Medications
Crizotinib (Xalkori)
A twice-daily capsule or pellet (Xalkori) for lung cancer and certain other tumors whose cells carry ALK or ROS1 gene changes; it blocks the faulty ALK/ROS1 growth signals (a tyrosine kinase inhibitor) that drive those cancers.
How Medicare covers it
Part D (forms used at home). Part A during a covered inpatient stay. No Part B clinician-administered form in the CMS Part B spending file.
| Coverage details | |
|---|---|
| Part B status | No crizotinib row in the CMS Part B Spending by Drug HCPCS file (RY26, data through 2024) — no J-code basis; coverage path is Part D. |
| Medicare Advantage | Most Medicare Advantage plans that include drug coverage (MAPD plans) use the same formulary-and-tier system; the plan's own drug list decides coverage and copay — check the plan's formulary. |
| Medicare Supplement (Medigap) | Medicare Supplement (Medigap) plans sold today do not include prescription drug coverage; drug coverage comes from Part D or an MAPD plan. |
What it treats
Xalkori (crizotinib) is a targeted cancer medicine that treats: adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, as detected by an FDA-approved test; children 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive (its safety and efficacy have not been established in older adults with ALCL); and adults and children 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
What it is for, in depth
Xalkori is a targeted (precision) cancer drug: it only works in tumors driven by ALK or ROS1 gene changes, so an FDA-approved tumor test is used to select patients. It treats metastatic ALK- or ROS1-positive non-small cell lung cancer in adults, relapsed or refractory ALK-positive anaplastic large cell lymphoma in children 1 year and older and young adults, and unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors in adults and children 1 year and older. Adults take 250 mg capsules twice a day; children are dosed by body surface area (280 mg/m2 twice a day), and oral pellets are available for patients who cannot swallow capsules. The signature side effect is vision disturbance, which is usually mild but can rarely be severe, and the drug also requires close monitoring of the liver, heart rate and rhythm, and blood counts. Treatment continues until the cancer progresses or toxicity becomes unacceptable.
How it works
Crizotinib is a kinase inhibitor. It blocks receptor tyrosine kinases including ALK, hepatocyte growth factor receptor (HGFR, c-Met), ROS1, and RON. In some cancers, gene translocations create ALK fusion proteins that are switched on all the time, driving cancer cells to grow and survive. Crizotinib blocks the phosphorylation (activation) of ALK, ROS1, and c-Met in tumor cells in a dose-dependent way and showed antitumor activity in animal tumor models, which slows or stops the growth of tumors carrying these changes.
How it is taken
Xalkori is taken by mouth, with or without food. For metastatic NSCLC in adults, and for IMT in adults, the recommended dose is 250 mg twice daily. For ALCL and for IMT in children, the dose is 280 mg per square meter of body surface area twice daily. Treatment continues until the disease progresses or side effects become unacceptable, with dose interruptions and reductions for toxicity, and lower doses for moderate or severe liver impairment or severe kidney impairment. During treatment, liver function tests are checked every 2 weeks for the first 2 months and then monthly, blood counts are checked weekly for the first month and then at least monthly, and eye examinations are done for children and young adults with ALCL and children with IMT. Xalkori comes as 200 mg and 250 mg capsules and as oral pellets in 20 mg, 50 mg, and 150 mg capsules (the pellets are for patients, such as young children, who cannot swallow capsules). Capsules should be swallowed whole.
Common side effects
In adults with NSCLC, the most common side effects (25% or more) were vision disorders, nausea, diarrhea, vomiting, edema (swelling), constipation, elevated transaminases (liver enzymes), fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. In patients with ALCL, the most common (35% or more) were diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis (mouth sores), fatigue, decreased appetite, fever, abdominal pain, cough, and itching, with grade 3–4 drops in neutrophils, lymphocytes, and platelets in 15% or more. In adults with IMT, the most common were vision disorders, nausea, and edema; in children with IMT, vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory infection, cough, fever, musculoskeletal pain, fatigue, edema, constipation, and headache.
Serious warnings
Xalkori can cause serious problems. Liver toxicity (hepatotoxicity) has been fatal in 0.1% of NSCLC patients in trials, and liver tests must be monitored, with the drug suspended, reduced, or permanently stopped for significant elevations. Interstitial lung disease/pneumonitis (lung inflammation) can be life-threatening and requires permanent discontinuation. Xalkori can prolong the QT interval of the heart, which can lead to dangerous rhythms, so ECGs and electrolytes should be monitored in patients at risk. It can cause bradycardia (very slow heart rate), so heart rate and blood pressure should be monitored regularly. Vision problems are common, and severe visual loss can occur — patients should be monitored and evaluated for eye toxicity, and Xalkori stopped in patients with severe visual loss. In children and young adults with ALCL and children with IMT, severe nausea, vomiting, diarrhea, and stomatitis can occur, and standard anti-nausea and anti-diarrhea medicines should be provided. Xalkori can cause fetal harm, so females of reproductive potential must use effective contraception.
Who should be careful
There are no absolute contraindications in the Xalkori label, but patients for NSCLC must be selected based on ALK or ROS1 positivity in the tumor using an FDA-approved test. Tell your doctor if you have liver or kidney impairment (dose adjustments apply for moderate or severe liver impairment and severe kidney impairment), a history of QT prolongation or slow heart rate, or if you take medicines that prolong the QT interval or slow the heart. Liver tests, blood counts, heart rate, blood pressure, and vision need regular monitoring during treatment. Xalkori can harm an unborn baby: females of reproductive potential should use effective contraception during treatment and for at least 45 days after the final dose, and males with female partners of reproductive potential should use condoms during treatment and for at least 90 days after the final dose, per the label's reproductive guidance.
Major interactions
Strong CYP3A inhibitors raise crizotinib blood levels and side-effect risk and should be avoided (grapefruit and grapefruit juice can also raise crizotinib levels); if a strong CYP3A inhibitor cannot be avoided, the Xalkori dose is reduced, and moderate CYP3A inhibitors should be used with caution. Strong CYP3A inducers lower crizotinib levels and can make Xalkori less effective, so they must be avoided. Because crizotinib raises the levels of CYP3A substrate drugs, Xalkori should be avoided with CYP3A substrates where even small level changes may lead to serious adverse reactions; if use cannot be avoided, the substrate's dose should be lowered per its labeling. Xalkori should also be avoided with drugs that prolong the QT interval and with drugs that cause bradycardia (such as beta-blockers), because Xalkori can cause both problems.
Cost and saving notes
If this drug is covered under your Medicare Part D plan and the cost is high, you can ask your plan for a tier exception to pay a lower cost share. If you have limited income, Extra Help (the Part D Low-Income Subsidy) can lower your Part D premiums and drug costs. In 2027, your total yearly out-of-pocket spending on covered Part D drugs is capped at $2,400, and you can spread those costs out in monthly payments through the Medicare Prescription Payment Plan.
Why it is in its tier
Crizotinib (Xalkori) sits on Tier 5 in 96.91% of the plans that list it (5325 of 5495 listing plans). Tier 5 is the specialty tier — instead of a flat copay, patients usually pay a percentage of the drug's cost (coinsurance), which is why specialty drugs feel expensive even with coverage. The data-visible drivers: It is a brand-only product with no generic version in the formulary data, and the CMS dashboard puts its average Part D spending at about $145,013 per beneficiary for 2024 — among the highest-cost drugs in the program, which matches where plans place it. It is listed by 100.0% of Part D plans. The tier shown is the most common one; individual plans vary.
Sources
What official patient guides say
Crizotinib (Xalkori) is taken by mouth twice a day, at around the same times each day, with or without food. Swallow the capsules whole — do not split, chew, or crush them, and do not touch capsules that are broken or crushed. If you vomit after a dose, do not take another one; just continue with your regular schedule. If you forget a dose, take it as soon as you remember, unless your next dose is due in less than 6 hours; in that case skip the missed dose, and never take a double dose. While taking it, do not eat grapefruit or drink grapefruit juice. Crizotinib can cause vision problems, dizziness, and tiredness, so do not drive or operate machinery until you know how it affects you, and protect your skin from sunlight with clothing, sunglasses, and sunscreen, since it can make skin more sensitive to the sun. Keep all appointments with your doctor and the laboratory — your heart rate and blood pressure will be checked regularly during treatment. Store the capsules in their tightly closed container at room temperature, away from excess heat and moisture (not in the bathroom) and out of children's reach.
Source: MedlinePlus — Crizotinib: MedlinePlus Drug Information
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 5495 |
| Total Part D plans | 5495 |
| Share of plans listing it | 100 |
| Formularies listing it | 286 |
| Tier | Plans |
|---|---|
| Tier 1 | 123 plans |
| Tier 2 | 1 plans |
| Tier 4 | 46 plans |
| Tier 5 | 5325 plans |
Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets resolved through the NLM RxNav (RxNorm) API.
What you pay
| With Medicare Part D | |
|---|---|
| Most common tier | Tier 5 |
| Typical copay | $0 — half of plans charge between $0 and $0 |
| Typical coinsurance | 26.0% of the price |
| Based on | 5237 plans that cover this drug · 2027 plan year |
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-07
Similar medications
Other medications in the same FDA pharmacologic class (Kinase Inhibitor):
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Part D spending averages (2024)
| Brand name | Generic name | Total claims 2024 | Total spending 2024 | Total beneficiaries 2024 | Rank by beneficiaries 2024 |
|---|---|---|---|---|---|
| Xalkori | Crizotinib | 2952 | 5.88751e+07 | 406 | 2182 |
Source: CMS Medicare Part D Spending by Drug (Drug Spending Dashboard), release RY26 P04 V10, data through 2024 (DSD_PTD_RY26_P04_V10_DY24_BGM.csv), downloaded 2026-10-30
Companies covering this drug
5,495 plans from 509 companies list this drug on a formulary for 2027. Search by company or plan name, or filter by tier. Cost sharing is the plan's published amount for this drug's tier in the initial coverage stage (1-month retail supply), where the plan publishes it; a blank means the plan does not publish it.
| Company | Plan | Tier | Copay | Coinsurance |
|---|
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Coverage and costs change. Drug lists (formularies), tiers, and copays can change during the year and differ by plan. Always check with your insurance company or plan directly to confirm what is covered and what you will pay.
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