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Inclisiran Price: $3,250 per Injection, $6,500 Yearly

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At a glance

  • Product / Leqvio (inclisiran) 284 mg/1.5 mL single-dose prefilled syringe, Novartis [1][2]
  • First-year injections / three: initially, at 3 months, and about 9 months after the first injection [1]
  • Later years / two injections, six months apart [1]
  • Who gives it / a healthcare professional; not self-injected [1]
  • Price per injection / no dollar figure given on this page
  • FDA approval / original approval 22 December 2021, NDA 214012 [2]
  • Missed-dose rule / a planned dose more than 3 months overdue restarts the schedule: dose, then 3 months later, then every 6 months [1]

How many injections does a year of inclisiran contain?

The label sets a single 284 mg subcutaneous dose, repeated at 3 months, then every 6 months [1]. That is three injections in the first year and two in each year that follows [1]. For an uninterrupted schedule, multiply the per-injection charge by three for the first year and by two for each later year.

Does the dose change with kidney or liver disease?

No. The label gives no dose adjustment for mild, moderate or severe renal impairment, or for mild to moderate hepatic impairment, so the injection count stays the same [1]. Inclisiran was not studied in end-stage renal disease or in severe hepatic impairment [1].

Who gives the injection

The label says Leqvio should be administered by a healthcare professional, into the abdomen, upper arm or thigh [1]. Patients do not inject it themselves. How a particular plan pays for it, and what the patient owes, is not covered on this page.

What happens if a dose is missed?

If a planned dose is missed by less than 3 months, it is given and the original schedule continues [1]. If a planned dose is more than 3 months overdue, the label says to restart: a dose then, another 3 months later, and doses every 6 months after that [1]. The number of injections in a particular year depends on when the missed dose occurs.

What the injections deliver

The two pivotal adult trials, ORION-10 (1,561 adults with atherosclerotic cardiovascular disease) and ORION-11 (1,617 adults with ASCVD or a risk equivalent), enrolled people already on maximally tolerated statins. At day 510, placebo-corrected LDL cholesterol fell 52.3% and 49.9% respectively [3]. Both trials measured LDL cholesterol; neither was designed to show fewer heart attacks or strokes [3]. The label cites cardiovascular outcomes trials of statins and of PCSK9 monoclonal antibodies as evidence that lowering LDL-C reduces major adverse cardiovascular events, and it does not report an outcomes result for inclisiran itself [1].

In 482 adults with heterozygous familial hypercholesterolemia (ORION-9, which used inclisiran sodium 300 mg, equivalent to the 284 mg label dose), LDL cholesterol fell 39.7% on inclisiran and rose 8.2% on placebo at day 510, a between-group difference of 47.9 percentage points [4].

Frequently asked questions

How much does inclisiran cost per injection?
This page gives no dollar figure. Leqvio is supplied as one 284 mg/1.5 mL single-dose prefilled syringe per dose [1][2], and the label sets three doses in the first year and two a year after that [1]. A yearly total is the per-injection charge multiplied by those counts.
How many injections are needed in the first year?
Three. The label directs 284 mg on day 1, again at 3 months, then every 6 months [1]. From the second year onward the schedule is two injections a year [1].
Is inclisiran covered by Medicare Part B or Part D?
This page does not state Medicare coverage rules. The label says a healthcare professional should administer the injection, so it is not a self-injected home product [1].
How much does inclisiran lower LDL cholesterol?
Adults on maximally tolerated statins saw placebo-corrected LDL cholesterol reductions of 52.3% in ORION-10 (1,561 patients) and 49.9% in ORION-11 (1,617 patients) at day 510 [3]. In 482 adults with heterozygous familial hypercholesterolemia, the reduction was 39.7% versus a rise of 8.2% on placebo [4].
What happens to the schedule if a dose is missed?
The label says that a dose missed by less than 3 months is given and the original schedule kept [1]. If a planned dose is more than 3 months overdue, the schedule restarts with a dose then, another 3 months later, and doses every 6 months after that [1]. The number of injections in a given year depends on when the missed dose falls.

References

  1. U.S. National Library of Medicine, DailyMed. Leqvio inclisiran injection (Novartis) prescribing information. Leqvio inclisiran injection (Novartis) label
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020;382(16):1507-1519. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol
  4. Raal FJ, Kallend D, Ray KK, Turner T, Koenig W, Wright RS, et al. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020;382(16):1520-1530. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia
Evidence overview for Inclisiran Price: $3,250 per Injection, $6,500 Yearly