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The FDA has accepted a new drug application for aficamten, a new obstructive hypertrophic cardiomyopathy drug. A goal date has been set for Sept. 26, 2025.

FDA Sets Goal Date for Cardiomyopathy Drug, Aficamten

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

Sixth Stelara Biosimilar, Yesintek, FDA-Approved 

A new nationwide study led by the Keck School of Medicine of USC aims to examine how type 1 diabetes impacts children's brain development and cognitive function, focusing on diverse participants and paving the way for early interventions and better diabetes management.

New Study to Explore Impact of Type 1 Diabetes on Children's Brain Development

If granted, Tremfya will be approved to treat children ages six and under with severe plaque psoriasis and children ages five and under with juvenile psoriatic arthritis.

Johnson and Johnson Submits FDA Request for Pediatric Tremfya Approval

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Duplication and other errors can turn population health into a guessing game and waste time and money.

Quality Lab Data: Why It Matters So Much

In July 2022, Amanda Butler found a lump in her right breast during a self-exam, which she did monthly. At the time, she didn’t have a gynecologist, but in a moment of what she calls “divine intervention” she ran into a friend of a friend in the bathroom at a wedding. This friend happened to be a gynecologist.

“I was like, ‘I know we literally just met two seconds ago, but I found this lump, and I don't have a gynecologist, could you do a breast exam on me?” Butler said in an interview with Managed Healthcare Executive.

Her now mutual friend gladly obliged and afterward advised Butler to get an ultrasound. This ultrasound led to a few biopsies, all the while the office staff reassured her that the lump was “probably nothing” because she was “so young.”

It was not nothing. It was breast cancer. She was BRACA 2+ and it had already spread to Butler’s lymph nodes. 

“Breast cancer is lifelong because this is something I’ll have to think about for the rest of my life,” Butler said. “It’s always in the back of my mind.”

Butler, then 32, had a double mastectomy with breast reconstruction.

Rather than just getting a single mastectomy, Butler opted for a double to eliminate risk for resurgence. Within a month, she froze her eggs and began chemo in November 2022. She is now cancer free and awaiting her second round of breast reconstruction surgery.

“I feel like I'm still in it, you know?” Butler said. “I don’t think I’ve fully processed this emotionally.”

Breast cancer is currently the most common cancer for women in the United States, accounting for about 

 of all female cancers every year. The American Cancer Society estimates there will be about 310,720 new cases this year, resulting in around 42,250 deaths.

Previous mammogram guidelines from The U.S. Preventive Services Task Force recommended that women start getting mammograms at age 50 every year or every other year. As of April 2024, the USPSTF urges women to begin mammogram checks every other year staring at age 40.

Early detection is especially important because breast cancer in women younger than 40 also tends to be more aggressive.

Butler, now 34, is one of a growing number of women under age 40 in the U.S. diagnosed with breast cancer.

For example, women born in 1990 had a 20% greater risk of developing breast cancer than women born in 1955, according to 

While active cancer is a huge battle in and of itself, and although survival rates have increased, 

 of survivors experience lasting physical and emotional challenges, a 

Journal of Midwifery and Women’s Health

As part of her breast reconstruction, Butler had to get expanders placed in her chest where they stayed for about a year. Expanders function as a placeholder for breast implants and are gradually filled with saline until they react the desired cup size.

Butler said while expanders were hard and uncomfortable, she only had one minor infection in the beginning. Once the expanders were taken out, the implants were put in. Her surgeon also did a fat transfer that filled in the area around the implant to make her breasts look natural. Numerous adjustment surgeries often follow because over time, the fat is reabsorbed by the body, which causes rippling and divots around the implant.

Butler has a popular TikTok account where she speaks openly about her experience with breast cancer, documenting everything from being in a hospital bed with a mask and surgical cap on to showing the ways the fat transfers have changed her body.

“People who aren’t in this are just like ‘oh, you’re getting a free boob job,’” Butler said. “That’s what I thought, too. Then then you go through it and realize it’s not a boob job, it’s an amputation.”

Katelyn Armstrong has also documented her breast cancer journey on her TikTok page, sometimes appearing shirtless to bring awareness to double mastectomies and shed light on the difficulties of life in remission.

Armstrong discovered her breast lump during a shower but thought nothing of it because she knew she had dense breast tissue. About two weeks later, the lump became painful. After s doctor’s appointment, so began the avalanche of mammograms, ultrasounds and biopsies.

The lump was first felt in October 2022. By December, she was diagnosed with triple positive breast cancer. She has been cancer-free since March 2023.

Armstrong had a double mastectomy in May 2022 at 35 years old. She chose a flat closure instead of a breast reconstruction.

“Nobody really talks about the emotional recovery of it,” Armstrong said in an interview. “You get a lot of, ‘oh, you're good now?’ questions when you finish treatment. The emotional recovery and physical effects of treatment that you deal with on an ongoing basis is lengthy. Sometimes it's forever.”

Because Armstrong’s breast cancer was hormone positive, she will be on a hormone suppressant medication for the rest of her life. Hormone suppressants turn off all the hormones in the body so that cancer doesn’t have anything to “feed” on if it comes back. As a result of hormone suppression, Armstrong has gone into early menopause.

“Couple that with the PTSD that you experience from your body basically betraying you…there is no guidance when you’re ‘done’ with medical stuff,” Armstrong said.

October is Breast Cancer Awareness month and for some survivors, it’s a double-edged sword. 

“October can be really a difficult time of the year for people in the breast cancer community,” Armstrong said. “As much as we’re so appreciative of the awareness, you're being assaulted by your perpetrator every day, for days. You can't even go to the grocery store without seeing pink ribbons on bananas.”

Both Butler and Armstrong shared ways to make this month easier on survivors and said it all starts with intention.

“I do think that there are issues with mass corporations using this as a way to raise money for themselves. Breast cancer is an easy way to do it because a lot of people have been touched by it,” Butler said.

Armstrong agreed and added it’s important to know where the proceeds are going and how much of them are going towards the cause. “At the end of the day, I think what it's become, is a business. Of course, the intentions are there, but you can have good intentions and still need to improve your method.”

“I think tapping into real survivors,” Butler said. “If you're going to help people with cancer, then it needs to 

The effects of breast cancer can remain long after the disease has left the body, serving as a traumatic daily reminder.

Clinical

Why Cancer Doesn’t Stop After Chemo, Survivors Speak Out 

Drugs to treat diabetes have been the focus of many efforts to bring down costs for both patients and payer. It’s not heard to see why.  More than 38 million people are diagnosed with diabetes in the United States, and treatment costs  continue to rise.  People with diabetes now account for one of every four healthcare dollars spent, according to a 

Pharmacy benefit managers (PBMs), including, CVS Caremark, say they’ve worked to ratchet down those costs — or, more precisely, the pace of the increases — by lowering the monthly out-of-pocket costs for insulin so they are at or below the $35 requirement for Medicare Part D plans imposed by the Biden Administration’s Inflation Reduction Act.

As far as formulary placement is concerned, CVS Caremark has switched up its diabetes coverage for 2025 

. The PBM, which is one of the "big 3" in the industry that manage the vast majority of prescriptions in the U.S., has removed several therapies to treat patients with diabetes in favor of newer products and generics, based on a review of the it's 

Performance Drug List – Standard Control

That list is CVS Caremark’s national formulary, a list of drugs that it provides clients. CVS Caremark’s clients, which include health plans and employers, can deviate from the formulary but as a practical matter the formularies have great sway over the drugs that health plans, employers, Medicaid managed care plans and other payers cover.

One notable change is the exclusion of the V-go Infusion Pump, an insulin delivery device that is worn like a patch and provides continuous subcutaneous insulin infusion. CVS Caremark instead prefers Omnipod products (Omnipod 5 and Omnipod Dash) or the Twiist infusion system.

The Twiist system was approved earlier this year and developed by a company cofounded by a former executive at CVS Health. Twiist was approved by the FDA in March 2024 and combines an automated insulin delivery with a continuous glucose monitoring (CGM) device for people ages 6 and up with type 1 diabetes. It uses Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels.

Twiist was developed by partners DEKA Research & Development and Sequel Med Tech, whose CEO and co-founder is Alan Lotvin, M.D., who held several high-ranking positions at CVS Health, including president of CVS Caremark from 2020 to 2023. DEKA was founded by Dean Kamen, the engineer who developed the Segway scooter.

CVS Caremark also has removed several of Merck’s products that treat diabetes, including the older Janumet/Janumet XR (sitagliptin and metformin) and Januvia (sitagliptin). Januvia was approved in 2006 and was the first dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed to treat patients with type 2 diabetes. It's wholesale acquisition cost (WAC) price is $573 for a bottle of 30 tablets. Janumet was approved in 2007, and Janumet XR  in 2012. Both have WAC prices of $573 for a bottle of 60 tablets.

As an alternative for Janumet, CVS Caremark has suggested patients instead use Zituvimet (saxagliptin-metformin), another DPP-4 inhibitor, which  the FDA approved in November 2023. It is manufactured by Zydus Lifesciences, a company located in India that was formerly known as Cadila Healthcare. An extended release version of Zituvimet was approved in July 2024.

Additionally, CVS has added to its national formulary saxagliptin, a generic of Onglyza, which is no longer available. Several generic versions of Onglyza were approved in 2023 to treat patients with diabetes. As an alternative for Januvia, CVS Caremark is recommending the generic saxagliptin or Zituvio, which was approved October 2023. WAC prices for Zituvimet and Zituvio are not readily available.

CVS Caremark has also added the unbranded biosimilar to Sanofi’s Lantus, which treats type 2 diabetes in adults and type 1 diabetes in both adults and children. Biocon Biologic’s Semglee (insulin glargine-yfgn) and an unbranded product launched in November 2021. At the time, they were the first interchangeable biosimilars to Lantus. Since then, a second interchangeable biosimilar has been approved, Lilly’s Rezvoglar (insulin glargine-aglr).

 by the Biosimilars Council found that Semglee at a list price of $269 30-day supply only had a modest uptake. The Biosimilars Council found that in the commercial space, payer controls were limiting the new-to-brand prescription starts. Within Medicare, the analysis found that Semglee was not covered by 38% of Medicare payers.

At the same time, Sanofi last year launched an unbranded insulin glargine that was about 60% versus Lantus.

The global insulin glargine market is expected to grow from $5.45 billion in 2024 to $8.43 billion in 2031, according to data from 

. Biosimilars and increasing incidence of diabetes are expected to boost market volume, the marketing intelligence and consulting company indicated.

CVS Caremark is removing Novo Nordisk’s Victoza (liraglutide), one of the much-talked about glucagon-like peptide 1  (GLP-1) drugs, and instead listing a generic version  that was approved this year. Teva launched the first generic of Victoza in June 2024 with a WAC price of $469.60 for the two-pen package and $704.40 for the three-pen package. Victoza’s list price is $543.51 for two pens and $815.27 for three pens.

CVS Caremark is also suggesting that patients consider several other GLP-1s instead of Victoza, including Mounjaro (tirzepatide), Ozempic (semaglutide), Rybelsus (semaglutide) and Trulicity (dulaglutide).

In other notable changes, CVS Caremark has added two HIV medications to its standard formulary: Apretude (cabotegravir), which is used for preexposure prophylaxis (PrEP), and Cabenuva (cabotegravir, rilpivirine), which is used to treat HIV infection in those age 12 and older. Both products are from ViiV Healthcare.

Additionally, CVS Caremark, had added two biosimilars to Herceptin (trastuzumab): Amgen’s Kanjinta and Pfizer’s Trazimera. Both treat patients HER2-overexpressing metastatic breast cancer, and both are preferred over Herceptin and other biosimilars, including Herzuma or Ogivri,

Among lung cancer drugs, CVS Caremark has added Augtyro (repotrectinib) to its formulary. It is a Bristol Myers Squibb drug that is used to treat patients with ROS1-positive non-small cell lung cancer and patients with solid tumors that have a NTRK gene fusion.

Within central nervous system disorders, CVS Caremark is including Zurzuvae (zuranolone), an oral therapy from Biogen/ Sage to treat women with postpartum depression. Zurzuvae launched in December 2023, and is a rapid-acting neuroactive steroid that targets the GABA-A receptor. It has WAC price of $15,900 for a 14-day course of treatment.

To treat patients with bipolar disorder CVS Caremark has added Abilify Asimtufii (aripiprazole); the PBM had previously included Abilify Maintena on its formulary. Both therapies are long-acting maintenance treatments from Otsuka and Lundbeck. 

Interestingly, the CVS Caremark formulary does not include Abilify, which has the same active ingredient but not in the long-acting formulation. Abilify is approved as a treatment for a number of mental health disorders, including bipolar disorder, major depressive disorder and schizophrenia.

CVS Caremark has removed several diabetes drugs  favor of newer products and generics, and is even favoring an insulin infusion system developed by a company that was cofounded by Alan Lotvin, a former executive at CVS Health.


Formulary Watch

CVS Caremark Makes Changes in Diabetes Coverage for 2025

A 25-year-old woman with vitiligo universalis, a severe form of vitiligo that causes nearly complete loss of skin color across the body, experienced significant repigmentation after starting dialysis, according to a new case 

Clinical, Cosmetic and Investigational Dermatology.

The patient, who had lost pigmentation in 95% of her body surface area for 15 years, began showing new areas of skin color within weeks of starting dialysis (also called hemodialysis), a treatment that filters waste and excess fluid from the blood when kidneys can no longer perform this function. She required the treatment three times weekly for kidney inflammation caused by lupus. After 11 months of treatment, color returned to more than 70% of her body surface area, including her face, arms, thighs, abdomen and back.

The case represents only the third documented instance of hemodialysis-induced repigmentation in patients with this severe form of vitiligo, according to the researchers led by Abdulaziz A. Alnoshan, M.D., of Security Forces Hospital in Riyadh, Saudi Arabia. The findings suggest hemodialysis may help restore the function of melanocytes, the cells responsible for producing skin pigment or color.

While vitiligo affects up to 1.8% of the population, cases this severe rarely show improvement. The researchers note that this unexpected return of skin color could provide new insights into potential therapeutic approaches, though more research is needed to better understand the mechanism behind how it happens.

Repigmentation case is just the third that has been reported.

Oleg Bess, M.D.

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