Egrifta (Tesamorelin) Manufacturer Bridge Programs

What Is Egrifta SV and Why Does It Cost So Much?

Egrifta SV (tesamorelin) is the only FDA-approved therapy for HIV-associated lipodystrophy, a condition in which antiretroviral therapy causes pathological accumulation of visceral adipose tissue. The FDA granted original approval in November 2010 based on two phase 3 randomised controlled trials (LIPO-010 and LIPO-011, combined N=816), in which tesamorelin 2 mg/day reduced visceral adipose tissue by a mean of 18% versus placebo at 26 weeks (pubmed.ncbi.nlm.nih.gov/21030600).

Because Egrifta SV has no generic equivalent and no biosimilar competitor as of mid-2025, Theratechnologies maintains near-monopoly pricing. The wholesale acquisition cost (WAC) runs roughly $5,800 to $6,400 per 30-day supply, making annual drug spend approximately $70,000 to $77,000 before any discounts. That figure explains why manufacturer access programs are not optional extras, for most patients they are the only path to treatment (fda.gov/drugs/drug-approvals-and-databases).

The Clinical Rationale Behind Access Efforts

HIV-related visceral lipodystrophy is associated with elevated cardiovascular risk. A 2018 analysis published in the Journal of the Endocrine Society found that visceral adiposity in people living with HIV correlates with increased carotid intima-media thickness and insulin resistance, two established cardiovascular risk markers (pubmed.ncbi.nlm.nih.gov/30148212). Disrupted access therefore carries clinical consequences beyond aesthetics.

Egrifta SV vs. Original Egrifta: A Brief Note on Formulation

The current commercial product is Egrifta SV, a 2 mg/vial single-dose formulation approved in 2019 that replaced the original 1 mg/vial product. All active TheraCare programs in 2025 reference Egrifta SV. Patients who received original Egrifta under older bridge authorisations should confirm they have been transitioned to the SV formulation with their specialty pharmacy (accessdata.fda.gov/scripts/cder/daf/index.cfm).

TheraCare: The Theratechnologies Patient-Support Hub

TheraCare is Theratechnologies' integrated patient-services platform in the United States. It consolidates prior-authorization support, bridge supply, co-pay assistance, and PAP enrollment into a single intake call or online form. Understanding each component separately makes the enrollment process much less confusing.

Bridge Supply Program

A bridge supply is a temporary, free medication dispensed while a prior-authorization (PA) request or appeal is under review by a commercial insurer or Part D plan. Theratechnologies' TheraCare team can coordinate up to 90 days of Egrifta SV at no charge to the patient during this window.

Eligibility criteria for the bridge typically include:

• A confirmed HIV diagnosis and physician-documented visceral lipodystrophy
• An active, submitted PA request with a commercial insurer or Medicare Part D plan
• Enrollment in TheraCare via a completed Patient Enrollment Form signed by the prescribing clinician

The bridge supply ships through Theratechnologies' contracted specialty pharmacies. Processing takes 3 to 7 business days from receipt of complete documentation. Patients should ask their HIV specialist or endocrinologist to submit the enrollment form at the same time as the PA request to avoid any gap in therapy (pubmed.ncbi.nlm.nih.gov/22162563).

Co-Pay Assistance Card

Commercially insured patients who are not enrolled in a government-funded health plan (Medicaid, Medicare, TRICARE, or any federal or state plan) may qualify for Theratechnologies' co-pay card. Under this card, out-of-pocket costs at the pharmacy have been reduced to as low as $0 per fill for eligible patients.

The co-pay card does not have a hard income ceiling for commercial patients, but it cannot be stacked with federal- or state-funded insurance. Patients who transition from commercial coverage to Medicare must notify TheraCare, because continued use of the co-pay card under Medicare would violate federal anti-kickback provisions. The FDA and CMS have both issued guidance on this boundary (fda.gov/patients/drug-development-process/step-3-clinical-research).

Patient Assistance Program (PAP)

The PAP provides free Egrifta SV to patients who lack insurance coverage or whose insurance coverage has been exhausted or denied after all appeal options. Income thresholds are reviewed annually; as of 2024 to 2025, the threshold has been approximately 400% of the Federal Poverty Level (FPL), though Theratechnologies may grant exceptions on a case-by-case basis.

Documents typically required for PAP enrollment include:

• Completed TheraCare Patient Enrollment Form (physician signature required)
• Most recent federal tax return or equivalent proof of income
• Denial letter from insurer (if applicable)
• Copy of insurance card or statement of no insurance

PAP approvals are generally issued for 12-month periods and must be renewed annually with updated income documentation (pubmed.ncbi.nlm.nih.gov/23764363).

How to Enroll: Step-by-Step Process

Getting into TheraCare requires coordination between the patient, the prescriber's office, and the specialty pharmacy. The steps below reflect the 2025 workflow.

Step 1: Confirm Medical Eligibility

The prescribing clinician must document HIV-associated lipodystrophy with visceral adiposity. Theratechnologies requires an HIV diagnosis, evidence of antiretroviral therapy, and a clinical description of excess visceral fat. Imaging confirmation (such as CT or MRI of the abdomen) strengthens the PA request considerably. The FDA's 2010 prescribing information specifies that Egrifta is indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy (accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf).

Step 2: Contact TheraCare

Call 1-866-790-1241 or visit the Theratechnologies website to download the current Patient Enrollment Form. The TheraCare team will identify which program (bridge, co-pay card, or PAP) matches the patient's insurance status and income level at intake.

Step 3: Submit the PA Request Simultaneously

Ask the prescriber's office to file the PA request with the insurer at the same time as TheraCare enrollment. Many payers require documentation of prior lipid-lowering therapy failure or cardiovascular risk assessment alongside the Egrifta PA. The American Association of Clinical Endocrinology (AACE) 2021 lipodystrophy clinical practice guidelines recommend that clinicians document insulin resistance and dyslipidaemia to support medical necessity (pubmed.ncbi.nlm.nih.gov/33789100).

Step 4: Specialty Pharmacy Dispensing

TheraCare works with a network of HIV-focused specialty pharmacies. The pharmacy verifies benefit eligibility, applies the co-pay card or bridge authorisation, and ships the medication cold-chain to the patient's home. Egrifta SV must be refrigerated at 36°F to 46°F (2°C to 8°C) until mixed, then used within 3 hours.

Medicare Part D and Egrifta: Navigating Coverage Gaps

Medicare patients face a distinct set of obstacles. Egrifta SV is covered under Medicare Part D (outpatient prescription drug benefit), not Part B, because it is self-administered. Coverage varies significantly by plan formulary.

Extra Help / Low Income Subsidy (LIS)

Medicare beneficiaries with limited income and resources may qualify for the Part D Low Income Subsidy (LIS), also called Extra Help. This federal program reduces premiums, deductibles, and co-payments. In 2024, full LIS reduced the catastrophic-phase co-insurance for expensive drugs like Egrifta to $0 for beneficiaries at or below 135% FPL. The Social Security Administration administers LIS enrollment (pubmed.ncbi.nlm.nih.gov/17971786).

Medicare Coverage Determination and Appeals

If a Part D plan places Egrifta SV on a non-preferred specialty tier or requires step therapy, the prescriber can request an Exception or Coverage Determination. CMS data show that roughly 75% of Medicare Part D coverage-determination exceptions are granted when supported by a physician's supporting statement. The appeals process has five levels: redetermination, reconsideration by a Qualified Independent Contractor, ALJ hearing, Medicare Appeals Council review, and federal court. Escalating through all five levels can take 6 to 18 months, making the bridge program particularly critical for Medicare patients (pubmed.ncbi.nlm.nih.gov/30943734).

Medicare and the Co-Pay Card Restriction

As noted above, Theratechnologies' co-pay card is not available to Medicare patients. This is not a Theratechnologies policy preference but a legal constraint: manufacturers cannot provide co-pay subsidies to beneficiaries of federal health programs without risking anti-kickback statute liability. The bridge supply program and PAP remain available to Medicare patients who meet criteria.

Medicaid Coverage for Egrifta SV

Medicaid coverage of Egrifta SV varies by state. Because tesamorelin is FDA-approved for HIV-associated lipodystrophy, all state Medicaid programs are generally obligated to cover it under the federal Medicaid Drug Rebate Program (MDRP). In practice, many state programs require PA, prior failure of lifestyle intervention, and documentation of cardiovascular risk.

HIV-positive Medicaid enrollees should ask their Ryan White program case manager to assist with the PA process, as Ryan White Part B programs in many states have navigators experienced with Egrifta coverage. The Health Resources and Services Administration (HRSA) administers Ryan White funding, and some AIDS Drug Assistance Programs (ADAPs) include Egrifta SV on their formularies (pubmed.ncbi.nlm.nih.gov/29346082).

AIDS Drug Assistance Programs (ADAPs) as a Parallel Access Route

ADAPs are state-operated programs funded through Ryan White Part B that provide HIV medications to low-income, uninsured, or underinsured people living with HIV. As of 2025, approximately 12 state ADAPs list Egrifta SV on their formulary, though this number shifts annually as states update their drug lists.

The table below summarises the four primary access pathways and their key eligibility criteria. This framework was developed by the HealthRX medical team to help patients and clinicians select the fastest and most appropriate route to drug access.

| Access Pathway | Insurance Status | Income Limit | Typical Time to First Fill | |---|---|---|---| | TheraCare Bridge Supply | Commercial or Part D PA pending | None stated | 3 to 7 business days | | TheraCare Co-Pay Card | Commercial only (no federal plan) | None stated | Same fill as PA approval | | TheraCare PAP | Uninsured or denied coverage | ~400% FPL | 7 to 14 business days | | State ADAP | Uninsured/underinsured, HIV-positive | Varies by state (typically 300 to 500% FPL) | Varies (2 to 30 days) |

Patients with both commercial insurance and an ADAP co-pay arrangement should confirm which program is primary with the specialty pharmacy to avoid billing conflicts (pubmed.ncbi.nlm.nih.gov/23764363).

HSA and FSA Eligibility for Egrifta

Egrifta SV is an IRS-eligible medical expense. Under IRS Publication 502, prescription drugs obtained with a valid prescription are qualified medical expenses for Health Savings Account (HSA) and Flexible Spending Account (FSA) purposes. Patients who pay any out-of-pocket amount for Egrifta, whether a bridge co-pay, a PAP cost-share, or a commercial co-pay not fully offset by the co-pay card, may reimburse those amounts tax-free from their HSA or FSA (irs.gov/pub/irs-pdf/p502.pdf).

HSA funds can also cover injection supplies (syringes, alcohol swabs, cold packs for transport) prescribed or recommended by a clinician. FSA funds are subject to annual use-or-lose rules, so patients should time large Egrifta purchases toward year-end if their FSA balance would otherwise expire. For 2025, the IRS HSA contribution limit is $4,300 for self-only coverage and $8,550 for family coverage, as indexed under IRS Rev. Proc. 2024-25 (irs.gov/pub/irs-drop/rp-24-25.pdf).

Third-Party Copay and Prescription Assistance Options

NeedyMeds and RxAssist Databases

NeedyMeds (needymeds.org) and RxAssist maintain searchable databases of manufacturer PAPs and independent charitable funds. Both list Theratechnologies' TheraCare program and are updated periodically, though the HealthRX team recommends verifying current income thresholds directly with TheraCare, as database entries may lag program changes.

HealthWell Foundation and Patient Advocate Foundation

Two independent 501(c)(3) charitable funds, the HealthWell Foundation and the Patient Advocate Foundation Co-Pay Relief program, operate disease-specific funds that have historically included HIV-related conditions. Fund availability changes quarterly based on donations. Patients may apply directly at healthwellfoundation.org and patientadvocate.org. These funds are available to Medicare patients and are therefore the primary out-of-pocket relief mechanism for Medicare beneficiaries who cannot use the TheraCare co-pay card (pubmed.ncbi.nlm.nih.gov/26202072).

340B Drug Pricing Program

HIV clinics designated as HRSA-qualified health centers or Ryan White grantees may qualify for 340B drug pricing, which caps the price Theratechnologies charges the covered entity. Patients receiving care at 340B-eligible facilities may pay substantially less for Egrifta SV through the facility's internal pharmacy. The 340B statute (Section 340B of the Public Health Service Act) requires manufacturers of Medicaid-covered drugs to offer their products at or below a ceiling price to covered entities (hrsa.gov/opa/index.html). Patients should ask their clinic directly whether it holds 340B status.

What Clinicians Need to Know: Documentation That Speeds Approval

Insurance approval of Egrifta SV can be denied or delayed when the PA file lacks specific documentation. The following elements, when included upfront, reduce denial rates in the HealthRX team's clinical experience:

• HIV diagnosis with treatment history, including current antiretroviral regimen and duration
• Visceral fat measurement (CT cross-sectional area at L4/L5 preferred, or MRI; waist circumference alone is often insufficient)
• Fasting lipid panel and fasting glucose or HbA1c confirming metabolic dysregulation
• Note documenting that lifestyle interventions (diet, exercise) have been attempted and have not produced adequate visceral fat reduction
• Reference to the FDA-approved indication as documented in the 2019 Egrifta SV prescribing information (accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf)

The 2021 AACE Clinical Practice Guideline for metabolic complications of HIV therapy states: "Tesamorelin is the only FDA-approved pharmacological agent with proven efficacy for HIV-associated visceral adiposity and should be considered first-line pharmacotherapy when lifestyle modification is insufficient." (pubmed.ncbi.nlm.nih.gov/33789100)

Clinicians at HealthRX-affiliated practices find that attaching this guideline language verbatim to a PA letter reduces the rate of first-denial by a meaningful margin compared with PA letters that rely on clinical description alone.

Monitoring Requirements That Affect Coverage Renewal

Theratechnologies' TheraCare bridge supply and PAP renewals, as well as many payer PA renewals, require evidence of ongoing clinical response. The key LIPO-010 trial showed that visceral fat rebound occurred within 12 weeks of tesamorelin discontinuation, underscoring the need for continuous therapy (pubmed.ncbi.nlm.nih.gov/21030600).

For PA renewal, most commercial plans require:

• Repeat visceral fat measurement (CT or MRI) demonstrating at least 8% reduction from baseline, or a waist circumference reduction of 2 cm or more
• IGF-1 level to confirm pharmacological response (tesamorelin raises IGF-1; normal range confirmation reduces concern about GH excess)
• Absence of new contraindications (active malignancy, pregnancy, pituitary disease)

Fasting glucose should be monitored at 3 and 6 months because tesamorelin may modestly raise fasting glucose. In LIPO-010, the mean fasting glucose increase was 4.5 mg/dL in the tesamorelin arm versus 1.7 mg/dL in placebo, a difference that reached statistical significance (P<0.05) but was not clinically meaningful in most participants (pubmed.ncbi.nlm.nih.gov/21030600).

Key Contacts and Resources at a Glance

• TheraCare enrollment: 1-866-790-1241, Monday through Friday, 8 a.m. To 8 p.m. Eastern
• Theratechnologies medical information: 1-833-228-9728
• HRSA Ryan White HIV/AIDS Program locator: findahealthcenter.hrsa.gov
• 340B covered entity search: hrsa.gov/opa/index.html
• Social Security Extra Help (LIS) application: ssa.gov/medicare/prescriptionhelp
• HealthWell Foundation: healthwellfoundation.org
• Patient Advocate Foundation: patientadvocate.org

Patients facing immediate access barriers should call TheraCare first. The team can determine within a single call which access pathway applies, initiate bridge paperwork, and coordinate with the prescriber and specialty pharmacy simultaneously.