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

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:
- The specific denial reason from the Explanation of Benefits.
- A physician letter of medical necessity that cites the FDA-approved indication and quotes the FDA labeling directly.
- Copies of relevant lab work, ART prescription records, and any imaging.
- 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
- Call the MCO member services number on the patient's Medicaid card before writing the prescription.
- Ask specifically whether Egrifta SV is covered and which specialty pharmacies are contracted for it.
- Send the prescription electronically to the confirmed specialty pharmacy, not a retail location.
- 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?
›What ICD-10 codes should I use to get Egrifta approved by Medicaid?
›How long does a Medicaid prior authorization for Egrifta last?
›Can I use HSA or FSA funds for Egrifta (tesamorelin)?
›What is the Theratechnologies Compass program and who qualifies?
›Is there a generic version of Egrifta that costs less?
›Can Egrifta be used off-label for growth hormone deficiency and would Medicaid cover that?
›What specialty pharmacies dispense Egrifta under Medicaid?
›How long does it take to get a Medicaid prior authorization approved for Egrifta?
›What happens if Medicaid denies Egrifta and I cannot afford it out of pocket?
›Does taking Egrifta affect HIV medications or antiretrovirals?
›How do I find out if my specific state Medicaid plan covers Egrifta?
References
- 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
- 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
- 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
- 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
- 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
- CMS. Medicaid Drug Rebate Program. Centers for Medicare and Medicaid Services. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html
- HRSA. 340B Drug Pricing Program. Health Resources and Services Administration. https://www.hrsa.gov/opa/
- IRS. Publication 502: Medical and Dental Expenses. Internal Revenue Service; 2024. https://www.irs.gov/publications/p502
- 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
- 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/