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Specialty Pharmacy Continuum • July/August 2020
POLICY
‘[Gene … therapies will] continue to push up drug spend, but they’re a small contributor to the entire system. It’s just a really big deal if you’re a medium-sized health plan or an employer group that has one, two or three of these claims.’ —Brett Sahli, PharmD
The Gene Rx Cost Cliff continued from page 1
never go back and visit a [gene therapy] administration again,” Dr. Mishler said during an AMCP webinar. The group took several steps to prepare. First, they reviewed clinical trial data to adopt the FDA-approved criteria for onasemnogene abeparvovec-xioi. They also worked with Prime Therapeutics, their pharmacy benefit manager, to seek out value-based outcome contract opportunities and make the terms more favorable. When the first
Drugs for rare and orphan conditions cost hundreds of thousands of dollars per year, and new gene therapies are pushing over
$1 million per year in annual costs. inquiry for coverage of the therapy was received by the payor’s customer service specialists June 4, 2019, the team was notified in hours. The Blue Cross team reached out to their employer group and started discussing how to cover the drug, as well as to one of the two specialty pharmacies that would be distributing the gene therapy. As it turned out, a vice president at the company knew the Blue Cross team from a former job with an infusion company, and spoke to the payor to offer assistance. They worked out a strategy
to direct bill the plan forr the drug, and ship the therapy to the provider. From there, more steps ensued. The committee’s provider relations ns talked to the physician who planned to administer onasemnogene abeparvovec-xioi in her office, and waited for her to become authorized to administer the gene therapy by the manufacturer. The doctor was relieved that Blue Cross was going to manage payment of the treatment, but the clinic’s chief financial officer wanted to buy and bill for the therapy instead. The insurer’s provider relations manager knew this CFO, and initiated a phone conversation appealing to the goal of getting the child treated without looking for means to profit. The CFO agreed. Then, a few days before the planned administration of the therapy, the local hospital got involved and wanted to offer the therapy in its outpatient infusion suite. A representative from the insurer’s institutional relations department, who knew the hospital’s CFO, stepped in, sending an email describing how everything was already set in place. Finally, everything went off as planned, and a local TV station even did a human interest story on the girl receiving treatment. Health plans should understand that no two gene therapies are going to be the same, especially for smaller plans with limited exposure to any one therapy that comes out, Dr. Mishler said. It also takes a village, he said: “You have to rely on those people who have the expertise and to
grease the skids to make sure things go well. Don’t underestimate those in your organization that already have relationships with providers.” One area of concern is who will track value-based contract outcomes, and what happens if the company is due a reimbursement for a member who has since moved to another health plan, he said.
$1 Million Treatment Gene and cell therapies can be considered new “drugs,” used in the diagnosis, cure, mitigation, treatment or prevention of disease, said Brett Sahli, PharmD, the senior director of value and health outcomes for Prime Therapeutics. The cost of these therapies needs to be on the radar of managed care stakeholders, Dr. Sahli stressed. Drugs for rare and orphan conditions cost hundreds of thousands of dollars per year, including chimeric antigen receptor T-cell/gene therapy, which runs more than $500,000 per treatment (JAMA Oncol 2018;4[7]:994-996). In fact, some new gene therapies cost more than $1 million per year, Dr. Sahli said during the webinar, citing in-house data from 2019. By 2025, the FDA may be approving 10 to 20 cell and gene therapy products annually, he added. These high-cost therapies can be likened to a monster truck on the
highway, Dr. Sahli said. “It’s really big on an individual basis—it’s the th new supersize. Gene and cell therapies are going to c continue to push up drug c spend, but they’re a small s contributor to the entire c system. It’s just a really big s deal d if you’re a medium-sized health plan or an employer group that has one, two or three of these claims. Then it’s not spread out anymore.” They’re also like monster trucks in that they’re not something you use every day, being made for one-time administration, Dr. Sahli said. And they present several challenges for health plans, beyond how to pay for and cover them. For example, will a member’s other health care costs be lowered by receiving the high-priced drug? Moreover, how will the treatment affect patients’ out-of-pocket costs or their need to travel for therapy? Among the approaches to managing gene therapy costs are annuities that spread payments out two or more years; milestone-based contracting (an annuity payment contingent on a positive outcome or a rebate based on performance failure); and risk pooling (paying into a pool so plans won’t have to bear the full cost), Dr. Sahli said. Longer term, he hopes to see portable patient registries that track members who switch plans. —Karen Blum The speakers were scheduled to present at AMCP’s Managed Care & Specialty Pharmacy annual meeting, which was canceled because of the COVID-19 pandemic. The organization made the information available via a webinar instead. Other than their employment, the sources reported no relevant financial relationships.
