Does Affinity Health Plan Cover Trulicity?

What Is Trulicity and Why Does Insurance Coverage Matter?

Trulicity (dulaglutide) is a once-weekly injectable GLP-1 receptor agonist manufactured by Eli Lilly. The FDA approved it in September 2014 for glycemic control in type 2 diabetes, and a second indication for cardiovascular risk reduction followed in 2020, based on the REWIND trial. [1] Because a single 4-pen box carries a wholesale acquisition cost near $985, insurance authorization determines whether patients can realistically afford it.

GLP-1 receptor agonists work by mimicking endogenous glucagon-like peptide-1, stimulating glucose-dependent insulin secretion, slowing gastric emptying, and reducing appetite. [2] Dulaglutide is available in four dose strengths: 0.75 mg, 1.5 mg, 3 mg, and 4.5 mg, each delivered by a single-use autoinjector pen once weekly. The 3 mg and 4.5 mg doses were approved in 2020 specifically to improve glycemic control further in patients who needed more than 1.5 mg. [1]

For members enrolled in a Medicaid managed care plan, the stakes are especially high. Most Medicaid beneficiaries have minimal disposable income. A prior authorization denial, an incorrect formulary lookup, or a missing step-therapy exception can leave a patient without medication for weeks. Understanding exactly how Affinity Health Plan handles Trulicity reduces that risk.

In the REWIND trial (N=9,901, median follow-up 5.4 years), dulaglutide 1.5 mg weekly reduced the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death by 12% relative to placebo (HR 0.88; 95% CI 0.79 to 0.99; P=0.026). [3] That cardiovascular outcome data strengthened the clinical case prescribers make when requesting prior authorization for higher-risk patients.

Who Is Affinity Health Plan?

Affinity Health Plan is a not-for-profit managed care organization headquartered in the Bronx, New York. It primarily serves members enrolled in Medicaid Managed Care, the Child Health Plus program, and New York State's Essential Plan. Affinity does not offer commercial large-group insurance or Medicare Advantage products in the same way that national payers do, which shapes how its pharmacy benefit is structured.

New York Medicaid managed care plans are required by the New York State Department of Health to cover all drugs in the State's Medicaid Preferred Drug Program (PDP) list without prior authorization if a prescriber certifies clinical appropriateness. [4] Drugs outside the preferred list, including some GLP-1 agents at certain dose levels, may still require a prior authorization request submitted through Affinity's pharmacy benefit manager.

Affinity contracts with a pharmacy benefit manager to adjudicate claims in real time at the pharmacy. That PBM relationship, and the current New York State Medicaid PDP list, defines what a member will pay, not a separate Affinity-specific drug formulary created in isolation.

Does Affinity Health Plan Cover Trulicity?

Affinity Health Plan may cover Trulicity for members with a documented diagnosis of type 2 diabetes mellitus (ICD-10 E11.xx), subject to prior authorization criteria. Coverage is not automatic, and the plan typically applies step therapy requirements before approving a branded GLP-1 agonist.

New York State Medicaid's Preferred Drug Program classifies GLP-1 receptor agonists as a drug class requiring clinical prior authorization for most agents. [4] As of 2024, the preferred agents within this class on the New York Medicaid PDP list have shifted in response to rebate negotiations, so the tier status of Trulicity specifically should be verified against the current published PDP list at time of prescribing.

The general prior authorization criteria Affinity applies for GLP-1 agents including Trulicity typically include:

Diagnosis requirement. The member must have a confirmed diagnosis of type 2 diabetes mellitus. Trulicity is not FDA-approved for type 1 diabetes, and its use in that setting is generally not covered by Medicaid managed care plans.

Step therapy. The member must have a documented trial of metformin (unless contraindicated by renal function, eGFR <30 mL/min/1.73m², or gastrointestinal intolerance) and often one additional agent such as a sulfonylurea or SGLT-2 inhibitor, with documented inadequate response or intolerance.

HbA1c threshold. Most prior authorization templates require a recent HbA1c result, frequently above 7.5% or 8.0%, to demonstrate suboptimal control on existing therapy.

Prescriber type. Some Medicaid managed care prior authorization templates give faster approval pathways when the request comes from an endocrinologist rather than a primary care provider, though either can submit.

Quantity limits. Even after approval, quantity is typically limited to four pens per 28-day supply, matching the approved once-weekly dosing schedule.

If Affinity denies a Trulicity prior authorization request, the prescriber can submit a peer-to-peer appeal, and the member can request a fair hearing through the New York State Office of Temporary and Disability Assistance.

How Prior Authorization Works in Practice

Prior authorization for Trulicity through Affinity typically follows a four-step sequence, and knowing each step reduces unnecessary delays.

Step 1: Prescriber submits PA request. The prescriber or their office staff submits a prior authorization form to Affinity's pharmacy benefit manager. This form should include the member's current HbA1c, list of prior diabetes medications with dates and documented reasons for discontinuation or failure, relevant comorbidities (cardiovascular disease, chronic kidney disease, obesity), and the requested dose.

Step 2: Affinity clinical review. A pharmacist or nurse reviewer at the PBM evaluates the request against criteria. Standard review takes up to 72 hours for non-urgent requests and 24 hours for urgent clinical situations under New York State Medicaid rules. [4]

Step 3: Approval or denial. If approved, an authorization number is generated and the member can fill the prescription at any in-network pharmacy. If denied, written notice is sent to both the prescriber and the member with the specific reason.

Step 4: Appeal if denied. The prescriber has 60 days from the denial date to submit a reconsideration. The member has 90 days to request a State fair hearing. Step-therapy exception requests citing the American Diabetes Association's Standards of Medical Care, which recommend individualized therapy based on comorbidities, are frequently persuasive at appeal. [5]

The ADA's 2024 Standards of Medical Care state that "for patients with type 2 diabetes and established cardiovascular disease or indicators of high cardiovascular risk, a GLP-1 receptor agonist with proven cardiovascular benefit is recommended." [5] Including that specific guideline language in a prior authorization appeal letter consistently strengthens the clinical argument.

What Will a Member Actually Pay?

For Medicaid members, the cost-share for an approved Trulicity prescription is governed by New York State Medicaid rules rather than a negotiated commercial copay tier. Under New York Medicaid, most beneficiaries pay $0 to $3 per prescription for covered drugs. [4] The practical cost to an Affinity Medicaid member who obtains prior authorization approval is often $0 or a nominal copay well below $5.

Essential Plan members, who earn between 139% and 200% of the federal poverty level and pay no premiums, typically have low fixed copays for prescription drugs, generally $0 for preferred drugs and up to $3 for non-preferred drugs on the Essential Plan formulary. [4]

Members who are denied coverage and choose to pay cash face a very different situation. The 2024 cash price for Trulicity 1.5 mg (4 pens, 28-day supply) ranges from approximately $850 to $1,020 depending on the pharmacy. GoodRx and manufacturer savings cards can reduce that figure but rarely to a level manageable on a Medicaid income.

Eli Lilly operates a patient assistance program called the Lilly Insulin Value Program, and its broader Lilly Cares Foundation program may provide Trulicity at no cost to uninsured or underinsured patients meeting income criteria. [6] Patients whose prior authorization is denied while an appeal is pending should ask their prescriber to contact Lilly Cares directly as a bridge option.

Clinical Evidence Supporting Trulicity Coverage Requests

Building a strong prior authorization request means referencing the evidence Affinity's clinical reviewers are trained to weigh. Three trials are most relevant.

AWARD-5 (N=1,098). In this 52-week randomized controlled trial, dulaglutide 1.5 mg reduced HbA1c by 1.1 percentage points from a baseline of approximately 8.1%, compared with 0.6 percentage points for sitagliptin 100 mg (P<0.001). [7] This positions dulaglutide favorably against DPP-4 inhibitors when step therapy has already included a DPP-4 inhibitor.

AWARD-2 (N=807). Dulaglutide 1.5 mg reduced HbA1c by 1.08 percentage points versus 0.63 percentage points for insulin glargine at 52 weeks (P<0.001), with a mean weight difference of approximately 3 kg in favor of dulaglutide. [8] For patients in whom weight gain on insulin is a concern, this trial supports the case for GLP-1 therapy.

REWIND (N=9,901, median 5.4 years). As noted above, dulaglutide 1.5 mg produced a 12% relative risk reduction in major adverse cardiovascular events versus placebo in patients with type 2 diabetes and either established cardiovascular disease or cardiovascular risk factors. [3] For an Affinity member with hypertension, prior MI, or chronic kidney disease, citing REWIND directly in the prior authorization request often moves the request from "step therapy required" to "approved with documented indication."

The FDA label for Trulicity also explicitly states the cardiovascular risk reduction indication. [1] Quoting both the label and REWIND simultaneously in a PA request leaves minimal room for a clinical reviewer to argue the therapy is experimental or not guideline-supported.

Alternatives to Trulicity That Affinity May Prefer

If prior authorization for Trulicity is denied or the step-therapy clock needs to start, Affinity may approve one of the following alternatives more readily, either because they sit on a preferred tier of the New York Medicaid PDP or because generic or biosimilar versions have reduced the plan's cost.

Metformin (generic). Cost to Medicaid is near $0. The American Diabetes Association still recommends metformin as first-line therapy for most patients with type 2 diabetes and an HbA1c <10%, and demonstrating a metformin trial satisfies the first step-therapy requirement for any GLP-1 PA request. [5]

Ozempic (semaglutide 0.5 mg to 2 mg weekly). Semaglutide has stronger cardiovascular outcome data from SUSTAIN-6 (N=3,297; HR 0.74 for MACE, P<0.001 for noninferiority, P=0.02 for superiority) and the FLOW trial for renal protection. [9] New York Medicaid may have negotiated a more favorable rebate for semaglutide in certain contract years, making it a preferred alternative.

Victoza (liraglutide 1.2 mg to 1.8 mg daily). The LEADER trial (N=9,340; HR 0.87 for MACE; P=0.01 for superiority) established liraglutide's cardiovascular benefit. [10] Once-daily injection is a drawback versus once-weekly dulaglutide, but it may sit on a preferred formulary tier.

Jardiance (empagliflozin). An SGLT-2 inhibitor rather than a GLP-1 agent, but the EMPA-REG OUTCOME trial (N=7,020; HR 0.86 for MACE; P=0.04 for superiority) supports its use in high-risk patients. [11] Medicaid plans sometimes prefer SGLT-2 inhibitors as an add-on before approving GLP-1 therapy.

If a provider has clinical reasons to prefer dulaglutide over these alternatives (for example, renal function precluding SGLT-2 use, gastrointestinal intolerance to daily liraglutide, or established cardiovascular disease with prior response to dulaglutide), those reasons should be documented explicitly in the PA form.

How to Appeal a Denial

A prior authorization denial for Trulicity from Affinity is not the end of the road. The appeals process has defined timelines, and most denials that are appealed with complete clinical documentation are overturned at least partially.

Expedited reconsideration. If the prescriber believes that waiting the standard review period poses an urgent health risk, an expedited request triggers a 72-hour maximum response window under New York Medicaid managed care rules. [4]

Peer-to-peer review. The prescriber can request a direct phone call with Affinity's medical director or the PBM's reviewing physician. In that call, the prescriber can cite REWIND, the ADA 2024 Standards, and the specific FDA-labeled cardiovascular indication. Peer-to-peer calls resolve a meaningful share of denials without requiring a formal fair hearing.

State fair hearing. Any Medicaid member whose claim is denied retains the right to request a fair hearing through New York State. The member must request the hearing within 90 days of receiving the written denial notice. While a hearing is pending, the plan is required to continue covering the disputed service under the "aid continuing" rule if the member requests the hearing within 10 days of the denial.

Exception for step therapy. New York State Public Health Law Section 4904 requires health plans to grant a step-therapy exception when the required prior medication is contraindicated, has already failed, or when starting step therapy would cause clinically significant harm. [4] Documenting that the patient has already failed metformin plus a second agent, or that metformin is contraindicated due to eGFR <30 mL/min/1.73m², satisfies this exception for most reviewers.

Practical Steps to Get Trulicity Covered by Affinity Today

Navigating the prior authorization process efficiently comes down to front-loading the documentation before the prescription is sent to the pharmacy.

First, the prescriber's office should call Affinity Member Services at 1-800-553-1918 to confirm the current formulary tier for dulaglutide and obtain the exact prior authorization form and fax number for the pharmacy benefit manager.

Second, pull a current HbA1c result, no older than three months, and a medication history showing prior diabetes drug trials with start dates, stop dates, and documented reasons for stopping.

Third, identify any cardiovascular comorbidities. A chart note stating "patient has established atherosclerotic cardiovascular disease per ACC/AHA criteria" and citing REWIND supports the FDA-labeled second indication and frequently moves the request from a glycemic-only review to a cardiovascular-risk-reduction review, which has a different (and often more permissive) approval pathway.

Fourth, submit the PA request with all supporting documentation at the same time, not in piecemeal installments. Incomplete submissions are a leading cause of delays.

Fifth, if the member cannot wait for the PA to resolve, contact Lilly Cares Foundation (1-800-545-5979) to request a bridge supply while authorization is pending. [6]

A well-constructed prior authorization request for Trulicity submitted to Affinity Health Plan, with HbA1c documentation, prior therapy failure evidence, and a cardiovascular comorbidity citation referencing REWIND's HR of 0.88 (P=0.026), gives the prescriber the strongest possible position for approval on the first submission.