Does Affinity Health Plan Cover Jardiance?

What Jardiance Is and Why Coverage Decisions Matter

Jardiance is the brand name for empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor manufactured by Boehringer Ingelheim and Eli Lilly. The FDA first approved it in August 2014 for glycemic control in adults with type 2 diabetes [1]. Since then, the agency has added two more indications: reducing cardiovascular death risk in adults with type 2 diabetes and established cardiovascular disease, and treating heart failure with reduced ejection fraction (HFrEF) regardless of diabetes status [2].

These expanded indications changed how payers think about Jardiance. It is no longer filed only under diabetes drugs. Insurers now evaluate it against cardiology and nephrology formularies as well, which affects how Affinity Health Plan places it on its drug lists.

How SGLT2 Inhibitors Work

Empagliflozin blocks SGLT2 receptors in the proximal renal tubule, causing the kidneys to excrete roughly 70 grams of glucose per day in the urine rather than reabsorbing it [3]. This lowers blood glucose independent of insulin secretion, which reduces hypoglycemia risk compared to sulfonylureas. The glucose loss also produces a mild osmotic diuresis that lowers blood pressure and reduces cardiac preload, contributing to the cardiovascular and renal benefits seen in trials.

FDA-Approved Indications That Drive Coverage Eligibility

Affinity Health Plan, like most insurers, ties prior authorization criteria to FDA-labeled indications. Your diagnosis code on the prescription matters significantly. The three main indications the FDA has approved are:

• Type 2 diabetes mellitus (adults), to improve glycemic control
• Cardiovascular risk reduction in adults with type 2 diabetes and established atherosclerotic cardiovascular disease [2]
• Heart failure with reduced ejection fraction (ejection fraction <45%), with or without diabetes [4]

The FDA also approved empagliflozin for chronic kidney disease (CKD) under the brand Jardiance in 2023, based on the EMPA-KIDNEY trial [5]. If your chart carries a CKD diagnosis code, your prescriber should note that indication explicitly on the prior authorization form, as it may open a different coverage pathway.

Affinity Health Plan Formulary Structure

Affinity Health Plan is a not-for-profit managed care organization primarily serving New York Medicaid, Child Health Plus, and Essential Plan members, with some commercial products. Because Affinity operates across multiple product lines, Jardiance coverage is not uniform across all plans.

Commercial vs. Medicaid Formularies

On Affinity commercial formularies, Jardiance typically sits at Tier 3 or Tier 4. Tier 3 drugs often carry copays of $50 to $100 per 30-day supply after meeting the deductible. Tier 4 drugs may require a percentage coinsurance of 25% to 40% of the negotiated price rather than a flat copay.

On Medicaid and Essential Plan formularies administered by Affinity, New York State's Preferred Drug List (PDL) governs which SGLT2 inhibitors are preferred. New York's PDL has historically listed at least one SGLT2 inhibitor as preferred, though the preferred agent changes with rebate negotiations [6]. Affinity Medicaid members pay no copay for preferred drugs and a small copay (often $1 to $3) for non-preferred brand drugs.

Step Therapy Requirements

Most Affinity commercial plans require step therapy before approving Jardiance. The typical sequence is:

1. A trial of metformin at maximally tolerated doses for at least 90 days
2. Documentation of inadequate glycemic control (HbA1c remaining above goal, typically >7.0% or >8.0% depending on plan criteria)
3. A trial of a generic sulfonylurea or generic DPP-4 inhibitor in some plan variants before an SGLT2 inhibitor is approved

If your provider is prescribing Jardiance for heart failure or CKD rather than diabetes alone, step therapy requirements are different. Heart failure pathways usually do not require a prior diabetes medication failure.

The EMPA-REG OUTCOME Trial: The Evidence Affinity Reviewers See

Prior authorization reviewers at managed care organizations look at exactly the same clinical trials your cardiologist cites. Knowing this evidence helps your prescriber write a stronger letter of medical necessity.

Cardiovascular Outcomes

The EMPA-REG OUTCOME trial enrolled 7,020 adults with type 2 diabetes and established cardiovascular disease. At a median follow-up of 3.1 years, empagliflozin 10 mg or 25 mg reduced the three-point MACE composite (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) by 14% relative to placebo (10.5% vs. 12.1%, hazard ratio 0.86, 95% CI 0.74-0.99, P<0.001 for non-inferiority; P=0.04 for superiority) [7]. Cardiovascular death alone fell by 38% (3.7% vs. 5.9%, HR 0.62, 95% CI 0.49-0.77) [7].

That 38% relative risk reduction in cardiovascular death is one of the most cited figures in diabetes cardiology. It appears in the 2023 American Diabetes Association Standards of Care, which recommends an SGLT2 inhibitor with proven cardiovascular benefit for patients with type 2 diabetes and established cardiovascular disease regardless of baseline HbA1c [8].

Heart Failure Outcomes

The EMPEROR-Reduced trial enrolled 3,730 adults with HFrEF (ejection fraction <40%) and showed empagliflozin 10 mg reduced the composite of cardiovascular death or hospitalization for heart failure by 25% relative to placebo (19.4% vs. 24.7%, HR 0.75, 95% CI 0.65-0.86, P<0.001) [9]. This trial included patients both with and without diabetes, establishing empagliflozin's benefit as a heart failure drug independent of its glucose-lowering effect.

The 2022 ACC/AHA Heart Failure Guideline gives SGLT2 inhibitors a Class I, Level A recommendation for patients with HFrEF to reduce hospitalization and cardiovascular mortality [10]. A Class I recommendation is the guideline's strongest endorsement. Including this citation in a prior authorization letter can be the deciding factor for approval.

Kidney Disease Outcomes

The EMPA-KIDNEY trial enrolled 6,609 patients with CKD, including many without diabetes. Empagliflozin 10 mg reduced the composite of kidney disease progression or cardiovascular death by 28% relative to placebo (13.1% vs. 16.9%, HR 0.72, 95% CI 0.64-0.82, P<0.001) [5]. The trial was stopped early at a median of 2.0 years because the benefit was clear enough that continuation was considered unethical.

These three trial results cover the three FDA-approved indications and give prescribers a strong evidence base for any prior authorization appeal.

How to Get Prior Authorization Approved

Getting a prior authorization approved for Jardiance through Affinity Health Plan involves a predictable set of steps. Organizing these in advance reduces delays significantly.

Step 1: Confirm Your Specific Plan's Formulary

Call the member services number on the back of your Affinity insurance card and ask the following questions directly:

• Is empagliflozin (Jardiance) on the current formulary?
• What tier is it on?
• Is prior authorization required?
• What are the coverage criteria for my diagnosis (ICD-10 code)?

Alternatively, use Affinity's online formulary search tool at their member portal. Formularies update quarterly, so a check done six months ago may no longer be accurate.

Step 2: Have Your Prescriber Submit a Complete PA Request

The most common reason prior authorizations are denied is incomplete documentation. The PA submission should include:

• Current HbA1c value and date of the test
• List of diabetes medications previously tried, with durations and reasons for discontinuation or inadequacy
• Relevant diagnosis codes (E11.x for type 2 diabetes; I50.x for heart failure; N18.x for CKD)
• A brief letter of medical necessity citing the EMPA-REG OUTCOME, EMPEROR-Reduced, or EMPA-KIDNEY trial as applicable [7, 9, 5]
• Relevant labs: eGFR, urine albumin-to-creatinine ratio (UACR), echocardiogram ejection fraction if heart failure is the indication

Step 3: If Denied, File an Appeal Immediately

Affinity Health Plan, like all plans operating in New York, must provide a written denial with the specific clinical reason. Your prescriber has the right to request a peer-to-peer review with the plan's medical director, usually within 24 to 72 hours of the denial.

For non-urgent appeals, Affinity must respond within 30 days. For urgent or expedited appeals, the response time is 72 hours [11]. If the internal appeal is denied, New York members can request an external appeal through the New York State Department of Financial Services, which uses independent reviewers.

Affinity Medicaid Coverage for Jardiance

Affinity Health Plan's Medicaid product follows New York State Medicaid rules. New York Medicaid covers SGLT2 inhibitors but may require PA even for Medicaid members depending on the agent and indication [6].

New York Medicaid PDL and SGLT2 Inhibitors

New York State uses a clinical drug review process through its Pharmacy & Therapeutics Committee. SGLT2 inhibitors as a class are covered under New York Medicaid, with preferred agents designated based on rebate negotiations and clinical evidence [6]. If Jardiance is non-preferred on the current PDL, your prescriber can request a medical exception by documenting a clinical reason why the preferred SGLT2 inhibitor is not appropriate for you specifically.

No-Cost Sharing for Medicaid Members

Medicaid members enrolled through Affinity generally pay $0 for preferred drugs and a minimal copay for non-preferred drugs. Cost is rarely the barrier for Medicaid members. The barrier is more often prior authorization, particularly for CKD indications where the diagnosis must be clearly documented with eGFR values.

What Jardiance Costs Without Insurance and Assistance Programs

If coverage is denied and you need to start treatment, knowing your out-of-pocket options prevents a gap in therapy.

Manufacturer Copay Card

Boehringer Ingelheim operates the Jardiance Savings Card program for commercially insured patients. Eligible patients may pay as little as $10 per month for a 30-day or 90-day supply, with a maximum annual savings of $3,600 [12]. This card is not valid for patients covered by Medicare, Medicaid, or any other federal or state government health program.

GoodRx and Retail Pharmacy Pricing

GoodRx discounts for Jardiance 10 mg (30 tablets) at major pharmacy chains range from approximately $480 to $530 depending on the pharmacy and your ZIP code as of early 2025. This is lower than the list price but still substantial for a monthly medication.

Patient Assistance Programs

Boehringer Ingelheim's Patient Assistance Program provides Jardiance at no cost to qualifying uninsured or underinsured patients who meet income criteria (generally below 400% of the federal poverty level) [13]. Your prescriber's office can submit the application, or you can apply directly through NeedyMeds.org or the manufacturer's website.

Generic Empagliflozin

The FDA has not yet approved a generic version of empagliflozin as of early 2025. The earliest patent expiration that could allow generic entry is around 2025 to 2026 for some formulations, but FDA review timelines may extend this. Once a generic is available, Affinity formularies will almost certainly move it to a preferred lower tier, which will reduce both the copay and the likelihood of prior authorization requirements.

Clinical Context: When Jardiance Is the Right Choice

Not every patient with type 2 diabetes needs Jardiance. Understanding the clinical profile helps you have a more productive conversation with your prescriber about whether fighting for coverage is the right path.

Who Benefits Most

The 2023 ADA Standards of Care recommend SGLT2 inhibitors as preferred add-on therapy (after metformin) for adults with type 2 diabetes who also have established atherosclerotic cardiovascular disease, heart failure, or CKD with UACR >300 mg/g or eGFR 20-60 mL/min/1.73m2 [8]. In these populations, the cardiovascular and renal benefits are independent of HbA1c, meaning the drug is useful even if blood sugar is already well controlled.

For patients whose only concern is glucose lowering and who lack cardiovascular or renal comorbidities, generic metformin, a sulfonylurea, or a generic DPP-4 inhibitor may achieve similar HbA1c reduction at a fraction of the cost, and Affinity is unlikely to approve Jardiance without first requiring those trials.

Contraindications and Cautions

Jardiance is contraindicated in patients with eGFR <20 mL/min/1.73m2 for its glucose-lowering indication, though lower eGFR thresholds apply for HFrEF and CKD indications per the updated FDA label [14]. The drug carries a black-box warning for limb amputation risk based on the CANVAS trial data for canagliflozin, though EMPA-REG OUTCOME did not show a statistically significant amputation signal for empagliflozin specifically [7, 15].

Diabetic ketoacidosis (DKA), sometimes euglycemic, has been reported with all SGLT2 inhibitors. The FDA added a warning for this in 2015 [16]. Patients should be instructed to hold empagliflozin 3 to 4 days before surgery or prolonged fasting.

Direct Quote from the ADA Standards of Care

The 2023 ADA Standards of Care states: "For patients with type 2 diabetes and established cardiovascular disease or indicators of high cardiovascular risk, established kidney disease, or heart failure, a sodium-glucose cotransporter 2 inhibitor with demonstrated cardiovascular benefit is recommended to reduce the risk of major adverse cardiovascular events and/or heart failure hospitalization and/or to slow kidney disease progression" [8].

This language is the clinical standard that prior authorization reviewers must weigh. If your prescriber quotes this directly in the letter of medical necessity, it frames the request within the ADA's highest-evidence recommendations.

Alternatives If Affinity Denies Jardiance Coverage

A denial is not the end. Several clinically similar options may face lower coverage barriers.

Other SGLT2 Inhibitors

Dapagliflozin (Farxiga) and canagliflozin (Invokana) are the two other SGLT2 inhibitors with FDA-approved cardiovascular or renal indications. Affinity's formulary may list one of these as a preferred SGLT2 inhibitor, making approval easier. The DAPA-HF trial (N=4,744) showed dapagliflozin reduced the composite of cardiovascular death or worsening heart failure by 26% in HFrEF patients (HR 0.74, 95% CI 0.65-0.85, P<0.001) [17]. The outcomes are clinically similar to empagliflozin's, so switching may be reasonable if it removes a coverage barrier.

GLP-1 Receptor Agonists

For patients whose primary goal is cardiovascular risk reduction and weight loss rather than heart failure or CKD management, a GLP-1 receptor agonist such as semaglutide (Ozempic) may be a more appropriate alternative. The SUSTAIN-6 trial (N=3,297) showed semaglutide 0.5 mg or 1 mg reduced three-point MACE by 26% relative to placebo (6.6% vs. 8.9%, HR 0.74, 95% CI 0.58-0.95, P<0.001 for non-inferiority) [18]. Affinity's formulary coverage for GLP-1 agents varies separately from SGLT2 inhibitors.

Practical Checklist Before Calling Affinity

Gather the following before contacting Affinity or your prescriber's office about a Jardiance prior authorization:

• Your Affinity member ID and group number
• Your most recent HbA1c result (lab date and value)
• A list of diabetes medications you have previously tried (drug name, dose, duration, reason stopped)
• Your most recent eGFR and UACR values if CKD is a factor
• Your most recent echocardiogram report showing ejection fraction if heart failure is the indication
• The ICD-10 diagnosis codes your prescriber plans to use

Having this information organized before the call cuts the time required for your prescriber's staff to complete the prior authorization form and reduces the likelihood of an administrative denial due to missing data.

The FDA's prescribing information for empagliflozin specifies a starting dose of 10 mg once daily in the morning, with or without food, and allows titration to 25 mg once daily for additional glycemic control in the type 2 diabetes indication [14]. The heart failure dose is 10 mg once daily and is not titrated upward. Ensure your prescription matches the indication-appropriate dose, since a mismatch between the dose and the stated indication can trigger an automatic prior authorization request even when the drug would otherwise be covered.