News Alert: G-BA Restricts Use of Novartis’s Leqvio in Germany

PRICENTRIC BRIEF:

  • The Federal Joint Committee (G-BA) has decided to restrict the prescription of Novartis’s Leqvio (inclisiran)
  • The assessment document states that G-BA finds it “justified to restrict the prescription of inclisiran,” as the “reimbursement amount will regularly be uneconomical”— the restriction means that the active ingredient, in this case inclisiran, cannot be prescribed as long as it has “additional costs compared to therapy with other lipid-lowering nuclei such as statins, anion exchangers, and cholesterol absorption inhibitors”
  • The G-BA estimates the annual cost of Leqvio monotherapy to be EUR 5,464.42 excluding rebates

THE DETAILS

BERLIN, Germany — The Federal Joint Committee (G-BA) has decided to restrict the prescription of Novartis’s Leqvio (inclisiran).

The G-BA has approved the therapy for adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in addition to dietary therapy when applied:

  • in combination with a statin or a statin with other lipid-lowering agents for patients who do not achieve the LDL-C goals with the maximum tolerable statin dose, or
  • alone or in combination with other lipid-lowering therapies in patients with statin intolerance or for whom a statin is contraindicated.

However, the assessment document states that G-BA finds it “justified to restrict the prescription of inclisiran,” as the “reimbursement amount will regularly be uneconomical.” The G-BA estimates the annual cost of Leqvio monotherapy to be EUR 5,464.42 excluding rebates.

G-BA can restrict or exclude the prescription of drugs if another, more economical treatment option with comparable therapeutic benefits is available.

The restriction means that the active ingredient, in this case inclisiran, cannot be prescribed as long as it has “additional costs compared to therapy with other lipid-lowering nuclei such as statins, anion exchangers, and cholesterol absorption inhibitors.”

All other therapeutic options have to be exhausted, and regular LDL apheresis or monoclonal antibody therapy are to be considered the last available option, according to the document.

The body also puts the potential population of patients who have not exhausted medicinal and dietary options to reduce their lipid levels at 271,500 to 389,900, compared to just 13,000 to 21,000 patients who have tried all other options and will now be eligible to receive Leqvio under the G-BA’s more restricted terms.

The European Commission (EC) approved the Novartis drug in December 2020 based on results from the ORION clinical development program, in which Leqvio led to effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of up to 52% in patients with elevated LDL-C despite maximally tolerated statin therapy.

In contrast to Germany’s restricting decision, the UK’s National Institute for Health and Care Excellence (NICE) recently issued draft final guidance recommending the therapy for the treatment of primary hypercholesterolemia or mixed dyslipidemia in patients who have already had a cardiovascular event, such as a heart attack or stroke.

NHS England, NHS Improvement and Novartis have also agreed on a “world first” population-level commercial deal to make Leqvio available with a discount to its list price.

The anti-cholesterol drug will be provided for wide access to patients at risk of heart disease and for whom conventional treatment has not worked, in particular those who also have persistently elevated LDL-C levels (2.6 mmol/l or more despite maximum tolerated statins with or without ezetimibe).

The new approach is “potentially game-changing,” according to Prof. Kausik Ray, MD, Professor of Public Health at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust.

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