Inclisiran now has its cost-effectiveness report from ICER. Should Novartis be concerned?

Novartis headquarters
Novartis' PCSK9 cholesterol drug inclisiran should cost between $3,600 and $6,000 a year to meet cost-effective standards, U.S. drug cost watchdog ICER said in a report. (Novartis)

The PCSK9 cholesterol drug class was previously the target in an acrimonious squabble between drugmakers and the Institute for Clinical and Economic Review. Now, the U.S. drug cost watchdog has come up with its assessment for a new member of the family.

Novartis’ inclisiran should cost between $3,600 and $6,000 a year to be cost-effective, ICER said in a recent report (PDF).

That range falls in line with the current list prices of two existing PCSK9 therapies—around $5,400 to $5,850 for Amgen’s Repatha and Regeneron’s Praluent. Inclisiran’s different from the other two antibody drugs in that it uses a small-interfering RNA to target PCSK9.

ICER’s price shouldn’t disturb Novartis much—unlike the harsh exchange of words the cost watchdog prompted from Amgen and Regeneron. The two antibody drugs first came to market in 2015 bearing annual costs of more than $14,000. At the time, ICER figured the drugs should cost much less—over 80% less. The companies initially fought back forcefully against ICER’s analysis but eventually budged as payers appeared to have used ICER’s benchmark in making their formulary decisions.

Novartis got inclisiran through its $9.7 billion acquisition of The Medicines Company. At the time, CEO Vas Narasimhan said the company would price the drug “within the approximate cost-effective range that has been put out in the past” so that it could avoid the payer pushback—and slow uptake—Repatha and Praluent have suffered.

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The two ends of ICER’s price range for inclisiran were based on two different evaluation metrics. The lower end was calculated for the drug to meet a $100,000 per quality-adjusted life-year threshold in the overall high LDL-cholesterol patients. To meet a $150,000 threshold for the equal value of life-years gained, the drug’s price may go up to $6,000.

Novartis has been touting inclisiran’s twice-yearly dosing, administered by a healthcare professional, as an advantage that could increase adherence. By contrast, Praluent and Repatha are self-administered by patients every two to four weeks.

RELATED: Novartis set to answer inclisiran's FDA rebuff by Q3. But what about an approval timeline?

In its report, ICER acknowledged that less frequent dosing gives inclisiran a convenience advantage, but said whether it improves long-term adherence remains “an untested assumption,” noting that the COVID-19 pandemic also adds uncertainty.

Novartis recently hit a manufacturing-related snag with the FDA’s review of inclisiran. The agency slapped a complete response letter on the drug’s application after noting what Narasimhan characterized as “primarily process control-related” issues in its paperwork. The agency hasn’t been able to inspect the drug’s third-party manufacturing facility in Italy thanks to COVID.

Earlier this week, Novartis said it plans to submit a response to the FDA’s questions around the second or third quarter but was unsure of a timeline after that.