Ryan Haumschild, Pharmacy, MBA, MS: Under the Affordable Care Act, we need to make sure we have an exception process. The exemption process must be clear and cannot create unnecessary stress for the provider or patient. We worked hard to make sure we had something that was easily acceptable. If there is an exception process, we will look for an indication from the FDA. We will look at the medical information about the patient and we will also make sure that people know how to submit that information, and then we will make a fairly timely examination. There are exemption processes. They’re appropriate, and we’ve done it in a way that’s pretty inconspicuous to the provider as long as the right information is provided. Clarifications have come out because some groups of payers are not being created [exceptions] as easy as the program intended, so it’s something we get feedback from some of our first users and covered lives. “Do you have problems completing this process of exceptions?” Is there anything we can do to improve it? ”We are constantly focused on that.
We make different rows when we review because [in the case of] timeliness for contraception or treatment of uterine fibroids, or any type of health of other women, patient adherence is related. If someone goes to the pharmacy or sends a prescription, which is a long time, and sometimes you will find that the patient does not fulfill that prescription or does not adhere to it. We have a special order to which these will go and be redirected. According to the ACA [Affordable Care Act], they want to make sure that it is a timely examination according to the indications. As long as we pay our due attention, we have a special order that will not reduce the motivation of patients to take therapy and will reduce any frustration on behalf of the provider.
Endometriosis and uterine fibroids are extremely important because they cause great pain for patients and affect the quality of life. We have made better access to therapies that are most appropriate for these patients and created an easy exclusion process so that patients can receive appropriate therapy approved by their physician as needed, as well as programs that look at their share of covered days. We know that adhering to these therapies usually leads to better outcomes - and quite quickly when we work on suppressing some hormonal [issues] with uterine fibroids. When we create a timely approach and better adherence, and then follow those patients, these are the types of programs that allow them to be the most successful.
There were many new participants in women’s health, and that is exciting for patients. It’s more complicated for payers because they want to make sure you always provide the right therapy to the right patient, but what would trigger a review is if we see a new mechanism of action, all new clinical efficacy data that we believe has improved care standards or safety profile. What many people don’t think about, but taxpayers think about, is patience. We want to make sure that clinical trial data is translated into real-world evidence. The better the drug from the adherence profile — perhaps taken once a day or taken orally to reduce any of the barriers to adherence —[the more] we will focus on [it]. The mechanism of action, safety, clinical profile and the way the drug is taken all affect the importance of class reviews, and we often do this to make sure we are up to date with care standards.
This transcript has been edited for clarity.