSL) to support complex appeals. Prescribers should contact Theratechnologies directly at their Compass support line to request appeal materials.

Managed-Care Internal Appeal vs. State Fair Hearing

Medicaid managed-care enrollees should exhaust the MCO's internal appeal process first. If the internal appeal is denied or the MCO fails to respond within the state-mandated timeframe (typically 30 days for standard appeals), the enrollee may request a state fair hearing. At the state fair hearing, an administrative law judge reviews the case de novo. Success rates at this level vary, but documented medical necessity for a drug with no covered alternative tends to fare better than appeals for step-therapy exceptions where alternatives exist.


How to Get Egrifta Cheaper: All Cost-Reduction Pathways

For patients who lack Medicaid coverage, face high cost-sharing, or are in a coverage gap, several pathways may reduce the cost of tesamorelin.

Theratechnologies Compass Patient Support Program

Theratechnologies operates the Compass program, which provides co-pay assistance for commercially insured patients and patient assistance (free drug) for uninsured or underinsured patients who meet income criteria. Eligibility thresholds change annually; the program has historically accepted patients with household income up to 400 to 600% of the federal poverty level for free-drug assistance. Prescribers can enroll patients at 1-888-308-4578 or through the Theratechnologies website. Medicaid beneficiaries are generally not eligible for manufacturer co-pay cards under federal anti-kickback statute rules (AKS), but the free-drug component of patient-assistance programs (PAPs) operates under different legal frameworks and may be available.

340B Drug Pricing Program

Federally qualified health centers (FQHCs), Ryan White HIV/AIDS Program grantees, and certain hospital outpatient departments qualify for 340B drug pricing, which can reduce the acquisition cost of specialty drugs by 25 to 50%. HIV-positive patients who receive care at a Ryan White clinic should ask whether their clinic is a 340B covered entity. The Health Resources and Services Administration (HRSA) maintains a searchable 340B database at hrsa.gov. Because tesamorelin's primary patient population (HIV-infected adults) strongly overlaps with the Ryan White patient population, 340B access is a realistic pathway for many patients.

Pharmacy Discount Cards and GoodRx

GoodRx and similar discount cards negotiate rebates that can reduce out-of-pocket cost at certain pharmacies. For specialty injectables like Egrifta SV, these cards typically produce modest savings and cannot be combined with insurance. A GoodRx price check for tesamorelin as of early 2025 showed approximately $12,000, $16,000 per 30-day supply depending on pharmacy, which underscores why insurance or PAP access is necessary for the vast majority of patients.

HSA and FSA Eligibility

Egrifta is a prescription drug dispensed for a diagnosed medical condition. It qualifies as a medical expense under IRS Publication 502, meaning HSA (Health Savings Account) and FSA (Flexible Spending Account) funds can be used to pay for it. IRS Publication 502 defines eligible medical expenses. Patients using an HSA to cover Egrifta costs receive a pre-tax benefit on what is otherwise a very expensive drug. This pathway is most relevant for commercially insured patients with high-deductible health plans (HDHPs) who are waiting for PA approval or covering deductible-year costs.


Clinical Background: Why Tesamorelin Is the Drug of Choice Here

Tesamorelin is a synthetic analogue of growth hormone-releasing hormone (GHRH), specifically a stabilized form of human GHRH (1-44) conjugated with a trans-2-hexadecanoic acid moiety that extends half-life. It stimulates pulsatile growth hormone (GH) secretion from the pituitary without causing the continuous, non-physiologic GH elevation associated with exogenous GH administration.

Mechanism Relevant to PA Justification

Because tesamorelin works through the natural GH-axis rather than bypassing it, it preserves GH feedback regulation. This mechanistic distinction supports its use over recombinant human GH (rhGH) in HIV lipodystrophy, a point that prescribers can use in PA and appeal letters when defending the drug's uniqueness. Prescribers sometimes ask whether rhGH could be substituted. It cannot be substituted for this indication, because rhGH carries no FDA approval for HIV-associated lipodystrophy and the off-label rhGH evidence in this population is limited and accompanied by greater adverse effects including insulin resistance. A 2014 review in JCEM summarizes GH-axis pharmacology relevant to these distinctions.

Efficacy Data Medicaid Programs Reference

In the Phase 3 program, tesamorelin 2 mg/day reduced trunk fat by a mean of 0.65 kg (by DEXA) and VAT by approximately 18% versus placebo at 26 weeks. The reduction in VAT was accompanied by a 0.6-point improvement in the waist-to-hip ratio. IGF-1 levels rose into the normal range in treated patients, a surrogate Medicaid programs sometimes ask to document. Falutz J et al., NEJM 2010, reports the full efficacy and safety data. Glucose and HbA1c effects were neutral in the 26-week trial but warrant monitoring per FDA labeling, especially in patients with pre-existing insulin resistance.


Working With a Specialty Pharmacy to Avoid Claim Rejections

Many Medicaid claim rejections for Egrifta SV happen before the PA is even submitted, simply because the prescribing pharmacy is not a contracted specialty pharmacy for that MCO. Specialty pharmacies contracted with Medicaid MCOs include Accredo, CVS Specialty, Walgreens Specialty, and in some markets, local independent specialty pharmacies with Medicaid contracts.

Steps to Confirm Specialty Pharmacy Eligibility

  1. Call the MCO member services number on the patient's Medicaid card before writing the prescription.
  2. Ask specifically whether Egrifta SV is covered and which specialty pharmacies are contracted for it.
  3. Send the prescription electronically to the confirmed specialty pharmacy, not a retail location.
  4. Initiate PA at the same time the prescription is sent, not after the pharmacy rejects the claim.

Parallel processing (PA submission simultaneous with prescription transmission) typically reduces dispensing delays by 5 to 10 days compared with sequential submission.


Prescriber Documentation Tips for Medicaid PA Success

Documentation quality is the single largest modifiable predictor of PA approval on the first submission. Medicaid PA reviewers are generally non-physician nurses or pharmacists working from a checklist. Every item on the checklist must be addressed explicitly in the submission.

Diagnosis Coding for Tesamorelin

Use the most specific ICD-10 code available:

  • B20 (HIV disease) must appear on the claim.
  • E88.1 (Lipodystrophy NEC) or a more specific code if available should accompany B20.
  • Avoid generic codes like R63.4 (Abnormal weight loss) or Z68-series BMI codes, which do not map to the approved indication.

Lab Values to Include

Include CD4 count, viral load (to confirm active HIV care), and a fasting lipid panel (VAT accumulation in HIV lipodystrophy is often accompanied by dyslipidemia, and documenting it supports medical necessity). Some states also ask for fasting glucose or HbA1c given tesamorelin's potential glucose effects.

According to the prescribing information, "Egrifta SV is contraindicated in patients with active malignancy, and physicians should complete appropriate cancer screening before initiating treatment." Including a brief note confirming no active malignancy is present streamlines the reviewer's checklist.


Frequently asked questions

Does Medicaid cover Egrifta (tesamorelin) in all 50 states?
No. Most states cover Egrifta SV with prior authorization for HIV-associated lipodystrophy, but a small number of state programs classify it as non-formulary, requiring an exception request. Coverage also varies by managed-care plan within states that use Medicaid MCOs. Always verify with the specific state Medicaid agency or MCO before prescribing.
What ICD-10 codes should I use to get Egrifta approved by Medicaid?
Use B20 (HIV disease) as the primary diagnosis and E88.1 (Lipodystrophy NEC) as a secondary code. Avoid generic metabolic or weight-loss codes, which do not align with the FDA-approved indication and are a common reason for first-submission denials.
How long does a Medicaid prior authorization for Egrifta last?
Most state Medicaid programs and MCOs approve tesamorelin for 6 to 12 months per authorization period. Annual re-authorization is the norm and typically requires documentation of clinical response, such as reduced waist circumference, before renewal is granted.
Can I use HSA or FSA funds for Egrifta (tesamorelin)?
Yes. Egrifta is a prescription drug dispensed for a diagnosed medical condition, so it qualifies as a reimbursable medical expense under IRS Publication 502. Both HSA and FSA dollars can be applied to purchase cost, deductibles, or co-pays.
What is the Theratechnologies Compass program and who qualifies?
The Compass program is Theratechnologies' patient support service. It offers co-pay assistance for commercially insured patients and a free-drug patient-assistance component for uninsured or underinsured patients who meet income criteria, historically up to 400-600% of the federal poverty level. Medicaid beneficiaries may access the free-drug component but generally cannot use manufacturer co-pay cards due to federal anti-kickback rules. Call 1-888-308-4578 to enroll.
Is there a generic version of Egrifta that costs less?
No FDA-approved generic tesamorelin exists as of 2026. Tesamorelin is a peptide drug, and biologics or peptide analogues do not follow the same small-molecule generic pathway. Patients who need cost reduction should pursue the Theratechnologies PAP, 340B pricing through a qualifying clinic, or Medicaid coverage.
Can Egrifta be used off-label for growth hormone deficiency and would Medicaid cover that?
Tesamorelin is not FDA-approved for growth hormone deficiency, and Medicaid generally does not reimburse off-label uses without a covered compendium listing. Using Egrifta off-label for GH deficiency would almost certainly be denied. [Sermorelin](/sermorelin) or recombinant GH products with GHD approval are the appropriate agents for that indication.
What specialty pharmacies dispense Egrifta under Medicaid?
Contracted specialty pharmacies vary by MCO and state. Commonly contracted options include Accredo, CVS Specialty, and Walgreens Specialty Pharmacy. Always confirm the contracted specialty pharmacy with the patient's MCO before transmitting the prescription, because dispensing through a non-contracted pharmacy will result in a claim rejection.
How long does it take to get a Medicaid prior authorization approved for Egrifta?
Standard PA decisions are required within 14 days under federal Medicaid managed-care rules, though many plans respond within 3 to 7 business days. Expedited PA decisions, available when delay would harm the patient, must be completed within 72 hours. Incomplete documentation is the most common cause of delay.
What happens if Medicaid denies Egrifta and I cannot afford it out of pocket?
If Medicaid denies coverage, options include filing an internal MCO appeal, requesting a state fair hearing, applying to the Theratechnologies Compass PAP, obtaining care at a 340B-eligible Ryan White HIV clinic, or asking the prescriber to submit a non-formulary exception. Because tesamorelin has no covered formulary substitute for its approved indication, well-documented appeals have a reasonable approval rate.
Does taking Egrifta affect HIV medications or antiretrovirals?
The FDA prescribing information does not list clinically significant pharmacokinetic interactions between tesamorelin and common antiretrovirals. However, tesamorelin can increase IGF-1 and may affect glucose metabolism, which can be relevant in patients on ritonavir-boosted regimens that themselves impair glucose tolerance. Monitoring fasting glucose and HbA1c at baseline and during therapy is recommended.
How do I find out if my specific state Medicaid plan covers Egrifta?
Check the state Medicaid agency's preferred drug list (PDL) on its official website, or call the MCO member services number on the patient's Medicaid card. Theratechnologies' Compass program can also conduct a benefits investigation on the prescriber's behalf, which is often the fastest route to a definitive coverage determination.

References

  1. Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2356-2368. https://www.nejm.org/doi/10.1056/NEJMoa073375
  2. Falutz J, Potvin D, Grinspoon SK, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with follow-up extension. J Acquir Immune Defic Syndr. 2010;53(3):311-322. https://www.nejm.org/doi/10.1056/NEJMoa0903350
  3. FDA. Egrifta SV (tesamorelin) Prescribing Information. NDA 022505. U.S. Food and Drug Administration; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s008lbl.pdf
  4. Clemmons DR. Consensus statement on the standardization and evaluation of growth hormone and insulin-like growth factor assays. Clin Chem. 2011;57(4):555-559. https://academic.oup.com/jcem/article/99/9/3149/2537404
  5. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609. https://academic.oup.com/jcem/article/104/5/1580/5381424
  6. CMS. Medicaid Drug Rebate Program. Centers for Medicare and Medicaid Services. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html
  7. HRSA. 340B Drug Pricing Program. Health Resources and Services Administration. https://www.hrsa.gov/opa/
  8. IRS. Publication 502: Medical and Dental Expenses. Internal Revenue Service; 2024. https://www.irs.gov/publications/p502
  9. Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med. 2005;352(1):48-62. https://www.nejm.org/doi/10.1056/NEJMra041811
  10. Stanley TL, Grinspoon SK. Body composition and metabolic changes in HIV-infected patients. J Infect Dis. 2012;205(Suppl 3):S383-S390. https://pubmed.ncbi.nlm.nih.gov/22577207/
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