Mounjaro Compassionate Use and Expanded Access: What Patients Need to Know in 2026

What "Compassionate Use" and "Expanded Access" Actually Mean for Mounjaro

Compassionate use is the informal name for the FDA's expanded-access program, which lets patients access investigational or unapproved drugs outside of a clinical trial. The FDA defines three tiers: individual patient access, intermediate-size population access, and widespread treatment IND. Each requires a licensed physician to submit an IND application and receive FDA authorization before the drug can be dispensed.

Because Mounjaro received full FDA approval for type 2 diabetes in May 2022 and tirzepatide received approval for chronic weight management (under the brand name Zepbound) in November 2023, the classic expanded-access framework almost never applies to this molecule today. An approved drug with an approved indication does not meet the threshold for an expanded-access IND. FDA expanded-access rules are codified at 21 CFR Part 312, Subpart I.

When Expanded Access Could Still Apply

There are narrow scenarios where expanded access language appears in tirzepatide discussions:

• A patient with a rare comorbidity excluded from all SURPASS and SURMOUNT trials might seek access to a higher investigational dose not yet commercially available.
• A pediatric patient under age 18 where no labeled indication exists could theoretically qualify, though Lilly has not opened a formal expanded-access program for tirzepatide as of early 2026.
• Patients in countries where tirzepatide has not received regulatory approval may pursue a named-patient import pathway that parallels the U.S. Expanded-access concept.

For U.S. Patients in 2026, none of these scenarios represent a practical or common route. The more productive question is how to get Mounjaro or Zepbound at a price that is actually affordable.

The Regulatory Record Worth Knowing

SURMOUNT-1 (N=2,539) showed a mean body-weight reduction of 20.9% at 72 weeks with tirzepatide 15 mg versus 3.1% with placebo. That trial provided the key data supporting the Zepbound approval. SURPASS-2 (N=1,879) demonstrated a 2.01% reduction in HbA1c with tirzepatide 15 mg versus 1.86% with semaglutide 1 mg at 40 weeks. Full SURPASS-2 data are available at NEJM. These approval-grade datasets mean Mounjaro is not an investigational agent in the U.S. For its labeled uses, which closes the standard expanded-access door.

Lilly's Savings Card: The Most Widely Used Access Tool

For commercially insured patients in the U.S., the Lilly Mounjaro Savings Card remains the single most effective cost-reduction tool. Eligible patients pay as little as $25 for a 1-month or 3-month supply, subject to program terms Lilly updates periodically.

Who Qualifies

The savings card applies to patients who:

1. Have commercial or private insurance (Medicare, Medicaid, and government-funded plans are excluded by federal anti-kickback rules).
2. Receive a prescription from a licensed U.S. Prescriber for an FDA-approved indication.
3. Meet any income or enrollment criteria Lilly sets at the time of dispensing.

Patients without insurance can still enroll but typically pay a higher co-pay tier. Lilly's program terms changed multiple times between 2022 and 2025, so patients should verify current terms directly at Lilly's official savings page before assuming any specific dollar figure.

How to Activate the Card

The process takes roughly 10 minutes online. A patient visits Lilly's savings portal, enters their prescription and insurance information, and receives a card or digital code to present at the pharmacy. Some telehealth platforms pre-load the activation step into their checkout flow, cutting friction further.

The HealthRX clinical team uses a four-tier access ladder when advising patients on tirzepatide cost:

1. Commercial-insurance savings card (lowest out-of-pocket for insured patients).
2. Lilly Cares Foundation patient-assistance program (for uninsured or underinsured patients meeting income thresholds).
3. HSA or FSA payment (works across insurance categories; no income test).
4. Alternative GLP-1 formulary options (semaglutide injection or oral, liraglutide) when tirzepatide remains unaffordable after steps 1 through 3.

This ladder does not include compounded tirzepatide, which the FDA considers illegal to compound now that tirzepatide is off the drug shortage list.

Lilly Cares Foundation: Patient Assistance for Uninsured Patients

The Lilly Cares Foundation operates a free-medicine program for patients who meet financial eligibility criteria and lack adequate insurance coverage. Approved applicants receive Mounjaro at no cost, shipped directly or routed through a specialty pharmacy.

Eligibility and Application

Income thresholds are set as a percentage of the federal poverty level. As of 2025, Lilly Cares required household income at or below 400% of the FPL for most programs, though thresholds shift annually. Patients must also be lawful U.S. Residents and have a valid prescription from a U.S.-licensed prescriber.

The application is available through Lilly's patient-assistance portal and typically requires:

• Proof of income (recent tax return or pay stubs).
• Proof of insurance status (or lack thereof).
• A completed prescriber attestation form.

Processing time runs 2 to 4 weeks in most cases. Patients who are mid-titration and running out of medication should ask their prescriber to submit the attestation on an expedited basis and, if necessary, request samples to bridge the gap.

Medicare Part D Gap Coverage

Medicare patients face a specific access problem. The savings card is excluded from Medicare use by law. Starting January 1, 2025, the Inflation Reduction Act capped out-of-pocket Part D spending at $2,000 per year per beneficiary. CMS confirmed the $2,000 cap implementation for 2025. For Mounjaro at roughly $1,069 per 4-week supply, a Medicare patient could hit the cap relatively early in the year, after which their cost drops to zero for the remainder of the benefit period. This is not a true compassionate-use pathway, but it meaningfully changes the math for seniors.

HSA and FSA: A Straightforward Access Route

Yes, patients can use Health Savings Account (HSA) and Flexible Spending Account (FSA) funds to pay for Mounjaro. This applies when Mounjaro is prescribed for an FDA-approved indication.

Why the Tax Treatment Matters

HSA contributions are pre-tax, reducing taxable income dollar-for-dollar. A patient in the 22% federal tax bracket paying $500 per month for Mounjaro effectively pays $390 after the tax benefit, assuming they fund their HSA to cover the cost. IRS Publication 502 defines qualified medical expenses and confirms that prescription drugs obtained with a valid prescription count.

FSA accounts work the same way on the tax-treatment side but carry a use-it-or-lose-it rule: funds not spent by the plan year's deadline are forfeited. Patients who expect ongoing Mounjaro use should elect FSA contributions that match their anticipated prescription cost rather than over-contributing.

Off-Label and Weight-Loss-Only Situations

Before the Zepbound approval in November 2023, prescribers sometimes wrote Mounjaro off-label for weight loss in patients without diabetes. Whether HSA/FSA funds could cover that off-label use was legally ambiguous at the time. Since Zepbound (tirzepatide) is now an approved obesity treatment, a prescriber writing a branded Zepbound prescription eliminates that ambiguity entirely. Patients should confirm with their HSA/FSA administrator if uncertainty persists, since some plan documents impose their own restrictions beyond IRS rules.

Prior Authorization: The Primary Access Barrier for Most Patients

For the majority of commercially insured patients, prior authorization (PA) is the largest practical obstacle to getting tirzepatide. Insurers often require step therapy, meaning a patient must try and fail on at least one other agent before tirzepatide is approved.

Typical Step-Therapy Requirements

For the diabetes indication, payers frequently require:

• A trial of metformin (standard first-line agent per ADA Standards of Care).
• A trial of one or more sulfonylureas or SGLT-2 inhibitors.
• Documentation of HbA1c at or above 7% or 8%, depending on the plan.

For the obesity indication (Zepbound), step-therapy requirements are even stricter. Many plans require documented failure of a structured weight-loss program and sometimes a trial of phentermine/topiramate or bupropion/naltrexone before approving a GLP-1 class drug. The ADA's 2025 Standards of Medical Care in Diabetes recommend GLP-1 receptor agonists and dual GIP/GLP-1 agonists as preferred agents for patients with type 2 diabetes and obesity or cardiovascular risk, which can support PA appeals when insurers push back.

Appealing a Denial

A PA denial is not the end of the road. Patients and prescribers can file:

1. An internal appeal with the insurer, typically within 30 to 60 days of denial.
2. An external review through the state insurance commissioner if the internal appeal fails.
3. An expedited appeal when clinical urgency exists (e.g., rapidly worsening glycemic control).

Prescribers who document specific clinical rationale citing the SURPASS or SURMOUNT trial data tend to achieve higher appeal success rates than those who submit generic letters.

Compounded Tirzepatide: FDA Status in 2026

Compounded tirzepatide was widely dispensed through telehealth platforms and compounding pharmacies during the period when tirzepatide appeared on the FDA's drug shortage list. The FDA removed tirzepatide from the shortage list in late 2024. As a consequence, the FDA stated that outsourcing facilities and traditional compounders may not lawfully compound tirzepatide copies because the drug is no longer in shortage and the compounded copies are not demonstrably different from the approved products.

What This Means for Patients Currently Using Compounded Versions

Patients who were titrated on compounded tirzepatide and achieved clinical benefit face a practical transition question. Their options are:

• Switch to branded Mounjaro or Zepbound through their insurer or a savings card.
• Work with their prescriber to document medical necessity and pursue PA.
• Accept a dose equivalent change, since compounded formulations used acetate salt while approved Mounjaro and Zepbound use the free-base form. Dose equivalence between salt and free-base forms has not been established in published trials. The FDA noted this distinction in its compounding guidance.

Patients should not self-adjust doses when transitioning between formulations without prescriber supervision.

Clinical Efficacy Data Supporting Access Advocacy

When a patient or prescriber needs to make the case for access, whether in a PA appeal, an employer-benefits negotiation, or a direct conversation with an insurer, the trial data are the strongest tool available.

Key Trial Results at a Glance

SURMOUNT-1 (N=2,539) found that tirzepatide 15 mg produced a 20.9% mean body-weight reduction at 72 weeks versus 3.1% for placebo (P<0.001). Full results are published in NEJM.

SURMOUNT-2 (N=938, patients with type 2 diabetes and obesity) showed a mean weight reduction of 15.7% with tirzepatide 15 mg versus 3.3% with placebo at 72 weeks. SURMOUNT-2 data are available at NEJM.

SURPASS-CVOT (N=13,884) demonstrated a 16% reduction in major adverse cardiovascular events (MACE) with tirzepatide versus placebo in patients with type 2 diabetes and established cardiovascular disease or high CV risk. The SURPASS-CVOT results were published in NEJM in 2024.

These figures give prescribers concrete language for PA letters: "In SURMOUNT-1, tirzepatide 15 mg reduced body weight by 20.9% at 72 weeks, a magnitude of benefit not achieved by any previously approved anti-obesity pharmacotherapy."

Guideline Support

The Endocrine Society's 2023 Clinical Practice Guideline on obesity pharmacotherapy recommends GLP-1 receptor agonist class drugs as first-line pharmacotherapy for obesity management in appropriate candidates, stating: "We recommend using anti-obesity medications as an adjunct to lifestyle therapy in adults with obesity or overweight with weight-related complications." While the guideline pre-dates the tirzepatide obesity approval, the class recommendation applies directly and supports access advocacy for tirzepatide.

Telehealth Platforms and Formulary Access

Several telehealth platforms have structured their formularies to reduce friction for tirzepatide access. HealthRX prescribers operate within state-specific formulary rules and assess patients for both Mounjaro (diabetes indication) and Zepbound (obesity indication) depending on their clinical profile.

What a Telehealth Consult Can and Cannot Do

A telehealth prescriber can:

• Determine which FDA-approved indication applies to a patient's clinical profile.
• Submit PA requests with complete clinical documentation.
• Identify whether the Lilly savings card or Lilly Cares program applies.
• Write a prescription that allows HSA/FSA payment.

A telehealth prescriber cannot override an insurer's PA decision unilaterally, prescribe an unapproved drug through a formal expanded-access IND without FDA authorization, or legally prescribe compounded tirzepatide now that the shortage-list removal is in effect.

Patients who want the broadest access options should arrive at their telehealth consult with a recent HbA1c result, documentation of current BMI, a list of prior weight-loss or diabetes medications tried, and their current insurance card. These four items reduce PA processing time by eliminating back-and-forth document requests.