Posted in Uncategorized, tagged Abatacept, Arava, Bristol-Myers Squibb, C-reactive protein, CRP, ESR, Food and Drug Administration, inflammation, iPhone, methotrexate, Orencia, Patient, rheumatoid arthritis, rheumatologist, treatment on November 20, 2012|
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The answer to this question eluded me over the years with the wide variety of RA medicines I’ve taken. It came up this week when my wife asked it again after seeing me go through a particularly long and nasty flare. I reminded her that there is no cure, only treatments for RA. But it did raise my curiosity.
In an attempt to answer this question, I went back to the Orencia package insert[i] – those 20 page, 5 point font documents that every pharmaceutical company puts inside their medicines – to try to find some answers. Bristol Myers Squibb likes to include a copy of these inserts every time they send me something in the mail. Most people probably don’t read these lengthy, highly technical documents that include information on dosage, indications, administration, warnings, side effects, and efficacy. There are likely some regulatory guidelines from the government dictating their contents since at the bottom of the document it says, “The Instructions for Use has been approved by the U.S. Food and Drug Administration”. I dug through the insert until finding the section on clinical response – in other words, how well does it work?
Most clinical researchers use a variety of tools to gauge RA drug efficacy. The Health Assessment Questionnaire – Disability Index (HAQ-DI) which is a short version of the full HAQ is one such measure.[ii] Here’s a link to an online version of the HAQ. Many rheumatologists have their patients complete a HAQ and I remember doing this at my very first visit. Another commonly used tool to assess is the Disease Activity Score 28 or DAS28. It uses a count of the number of tender and swollen joints plus either a sedimentation rate (ESR) or c-reactive protein (CRP) blood test of inflammation. There is also an online version of DAS28 and an app for the iPhone. According to one site, “A DAS28 score higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.”[iii]
According to the online DAS28, I currently have high disease activity. One of the clinical studies on Orencia reported in the insert, “…a greater proportion of patients treated with ORENCIA plus methotrexate achieved a low level of disease activity as measured by a DAS28-CRP less than 2.6 at 12 months compared to those treated with methotrexate plus placebo.” The proportions reported were 41% of patients on Orencia/Methotrexate reached a DAS28 of less than 2.6 compared to 23% of placebo patients. That means that a larger proportion of patients, 59%, did not reach remission.
I’ve been on Orencia plus Arava for 11 months now and am not currently in that minority who reached remission. In fact, just the opposite has happened. It’s hard to tell at this point if this combination of disease modifying drugs is not working for me or it’s just a nasty flare induced by too much work in the past few months. But this will be a conversation my rheumy and I will have at our next visit in early December. I am very hesitant to try yet another treatment regimen as I’ve already been through a truck load. But my rheumy encouraged me there’s still hope and other treatments to try and her goal is remission.
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Posted in Uncategorized, tagged Abatacept, Amgen, Bristol-Myers Squibb, humira, infusion, insurance, Orencia, Pharmaceutical industry, RA, rheumatoid arthritis, United States on July 9, 2012|
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I’ve been on four biological medicines over the past 3 ½ years to treat rheumatoid arthritis. I’m thankful for these complex drugs as it’s clear that they slowed disease progression. I’m currently taking Orencia. After a recent Orencia infusion, my insurance company sent an Explanation of Benefits (EOB) form showing the cost and coverage of the medicine and infusion services (see a photo of the form). The form shows that the charges billed by the infusion clinic for the Orencia was $4,425 for 1,000 mg of medicine. I’m curious about the source of this cost and can only assume that this is the cost suggested by the drug manufacturer Bristol-Myers Squibb…sort of like a “suggested retail price.” The adjustments made by the clinic were for $2,609.25 making the final cost of the drug that the insurance company agreed to pay $1,815.75. The mark-up on Orencia must be huge if the adjustment was almost 59% less than the original cost. Insurance companies obviously know the price structures to medicines and know what price pharmaceutical companies and clinics will actually accept in order to cover their costs. The clinic also charged $367 for the infusion which included the nurse and equipment. My insurance company agreed to pay $260 for these services. The total cost of this infusion was $2,076.29. A total annual cost of such infusion treatments would be $24,912. And that does not include other costs associated with my RA treatment including other medicines, doctor visits, blood tests, imaging, and surgeries.
I had already met my deductible for the year so there were no out-of-pocket expenses this time. However, pharmaceutical companies know that deductibles and co-pays can present huge financial challenges to patients and many offer co-pay assistance. Bristol-Myers Squibb provides an assistance plan where they will pay all but $5 of each infusion co-pay costs (just for the medicine, not the clinic costs). They actually sent me a debit card and loaded it with “cash” ready to be used to pay the clinic any co-pays not covered by insurance. I used this card to pay for thousands of dollars of co-pay costs to the clinic during the first six months of the year.
Biological medicines are understandably expensive because of the complex manufacturing processes involved. Such medicines also have extended patent protection over chemical pharmaceuticals in order to help drug companies recoup the extensive cost of research and development. Those costs are passed onto the patient. Every time an Orencia commercial comes on the TV, I wonder about the cost of publicity – a relatively new thing in the pharmaceutical industry.
The wild difference in charged costs versus covered costs as shown on the EOB can only make one wonder about drug company profit margins. Clearly biologicals are big business. In 2010, Amgen’s Enbrel had over $3 billion in sales just in the United States.[i] This represented 23% of Amgen’s annual sales. Humira is projected to be the world’s biggest revenue drug by 2016 with over $10 billion in annual sales.[ii]
The real cost of Orencia isn’t a mystery that I will likely solve any time soon. There are numerous business and political players involved. I’m just thankful for a medicine to treat RA, insurance coverage, and co-pay coverage by the pharmaceutical company.
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Posted in Uncategorized, tagged Abatacept, Adalimumab, enbrel, humira, infusion, Orencia, RA, rheumatoid arthritis, treatment, Tumor necrosis factor-alpha, Tumor necrosis factors on June 25, 2012|
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Today was a scheduled Orencia infusion. I began this medication last January after Humira stopped working. Orencia is different than Humira and Enbrel, the most common biological medicines for RA, in that it is designed to inhibit T-lymphocyte cells in the immune system while Humira and Enbrel block TNF-alpha. It’s usually used as a second line biological treatment if TNF blockers don’t work.
The treatment begins with three loading sessions every two weeks and then moves to once a month infusions. For my weight, the normal dose is 750mg. However, my new rheumatologist wanted to up the dose to 1,000mg as it wasn’t having the full anticipated impact and some recent research shows that an increased dose is beneficial for some patients. She also added 10mg of Arava (leflunomide) in an effort to combine a disease modifying drug with a biological.
The morning began like any other day except that I tried to keep myself hydrated and I took some Tylenol and 50mg of Tramadol before leaving the house. This was an effort to keep headaches at bay since I’ve experienced them after infusions in the past. I also had similar reactions with Humira injections. I recently switched rheumatologists at a new clinic. Orencia must be administered in an infusion clinic and this would be my first visit. The infusion clinic is on the 5th floor of a brand new building and is near the Oncology offices. That is because many cancer patients are receiving chemotherapy via infusion. It feels a little strange walking into such a place as you know that many of the patients around you are in serious and life threatening situations. The clinic itself was bright and cheery with small and private cubicles for each patient. Unlike other doctor offices, you just walk in and immediately meet a nurse who escorts you to a cubicle.
Once settled into a comfortable lounge-like chair, blood pressure measurements were taken and then an infusion needle was inserted into a vein. I’ve had infusions in my elbow, arm and hand. Today the choice site was the hand. The stick began with a slight sting that then grew more painful to the point of major discomfort. The nurse said that there are many nerve endings in the back of the hand and that the needle must be irritating them. She placed a warm compress on the site but the pain was almost unbearable. She offered to re-stick me but the pain subsided a little. Four vials of blood were drawn as is typical with each infusion. These samples will be used to run typical RA blood tests like complete blood count (CBC), sed rates, and liver panels all in an effort to make sure that everything is normal since the array of RA medicines can impact these markers.
The medicine is contained in a solution and is infused, not dripped, meaning that a pump provides the force pushing it into your body. The pump makes a whirring sound every few seconds. At this point, I could pull out my iPad, listen to music, and read a book. For Orencia, the infusion takes about 45 minutes. That’s not bad compared to 3-4 hours for Remicade, another TNF blocker used for RA. When the medicine is gone out of the bag, a beeping on the pump alerts the nurse. Some saline solution is pushed through the drip line to flush all of the expensive medicine into your body. I can always feel a cold sensation in my arm during this time. Finally, a pressure bandage is wrapped to keep the site from bleeding and they advise leaving it on for 30 minutes.
View of Space Needle from Gates Foundation
It’s all over in a pretty short period and after setting up an appointment for the next infusion, I’m out the door. Today I was fortunate enough to be able to meet a friend for lunch. He works at the Gates Foundation – the largest non-profit in the world. I was able to put the infusion behind and take a tour of the amazing, environmentally friendly building before enjoying some sushi. There was no headache today and for that, I’m thankful. But the real story will be if Orencia impacts RA symptoms over the long term.
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