Medications
Iptacopan (Fabhalta)
A capsule (Fabhalta) for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder where red cells break down; it blocks complement factor B in the immune system. It is also approved for certain kidney and blood conditions.
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 iptacopan 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
Fabhalta (iptacopan) treats adults with paroxysmal nocturnal hemoglobinuria (PNH), adults with IgA nephropathy (IgAN) at risk of rapid progression (to reduce protein in the urine), and adults with C3 glomerulopathy (C3G, to reduce protein in the urine).
What it is for, in depth
Fabhalta (iptacopan) targets the alternative complement pathway, an immune alarm system that stays switched on in several rare diseases. In paroxysmal nocturnal hemoglobinuria (PNH), that overactivity destroys red blood cells, causing anemia and blood-clot risk; in IgA nephropathy and C3 glomerulopathy, it injures the kidney filters and leaks protein into the urine. Fabhalta was the first oral treatment for PNH and is also approved to lower urine protein in adults with those two kidney diseases. Because blocking complement weakens defense against certain bacteria, vaccination comes first and the drug ships only through a safety (REMS) program. It comes as a 200 mg capsule taken twice daily.
How it works
Fabhalta blocks factor B of the alternative complement pathway — part of the immune system that, when overactive, destroys red blood cells in PNH and damages the kidneys in IgAN and C3G. Blocking factor B limits that complement-driven damage.
How it is taken
Capsules (200 mg) taken by mouth twice a day, with or without food, swallowed whole (not opened, broken, or chewed). Treatment for PNH continues on this schedule; blood tests and, for the kidney diseases, urine protein are monitored.
Common side effects
['Headache', 'Nasal and throat inflammation (nasopharyngitis)', 'Diarrhea', 'Abdominal pain', 'Bacterial and viral infections', 'Nausea', 'Rash', 'Joint pain (arthralgia)']
Serious warnings
['Serious infections from encapsulated bacteria (such as meningococcus, pneumococcus, and Haemophilus influenzae type B), which can be fatal — vaccination at least 2 weeks before starting is required, and Fabhalta is available only through a restricted program (REMS) (see boxed warning)', 'Raised cholesterol and triglycerides — lipid tests are monitored and treatment may be started for high cholesterol', 'Stopping Fabhalta in PNH can trigger renewed red-cell breakdown (hemolysis) — patients are monitored for at least 2 weeks after stopping', 'Possible harm to an unborn baby — effective contraception is advised during treatment and for 5 days after the last dose']
Boxed warning
Fabhalta increases the risk of serious infections, including infections that can be fatal, caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B. Vaccination against these bacteria should be completed or updated at least 2 weeks before the first dose (unless the risks of delaying treatment outweigh the infection risk), and patients must be watched for early signs of serious infection. Because of this risk, Fabhalta is available only through a restricted distribution program (the Fabhalta REMS).
Who should be careful
['Anyone with an unresolved serious infection from encapsulated bacteria (label contraindication is none, but treatment should not start during such an infection)', 'Anyone not vaccinated against meningococcal, pneumococcal, and Hib bacteria (vaccinate first when possible)', 'People with high cholesterol or triglycerides (monitoring)', 'Anyone pregnant, planning pregnancy, or breastfeeding (not recommended while breastfeeding)', 'People with severe liver impairment (not recommended)']
Major interactions
['Strong CYP2C8 inducers such as rifampin — not recommended (they lower Fabhalta levels)', 'CYP2C8 inhibitors such as gemfibrozil — can raise Fabhalta levels; monitoring is advised', 'Other complement inhibitors — no added benefit established; switching is managed by the prescriber']
Cost and saving notes
Fabhalta is a brand-only specialty (Tier 5) drug dispensed through a restricted REMS program, and plans require prior authorization for the PNH, IgA nephropathy, or C3G diagnosis. 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, and the Medicare Prescription Payment Plan can spread that cost over the year.
Why it is in its tier
Iptacopan (Fabhalta) sits on Tier 5 in 83.33% of the plans that list it (10 of 12 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 $252,095 per beneficiary for 2024 — among the highest-cost drugs in the program, which matches where plans place it. Only 0.22% of Part D plans list it at all, so many readers will find their plan does not list it and covers a similar drug instead. The tier shown is the most common one; individual plans vary.
Sources
What official patient guides say
Iptacopan comes as a capsule to take by mouth twice a day, with or without food, at around the same times every day; swallow the capsules whole and do not split, chew, or break them, and continue to take iptacopan even if you feel well — do not stop taking it without talking to your doctor. If you forget a dose, take the missed dose as soon as you remember it, even if it is almost time for the next dose, and then continue your regular dosing schedule. Unless your doctor tells you otherwise, continue your normal diet. Keep this medication in the container it came in, tightly closed, and out of reach of children, 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 to check your body's response, and you will need to receive certain vaccines at least 2 weeks before you begin treatment; your doctor may also monitor you and order laboratory tests for at least 2 weeks after you finish treatment.
Source: MedlinePlus Drug Information
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 12 |
| Total Part D plans | 5495 |
| Share of plans listing it | 0.22 |
| Formularies listing it | 5 |
| Tier | Plans |
|---|---|
| Tier 1 | 2 plans · See the 2 plans on this site at this tier |
| Tier 5 | 10 plans · See the 10 plans on this site at this tier |
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 coinsurance | 25.0% of the price |
| Based on | 10 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
Coverage by plan and tier
Of the 5,495 Medicare drug plans we track for 2027, 12 list Iptacopan (Fabhalta) — 0.2% of plans. Most of those plans put it on Tier 5: 10 plans, 83.3% of the plans that list it. Other plans place it on Tier 1 (2 plans). For example: Mass General Brigham SCO (HMO D-SNP) puts it on Tier 1; Mass General Brigham One Care (HMO D-SNP) puts it on Tier 1; Mass General Brigham Advantage Secure (HMO-POS) puts it on Tier 5. You can compare these plans side by side on our Medicare Advantage hub. A tier is not a price. What you pay also depends on whether you have met your plan's deductible, whether the drug costs a flat copay or a share of the price, and whether you get Extra Help or Medicaid.
Read next
Part D spending averages (2024)
| Brand name | Generic name | Total claims 2024 | Total spending 2024 | Total beneficiaries 2024 | Rank by beneficiaries 2024 |
|---|---|---|---|---|---|
| Fabhalta | Iptacopan HCl | 724 | 3.25202e+07 | 129 | 2631 |
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
Part D and Medicare Advantage plan sponsors that list this drug on a formulary, 50 at a time.
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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