Over the past few years, excitement over a coming wave of potentially curative gene therapies has given way to concern over their million-dollar price tags. Paying over a period of time and for good outcomes have been mulled as strategies to help more patients get access to the drugs, but there's been slow adoption.
Last week, insurer Cigna Corp. introduced a program designed to "take away all the excuses by which anyone would not want to participate."
Embarc Benefit Protection aims to help all sorts of payers, including employers, unions and health plans, provide coverage for Zolgensma, a $2.1 million therapy for children under two with spinal muscular atrophy, and Luxturna, an $850,000 therapy for an inherited retinal disease.
Members would pay a fee under $1 per member per month to provide patients with access to the treatments.
"We've been working on this for quite a while, thinking about is there a balanced solution that takes into account the needs of the biopharmaceutical industry, the needs of the payers, the needs of the providers but most importantly the needs of the patient, and we think we've hit upon a pretty good solution," Dr. Steve Miller, Cigna's chief clinical officer, said during an interview.
Patients would have no copayments, for example. Employers and other payers would have predictability in benefit costs and the best possible price tag for the gene therapy, he said. Drugmakers would be ensured payment for their products.
Cigna would white-label the program, aimed to begin in 2020, to entice competitors to participate. But Miller insisted Cigna is not trying to profit off Embarc. He said Cigna has been in talks with government payers to participate and while there's interest among legislators and regulators, red-tape would likely prevent them from joining anytime soon.
Employers, in particular, are fretting over how to provide access to million-dollar drugs. The latest annual survey from the National Business Group on Health, a D.C.-based association representing large self-funded employers, found that six in 10 of its member companies are "very concerned" about the cost of million-dollar treatments under review by the Food and Drug Administration.
Steve Wojick, the National Business Group on Health vice president of public policy, said the program "would help, to a certain extent, employers in terms of smoothing out the spikes that they would experience in expenses and adding a little bit more financial predictability, but it still doesn't get at the underlying issue of (the U.S.'s) broken pricing model for specialty pharmacy in particular."
About a fifth of employers surveyed said they will delay including gene therapies in the formulary. A third of employers said they want to directly contract with a PBM or drugmaker in 2021 or 2022 to pay for specific therapies based on outcomes or for use in certain populations. Fewer—22%—said they would purchase stop-loss insurance to help offset the costs of those drugs in 2021 and later.
The pipeline for gene therapies is robust. Zolgensma and Luxturna are the only two FDA-approved gene therapies on the market. Research firm Evaluate estimates about 68 others are in development.
Miller said that some of those therapies, which include treatments for sickle cell anemia and hemophilia, differ from the initial therapies in the Embarc program because an insurer would already know from the outset that there are patients with those conditions in the population.
"At that point in time we would have to convert this from a services company to truly a type of insurance product that we'd underwrite the participants," he said, adding that he hopes the reserves created by the fees would abate the cost so the drugs become perpetually less expensive.
A spokeswoman for pharmacy giant CVS Health, which owns insurer Aetna, said the company is developing alternative payments models, including annuity payments that spread the cost of expensive drugs over a period of time, and stop-loss insurance products designed specifically for gene therapies. She also said CVS is exploring outcomes-based contracts and refining its formulary and utilization management strategies for high-cost therapies with available alternatives.
Meanwhile, a spokeswoman for Anthem said in an email that managing the high cost of gene therapies while also ensuring patients have access would require "proven therapy management techniques along with innovations that change how we pay for therapies."
The health insurer and its in-house PBM IngenioRx are monitoring the gene therapy pipeline and tracking patient outcomes, which serves as the basis for value-based arrangements that Anthem is working on with drugmakers, the spokeswoman said. Anthem is also evaluating the development of stop-loss products.