HHS Secretary Xavier Becerra declared the ongoing spread of monkeypox virus in the United States a Public Health Emergency (PHE) and is expanding monkeypox vaccine distribution.

"Ending the monkeypox outbreak is a critical priority for the Biden-Harris Administration. We are taking our response to the next level by declaring a public health emergency,” 

 in a statement. “With this declaration, we can further strengthen and accelerate our response further.”

U.S. monkeypox cases have soared to 7,510 as of Aug. 5, 2022, according to the 

“President Biden has called on us to explore every option on the table to combat the monkeypox outbreak and protect communities at risk,” added White House National Monkeypox Response Coordinator Robert Fenton. “We are applying lessons learned from the battles we’ve fought — from COVID response to wildfires to measles, and will tackle this outbreak with the urgency this moment demands.”

HHS has shipped more than 602,000 doses of the Jynneos (Bavarian Nordic) monkeypox vaccine to states and jurisdictions — an increase of 266,000 in the past week. The agency has allocated 1.1 million doses to states and jurisdictions and is making more doses available as jurisdictions use their current supply.

In addition, HHS has accelerated the delivery of an additional 150,000 vaccine doses. “The doses, which were slated to arrive in November will now arrive in the US in September,” the agency said.

The FDA is also exploring new strategies that could help get vaccines to affected communities across the country, including a new dose-sparing approach that could increase the number of doses available, up to five-fold, HHS said.

President Joseph R. Biden also recently appointed Robert Fenton of the Federal Emergency Management Agency as White House National Monkeypox Response Coordinator and Demetre Daskalakis, M.D., with the CDC as White House National Monkeypox Response Deputy Coordinator.

In early July, HHS said the Strategic National Stockpile 

 of Jynneos to 15 jurisdictions across the United States as part of the initial phase of the strategy. An additional 11,565 doses have been ordered by jurisdictions and those are being processed for delivery.

Once requests for vaccine are made by the jurisdictions and approved by the CDC, the Strategic National Stockpile prepares the vaccine for shipment and can deliver the doses as soon as the next day, HHS said.

Data on Jynneos deliveries are publicly available every Wednesday at 

Articles

Confirmed cases of monkeypox in the United States have reached more than 7,500, according to the CDC.

HHS Declares Monkeypox Emergency, Expands Vaccine Distribution

 a supplemental new drug application (sNDA) for Bayer’s Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubequa is oral an androgen receptor inhibitor that is also approved to treat non-metastatic castration-resistant prostate cancer.

“This new indication for NUBEQA Nubeqa is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients,” Matthew Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, said in a press release.

The approval was made under the FDA’s Real-Time Oncology Review (RTOR) pilot program based on results of the phase 3 ARASENS trial. Results demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint, with a reduction in the risk of death by 32% for those treated with Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel. Treatment with Nubeqa plus androgen deprivation therapy and docetaxel also resulted in a statistically significant delay in time to pain progression.

The ARASENS results were presented earlier this year at the 2022 ASCO GU Cancers Symposium and simultaneously published in 

Incidence of adverse reactions was similar between both study arms. Adverse reactions reported for Nubeqa with docetaxel above 10% were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. Serious adverse reactions occurred in 45% of patients receiving Nubeqa and in 42% of patients receiving placebo. Fatal adverse reactions occurred in 4% of patients receiving Nubeqa and in 4% of patients receiving placebo.

Nubeqa is being investigated other studies across various stages of prostate cancer.

Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer. 

FDA Approves Additional Indication for Nubeqa

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

Tucked into the Inflation Reduction Act, approved by the Senate this past weekend, are some provisions that address the price of prescription drugs, including capping insulin at $35 for Medicare beneficiaries. The Senate approved the final bill on Sunday after a weekend of voting on proposed amendments in a 51-50 vote, with Vice President Kamala Harris providing the tie-breaking vote.

, the bill contained several measures on drug pricing as part of the fiscal year 2022 reconciliation. These include:

Allowing Medicare to negotiate directly for price of prescription drug

Capping Medicare patients’ out-of-pocket costs at $2,000 per year

Expanding copay assistance for low-income Americans

Creating a new inflation rebate, providing for Medicare to receive rebates on drug price increases above inflation rate.

That last measure, however, didn’t make it passed the full Senate. The inflation rebate, however, was nixed because the language in the bill didn’t comply with Senate rules. In a 

 Senate Finance Committee Chair Ron Wyden (D-Ore), said the legislation would have put a check on pharmaceutical companies’ ability to price gouge.

Additionally, an effort to put a $35 cap on insulin for patients outside of Medicare failed when the Senate wouldn’t allow a waiver of procedural rule. But the $35 cap will apply for Medicare beneficiaries.

This follows many efforts by many stakeholders to lower the costs of insulins. UnitedHealthcare has ended copays for some drugs, including some insulins, to its members and Optum has teamed up with Sanofi to offer $35 insulin those without insurance.

If insulin copays were capped at $35, Part D enrollees would save 35% on average, according to an updated

 from the Kaiser Family Foundation. Among Medicare Part D insulin users who do not receive low-income subsidies, average out-of-pocket costs per prescription across all insulin products was $54 in 2020, an increase of 39% since 2007. Among insulin users without Part D low-income subsidies, the average annual out-of-pocket spending on insulin per user increased by 76% between 2007 and 2020, from $324 to $572.

Related: Study: Medicare Part D Enrollees’ Spending for Insulin Increased

In the Senate bill, the drug price negotiation provision only applies to a handful of product: for 10 drugs covered by Medicare in 2026, increasing to 20 drugs in 2029 with the 

 by the Kaiser Family Foundation released before the vote indicated that the magnitude of savings would depend on which drugs were chosen and the price reductions achieved.

The $2,000 cap on out-of-pocket costs is the first major change to Medicare Part D in more than a decade. The Kaiser Family Foundation indicated this cap would help beneficiaries who take high-priced drugs for conditions such as cancer or multiple sclerosis. For example, in 2020, among Part D enrollees without low-income subsidies, average annual out-of-pocket spending for the cancer drug Revlimid was $6,200 (used by 33,000 beneficiaries); $5,700 for the cancer drug Imbruvica (used by 21,000 beneficiaries); and $4,100 for the MS drug Avonex (used by 2,000 beneficiaries), according to the KFF.

“Letting Medicare negotiate for the costliest drugs is a common-sense way to lower costs for Medicare beneficiaries and increase access for low-income seniors who might otherwise be unable to afford their medications,” Rep. Don Beyer (D. Va.) of the Joint Economic Committee said in a 

The House is expected to review and vote on this bill this week.

The Inflation Reduction Act also allows Medicare to negotiate prices on some drugs and caps out-of-pocket costs for Medicare beneficiaries. 

Senate Passes Bill that Caps Insulin at $35 for Medicare Beneficiaries

 a tablet formulation of AstraZeneca’s Calquence (acalabrutinib) for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and for patients with relapsed or refractory mantle cell lymphoma, which is approved under accelerated approval based on overall response rate.

“Patients with blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease,” John C. Byrd, M.D., chair of the Department of Internal Medicine at the University of Cincinnati, said in a press release. The U.S. approval of acalabrutinib in a tablet form enables co-administration of with a proton pump inhibitor.”

The approval was based on results from the ELEVATE-PLUS trials, which showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule. The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors, antacids and H2-receptor antagonists. The majority of observed adverse events in these studies were mild with no new safety concerns identified.

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

FDA Approves Tablet Form of Calquence 

 Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

The agency had accepted the supplemental biologics license application (sBLA) in July 2022, and the company had indicated that the Prescription Drug User Fee Act date (PDUFA) action date was during the fourth quarter of the 2022.

“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, said in a press release. “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”

Related: FDA Accepts sBLA for Enhertu in Low HER2 Breast Cancer

Enhertu is an engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

About 80% to 85% of those new cases were previously considered to be HER2-negative subtype, which means the tumors do not overexpress, or make too many copies of the HER2 protein. Of that proportion of breast cancer diagnoses, about 60% of patients previously classified as having HER2-negative subtype can now be considered as HER2-low and are now eligible to receive Enhertu. Prior to today’s approval, HER2-low patients received endocrine therapy or chemotherapy.

, a randomized, multicenter, open label clinical trial that enrolled 557 adult patients with unresectable or metastatic HER2-low breast cancer. The trial included two cohorts: 494 hormone receptor positive patients and 63 hormone receptor negative patients. The results showed improvement in both progression-free survival and overall survival in people with unresectable or metastatic HER2-low breast cancer.

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

FDA Approves Enhertu for HER2 Low Breast Cancer

One of the lasting effects of the COVID-19 pandemic has been an epidemic of COVID-19 “long-haulers,” those who have post-infection conditions that can last anywhere from months to years. An 

estimated 7.7 to 23 million Americans have developed long COVID

, and roughly 1 million people may be out of the workforce at any given time due to the condition — equivalent to about $50 billion in lost earnings annually, the Department of Health and Human Services (HHS) said in a 

Some of the symptoms include fatigue, fever, headache, brain fog, and joint and muscle pain, well as difficulty breathing, chest pain, or heart palpitations. Long COVID has even been identified as disability under the Americans with Disabilities Act.

“Long COVID can hinder an individual’s ability to work, attend school, participate in community life, and engage in everyday activities,” said HHS Secretary Xavier Becerra. “As our nation continues to make strides in the fight against COVID-19, these reports are critical to shine a light on long COVID’s impact and how to match people to resources.”

To that end, the Department of Health and Human Services has released two reports that “pave an actionable path forward to address long COVID and associated conditions.”

The National Research Action Plan on Long COVID

, created in coordination with 14 government departments and agencies, has introduced the first U.S. governmentwide national research agenda focused on advancing prevention, diagnosis, treatment, and provision of services and supports for individuals and families experiencing long COVID.

 details advances in current research and charts a course for future study to better understand prevention and treatment of long COVID. 

The Services and Supports for Longer-Term Impacts of COVID-19 report

 highlights resources for healthcare workers and those effected by broader effects of COVID-19.

Research priorities include building on extensive ongoing research, primarily led by CDC and the Veterans Affairs, to conduct additional studies of long COVID risk factors, health trajectories and outcomes that are inclusive of age, gender, race, ethnicity, geographic location, socioeconomic status, insurance coverage status, pregnancy status, and disability status — enabled by new capabilities in data analytics, HHS said.

HHS is also supporting studies that can “rapidly adapt to examine risk and protective factors as they emerge (i.e., new variants, vaccinations, repeat infections, and therapies for COVID-19) on risk of long COVID,” the agency said.

Then agency also wants to expand the portfolio of studies, including the RECOVER Initiative and others, on the effectiveness of therapeutics to prevent and treat long COVID to include antivirals, anti-inflammatory, immune modulators, and other existing or new treatments.

Meanwhile, long COVID researchers expect to have the results from three major trials later this year or sometime next year, per 

. Axcella Therapeutics, 9 MetersBiopharma'sAT1011 will likely have results in the second half of 2022, while Virios’s IMC-2 will convey results in the first half of 2023.

 topline results from its phase 2a randomized, double-blind, placebo-controlled investigation of AXA1125 in patients with fatigue related to long COVID.

“Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated 100 million patients worldwide with fatigue as the most common symptom reported,” Axcella said in a statement.

In Axcella’s study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 28 days, with a one-week safety follow-up period.

Endpoints included phosphocreatine recovery time following moderate exercise as assessed by 31P-magnetic resonance spectroscopy, which was included to assess mitochondrial function, and clinically relevant endpoints including self-reported mental and physical fatigue as assessed by the Chalder Fatigue Questionnaire, six-minute walk test, as well as serum lactate levels.

Subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared with those who received placebo, Axcella said.

“The results of this trial encourage us to further evaluate the multi-targeted effects of AXA1125 on mitochondrial and related biomarkers to advance our understanding of the benefits AXA1125 delivers to Long COVID patients,” said Karim Azer, Ph.D., vice president of platform and discovery at Axcella.

A rise in the number of long COVID is sparking research efforts by the HHS, the CDC and drug companies to understand the conditions and develop treatments.

Long COVID-19 a Priority for Biden Administration, Drug Developers

 by three months the review of Reata Pharmaceuticals’ omaveloxolone for the treatment of patients with Friedreich’s ataxia, a rare, genetic, degenerative neuromuscular disorder.

The company has submitted updated data from the MOXIe Extension study, including delayed-start analysis using a March 2022 data cut-off and a new propensity-matched analysis using patient data from the Clinical Outcome Measures in Friedreich’s Ataxia Study as controls. Additionally, Reata submitted an analysis of the relevance of Nrf2, the target of omaveloxolone, to the pathophysiology of Friedreich’s ataxia.

These submissions were provided as confirmatory evidence of the results of the MOXIe Part 2 study in response to concerns raised by the FDA during the mid-cycle communication meeting. The FDA determined that these submissions were a major amendment to our NDA and extended the Prescription Drug User Fee Act date to provide time for a full review of the new data and analyses.

The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.

“We are pleased with the FDA’s decision to review the new information we recently provided to the Division,” Warren Huff, Reata’s chief executive officer, said in a press release. “We remain committed to our goal of working with the FDA to secure regulatory approval for omaveloxolone as quickly as possible for patients with this severe disease that has no approved therapies.”

Patients with Friedreich’s ataxia typically experience symptoms in childhood, including progressive loss of coordination, muscle weakness, and fatigue that commonly results in motor incapacitation with patients requiring a wheelchair in their 20s. It impacts about 5,000 children and adults in the United States and 22,000 individuals globally. Currently, there are no approved therapies for the treatment of Friedreich’s ataxia.

Omaveloxolone is an oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.

The FDA has granted orphan drug, fast track, and rare pediatric disease designations to omaveloxolone for the treatment of Friedreich’s ataxia.

FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia

 Myfembree (relugolix, estradiol, and norethindrone acetate) as a one-pill, once-a-day therapy for the management of moderate-to-severe pain associated with endometriosis. Developed by Myovant Sciences and Pfizer, Myfembree is also approved for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

“This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of <1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended,” Linda Giudice, M.D., Ph.D., distinguished professor at the University of California, San Francisco (UCSF), and chair, SPIRIT Program Steering Committee, said in a press release.

 the review of the supplemental new drug application (sNDA) for the endometriosis indication. Regulators want additional time to review information they had requested from the companies regarding bone mineral density.

Related: FDA Extends Review of sNDA for Myfembree

The approval for the endometriosis indication is supported by one-year efficacy and safety data, including 24-week data from the phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in 

 and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. 

The trials each met their co-primary endpoints with 75% of women in the Myfembree group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at week 24. Adverse reactions occurring in at least 3% of women treated with MYFEMBREE and greater than placebo were: headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.

The open-label extension study showed mean bone mineral density loss of less than 1% from baseline through one year of treatment; some patients (19.7%) had losses >3%. Annual bone density measurement is recommended while treating women for endometriosis.

The approval had been delayed as the regulatory agency reviewed data on Myfembree's impact on bone mineral density.

FDA Approves Myfembree to Treat Endometriosis

Legislative and Federal Trade Commission efforts to rein in the PBM industry could lead to some unintended consequences, according to Susan Lang, CEO and founder of XIL Health. The PBM industry is facing increased scrutiny over policies and practices that have developed over the last decade alongside structural changes in healthcare that have led to more Americans facing higher out-of-pocket costs.

Structural changes in the market have created several pressures in healthcare, Lang said in an interview with 

. “This has created a misalignment between the PBMs, their clients and consumers.” In particular, the consolidation of health plans and PBMs has created a very different healthcare system with different incentives from just a few years ago.

As a consequence, the Federal Trade Commission (FTC) has launched an investigation into PBM practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement. Separately, the FTC indicated in an enforcement policy statement that indicates rebates and fees that exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws.

Related: FTC Launches Investigation of PBMs

At the same time, numerous lawsuits have been filed and legislative efforts aim to force transparency within the PBM industry, requiring them to report how much money they make through spread pricing and pharmacy fees.

 by the Center for Medicare & Medicaid Services to eliminate direct and indirect remuneration fees, the “clawbacks” that PBMs use to take money back from pharmacies — will help address some of the biggest complaints about PBMs.

But Lang said that this is likely to be a win-lose game. “This is a multi-billion-dollar space that is dominated by Fortune 100 companies,” she said. “These big Fortune 100 companies, whether they are drug manufacturers or PBMs, or large pharmacies or a health plans, they are now fighting each other to get to the amount of revenue and profit they need to fund their earnings. So, if you can take the DIR fees away, the question will be, how do they refill that bucket of lost revenue?”

The integration of PBMs and health plans is just one major shift impacting the marketplace, she said. The two others — including high deductible plans and the gig economy — impact consumers’ ability to access healthcare.

On the integration front, the three large PBMs are now part of large healthcare companies, with the most recent one being Cigna’s acquisition of Express Scripts in 2018. Optum and OptumRx are a part of UnitedHealthcare. CVS’s businesses include both the PBM Caremark and the health insurer Aetna.

Lang, who once worked for Express Scripts, said this consolidation changes the way the PBMs think about the industry. “Contracts now are so vague that nobody actually knows what the contract says anymore,” she said. “Even those of us who have written contracts for years can’t even interpret them.” 

For example, Lang said, “brand” and “generic” are not defined in these contracts even though FDA approves drugs based on standard definitions. “It’s anything that PBM wants it to be,” she said. “They can take a generic drug and classify that as a brand where you’ll have a higher copay. And they can take a brand drug and classify it as generic, so you’ll have a lower copay, depending on what benefits them the most. This is horrible for the pharmacies, because pharmacies never know how they’re going to get paid.”

She said there has been a slow erosion of clarity overtime in an effort to protect earnings.

“It used to be that when we put a new program in place, we made sure it benefited both our clients and the consumers and that neither were harmed,” she said. “That has gone out the window.”

Additionally, Lang said rebates that PBMs get from manufacturers are not passed along to consumers. This is especially important as more specialty and high-cost therapies have been approved.

Although nine out of 10 prescriptions filled are for generic drugs and less than 2% of the population uses specialty drugs, they now account for more than half of all drug spend. PBMs and insurance companies have developed many strategies to manage specialty drugs, including using prior authorization and other utilization management tools, placing these drugs on higher tiers on the formulary, and asking patients to pay a higher co-pay.

“This has opened the door to GoodRx and others to say if you pay cash, you can get a better price,” Lang said. “Something’s wrong with that picture. If you’re paying premiums to have insurance, and you can get a drug cheaper without insurance, there’s something completely wrong with the economics of this industry. There’s a misalignment going on here.”

The integration of PBMs/healthcare companies and the changes in PBM strategies come at the same time that shifts happening on the consumer end are making it difficult for patients to access the care they need. One such trend is the increased use of high deductible health plans. From 2009 to 2020, the percentage of workers at all firms enrolled in plans with a deductible of more than $1,000 has risen from 17% to 47%, 

 to the Peterson-KFF Health System Tracker. In smaller companies of three to 199 employees, the percentage of workers in these plans was 34% in 2009 and 57% in 2020.

Although premiums in these plans can grow more slowly, consumers face higher out-of-pocket costs. “Families may not be able to afford high deductible plans, so they go later to the doctor, or they won’t take all their medicines,” Lang said.

The Commonwealth Fund’s Biennial Health Insurance Survey from 2020 

 that deductibles have grown faster than incomes, and people who get coverage through the Affordable Care Act marketplaces are more likely to face deductibles that are higher relative to their incomes than those in employer plans.

Another significant shift is the growth of the gig economy, placing more pressure on the marketplace,” Lang said.

People working in nontraditional, short-term or contract work may not have health insurance, or they may buy insurance through the ACA marketplaces or from online companies offering short-term plans that may leave them underinsured. Unlike plans offered through the ACA, these short-term plans may have pre-existing condition clauses and may not guarantee renewal.

 to Pew Research Center in a December 2021 survey of people who work for platforms such as Uber, TaskRabbit, or DoorDash, 16% of Americans earned money in. About 30% of those surveyed said this was their main income. And

 to Statista, 24% of full time freelancers purchased insurance on their own.

These structural changes, Lang said, are likely to lead to a vastly different healthcare market in the future, Already, she said, we are seeing nontraditional entrants in the marketplace such Amazon and Mark Cuban Cost Plus model for prescription drugs. She said there is a lot of private equity money working to develop new technology solutions and new innovations.

Amazon in 2018 acquired the online pharmacy PillPack and now delivers prescription through Amazon Pharmacy. And just recently Amazon agreed 

 One Medical, a primary care organization, for about $3.9 billion. This proposed acquisition is not without controversy, with concerns about privacy, and Amazon could find it difficult to make a profit in primary care.

But One Medical uses a subscription-based model for providing primary care in 12 markets, as well as through virtual care.

Lang suggests we will likely see more subscription-based models and other innovations in the pharmacy space as well to address some of the misalignments. “Consumers can budget for this without these big out-of-pocket expenses. One of the problems is a lack of transparency especially with the high deductible plans. Consumers go to the pharmacy or the doctor, they don’t know what it’s going to cost until they get there.”

Susan Lang, CEO and founder of XIL Health, talks about the shifting trends and pressures that have led to a misalignment between the PBMs, their clients and consumers.

FTC’s PBM Investigation Could Lead to Unintended Consequences

 to pharmacies abiraterone 250 mg for $160 per bottle of 120 tablets, which is typically a month’s supply . CivicaScript recommends that pharmacies charge patients no more than $171 per bottle (CivicaScript’s maximum retail price).

This is significantly less than prices offered at many pharmacies, according to 

. The lowest GoodRx price for the most common version of abiraterone is around $187.00, 96% off the average retail price of $5,024.47.

Abiraterone is hormone therapy that is used together with prednisone to treat patients with metastatic prostate cancer. Its branded counterparts include Janssen’s Zytiga, which is available as 250 mg or 500 mg tablets, and Sun Pharma’s Yonsa, which is available as a 125 mg tablet.

Initially, CivicaScript’s abiraterone will be available through Lumicera Health Services, a specialty pharmacy that focuses on medicines for chronic and serious conditions, and through Intermountain Healthcare. Additional pharmacies will be listed on the CivicaScript website as they come on board.

Starting in 2024, CivicaScript plans to distribute low-priced insulin. Civica is building a manufacturing facility in Petersburg, Virginia, and has entered into a co-development and commercial agreement with GeneSys Biologics for three insulin biosimilars: glargine, lispro and aspart (biologics corresponding to Lantus, Humalog and Novolog, respectively).Civica plans to set a recommended price to the consumer of no more than $30 per insulin vial and no more than $55 for a box of five insulin pen cartridges, a significant discount to prices charged to uninsured individuals today.

Related: Civica’s Allan Coukell Talks about Its Insulin Program

CivicaScript was co-founded in 2020 by Civica Inc., the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies to bring affordable versions of common but high-priced generic medicines to market.

Additionally, the pharmacy benefit manager Navitus Health Solutions last month

 it had joined CivicaScript as a founding member, offering CivicaScript’s products alongside other therapies, and members will be incentivized to use those.

“This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication,” Kim Keck, president and CEO of BCBSA, said in a statement.

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

Long COVID-19 a Priority for Biden Administration, Drug Developers

FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia

FDA Approves Myfembree to Treat Endometriosis

FTC’s PBM Investigation Could Lead to Unintended Consequences

CivicaScript Launches Generic Abiraterone