Egrifta (Tesamorelin) HSA/FSA Eligibility and How to Lower Your Cost
At a glance
- Drug class / Growth hormone-releasing factor (GRF) analog, subcutaneous injection
- IRS eligibility / Prescription drugs qualify for HSA and FSA reimbursement under IRC §213(d)
- Manufacturer / Theratechnologies Inc.
- FDA-approved indication / Reduction of excess abdominal fat in HIV-associated lipodystrophy (adults)
- Off-label use in women / Visceral adiposity in metabolic disease, GH deficiency states
- Pregnancy status / Contraindicated, teratogenicity risk; reliable contraception required
- Lactation status / Unknown transfer; breastfeeding not recommended during treatment
- Life-stage note / Postmenopausal women may have lower baseline GH pulsatility, which changes the clinical picture
- Cost range (2025) / Specialty pricing varies widely; patient-assistance and copay programs available
Can You Use HSA or FSA Funds for Egrifta?
Yes. Egrifta (tesamorelin) is a prescription medication, and the IRS classifies prescription drugs as qualified medical expenses eligible for both Health Savings Account (HSA) and Flexible Spending Account (FSA) reimbursement under Internal Revenue Code §213(d). That rule covers the cost of the drug itself, including specialty-pharmacy dispensing fees billed as part of the prescription.
You do not need a special letter of medical necessity to use HSA or FSA funds for a prescription drug. The prescription itself is the documentation. Keep the pharmacy receipt or Explanation of Benefits (EOB) showing the drug name, date of service, and your out-of-pocket amount, because your plan administrator may ask for it.
What the IRS Actually Says
IRS Publication 502 states that amounts paid for prescription medicines or drugs are deductible medical expenses, and the same definition governs HSA and FSA qualified expenses. A drug counts if it requires a prescription under federal or state law. Tesamorelin is a Schedule-unscheduled but prescription-only biologic, so it qualifies.
How to Pay or Get Reimbursed
Option 1: Swipe your HSA/FSA card at the pharmacy. Many specialty pharmacies that dispense Egrifta accept HSA/FSA cards at point of sale. Ask the pharmacy to confirm before your first fill.
Option 2: Pay out of pocket, then submit. Pay the pharmacy directly, then log in to your HSA custodian or FSA administrator portal, upload the itemized receipt, and request reimbursement. Processing typically takes 5 to 10 business days.
Option 3: Reimburse yourself from HSA later. Unlike FSAs, HSAs have no deadline for reimbursement as long as the expense occurred after the account was opened. You can pay now and pull the funds years later, letting the HSA grow tax-free in the interim.
How FSA Differs from HSA for This Purchase
Both account types cover the same universe of qualified expenses, but the mechanics differ in ways that matter for an expensive specialty drug like Egrifta.
FSA Timing Rules
FSAs are "use it or lose it" in most plans. If your plan year ends December 31 and you fill Egrifta in November, make sure you have enough remaining FSA balance and that the claim is submitted before the run-out deadline (often 90 days after year-end). The IRS allows employers to offer either a $660 rollover (2025 limit) or a 2.5-month grace period, but not both. Confirm which option your employer chose.
HSA Contribution Limits for 2025
For 2025, the IRS set HSA contribution limits at $4,300 for self-only coverage and $8,550 for family coverage. If your Egrifta out-of-pocket cost exceeds your current HSA balance, you can contribute up to the annual limit and then spend it immediately, as long as you are enrolled in a qualifying High-Deductible Health Plan (HDHP).
Limited-Purpose FSAs
Some employers offer limited-purpose FSAs that cover only dental and vision before you meet your deductible. Prescription drugs like Egrifta are generally not covered under a limited-purpose FSA until your HDHP deductible is met. Check your plan documents.
What Egrifta Costs and Why It Matters for Your Account Strategy
Egrifta is a specialty biologic. Without insurance or assistance programs, specialty injectable therapies in this class can carry list prices exceeding $10,000 per month. Your actual cost depends on insurance coverage, specialty-pharmacy contracts, and any assistance programs you use. Understanding your real out-of-pocket cost before your plan year starts lets you elect enough FSA funds or plan HSA contributions strategically.
Insurance Coverage and Prior Authorization
Most commercial insurers and Medicare Part D plans require prior authorization for Egrifta. Your prescriber must document the FDA-approved indication (HIV-associated lipodystrophy with excess visceral fat) or, for off-label use, the medical rationale. Prior authorization approval directly affects what you owe, which in turn determines how much HSA or FSA funding you need.
Theratechnologies Patient-Support Programs
Theratechnologies offers a patient-support program called Egrifta SV Support. The program may include:
- Copay assistance for commercially insured patients
- Referral to independent charitable foundations for patients who are underinsured or on Medicare
- Specialty-pharmacy coordination and injection training
Contact the manufacturer directly or ask your prescriber's office to initiate enrollment. Program terms change, so verify current eligibility criteria when you apply.
Independent Copay Foundations
If you are on Medicare or Medicaid, manufacturer copay cards cannot legally be used. Independent foundations such as the HealthWell Foundation and the Patient Advocate Foundation occasionally fund HIV-related specialty medications. Availability depends on current funding cycles. Your specialty pharmacy's patient-access team can run a real-time foundation search on your behalf.
How to Submit an HSA/FSA Claim for Egrifta: Step by Step
Getting reimbursed is straightforward if you keep the right paperwork.
- Get an itemized receipt. Ask your specialty pharmacy for a receipt that shows the drug name (tesamorelin or Egrifta), NDC number, date dispensed, quantity, and your out-of-pocket payment.
- Log in to your account portal. Access your HSA custodian (Fidelity, HealthEquity, Optum, etc.) or FSA administrator portal.
- Select "Submit a Claim" or "Request Reimbursement." Upload the itemized receipt as a PDF or photo.
- Enter the expense date. Use the date of dispensing, not the date you paid.
- Submit and track. Most platforms confirm receipt by email and process within 5 to 10 business days.
Keep copies of all receipts for at least three years in case of an IRS audit of your HSA or FSA account.
Women's-Health Context: Why Women Are Using Tesamorelin Off-Label
Egrifta's FDA approval covers HIV-associated lipodystrophy, but clinicians prescribe tesamorelin off-label for visceral adiposity and growth hormone (GH) deficiency states in women without HIV. Understanding the women's-health context helps you and your prescriber document medical necessity accurately, which matters for both insurance coverage and HSA/FSA compliance (you still need a valid prescription).
Growth Hormone Physiology Across the Female Life Span
Women naturally secrete more GH pulses per day than men, but pulse amplitude and 24-hour GH secretion decline with age. In women, the menopause transition accelerates the age-related fall in GH pulsatility, contributing to increased visceral fat accumulation, reduced lean mass, and metabolic changes that resemble those seen in clinical GH deficiency. Estrogen status modulates GH secretion: oral estrogen reduces hepatic IGF-1 generation and may blunt GH action, while transdermal estrogen has a smaller effect on IGF-1. A study published in the Journal of Clinical Endocrinology and Metabolism found that the route of estrogen administration significantly affected IGF-1 levels in postmenopausal women.
Perimenopause and Post-Menopause
Postmenopausal women represent a population where visceral fat accumulation is particularly pronounced. Visceral adipose tissue increases by roughly 49% across the menopause transition independent of total body weight change. Tesamorelin reduces visceral fat by stimulating endogenous GH release, which in turn increases IGF-1 and promotes lipolysis in visceral depots. In the key phase 3 trials (LIPO-010 and LIPO-011), tesamorelin reduced visceral adipose tissue by approximately 18% versus placebo at 26 weeks. Those trials enrolled predominantly male participants; the sex-disaggregated response data in women are limited, and this evidence gap is worth discussing with your clinician.
PCOS and Insulin Resistance
Women with polycystic ovary syndrome (PCOS) often have elevated visceral fat and insulin resistance despite normal body weight. PCOS affects approximately 8 to 13% of women of reproductive age worldwide. GH-axis dysregulation has been described in PCOS, with some studies showing blunted GH pulse amplitude. Whether tesamorelin offers a clinical benefit in PCOS-related visceral adiposity has not been established in controlled trials; any use in this population is experimental and extrapolated from the HIV lipodystrophy data.
The table below summarizes how tesamorelin's clinical picture may differ across female life stages. This framework is derived from published physiology data and WomanRx editorial synthesis, not from a single clinical trial.
| Life Stage | GH Pulsatility | Visceral Fat Risk | Key Clinical Note | |---|---|---|---| | Reproductive years | Higher amplitude | Moderate | Contraception mandatory during treatment | | Perimenopause | Declining | Increasing | Estrogen route affects IGF-1 response | | Post-menopause | Low | High | Most pronounced visceral fat accumulation; lowest GH secretion | | PCOS (any age) | Variable, often blunted | Elevated | No controlled trial data; off-label only |
Pregnancy, Lactation, and Contraception: Required Reading Before You Start
This section is required for any woman considering tesamorelin, regardless of your primary reason for taking it.
Pregnancy
Tesamorelin is contraindicated during pregnancy. The FDA prescribing information for Egrifta states that the drug should not be used in pregnant women. Animal reproduction studies showed fetal harm. Human data are absent because pregnant women were excluded from clinical trials. Because the fetal risk cannot be quantified but animal data signal harm, the safe clinical position is to avoid any exposure during pregnancy.
If you become pregnant while taking Egrifta, stop the drug immediately and contact your prescriber. The drug's half-life is short (approximately 26 minutes for the intact peptide), so systemic clearance after stopping is rapid.
Trying to Conceive
If you are actively trying to conceive, tesamorelin is not appropriate. Discuss the timeline for stopping treatment with your prescriber before attempting pregnancy. Because the drug is cleared quickly, a brief washout is sufficient from a pharmacokinetic standpoint, but your underlying condition and any concurrent medications may require a longer planned interval.
Contraception Requirement
The Egrifta prescribing label specifies that women of childbearing potential should use effective contraception during treatment. "Effective contraception" in this context means a method with a failure rate below 1% per year with typical use, such as an IUD, implant, combined hormonal contraceptive, or sterilization. Barrier methods alone are not considered sufficiently reliable for a drug with fetal risk.
Note that if you use combined oral contraceptives (COCs) concurrently, the oral estrogen component may reduce IGF-1 generation and potentially blunt the metabolic response to tesamorelin, as described above under estrogen pharmacology. Transdermal or vaginal hormonal contraceptives may have less interaction. Discuss this with your prescriber.
Lactation
The transfer of tesamorelin into human breast milk has not been studied. The FDA label states that it is not known whether tesamorelin is excreted in human milk. Because tesamorelin is a peptide, it may be partially degraded in the infant's gastrointestinal tract if ingested, but systemic absorption in a nursing infant cannot be ruled out. The conservative clinical recommendation is to avoid breastfeeding during treatment. If continuation of breastfeeding is a priority, tesamorelin is not the right choice at this time.
Postpartum
In the postpartum period, GH physiology is altered by the hormonal changes of parturition and, if breastfeeding, by prolactin. There are no data on tesamorelin use in the postpartum period. Until you have stopped breastfeeding and your prescriber has confirmed that tesamorelin is appropriate, hold treatment.
Who This Treatment Is Right For (and Who Should Not Use It)
Likely Right For You If:
- You have HIV-associated lipodystrophy with documented excess visceral fat (the FDA-approved indication)
- You have a confirmed GH deficiency diagnosis and your endocrinologist has determined tesamorelin is an appropriate off-label option
- You are postmenopausal with significant visceral adiposity and have not responded to lifestyle and hormonal interventions, and your clinician has a clear rationale for off-label use
- You have commercial insurance or access to patient-assistance programs that make the cost manageable
- You are not pregnant, not trying to conceive, and not breastfeeding, and you are willing to use reliable contraception
Not Right For You If:
- You are pregnant or planning pregnancy in the near term
- You are breastfeeding
- You have active malignancy (GH stimulation is contraindicated with active or suspected cancer)
- You have pituitary disease or recent pituitary surgery that would make GH stimulation inappropriate
- You have diabetic retinopathy, as GH elevation may worsen this condition
- You have hypersensitivity to tesamorelin or any excipient in the formulation
Additional Ways to Lower Your Egrifta Cost
Specialty Pharmacy Shopping
Not all specialty pharmacies price Egrifta identically. Some health system specialty pharmacies, integrated PBM pharmacies, or 340B-eligible clinic pharmacies may offer lower acquisition costs. Ask your prescriber whether a 340B-eligible clinic (typically a federally qualified health center or HIV clinic) is an option for your situation.
Appeals for Insurance Denial
If your insurer denies prior authorization, you have the right to appeal. The Affordable Care Act requires insurers to provide a clear appeals process. Your prescriber can submit a peer-to-peer review or letter of medical necessity. A second denial can be taken to an external independent review. Patient advocacy organizations focused on HIV care may also have appeal letter templates.
Stacking Savings
You may be able to combine an HSA/FSA payment with a manufacturer copay card. The copay card reduces your out-of-pocket charge to the pharmacy; you then pay that reduced amount using HSA or FSA funds. This "stacking" is legal as long as you are not on a federal government program (Medicare, Medicaid, TRICARE). Confirm the mechanics with your specialty pharmacy before assuming this works at your specific pharmacy.
Tax Deduction as a Fallback
If you exhaust your HSA/FSA funds, out-of-pocket medical expenses (including prescription drugs) that exceed 7.5% of your adjusted gross income are deductible on your federal tax return under IRC §213. This is not as efficient as pre-tax HSA/FSA dollars, but it provides some relief for very high annual drug costs.
Evidence Gap: What We Know and Do Not Know About Tesamorelin in Women
Women have been historically underrepresented in GH-axis research. The phase 3 trials that supported Egrifta's FDA approval enrolled a predominantly male cohort of HIV-positive adults. In LIPO-010, approximately 85% of participants were male. Sex-stratified efficacy and safety data from these trials are not available in published form, meaning that the visceral fat reduction magnitude, IGF-1 response, and side-effect profile in women are extrapolated from a male-dominant dataset.
A review of GH secretion across the menstrual cycle found that GH pulse frequency and amplitude vary with estrogen and progesterone levels, which suggests that tesamorelin's stimulation of endogenous GH may produce different IGF-1 responses depending on where a woman is in her cycle or her menopausal status. This has not been studied prospectively in tesamorelin trials.
The AACE/ACE Guidelines on the Diagnosis and Treatment of Adult Growth Hormone Deficiency acknowledge the sex difference in GH secretion and IGF-1 interpretation, recommending sex-specific IGF-1 reference ranges. Your clinician should use a reference range calibrated to your age and sex when monitoring IGF-1 on treatment.
Side effects reported in trials include fluid retention, arthralgias, peripheral edema, and injection-site reactions. Women may be more sensitive to fluid retention effects of GH axis stimulation, though direct comparative data are lacking. A meta-analysis of GH replacement in adults found that women required lower GH doses than men to achieve equivalent IGF-1 targets, a finding that likely extends to GH secretagogues like tesamorelin but has not been confirmed in a tesamorelin-specific study.
Frequently asked questions
›Can I use my HSA or FSA to pay for Egrifta (tesamorelin)?
›Do I need a letter of medical necessity to use HSA/FSA funds for Egrifta?
›How do I submit an HSA or FSA reimbursement claim for Egrifta?
›Is there a manufacturer copay card or discount program for Egrifta?
›Can I use an FSA for Egrifta if my FSA is a limited-purpose FSA?
›What is the out-of-pocket cost of Egrifta without insurance?
›Is Egrifta (tesamorelin) safe during pregnancy?
›Can I breastfeed while taking Egrifta?
›Does tesamorelin work differently in women than in men?
›Can postmenopausal women use tesamorelin?
›Can women with PCOS use tesamorelin?
›How do I get Egrifta cheaper if I have commercial insurance?
›Can I stack a manufacturer copay card with HSA or FSA funds for Egrifta?
References
- Internal Revenue Service. Publication 502: Medical and Dental Expenses. Updated annually. https://www.irs.gov/publications/p502
- Internal Revenue Service. Notice 2005-42: Health Flexible Spending Arrangements. https://www.irs.gov/pub/irs-drop/n-05-42.pdf
- Internal Revenue Service. Revenue Procedure 2024-25: HSA Contribution Limits for 2025. https://www.irs.gov/pub/irs-drop/rp-24-25.pdf
- U.S. Food and Drug Administration. Egrifta (tesamorelin) Prescribing Information. Theratechnologies Inc. Revised 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf
- 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):2359-2370. https://pubmed.ncbi.nlm.nih.gov/19584183/
- Falutz J, Mamputu JC, Potvin D, 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 safety extension data. J Acquir Immune Defic Syndr. 2010;53(3):311-322. https://pubmed.ncbi.nlm.nih.gov/20554704/
- Veldhuis JD, Liem AY, South S, et al. Differential impact of age, sex steroid hormones, and obesity on basal versus pulsatile growth hormone secretion in men as assessed in an ultrasensitive chemiluminescence assay. J Clin Endocrinol Metab. 1995;80(11):3209-3222. https://pubmed.ncbi.nlm.nih.gov/9626104/
- Bellantoni MF, Vittone J, Campfield AT, Bass KM, Harman SM, Blackman MR. Effects of oral versus transdermal estrogen on the growth hormone/insulin-like growth factor I axis in younger and older postmenopausal women: a clinical research center study. J Clin Endocrinol Metab. 1996;81(8):2848-2853. https://pubmed.ncbi.nlm.nih.gov/10352397/
- Toth MJ, Tchernof A, Sites CK, Poehlman ET. Effect of menopausal status on body composition and abdominal fat distribution. Int J Obes Relat Metab Disord. 2000;24(2):226-231. https://pubmed.ncbi.nlm.nih.gov/17490952/
- Balen AH, Morley LC, Misso M, et al. The management of anovulatory infertility in women with polycystic ovary syndrome. Hum Reprod Update. 2016;22(5):560-572. https://pubmed.ncbi.nlm.nih.gov/26526303/
- Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML; Endocrine Society. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609. https://pubmed.ncbi.nlm.nih.gov/21700476/
- Johannsson G, Rosén T, Bengtsson BA. Individualized dose titration of growth hormone (GH) during GH replacement in hypopituitary adults. Clin Endocrinol (Oxf). 1997;47(5):571-581. https://pubmed.ncbi.nlm.nih.gov/16940456/
- Healthcare.gov. Appeal a Health Insurance Marketplace Decision. U.S. Centers for Medicare and Medicaid Services. https://www.healthcare.gov/appeal-insurance-company-decision/