Does Affinity Health Plan Cover Farxiga?

What Is Farxiga and Why Does Coverage Matter?

Farxiga (dapagliflozin 10 mg, manufactured by AstraZeneca) is an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor approved by the FDA for three distinct indications: glycemic control in adults with type 2 diabetes, reducing the risk of cardiovascular death or worsening heart failure in adults with heart failure with reduced ejection fraction (HFrEF), and reducing the risk of sustained eGFR decline, end-stage kidney disease, or cardiovascular or renal death in adults with CKD [1]. Because the drug carries a retail price of roughly $600 to $700 per month, insurance coverage is not a minor administrative detail. It directly determines whether patients can maintain therapy long enough to realize the organ-protective benefits documented in large randomized controlled trials.

The FDA first approved dapagliflozin for type 2 diabetes in January 2014, expanded the label to HFrEF in May 2020 after the DAPA-HF results, and added the CKD indication in April 2021 following DAPA-CKD [2]. Each label expansion was accompanied by updated AstraZeneca manufacturer coupon programs, but those programs are typically unavailable to patients enrolled in government-sponsored plans such as Medicaid, the product line most commonly administered by Affinity Health Plan in New York [3].

The American Diabetes Association's 2024 Standards of Care explicitly state that SGLT2 inhibitors with proven cardiovascular benefit should be used in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, heart failure, or CKD regardless of baseline A1C [4]. That guideline language is clinically meaningful for coverage disputes: if your insurer's criteria restrict Farxiga to patients with A1C above a specific threshold, the ADA recommendation provides grounds for a medical-necessity appeal.

How Affinity Health Plan Formularies Are Structured

Affinity Health Plan is a Medicaid managed-care organization serving New York City and surrounding counties. Its formularies are governed by New York State Department of Health (NYSDOH) Medicaid rules, which mandate that certain drug classes be covered but permit plans to place drugs on preferred or non-preferred tiers and to impose prior authorization or step-therapy protocols [5].

Formularies are updated at least annually, typically on January 1. Mid-year changes are permitted for newly approved drugs but are rarely applied to remove existing coverage. Farxiga has appeared on Affinity's Medicaid formulary since approximately 2020, following the HFrEF approval that gave the drug multi-indication status.

Tier placement determines your cost-sharing. A Tier 2 placement under a standard Medicaid plan usually means a $1 to $3 copay per 30-day supply. Tier 3 placement on a managed Medicaid product may carry a $8 to $11 copay. Neither tier removes coverage; they shift a small cost to the member. The larger practical barrier is prior authorization (PA), not the copay itself.

New York State's Medicaid pharmacy rules require that any step-therapy restriction on a drug with an FDA-approved indication for a life-threatening or chronic condition be clinically justified [6]. Because CKD and HFrEF both qualify as chronic conditions with significant mortality risk, step-therapy overrides are more accessible for those indications than for uncomplicated type 2 diabetes alone.

What Prior Authorization Criteria Typically Look Like

Prior authorization criteria for Farxiga under managed Medicaid plans generally require the prescriber to document at least one of the following: a diagnosis of type 2 diabetes with A1C at or above 7.0% despite at least 90 days of metformin at a maximally tolerated dose; a confirmed diagnosis of HFrEF with ejection fraction at or below 40%; or a confirmed diagnosis of CKD with eGFR between 25 and 75 mL/min/1.73 m² and urine albumin-to-creatinine ratio (UACR) above 200 mg/g [7].

These thresholds map directly onto the enrollment criteria used in the key trials. DAPA-HF enrolled patients with EF below 40% and NYHA class II to IV symptoms [8]. DAPA-CKD enrolled patients with eGFR 25 to 75 and UACR 200 to 5,000 [9]. If your patient meets trial-enrollment criteria, they almost certainly meet the PA criteria as written.

The HealthRX PA Preparation Framework for Farxiga under Managed Medicaid:

1. Confirm the active plan year formulary at the plan's website or by calling the pharmacy benefit line.
2. Obtain the PA criteria document (plans must provide this on request under CMS transparency rules).
3. Gather objective documentation: most recent A1C, echocardiogram report with EF percentage, or eGFR and UACR from a lab within the past 6 months.
4. Submit the PA with the specific ICD-10 code that matches the approved FDA indication (E11.65 for type 2 diabetes with hyperglycemia, I50.20 for HFrEF, N18.3 or N18.4 for CKD stage 3 or 4).
5. If denied, file a Level 1 internal appeal within 60 days, attaching the ADA 2024 Standards of Care page and the relevant trial abstract from PubMed.
6. If the Level 1 appeal is denied, request an external appeal through the New York State Department of Financial Services, which must be decided within 30 days for non-urgent cases.

The Clinical Evidence Supporting Medical-Necessity Arguments

When insurers deny Farxiga, the appeal response should reference the specific trial data behind each approved indication. Vague references to "studies showing benefit" are far weaker than named trial citations with effect sizes.

For heart failure: DAPA-HF (N=4,744) showed that dapagliflozin 10 mg reduced the composite of worsening heart failure or cardiovascular death by 26% compared with placebo (hazard ratio 0.74 to 95% CI 0.65 to 0.85, P<0.001) over a median follow-up of 18.2 months [8]. The benefit was consistent regardless of whether patients had diabetes. This trial was published in the New England Journal of Medicine in 2019 and formed the primary basis for the FDA's 2020 label expansion.

For chronic kidney disease: DAPA-CKD (N=4,304) showed that dapagliflozin reduced the risk of sustained eGFR decline of 50% or more, end-stage kidney disease, or renal or cardiovascular death by 39% compared with placebo (hazard ratio 0.61 to 95% CI 0.51 to 0.72, P<0.001) [9]. The Data Safety Monitoring Board recommended stopping the trial early because the benefit was so consistent. Again, the benefit was present in both diabetic and non-diabetic patients with CKD.

For type 2 diabetes cardiovascular outcomes: The DECLARE-TIMI 58 trial (N=17,160) showed dapagliflozin reduced hospitalizations for heart failure by 27% (hazard ratio 0.73 to 95% CI 0.61 to 0.88) in a broad population of patients with type 2 diabetes and either established cardiovascular disease or multiple risk factors [10]. That trial population is broader than DAPA-HF and supports coverage for patients who do not yet have overt HFrEF.

The American College of Cardiology and American Heart Association 2022 Heart Failure Guidelines give SGLT2 inhibitors a Class I, Level of Evidence A recommendation for patients with HFrEF to reduce hospitalization and mortality, using language that is directly quotable in an appeal: "In patients with symptomatic chronic HFrEF, SGLT2i are recommended to reduce HF hospitalizations and cardiovascular mortality" [11].

What Happens If Affinity Denies the Claim

A coverage denial is not the end of the road. Federal and New York State law provide multiple appeal pathways, and the data on appeal outcomes are worth knowing.

Under CMS regulations applicable to Medicaid managed care, members have the right to a plan-level internal appeal, followed by a state fair hearing if the internal appeal is denied [12]. New York also offers an external appeal process through the Department of Financial Services for adverse benefit determinations related to medical necessity. The external appeal must be conducted by an Independent Review Organization (IRO) that is certified by the state.

CMS data from Medicare Part D (the closest available proxy for managed Medicaid) show that approximately 60% of medication prior-authorization appeals are resolved in the enrollee's favor when complete clinical documentation is provided [13]. The success rate climbs when the prescribing physician submits a letter of medical necessity that specifically cites guideline language and trial data rather than simply restating the diagnosis.

Practical steps after a denial: ask the prescribing provider's office to request a peer-to-peer review with the plan's medical director. This call, which can typically be scheduled within 72 hours, allows the clinician to present the clinical rationale directly. Peer-to-peer reviews resolve a meaningful share of PA denials before a formal appeal is filed.

If all appeals fail, several alternative paths exist. The AstraZeneca AZ&Me Prescription Savings Program covers Farxiga at no cost for commercially insured patients who meet income criteria, though government-plan patients are excluded [3]. The NeedyMeds database and state pharmaceutical assistance programs (SPAPs) may offer additional support for Medicaid members in New York.

Step Therapy and How to Override It

Some Affinity plan products require step therapy for the type 2 diabetes indication, meaning a patient must try and fail metformin before Farxiga will be approved. Metformin failure can mean intolerance (gastrointestinal side effects, contraindication due to eGFR <30 mL/min/1.73 m²) or inadequate glycemic response (A1C remaining above target after 90 days at 1 to 000 mg twice daily).

New York State Law (Public Health Law Section 4900 et seq.) and implementing NYSDOH regulations require that step-therapy protocols include a clearly defined exception process. Exceptions must be granted when step therapy would be clinically contraindicated, when the required drug was previously tried and failed, or when the requested drug is the standard of care for the patient's specific clinical situation [6].

For patients with CKD and eGFR <30, metformin is contraindicated by FDA labeling and by the FDA-approved Farxiga prescribing information [1]. This contraindication is itself sufficient grounds to bypass metformin step therapy. For patients with HFrEF, metformin is not the relevant comparator at all, since the HFrEF indication does not involve blood sugar management. Step therapy for heart failure patients should be challenged immediately on those grounds.

The KDIGO 2022 Clinical Practice Guideline for Diabetes Management in CKD recommends metformin as first-line therapy only when eGFR is at or above 30 mL/min/1.73 m², and recommends adding an SGLT2 inhibitor for patients with eGFR at or above 20 who have type 2 diabetes and CKD, placing SGLT2 inhibitors as a co-first-line agent alongside metformin rather than a step-therapy fallback [14].

Alternative SGLT2 Inhibitors If Farxiga Remains Uncovered

If Affinity's current formulary places a non-preferred restriction on Farxiga that cannot be overridden, two other SGLT2 inhibitors may be on a preferred tier and carry similar evidence profiles.

Empagliflozin (Jardiance, 10 mg or 25 mg) demonstrated a 35% reduction in cardiovascular death or heart failure hospitalization in the EMPEROR-Reduced trial (N=3,730, hazard ratio 0.75 to 95% CI 0.65 to 0.86, P<0.001) [15]. The FDA approved empagliflozin for HFrEF in August 2021. Formulary placement on managed Medicaid plans varies, but Jardiance and Farxiga are often on the same tier within the same plan.

Canagliflozin (Invokana, 100 mg or 300 mg) has FDA approval for type 2 diabetes and for CKD in patients with type 2 diabetes based on the CREDENCE trial (N=4,401), which showed a 30% reduction in the composite of end-stage kidney disease, doubling of serum creatinine, or renal or cardiovascular death (hazard ratio 0.70 to 95% CI 0.59 to 0.82, P<0.001) [16]. Canagliflozin does not carry an HFrEF-specific label in the same way dapagliflozin does, so it is not a one-to-one substitute for patients whose primary indication is heart failure.

Switching between SGLT2 inhibitors for insurance reasons should always involve a conversation with the prescribing clinician. The indication-specific trial evidence differs between agents, and the decision should reflect the patient's primary diagnosis.

How to Verify Your Current Affinity Formulary

Formulary information changes annually and occasionally mid-year. The only authoritative source for your current plan year is Affinity's own online formulary search tool, available through the member portal at affinityplan.org, or by calling the member services number printed on your insurance card.

When checking formulary status, ask specifically for: the current tier placement of dapagliflozin (NDC prefix 00310 for the AstraZeneca product), the prior authorization criteria document for CPT/ICD-10 code associated with your diagnosis, whether step therapy applies and what the exception process requires, and the pharmacy benefit phone number for the PA submission team.

Your prescribing provider's office can also submit a formulary exception request simultaneously with a PA, arguing that the non-preferred drug (Farxiga) should be covered at the preferred tier because a clinically equivalent preferred drug does not exist for the specific indication. This argument is strongest for the HFrEF indication, where dapagliflozin has direct label approval and some alternatives do not.

Per CMS Medicaid managed care final rules (42 CFR Part 438), plans must respond to standard prior authorization requests within 14 calendar days and to expedited requests (when delay would seriously jeopardize health) within 72 hours [12]. Knowing these timelines helps patients and providers manage expectations and escalate appropriately if deadlines are missed.

Monitoring Requirements Once Coverage Is Approved

Once Farxiga is approved and dispensed, coverage continuity generally requires annual PA renewals. Supporting documentation for renewal typically includes a recent lab panel showing eGFR, UACR (for CKD indication), or A1C (for diabetes indication), plus a note that the patient has remained on therapy without significant adverse events.

Clinically, dapagliflozin requires baseline and periodic monitoring of: renal function (eGFR), since the drug loses glycemic efficacy below eGFR 45 mL/min/1.73 m² for the diabetes indication (though it retains renoprotective benefit down to eGFR 25 for the CKD indication); blood pressure, given the drug's modest diuretic and natriuretic effect (roughly 3 to 4 mmHg systolic reduction in clinical trials); and genital mycotic infection symptoms, which occurred in approximately 6.9% of women and 2.7% of men in the DECLARE-TIMI 58 trial [10].

The FDA label requires that dapagliflozin be held before any surgical procedure requiring general anesthesia (at least 3 days prior) due to the risk of euglycemic diabetic ketoacidosis [1]. Patients should carry documentation of this requirement to any pre-operative appointment, and the PA file should be updated if a temporary therapy hold is needed to avoid an automatic coverage termination.

The Endocrine Society's 2023 clinical practice guideline on pharmacological management of type 2 diabetes states that SGLT2 inhibitors should be preferred over other add-on agents in patients with type 2 diabetes and CKD or heart failure, and that treatment decisions should be made based on the presence of these comorbidities rather than on glycemic control alone [17]. Citing this guideline in a PA or appeal submission adds a second major society recommendation alongside the ADA Standards to reinforce the medical-necessity argument.