New strategies are indicated for new Soliris indications

A lot of drugs are effective at treating more than one condition. A drug like Soliris may launch with label approval to treat one condition. Then the manufacturer applies to the FDA for approval for to treat new indications with a new drug application (NDA). The data from the new clinical trials in the NDA helps us understand more about what the drug can do.

These new indications are good news for people with rare conditions with few or no treatment options. But with drugs that can cost hundreds of thousands of dollars a year per patient, it’s our job to make sure that the right drug gets to the right patient.

Drugs covered under the medical benefit often bypass the tools used to manage appropriate use of prescription drug costs under the pharmacy benefit. It doesn’t have to be that way. Prime’s strategy for managing medical drug spend has evolved over two decades of working with our clients’ medical benefit data. It keeps the patient at the center of the decision-making process. It includes:

• Formulary management
• Network management
• Utilization management
• Clinical management

For Soliris, the focus for managing medical drug spend is in network and utilization management.

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Strategies to support medical drug management decisions

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In the beginning, Soliris was the only approved drug for two rare conditions

Launched in 2007, the FDA approved Soliris to treat paroxysmal nocturnal hemoglobinuria (PNH). In 2011, the FDA approved Soliris to treat atypical hemolytic uremic syndrome (aHUS). It was the first ever treatment for either of these rare, orphan conditions.

What more can Soliris do? In December 2016, Soliris received FDA approval to treat adult patients with generalized myasthenia gravis (MG). There are several other treatments available that treat MG, but not all treatments work for all people with MG.

Utilization management (UM) includes medical drug review and medical claim edits

The clinical trial for the new MG indication tested Soliris only for efficacy on 5 to 10 percent of the population with MG. But the new labeling from the FDA approved the use of Soliris for almost everyone with MG.

Prime uses medical drug review to reserve coverage approval of Soliris for the 5 to 10 percent of the population with MG that are specified, based on the clinical trials.¹

It’s a different UM strategy for PNH and aHUS. Under the medical benefit, we use medical claim edits. Prime found patients using Soliris at a higher than appropriate dose for the patient’s diagnosis (PNH and aHUS). Moving to appropriate dosing saved $100,000 per patient per year.

Network management looks at site of care and reimbursement

Most infusions occur in the three locations below, but hospital outpatient facilities may cost 2-3x more than other locations for the same drug.

• A hospital outpatient facility
• A doctor’s office
• Infusion at a patient’s home

In severe cases, Soliris has to be infused while the patient is hospitalized. But when hospital-based infusion isn’t needed, using other locations can save money. Prime’s site of care policy restricts Soliris administration from hospital administration. This saved Prime’s plans $281,000 per member annually. That’s a book of business savings of $52.5 million for Soliris. Prime also revised the reimbursement equation used with providers to give them a more reasonable margin and us the savings we needed:

From this: traditional reimbursement equation ASP*+20% = $100,000 to $300,000 profit per member per year.
To this: Prime’s reimbursement solution ASP + flat rate of $300 to $500 = $300 to $500 profit per member per year.

*average sales price=ASP

At Prime, we want specialty drugs to be available to those who can benefit the most from them. We do the research. We study the market. And in quarterly meetings with our Blue Plan clients, we share information, to shape and optimize the most effective medical drug management strategies. Our goal, always, is healthy outcomes and lowest net cost.

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References

1. Starner CI, Vande Valle SE, Gunderson BW, Gleason PP. Exculizumab for Myasthenia Gravis: A Comprehensive Integrated Medical and Pharmacy Claims Analysis of Impact on Potential Uptake and Expenditures Among 15 million Commercially Insured Members. Poster Presentation at AMCP meeting; April 2018; Boston, MA. J Manag Care Spec Pharm 2018;24(4-a Suppl):S65. Accessed at: https://www.primetherapeutics.com/content/dam/corporate/Documents/Newsroom/Pressreleases/2018/document-amcpspring18-eculizumab.pdf

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