Medication substitution for biologics must include patient, physician


By Cheryl Portman - Guest Columnist



Ulcerative colitis is a chronic, painful disease that affects 1.6 million people across the United States. In 2008, I became one of them.

I’ll be the first to admit that living with this illness has not been easy. Symptoms include nausea, headaches, intestinal cramps, vomiting, uncontrollable diarrhea, intestinal bleeding, joint pain and insomnia. Each day brings a new set of challenges.

Following my diagnosis, my physician prescribed a common medication to help control my symptoms. Unfortunately, what works for one patient doesn’t always work for all of us.

Instead of putting me on the road to recovery, this medication made daily life even more agonizing. My health deteriorated. I had to go on steroids for nearly a year to get into remission.

It wasn’t until two years later, when I was hospitalized and prescribed a biologic, that I got my life back.

Biologics are FDA-approved breakthrough treatments used to prevent, diagnosis, manage and even cure a variety of serious illnesses. Unlike traditional drugs, they are made by or from living cells through highly complex manufacturing processes.

These innovative medications offer a much-needed alternative to patients like me who don’t respond well to traditional treatments.

Growing demand for biologics has led to the introduction of a new product to help patients with chronic diseases has been introduced to the market. Biosimilars, as their name suggests, are highly similar versions of biologics.

Because these medications are made with living materials, a biosimilar cannot be an exact copy of a biologic. But a biosimilar can be close enough in biologic makeup that, in some cases, it could be considered interchangeable with a biologic.

Legislation has been filed in Kentucky that would allow pharmacists to substitute a biosimilar – which is often significantly lower in cost than the matching biologic – when they believe it is in a patient’s best interest.

Increasing patient access to innovative treatments is critical to improving health outcomes, especially among those who suffer chronic diseases, but patient safety must be the number one priority.

People living with chronic diseases know that it often takes years and years of trial and error before finding a treatment plan that truly works for them. Even the slightest change can have devastating impacts on our health and wellbeing. Our representatives in Frankfort must keep this in mind when considering any measure that would impact a patient’s medication regimen, such as Senate Bill 134.

If my pharmacist recommended substituting a lower cost biosimilar for my biologic, I would want to discuss it with my physician first. Price is not the only factor in determining whether a biosimilar should be substituted, and it is critical that patients and physicians always be a part of this decision-making process.

My doctor, who has been working with me since I was first diagnosed, knows my medical history and how to treat my condition best. I would not feel comfortable if my pharmacist made such a big decision concerning my treatment regimen without getting his input and consulting me first.

Biologics have played an important role in keeping my ulcerative colitis under control, and it is exciting to see biosimilars enter the market. My hope is that these innovative medicines, which could be a lower cost alternative to biologics, will help even more patients living with ulcerative colitis and other painful, chronic diseases.

But above cost-savings, patient safety must come first. That’s why any discussion around substitution of biosimilars and biologics must involve all who are impacted – including patients and physicians.

Cheryl Portman is a Kentuckian living with ulcerative colitis.

By Cheryl Portman

Guest Columnist

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