Gene Therapy Solutions

Hundreds of gene therapies are in various stages of development for a wide range of conditions, which were previously untreatable or at least incurable. While there are only a handful of approved gene therapies today, the U.S. Food and Drug Administration anticipates it will be approving 10 to 20 cell and gene therapies annually by 2025.https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics These innovative treatments bring great hope and promise for patients and their families. However, the therapies approved so far are expensive — the most expensive north of $2 million for a single dose. Future treatments are likely to continue that trend, and if they do, it could have a large — immediate and long-term — impact on clients and the nation’s health care system. 

Just 5,000 individuals being treated by gene therapy each year, with treatments priced at $2 million each, would add $10 billion per year to the nation’s health care bill.

Many of these conditions currently require lifetime care and treatment and that can be expensive, but the cost impact is spread out over a long period. With very expensive gene therapies, payors face a large one-time cost that — even accounting for only a few members needing the treatment — could put a small or self-insured employer out of business. This may lead some to exclude coverage.

Our role is to help reduce the costs of treatments, while ensuring appropriate utilization of cutting-edge therapies.

In addition to refining foundational medical and pharmacy benefit strategies, we are developing various approaches to help payors mitigate what could be a detrimental impact from a large one-time cost for gene therapy treatment for one or a few plan members.

We offer two financial protection solutions to payors:

	Stop-loss offers eligible clients financial protection against unexpected, high-cost gene therapy claims.*
	Installment Payment Plan allows eligible clients to pay for a gene therapy over several years, mitigating the immediate financial impact of the claim/smoothing the impact of an immediate, large incurred cost.

We offer two financial protection solutions to payors:

	Stop-loss offers eligible clients financial protection against unexpected, high-cost gene therapy claims.*
	Installment Payment Plan allows eligible clients to pay for a gene therapy over several years, mitigating the immediate financial impact of the claim/smoothing the impact of an immediate, large incurred cost.

Both products may offer clients an alternative to excluding high-cost gene therapies.

In addition to financial protection programs, there are other potentially complementary approaches health plans and employers can utilize to reduce the cost impact of gene therapies including extending a model such as Aetna’s National Medical Excellence Program to gene therapy, value-based contracting, and an evolution of the role of specialty pharmacy to encourage direct dispensing to prevent costs from increasing because of the practice known as “buy-and-bill.”

Making sure gene therapy-based treatments are accessible for all those who need them requires innovative partnerships, as well as new ways of providing health insurance and pharmacy benefit design. Without solutions to help payors manage the cost, some may make the choice to exclude coverage, which could jeopardize patient access to these potentially life-saving medications.

At CVS Health, we are designing programs for our clients that can help mitigate the cost impact and ensure better access to appropriate therapies. Such solutions, if implemented, are likely to prove extraordinarily important in helping ensure that the price of gene therapies do not prove unsustainable for our health care system.
 

Want to learn more about how to help reduce the cost impact of gene therapies? Ask Us