FDA Approves Novartis Drug That Will Go Up Against PCSK9s

by Angela Maas

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency on Dec. 22 finally approved it. The new first-in-class therapy, Leqvio, targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein. The company says the drug will be available in early 2022. 

Payers signal preference for Leqvio’s cost, administration 

• Dosing of the small interfering RNA (siRNA) therapy is via a subcutaneous injection by a health care professional with an initial dose, another dose three months later and then every six months. The cost for the first year of treatment is $9,750 and $6,500 for subsequent years. 
• The cost is slightly higher than those of the two competing therapies, both PCSK9 inhibitors: Amgen Inc.’s Repatha (evolocumab) and Regeneron Pharmaceuticals, Inc.’s Praluent (alirocumab) are both right around $5,850 annually. Those drugs also have more frequent dosing, although patients can administer the products themselves via subcutaneous injection. 
• Respondents to a third-quarter 2020 poll from MMIT’s Zitter Insights cited Leqvio’s route of administration, cost, safety and efficacy as their top factors in preferring the drug over Praluent and Repatha. 
• Payers representing 61% of lives said they were likely to cover Leqvio’s use only in people on maximally tolerated statin therapy. To prefer Leqvio over the PCSK9s, payers were seeking a wholesale acquisition cost that is 47% below that of both drugs. 
• “While the target of Leqvio is not unique, the approach is,” Winston Wong, Pharm.D., president of W-Squared Group, tells AIS. “The target is the PCSK9 enzyme, and the mechanism is via a gene downregulation, as opposed to inhibition as we see from the current PCSK9 inhibitors.” 

Novartis bets on population health 

• Novartis is taking a somewhat different approach with its go-to-market model, targeting approximately 200 health systems to identify patients who may qualify for treatment with Leqvio. The company says it assumes that patients will be visiting their health care providers every six months, at which time they may administer the injection 
• It also will work with cardiologists on reimbursement for the product, which will fall under Medicare Part B and the medical benefit for commercial plans, as opposed to the self-administered PCSK9s, which are covered under Part D and the pharmacy benefit.
• “The population health approach is not something new,” says Mesfin Tegenu, R.Ph., CEO and chairman of RxParadigm. “But it is one that makes sense in attempting to address to current challenges of this disease. I understand why people say it is uncertain if this strategy will succeed because we are stuck in the current one-size-fits-all outdated drug management model. I personally see no reason why it would not succeed."

From Radar on Specialty Pharmacy

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