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IPD'S DRUG & CLINICAL REVIEW:
THE GROWING CLASS OF COMPLEMENT INHIBITORS

"...One of the major challenges for payers is that these therapies are extremely expensive. The annual cost of these therapies for PNH is around $450,000 for Ultomiris and Empaveli, and $500,000 for Soliris, based on wholesale acquisition cost. Because of the high cost and specific approved indications, most payers will impose clinical criteria to ensure appropriate utilization. For Soliris, Ultomiris, and Enjaymo, which are intravenous medications, these drugs are typically covered under the medical benefit.


Besides prior authorization, another management strategy for these therapies is utilizing site-of-care policies that encourage patients to move away from higher-cost settings, like hospital outpatient infusion centers, to lower-cost settings, such as physician offices, ambulatory infusion centers, and home infusion, when appropriate. Many payers have experienced significant cost savings by establishing these policies. Additionally, some payers mandate the use of a specialty pharmacy or white bagging for Soliris and Ultomiris administration, and do not allow buy-and-bill of the drug.

And then we have products like Empaveli and Tavneos, which are self-administered products managed on the pharmacy benefit. Empaveli is a self-administered subcutaneous product, and Tavneos is oral. Generally, management on the pharmacy benefit allows payers to implement management strategies, such as prior authorization and step therapy, more easily than they can with medical benefit products. To use Tavneos as an example, this is a complement inhibitor approved as adjunct to standard therapy with rituximab or cyclophosphamide, plus azathioprine and a glucocorticoid. Payers have really used the Phase 3 ADVOCATE trial to model their criteria for Tavneos versus its FDA label alone. We’ve seen many policies which use the clinical inclusion criteria from the trial, as well as some payers who are only approving the drug for a total of 52 weeks due to its limited data and lack of long-term follow-up studies."

Our Executive Clinical Pharmacy team talks through the complement inhibitor drug class and pipeline.

 

Topics included in this episode:

  • Overview and Basic Definitions of Complement Inhibitors

  • Complement Inhibitor Examples

  • Current Approvals

  • Side Effects

  • Current Complement Inhibitor Pipeline

  • Complement Inhibitor Class Management

  • Manufacturer Challenges

  • Implications and Final Notes