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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

Here’s what you missed this week on Managed Healthcare Executive.

MHE Week in Review – New Medicare Proposal, Trump’s NIH Director Nominee and More

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Tony Willoughby, Pharm.D., is CEO of Stellus Rx.

Tapping the potential of digital pharmacy involves creating conditions that allow pharmacists to build trusting relationships with patients, tighter integration pharmacists into care plans and authentic patient engagement. 

Beyond the First Wave of Digital Pharmacy Innovation

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

Clinical

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.

The two previous case reports documenting similar skin color restoration in vitiligo patients undergoing hemodialysis include one involving a 60-year-old African American woman and another involving a 45-year-old woman – while similar repigmentation has also been observed in patients receiving chemotherapy and corticosteroid therapy.

The researchers suggest two ways that hemodialysis might help restore skin color: First, the treatment removes certain substances from the blood that normally suppress the immune system. Second, hemodialysis improves blood circulation, which may help pigment-producing cells move to areas where they're needed and multiply.

“The phenomenon of repigmentation in vitiligo universalis is exceptionally rare,” the study authors wrote. “To our knowledge, this case represents one of the very few instances documented in the literature, providing a unique opportunity to explore potential mechanisms and contribute to the understanding of this rare occurrence.”

Repigmentation case is just the third that has been reported.

Dialysis Unexpectedly Spurred Skin Repigmentation in Patient with Rare Form of Vitiligo

A new study shows that gene therapy may benefit spinal muscular atrophy (SMA) patients who require breathing support through tracheostomy — a group typically excluded from clinical trials.

, examined data from the RESTORE registry for 34 patients with tracheostomies who received Zolgensma (onasemnogene abeparvovec). Led by Laurent Servais, M.D., of the University of Oxford, the study represents the first significant analysis of gene therapy outcomes in this high-risk population.

Thirty-three of the patients had two SMN2 gene copies, while one patient had a single copy. Most patients (88%) were diagnosed clinically rather than through newborn screening. The median age at diagnosis was 3.5 months, with patients receiving initial treatment at 5 months and requiring tracheostomy at approximately 9 months.

"There were no new safety findings with [Zolgensma] treatment in patients with SMA with tracheostomy across real-world settings," the study authors wrote. While four patients experienced serious treatment-related adverse events, these aligned with Zolgensma's known safety profile. Two deaths occurred during the study period, neither related to the treatment.

The findings suggest that patients requiring tracheostomy — who are often considered too ill for gene therapy — may still benefit from treatment. Eight patients received Zolgensma alone, while 26 received additional therapies before or after gene therapy.

Without treatment, nearly all patients with type 1 SMA, the most severe form, require respiratory assistance within their first year of life. Historically, ventilated SMA patients had a life expectancy of just two to three years. However, early diagnosis through newborn screening programs, combined with timely treatment initiation, has shown promise in delaying or reducing the need for ventilatory support.

 has shown that Infants with spinal muscular atrophy (SMA) who receive a gene therapy in the first year of life can typically avoid permanent ventilation. A different 

 published in August showed that patients with SMA who were on long-term ventilation via tracheostomy before receiving Zolgensma showed significant improvements in respiratory function over a mean follow-up period of 7.6 months.

Both of these studies add to the body of evidence showing potential benefits and improvements for older SMA patients receiving gene therapy.

The study drew on data from the RESTORE registry for 34 patients with tracheostomies who received Zolgensma (onasemnogene abeparvovec). 

Gene Therapy Shows Promise for SMA Patients with Tracheostomies

The FDA has approved a new Imatinib oral formulation called Imkeldi to treat specific leukemias and other cancers in pediatric patients over the age of one and adults, according to a news release published 

. It was developed by Shorla Oncology and approved for 10 indications. Imatinib was first approved as a tablet with the name Gleevec in 2001 and is marketed by Novartis.

“Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area,” Sharon Cunningham, CEO of Shorla said in the news release.

Imkeldi is a tyrosine kinase inhibitor, which means it can slow or prevent the growth of cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD) and gastrointestinal tumors (GIST).

This year, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD and up to 6,000 with GIST, the press release says.

Specific indications include but are not limited to:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

Dosage is dependent on indication. Doses of 400 mg and 600 mg should be given once a day and an 800 mg dose should be administered as 400 mg twice a day. All doses should be taken with a large glass of water and a full meal.

The most common adverse reactions reported were edema, nausea and vomiting, according to the 

Superficial edema was also seen in 2-6% of CML patients treated with Imatinib. In GIST patients, severe fluid retention was seen in 9 - 13.1%.

Liver function should also be monitored, as well as signs of hematologic toxicity. Complete blood counts should be performed weekly for the first month of treatment and biweekly for the second month.

Grapefruit juice should be avoided during treatment with Imatinib. Breastfeeding women should not take Imatinib.

Imkeldi will arrive in the United States on Jan. 6, 2025 and customer shipments will begin no later than Jan. 13, Rayna Herman, CCO of Shorla said in an email. It will cost $2,350 per bottle. 

Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing to a wider range of patients, pediatric patients included. 

Tony Willoughby, Pharm.D.

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