Does Affinity Health Plan Cover Jardiance?

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At a glance

  • Drug name / Jardiance (empagliflozin), an SGLT2 inhibitor
  • FDA-approved indications / Type 2 diabetes, heart failure with reduced ejection fraction, chronic kidney disease
  • Typical formulary tier / Tier 3 (preferred brand) or Tier 4 (non-preferred brand) on most Medicaid managed-care plans
  • Prior authorization / Usually required for brand-name SGLT2 inhibitors
  • Step therapy / Many plans require a trial of metformin or another generic first
  • Copay card / Boehringer Ingelheim offers a savings card that may reduce out-of-pocket cost to as low as $10/month for eligible commercially insured patients
  • Denial option / You have the right to appeal any coverage denial within the timeframes your plan specifies
  • Key clinical evidence / EMPA-REG OUTCOME (N=7,020) showed a 38% relative risk reduction in cardiovascular death with empagliflozin vs. Placebo

What Is Jardiance and Why Does Coverage Matter?

Jardiance is the brand name for empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor first approved by the FDA in August 2014 for glycemic control in adults with type 2 diabetes. The FDA later expanded its label to include reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, reducing the risk of hospitalization for heart failure, and slowing the progression of chronic kidney disease (CKD) [1].

The Clinical Case for Empagliflozin

The EMPA-REG OUTCOME trial (N=7,020) demonstrated that empagliflozin reduced the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke by 14% compared with placebo (hazard ratio 0.86; 95% CI 0.74 to 0.99; P<0.001 for non-inferiority, P=0.04 for superiority) [2]. Cardiovascular death alone was reduced by 38%. That trial changed how cardiologists and endocrinologists prescribe glucose-lowering therapy, and the American Diabetes Association's 2024 Standards of Care now explicitly recommend SGLT2 inhibitors for patients with type 2 diabetes plus atherosclerotic cardiovascular disease, heart failure, or CKD regardless of baseline HbA1c [3].

Why Cost and Coverage Create Access Barriers

Jardiance's list price runs approximately $600 to $700 per 30-day supply without insurance. Even with coverage, members on high-deductible health plans can face hundreds of dollars per month in out-of-pocket costs until the deductible is met. For Medicaid members enrolled in Affinity Health Plan, cost-sharing is typically much lower, but prior authorization and step therapy requirements can delay access by weeks.


How Affinity Health Plan Formularies Work

Affinity Health Plan operates Medicaid managed-care and Child Health Plus plans primarily in New York State. Like all Medicaid managed-care organizations (MCOs) in New York, Affinity must follow the New York State Medicaid Preferred Drug Program (PDP), which designates preferred and non-preferred drugs and specifies when prior authorization is required [4].

Formulary Tiers and SGLT2 Inhibitors

Most Medicaid MCO formularies in New York place brand-name SGLT2 inhibitors, including Jardiance, on a preferred or non-preferred brand tier. The distinction matters:

  • Preferred brand tier: Lower copay, prior authorization still typically required but approval criteria may be broader.
  • Non-preferred brand tier: Higher copay or cost-share, stricter prior authorization criteria, and step therapy often required.

The exact tier assignment for Jardiance on Affinity Health Plan can change annually with each plan year. The only way to confirm the current tier is to download Affinity's formulary document directly from their website or call Member Services at the number printed on your insurance card.

Step Therapy Requirements

New York State Medicaid and most MCO plans require step therapy before authorizing brand-name SGLT2 inhibitors. Step therapy means a member must first try a preferred generic agent, most often metformin 500 mg to 2,000 mg daily, and demonstrate either inadequate glycemic control or a contraindication before Jardiance will be approved [5]. The ADA defines inadequate control as an HbA1c that remains above the individualized target after at least 90 days of therapy at maximally tolerated doses [3].


Prior Authorization for Jardiance: What Affinity Typically Requires

Prior authorization (PA) is a written request from your prescribing clinician asking the plan to approve coverage before the pharmacy can dispense the medication. Affinity Health Plan, consistent with New York Medicaid MCO standards, generally requires PA for brand-name SGLT2 inhibitors.

Typical Documentation Needed

Your clinician's office will need to submit clinical notes that include:

  1. A confirmed diagnosis of type 2 diabetes (ICD-10: E11.x), heart failure (I50.x), or CKD (N18.x) supported by laboratory data.
  2. Evidence of step therapy completion or a documented reason why step therapy is contraindicated (for example, an eGFR <30 mL/min/1.73m² makes metformin contraindicated per FDA labeling) [6].
  3. Recent HbA1c results or eGFR values within the past 6 to 12 months.
  4. A clinical rationale explaining why Jardiance is preferred over a lower-tier alternative.

Turnaround Times

Under New York State law and Medicaid managed-care contracts, plans must respond to standard PA requests within 3 business days and urgent requests within 24 hours [4]. Ask your clinician to mark the request as urgent if your clinical situation warrants faster review.

How to Check PA Status

Your clinician's office can call Affinity's Provider Services line to check status. Members can also call Member Services directly. Keep a written record of every call, including the date, representative name, and reference number.


What Happens if Affinity Denies Coverage?

A denial is not the final word. Federal Medicaid law and New York State regulations give you specific rights to challenge a coverage decision.

Step 1: Request the Denial in Writing

Affinity must send you a written Notice of Action explaining the reason for denial, the criteria used, and your appeal rights. This notice typically arrives within 5 to 7 business days of the decision.

Step 2: File an Internal Appeal

You or your clinician can file an internal appeal, sometimes called a plan-level grievance. Affinity must resolve standard appeals within 30 calendar days. Expedited appeals, appropriate when your health could be seriously harmed by waiting, must be resolved within 3 calendar days under New York Medicaid rules.

Step 3: Request a Fair Hearing

If the internal appeal is denied, you have the right to a New York State Fair Hearing before an Administrative Law Judge. You can request a Fair Hearing at any point after you receive a denial, and you do not have to wait for the internal appeal to finish. During the Fair Hearing process, Medicaid members may be entitled to continuation of benefits, meaning Jardiance coverage continues while the hearing is pending, provided the request is filed within the required timeframe.

Step 4: External Appeal

New York State also offers an external appeal process through the Department of Financial Services (DFS) for commercially insured members. An independent organization reviews the clinical evidence and can overturn the plan's decision [4].


Alternatives If Coverage Is Denied or Delayed

While an appeal is pending, several options may help bridge the gap.

Manufacturer Savings Programs

Boehringer Ingelheim and Eli Lilly co-market Jardiance and offer a savings card program for eligible commercially insured patients. Eligible patients may pay as little as $10 per 30-day supply. Medicaid members are not eligible for manufacturer copay cards under federal anti-kickback rules, but they may qualify for the patient assistance program if they meet income and insurance criteria. Details are available directly through the manufacturer.

Therapeutic Alternatives Within the SGLT2 Class

If Jardiance is denied, your clinician may consider other SGLT2 inhibitors that sit on a preferred tier for Affinity's formulary. Dapagliflozin (Farxiga) and canagliflozin (Invokana) are in the same drug class. The DAPA-HF trial (N=4,744) showed dapagliflozin reduced the composite of worsening heart failure or cardiovascular death by 26% compared with placebo (hazard ratio 0.74; 95% CI 0.65 to 0.85; P<0.001) [7], a clinically meaningful outcome that supports dapagliflozin as a reasonable alternative when formulary access to empagliflozin is restricted.

GoodRx and Other Discount Programs

For members who cannot wait for an appeal, GoodRx and similar pharmacy discount programs sometimes reduce the cash price of Jardiance to below the plan's cost-share tier, though prices vary by pharmacy and zip code.


How to Confirm Your Specific Jardiance Benefit Today

Because formularies change annually and individual plan documents govern your actual benefit, no third-party article can confirm your coverage with certainty. Here are the specific steps to get a definitive answer.

Check the Formulary Document

Affinity Health Plan publishes its formulary, also called the Drug List, on its website. Search for "empagliflozin" or "Jardiance" in the formulary search tool. Note the tier, any PA requirement noted with a "PA" symbol, and any quantity limits.

Call Member Services

The Member Services number is printed on the back of your insurance card. Ask specifically:

  • Is Jardiance (empagliflozin) covered on my current formulary?
  • What tier is it?
  • Is prior authorization required?
  • Is step therapy required, and what does my claims history show?
  • What is my expected copay or cost-share after meeting my deductible?

Write down the representative's name, the date, and any reference number provided.

Ask Your Prescriber's Office to Run a Benefits Investigation

Most specialty pharmacy teams and endocrinology offices have staff who routinely run electronic benefits investigations through platforms like CoverMyMeds or directly with the plan. This process can confirm PA requirements and initiate the authorization request in one step.

The framework below summarizes the decision pathway a clinician should use when prescribing Jardiance to an Affinity Health Plan member, from initial formulary check through appeal, as a reference for care teams navigating coverage barriers.

Affinity Jardiance Access Decision Framework (HealthRX Clinical Team)

  1. Confirm indication: type 2 diabetes, heart failure, or CKD per FDA labeling [1].
  2. Check current Affinity formulary tier for empagliflozin.
  3. If PA required: Submit clinical documentation including diagnosis, HbA1c or eGFR, and step therapy history.
  4. If step therapy required and not completed: trial metformin for 90 days minimum unless contraindicated (eGFR <30 mL/min/1.73m²) [6].
  5. If denied: File internal appeal within the plan's stated deadline, citing EMPA-REG OUTCOME cardiovascular mortality data [2] and ADA 2024 guidelines [3].
  6. If internal appeal denied: Request New York State Fair Hearing and consider expedited timeline if clinically urgent.
  7. Concurrently: Explore manufacturer patient assistance and therapeutic alternatives (dapagliflozin, canagliflozin) on preferred tiers.

Clinical Indications That Strengthen a Prior Authorization Request

The FDA-approved indications for Jardiance now extend well beyond blood sugar control alone. When your clinician writes the PA request, citing the specific labeled indication that applies to you strengthens the case considerably.

Type 2 Diabetes with Cardiovascular Disease

The EMPA-REG OUTCOME trial enrolled adults with type 2 diabetes and established cardiovascular disease. The 38% relative reduction in cardiovascular death is one of the largest cardiovascular benefits seen with any glucose-lowering agent [2]. Payers and their clinical reviewers are familiar with this data.

Heart Failure

The EMPEROR-Reduced trial (N=3,730) showed empagliflozin reduced the composite of cardiovascular death or hospitalization for heart failure by 25% compared with placebo (hazard ratio 0.75; 95% CI 0.65 to 0.86; P<0.001) in patients with heart failure with reduced ejection fraction, regardless of diabetes status [8]. A separate trial, EMPEROR-Preserved (N=5,988), demonstrated a 21% reduction in the same composite endpoint in patients with heart failure with preserved ejection fraction [9]. Both indications are now in the FDA label, which gives prescribers a strong regulatory basis for PA approval even in patients without diabetes.

Chronic Kidney Disease

The EMPA-KIDNEY trial (N=6,609) showed empagliflozin reduced the risk of kidney disease progression or cardiovascular death by 28% compared with placebo (hazard ratio 0.72; 95% CI 0.64 to 0.82; P<0.001) across a broad range of eGFR values down to 20 mL/min/1.73m² [10]. The FDA approved this CKD indication in 2023. Plans that might deny Jardiance for a patient with modest glucose elevation may approve it readily for a patient with CKD and an eGFR of 25 mL/min/1.73m².


Relevant Guidelines Supporting Medical Necessity

Including guideline language in a PA request or appeal letter can shift a denial to an approval. Two documents are particularly persuasive.

The ADA 2024 Standards of Medical Care in Diabetes state: "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 as part of the glucose-lowering regimen independent of baseline HbA1c" [3].

The American Heart Association and the American College of Cardiology 2022 Guideline for the Diagnosis and Management of Heart Failure assigns a Class I (Level of Evidence A) recommendation to SGLT2 inhibitors for patients with heart failure with reduced ejection fraction to reduce the risk of heart failure hospitalization and cardiovascular mortality [11]. A Class I recommendation is the highest level of endorsement in cardiology guidelines.

Citing both documents in a PA appeal letter frames Jardiance not as a convenience but as standard-of-care therapy backed by major specialty society guidelines.


Special Populations and Coverage Nuances

Pediatric Members

The FDA approved empagliflozin for children aged 10 years and older with type 2 diabetes in December 2023. Affinity Child Health Plus plans may cover Jardiance for this population, but PA criteria for pediatric patients may differ from adult criteria. Confirm with Affinity's pharmacy department directly.

Dual-Eligible Members (Medicare-Medicaid)

Members enrolled in both Medicare and Medicaid (dual-eligibles) may have Jardiance covered through their Medicare Part D plan rather than through Affinity Medicaid. In that case, the Medicare Part D formulary and PA rules apply, not Affinity's Medicaid formulary. Coordination of benefits questions should go to both the Medicare plan and Affinity simultaneously.

Members Who Have Changed Plans Recently

Formulary placement for Jardiance may differ between the plan you had last year and the one you have now. If you recently changed plans or your employer changed insurance carriers, re-verify coverage even if Jardiance was covered before.


Frequently asked questions

Does Affinity Health Plan cover Jardiance?
Affinity Health Plan may cover Jardiance (empagliflozin) depending on the specific plan type, formulary tier for that plan year, and whether prior authorization criteria are met. Confirm coverage by checking the current Affinity formulary document or calling Member Services at the number on your insurance card.
What tier is Jardiance on Affinity Health Plan's formulary?
Brand-name SGLT2 inhibitors like Jardiance are typically placed on a preferred brand (Tier 3) or non-preferred brand (Tier 4) tier on Medicaid managed-care formularies. The exact tier for your plan year can change annually and should be verified directly with Affinity.
Does Affinity require prior authorization for Jardiance?
Prior authorization is typically required for brand-name SGLT2 inhibitors including Jardiance on Medicaid managed-care plans. Your prescriber's office submits clinical documentation including your diagnosis, relevant lab values, and step therapy history to support the request.
What happens if Affinity denies coverage for Jardiance?
You have the right to file an internal appeal, and if that is denied, to request a New York State Fair Hearing. During the Fair Hearing process, Medicaid members may be eligible for continuation of benefits while the hearing is pending, provided the request is filed within the required timeframe.
Does Affinity require step therapy before covering Jardiance?
Most Medicaid managed-care plans in New York require step therapy, meaning a trial of a preferred generic agent such as metformin, before approving a brand-name SGLT2 inhibitor. Exceptions exist when step therapy agents are contraindicated, for example when eGFR is below 30 mL/min/1.73m2.
Can I use a Jardiance copay card with Affinity Health Plan?
Federal rules prohibit Medicaid beneficiaries from using manufacturer copay assistance cards. However, patients who meet income and insurance criteria may qualify for Boehringer Ingelheim's patient assistance program. Commercially insured Affinity members may be eligible for the copay savings card.
Are there alternatives to Jardiance that Affinity might cover more easily?
Dapagliflozin (Farxiga) and canagliflozin (Invokana) are SGLT2 inhibitors in the same class. One or both may be on a preferred tier for Affinity's formulary, meaning lower cost-share and potentially less stringent prior authorization. The DAPA-HF trial showed dapagliflozin reduced the composite of worsening heart failure or cardiovascular death by 26% vs. Placebo.
Is Jardiance covered for heart failure patients on Affinity Health Plan?
Jardiance has FDA approval for reducing the risk of cardiovascular death and hospitalization for heart failure in adults, regardless of whether they have diabetes. Affinity may cover this indication, but prior authorization documentation should reference the specific heart failure indication and relevant trial data such as EMPEROR-Reduced.
Is Jardiance covered for chronic kidney disease on Affinity Health Plan?
The FDA approved empagliflozin for chronic kidney disease in 2023 based on the EMPA-KIDNEY trial (N=6,609), which showed a 28% reduction in kidney disease progression or cardiovascular death. Affinity may cover this indication; your prescriber should document the CKD diagnosis and eGFR in the prior authorization request.
How long does prior authorization take with Affinity Health Plan?
Under New York State Medicaid managed-care rules, plans must respond to standard prior authorization requests within 3 business days and urgent requests within 24 hours. Ask your prescriber to flag the request as urgent if your clinical situation warrants faster review.
What lab values should my doctor include in a Jardiance prior authorization request?
Include recent HbA1c (within 6 to 12 months), eGFR and urine albumin-to-creatinine ratio if CKD is the indication, echocardiogram results if heart failure is the indication, and documentation of any prior drug trials required by step therapy.
Does Affinity Health Plan cover Jardiance for children?
The FDA approved empagliflozin for patients aged 10 and older with type 2 diabetes in December 2023. Affinity's Child Health Plus formulary may include coverage for this population, but pediatric prior authorization criteria may differ from adult criteria. Contact Affinity directly to confirm.

References

  1. U.S. Food and Drug Administration. Jardiance (empagliflozin) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s036lbl.pdf
  2. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2128. https://www.nejm.org/doi/10.1056/NEJMoa1504720
  3. American Diabetes Association Professional Practice Committee. Standards of Medical Care in Diabetes 2024. Diabetes Care. 2024;47(Suppl 1):S1-S321. https://diabetesjournals.org/care/issue/47/Supplement_1
  4. New York State Department of Health. Medicaid Managed Care Model Contract and Prior Authorization Requirements. https://www.health.ny.gov/health_care/managed_care/
  5. Centers for Medicare and Medicaid Services. Medicaid Preferred Drug Programs and Prior Authorization. https://www.medicaid.gov/medicaid/prescription-drugs/preferred-drug-programs/index.html
  6. U.S. Food and Drug Administration. Metformin hydrochloride prescribing information: renal impairment contraindication. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021202s021lbl.pdf
  7. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008. https://www.nejm.org/doi/10.1056/NEJMoa1911303
  8. Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413-1424. https://www.nejm.org/doi/10.1056/NEJMoa2022190
  9. Anker SD, Butler J, Filippatos G, et al. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461. https://www.nejm.org/doi/10.1056/NEJMoa2107038
  10. The EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388(2):117-127. https://www.nejm.org/doi/10.1056/NEJMoa2204233
  11. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Diagnosis and Management of Heart Failure. J Am Coll Cardiol. 2022;79(17):e263-e421. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001063