For people living with severe diseases, the journey to diagnosis and treatment can be challenging, but affordable access to their prescribed medicines should not be another major hurdle. 

Insurers and pharmacy benefit managers (PBMs) – the intermediaries between manufacturers and insurers – use a range of tactics to keep their costs down. Unfortunately, these tactics are deployed to the detriment of patients and have recently led to more scrutiny from both Congress and the Federal Trade Commission for their impact on the accessibility and affordability of prescription drugs. 

In a previous Voices on Value post, we explored barriers to affordable access patients may face, including discounts patients don’t receive, step therapy, and co-pay accumulators and maximizers. We are now taking a deeper dive into the challenges these tactics create for patients by hearing directly from a leader within the patient community on how we can work together throughout the healthcare system to ensure patient access to necessary treatments. 

Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute, has been a national policy and advocacy leader in the HIV community for over 20 years. However, his advocacy efforts extend to a wide range of patient communities, especially on issues of patient access. UCB has worked with Schmid and the HIV+Heptatitis Policy Institute over the years on several initiatives, including the All Copays Count Coalition, to help improve patient affordability. 

Carl joined Hannah Lynch, Associate Director, U.S. Public Policy at UCB, to discuss how we can evolve the healthcare system to better serve people living with severe diseases and help them overcome access barriers. 

Note: The conversation has been edited and condensed for clarity.

1. Why do patients experience frustration when trying to access their medicine? What role do insurers and pharmacy benefit managers play in patients being able to access their medications/treatments?

Carl Schmid: Insurers and pharmacy benefit managers play a major role. They're the ones that really make a lot of the decisions on if the drug is covered or not. You may also have to jump through prior authorization or step therapy hurdles. Then you have to pay for the drug, and there are different costs associated with the drug depending on the cost-sharing for the formulary tier it is on. 

There are so many barriers that patients face even though they have insurance. We hear from patients all the time about their access barriers to care. For instance, a person with HIV reached out to me recently who got stuck with a $2,400 bill. They were shocked. I told them, “You're not alone. Other people are doing this." And I explained to him, "You're apart of a co-pay accumulator.” It's hard enough to go through life. It’s unfortunate when people think they have insurance and coverage, but then they can't access the medicine they really need.

Hannah Lynch: Patients can often experience frustration trying to obtain their prescription medication because there's such a lack of transparency and confusion around the utilization management tools a health plan or PBM may be using, like prior authorization or step therapy. It can be frustrating for patients in terms of the time it takes to navigate this process and the delay in care they receive. 

2. How do we ensure that the high value of new and innovative medicines coming to market is reflected in insurance and PBM coverage determinations?

Schmid: Once a medicine is approved, it needs to be covered by insurers, and it really depends on the payer. There's different laws and regulations. There are certain drug classes that all medicines have to be on formulary. But again, all medicines can face prior authorizations, different tiering levels, and cost-sharing amounts. That’s why it's important for the patient community and the provider community to speak up to make sure new medicines are covered. And, of course, pharmaceutical companies also have a role as well.

Lynch: There are several ways we can help ensure that these new and innovative treatments that are coming to the market are available for patients at the end of the day. As the pharmaceutical industry, it is on us to communicate directly with payers how these new treatments create value for patients and improve patient outcomes. 

We must also continue to work on removing barriers, such as prior authorization or step therapy, that will prevent or delay access to treatment for patients. 

3. How are tools used by insurers or PBMs, like step therapy, creating barriers to affordable access to medicines for patients?

Schmid: More and more insurers and PBMs are putting prior authorization and step therapy requirements in place, which delays or blocks care and treatment for patients. There's a reason why a doctor or provider prescribes a certain medicine for a patient. And there are some practical reasons for step therapy, but a lot of times, it's based on negotiations between PBMs and manufacturers. PBMs are trying to extract additional rebate dollars from manufacturers.

In the HIV community, these tools really impact a person’s life, and if they’re going to live or not. Denying treatment to people that need it, particularly cures or lifesaving medications, not only hurts the patient and their livelihood, but also their employment status, how they live every single day, and society too.

Lynch: Step therapy is a practice that is put in place by the [insurance] plan, and it's often not in the best interest of the patient. In some cases, it can lead to worsening health outcomes for patients by delaying access to the most effective treatment or increase the out-of-pocket burden they may face. That's why it's important for us at UCB to work with patient groups to remove these barriers to care.

There are currently both federal and state efforts to establish a clear and timely process for a patient or physician to request an exception to a step therapy protocol which would help patients access their treatments more quickly. At the federal level, this bill is called the Safe Step Act. There's actually been a lot of movement on this issue right now as Congress debates the larger PBM reform packages. UCB has been very supportive of this issue and is working closely with the patient community to ensure step therapy override is included in the final PBM reform package. 


4. How are co-pay accumulators and/or maximizers impacting patients?

Schmid: Co-pay accumulator programs and maximizers are another barrier to access to prescriptions for people who rely on them and need them. It’s such a bizarre practice. Patients get co-pay assistance from the manufacturer and the insurers collect it, but it doesn't count towards the person's out-of-pocket cost or deductible. Then, when the co-pay assistance runs out, the patient is stuck with an unanticipated huge bill. It could be thousands of dollars.

Lynch: One of the things that we're concerned about is that due to these programs, patients will be caught off guard with a higher price to fill their prescription than what they were expecting. They then may make a decision right then to discontinue their care, leading to disease progression or poorer health outcomes. And no one ever wants to see that happen.

We've been working closely with advocates, like Carl, and other patient groups that are really leading this effort, to hear about how we can best help advocate to have these practices either made more transparent or banned altogether.

Schmid: The patient community has fought back on this practice. Insurers are collecting more money than they should be. My organization has actually filed a suit against the U.S. government, and the patient community has also put together a coalition –  the All Copays Count Coalition. It’s an uphill battle, unfortunately, but we're going to continue to fight together.

5. Are patients encountering any other barriers? Have you seen or heard from patients about these tactics or others becoming more common?

Schmid: A new barrier patients face is called “alternative funding programs.” What’s happening is these outside entities are partnering with employer-sponsored plans to stop coverage for certain specialty medicines and instead require people to use manufacturer’s assistance programs. And remember, these people have insurance. We feel that what they’re doing is illegal and very risky for a patient. Additionally, those costs don't count towards a person’s insurance and your deductible.


6. What types of initiatives, from patient education to policy advocacy, are your organizations leading to overcome these barriers?

Lynch: One of the ways that UCB has been working with patient groups on these advocacy efforts is by acting as a resource for them. We can help provide data, assist with patient education in the communities we serve, and listen to people share their stories. Additionally, we help educate policymakers about the issues patients are experiencing and the tools insurers or PBMs use that can hinder patient access in order to help them support policies that will create better access for patients.

Schmid: We're working to overcome these barriers on a number of fronts, including by partnering with other patient groups nationwide. One of the initiatives we've been working on is limiting cost sharing and how much people have to pay for their medicines by implementing a standardized benefit design by insurers.

I also work closely with the National Association of Insurance Commissioners, who regulate insurers in the private market. We are talking about step therapy and co-pay accumulators, and we're pushing them to take action.

There's a lot going on around the country and in Congress to try to address some of these issues. And it's great that the patient community is working together to make sure this is happening, and it's also great to have the support of pharmaceutical companies. 

7. How can other stakeholders within the healthcare system/value chain support patient advocacy organizations to continue advocating for better patient access and a more sustainable healthcare system?

Schmid: It’s great to partner with the pharmaceutical companies. They really do partner with a number of patient groups, and UCB, I think, is a fine example of that. The industry helps by providing their expertise, assisting with organizing certain patient groups, and talking about the value of their medicines, including their pricing decisions with the patient community. It’s important to talk about those issues, and providing this information helps patients be better advocates. 

Lynch: Stakeholders throughout the value chain can work with patient advocacy groups by supporting their education and advocacy efforts, participating in their outreach days, helping make connections, and sharing information. There's work to do, and I think it's most effective when we all work together as a community to advocate on behalf of patients.