The informtion set out below was published on the GoodRx website...

The informtion set out below was published on the GoodRx website on 20th May'21.
It is a good read and is targetted at consumers who purchase oral contraceptives on prescription.

The author of the article is suggesting it will retail for around US$200 per 28 day supply.

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What You Need to Know About Nextstellis, the New Oral Birth Control Pill With a Plant-Based Estrogen


Cydnee Ng, PharmD
Cydnee Ng, PharmD, is a drug information pharmacist at GoodRx. She received her Doctor of Pharmacy from UC San Diego. She is passionate about advocating for health and medication education.
May 20, 2021, 9:02AM (PT)

Key takeaways:

• Nextstellis (drospirenone and estetrol) is a combination oral contraceptive (birth control) that the FDA recently approved.
• One of the two ingredients in Nextstellis, estetrol, is the first new type of estrogen that the FDA has approved in over 50 years and can be made from plants.
• Nextstellis might be less likely to cause side effects compared to other oral contraceptive options, since estetrol works differently than other estrogens typically found in these pills.
• In a clinical study, Nextstellis worked well to prevent pregnancy with low amounts of breakthrough bleeding and spotting.

Oral contraceptives are one of the most commonly used methods to prevent pregnancy. As of 2019, about 14% of people between the ages of 15 and 49 in the U.S. are taking some type of oral birth control — that’s over 10 million people! But finding the right oral contraceptive for you — one that works well but is also tolerable — can be frustrating and often takes some trial and error.
Since the 1960s, there have been many combination birth control pills with varying amounts of progestins and estrogens. These components are chemically made to look and act like the natural progesterone and estrogen hormones in your body. Although there are many different progestins available, ethinyl estradiol has been the mainstay of estrogens and is found in more than 97% of combination oral contraceptives (COC).
In April 2021, the FDA approved a new COC called Nextstellis (drospirenone and estetrol) for the prevention of pregnancy. This is both the debut of a new type of estrogen (the first in over 50 years) and the first plant-based estrogen to ever be approved for birth control.
In this article, we’ll cover what Nextstellis is, how it’s different from other combination birth control pills, and how well it works.
What is Nextstellis, and how does it work?

Nextstellis is a COC that contains 3 mg of drospirenone (a progestin) and 14.2 mg of estetrol (an estrogen). To date, it’s the first and only contraceptive that contains estetrol.

Drosperinone and estetrol work together to prevent pregnancy. They stop your body from releasing an egg and create an environment that makes it both harder for sperm to move through and harder for a fertilized egg to attach and grow. In addition, drospirenone helps counteract some side effects, including changes in acne, facial and body hair, and weight.
Nextstellis comes in 28-day blister cards containing 24 active pills with drospirenone and estetrol and four inactive pills without any hormones (placebo pills). The pills should be taken at the same time every day in the order instructed on the blister card.

Depending on when in your monthly bleeding cycle you start this medication or if you’ve been using another form of hormonal birth control, you might need to use a back-up birth control method (like a condom) for 7 days after first starting Nextstellis. It’s best to double check with your provider about this before you pick up your first pack from the pharmacy.

How is Nextstellis different from other oral contraceptives?

Nextstellis is different from other oral contraceptives because it contains a new type of estrogen called estetrol. This is the first new estrogen approved by the FDA in over 50 years. Since most COCs contain ethinyl estradiol, Nextstellis provides a new option for people to try. This could be helpful if you can’t tolerate ethinyl estradiol.

Estetrol is a “native estrogen with selective actions in tissues,” or NEST for short. Let’s break down what this term means.

• Native estrogen: Estetrol is made naturally in the body. It’s made at a specific time during pregnancy by the liver of an unborn baby.
• Selective actions in tissues: Estetrol acts differently in different parts of the body. It works mainly on parts of the body responsible for preventing pregnancy and regulating monthly bleeding cycles. In other areas commonly linked to side effects, such as acne and facial hair, estetrol has a lesser effect.

Because of estetrol’s selective actions, Nextstellis can work well to prevent pregnancy while having fewer side effects than most oral contraceptives with ethinyl estradiol.

Besides preventing pregnancy, Nextstellis may have a lower risk of causing breast cancer compared to ethinyl estradiol. Early animal studies showed that estetrol caused less changes to breast tissue than changes typically seen in the early stages of cancer. However, we would need more research to know if this is also true in humans.

If you’re worried about changes in acne, facial and body hair, or sex drive, Nextstellis might be less likely to cause these problems than other oral contraceptives. Compared to ethinyl estradiol, estetrol has a lesser effect on other hormones that play a role in causing these side effects.
Are there side effects?

Breakthrough bleeding or spotting is the most common reason why people want to switch or stop taking birth control. Luckily, Nextstellis has a low rate of this bothersome side effect compared to most COCs, which can cause breakthrough bleeding in as much as 50% of people who use them.

In a clinical study of people between the ages of 16 and 50, 30% of study participants experienced breakthrough bleeding or spotting during their first cycle taking Nextstellis. Over time, the rate of this side effect lowered and happened to 16% to 22% of people during cycles after that.

Other side effects that might happen while taking Nextstellis include:

• Headaches
• Menstrual cramps
• Urinary tract infection (UTI)
• Acne
• Weight gain
• Breast pain or tenderness
• Mood swings
• Lowered sex drive

Like with other hormonal contraceptives, there is a risk of blood clots with Nextstellis. In general, you’re at higher risk if you’re over 40 years old, smoke, or have certain health conditions, like diabetes, high blood pressure, or high cholesterol. Your risk is even higher if you’re both over 35 years old and you smoke. If you have any of these risk factors, it’s best to discuss whether Nextstellis is right for you with your healthcare provider.
How effective is it?

According to the results of the clinical study, Nextstellis is 98% effective at preventing pregnancy for people between the ages of 16 and 50. Its effectiveness is almost the same as implants and intrauterine devices (devices placed in your uterus, also called IUDs), which are over 99% effective and considered the most effective non-surgical birth control method.

The high effectiveness of Nextstellis is impressive compared to other COCs, which are generally 91% effective. Similar to other oral contraceptives, Nextstellis might not work as well if you have a body mass index (BMI) of 30 kg/m² or greater. More studies looking at how well Nextstellis works to prevent pregnancy can help confirm exactly how effective it is.
Why is the FDA’s approval of Nextstellis so important for the environment?

In addition to the differences mentioned above, estetrol is made through a plant-based process and is more environmentally friendly than other estrogens. Your body gets rid of estrogens like ethinyl estradiol as body waste (urine and feces). Even after treating wastewater, this hormone can find its way into oceans, lakes, and rivers.

Estrogens, including ethinyl estradiol, are also sometimes added to livestock diets, which are then found in animal waste and can get into run-off water. Estrogen from human and animal waste is dangerous for marine life and negatively impacts how fish mature and reproduce.
Because of its design, ethinyl estradiol doesn’t break down easily and stays longer in your body. But this also means that it can build up in the environment. Compared to ethinyl estradiol, estetrol doesn’t build up in marine life as much and disappears from the environment quicker.

Since Nextstellis contains estetrol, it can hopefully contribute less to water pollution and environmental harm than birth control pills with ethinyl estradiol.
How much will Nextstellis cost?

Since Nextstellis isn’t available quite yet, we’re not sure how much it will cost, but we expect it to be similar to other brand-name birth control pills, which tend to cost around $200 for a 28-day supply. Because the FDA just approved it, it will likely be some time before a generic version is available.

Under the Affordable Care Act (ACA), however, many insurances cover birth control at no cost. There are some exceptions to this, though, so it’s best to check with your insurance provider to see if Nextstellis is covered before heading to the pharmacy. If you don’t have insurance, be sure to check the Nextstellis GoodRx page to help lower the cost of your prescription.

When will Nextstellis be available?

Good news! You don’t have to wait very long since Nextstellis is expected to be available by the end of June 2021. Talk to your healthcare provider if you’re interested in trying this new plant-based oral contraceptive once it becomes available. Through GoodRx Care, people between the ages of 18 and 50 years old can speak to a provider for a birth control prescription from the comfort of their home.
The bottom line

Nextstellis is a newly approved, environmentally-friendly combination oral contraceptive that will provide another option for people who want or need birth control. To date, it’s the first and only birth control containing estetrol, a different estrogen than what’s found in most other estrogen-containing contraceptives. Nextstellis is very effective at preventing pregnancy and, in studies, has fewer side effects than other hormonal contraceptives. It is due to launch this June, so be sure to speak with your provider if you’re interested in trying it.