This essay is part of a series exploring what is required for scientific progress to be made in our understanding of women’s health and our ability to treat the conditions that impact the lives of women everywhere. Learn more about why this is necessary and explore the other challenges and topics.
Do women want better treatments? Can they afford them?
Companies with women’s health therapeutics must jump higher to prove to investors they can overcome challenges with insurance companies and patients.
New treatments for women’s health conditions face many challenges in the development process. From a lack of data, samples, models, and funding to the exclusion of women from clinical trials, the road is long and hard. Unfortunately, once a women’s health therapeutic navigates all of those challenges, it still has to get to market. This requires getting covered by insurance and educating women who just aren’t that interested.
Insurance Coverage is Messy
Insurance coverage in the United States is complex and messy and it is required for a novel new therapeutic to be successful. Due to the high cost of medical treatments, most patients can never afford to pay the costs, and thus, if the insurance industry will not cover treatment, it doesn’t stand a chance of surviving in the market.
To determine if a treatment is covered, insurance companies use Current Procedural Terminology (CPT) codes that correspond to the coverage provided by doctors. For example, CPT code 99215 indicates that they performed a lung biopsy on a patient. Doctors use these codes to let the insurance company know what procedure they performed so that they can get reimbursed for the cost of performing that procedure.
These codes are copyrighted by the American Medical Association and are not available for normal people to see. They might come up on your coverage statements from your insurance provider, but in general, it’s part of the inner workings that patients don’t need to think about all too often.
However, these codes are very important to companies developing novel new therapeutics or treatments. If a new treatment does not fall within one of the existing codes, insurance will not cover it and patients have to pay out of pocket. Due to the high cost of medical treatments, most patients could never afford to pay the costs. Therefore if a novel new therapeutic doesn’t have a corresponding CPT code, it is essentially DOA. The codes being copyrighted presents a challenge for entrepreneurs trying to determine if a new treatment will be covered. There is no easy way for them to answer the question, “Will insurance pay for this new treatment that I have created?”
If the answer is no, there is a process to get new CTP codes added and approved. After talking with several entrepreneurs about this process, there are a couple of approaches. One is to show that you will save the insurance companies money. Ava Fertility was able to get coverage for their fertility tracking device because they were able to prove through published medical papers that they could reduce the need for more expensive fertility treatments. Another is to get Medicaid or Medicare to support your treatment. Private insurance coverage will generally follow public insurance.
However, other companies have not been so successful. One example is Phexxi, a gel that regulates vaginal pH to limit sperm mobility and reduce the chances it reaches an egg. Phexxi was approved by the FDA in 2020. “After the [Affordable Care Act] passed in 2010, the federal Health Resources & Services Administration (HRSA) developed guidelines for women’s preventive services” which outline 18 types of contraception and require insurance companies to cover at least one option from each type.¹ Newer types of contraception, like Phexxi, don’t fit into the predefined categories. Insurance companies can then deny coverage outright or, as in the case of Phexxi, bucket them with other less expensive options (like spermicide) and deny coverage.²
This challenge doesn’t just affect new products coming to market. Numerous entrepreneurs mentioned the lack of CPT codes covering any kind of menopause treatment. Not only do companies looking to provide better menopause therapeutics struggle, but women struggle to get appointments with doctors who cannot get paid, or get paid significantly less, to see them about menopause. As a result, many women have to pay out of pocket for concierge menopause treatment, which immediately means it isn’t available to everyone. One entrepreneur talked about the need to prove the economic cost of menopause to get it to be taken seriously by insurance companies and start getting coverage for care and treatments.
No matter how you spin it, the insurance industry is a behemoth and presents a significant challenge to biotech startups trying to launch novel new therapeutics. While larger more established companies might have the depth to be able to lobby the industry for support, startups and newer therapeutics struggle.
Shame, Acceptance, and Education
If a new company in the women’s health space survives the clinical trial process, is proven to be effective, and is covered by insurance, they still have to educate the population to the need above and beyond other products.
One investor talked about women’s apathy towards their health situation. People are aware of conditions like cancer, heart disease, erectile dysfunction, and the need for therapeutics. When it comes to many women’s health conditions, there is acceptance and shame.
Urine incontinence, also known as peeing-your-pants-just-a-little-when-you-laugh-or-sneeze, affects 1 in 4 women and up to 75% of women over 65. Yet, only 45% of people who experience it weekly discuss it with their doctor. Most are either ashamed or have accepted it as a normal experience.³
Although 84% of women indicate that the symptoms of menopause interfere with their daily lives, 42% say they have never discussed the topic with a health care provider. A study conducted at Yale University reviewed the insurance claims of 500,000 women and found that of those who did seek medical attention, nearly three-quarters are left untreated.⁴
Endometriosis is estimated to affect 11% of women and to be responsible for up to 50% of infertility.⁵ Yet it takes between 4 and 8 years on average for women to be diagnosed.⁶ ⁷ The most common symptom of endometriosis is chronic pain with periods, which is often dismissed in women and by women as normal. According to the paper, The Girl Who Cried Pain, long-held biases “have led health-care providers to discount women’s self-reports of pain at least until there is objective evidence for the pain’s cause.”⁸ The only diagnostic for endometriosis is surgical, and so women wait years to be diagnosed and treated.
This affects companies in women’s health in two ways. First, women are not looking for solutions which means that companies then have to work significantly harder to find and educate possible customers. The second problem is that when women bring their problems up to doctors, they are often minimized or not believed, which means health care companies also have to work to educate physicians. This burden costs significantly more money and makes success harder to find.
Investors who are looking to invest in women’s health therapeutics know that they cannot get the hoped-for returns on their investment if a product cannot be brought to market or will face significant challenges when brought to market. As a result, they are more likely to critically evaluate women’s health therapeutics to ensure that they have the backing of the insurance companies and the marketing capabilities to reach their target patients and physicians. This additional scrutiny means that women’s health companies have to jump that much higher to prove they can survive and thrive in the market to receive the required funding.
Footnotes:
- https://www.hrsa.gov/womens-guidelines-2019
- https://www.npr.org/sections/health-shots/2021/07/21/1018483557/contraception-is-free-to-women-except-when-its-not
- https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/is-urine-incontinence-normal-for-women
- https://www.aarp.org/health/conditions-treatments/info-2018/menopause-symptoms-doctors-relief-treatment.html
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2941592/
- https://pubmed.ncbi.nlm.nih.gov/8671344/
- https://pubmed.ncbi.nlm.nih.gov/28440744/
- https://papers.ssrn.com/sol3/papers.cfm?abstract_id=383803
