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Ensuring Timely Access to Therapy for Reproductive Health


A payer discusses medical exceptions processes and triggers for a class review for drugs in women’s health, along with wraparound programs for uterine fibroids and endometriosis.

Ryan Haumschild, PharmD, MBA, MS: According to the Affordable Care Act, we have to make sure we have an exceptions process. The exceptions process has to be clear, and it can’t create undue stress on the provider or the patient. We’ve worked hard to make sure we have something that’s easily acceptable. If there’s an exceptions process, we’re going to look for the FDA indication. We’re going to look at medical information about the patient and also make sure people know how to submit that information, and then we’ll create a pretty timely review. Exceptions processes exist. They’re appropriate, and we’ve done it in a way that is pretty seamless for the provider as long as the right information is being submitted. Clarifications have come out because some payer groups are not creating [exceptions] as easily as the program intended, so that’s something we’re getting feedback on from some of our frontline users and covered lives. “Do you have any issues filling out this exception process? Is there anything we can do to improve it?” We’re constantly focused on that.

We create different queues when we review because [in the case of] timeliness for contraception, or treatments for uterine fibroids, or any type of other women’s health, patient adherence is linked. If someone goes to a pharmacy or sends a prescription, and there’s a long lead time, and sometimes you’ll find that the patient doesn’t fill that prescription or doesn’t maintain adherence. We have a separate queue where these will go to and be routed. According to the ACA [Affordable Care Act], they want to make sure it’s a timely review according to the indication. As long as we’re doing our due diligence, we have a separate queue that won’t decrease any type of patient motivation to take therapy and will decrease any frustration on behalf of the provider.

Endometriosis and uterine fibroids are extremely important because they lead to a lot of pain for patients and impact quality of life. We’ve created better access to the therapies that are most appropriate for these patients and created an easy exceptions process so patients can get the right therapy approved as needed by their prescriber, as well as programs that look at their proportion of days covered. We know adherence to these therapies usually leads to better outcomes—and rather quickly when we work on suppressing some of the hormonal [issues] with uterine fibroids. When we create timely access and better adherence and then monitor those patients, those are the types of wraparound programs that allow them to be the most successful.

There have been a lot of new entrants into women’s health, and that’s exciting for the patients. It’s more complex for the payers because you want to make sure you’re always providing the right therapy to the right patient, but what would trigger a review is if we see a new mechanism of action, any new clinical efficacy data that we feel has improved upon the standard of care or an improved safety profile. One that not many people think about, but payers do, is patient adherence. We want to make sure that data from the clinical trials translate to real-world evidence. The better a medication is from an adherence profile—maybe taken once a day, or taken orally to decrease any of the barriers to adherence—[the more] we’re going to focus on [it]. Mechanism of action, safety, clinical profile, and the way the medication is taken, they all play into the importance of a class review, and we do those frequently to make sure we’re staying up to date on the standards of care.

This transcript has been edited for clarity.

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