Biologic treatments for rheumatoid arthritis are some of the most expensive medications on the market. Do you ever wonder if they’re worth it? Do you ever daydream about what you’d do if you could just take the money instead of the treatment? Read my ramblings on the subject on rheumatoidarthritis.net here: https://rheumatoidarthritis.net/living/i-dont-feel-16000-better/
Today CVS Health issued a news release announcing their Transform Rheumatoid Arthritis Care™ program. At least they were honest. In the first sentence, it clearly states that the purpose of this program is to “help the company’s pharmacy benefit management (PBM) clients better manage care and costs for rheumatoid arthritis (RA).” At least they didn’t lie and say it was for the benefit of patients.
For those of you who don’t know what a PBM is, they are the organizations that insurance companies use to determine such things as what drugs are covered and for how much and whether step therapy is required before approval. They exert an amazing amount of control over what drugs are available to patients and what those drugs cost. In a previous post, I debunked one of the major PBM’s assertions where they misstated the American College of Rheumatology treatment guidelines for their own purposes.
It’s a known fact that RA drugs – particularly biologics – are some of the most expensive medications prescribed. I acknowledge that we need to manage these costs as much as possible – but I disagree that it should be at the expense of patient care or interfere with the doctor’s right to design the best treatment plan possible. Even the National Institute of Health (NIH) has stated, “The treatment of RA has been transformed in the last decade with the introduction of several targeted biologic agents. Although biologic agents are more costly in the short term than conventional disease-modifying antirheumatic drugs, drug-specific costs may be offset by significant improvements in RA symptoms, slowed disease progression, and improved physical function and quality of life for patients.”
What are some of the key points CVS Health’s new program that I think may be directly or indirectly harmful to patients?
- It encourages the “use of lower-cost therapies”. Translated into patient language, that means that patients may not have immediate access to biologic medications until first “failing” on older, less costly treatments such as triple therapy (sulfasalazine [a sulfa drug], hydroxychloroquine (Plaquenil), and methotrexate).
- Under outcomes-based contracts, pharmaceutical companies might be penalized if patient targets or goals are not reached. Most patients are prescribed an anti-TNF drug as their first biologic. It’s a well-documented fact that approximately 30% of patients fail on their first TNF biologic within the first year. How will penalizing the manufacturer (1) help the patient or (2) lower drug costs (the program’s goal)?
- Changing to an indication-based formulary. This means that instead of a certain class of drugs being covered for a condition, medications are placed on the formulary (payment scale) based on the specific drug. For example, all anti-TNF drugs (the most commonly prescribed RA biologics) might not be covered. According to CVS’s Carefirst statement the following, commonly prescribed RA drugs have been removed from the formulary for rheumatoid arthritis: Actemra, Cimzia, Kineret, Orencia (infused), Simponi, and Xeljanz/XR. This can severely limit the affordable treatment choices for patients.
- According to the news release, a PBM could save up to 5 percent on RA drugs. That translates to $500,000 over 100,000 patients – or about $5 a patient. First of all, I will gladly pay the $5 to be given access to the drugs that my doctor thinks is the best treatment plan. And second – back to the patient – while this might save the PBM money, there is no indication that these health care savings will be passed to the patient.
For me, there are two inescapable conclusions. The first is that these types of pharmacy programs border on practicing medicine by dictating what treatments are available on an affordable basis to the patient. The second is that all the focus is on saving money while apparently no thought is given to the debilitating effects on patients who are denied effective treatments.
I’ve been seething since I read Prime Therapeutics’ October 17 news release asserting that patients are being prescribed biologics outside of American College of Rheumatology (ACR) guidelines. The referenced Prime Therapeutic reports assert that patients are being switched from conventional DMARDs to more-expensive biologic treatments before the DMARD therapy is given a proper chance to work (as much as 24 weeks – or almost six months). The report concludes this has caused an unwarranted higher total cost of care for RA patients. The conventional first-line DMARD is methotrexate (MTX) and the triple therapy of MTX/hydroxycholoquine/sulfasalazine was also discussed.
For those of you who are not familiar with Prime Therapeutics, they manage pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. Their opinions affect more than 20 million people. For many, this is the entity that determines whether or not their prescribed medication treatments are approved and whether there are pre-approvals or step-therapies involved.
I get it. Someone needs to keep an eye on keeping prescription costs in line. But focusing solely on the cost/benefit ratio excludes the patient’s best interests from the equation. Even the National Institute of Health (NIH) has stated, “The treatment of RA has been transformed in the last decade with the introduction of several targeted biologic agents. Although biologic agents are more costly in the short term than conventional disease-modifying antirheumatic drugs, drug-specific costs may be offset by significant improvements in RA symptoms, slowed disease progression, and improved physical function and quality of life for patients.”
I could spend pages taking Prime’s conclusions to task, but I will limit my comments to four major points:
- While the report tracked when patients were switched to a biologic, the reasons why the patients were switched were not included. By excluding this data, the report appears to imply that switching from conventional DMARD therapy was done without medical merit. This is not necessarily true. For example, there are patients who have concerning side effects from MTX including liver toxicity. There are other valid medical reasons for switching from MTX including other drug interactions and patient compliance issues.
- Physicians are the best judge of which drugs will be the most effective for their patients. They see the living results of treatment plans every day in their practice and they have front-line knowledge of which medications are the best choices for their patients based on a number of variable factors. As an example, not all patients are diagnosed in the early/mild stages of the disease. In fact, many are misdiagnosed for an extended time and, by the time the rheumatologist sees them, may have developed an aggressive/severe disease state. It should be the physician’s call as to whether conventional DMARD therapy is the best choice or whether more powerful biologics are needed. A simile to Prime Therapeutics report would be if your house was on fire and when you called 9-1-1 they said you must try a fire extinguisher first because it cost the city a lot of money to send out a fire brigade.
- Patients are financially involved in these decisions. Yes, RA drugs are some of the most expensive drugs there are, but companies such as Prime seem to forget that patients share in paying for these drugs. Either the drugs aren’t covered at all, have only a percentage of the cost covered or the patient’s coverage has high deductibles and/or copay amounts. Patients have as much or more motivation to control health care costs as companies such as Prime. I recently met an RA patient who had to make the choice of paying for her RA treatment or pay for college to finish her degree. These kinds of personal sacrifices are not unusual and underscore the importance that patients put on finding an effective treatment.
- Some of the information in the Prime Therapeutics’ news release is suspect. For example, there is a quote in the Prime Therapeutics’ news release that starts, “RA guidelines supporting use of conventional DMARDs before biologics have been in place for more than two decades …” This is an interesting statement given that the first biologic, Enbrel, wasn’t introduced until 1998, less than two decades ago. In addition, both the NIH and the ACR both reference the ACR’s 2008 recommendations for the use of nonbiologic and biologic DMARDs in RA (published less than one decade ago). These recommendations clearly state that the ACR, “… has not previously developed recommendations for recommendations for biologic agents.” The ACR updated these recommendations in 2012, which was five years ago (not two decades). The latest ACR guidelines are from 2015 and cover the overall treatment of RA, including the use of biologic and nonbiologic DMARDs. I’m not sure where the Prime Therapeutics got their two decades of recommendations. True, they may be referencing some other, less-prominent guidelines but in the US the ACR is the defining authority. And if they did actually get this statement incorrect, it makes you wonder what else is incorrect in their information.
I actually read the ACR’s 2015 Guideline for the Treatment of RA and, as much as I searched, I couldn’t find any reference to how long a patient should be on “conventional DMARD” treatment before being transitioned to a biologic. In fact, contrary to Prime Therapeutics assertion that switching between conventional DMARDs and biologics is contrary to the ACR guidelines, the ACR recommendations clearly state the following:
This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients’ values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.
I am in favor of controlling prescription costs. I also strongly believe that controlling costs should not interfere with practicing medicine or with prescribing appropriate treatment plans for a patient. Unfortunately, the influence that Prime Therapeutics wields has the ability to do just that.
Thanks for checking in.
On Wednesday, August 2, FDA advisors voted 12-1 against approving the promising new RA drug, sirukumab. In a field dominated by TNF-targeted biologics, this was a new anti-IL-6 drug. Actemra and the recently announced Kevzara are the only other two IL-6 drugs on the market. While the trials proved that the drug’s effectiveness is “robust”, the primary concern, as reported by Medpage Today, is the drug’s safety, although earlier reports also mention potential flaws in the trial design that could impact the trial’s reported results.
I have mixed emotions about this announcement. On one hand, I hate to have major setbacks for what appears to be a great new option for RA patients, on the other hand, I want our drugs to be as safe as possible and applaud the caution in withholding approval.
There was another discordant note in this news story, however, that took me aback. This was the soundbite from the one person who voted FOR approval of the drug — he was the “1” in the 12-1 vote. His name is James Katz, MD and he is the director of the rheumatology fellowship and training branch of the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases in Bethesda, Md. According to MedPage, he said, “This drug doesn’t scare me any more than the other biologics. I’m scared of all the biologics.” And this is the guy who voted for approval???
Why does this bother me?
In a world of fake news and quotes taken out of context, I went in search of the full statement to see if he elaborated further. I was on a panel recently with another leading rheumatologist who stated, “RA is a serious disease and it takes serious treatments to combat it.” And let’s face it, serious drugs can be scary. I thought perhaps that Dr. Katz’s comment about biologics were along these lines.
But other than the mention in Medpage, I haven’t (yet) been able to find anything further on the comment. (I’m still looking so if you find it before I do, please let me know.)
My concern is the effect of these words can have on RA patients, particularly those who are contemplating a biologic for the first time. Yes, it’s true that biologics can have serious side effects. But it’s also true that thousands of thousands people use them on a daily basis without problem and are able to lead fuller, more productive lives by helping control the devastating effects of this disease. While treating RA is serious business, NOT treating RA is even more serious. Without treatment, RA can be debilitating and, once the damage is done, it cannot be reversed.
I personally am on a biologic and methotrexate and I am doing better than I have in a long while. But that’s not the right answer for everyone. I think treatment plans need to be personal, that they need to be decided upon by the patient and the doctor, and that the full mosaic of information needs to be considered when making that decision — not just a soundbite.
I hope the soundbites in your life today are happy news. Thanks for checking in.
I’ll admit to being terrified of needles growing up. I’d pass out getting blood drawn or (once) even getting an injection. Fast forward to today and being an RA patient. Not only do I get blood drawn once a month for lab work, I give myself a weekly injection and get regular infusions of a biologic medication.
The decision to use a biologic medication is significant and should be discussed with your doctor before you begin treatment, when you start the treatment and as you move forward. The decision of which treatment that’s right for you is also an important discussion. One of the things to consider is the delivery method. That is to say, are you more comfortable with an injection that you give yourself at home or an infusion administered at a medical facility? Doing your homework before having that discussion with your doctor will help you be prepared and better understand your options. There are some excellent online resources including an entire section dedicated to biologic treatments on JointDecisions.com.
Over the years, my journey with RA has included being on nearly all the biologic treatments, so I’ve had a lot of experience with both injections and infusions. The hardest part for me was getting over the fear of the injection or infusion and the actual experience has not been that bad (even for someone like me who has always disliked needles).
That being said, there are some things to consider for both injections and infusions, including the following:
Biologic injections that you (or a caregiver/loved one) do at home are a convenient alternative because you can determine an injection schedule that works for you. I used to do my injections in the evening. I seldom had any side effects from the medication but if, for example, I developed a mild headache, then I’d generally be in bed asleep for the night and it would be gone when I woke up.
Injectable biologics need to be stored and disposed of correctly. The medications need to be refrigerated which isn’t a problem when you’re at home, but is a consideration if you travel a lot and have to keep the medication cold while away. You should also dispose of the used syringes in a responsible manner. Regulations vary by location but I use a mail-order service that, for a small fee, disposes of my full containers and sends me a new one.
In my opinion, the two biggest considerations are the dosing schedules and syringe type.
The dosage schedules for injectable biologics vary. While the decision on which treatment is the right one for you should be the one with the best chance of success, if the injection schedule is going to be difficult for you, it is something you should discuss with your doctor as part of the overall treatment choice.
Injectable biologics generally come in a prefilled syringe or a prefilled automatic pen injector, and some medications are offered in both forms. Although some medications still come in a vial and syringe combination, the prefilled option is great because they can help eliminate any dosage errors.
The prefilled syringes I have used have all been slightly different, but they all generally resemble the syringes your doctor uses to give you injections. They have a needle on one end and a plunger on the other end with the medication in between. You insert the needle end into the injection site (usually the top of your thigh or your abdomen) and push with the plunger to inject the medication. The really nice thing about the syringes is that you can manage the injection speed to as slow or as fast as you need to be comfortable.
Automatic pen type injectors are, in my opinion, super easy to use. They generally look like a tube with a push button on one end. You press the end of the tube against your skin, push the button and about 10 to 15 seconds later, you’re done until next time. This type of syringe automatically injects the medication for you, eliminating the need to actually inject yourself with a needle, which can be difficult for some people.
I had been on injectable medications for a while when my rheumatologist first changed me to an infusion treatment better suited for me.
I get my infusions at a designated room at my doctor’s office, but I’ve also had one at the hospital and I know people that go to special infusion centers that are set up for these kinds of procedures. The medication is delivered via an IV into your bloodstream. Depending on the medication, the infusion can be as quick as half an hour or may take several hours. However, the time between infusions is usually longer than it is than for injections.
The first time you have an IV (or for me, even the 10th or 12th time) can be scary. This is normal and any anxiety you have should fade over time. I personally have a great infusion nurse who makes it her goal to make me as comfortable as possible and the other infusion nurses I’ve met are very capable and very compassionate.
I occasionally get asked if I have a preference of injections or infusions. Both have their strong points. My personal preference would be NOT to have RA at all and to never have to consider one over the other. But since I do, I’m glad that there are advanced medications out there and that there are good options available to the doctor and to the patient.
I am especially glad there is such a strong community of RA patients and support organizations, such as Joint Decisions (http://www.jointdecisions.com). I feel that the more knowledge someone has, the more empowered they become to manage their condition and have a meaningful dialogue with their doctors. Groups such as Joint Decisions help provide the education and information that help make us better informed people and therefore better advocates for our own healthcare.
This post is sponsored by Joint Decisions, an educational initiative developed by Janssen Biotech, Inc. that empowers people living with RA to take a more active role in the management of their disease and have more open and honest conversations with their doctors. I was compensated by Janssen for my time spent collaborating on content for Joint Decisions.