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

What "Compassionate Use" Actually Means for an Approved Drug Like Trulicity

Compassionate use, also called expanded access, is an FDA pathway that lets patients outside a clinical trial access an investigational drug. The FDA defines it under 21 CFR Part 312, Subpart I, and it applies specifically to unapproved therapies or unapproved new indications being studied in trials. Trulicity received full FDA approval for type 2 diabetes in September 2014, and its cardiovascular indication was added in 2020 following the REWIND trial. Because the drug is already on the market, the traditional compassionate use IND structure does not apply.

When Expanded Access Is Relevant for Dulaglutide

There is one scenario where expanded access language still matters: off-label investigational use. Researchers are studying dulaglutide in non-alcoholic steatohepatitis (NASH), Parkinson's disease, and obesity outside its labeled indications. Patients enrolled in those trials gain access through standard IND protocols, not a Lilly-specific compassionate use program. The FDA's expanded access database is the correct place to search for any open individual patient or intermediate-size population protocols for dulaglutide.

What Patients Are Usually Looking For

Most patients who search "Trulicity compassionate use" are not seeking an investigational pathway. They need help paying for a drug their insurer denied or that costs more than they can manage. The rest of this article addresses those real-world access barriers directly.

The Clinical Case for Accessing Trulicity: Why Cost Barriers Matter

Understanding the clinical stakes helps explain why access programs exist at all.

REWIND Trial: Cardiovascular Outcomes

The REWIND trial (N=9,901, median follow-up 5.4 years) compared dulaglutide 1.5 mg weekly against placebo in adults with type 2 diabetes who had established cardiovascular disease or multiple risk factors. Dulaglutide reduced major adverse cardiovascular events (MACE) by 12% relative to placebo (HR 0.88, 95% CI 0.79 to 0.99, P<0.026). Non-fatal stroke was reduced by 24% (HR 0.76). Losing access to the drug carries real cardiovascular risk for patients in that population.

Glycemic Efficacy

The AWARD program established dulaglutide's glucose-lowering profile. AWARD-5 (N=1,098, 104 weeks) showed dulaglutide 1.5 mg reduced HbA1c by a mean of 0.99 percentage points more than sitagliptin 100 mg. A 2014 Lancet paper on AWARD-5 reported 52-week HbA1c reductions of 1.10% for dulaglutide 1.5 mg vs. 0.39% for sitagliptin. For patients who have tried and failed metformin, sulfonylureas, or DPP-4 inhibitors, dulaglutide may be the next appropriate step per the 2024 ADA Standards of Care, making affordable access a clinical priority rather than a convenience.

ADA Guideline Positioning

The 2024 American Diabetes Association Standards of Medical Care in Diabetes recommends GLP-1 receptor agonists as preferred add-on therapy for patients with type 2 diabetes and established atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease, independent of HbA1c. When a guideline-recommended drug is unaffordable, it represents a health equity problem, not just a financial one.

Lilly's Official Patient Assistance and Savings Programs

Eli Lilly runs several programs. Eligibility criteria and dollar amounts shift every year, so the figures below reflect the most recently published terms as of early 2026. Always verify current terms directly with Lilly before counseling patients.

Lilly Cares Foundation Patient Assistance Program (PAP)

The Lilly Cares Foundation provides free Trulicity to qualifying patients. The foundation's stated eligibility standard requires that applicants:

• Have no prescription drug coverage for Trulicity, or have exhausted coverage
• Meet income guidelines (generally at or below 400% of the federal poverty level, which was $58,320 for a single person in 2025)
• Be a U.S. Resident and have a valid prescription from a licensed U.S. Prescriber

Applications go through the prescribing physician's office or directly through LillyCares.com. Processing time is typically 2 to 4 weeks after a complete application is received. Drug is shipped directly to the prescriber or, in some cases, to the patient depending on state law.

Lilly Savings Card (Commercial Insurance)

For commercially insured patients who meet eligibility requirements, Lilly's savings card program can reduce out-of-pocket cost to as low as $35 per month. This program excludes Medicare, Medicaid, and other federal health programs. Income thresholds for the savings card program are separate from, and generally less restrictive than, the PAP thresholds. Patients can enroll at Lilly's brand website or through their pharmacist at point of sale.

Insulin Value Program (Broader Lilly Umbrella)

Although named for insulin, Lilly's $35 out-of-pocket cap initiative for select products has been expanded over time. Patients should confirm directly with Lilly whether Trulicity falls under any capped-cost program in their state, as state-level agreements vary.

Insurance and Prior Authorization Pathways

Prior authorization (PA) is the most common barrier to Trulicity access in insured patients. Navigating it correctly can save months of delay.

Why Insurers Require Prior Authorization for GLP-1 Drugs

Most commercial plans and Medicare Part D plans require PA for GLP-1 receptor agonists because of their high list price. Common PA criteria include:

• Confirmed type 2 diabetes diagnosis (HbA1c typically >7.0% or >7.5% depending on the plan)
• Documented trial and failure of metformin at an adequate dose (usually 1,000 to 2,000 mg/day for at least 90 days)
• Body mass index (BMI) criteria vary; some plans use BMI <27 as an exclusion unless a cardiovascular indication is documented
• Step therapy requirements may mandate a trial of a sulfonylurea or DPP-4 inhibitor first

How to Appeal a Denial

If a PA is denied, the prescriber can file a Level 1 appeal, then a Level 2 appeal, and ultimately an independent external review under the Affordable Care Act for non-grandfathered plans. The CMS guidance on internal appeals and external review outlines timelines: insurers must respond to urgent PA appeals within 72 hours and standard appeals within 30 days.

A peer-to-peer call between the prescriber and the insurer's medical director is often the most efficient tool. The prescriber should reference the REWIND cardiovascular outcome data and the ADA 2024 guideline language to support medical necessity, especially for patients with established ASCVD.

Step Therapy Override Laws

As of 2025, 34 U.S. States have enacted step therapy override legislation that allows prescribers to bypass insurer step therapy requirements when a patient has already tried and failed the preferred drug, or when the preferred drug is contraindicated. The ADA has published a summary of these state protections. Prescribers should confirm their state's specific statute when filing an override request.

HSA, FSA, and HRA Coverage for Trulicity

Trulicity is prescription-only. Prescription medications are qualified medical expenses under IRS Publication 502, which governs HSA and FSA spending. The IRS definition of qualified medical expenses explicitly includes insulin and other prescription drugs used to treat a diagnosed medical condition.

Using an HSA

A health savings account (HSA) requires enrollment in a high-deductible health plan (HDHP). For 2026, the IRS minimum deductible for an HDHP is $1,650 for self-only coverage and $3,300 for family coverage. Once the deductible is met, HSA funds can pay for Trulicity at any network or out-of-network pharmacy. Funds roll over year to year, making the HSA useful for high-cost prescriptions.

Using an FSA

A flexible spending account (FSA) does not require an HDHP. The 2026 FSA contribution limit is $3,300 per employee per year (pending IRS confirmation). Trulicity prescriptions are FSA-eligible at point of sale using the FSA debit card or through reimbursement submission with a receipt. Note that most FSA funds have a use-it-or-lose-it rule at plan year end, though a grace period of 2.5 months or a $640 rollover may apply depending on the employer plan.

Using an HRA

A health reimbursement arrangement (HRA), funded solely by the employer, can also reimburse Trulicity costs if the employer's plan document includes prescription drugs as eligible expenses. Individual coverage HRAs (ICHRAs) introduced under the 2019 HHS rule allow employers to reimburse individual insurance premiums and qualified medical expenses. CMS published the ICHRA final rule in June 2019. Employees should review their Summary Plan Description to confirm Trulicity is covered.

Third-Party and State-Level Discount Options

Manufacturer-Independent Discount Programs

Pharmacy benefit discount programs like GoodRx, RxSaver, and NeedyMeds list coupon prices for Trulicity. Prices through these programs vary significantly by pharmacy and location. As of late 2025, GoodRx listed discounted cash prices in the range of $680, $760 per 4-pen carton for the 1.5 mg dose at major chains, compared to a list price near $990. These discounts cannot be combined with insurance; patients must choose one or the other at point of sale.

State Pharmaceutical Assistance Programs (SPAPs)

More than 20 states operate SPAPs that help low-income seniors and people with disabilities pay for prescription drugs. Programs like Illinois' Pharmaceutical Assistance Program (Illinois Circuit Breaker), Pennsylvania's PACE/PACENET, and New Jersey's PAAD each have their own income thresholds and covered drug lists. The Medicare Rights Center maintains a state-by-state SPAP directory. Trulicity is included in some state formularies and excluded from others; a pharmacist or social worker can confirm quickly.

340B Drug Pricing Program

Federally qualified health centers (FQHCs), rural health clinics, and certain hospital outpatient departments that participate in the 340B program can purchase Trulicity at a legally mandated discount of roughly 25 to 50% off the list price. Patients who receive care at a 340B-covered entity may see substantially lower pharmacy costs without any separate enrollment. HRSA administers the 340B program and maintains a public database of covered entities.

Telehealth Access and the HealthRX Pathway

The HealthRX clinical team has developed a five-step access triage framework for patients who contact us about GLP-1 affordability. The steps run in parallel, not sequentially, to minimize time to first dose:

1. Insurance verification and PA submission on Day 1. The prescriber submits the PA with REWIND and ADA 2024 guideline documentation attached.
2. Lilly savings card or PAP enrollment on Day 1. A care coordinator completes enrollment while the PA is pending, so the backup pathway is ready if the PA is denied.
3. 340B entity check on Day 2. If the patient has access to a federally qualified health center within reasonable distance, the care coordinator flags it.
4. SPAP screening on Day 3. The care coordinator checks the patient's state SPAP eligibility using income and age data already collected during enrollment.
5. HSA/FSA counseling at the first prescription visit. The prescriber or care coordinator confirms whether the patient's health plan supports an HSA or FSA and that Trulicity qualifies.

This framework typically resolves access within 7 to 14 days for commercially insured patients. Uninsured patients using the Lilly Cares PAP may wait 2 to 4 weeks for the first shipment.

Alternatives When Trulicity Remains Unaffordable

If all access programs fail or have processing delays, the prescriber should consider whether a formulary-preferred GLP-1 or comparable agent is available. Semaglutide (Ozempic, weekly injection) is on formulary for many commercial plans and carries its own savings programs. The SUSTAIN-6 trial (N=3,297, 104 weeks) showed semaglutide 0.5 mg and 1.0 mg reduced MACE by 26% (HR 0.74, P<0.001), a similar cardiovascular magnitude to REWIND. Switching to a formulary-preferred agent is sometimes faster than appealing a PA denial for Trulicity.

For patients with type 2 diabetes and heart failure with reduced ejection fraction, empagliflozin (Jardiance) is also guideline-supported and may be available at lower cost through generic competition or plan formulary positioning.

The prescriber's goal is continuous, guideline-concordant therapy. A short bridge on a formulary-preferred alternative beats a 60-day coverage gap while a PA appeal is processed.

Documentation Your Prescriber Needs to Support Access

Getting the PA or PAP approved faster depends on complete, specific documentation. Prescribers should have the following ready:

• Most recent HbA1c result with the date (within 90 days is ideal for most payers)
• List of prior diabetes medications with start and stop dates and reason for discontinuation
• Cardiovascular risk documentation: confirmed ASCVD diagnosis, 10-year ASCVD risk score, or presence of heart failure or CKD stage 3+
• Most recent eGFR and urine albumin-to-creatinine ratio (UACR) if renal protection is part of the justification
• Body weight and BMI if the prescriber is also using dulaglutide for weight management in a comorbid context
• The ADA 2024 Standards of Care section 9 (Pharmacologic Approaches to Glycemic Treatment) citation as a written reference in the PA letter

Specificity matters. Payers are more likely to approve a PA letter that states "patient tried metformin 2,000 mg/day for 6 months (January, June 2025) with HbA1c remaining at 9.1%, discontinued due to GI intolerance" than one that says "failed metformin."

Monitoring After Access Is Secured

Once a patient is on dulaglutide, the ADA 2024 Standards recommend checking HbA1c every 3 months until at goal, then every 6 months. Renal function (eGFR, UACR) should be rechecked at 3 months after any medication change and annually thereafter. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) are contraindicated for all GLP-1 receptor agonists, including dulaglutide, per the FDA prescribing information for Trulicity.

Gastrointestinal side effects (nausea, vomiting, diarrhea) are most common during the first 4 to 8 weeks, particularly during dose escalation from 0.75 mg to 1.5 mg. Patients who experience persistent nausea should contact their prescriber before discontinuing. Many GI side effects resolve by week 8 without a dose change.

The recommended starting dose for most adults is dulaglutide 0.75 mg once weekly. The dose may be increased to 1.5 mg after 4 weeks. Further escalation to 3.0 mg or 4.5 mg can occur at 4-week intervals for additional glycemic control. The 4.5 mg dose showed a mean HbA1c reduction of 1.87% in the AWARD-11 trial (N=1,842, 36 weeks) compared to 1.21% for the 1.5 mg dose, per Dungan et al. In The Lancet Diabetes and Endocrinology (2020).