Medicare Coverage for Kisunla: What You Need to Know

Medicare covers Kisunla, but only under specific conditions

Kisunla (loncastuximab tesirine) is a cancer treatment approved by the FDA in 2023 for certain types of lymphoma. Medicare Part B covers Kisunla when it is given in a hospital outpatient setting or an infusion center, but coverage depends on your specific diagnosis, whether your doctor considers it medically necessary for your condition, and which Medicare plan you have.

The drug is expensive — the list price is several thousand dollars per dose — but you do not pay the full amount. How much you pay out of pocket depends on whether you have Original Medicare, a Medicare Advantage plan, or both, and what your plan's cost-sharing rules are.

Key Takeaways

Medicare Part B covers Kisunla when administered in a hospital outpatient department or infusion center, not when self-injected at home.
Your doctor must document that Kisunla is medically necessary for your specific type of lymphoma and that you meet the FDA-approved use.
Original Medicare covers 80 percent of the approved amount after you meet your Part B deductible; Medicare Advantage plans have different cost-sharing rules that vary by plan.
You should ask your doctor's office to check coverage with Medicare before your first infusion to understand your out-of-pocket costs.
If Medicare denies coverage, your doctor can request a review, and you have the right to appeal the decision.

How Medicare Part B covers Kisunla

Kisunla is classified as a Part B drug because it is administered by a healthcare provider in a medical setting, not taken at home. Part B covers drugs given in hospital outpatient departments, ambulatory surgery centers, and infusion clinics. The drug itself is covered under Medicare's Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) benefit when the setting meets Medicare's requirements.

Your doctor's office or infusion center will bill Medicare directly for the drug and the administration fee. You are responsible for your share of the cost after Medicare pays its portion. With Original Medicare, you pay 20 percent of the Medicare-approved amount after you have met your annual Part B deductible (which is $240 in 2024, though this amount changes yearly).

If you have a Medicare Advantage plan, your out-of-pocket cost depends on your specific plan's formulary and cost-sharing structure. Some plans cover Kisunla with a copay; others use coinsurance (a percentage of the cost). You should contact your plan directly to learn your exact cost-sharing amount before treatment begins.

When Medicare will and will not cover Kisunla

Medicare covers Kisunla only when it is used for an FDA-approved indication. Kisunla is approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who have already tried other treatments. If your lymphoma is a different type or stage, or if you have not yet tried standard treatments, Medicare may deny coverage.

Your doctor must submit documentation showing that you meet the approved use criteria. This documentation includes your pathology report confirming the type of lymphoma, records of prior treatments you have received, and a clinical note explaining why your doctor believes Kisunla is medically necessary for you. Medicare's medical review contractors examine this information before approving or denying coverage.

Medicare will also deny coverage if Kisunla is given in a setting that does not may have access to — for example, if you receive it at a doctor's office that is not set up as an approved infusion center. The setting must be enrolled in Medicare and meet specific requirements for administering chemotherapy and other complex drugs.

What you pay out of pocket

Your out-of-pocket cost for Kisunla depends on your Medicare plan type and your annual deductible status. If you have Original Medicare and have not yet met your $240 Part B deductible for the year, you pay the full cost of the drug and administration until the deductible is satisfied. After that, you pay 20 percent of the Medicare-approved amount for each infusion.

The Medicare-approved amount is not the same as the list price. Medicare negotiates rates with providers, and the approved amount is typically lower than what the drug manufacturer charges. Your 20 percent coinsurance is calculated on the approved amount, not the list price.

If you have a Medigap policy (supplemental insurance), it may cover some or all of your 20 percent coinsurance, depending on which Medigap plan you have. Plans G, F, and C cover Part B coinsurance; other plans cover it partially or not at all. Check your Medigap policy documents or call your Medigap insurer to confirm.

Medicare Advantage plans and Kisunla

Medicare Advantage plans (Part C) must cover all drugs that Original Medicare covers, but they can set their own cost-sharing amounts and may require prior authorization before you receive the drug. Some plans require your doctor to submit a request showing medical necessity before approving Kisunla; others approve it automatically if you meet the diagnosis criteria.

Your plan may also require you to use an in-network infusion center or hospital. If you go out of network, you may pay a higher cost-sharing amount or the plan may not cover the drug at all. Before scheduling your first infusion, call your Medicare Advantage plan and ask whether Kisunla is covered, what your copay or coinsurance will be, whether prior authorization is needed, and which infusion centers are in your plan's network.

Getting prior authorization and handling denials

Some Medicare plans require prior authorization, meaning your doctor must receive written approval from Medicare or your plan before you can receive Kisunla. Your doctor's office usually handles this request. They submit your medical records, pathology results, and treatment history to Medicare's medical review contractor, who decides whether to approve the drug for your specific situation.

Prior authorization typically takes 5 to 10 business days. If Medicare or your plan denies the request, your doctor receives a written explanation of the reason. Common reasons for denial include: the diagnosis does not match an FDA-approved use, you have not tried required prior treatments, or the infusion center is not Medicare-enrolled.

If your coverage is denied, you have the right to appeal. Your doctor can request a reconsideration and submit additional medical evidence. You can also file your own appeal with Medicare. The appeals process has multiple levels, and you can request a hearing before a Medicare administrative law judge if earlier appeals are denied. Your doctor's office can guide you through this process.

Questions to ask your doctor and Medicare

Before your first Kisunla infusion, ask your doctor's office these questions: Has Medicare or your plan approved Kisunla for your diagnosis? Will the infusion center bill Medicare directly, or will you receive a bill? What is the expected cost-sharing amount per infusion? How many infusions are planned, and over what time period?

Contact your Medicare plan (or Medicare directly if you have Original Medicare) and ask: Is Kisunla covered under my plan? Do I need prior authorization? What is my cost-sharing amount? Which infusion centers are in network? What should I do if I receive a bill I believe Medicare should have covered?

If you receive a bill that seems incorrect, do not ignore it. Contact your infusion center's billing department and ask them to verify that the claim was submitted to Medicare correctly. If there is a dispute, you can file a complaint with Medicare or your state's insurance commissioner.

Frequently Asked Questions

Will Medicare cover Kisunla if I have not tried other treatments yet?

No. Kisunla is approved only for lymphoma that has come back or stopped responding to prior treatments. Medicare will not cover it as a first-line treatment. Your doctor must document that you have already received standard treatments before Kisunla can be considered.

What if my infusion center is not in my Medicare Advantage plan's network?

Contact your plan before scheduling treatment. Out-of-network infusions may not be covered at all, or you may pay a much higher cost-sharing amount. Your plan may be able to grant an exception if there is no in-network center near you, but you need to request this in advance.

Can I get Kisunla at home instead of at an infusion center?

No. Kisunla must be administered by a healthcare provider in a medical setting. Medicare does not cover it for home infusion. If your doctor believes home infusion is medically necessary for you, they can request an exception, but this is rarely approved.

What happens if Medicare denies coverage and I receive the infusion anyway?

You may be responsible for the full cost of the drug and administration. Before proceeding with treatment after a denial, ask your doctor whether they believe an appeal will succeed and whether the infusion center will bill you directly if the appeal is pending.

Does my Medigap plan cover the cost-sharing for Kisunla?

It depends on which Medigap plan you have. Plans F, G, and C cover Part B coinsurance; other plans cover it partially or not at all. Check your Medigap policy or call your insurer to confirm what your plan covers for cancer drug coinsurance.

This guide is for general information only and is not medical, financial, legal, or other professional advice. For decisions specific to your situation, consult a qualified professional. See our Editorial Policy.