Does Medicare Cover Nemluvio? Part D, Prior Authorization, and Appeals

Medicare can cover Nemluvio, but only through Part D, and only if the specific plan lists it. Part B does not pay for Nemluvio because the drug is a self-injected biologic that Medicare treats as self-administered. Whether any given Part D plan covers it depends on that plan’s formulary, and coverage almost always comes with prior authorization and quantity limits. Patients whose plans exclude Nemluvio can request a formulary exception, appeal a denial, or apply to the manufacturer’s patient assistance program.

Why Part B Will Not Pay

Medicare Part B covers drugs a clinician administers in a medical setting. Drugs patients usually give themselves are excluded by regulation, and CMS presumes any subcutaneous injection is self-administered unless the record shows otherwise.¹ Nemluvio comes as a prefilled pen the patient injects at home after training, and as of June 2026 CMS formally added it to the Self-Administered Drug exclusion list under HCPCS codes J3490 and J3590.² Even an injection given in a doctor’s office will not be billable to Part B.

Part D Coverage Depends on Your Plan

Part D is where Nemluvio belongs, but each Part D plan builds its own formulary, so coverage varies. Independence Blue Cross, for example, lists Nemluvio on its 2026 Premium Formulary at Tier 2, subject to prior authorization, specialty pharmacy dispensing, and quantity limits.³ Other plans may place it on a different tier, add stricter restrictions, or leave it off entirely. The only reliable way to know is to search your plan’s formulary or call the plan directly.

The list price of Nemluvio is roughly $4,240 per pen, so plan coverage matters a great deal.

Prior Authorization Criteria

Plans that cover Nemluvio almost always require prior authorization before dispensing. Common criteria include:

A confirmed diagnosis and prescription from or in consultation with a dermatologist, allergist, or immunologist.
For atopic dermatitis, at least 28 consecutive days on a medium-to-high-potency topical corticosteroid with inadequate results, plus involvement of at least 10% of body surface area.⁴
For prurigo nodularis, at least 20 identifiable nodules, pruritus lasting six weeks or more, and failure of prior topical treatments.⁵
No concurrent use of another biologic immunomodulator or a JAK inhibitor.⁴

Initial approvals are often limited to four months. To continue past that, the prescriber must document that the patient is responding, at which point plans typically extend authorization for up to a year.

Quantity Limits

Most plans cap each fill at a 28-day supply, matching the every-four-weeks dosing schedule. The loading dose, which uses two pens at once, may need its own prior authorization. Some plans allow up to a three-month supply per fill.⁵

What You Will Actually Pay

For 2026, the Part D deductible is $615, after which cost-sharing depends on the drug’s tier under the plan.⁶ Under the Inflation Reduction Act, total out-of-pocket spending on covered Part D drugs is capped at $2,100 per year. Once you reach that cap, you pay nothing more for covered prescriptions for the rest of the year.⁷ Given Nemluvio’s price, most patients on a covering plan will hit the cap quickly.

One catch: money you spend on a drug your plan does not cover does not count toward the $2,100 cap.⁷ If your plan excludes Nemluvio and you pay cash, those dollars do not help you reach the ceiling.

Extra Help for Low-Income Beneficiaries

Medicare’s Extra Help program (the Low-Income Subsidy) cuts costs sharply for people who qualify. Enrollees pay no Part D premium, no deductible, and no more than $12.65 per brand-name drug in 2026, with copays dropping to $0 once total drug costs reach $2,100.⁸ For a specialty biologic at Nemluvio’s price, this can be the difference between staying on treatment and stopping.

If Your Plan Denies Coverage

Two paths open up when a Part D plan refuses to cover Nemluvio: a formulary exception request and, if that fails, a formal appeal.

Formulary Exceptions

Any Part D enrollee, or their prescriber, can ask the plan to cover a non-formulary drug. The prescriber submits a supporting statement explaining why covered alternatives would be less effective or would cause adverse effects. The plan must respond within 72 hours for a standard request, or 24 hours if expedited.⁹ If granted, the exception generally lasts through the rest of the calendar year, as long as the prescription continues and the drug remains appropriate.¹⁰

Appeals

A denial of either a prior authorization or a formulary exception can be appealed. The first step, redetermination by the plan, must be filed within 65 days of the denial, and the plan has 7 days to respond (72 hours if expedited). If that fails, four further levels are available: review by an Independent Review Entity, an Administrative Law Judge hearing, the Medicare Appeals Council, and federal district court. Each denial notice explains how to move to the next level.¹¹ Free help with any stage is available through the State Health Insurance Assistance Program (SHIP).¹²

Manufacturer Assistance for Medicare Patients

Galderma runs several support programs for Nemluvio, but the ones that matter for Medicare beneficiaries are different from those offered to commercially insured patients.

First, a boundary. Anyone enrolled in Medicare, Medicare Advantage, Medicaid, TRICARE, or any other federal or state health program is barred from the GPS for Nemluvio Commercial Copay Program and the Quick Start Program.¹³ This is federal anti-kickback law, not a Galderma choice, and no workaround exists.

Bridge Program

Medicare patients already on Nemluvio who hit a temporary coverage gap, for example during a plan change or a pending re-authorization, may qualify for the Bridge Program. It supplies up to three months of free medication while the prescriber pursues coverage. Eligibility ends once coverage is obtained or a final determination is made.¹³

Patient Assistance Program

For Medicare Part D beneficiaries who cannot afford Nemluvio or whose plans do not cover it, Galderma’s Patient Assistance Program can supply the drug at no cost for the rest of the calendar year. Applicants must show financial need through automatic income verification or by reporting household income on the enrollment form; specific income thresholds are not published.¹⁴ If you use the PAP, notify your Part D plan and make sure the free medication is not counted toward your True Out of Pocket (TrOOP) expenses.¹³

Enrollment is available at galdermaps.iassist.com or by calling 1-855-636-5884, Monday through Friday, 8:00 AM to 8:00 PM Eastern.¹⁵

1
CMS. Self-Administered Drug Exclusion List
2
CMS. Self-Administered Drug Exclusion List
3
Independence Blue Cross. 2026 Premium Formulary
4
Cigna. Nemluvio Coverage Position Criteria
5
Nemluvio HCP. Nemluvio Access Toolkit
6
UnitedHealthcare. Part D Changes
7
PAN Foundation. Understanding the Medicare Part D Cap
8
Medicare.gov. Get Help With Drug Costs
9
CMS. Medicare Part D Exceptions
10
Cornell Law Institute. 42 CFR § 423.578 – Exceptions Process
11
Medicare.gov. Drug Plan Appeals
12
Medicare.gov. Medicare Appeals
13
Galderma. GPS for Nemluvio Terms and Conditions
14
Nemluvio HCP. Nemluvio Enrollment Form
15
Nemluvio. Galderma Patient Services