Medications
Quizartinib (Vanflyta)
A tablet (Vanflyta) for newly diagnosed acute myeloid leukemia (AML) with a FLT3-ITD mutation, used with chemotherapy and then alone; it blocks the FLT3 growth signal. A mutation test is done before starting.
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 quizartinib 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
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, detected by an FDA-approved test, in adults — used in combination with standard cytarabine and anthracycline induction chemotherapy and cytarabine consolidation, and then on its own as maintenance therapy after consolidation.
What it is for, in depth
Vanflyta (quizartinib) is a targeted tablet for a specific genetic subtype of acute myeloid leukemia: AML whose cells carry a FLT3-ITD mutation, found by an FDA-approved test before treatment starts. It is built into the whole arc of therapy — added to standard cytarabine and anthracycline induction chemotherapy, continued with cytarabine consolidation, and then taken alone as maintenance to help keep the leukemia from returning. Its defining risk is electrical, not chemical: Vanflyta lengthens the QT interval of the heartbeat in proportion to its blood level, and torsades de pointes and cardiac arrest have occurred, so treatment runs with scheduled ECGs, potassium and magnesium checks, dose reductions alongside strong CYP3A inhibitors, and dispensing only through the VANFLYTA REMS restricted program. The tablets contain 17.7 mg or 26.5 mg of quizartinib and are taken once a day.
How it works
Quizartinib is a small-molecule inhibitor of the FLT3 receptor tyrosine kinase. It and its major active metabolite block FLT3 signaling, which stops the growth of leukemia cells that depend on the FLT3-ITD mutation.
How it is taken
Film-coated tablets (containing 17.7 mg or 26.5 mg of quizartinib) by mouth once a day, with or without food, at about the same time each day. The exact dose differs across the induction, consolidation, and maintenance phases of treatment and is reduced when strong CYP3A inhibitors are used; the full prescribing information gives the phase-by-phase schedule.
Common side effects
['Low blood counts, including febrile neutropenia (fever with very low white blood cells)', 'Diarrhea', 'Mouth sores and inflammation (mucositis)', 'Nausea and vomiting', 'Abdominal pain', 'Headache']
Serious warnings
['QT prolongation, torsades de pointes, and cardiac arrest (see boxed warning) — ECGs and electrolytes are monitored throughout treatment, and the drug is reduced, interrupted, or permanently stopped as appropriate', 'Restricted distribution — because of the QT risk, Vanflyta is available only through the VANFLYTA REMS program (see boxed warning)', 'Harm to an unborn baby (embryo-fetal toxicity) — effective contraception is advised for women who can become pregnant and for men with female partners who can become pregnant']
Boxed warning
Vanflyta lengthens the heart's QT interval in a dose- and concentration-related way, which can cause a dangerous abnormal heart rhythm (torsades de pointes) and cardiac arrest, both of which have occurred in patients taking it. Before and during treatment, potassium and magnesium levels are checked and corrected, and ECGs are done at baseline, weekly during induction and consolidation, weekly for at least the first month of maintenance, and periodically after that. It must not be given to patients with severely low potassium, severely low magnesium, or long QT syndrome, and treatment must not be started or the dose raised if the corrected QT interval (QTcF) is over 450 ms. The dose is reduced when it is used with strong CYP3A inhibitors. Because of this heart risk, Vanflyta is available only through a restricted program, the VANFLYTA REMS.
Who should be careful
['People with severely low potassium or severely low magnesium (label contraindication)', 'People with long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes (label contraindications)', 'People whose corrected QT interval (QTcF) is over 450 ms — treatment is not started and the dose is not raised', 'People taking other QT-prolonging drugs or strong CYP3A inhibitors (closer ECG monitoring and dose reduction)', 'Anyone pregnant or who could become pregnant, and women who are breastfeeding (the label advises not to breastfeed)']
Major interactions
['Strong CYP3A inhibitors — they raise quizartinib levels and QT risk; the Vanflyta dose is reduced', 'Strong or moderate CYP3A inducers — avoid combined use; they lower quizartinib levels and may reduce efficacy', 'Other QT-prolonging drugs (examples in the label include azole antifungals, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus) — ECGs are monitored more often if combined use is required', 'BCRP substrate drugs — avoid combined use where possible; quizartinib can raise their adverse effects']
Cost and saving notes
Quizartinib (Vanflyta) is a brand-only specialty leukemia drug that sits on Tier 5 in most Part D plans, and it can only be dispensed through the restricted VANFLYTA REMS program. Plans require prior authorization documenting the FLT3-ITD test result. Ask about a tier exception, and check Extra Help if your income is limited. The 2027 Part D out-of-pocket cap is $2,400 for the year, and the Medicare Prescription Payment Plan can spread that cost across the year.
Why it is in its tier
Quizartinib (Vanflyta) 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 $74,108 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
- VANFLYTA (QUIZARTINIB) TABLET, FILM COATED [DAIICHI SANKYO INC.] — DailyMed
- MedlinePlus — National Library of Medicine
- MedlinePlus Drug Information
What official patient guides say
Quizartinib comes as a tablet to take by mouth, usually with or without food once a day, at around the same time every day; swallow the tablets whole and do not split, chew, or crush them. Unless your doctor tells you otherwise, continue your normal diet. If you forget a dose, take the missed dose as soon as you remember it; however, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule, and do not take a double dose to make up for a missed one — and if you vomit after taking quizartinib, do not take another dose, just continue the normal dosing schedule with the next dose. Keep this medication in the container it came in, tightly closed, stored at room temperature and away from excess heat and moisture (not in the bathroom). Keep all appointments with your doctor and the laboratory; your doctor will order certain lab tests before starting therapy and during therapy to check your body's response, and may order electrocardiograms (EKGs) before and during treatment.
Source: 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 2026-11-08
Similar medications
Other medications in the same FDA pharmacologic class (Kinase Inhibitor):
Read next
Part D spending averages (2024)
| Brand name | Generic name | Total claims 2024 | Total spending 2024 | Total beneficiaries 2024 | Rank by beneficiaries 2024 |
|---|---|---|---|---|---|
| Vanflyta | Quizartinib Dihydrochloride | 434 | 7.85542e+06 | 106 | 2702 |
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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