How Humana’s 2025 Medicare Advantage prior authorization criteria are tightening for new Alzheimer’s drugs Leqembi and Kisunla after CMS’s national coverage determination

How Humana’s 2025 Medicare Advantage Prior Authorization Criteria Are Tightening for New Alzheimer’s Drugs Leqembi and Kisunla After CMS’s National Coverage Determination

Humana’s 2025 Medicare Advantage (MA) formularies are putting stricter prior authorization (PA) requirements in place for two new Alzheimer’s therapies: Leqembi (lecanemab-irmb, Eisai/Biogen) and Kisunla (donanemab-azbt, Eli Lilly). Both therapies target amyloid beta plaques, and their coverage tracks directly with the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) that took effect July 6, 2023, and was updated mid-2024 for Kisunla. CMS now mandates registry participation and data submission to justify payment for these expensive, disease-modifying drugs. Insurers like Humana are translating that framework into day-to-day rules that decide whether patients get timely access or run into extra paperwork.

This analysis walks through Humana’s 2025 approach under that CMS direction, what documentation providers must now submit, how costs hit patients and plan budgets, and where pharmacists and benefits managers will feel the most administrative weight.

Background: CMS Sets the Coverage Framework

CMS NCD 200.3, finalized in July 2023, set one clear condition: anti-amyloid monoclonal antibodies for Alzheimer’s are covered under Medicare Part B only when used within FDA labeling and in CMS-approved registries collecting real-world outcome data. The move followed heavy public pressure after the uneven treatment of Aduhelm (aducanumab-avwa, Biogen), which created widespread confusion about what Medicare would actually fund.

By 2024, CMS expanded that rule to include both Leqembi and Kisunla once Kisunla gained FDA approval on July 2, 2024. National coverage now applies everywhere, but clinicians must prove amyloid pathology through PET imaging or CSF biomarker testing and document registry enrollment. Plans retain leeway to add PA checks as long as they stay within the framework.

Humana’s Translation of the CMS Rules

Under Medicare regulations, Humana’s MA-PD plans must mirror Part B coverage but can enforce compliance through their PA process. The 2025 Advanced Medical Necessity Criteria classify Leqembi and Kisunla within a special coverage group requiring clinical documentation and registry proof before approval.

Table 1. Coverage Classification for Anti-Amyloid Alzheimer’s Drugs (Humana MA, 2025)

Both must be billed through the medical benefit, not Part D. That means claims flow through Humana’s provider portal. The PA template aligns with CMS registry data fields but adds checks for PET or CSF confirmation and a neurologist’s diagnostic signature.

Where the Criteria Tighten in 2025

New Layers of Documentation

Last year’s Leqembi authorization asked for diagnosis, baseline cognitive tests, and basic amyloid proof. The 2025 form adds six new elements, and not trivial ones:

• Registry enrollment verification and a plan for ongoing data submission
• Neurologist statement confirming mild disease stage (CDR-Global 0.5-1.0)
• Recent MRI scan showing no extensive microhemorrhages or edema
• APOE ε4 genotype results to confirm risk discussion
• Evidence of infusion risk counseling for patient and family
• Signed consent aligned with CMS registry terms

Humana formalized these in an August 2024 utilization bulletin citing CMS’s focus on real-world safety tracking. The registry verification step changes workflow more than anything else.

Reauthorization and Duration Differences

Leqembi is ongoing therapy, indefinite infusions every two weeks. Kisunla gets dosed less often and can stop after amyloid clearance, usually around six cycles across 18 months. Humana structures reauthorizations accordingly:

• Leqembi: Renew at 12 months with proof of cognitive stability.
• Kisunla: Review after six doses or when amyloid clearance is documented; continuation requires neurologist explanation.

This cuts both ways. On the one hand, tighter oversight; on the other, a nod to different scientific rationales behind the two labels.

Facilities and Network Rules

These drugs must be infused in centers equipped for MRI monitoring and ARIA management. Humana now restricts coverage to “Certified Alzheimer’s Infusion Centers.” Claims from noncertified facilities will bounce unless pre-cleared for exception.

Earlier policy allowed greater flexibility, even home infusions in some markets. Not anymore. The company leans heavily on safety data, pointing to trial-reported ARIA rates exceeding 20% in major NEJM studies. Look, whether that’s a necessary precaution or an overcorrection depends on how much you trust site-level monitoring, personally, I think we’ll see that debated for years.

Cost Pressures Visible in the Data

CMS claims data from late 2024 peg Leqembi’s annual cost near $26,500 before administration, with Kisunla entering around $32,000. Each infusion costs another $400-$500 depending on locale.

Humana’s 2025 actuarial filings assume roughly 1,950 MA members on these therapies, up 30% year over year. The company expects over 90% of claims to need PA and recertification to manage that spending.

Table 2. 2024-2025 Projected Utilization Estimates for Anti-Amyloid Drugs (Humana MA-PD)

No mystery here: those numbers explain the policy tightening. When one drug class carries per-member costs triple typical Part B levels, pressure builds fast under capitation.

How Registry Rules Shift Day-to-Day Operations

CMS requires prescribers to enter each patient into an approved registry tracking demographics, outcomes, and adverse events. The main contract runs through the Alzheimer’s Network for Treatment and Outcomes (ANTO). Each claim includes a registry ID; Humana’s system cross-checks it before approval releases.

Pharmacists now coordinate more closely with neurology offices. Even though billing stays under Part B, details like registry numbers flow through pharmacy distribution records. Miss one piece, and claims hang in limbo, delayed payment, delayed scheduling, frustrated families.

CMS’s 2024 FAQ confirms these registries serve dual purposes: safety monitoring and future policy guidance. Humana repeats that line directly on its PA forms. The link between real-world data and ongoing reimbursement gives these forms sharper teeth than before.

Registry vs. Insurer Review

There are two separate checkpoints: CMS registry submission and insurer authorization. The table below outlines how they interact.

Table 3. Process Flow for Leqembi and Kisunla Authorizations (Humana MA, 2025)

How Humana Compares With Other Major Plans

UnitedHealthcare, Aetna, and Elevance Health have made similar moves, but Humana was first to bake registry verification directly into its electronic PA workflow. Others let registry confirmation come later, risking retroactive denials. Humana front-loads the check, less cleanup later, more friction up front.

Humana’s 2024 data show average four- to six-day PA turnaround under Part B. Adding registry cross-verification may push that closer to a week. Clinics planning ahead can save time by enabling direct EHR transmission of registry data through Availity Essentials, the preferred ePA link.

Clinical Boundaries Behind the PA Rules

Humana limits coverage to the FDA-labeled populations, mild cognitive impairment or mild dementia due to Alzheimer’s. That’s not arbitrary. The CLARITY-AD and TRAILBLAZER-ALZ2 trials found statistically significant slowing of decline only in early disease. Moderate and severe cases didn’t show measurable value.

So the rule stands. Insurers keep to evidence. Everything else would invite both wasted dollars and false hope.

Special MRI Monitoring Checks

ARIA risk runs around 13-14% for Leqembi, slightly higher for Kisunla, per 2023-2024 regulatory filings. Humana now requires MRIs at baseline, before the seventh infusion, and anytime symptoms suggest ARIA. Skip one, lose reauthorization. Simple as that.

Kisunla brings roughly 24% combined ARIA rates, but since therapy ends once plaques clear, PA approvals are time-limited. Facilities need tight tracking on number of doses, claim mismatches are common otherwise.

Cost-Sharing and Plan Design Impact

For Part B drugs, standard coinsurance is 20% unless plan design caps it. With Leqembi’s annual cost near $26,500, patients face about $5,000 out of pocket unless they hit a maximum or buy into a supplemental benefit. Some regional Humana plans now attach a “Part B Plus Rx” rider that limits such exposure to $2,000 per year, but it’s not widespread.

Employers running group retiree MA plans need to plan for this wave. Early Alzheimer’s therapy uptake sits squarely in the retiree demographic. Underestimating that utilization can blow up 2026 premium targets in a hurry.

Table 4. Approximate Cost-Sharing Scenarios for Leqembi and Kisunla (Humana MA 2025)