Cost Of Biologics For Ulcerative Colitis

Side Effects In Children

In clinical studies, children with Crohns disease or ulcerative colitis had certain side effects more often than adults.

Side effects that occurred more often in children were:

• anemia
• low level of white blood cells
• flushing
• bacterial and viral infections
• allergic reactions of the throat and lungs

Your doctor will monitor your child for these side effects during and after Remicade treatment.

Pros And Cons Of Biologics

One of the biggest advantages of using biologics is that they target certain areas of inflammation in your body, rather than affecting your entire immune system the way steroids or immunosuppressants might. For some people, this targeted attack may mean less severe side effects and fewer side effects in general.

Biologics have also to reduce the need for surgery or hospitalization.

However, one drawback of biologics is that they can be quite expensive . Even biosimilars, which are medications that are incredibly similar to certain biologics that are supposed to be much cheaper , are still expensive.

Another potential issue of biologics is that many of them have to be administered via IV or injection. This can make taking them more complicated than taking a pill.

Its also possible for biologics to stop being effective over time, in which case you will need to work with your doctor to find either another biologic to try or another form of medication.

Like most medications, biologics have possible side effects, including:

• a reaction, such as redness or swelling, at the injection site
• headaches
• chills
• a severe allergic reaction

Some more serious risks include decreased immune system function that can leave you susceptible to infections. You may also be more likely to experience:

• lymphoma
• a worsening of heart conditions
• arthritis

Which Is The Most Cost

Infusion costs heavily influence the overall cost-efficacy of ulcerative colitis treatment.

Researchers have found that as long as infusion costs are less than $1974, infliximab is the most cost-effective treatment option for patients with moderate-to-severe ulcerative colitis .

If the costs exceed $1974, then adalimumab is the most cost-effective treatment. They also found that due to high drug costs, vedolizumab is best used as a second-line biologic after treatment failure, according to the study published by BMJ Open Gastroenterology.

There are currently no clinical trials that compare the efficacy of the drugs, which can make it difficult to choose the best treatment. Both drugs, adalimumab and infliximab, are antibodies to tumor necrosis factor- .

They are also fist-line treatments for moderate-to-severe UC. The drug vedolizumab was recently deemed a potential first-line treatment, but it is unknown whether the intestinal-specific 47 integrin inhibitor is more cost-effective.

The researchers created a decision analytic tree to compare the cost efficacy of the drugs in regard to mucosal healing at 1 year. They compared the ACT trials for infliximab, the ULTRA trials for adalimumab, and the GEMINI trials for vedolizumab.

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How Long Do Biologics Take To Work

Biologic therapy can take time to start working. Some people living with Crohn’s disease or ulcerative colitis experience relief soon after their first dose. Depending on the medication, it can take several weeks to notice an improvement in symptoms. It is important to stick to your treatment plan and give your biologic medication time to take effect.

Several MyCrohnsAndColitisTeam members have shared questions and experiences about how long it takes biologic drugs to work. One member asked, “Has anyone been on Humira? How long does it take to work?” In response, another member offered, “I’ve been on Humira for eight months. It worked for me right away.”

Demographic And Clinical Characteristics

Demographic and clinical characteristics at index , were collected. The 25 most common medications prescribed during the 12-month pre-index period were obtained, and those related to 5-ASA, steroids, or immunosuppressants are reported. Immunosuppressant use in the post-index period is also reported.

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Interactions With Other Medications

Interactions between biologics and other medications can be significant, and each type of biologic drug can present different risks.

A doctor should be aware of all the over-the-counter or prescription medications, and all the supplements, herbal medications, and vitamins that a person takes before they prescribe a biologic.

Anyone using a biologic for UC should speak with a doctor before receiving a vaccine. For people who use certain biologic medications, including golimumab, infliximab, and adalimumab, having a live vaccine can be dangerous, and doctors recommend avoiding it.

, this type of treatment costs $10,00030,000 per year, on average, and the more expensive types can cost more than $500,000 annually.

A doctor may instead recommend a type of drug called a biosimilar. There is very little clinical difference between these drugs and biologics. Biosimilars are less expensive but just as safe and effective.

The Food and Drug Administration approved the use of biosimilars in an effort to reduce costs. However, the FDA do not regulate whether insurance companies cover the costs of these drugs.

The following table provides an overview of the biologics available to treat UC. The abbreviation IV stands for intravenous.

What Blood Tests Will I Need Before Or During Humira Treatment

Youll need several tests before starting Humira treatment and while you take the drug, including:

• Tuberculosis . Before you start taking Humira, your doctor will check you for TB. While you take the medication, theyll monitor you for any symptoms of infection. This is because Humira can weaken your immune system and make you more likely to develop an infection.*
• Hepatitis B. Your doctor will also want to see if you have the hepatitis B virus . Humira can cause HBV to become reactivated in people who previously had active HBV. Your doctor may keep testing you for HBV while you take Humira and for several months after you stop your treatment.
• Liver function. While you take Humira, your doctor will likely order blood tests to make sure your liver is working properly. Humira can cause liver damage and sudden liver failure in rare cases.
• Humira level. During your treatment with Humira, your doctor may also order lab tests to check the level of Humira in your blood. Although more research is needed, keeping Humira levels in the blood within a specific range may be ideal for treatment.
• Humira antibodies. In addition, your doctor may order a blood test that checks for antibodies to Humira. People who form antibodies against Humira are less likely to respond well to the drug.

If you have questions about what tests youll need before and during your Humira treatment, check with your doctor.

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Budget Impact Of Adding Vedolizumab To A Health Plan Formulary As Another First

, Michele Wilson, MSPH Aaron Lucas, PhD, MPH Ann Cameron, MA, PhD Michelle Luo, PhDMr Wilson is Director of Health Economics, RTI HealthSolutions, Research Triangle Park, NC Dr Lucas is SeniorHealth Economist, RTI Health Solutions Dr Cameronis Associate Director of Global Health Economics andOutcomes Research, Xcenda LLC, Palm Beach, FL DrLuo is Head of GI Global Outcomes Research, TakedaPharmaceuticals, Cambridge, MA.

BACKGROUND: Vedolizumab is a biologic drug approved by the US Food and Drug Administration for the treatment of adults with moderately to severely active Crohns disease or ulcerative colitis who have had inadequate response to, lost response to, or were intolerant of immunomodulators or tumor necrosis factor blocker therapy, or who had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid therapy. The biologics approved by the FDA for CD and/or UC include adalimumab, infliximab, golimumab, certolizumab, and ustekinumab.

OBJECTIVE: To assess the budget impact of including vedolizumab in a health plan formulary among current options as a preferred first-line biologic therapy for UC and CD rather than only for patients who failed anti-TNF therapy.

Key Words: adalimumab, anti-TNF biologic drug, budget impact model, certolizumab, Crohns disease, golimumab, health plan formulary, infliximab, ulcerative colitis, vedolizumab

Am Health Drug Benefits.

Disclosures are at end of text

Methods

Comparators

Costs

Results

Humira Pen And Other Forms

Humira comes in three forms: a prefilled pen, a prefilled syringe, and a vial of liquid solution. The drug is given as a subcutaneous injection. A healthcare professional can give you Humira injections. But you may be able to give yourself injections at home with the pen or syringe if your doctor approves. Youd need to be trained first.

Both the pens and syringes are prefilled with a single dose of Humira and come with needles. There are also special Humira starter packs available that contain several prefilled pens or syringes.

Humira also comes in a single-dose vial. But this form can only be used by healthcare professionals. You wont be able to use vials yourself.

If you have questions about which form of Humira is right for you or how to give yourself injections, talk with your doctor.

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Biologics And Beyond In Ibd

This research is part of a new era of IBD care at Cleveland Clinic combining novel medical and surgical therapies with pioneering research. The outcome is IBD care that is setting a high standard, exceeding that of traditional IBD centers of excellence.

Perhaps the most fundamental shift has been the introduction of Cleveland Clinics IBD medical home, which pairs patients with a team of colorectal surgeons, pain specialists, pharmacists, dietitians, social workers, psychologists and others, all led by a gastroenterologist.

While its still early, were seeing that our patients with ulcerative colitis and other inflammatory bowel diseases experience improved quality of life, decreased emergency department visits and hospitalizations, and reduced total cost of care thanks to the medical home model, says Dr. Regueiro, who leads the program. We plan to set the trends for treating these diseases for many years to come.

Assignment Of Maintenance Medication

To examine the market share of patients primary IBD medication, we followed a hierarchical system to classify patients receiving more than one medication . Patients receiving a biologic medication were assigned to the maintenance biologic category, regardless of concomitant use of immunomodulators, 5-ASAs, or corticosteroids. Patients receiving an immunomodulator were assigned to the maintenance immunomodulator category, regardless of concomitant use of 5-ASAs or corticosteroids. Patients receiving a 5-ASA were assigned to the maintenance 5-ASA category regardless of concomitant use of corticosteroids. Patients who were only receiving corticosteroids were assigned to the corticosteroid category, and we assumed that these patients were not on an appropriate IBD maintenance medication.

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Table 3strengths And Limitations Of Randomized Controlled Trials Using The Cochrane Risk Of Bias Tool14

AUC = area under the curve, AZA = azathioprine, CI = confidence interval, CUCQ = Crohns and Ulcerative Colitis, CySIF = Comparing Cyclosporine with Infliximab in steroid-refractory severe attacks of ulcerative colitis, EQ-5D = European Quality of Life-5 Dimensions, IBDQ = Inflammatory Bowel Disease Questionnaire, IFX = infliximab, OR = odds ratio, QAS = quality-adjusted survival, QoL = quality of life, SAE = severe adverse effect, SAR = severe adverse reaction, SF-36 =36-item Short Form Health Survey , UC = ulcerative colitis

Humira For Crohns Disease

Humira is FDA-approved to treat moderate to severe Crohns disease in adults thats active. Active means that you have symptoms.

The goal of Humira is to ease the signs and symptoms of CD and help you reach remission, which is a time when you dont have symptoms.

CD explained

CD is a form of inflammatory bowel disease. CD can affect any part of your digestive tract, but it most commonly occurs in the small intestine and the large intestine . CD often causes symptoms such as diarrhea, stomach cramps, bloody stools, fatigue , weight loss, and frequent bowel movements.

Its believed that an overactive immune system is a factor in causing CD. Humira treats CD by blocking a protein called TNF. This decreases the activity of your immune system, leading to a reduction in the number and severity of CD symptoms.

Effectiveness for Crohns disease in adults

In adults with CD, Humira has been shown to be effective at causing and maintaining both remission and significantly easing CD symptoms.

In clinical studies, people with CD were treated with either Humira or a placebo. Researchers found that 21% to 36% of people who took Humira had a CD remission by week 4. This is compared with 7% to 12% of people who took a placebo.

Of the people who took Humira, 52% to 58% found that their CD symptoms eased significantly by week 4, compared with 34% of people who took a placebo.

Humira for Crohns disease in children

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The Pros And Cons Of Biologics For Ulcerative Colitis

The introduction of biologics has changed treatment for many people with ulcerative colitis. Heres what you need to know about the risks and benefits.

Over the past 15 years, treatment options for ulcerative colitis have expanded quite a bit. Among the newer options is a class of drugs called biologics.

Biologics are derived from natural sources, such as human or animal genes or microorganisms, and are designed to act on the immune system, specifically the parts that play key roles in fueling inflammation.

As inflammation is thought to be a cornerstone of the process involved in the manifestation of inflammatory bowel diseases, like Crohns disease and ulcerative colitis, they have proved to be very effective as treatment for certain patients, says Donald Tsynman, MD, a gastroenterologist at NewYork-Presbyterian Hospital in New York City.

The fact that biologics target the activity of the patients own immune system is what sets them apart from some other medications for ulcerative colitis, Dr. Tsynman says.

Will Biosimilars Give Greater Access To Biologics In Ibd

The introduction of biosimilars – medicines that are very similar to an original biologic therapy which has come off patent – has increased competition in the biologics market. An increase in competition has resulted in a decrease in the cost of this type of therapy, the most expensive in inflammatory bowel disease . So, does this mean more inflammatory bowel disease patients will be prescribed biologics at an earlier stage in their treatment? We take a look.

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Biologics Are Targeted Medications

While many UC medications have wide-ranging effects on your immune system, biologics are designed to block specific steps in the inflammatory process.

One group of biologic drugs for UC, known as anti-TNF drugs or TNF inhibitors, block a protein called tumor necrosis factor alpha that promotes inflammation in your intestines and certain other organs. Another type of biologic, integrin receptor antagonists, blocks a protein on the surface of cells that can move out of blood vessels and into certain tissues.

Prognostic Testing: The Start Of Precision Medicine In Ibd

Being able to effectively predict the course of IBD at the time of diagnosis to identify an individual patients risk of experiencing frequently relapsing disease would allow those patients at high-risk to be prescribed biologics earlier, which could improve their chance of going into remission and reduce the probability of disease-related complications.

Although clinical criteria have been reported to associate with outcome, these perform poorly when tested, making it difficult to identify high-risk patients. Recent years have brought important insights into the biology underlying different disease course in IBD patients, in particular the understanding of the impact of the immunological state known as T-cell exhaustion12,13. This has allowed the development of PredictSURE IBDTM, a fully validated, CE marked whole blood prognostic test for Crohns disease and ulcerative colitis14. Using qPCR, PredictSURE IBD measures the expression of 17 genes and a proprietary algorithm to sort patients into high- and low-risk subgroups.

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Humira For Juvenile Idiopathic Arthritis

Humira is FDA-approved to treat juvenile idiopathic arthritis thats moderate to severe, polyarticular, and active in children ages 2 years and older. Polyarticular means that the condition affects more than one joint. And active refers to the fact that the child has symptoms.

JIA, which was previously known as juvenile rheumatoid arthritis, is the most common type of arthritis found in children. Children with JIA often have joint pain, swelling, and stiffness. Most cases are mild, but if left untreated, JIA will likely worsen and can lead to chronic pain and joint damage.

Its not known exactly what causes JIA, but its believed that its the result of an autoimmune disease. This is a type of disease in which your immune system attacks your bodys own cells by mistake. Humira treats JIA by blocking a protein called TNF. This decreases the activity of your immune system.

Effectiveness for juvenile idiopathic arthritis

Humira was studied in children ages 4 to 17 years with polyarticular JIA. All children in the study had previously tried other medications for JIA. In this clinical study, researchers wanted to see whether Humira was more effective at reducing the severity of JIA symptoms compared with a placebo.