Advancing Women's Health Through Formulary Coverage Innovations

Susan Cantrell

Awareness around women’s health is growing nationwide. This year, the FDA approved Miudella—the first new non-hormonal intrauterine device in more than 40 years. In another milestone, Aetna announced expanded fertility coverage and became the first national insurer to offer intrauterine insemination benefits to all members, regardless of sexual orientation or partner status.

Susan Cantrell, CEO of the Academy of Managed Care Pharmacy, spoke with Managed Healthcare Executive about these developments, the ongoing need to address healthcare disparities, and the critical role managed care pharmacy professionals play in advancing women’s health.

This interview has been edited for length and clarity.

MHE: How are women's health therapies, such as menopause management therapies, typically treated in formularies?

Cantrell: When it comes to menopause-related therapies, there's no single coverage criterion that applies across the board, like many other categories of treatment. It is up to the individual insurer as well as whether it's a commercial, Medicaid or Medicare plan through the exchanges.

One thing that would be common among almost all of those would be the fact that the coverage would focus only on FDA-approved therapy.

There are many unapproved therapies for menopause-related symptoms that are widely used, for example, bioidentical hormone therapy, but in most cases, those would not be covered because they are not FDA approved. Beyond that, once you look at FDA-approved therapy, you may have some therapies that require prior authorization for the patient to be able to access them. There's a balance between clinical decision-making and ensuring appropriate therapy, and then also making sure that we try the more established therapies before moving on to something that might be costlier and less tried and true.

MHE: What is Miudella, and why is it different than other IUD options on the market?

Cantrell: Miudella is a new, non-hormonal intrauterine contraceptive device (IUD) that lasts for eight years. It’s only the second one available. I think what's most important to think about is it offers an option for women who are unable to or it's inadvisable for them to use hormone-based contraceptive devices. The additional benefit that it's said to have is the fact that it's a little bit more flexible. It is a copper-based device, but it's more elastic, if you will, and that helps reduce pain associated with insertion.

MHE: Aetna is the first major insurer to cover intrauterine insemination. If approximately 2.4 million women in the United States experienced infertility, why isn't coverage more common?

Cantrell: Aetna is looked at as a market leader when it comes to coverage for infertility treatments. There are many reasons why coverage varies from one health plan and one of those is cost. We don't have unlimited resources, and part of what health plans and government programs must do is steward those health care resources, so unfortunately, there is not broad coverage across the spectrum for intrauterine insemination.

Another thing to think about is that infertility treatments are typically an option for employer-provided health benefit plans that employers can choose to take. Many do, but many don't, likely due to the cost associated with it. In fully insured employer-sponsored plans, it's up to the employer to decide exactly what will and won't be covered. The health plan, in those types of cases, is just the administrator of the benefit.

It's exciting to see a major national health plan like Aetna step up to the plate and say, ‘we're going to cover this therapy for individuals regardless of their sexual orientation or partner status.’ I think that also speaks to a focus on equitable coverage across the spectrum of the population.

MHE: How can managed care pharmacists expand access to these treatments at an affordable cost?

Cantrell: I think managed care pharmacists have a really important role to play in expanding access and ensuring appropriate therapy for all cases, and that includes broader women's health therapies as well as infertility treatments.

We all know our health care benefits can be complex and confusing, and I think managed care pharmacy professionals should explain and demystify the treatment options that might be available, as well as how they're covered and how the patients can navigate the complexities of getting that coverage.

MHE: Are there any disparities in how different plans or PBMs cover therapies, and how does that affect patient access?

Cantrell: There are variations, and certainly disparities exist in healthcare, and that's been a strategic priority for AMCP for the last five years, addressing disparities among certain populations and socioeconomic status and other factors, and really trying to close the gap.

When pharmacy benefit managers and plans are looking at coverage, they consider the special needs of the population. A good example that comes to mind is migraine treatment, certainly not specifically a women's health issue, but much more common in women than in men. We know it has significant clinical, quality of life and economic implications for the population, so how do we make sure that the therapies that are out there effectively treat and, in some cases, prevent migraine are being used appropriately? That's where those formulary decisions and clinical guidelines by the medical specialty societies come into play. Letting the clinical data be the guideline helps close those disparities.

Affordability creates a disparity as well. We have come a long way with health care coverage, and we don't want to take a step back, because having comprehensive health care coverage that includes a pharmaceutical benefit is critically important.

MHE: What is AMCP doing to improve equitable access to women's health therapies across different populations?

Cantrell: During COVID-19, the disparities that exist in our healthcare system came to light in a way that hadn't happened before. Our board of directors in its strategic planning process, really elevated the topic of closing the gap on disparities in medication access and use among certain patient populations, including women, minorities and patients who live in rural areas.

We had an advisory group that really helped guide us in the development of resources, and one thing that came out of that was a series of action briefs we called Health Equity Action Briefs. They cover data that's needed to assess health equity, including the use of the CMS Z codes, which are available and have been for years but are underutilized.

We've had a tremendous amount of excitement too among members to really embrace this issue. One of the great early leaders is SCAN health plan, which is a large Medicare and Medicare Advantage provider in southern California. They cover minority populations and, in some cases, Native American populations.

MHE: Have you seen examples of formulary policy changes, including more menopause therapies, or reducing cost sharing, has led to improved patient outcomes or satisfaction?

Cantrell: I'll use one easy example, and that's cost sharing. In some cases, high-cost sharing does show a correlation with non-adherence. Some effort to lower patient cost sharing, especially with high-cost medications, has been shown to benefit overall adherence to therapy and ultimately, patient outcomes. However, that's not the only factor. Even in some cases where there is little or no cost sharing, especially with generic drugs, for example, there's still an issue with patients not using their medications appropriately. So, it really is multifactorial, and I think that's one of the questions our members really focus on is, ‘what are those factors, both in the population but also in the individual patient?’