Cell and gene therapies (CGTs) are some of the most promising and exciting medical advancements taking place today. Some existing CGTs treat previously untreatable rare diseases, and there are hundreds of CGTs in clinical development to treat various types of cancer, hemophilia, sickle cell and other blood disorders, Alzheimer’s disease, and numerous rare conditions. The prospect of curative therapies which stop a disease in its tracks or even reverse the damage caused by the disease has the potential to change the course of medicine and improve the lives of millions of people. However, these new treatments also come with new complexities, one of the most pressing of which is price.
As a safety net program, Medicaid is responsible for providing care to some of America’s most needy populations. Enrollees in the Medicaid program have the potential to benefit greatly from CGTs on the market today and those to come in the next few years. Many patients with rare diseases and chronic life-threatening conditions and their families are eager to access these groundbreaking therapies. But for the Medicaid program, there are multiple challenges that states must navigate to ensure access to medically necessary therapies while also being good stewards of the taxpayer dollar and ensuring a sustainable program for all patients served by Medicaid. There is an urgent and ongoing need for new tools and approaches in Medicaid’s coverage and payment of CGT to provide patients with access to breakthrough cures.
Leavitt Partners provides in-depth analysis of the challenges in CGT coverage and payment in Medicaid, as well as opportunities for improvement, including concrete recommendations to improve coverage and payment. Leavitt Partners also helps patients access CGTs. Over 45 experts from stakeholders including state Medicaid directors and experts, providers, Medicaid health plans, manufacturers, and federal policymakers were consulted in outlining these challenges and moving toward solutions.
In this white paper, Leavitt Partners provides an overview of the CGT landscape in Medicaid. The paper starts by reviewing the science of CGTs, the pipeline of future therapies, and the basics of the FDA review process. Next, the paper explains how Medicaid currently covers and pays for CGTs and identifies various value-based and other payment arrangements being used by states.
Download the white paper here.