The number of formulary exclusions from the nation’s three largest pharmacy benefits managers — Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—increased significantly in 2021, according to a new analysis.

Many exclusions are brand name treatments with generic equivalents but the PBMs are also leaving off more specialty meds, according to the Philadelphia-based 

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“The practice of formulary exclusion began in 2014. Since then, the number of products excluded from the national preferred formularies of the three largest PBMs has grown dramatically,” wrote Fein, Ph.D., whose 

 website is widely read in the industry.  “The growth in excluded products shows how competitive many specialty therapy categories have become — and the undisclosed but presumably significant rebates generated by these products.”

CVS Caremark removed 57 drugs and added 6 drugs back in its 2021 standard formulary, according to Fein. Express Scripts expanded it exclusion list by 70 medications. OptumRx excluded 27 more medication in its 2021 standard formulary; by Fein’s tally, that OptumRx’s total exclusion now has 476 products on it.

Express Scripts excluded some major medications in its 2021 standard formulary, including the psoriasis drug secukinumab (Cosentyx, Novartis), the cancer medication  Calquence (AstraZeneca), and the PCSK9 inhibitor Praluent (Regeneron, Sanofi).

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Among the notable exclusions in CVS Caremark’s 2021 standard formulary are: the antidepression blockbuster paroxetine hydrochloride (Paxil, GlaxoSmithKline), pegfilgrastim (Neulasta, Amgen), and the otic anti-inflammatories/anti-infectives ciproflaxin hydrochloride (Cipro HC, Bayer) and (Ciprodex, Novartis).

OptumRx/ United Health excluded the blockbuster insulin Lantus (Sanofi) and anti-infection drug Neupogen (Amgen) in favor of the drugs’ biosimilars. The PBM also excluded leukemia treatment Gleevec (Novartis).

The PBMs differ in how they handle formulary exclusions and additions,

 noted. Express Scripts and OptumRx both excluded Cosentyx, but CVS Caremark did not. CVS Caremark excluded etanercept (Enbrel, Wyeth) for psoriasis only, but Express Scripts and OptumRx did not.

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Articles

CVS Caremark, Express Scripts and OptumRx have increased the number of medications that are excluded from their national formularies.

Top PBMs increase number of formulary exclusions in 2021 

President-elect Joe Biden’s economic stimulus and COVID-19 relief plan includes $415 billion in emergency spending to hike vaccinations, testing, contact tracing, genomic sequencing, and other COVID-19 relief efforts.

The proposals are part of Biden’s $1.9 trillion stimulus proposal unveiled on January 14.

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“The vaccine rollout in the United States has been a dismal failure thus far. …. We’ll have to move heaven and earth to get more people vaccinated, to create more places for them to get vaccinated, to mobilize more medical teams to get shots in people’s arms, to increase vaccine supply to get it out the door as fast as possible,” Biden said in an address, Stat 

. “But we need about $400 billion in funding from Congress to make all of what I just said happen.”

Biden’s is proposing $20 billion for a national vaccination program, $30 billion for purchasing supplies and protective gear, and $50 billion for a scaled-up diagnostic testing program.

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Testing funding would likely be prioritized for rapid antigen tests, a Biden adviser said, according to 

 reported that  Biden will urge Congress to provide $160 billion in funding as part of launching the national vaccination program, expanding testing, mobilizing a public-health jobs program, and other steps to build capacity to fight the virus.

In a speech on Friday. Biden outlined his COVID vaccination plan. He mapped out five points:

Work with states to open up vaccination to more priority groups. 

Biden said his administration will work with states to allow people other than healthcare workers to get vaccinated. He specifically mentioned people 65 and older and essential workers such as educators, first responders and grocery store workers.

Biden promised that there were 100 federally supported vaccination centers set up during the first month of his administration. He also mentioned mobile clinics, expanding the pool of healthcare workers who could administer the vaccine, and 100% federal reimbursement of costs if state use their National Guard in COVID-19-related efforts.

 Biden referred somewhat vaguely to a “new major effort” to work with independent and chain pharmacies. “This program will expand access in neighborhoods across the country so you can make an appointment and get your shot conveniently and quickly.”

Ramp up supply and don’t hold doses back.

 The president-elect again said his administration would use the Defense Production Act to accelerate the manufacturing of supplies and equipment needed to administer the vaccine. Biden also said his administration is moving to a policy of having the first dose of vaccine administered to people as soon as the supply is available rather than holding back doses for the second dose as the Trump administration did. But in his remarks on Friday, Biden also stressed that administration is not veering from the two-dose schedule of the two vaccines that are currently available, the Pfizer-BioNTech and the Moderna vaccines.

Biden promised to “honest and transparent about where we stand — both the good news and the bad.” State and local officials, he said, haven’t known how much vaccine they will be getting so they can’t plan. “That stops with when we are in office,” Biden promised.

Despite his criticism of the vaccine rollout, Biden believes the U.S. will meet his goal of administering 100 million vaccine shots in his first 100 days in office.

Biden is requesting additional funding for genomic sequencing efforts due to the new SARS-CoV-2 variant, B.1.1.7, that is spreading rapidly across the United Kingdom, the U.S., and other countries.

 the variant, which is more contagious than SARS-CoV-2, will likely become the dominant strain in the U.S. by March.

FDA clears Regeneron’s COVID-19 monoclonal antibody treatment and a home test

His vaccination plans call for creation of 100 federally support community vaccine sites in the first month of his administration.

Biden stimulus plan beefs up COVID-19 vaccinations and testing

Farxiga, AstraZeneca) Priority Review to treat new or new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).

Farxiga,a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been used to improve glycemic control in adults with T2D for around 10 years, AstraZeneca said in a 

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“This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the U.S.,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type 2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease.”

In the U.S., 37 million people are estimated to have CKD, and the condition is associated with a heightened risk of heart disease or stroke or the need for dialysis or kidney transplant.

Blockbuster diabetes drug snags new heart indication

FDA’s decision to grant Priority Review was based on a Phase 3 trial showing that Farxiga

 on top of standard of care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced the risk of the composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion.

It also significantly reduced the risk of death from any cause by 31% compared to placebo, AstraZeneca said.

Last October, FDA granted Farxiga Breakthrough Therapy Designation in the U.S. for patients with CKD with and without T2D. FDA will set its Prescription Drug User Fee Action date for this indication for Farxiga during the second quarter.

Drug’s indication expanded to reduce heart attack, stroke risk

AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.

Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease

MarcoGenics says its new breast cancer treatment will be available in March.

Margenza, in combination with chemotherapy, is used treat patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

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“Early detection and treatment have had a positive impact on the survival of patients with breast cancer, but the prognosis for people diagnosed with metastatic breast cancer remains poor, and additional treatments are needed,” said 

, MD, professor of medicine and director of Breast Oncology and Clinical Trials Education at University of California-San Francisco Helen Diller Family Comprehensive Cancer Center, in a 

“As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head Phase 3 clinical trial, Margenza with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” Rugo added.

FDA’s approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial.

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The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy compared with trastuzumab (Herceptin, other brand names) plus chemotherapy.

The objective response rate for Margenza plus chemotherapy was 22%, and the ORR for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021, according to MacroGenics.

Margenza includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity. In addition, the medication can cause infusion-related reactions (IRRs). IRRs occurred in 13% of patients treated with Margenza, with the majority reported as Grade 2 or less.

The recommended dosage of Margenza is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

New treatment for metastatic HER2-positive breast cancer is called Margenza.

MacroGenics treatment for HER2-positive breast cancer to be available in March

Many pharmaceutical manufacturers are raising prices this year, but at a lower rate than in the past couple of years, according to a new analysis.

On January 1, about 70 pharma makers raised prices on their products, according to an analysis from Rx Savings Solutions, 

However, the average increase of 3.3% was less than the price increases in previous years. In January 2020, manufacturers raised prices a significant 5.8%, and raised them 6.3% on average in 2019.

This year, Pfizer had the most price increases, raising prices by 5% or less on more than 200 products.

However, in 2020, brand name drug net prices dropped for the third consecutive year and brand name drug list prices grew at their slowest rate in at least 20 years, according to a 

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Brand-name drug list prices grew by 4.2%, but net prices declined by -2.2%. So, the gross-to-net gap in prices was -6.0%, Drug Channels said.

“As list prices rise, the dollar value of the manufacturer’s rebates and discounts grows. The manufacturer provides larger rebates to offset the increase in list prices,” Drug Channels said. “Hence, the total value of the gross-to-net bubble expanded to an astounding $175 billion for 2019, despite the slowing growth in list prices and the negative growth rates for net price.”

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Many pharmaceutical manufacturers are raising prices this year, but at a lower overall rate than in the past couple of years, according to a new analysis.

Drugmakers raising prices in 2021 but at lower rate

FDA approved the first generic version of an emergency kit to treat low blood sugar. The result could be competition for Eli Lilly and other pharma companies that have dominated the market with their brand-name products.

FDA granted the approval of glucagon for injection USP 1 mg/vial, packaged in an emergency, kit to 

 to treat severe hypoglycemia, which may occur in patients with diabetes mellitus.

FDA clears first ready-to-use insulin for IV injection

The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel and colon when diminished intestinal motility would be advantageous, FDA said in a 

“Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” said 

, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand-name counterparts.”

Overall U.S. sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020, according to IQVIA, while sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million for the same time period, Amphastar said in a 

“Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product,” Amphastar CEO and President 

Amphastar plans to have the glucagon emergency kit available within two months.

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Amphastar Pharmaceuticals’ generic version will offer stiff competition to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar.

FDA clears first generic for treatment for severe hypoglycemia

FDA has cleared a new biosimilar to Rituxan rituximab (Rituxan), which when it gets on the market may further erode sales of Roche's blockbuster treatment for non-Hodgkin's lymphoma (NHL) and other cancers.

Amgen recently achieved FDA approval for rituximab-arrx (Riabni) to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) (Wegener's Granulomatosis), and microscopic polyangiitis (MPA).

FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment

The biosimilar is expected to be available in January. Sales of Roche's Rituxan reached $6.54 billion in 2019, so any competitor to Rituxan has much to gain.

Riabni’s wholesale acquisition cost (WAC) in the U.S. is nearly 24% lower than Rituxan at $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, according to an Amgen  

FDA fast-tracks investigational leukemia treatment

The FDA approved Celltrion's rituximab-abbs (Truxima), the first biosimilar to Rituxan, in 2018. The agency approved Pfizer's Ruxience (rituximab-pvvr) a year later.

Riabni, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness, Amgen said.

FDA grants full approval for combination leukemia treatment

The biosimilar to Rituxan is expected to erode market share of the mainstay cancer drug for Roche.

Biosimilar to Rituxan expected to hit market in January

Relugolix (Orgovyx, Myovant Sciences) works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make, FDA said in a 

First prostate cancer imaging drug approved

Current FDA-approved hormone treatments for advanced prostate cancer of this type are injected or placed as small implants under the skin.

“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic,” Pazdur added.

Prostate cancer drug poised to generate big sale

The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every 3 months for 48 weeks.

In the 622 patients who received Orgovyx, the castration rate (measuring testosterone levels) was 96.7%.

The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

FDA fast-tracks novel MAB neuroblastoma treatment

Orgovyx, the first oral drug in its class, may help reduce clinic visits for men with prostate cancer. Fewer visits may be important during the COVID-19 pandemic.

The FDA recently approved a monoclonal antibody treatment for both pediatric and adult patients to treat neuroblastoma in bone marrow.

Naxitamab-gqgk (Danyelza, Y-mAbs Therapeutics) 40mg/10ml is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), as a treatment treat pediatric and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

FDA cleared Danyelza under Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations. Y-mAbs said in a 

 that the drug would be available in the “coming weeks”.

Danyelza is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. It is administered to patients 3 times in a week in an outpatient setting.

“We believe that Danyelza in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available,” said 

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FDA is requiring a boxed warning for Danyelza, noting that it has been shown to cause serious infusion reactions including anaphylaxis, cardiac arrest, bronchospasm, stridor, and hypotension. In addition, the medicine can cause severe pain and hypertension.

The agency’s approval is supported by clinical evidence from 2 pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease. “Danyelza appears to be well tolerated with few discontinuations of treatment in the clinical trials and adverse events were clinically manageable,” YmAbs said.

Blockbuster Keytruda earns new breast cancer indication

The monoclonal antibody medicine treats neuroblastoma in the bone and bone marrow.

Moderna’s experimental COVID-19 vaccine is “highly effective”, FDA said, which will likely lead to an official Emergency Use Authorization (EUA) approval by the agency very soon.

In addition, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) will purchase an additional 100 million doses of Moderna’s mRNA-1273 vaccine, HHS said in a 

Pfizer COVID-19 vaccine results positive, but questions remain

“If authorized by the FDA for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans,” HHS said.

 EUA to Pfizer-BioNTech’s COVID-19 vaccine on December 11, and the vaccine has already been administered to some healthcare professionals.

 on Moderna’s 30,000-person clinical study along with the agency’s own analysismahead of its advisory committee review of the vaccine candidate on Thursday.

Moderna found that the vaccine was 94.1% effective in protecting people against COVID-19, and new documents suggest that the vaccine begins to prevent asymptotic infections after the first dose. After the first dose, there were about two-thirds fewer cases of asymptomatic coronavirus infections among those who received the vaccine than among those who received a placebo, 

In addition, the research suggested benefit of the vaccine in preventing severe COVID-19.

The FDA found no specific safety concerns that would preclude its authorization of the vaccine, 

 reported. Severe adverse reactions were rare but occurred more frequently after the second dose of the vaccine than after the first dose.

FDA deemed Moderna’s vaccine candidate “highly effective,” so the agency  may grant an emergency use authorization later this week. 