Does Affinity Health Plan Cover Trulicity?

What Is Trulicity and Why Does Formulary Placement Matter?

Trulicity is a once-weekly injectable GLP-1 receptor agonist approved by the FDA on September 18, 2014, for glycemic control in adults with type 2 diabetes. Its active ingredient, dulaglutide, stimulates insulin secretion, suppresses glucagon, and slows gastric emptying. The REWIND trial (N=9,901, median follow-up 5.4 years) demonstrated that dulaglutide 1.5 mg reduced the composite of major adverse cardiovascular events (MACE) by 12% versus placebo in patients with type 2 diabetes who had established or risk-factor-driven cardiovascular disease, with a hazard ratio of 0.88 (95% CI 0.79 to 0.99, P=0.026) [1].

That cardiovascular outcome data matters for insurance coverage because the FDA label update following REWIND gave prescribers a clinical argument for medical necessity beyond glucose control alone.

How GLP-1 Formulary Decisions Work

Pharmacy benefit managers (PBMs) negotiate rebates with manufacturers and assign drugs to formulary tiers. Tier 1 drugs are typically generics. Tier 2 covers preferred branded drugs. Tier 3 and Tier 4 are non-preferred or specialty drugs with higher member cost-sharing. Trulicity sits on Tier 3 or Tier 4 on the majority of Medicaid-managed care and commercial plans because competing GLP-1 agents (particularly liraglutide or semaglutide) may carry larger rebate arrangements with a given PBM in any plan year.

Affinity Health Plan's Formulary Structure

Affinity Health Plan operates primarily as a managed Medicaid and Child Health Plus plan in New York State, with some commercial and Medicare Advantage lines. Each product line maintains a separate formulary, updated annually every January 1. Because New York Medicaid sets GLP-1 coverage policy partly through the New York State Medicaid Drug Utilization Review (DUR) Board, Affinity's Medicaid formulary must comply with state-level step-therapy rules while still applying its own prior authorization criteria on top of those state rules.

For the most current formulary placement, members should check the Affinity Health Plan online formulary search tool at www.affinityplan.org or call Member Services at the number on their insurance card. Formularies change every plan year and mid-year exceptions can occur.

Prior Authorization Requirements for Trulicity on Affinity Plans

Prior authorization (PA) is the insurance process by which a prescriber submits clinical documentation to justify a drug's medical necessity before the plan will cover it. Affinity Health Plan typically requires PA for Trulicity across most of its product lines. Failing to obtain PA before dispensing means the claim will be denied at the pharmacy.

Typical Step-Therapy Criteria

Step therapy means the plan requires documented failure of, or contraindication to, a lower-tier drug before approving the requested agent. For Trulicity, Affinity's PA criteria commonly require:

• A confirmed diagnosis of type 2 diabetes (ICD-10: E11.x), not type 1
• Documentation that the member has tried metformin at an adequate dose (typically 1,000 to 2,000 mg/day) for at least 90 days, or has a documented contraindication such as eGFR <30 mL/min/1.73 m²
• In some plan years, documented trial of a sulfonylurea (e.g., glipizide or glimepiride) or a DPP-4 inhibitor
• HbA1c above the plan's threshold (often >7.5% or >8.0%) despite the step agents
• Prescriber attestation of the cardiovascular risk profile if the PA request cites the REWIND cardiovascular outcome data

The American Diabetes Association (ADA) 2024 Standards of Care recommend a GLP-1 receptor agonist with proven cardiovascular benefit for patients with type 2 diabetes and established atherosclerotic cardiovascular disease, regardless of baseline HbA1c [2]. Citing that guideline language in the PA request substantially strengthens the clinical justification.

How Long Prior Authorization Takes

Most PA decisions under New York State managed care regulations must be rendered within 3 business days for non-urgent requests and 72 hours (or sooner) for urgent requests. If Affinity denies the PA, the prescriber has the right to request a peer-to-peer review with the plan's medical director, which is one of the most effective interventions for overturning a denial.

What Trulicity Costs Without or With Coverage

Understanding list price versus net cost shapes the negotiating strategy when dealing with a PA denial.

List Price and AWP

Trulicity's average wholesale price (AWP) in 2024 was approximately $924 to $986 for a 4-pen carton (a roughly 28-day supply at once-weekly dosing). That figure represents the pre-rebate, pre-negotiation list price. Almost no patient pays AWP directly, but it sets the baseline for copay calculations on Tier 3 and Tier 4 formulary placements.

Member Cost-Sharing on Affinity Plans

On a typical Affinity commercial plan with Tier 3 placement, a member might owe 25 to 40% coinsurance after meeting the deductible. On Tier 4 specialty, cost-sharing may reach 30 to 50% coinsurance, translating to $275, $490 out-of-pocket per month. Medicaid members generally face minimal or no cost-sharing for covered drugs under New York Medicaid rules, but coverage is conditional on the PA being approved.

Eli Lilly's Savings Programs

Eli Lilly operates the Lilly Cares Foundation patient assistance program for uninsured or underinsured patients who meet income requirements (generally at or below 400% of the Federal Poverty Level) [3]. Commercially insured patients who do not use government insurance may qualify for the Lilly savings card, which has capped monthly costs for eligible patients. These programs do not apply to Medicaid or Medicare beneficiaries under federal anti-kickback rules.

How to Get Trulicity Approved on Affinity Health Plan

A systematic approach to prior authorization dramatically improves approval rates. The following framework reflects standard practice guidance from clinical pharmacists and endocrinologists who manage high-volume PA workflows.

Step 1: Confirm Formulary Status Before Writing the Prescription

Have the prescriber's office or the patient check the exact formulary year and Affinity product line (Medicaid, Child Health Plus, commercial, Medicare Advantage) before submitting. The National Drug Code (NDC) matters. Affinity may cover the 0.75 mg dose on a different tier than the 1.5 mg dose.

Step 2: Gather All Required Clinical Documentation

The PA packet should include:

• Current HbA1c lab result (dated within 6 months)
• List of all prior diabetes medications with start dates, doses, duration, and reason for discontinuation or inadequate response
• Any diagnoses of atherosclerotic cardiovascular disease, chronic kidney disease (CKD), or heart failure, with supporting records
• Office notes documenting the prescriber's rationale for choosing dulaglutide specifically

Step 3: Reference Guideline Language Explicitly

The ADA 2024 Standards of Care state: "For patients with type 2 diabetes and established cardiovascular disease... A GLP-1 receptor agonist with proven cardiovascular benefit is recommended." [2] Quoting that sentence directly in the PA letter ties the clinical decision to a national guideline and makes denial harder to sustain.

Step 4: Request a Peer-to-Peer if Denied

A 2022 analysis published in Health Affairs found that physician peer-to-peer calls resolved prior authorization disputes in favor of the prescriber in approximately 75% of cases when the prescriber participated directly rather than delegating to staff [4]. Schedule the call, prepare a 3-minute clinical summary, and reference both the REWIND data and ADA guidelines.

Step 5: File a Formal Appeal if the Peer-to-Peer Fails

New York State law (NY Public Health Law §4910) gives members the right to an internal appeal and then an external appeal through an independent organization. External appeals in New York are binding on the insurer. A 2019 New York State Department of Financial Services report found that external appeal decisions favored the member in approximately 47% of cases statewide, across all drug classes [5].

Clinical Alternatives if Trulicity Remains Uncovered

If Affinity denies Trulicity after exhausting PA and appeals, several GLP-1 and non-GLP-1 alternatives may carry more favorable formulary placement.

Other GLP-1 Receptor Agonists

Semaglutide (Ozempic, 0.5 mg, 1 mg, or 2 mg weekly injection) is FDA-approved for type 2 diabetes and demonstrated a 26% reduction in MACE in the SUSTAIN-6 trial (N=3,297, hazard ratio 0.74, 95% CI 0.58 to 0.95, P<0.001 for non-inferiority, P=0.02 for superiority) [6]. Some Affinity formularies place Ozempic on a more favorable tier than Trulicity in a given plan year, depending on rebate contracts.

Liraglutide (Victoza, 1.2 mg or 1.8 mg daily injection) showed a 13% MACE reduction in the LEADER trial (N=9,340, hazard ratio 0.87, 95% CI 0.78 to 0.97, P<0.001 for non-inferiority) [7]. It has a longer track record on many Medicaid formularies and may be Tier 2 preferred on some Affinity plans.

Exenatide extended-release (Bydureon BCise, 2 mg weekly) is a lower-cost branded option and in some states has generic or authorized-generic pathways that reduce member cost-sharing.

SGLT-2 Inhibitors as a Complementary or Alternative Path

If a GLP-1 is entirely inaccessible, the ADA 2024 Standards of Care also recommend SGLT-2 inhibitors (empagliflozin, canagliflozin, dapagliflozin) for patients with type 2 diabetes and atherosclerotic cardiovascular disease or CKD [2]. Empagliflozin reduced cardiovascular mortality by 38% versus placebo in the EMPA-REG OUTCOME trial (N=7,020, hazard ratio 0.62, 95% CI 0.49 to 0.77, P<0.001) [8]. These agents carry different formulary placements and PA criteria and may be more accessible on a given Affinity plan.

Understanding Your Affinity Plan Type and Why It Changes the Answer

Not every Affinity member is on the same plan. The coverage answer for Trulicity differs meaningfully across Affinity's product lines.

Medicaid Managed Care

New York Medicaid covers a broad range of diabetes medications, but GLP-1 agents typically require PA and step therapy as described above. Cost-sharing for approved drugs is minimal (often $0, $3 copay for Medicaid members). The state's Medicaid Drug Utilization Review Board reviews GLP-1 policies periodically, so coverage rules may shift between years.

Child Health Plus

Child Health Plus is New York's state-subsidized plan for children. Trulicity is not commonly prescribed in pediatric populations, and the FDA label for dulaglutide specifies adult use. Pediatric use off-label for adolescent type 2 diabetes has been studied but FDA approval in that age group has not been granted as of the 2025 publication date of this article [9].

Commercial Plans

Affinity's commercial lines (employer-sponsored and individual market) follow their own formularies negotiated with a PBM. These vary by employer group contract. Some employer groups have carved out the pharmacy benefit to a separate PBM, meaning Affinity's formulary document may not apply. Always confirm with the PBM printed on the prescription insurance card, not the medical insurance card.

Medicare Advantage

Affinity Medicare Advantage plans have a Part D drug benefit. Each plan files its formulary annually with CMS. Medicare Part D plans are prohibited from excluding all drugs in a therapeutic class, but they can require PA and step therapy. The CMS Medicare Plan Finder (medicare.gov) allows members to check exact 2025 Part D cost-sharing for dulaglutide by plan and pharmacy.

What Prescribers Should Document to Maximize Approval Odds

Physician documentation quality is the single largest modifiable factor in PA outcome. Sparse chart notes that say only "patient needs Trulicity" are denied far more often than notes that contain specific clinical reasoning.

Cardiovascular Risk Documentation

Prescribers should document in the chart, explicitly, whether the patient has:

• Established atherosclerotic cardiovascular disease (prior MI, stroke, or peripheral arterial disease)
• Multiple cardiovascular risk factors (age 55+ with hypertension, dyslipidemia, or smoking history)
• CKD (eGFR 15 to 60 mL/min/1.73 m², albuminuria >300 mg/g)
• Heart failure (HFrEF or HFpEF)

The REWIND trial enrolled patients with either established cardiovascular disease (31.5% of the population) or cardiovascular risk factors only (68.5%), which means the CV benefit argument in the PA letter applies to a wide population, not just those with prior cardiac events [1].

Weight and Metabolic Considerations

The AWARD-11 trial (N=1,842) showed that dulaglutide 4.5 mg (a higher dose than FDA-approved for type 2 diabetes but studied for potential weight indications) produced 10.0% body-weight reduction at 36 weeks versus 6.5% for the 1.5 mg dose [10]. For patients where weight reduction is a documented clinical goal alongside glycemia, noting baseline BMI and target weight in the PA request adds clinical depth.

Frequently Asked Questions