Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Payers recognize that cell and gene therapies provide great innovation, and the market is starting to adapt, creating new solutions and reimbursement methods, according to a recent survey of managed care organizations and PBMs. The findings were presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting in Denver, Oct. 18-21, 2021.

The survey was conducting by FoCUS Project, which is part of MIT Center for Biomedical Innovation. FoCUS was launched in 2016 to develop new models and solutions for the reimbursement of cell and gene therapies.

“The purpose FoCUS is to ensure that there’s sustainable access for patients to these new one-time, durable therapies,” Jane F. Barlow, M.D., senior advisor, FoCUS Project, MIT Center for Biomedical Innovation, said in an interview with FormularyWatch. She is also executive VP and chief clinical officer at Real Endpoints.

 a request for information survey with 12 health plans and PBMs that have been known to cover cell and gene therapies. The purpose was to understand how the market is adopting new solutions that are being offered to different stakeholders to help support these emerging products.

The survey found that payers used four broad categories for covering cell and gene therapies. These include payer reinsurance/stop-loss/risk carve out solutions; contract negotiation and data management services for payers and pharmaceutical companies; provider contract negotiation services; or financial and pharmaceutical company warranty services.

“We're seeing the market respond to the challenges of selling gene therapy, with new products and solutions. But there's really no one solution that’s going to address all of the stakeholder concerns. As in most things, there's no magic bullet,” Barlow said.

Most market solutions have established methodologies or systems to track patient outcomes over time. Five organizations included performance guarantees as part of their solution. None of the solutions required additional payment from the patient over and above their usual plan benefit cost share. Several did require data sharing or clinical follow up to assess outcomes.

BCS Financial, CVS Health, and OptumRx are using stop-loss solutions for self-insured employers in exchange for a fixed per member, per month fee. BCS’s solution is for very large employer who generally self-insure without stop-loss coverage. CVS Health solution is for Caremark or Aetna self-insured companies without stop-loss coverage and there are separate eligibility requirements. OptumRx provides cost and quality management services including outcomes-based contracts.

MedImpact Healthcare Systems and OutcomeRx offer specialty carve-out reinsurance with a per member, per month fee to take on the risk of high-cost therapy claims. Evernorth’s Embarc Benefit Protection Plan brings together health services, medical management, and specialty pharmacy expertise in a carve-out designed to shield health plans and customers from high costs. PayRx offers a plan that expands traditional pharmaceutical payment assistance programs via a proprietary analytics model.

Two payers offer contract management and data management services for payers and pharmaceutical companies. Audaire’s Gene and Cell Therapy Outcomes Management Service offers a range of services, including negotiation of performance-based contracts on a plan’s behalf; automatic data capture of patients and providers; data aggregation; contract administration on behalf of the plan; patient tracking, and patient portability.

Real Endpoints’ Marketplace is a forum payers and pharmaceutical companies to efficiently develop and implement performance-based contracts. Real Endpoints acts as a third party to assess and manage performance of these contracts.

Two companies offer contract negotiation services: Blue Cross Blue Shield Association and Emerging Therapy Solutions.

Three companies offer financial and warranty services. August Care Health offers an Outcomes-based Financial Solutions platform that provides the opportunity to move from high upfront costs to paying for achieved performance. CVS Health offers an installment payment plan for gene therapies that allows health plans to pay over several years, smoothing the impact of an immediate large, incurred cost.

OutcomeRx’s Specialty Therapy Warranty is an outcomes-based contract mechanism that serves as a risk sharing mechanism between payers and pharmaceutical companies by guaranteeing the efficacy/durability of cell and gene therapies.

Barlow said plans may have different risks depending on their size and who their beneficiaries are, and going forward, it will be important for payers to assess the risks and challenges that are most important and develop a strategy for those risks.

“There really are not a lot of cell and gene therapies on the market right now. But when you look at the pipeline, over time, there are expected to be quite a few products on the market. By 2030, we're projecting somewhere between 54 and 74 cell and gene therapy approvals, so there will be like more of a cumulative effect,” Barlow said.

So far there have been eight such approvals, although seven were available when the FoCUS survey was conducted.

 Enzyvant Therapeutics’ Rethymic (allogeneic processed thymus tissue-agdc), a one-time therapy for immune reconstitution in pediatric patients with congenital athymia. Rethymic is engineered human thymus tissue designed to regenerate the thymic function.

Available cell and gene therapies include:

 March 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma. This is a B-cell maturation antigen-directed genetically modified autologous chimeric antigen receptor T-cell therapy. This is the first cell-based gene therapy for multiple myeloma. It was developed by Bristol Myers Squibb and bluebird bio.

 Feb. 5, 2021, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. It consists of autologous T cells that are genetically modified to produce a CAR protein, allowing the T cells to identify and eliminate CD19-expressing normal and malignant cells. It was developed by Bristol Myers Squibb.

 in August 2017 to treat pediatric and young adult patients with a form of acute lymphoblastic leukemia and 

n May 2018 to treat adults with relapsed, large B-cell lymphoma. It is an autologous CAR T cell therapy directed at CD19. It was developed by Novartis.

Luxturna (voretigene neparvovec-rzyl) was 

 in December 2017 to treat children and adults with an inherited form of vision loss that leads to blindness. Luxturna delivers a normal copy of the RPE65 gene directly to the retinal cells. It was developed by Spark Therapeutics.

Tecartus (brexucabtagene autoleucel) was 

 in July 2020 to treat adult patients diagnosed with mantle cell lymphoma, and it was 

 Oct. 1, 2021 to treat adult patients with B-cell precursor acute lymphoblastic leukemia. It was developed by Kite, a Gilead company.

 in March 2018 to treat large B-cell lymphoma, including non-Hodgkin lymphoma, and it was 

 March 8, 2021, to treat adult patients with relapsed refractory follicular lymphoma. it is an autologous, CD-19 directed CAR T. It was developed by Kite, a Gilead company.

Zolgensma (onasemnogene abeparvoved-xioi) was 

 in May 2019 to treat children with spinal muscular atrophy. It is an adeno-associated virus vector gene therapy. It was developed by Novartis.

Articles

Most of the solutions have established systems to track patient outcomes over time, and several include performance guarantees as part of their solution.

Survey: Payers are Creating New Reimbursement Solutions for Gene Therapies

 a new low-dose tablet dosage form of Gilead’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) for pediatric patients living with HIV-1 infection.

The approval is based on data from a cohort of patients in a phase 2/3 study, which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing between 14 kg and 25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase.

Nearly 3 million children worldwide under the age of 19 are living with HIV. An estimated 120,000 children and adolescents died from AIDS-related causes in 2020. About 72% of these deaths occurred among children under 10 years old.

In February 2018, the FDA approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg.

“Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them,” Carina Rodriguez, M.D., professor of pediatrics and division chief of pediatric infectious diseases at the University of South Florida Morsani College of Medicine, said in a statement.

This low-dose formulation of Biktarvy is for younger children living with HIV.

FDA Approves Biktarvy for Young Children with HIV

 to Omeros about its biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

 the destruction of red blood cells, low platelets, and organ damage due to the formation of microscopic blood clots in capillaries and small arteries. It can lead to worsen outcomes in patients who have undergone stem cell transplants. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population, and recent reports suggest it occurs in about 40% of allogeneic transplants.

In the CRL, FDA indicated it was difficult to assess the treatment effect of narsoplimab in HSCT-TMA. Regulatory officials are requesting additional information to support approval, including data on chemistry, manufacturing and controls (CMC), safety, or nonclinical issues precluding approval raised in the CRL.

Narsoplimab is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), an enzyme of the lectin pathway of complement, which is part of the immune system. Narsoplimab is the first drug candidate submitted to FDA for approval in for this indication. It has breakthrough therapy and orphan designations in both HSCT-TMA and immunoglobulin A (IgA) nephropathy or chronic kidney disease. The company also has a phase development program in IgA.

Omeros plans to request a Type A meeting, which is a 

 between sponsors and regulators for stalled product developments.

Omeros’ application had been accepted in January 2021 for the thrombotic microangiopathy indication.


Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.


FDA Issues Complete Response Letter to Omeros for Narsoplimab

 for United Therapeutics’ new drug application for Tyvaso DPI (treprostinil), for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The regulatory agency noted a deficiency related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.

Tyvaso DPI is a drug-device combination therapy comprised of a dry powder inhalation formulation of treprostinil. It was developed through a collaboration with MannKind, which developed the inhalation technology that is also used in MannKind’s Afrezza (insulin human) inhalation powder product.

A nebulized formulation of Tyvaso is already available to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

 the NDA for Tyvaso DPI in April 2021. The application was based on the BREEZE clinical study evaluating the use of the DPI formulation in patients who transitioned from the inhalation solution, with additional pharmacokinetic data from healthy volunteers.

Company officials expect the DPI version to be available by the summer of 2022. “We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier,” Martine Rothblatt, Ph.D., chairperson and chief executive officer of United Therapeutics, said in statement.

The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.

FDA Issues Complete Response Letter for Tyvaso DPI

 Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Developed by Oyster Point Pharma, it is the first nasal spray approved for this indication.

The therapy is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease.

Tyrvaya is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease. Nasal delivery may allow some patients who have difficulty independently administering topical eye drops.

The approval was based on three clinical trials with more than 1,000 patients with mild, moderate, or severe dry eye. Of the patients treated, 52% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-2 study.

The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5% to 16% of patients were cough, throat irritation, and instillation-site (nose) irritation.

Tyrvaya will be available in November 2021 in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril.

“I see many patients in my practice whose lives are impacted by dry eye disease. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient,” Ed Holland, M.D., director of Cornea Services at Cincinnati Eye Institute and professor of Ophthalmology at the University of Cincinnati, said in a statement.

Dry eye disease is a chronic condition that impacts an estimated 38 million people in the United States.

Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease. 

 FDA Approves Tyrvaya for Dry Eye Disease

 Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or an adjunct to lithium or valproate.

Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity. It was approved in June 2021 based on the ENLIGHTEN clinical program. In the ENLIGHTEN-1 study of 403 patients experiencing an acute exacerbation of schizophrenia, Lybalvi demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared with placebo.

In the ENLIGHTEN-2 study of 561 patients with stable schizophrenia, Lybalvi met the two primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared with the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared with the olanzapine group.

“Patients living with bipolar I disorder or schizophrenia commonly cycle through multiple therapeutic options in the course of their treatment journey. The availability of a new, efficacious and differentiated treatment option is a significant development for patients as they make treatment decisions with their healthcare provider,” Michael Pollock, CEO of the Depression and Bipolar Support Alliance, said in a statement.

The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.

Alkermes Launches the Antipsychotic Lybalvi 

 the first interchangeable biosimilar for AbbVie’s Humira (adalimumab) for multiple chronic inflammatory disease. Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved by the FDA on Friday, Oct. 15, 2021.

Boehringer Ingelhiem will make Cyltezo available when its commercial license begins on July 1, 2023. This date was the 

 with AbbVie. Boehringer Ingelheim will pay royalties to AbbVie for licensing its Humira patents once Cyltezo.

Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s phase 3 randomized VOLTAIRE-X clinical trial. Data showed that switching several times between Cyltezo and Humira resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety.

To be a biosimilar to an approved reference biologic, companies must demonstrate there are no clinically meaningful differences in terms of safety, potency and purity. Cyltezo was 

 in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

To achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients. A biosimilar with an Interchangeable designation can be automatically substituted by a pharmacist for the reference product.

“As the first Interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products, Martin Alan Menter, M.D., chairman of the Division of Dermatology at Baylor University Medical Center, said in a statement.

Boehringer Ingelhiem will make Cyltezo available when its commercial license begins on July 1, 2023.

FDA Approves First Interchangeable Biosimilar of Humira

Formulary Watch Drug Shortages Update — October 17, 2021

The FDA’s Vaccines and Related Biological Products Advisory Committee recommended authorizing a second dose of Johnson & Johnson vaccine for as early as two months after the initial dose. The committee voted unanimously 19-0 in favor of the emergency use authorization.

“Today's recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, said in a statement.

 ahead of the meeting, the company indicated that the administration of a booster dose would strengthen immune responses and ensure optimal and durable protection against symptomatic COVID-19 as well as increase protection against severe/critical COVID-19 across populations and SARS-CoV-2 variants.

J&J had submitted data to support its application for an emergency use authorization early in October 2021. The submission includes recent results from the 

 that found a booster of the J&J COVID-19 vaccine given 56 days after the primary dose provided 94% protection against moderate-to-severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

Also part of the submission is phase 1/2a 

 showing that when a booster of the vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.

 that confirmed the long-lasting protection of its COVID-19 vaccine. There was no evidence of reduced effectiveness over the study duration conducted from March to July 31, 2021. Comparable vaccine effectiveness was demonstrated when the study was extended to August 31, 2021, including when the Delta variant became dominant in the United States.

Related: Advisory Committee Recommends Moderna COVID-19 Booster

The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.

FDA Advisory Committee Recommends Approval of J&J COVID-19 Booster

 a supplemental new drug application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti (brexpiprazole). The FDA has granted Otsuka and Lundbeck priority review.

Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the United States for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults.

Rexulti was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.

The submission has been completed one year earlier than planned. This was made possible by doing an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and six-month data from the ongoing open-label, long-term trial in adolescent schizophrenia patients (Trial 331-10-236).

“By using an extrapolation approach in accordance with new regulatory guidance, our goal is to offer a new treatment option to adolescent patients at an accelerated pace compared to previous regulatory guidance,” Johan Luthman, Ph.D., executive vice president, Research and Development, Lundbeck, said in a statement.

Based on an interim analysis of the ongoing long-term trial, Rexulti appears to be a potential treatment option for adolescent patients with schizophrenia, with a safety profile consistent of that observed in adult patients. The most common adverse event was drowsiness with an incidence of 10.2%, and the incidence of restlessness was 2.4%. The results of the more than 100 adolescent patients treated for at least six months from the trial will be presented at the Psych Congress taking place October 29 to November 1, 2021, and will be published in 2022.

The FDA is expected to complete its review of the sNDA by December 2021.

Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.

Otsuka, Lundbeck Submit sNDA for Rexulti in Adolescents with Schizophrenia

Managed care organizations are anticipating pharmacy benefit plans to include preferred biosimilars and negotiate rebates/contracts, but legal and regulatory hurdles still exist, finds a survey of 51 payers conducted by AmerisourceBergen/Xcenda. The results were presented at the Academy of Managed Care Pharmacy Nexus 2021 meeting in Denver, Oct. 18-21, 2021.

“About 59% of those we surveyed said they agreed that biosimilars have provided their organization with meaningful savings. We have another 35% of people say they somewhat agree with that statement,” Tasmina Hydery, Pharm.D., assistant director in integrated technology solutions at AmerisouceBergen/Xcenda, said in an interview with FormularyWatch.

But Hydery pointed out that because of rebates on the reference products, the reference product can be less expensive. “Even though the sticker price for a biosimilar looks lower, the reference product actually was lower cost to the plan. You have to look beyond the wholesale acquisition cost and at the net price.”

Payers will continue to contract with specific biosimilars in order to drive down pricing and make them preferred, Jennifer Snow, MPH, vice president, reimbursement policy insights at AmerisourceBergen/Xcenda, said in an interview. “They will also implement utilization management but there will be a difference in where they drive preferences and that will drive the utilization as well,” she said.

There is a lot of momentum with biosimilars, Hydery said. “Based on other research we’ve done, we know there is increased utilization of biosimilars over time. When biosimilars first came to the market in 2015, there wasn’t that much preferencing of the biosimilars to the reference product, but now things are changing. There are health plans that are preferring biosimilars to the reference products, and part of that is because of the contracting and negotiating. When that happens, that’s when we see more utilization.”

Complicating the uptake of biosimilars are the various state laws that allow for interchangeability and substitution, Snow said. “We’re watching the legislative and regulatory environment in Washington to see what’s next and whether it is sustainable. There is a lot of interest in biosimilars in the White House and in Health and Human Services,” she said

But the question is what decisions will be made in terms of policy that could potentially hinder the biosimilar market, making it unsustainable. One example of a policy that could hinder biosimilars is consolidated billing codes.

“Currently the market has worked very well if you follow the ASPs in both the innovator and the biosimilar, you can see it certainly drives prices down,” she said. “But biosimilars are never going to be the ‘Hatch-Waxman’ of savings. We should have always been looking this as a 20% savings. It was never going to be pennies on the dollar.”

To help payers assess state regulation, in March 2021, Xcenda launched a Biosimilars Resource Hub within 

, an online platform supporting a community of more than 2,500 health care decision makers in the United States. It enables an information exchange between life-sciences organizations and health care decision makers.

There is a lot of momentum with biosimilars in the pipeline as well, Hydery said. “There will likely be more than one biosimilar for reference products and that creates for payers and manufacturers to negotiate to drive costs down.”

To date, 32 approvals of biosimilars and 20 launches in the United States. Several biosimilars have been approved over the last few months.

Hydery said a biosimilar to be watched is Semglee, the first biosimilar insulin to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. The FDA 

 this is July as an interchangeable with its reference product, Sanofi’s Lantus (insulin glargine). Interchangeability is a first for an insulin biosimilar.

“Insulin has been a huge focus in conversations about cost and affordability. Semglee will be available by the end of the year. This means that payers and pharmacies have some time to prepare for this launch and how they would operationalize this,” Hydery said.

That is already beginning. Express Scripts just announced it will add Semglee as a preferred therapy on its formulary beginning January 2022. Express Scripts estimates cost savings of $20 million in 2022 by preferring Semglee injection on its National Preferred Formulary, which includes more than 28 million lives.

More about Express Scripts’ coverage of Semglee

Another biosimilar to watch is Cyltezo (adalimumab-adbm), an interchangeable biosimilar of Humira. The FDA 

 this biosimilar on Oct. 15, 2021, to treat patients with chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

“Humira generates a lot of spending because it is approved for several indication and a lot of people have received it, and it is fairly high cost,” Hydery said. “A year and a half from now, the patent will be expiring, and biosimilars will be making their ways on to the market.”

Cyltezo available when its commercial license begins on July 1, 2023. This date was the 

AmerisourceBergen/Xcenda survey finds payers believe biosimilars provide costs savings, and they are expected to continuing contracting with manufacturers.



Survey: Biosimilars are Gaining Momentum Among Payers

 one lot of Cubicin (daptomycin for injection) 500 mg because a piece of glass was found in a vial. About 22,000 vials are affected by this recall.

The company warns that intravenous infusion of glass particulates has the potential to cause serious health consequences even if the glass is withdrawn from the vial. Serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening.

Cubicin is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections in adult and pediatric patients, as well as Staphylococcus aureus bloodstream infections in adult patients and children.

Cubicin is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake, NDC 67919-011-01. There were 76,163 total vials manufactured in the affected lot; and of those vials, 21,603 have been distributed.

The affected lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022. This product was distributed to wholesalers in the United States between June 1, 2021, and Sept. 9, 2021.

Glass was found in one vial of Cubicin, which treats patients with Staph infections of the skin and blood.

Merck Recalls One Lot of Cubicin

Express Scripts will add Viatris’ Semglee (insulin glargine-yfgn) injection as a preferred therapy on its formulary beginning January 2022. The FDA 

 Semglee as the first biosimilar insulin to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

Express Scripts estimates cost savings of $20 million in 2022 by preferring Semglee injection on its National Preferred Formulary, which includes more than 28 million lives. The National Preferred Formulary will exclude the reference product, Lantus.

Related: Express Scripts Releases 2022 Formulary List

“We have advocated for more than a decade for a safe and effective pathway to bring biosimilars to market because they hold tremendous promise for cost savings for patients, plans and our entire health care system,” Amy Bricker, president of Express Scripts, said in a statement. “The FDA approval of the first interchangeable biosimilar signals a historic opportunity to realize these cost savings for our clients and members. This important designation is another milestone toward a pathway for the full adoption of biosimilars, which is critically important to making high-cost medications more affordable for patients, employers and health plans.”

Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. It is not recommended for treating diabetic ketoacidosis. In a 

, Viatris officials said commercial preparations for launch are under way.

Related: FDA Approves First Biosimilar Insulin

Express Scripts, an Evernorth company, will also add Semglee to its Patient Assurance Program, which protects patients from high out-of-pocket costs by capping member copays at $25 for up to a 34-day supply of select diabetes medications. Beginning January 1, 2022, the program will expand to include select cardiovascular medications that have been proven to reduce the risk of stroke.

Semglee injection also will be added to the company's SafeGuardRx Diabetes Care Value program, a value-based care solution that provides support to people with diabetes.

An Evernorth analysis estimates biosimilars could reduce drug spending 

Express Scripts will put the first interchangeable biosimilar insulin on its National Preferred Formulary and exclude Lantus, the reference product.

Express Scripts to Cover the Biosimilar Semglee

The FDA was unable to complete review of UCB’s biologics license application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of Oct. 15, 2021.

The agency has determined that on-site inspections of the European manufacturing facilities for bimekizumab are required before the FDA can approve the application. The FDA indicated that they were unable to conduct the inspections during the current review cycle due to COVID-19 related restrictions on travel. Therefore, the FDA is deferring action on the application until the inspections can be completed.

This was the only reason cited for the delay in approval, according to officials at UCB

“We are currently in contact with the FDA to schedule the inspections of our manufacturing facilities as soon as possible,” Iris Loew Friedrich, M.D, Ph.D., chief medical officer and executive vice president, development UCB, said in a statement. “We have provided the agency with the manufacturing schedules through the first quarter of 2022, and we are eager to assist the FDA to allow its assessment of bimekizumab to be finalized. We are committed to bringing bimekizumab to patients in the United States with moderate to severe plaque psoriasis as soon as possible.”

Under FDA guidance relating to preapproval inspections during the COVID-19 pandemic, the agency may defer action on a pending application when a facility inspection is planned but cannot be completed by the PDUFA goal date due to COVID-related travel restrictions.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both interleukin 17A and interleukin 17F, two key cytokines driving inflammatory processes. The FDA had accepted UCB's application for bimekizumab in September 2020.

In August 2021, bimekizumab received marketing authorization in countries of the European Union/European Economic Area and Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Regulatory reviews are under way in Australia, Canada, Switzerland, and Japan.

COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.

FDA Misses PDUFA Date for Bimekizumab

 ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection. It was developed by Adamis Pharmaceuticals.

This is the second product available to treat opioid overdose. Narcan is available as both an injection and a nasal spray, which was approved in 2015.

ZIMHI received approval through the 505(b)(2) approval pathway, which allows review of FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. In this case, Adamis’ application relied, in part, on the FDA’s finding of safety and effectiveness for Narcan injection to support approval.

According to the CDC, drug overdoses resulted in about 96,779 deaths in the United States during the 12-month period ending March 2021, which was a 29% increase over the prior 12-month period. Drug overdoses are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogues, responsible for the largest number of those deaths.

“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Jeffrey Galinkin, M.D., an anesthesiologist, and former member of the FDA Advisory Committee for Anesthetics, Analgesics

ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.

Survey: Biosimilars are Gaining Momentum Among Payers

Merck Recalls One Lot of Cubicin

Express Scripts to Cover the Biosimilar Semglee

FDA Misses PDUFA Date for Bimekizumab

FDA Approves ZIMHI to Treat Opioid Overdose