Including the Patient’s Perspective in Valuing Treatments for Arthritis

Sandie Preiss

More than 50 million adults and approximately 300,000 children in the United States have some form of physician-diagnosed arthritis. With so many lives affected by this chronic condition, it is important to understand how the value of treatments for arthritis is being assessed. This question takes on an even greater importance given that the Institute for Clinical and Economic Review (ICER) will be hosting a meeting on March 24 to discuss its report on treatments for rheumatoid arthritis.

NPC President Dan Leonard sat down for a Q&A session with Sandie Preiss, Vice President for Advocacy and Access at the Arthritis Foundation. The Arthritis Foundation calls itself the “Champion of Yes” as it works to guide families affected by arthritis in developing personalized plans for living a full life, while also working toward better treatments and ultimately a cure. The foundation leads and funds cutting-edge scientific research.

Dan Leonard (DL): Sandie, thanks for taking the time to discuss this important issue. When we talk about value in the context of ensuring access, what does value mean to a patient with arthritis? Is there an “averagearthritis patient?

Sandie Preiss (SP): There isn’t a typical arthritis patient. RA is a complex disease requiring personalized and nuanced treatment. As background, we don’t understand the cause of rheumatoid arthritis (RA) and it disproportionately affects women. We know that it is an abnormal response to the immune system and that there is inflammation and joint damage that occurs. Patients often have to cycle through several medications before they find the one that is effective for them. In addition to RA, 47 percent of our patient population has a comorbid condition. Most commonly, these are depression, diabetes and cardiovascular disease.

On top of the mental health issues associated with the constant pain and physical challenges, patients face myriad access to care issues. The RA space has many innovative therapies available, yet there are many patients who were diagnosed prior to the advent of biologics. Those patients have completely different experiences and treatment needs than those individuals who were diagnosed post-biologics. So again, there is no “average” arthritis patient.

When it comes to value, it’s difficult to come up with one standard answer. Each individual patient and prescriber must decide through a process of shared decision-making how they define value. Further, the system has to allow for that kind of individualized care. For example, regarding administration methods, there are some patients with RA who want to self-inject, some who want to be infused, and others who only want to take a pill. I think these are all reasonable desires and expectations on the side of the patients.

Though we have many therapies available for RA patients, the side-effect profile of many of these drugs is less than ideal. There are also issues to consider like whether a patient is a female in childbearing years versus post-childbearing years, or if a patient has certain activities that they think are absolutely critical to their life. I can’t put one set of rules or model out there for you but I can raise questions that patients and prescribers can answer about what they view as value. That is why I am so troubled by these value models that try to make one-size-fit-all.

DL: What does the patient experience look like? And how do you factor that into value assessments? How can the patient voice be reflected in the value assessments that are put together?

SP: At the Arthritis Foundation, we routinely survey arthritis patients about their experiences. One finding revealed that between 40 percent and 60 percent of RA patients failed to meet the American College of Rheumatology’s “50 percent improvement criteria,” after taking one of the three first-generation biologics for at least six months. That supports our belief that treating RA patients requires trial and error because what works for one RA patient may not work for another RA patient. Not only do we not know what works for each patient, we also don’t know how long it’s going to work for a patient. Even if a patient is currently stable on a medication, that could change over time. If you look at data about the patient population cycling through drugs, they can cycle through three or four biologics before they are stable. As it relates to value assessments, it’s difficult to answer these questions based on the aggregate patient experience as we know it today.

DL: As you mentioned, a number of patients that you work with and represent have comorbidities. What happens when they take multiple medications or have access restrictions? What are the consequences of that?

SP: Without question, it is a lot for patients to manage. Recently, Ann M. Palmer, CEO and president of the Arthritis Foundation, and Cavan Redmond, Arthritis Foundation board member, former CEO of WebMD, and health care executive, held personal meetings with government officials, PBMs, pharmaceutical companies and insurance industry leaders as part of our nonprofit Prescription for Access initiative that is addressing the concerns of our constituents and working to create a shared understanding of the issues people with arthritis face. We wanted to understand what these stakeholders believed would enhance the health care delivery system. In addition, we met with more than 100 patients to learn about challenges they face dealing with health care, such as denied claims, managing the paperwork, etc.

One of the interviews that was most enlightening was a woman with RA who has four children also diagnosed with RA. We asked her to share how she manages everything. As it turns out, her husband is employed by a large corporation and she has high-quality insurance, but she said that she lets the benefit statements pile up for two weeks before she can emotionally prepare herself to go through them. This type of administrative burden is unacceptable for patients. We also learned that patients are not only concerned with access to care, but also with the overall lack of transparency in the system. Patients want to understand how to manage appeals, denials and any accidents that happen like coding errors.

DL: Where can patients go when they have these situations?

SP: There are several resources for patients. As you probably know and as an example, pharmaceutical companies offer patient assistance programs, but one of the things we learned during these interviews was that many patients don’t know about these programs and don’t consider calling a drug company for assistance. Some patients even told us that they would not want to use a co-pay card for fear that, after they start using one, it would be taken away from them. They also did not want to take away assistance from someone who is less fortunate than them.

To help patients with arthritis manage the health care part of their disease, the Arthritis Foundation Prescription for Access initiative created Internet-based tools on how to appeal a claim, the information patients should keep for their records (i.e., step therapy guidelines), how to manage their disease, and the resources pharmaceutical companies have available for patients.

We also learned that every facet of the health care system believes they put the patients first. However, the patient is getting lost in this journey, even with basic issues like contacting the insurer. We reviewed 65 insurance companies to see if they had a chat feature to assist patients with claims denials and found that only two had a feature where you could get answers – but it was only open from 9 a.m. to 5 p.m.

Patients need more resources and support as they navigate this complicated health care system. In addition to the tools offered under the Prescription for Access initiative, the Foundation offers resources for patients, such as mobile apps that identify exercises that are best for a person’s individual arthritis, a local resources finder and a 24-7 Arthritis Helpline. 

DL: Do you believe we are truly living in an era of medical innovation when it comes to arthritis?

SP: Absolutely. We recently conducted a survey on patients who were biologic naïve for five years after diagnosis (most likely because the drug wasn’t available yet) and learned that biologic naïve patients are 44 percent more likely to be on disability and are 400 percent more likely to have seven or more joint replacements over the course of their disease. Additionally, when we celebrated the 30th anniversary for our Juvenile Arthritis Conference in 2014, there were only a limited number of wheelchairs – but when I looked at pictures taken 30 years ago there was a sea of wheelchairs.

DL: What are your thoughts on the ICER tools and what they are trying to do?

SP: ICER has been very responsive. We will be the first patient advocacy organization to present at the public meeting on March 24, 2017. We were invited to review and comment on the evidence report before it went public and believe ICER listened to the Arthritis Foundation and our patient representatives.

Yet we do not believe ICER’s value model is comprehensive enough for the RA patient population. Although they have reported our survey results [in the RA study] and listened to us, all our concerns are not reflected in their current value model, which doesn’t consider the unique nature of RA patients. RA is a very different experience from patient to patient – no experience is alike.

ICER is now part of the health care landscape and readily admits that working with patient advocacy organizations has been a learning experience. They are continuing to make changes in their procedures to accommodate the patient voice.

DL: What does the future hold for arthritis treatment and innovation?

SP: One of the biggest issues is that 27 million of the 54 million who have arthritis actually have osteoarthritis and there is no disease-modifying drug available to them. In the next five years, I hope that we see disease-modifying drugs approved for osteoarthritis and, of course, a cure for all forms of arthritis.

Further, one in three veterans has doctor-diagnosed post-traumatic osteoarthritis and we believe that there are many more active service members who have post-traumatic osteoarthritis because of their military service. Arthritis has a serious impact on military readiness and retention and is the second most common reason for discharge from the army (combat injuries are the first). We need more arthritis related research on this population.

Also, we need to increase patient participation in clinical trials, which includes making it easier and more accessible for patients to sign up.

DL: Thanks so much for speaking with us, Sandie.

For additional information about the Arthritis Foundation, visit their website. For more about value framework assessments, check out NPC’s Guiding Practices for Patient-Centered Value Assessment and Current Landscape: Value Assessment Frameworks and watch the video from our conference, Assessing Value: Promise and Pitfalls.