New menopause drugs treat hot flashes, but women face insurance hurdles

New drugs have finally hit the market or are in development to treat the debilitating symptoms of menopause, specifically the hot flashes that cause hot flashes. But doctors say insurance companies either don't pay for them or force women to try and fail with other, perhaps less effective drugs.

The situation has left women who could benefit from new drugs at the mercy of health insurance companies.

“It's not like a doctor writes you a prescription and you go to the pharmacy to pick it up,” explained Alina Salganicoff, senior vice president and director of women's health policy at KFF, a nonprofit research organization. health policies. “New drugs often cost a lot of money, and insurance plans can be very reluctant to cover them.”

What are the new medicines?

Hormone replacement therapy is often recommended during menopause, but some women, such as breast cancer patients, cannot receive it because the added hormones could encourage the development of cancer.

However, the new drugs have nothing to do with hormones.

The company Bayer announced this Thursday that its non-hormonal medicine elinzanetant “significantly” reduced the number and severity of hot flashes – intense explosions of body heat that can occur day or night – among women in clinical trials. Elinzanetant acts on two brain receptors: one, called NK-3, regulates body temperature. The other, NK-1, also affects mood and sleep.

In fact, participants reported that they slept better during the time they took the pill in the trial.

Dr. JoAnn Pinkerton, professor of obstetrics and gynecology and director of the Midlife Health Center at the University of Virginia School of Medicine, led one of the elinzanetant trials.

“We have not seen all the data,” he said, “but worked very well in reducing the frequency and severity of hot flashes. “It improved sleep and overall quality of life.”

Bayer said it plans to present its data to the Food and Drug Administration (FDA) this year. If approved, it would be the second non-hormonal anti-shortness drug.

Last year, the FDA gave the green light to fezolinetant, a drug from Astellas, marketed as Veozah. The drug acts on NK-3, the receptor that controls body temperature. A recent study has shown that it can reduce hot spells for almost six months.

The “time” of menopause

Well-known figures have begun to speak publicly about this disease, which previously seemed taboo, despite the fact that approximately half of the population suffers from it.

Earlier this month, for example, actress Halle Berry declared, “I'm in menopause!” at a media event on Capitol Hill to help introduce a congressional bill that aims to boost menopause care.

“Menopause is going through a special moment”said Dr. Rajita Patil, director of the Comprehensive Menopause Care Program at UCLA Health in California. “But in reality it should have happened much earlier. “It’s not like menopause is a new diagnosis.”

Still, some insurance companies are reluctant to pay for new menopause therapies. Kaiser Permanente, for example, requires women to try at least two other non-FDA-approved drugs to treat hot flashes before switching to Veozah (fezolinetant), a month's supply of which can cost at least $550. pain reliever gabapentin and an antidepressant sold as Effexor.

“Women are asked to try drugs that are not specifically approved by the FDA for the treatment of hot flashes before reaching a drug that is actually approved by the FDA to treat hot flashes,” said Dr. Stephanie Faubion. , medical director of the North American Menopause Society and director of the Mayo Clinic Center for Women's Health. “It's frustrating”.

Pinkerton added: “I think most healthcare providers encounter obstacles when it comes to simply deciding what is the best medication for their patients.”

Bayer would not reveal the price of elinzanetant until the FDA approves it. According to analysts, could cost as much or more than Veozah.

A change of life

Cindy Laughery, 60, a pediatric organ transplant nurse at the University of Virginia School of Medicine, began having hot flashes and trouble sleeping — hallmark signs of menopause — about six years ago.

“I would turn very red and sweat a lot,” she said. “People stopped me and asked me if I was okay.”

Cindy Laughery suffered up to 15 hot breaths a day before she started taking an experimental drug that affects the way the brain regulates mood and body temperature.

I felt these sudden hot flashes at least 10 to 15 times a day. It took her hours to fall asleep at night. Laughery joined Bayer's elinzanetant trial.

Cindy Laughery suffered up to 15 hot flashes a day, she said, before she started taking an experimental drug that affects the way the brain regulates mood and body temperature.

It was a “life change,” he said. Suffocation began to be infrequent. When they did appear, they were much milder.

“It was a revelation,” he said. “I suddenly felt like I could get up and feel really good.”

While Laughery said he didn't experience any negative side effects, Pinkerton said the drug was linked to fatigue, headaches and muscle aches in some study participants.

What if the insurance doesn't cover the medicine?

KFF's Salganicoff offers these tips:

Go to your insurance company's website and search for your medication. The site should tell you the exact steps to follow to receive coverage for the drug.

Contact your doctor's office. Doctors often receive coupons or have inside information about drug discounts. They can also act as patient advocates.

Assert your rights as a patient and appeal insurance denials. “The fact that the first answer is negative does not mean that it is the final one,” Salganicoff said. “This is where persistence pays off.”