Did the administration consider the importance of autoimmune disease medicines to patients in price setting process

For millions of Americans who have been diagnosed with an autoimmune disease, breakthroughs in medical innovation have been nothing short of life changing. This continued progress is now at risk because of the Inflation Reduction Act's (IRA) price setting provisions.

We talked about the impacts of the IRA for patients living with diabetes last time. Today, given that two medicines for autoimmune diseases have been subject to price setting, we're looking at the importance of medicines for patients with these conditions. While a healthy immune system protects and defends the body against infections and diseases, an immune system that has an autoimmune disease can malfunction and mistakenly attack a person's cells, tissues and organs. Common autoimmune diseases include rheumatoid arthritis, Crohn's and psoriasis.

The impact: There are more than 80 different autoimmune diseases impacting approximately 50 million people in the United States.

• Up to 25% of patients with an autoimmune disease have more than one autoimmune disease.
• Approximately 80% of autoimmune patients are women.
• At least 67,000 Medicare Part D patients rely on the autoimmune medicines selected for price setting.

How far the industry has come: Scientific advancement for autoimmune diseases is not easy, but researchers are relentless in their pursuit of new and better treatments for patients.

• The U.S. Food and Drug Administration recently approved a new treatment for a rare autoimmune disease that damages the liver.
• The agency also recently approved a new treatment for an autoimmune disease that slowly attacks a part of the body that insulates and protects the body's nerves.
• In recent years, biopharmaceutical researchers have developed a number of treatments that are improving outcomes for patients with lupus, a debilitating and fatal autoimmune illness that disproportionately impacts women and people of African dissent.
• Today there are a wide range of treatments for relapsing forms of multiple sclerosis, which is important for this patient population as treatment response can be highly variable. A wide range of treatment choices is important to ensure patients can slow disease progression and reduce disability. There is now also FDA-approved treatment available for primary progressive MS, a particularly aggressive form of the disease.

Access to autoimmune treatments makes a difference: Patients with autoimmune diseases can live fuller lives due to advances in medicines. These treatments also impact the overall health care system. The costs associated with just 7 of the 100+ known autoimmune diseases are estimated to total between $51.8 and $70.6 billion annually. These figures don't include the many indirect costs of these diseases, including lost productivity at work, higher childcare costs and reduced quality of life. Access to medicines helps lower these costs for our health care system.

IRA threatens the progress on the horizon: There are more than 300 medicines in the R&D pipeline for autoimmune diseases - including 51 treatments in development for rare autoimmune diseases. But the IRA's price setting provisions will have a long-term impact on drug development, with some analysts estimating that as many as 139 fewer medicines may be developed over the next decade. Autoimmune diseases could be particularly impacted because progress against them relies heavily on continued R&D conducted on medicines after they've been approved. The IRA makes this kind of "post-approval" research difficult to do.

The bottom line: Government price-setting puts this progress at risk. The IRA's drug price setting provisions dismiss the value of autoimmune treatments and stand to delay, and potentially prevent, these types of innovative medicines coming to market and reaching the patients who need them most.

Learn more about how price setting can undercut the immense value new medicines provide.

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