Jardiance Compassionate Use and Expanded Access: How to Get Empagliflozin If You Can't Afford It or Don't Qualify for Standard Prescribing

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

Compassionate use is a formal FDA pathway, governed under 21 CFR Part 312, Subpart I, that lets patients access an investigational drug outside of a clinical trial when no comparable therapy exists. The term is often misapplied to approved drugs. Jardiance received its first FDA approval in August 2014 for type 2 diabetes, a heart failure indication in 2021, and a chronic kidney disease indication in 2023, so it is not an investigational agent. [1]

Because empagliflozin is commercially available for three distinct indications, Boehringer Ingelheim has no reason to maintain an open IND-based expanded-access program. If a patient's condition falls outside the labeled indications, for example, type 1 diabetes or non-alcoholic steatohepatitis, a prescriber could still write an off-label prescription, but that is distinct from FDA-regulated compassionate use.

When a True Expanded-Access Request Might Still Apply

Off-label use covers the practical majority of situations. A genuine expanded-access petition to the FDA is warranted only when empagliflozin is under active investigation for a condition and no other approved or commercially available agent addresses the patient's need. Physicians who believe this threshold is met can submit an emergency IND request to FDA's Office of Oncology Products or the relevant review division. The FDA grants single-patient emergency INDs in as few as one business day in life-threatening situations. [2]

Off-Label Use Is Not the Same as Expanded Access

Off-label prescribing carries no special regulatory filing requirement. Physicians routinely prescribe empagliflozin off-label for conditions such as type 1 diabetes with an endocrinologist's oversight, obesity-associated cardiometabolic risk, or polycystic kidney disease. The clinical evidence for some of these uses is growing: the EMPA-KIDNEY trial (N=6,609) showed empagliflozin reduced the risk of kidney disease progression or cardiovascular death by 28% (hazard ratio 0.72, 95% CI 0.64 to 0.82, P<0.001) in patients whose eGFR ranged as low as 20 mL/min/1.73 m², a population well below earlier labeled thresholds. [3]

The Real Access Problem: Cost

The list price of Jardiance sits near $650 per month at major pharmacy chains in 2026. For uninsured adults or those in the Medicare Part D coverage gap, that price is prohibitive. SGLT2 inhibitors are now endorsed by Class I / Level A recommendations in the 2023 AHA/ACC Heart Failure Guidelines for patients with HFrEF regardless of diabetes status, which means access failures translate directly into preventable hospitalizations. [4]

Why There Is No Generic Yet

Boehringer Ingelheim's U.S. Patent on empagliflozin runs through late 2025 on the compound patent, but secondary formulation and method-of-use patents extend market exclusivity into 2026 and potentially beyond. The FDA's Orange Book listed no approved abbreviated new drug applications (ANDAs) for empagliflozin as of the date of this article's review. Generic entry timing depends on patent litigation outcomes; analysts estimate first generics could reach pharmacy shelves in late 2026 at the earliest, though litigation delays are common. [5]

Price Benchmarking Across Purchase Channels

| Purchase Route | Estimated Monthly Cost (10 mg, 30 tabs) | |---|---| | Cash price at major retail chain | $620, $680 | | GoodRx / discount coupon (varies by ZIP) | $400, $520 | | Mark Cuban Cost Plus Drugs | Not available as of 2026 | | Canadian online pharmacy (personal import) | $90, $140 (legal gray area, see below) | | With BI/Lilly $10 copay card | $10 (commercially insured only) | | Medicare Part D (benchmark plan, gap phase) | $180, $260 (before Extra Help) |

Personal importation of prescription drugs from Canada for personal use is technically prohibited under the Federal Food, Drug, and Cosmetic Act, though FDA enforcement discretion has historically tolerated small quantities. The FDA's own guidance document notes that it "may use enforcement discretion" for personal importation when the drug is not available domestically and poses no undue risk, but empagliflozin does not meet those criteria because it is domestically available. [6] Patients who pursue this route do so at their own legal and clinical risk.

Boehringer Ingelheim's "Together in Health" Patient Assistance Program

Boehringer Ingelheim operates a patient assistance program under the brand name "Together in Health" that can provide Jardiance at no cost to qualifying patients. This is the closest functional analog to compassionate use for patients who cannot afford the drug.

Eligibility Criteria (2026)

• U.S. Resident with a valid prescription from a licensed U.S. Prescriber
• No active prescription drug coverage, or coverage that does not include Jardiance
• Annual household income at or below 400% of the federal poverty level (approximately $60,240 for a single person in 2026, based on HHS poverty guidelines [7])
• Some cases above 400% FPL may qualify on a case-by-case basis with documented financial hardship

How to Apply

Applications are submitted through the Together in Health portal at togetherinhealth.com or by calling 1-800-556-8317. The prescriber must complete a section of the form. Processing typically takes 2 to 4 weeks; a 30-day emergency supply bridge may be available while the application is reviewed. Documents required include proof of income (most recent federal tax return or two recent pay stubs), proof of residency, and the prescriber's NPI number.

What the Program Covers

Approved patients receive a 90-day supply of Jardiance at no charge, renewable quarterly as long as eligibility criteria are maintained. The drug ships directly to the patient's home or, in some cases, to the prescriber's office.

The HealthRX access team has developed a stepwise decision framework for patients and prescribers navigating Jardiance cost barriers:

1. Commercially insured: Apply for the $10/month Jardiance copay savings card at jardiance.com/savings before filling the first prescription.
2. Uninsured, income <400% FPL: Apply to Together in Health PAP directly; bridge supply available.
3. Medicare/Medicaid: Copay card is ineligible. Apply for Extra Help (Low Income Subsidy) through SSA.gov; benchmark Part D plans in your ZIP code using Medicare.gov Plan Finder.
4. Commercially insured with high deductible: Use HSA or FSA funds; Jardiance qualifies under IRS Pub. 502 as a prescribed medicine.
5. Income >400% FPL, uninsured: Request NeedyMeds or RxAssist database search for state-specific programs; consider GoodRx discount at pharmacy until PAP decision is made.
6. Off-label indication, no coverage: Prescriber must document medical necessity for prior authorization appeal; cite EMPA-KIDNEY or EMPEROR trial data as applicable.

The $10 Copay Card: Who Qualifies and How It Works

Boehringer Ingelheim and Eli Lilly jointly market Jardiance and jointly administer the Jardiance Savings Card. Eligible patients pay as little as $10 per monthly fill, with a maximum savings cap that the manufacturer adjusts annually.

Who Is Ineligible

Federal law prohibits using manufacturer copay assistance with any federal health insurance program. Patients covered by Medicare Part A or B, Medicare Part D, Medicaid, TRICARE, Veterans Affairs benefits, or any other federally funded program cannot use the copay card legally. Using it anyway constitutes a federal Anti-Kickback Statute violation and exposes both the patient and pharmacy to liability. [8]

Practical Mechanics

The savings card is enrolled online at jardiance.com/savings or by phone. The card is presented at the pharmacy at the time of dispensing. Most major chains (CVS, Walgreens, Rite Aid, Walmart, Kroger) accept it. Some narrow-network employer plans designate specialty pharmacies; confirm with your plan before filling.

Medicare Part D and the Low Income Subsidy

Medicare patients hit by the coverage gap (historically called the "donut hole") face out-of-pocket costs even after the Inflation Reduction Act's 2025 cap of $2,000 on annual Part D out-of-pocket spending. [9] Patients who reach that cap pay $0 for covered drugs for the rest of the calendar year, which substantially changes the calculus for Jardiance affordability in the second half of the year.

Extra Help (Low Income Subsidy)

The Social Security Administration's Extra Help program reduces Part D premiums, deductibles, and copayments for beneficiaries with limited income and resources. In 2026, a single person with income below approximately $22,590 and resources below $16,660 qualifies for full Extra Help. Jardiance is covered on most Part D formularies at Tier 3 or Tier 4; with full Extra Help, the copay drops to a nominal $3.95, $9.85 per fill. Apply at ssa.gov/extrahelp or call 1-800-772-1213.

HSA and FSA Eligibility for Jardiance

Yes, Jardiance is HSA and FSA eligible. Under IRS Publication 502, prescription medications qualify as medical expenses for purposes of health savings accounts and flexible spending accounts, provided the drug is prescribed by a licensed healthcare provider. [10] There is no special approval process required at the pharmacy counter. Present your HSA debit card or FSA card as payment, and keep the receipt showing the prescription number for your records in case of IRS audit.

Contribution Limits and Planning

In 2026, HSA contribution limits are $4,300 for self-only coverage and $8,550 for family coverage under a high-deductible health plan. A patient paying the GoodRx cash price of approximately $480/month for Jardiance would exhaust a self-only HSA in roughly nine months, so HSA use is best reserved for patients who also have an employer contribution or who are using the account strategically alongside other qualifying expenses.

FSA funds are "use it or lose it" within the plan year (with a grace period or $640 rollover allowed by some employers in 2026). Pre-loading an FSA with Jardiance costs in mind at open enrollment avoids mid-year cash-flow problems.

Clinical Background: Why Access Matters

Jardiance's cost barriers translate to real cardiovascular and renal outcomes. The EMPA-REG OUTCOME trial (N=7,020 patients with type 2 diabetes and established cardiovascular disease) demonstrated that empagliflozin 10 mg or 25 mg reduced the primary composite outcome of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke by 14% vs. Placebo (HR 0.86, 95% CI 0.74 to 0.99, P<0.001 for non-inferiority, P=0.04 for superiority). [11] Cardiovascular death specifically was reduced by 38%.

Heart Failure Evidence

The EMPEROR-Reduced trial (N=3,730) showed empagliflozin reduced the composite of cardiovascular death or hospitalization for heart failure by 25% (HR 0.75, 95% CI 0.65 to 0.87, P<0.001) in patients with HFrEF. [12] EMPEROR-Preserved (N=5,988) extended these findings to HFpEF, reducing the same composite endpoint by 21% (HR 0.79, 95% CI 0.69 to 0.90, P<0.001). [13]

Kidney Disease Evidence

The EMPA-KIDNEY trial enrolled 6,609 patients, including those with non-diabetic CKD and eGFR as low as 20, and was stopped early at a median follow-up of 2.0 years because of clear efficacy. Empagliflozin reduced the risk of kidney disease progression or cardiovascular death by 28% (HR 0.72, P<0.001). [3] The FDA approved the CKD indication based substantially on this data.

The American Diabetes Association's 2024 Standards of Care state: "For patients with type 2 diabetes and CKD, use of an SGLT2 inhibitor in patients with eGFR ≥20 mL/min/1.73 m² is recommended to reduce the risk of CKD progression and cardiovascular events." [14] A patient unable to afford Jardiance and not meeting criteria for alternatives such as dapagliflozin (which has similar indications) may genuinely be at risk for outcomes that the drug would prevent.

Prior Authorization Appeals and Step Therapy Exceptions

Many commercial insurers require prior authorization for Jardiance or mandate step therapy (trying metformin and/or a sulfonylurea first). Step therapy requirements can sometimes be waived.

Building a PA Appeal

A prior authorization appeal should include:

• The patient's current HbA1c, eGFR, and UACR values
• Documentation of contraindications to required step-therapy agents (e.g., metformin contraindicated at eGFR <30)
• Reference to the AHA/ACC 2022 Guideline on Cardiovascular Disease Management for patients with Class I recommendations for SGLT2 inhibitors [4]
• A letter of medical necessity from the prescriber citing specific trial data

Most states now have step therapy exception laws requiring insurers to grant exceptions within 72 hours for urgent cases. The National Alliance of Mental Illness (NAMI) and the American Heart Association have published summaries of state-level protections. [15]

The Role of the Prescriber

Prescribers carry most of the administrative burden in PA appeals. HealthRX clinicians can prepare a structured letter of medical necessity on behalf of patients, citing EMPA-KIDNEY, EMPEROR-Reduced, or EMPEROR-Preserved data as relevant to the patient's specific indication.

Comparing Jardiance Access to Other SGLT2 Inhibitors

If Jardiance access is blocked by cost or formulary position, two other SGLT2 inhibitors with overlapping indications deserve consideration.

| Drug | Brand | Key Approved Indications | PAP Available | Generic Available | |---|---|---|---|---| | Empagliflozin | Jardiance | T2DM, HF (HFrEF + HFpEF), CKD | Yes (Together in Health) | No (2026) | | Dapagliflozin | Farxiga | T2DM, HFrEF, HFpEF, CKD | Yes (AZ&ME) | No (2026) | | Canagliflozin | Invokana | T2DM, CKD | Yes (J&J CarePath) | No (2026) |

The head-to-head SGLT2 inhibitor trial data are limited; no large randomized trial has directly compared empagliflozin to dapagliflozin for cardiovascular or renal endpoints. Class-effect assumptions are reasonable for most indications, but prescribers should note that canagliflozin's CKD indication in CREDENCE (N=4,401) was limited to eGFR 30 to 90, whereas EMPA-KIDNEY extended coverage to eGFR as low as 20. [16]

Practical Steps Checklist for Patients and Caregivers

1. Confirm your indication is FDA-approved or that your prescriber has documented medical necessity for off-label use.
2. Check your insurance formulary tier and prior authorization requirements before the first fill.
3. If commercially insured: enroll in the Jardiance Savings Card at jardiance.com/savings.
4. If uninsured or income <400% FPL: apply to Together in Health at togetherinhealth.com or 1-800-556-8317.
5. If on Medicare: apply for Extra Help at ssa.gov/extrahelp and compare Part D plans during open enrollment.
6. If paying out of pocket: compare GoodRx prices across pharmacies in your ZIP code; prices vary by up to $120 for the same supply.
7. Use HSA or FSA funds if available, no special steps needed beyond presenting the payment card.
8. If prior authorization is denied: request a peer-to-peer review between your prescriber and the insurer's medical director within 5 business days.
9. If all options fail: ask your prescriber to contact the Boehringer Ingelheim Medical Information line (1-800-542-6257) for case-by-case assistance.