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Lo and behold…… the FDA approved yet another biosimilar to Filgrastim.
This follow-on product joins two previously approved biosimilars to Neupogen and was christened Releuko (filgrastim-ayow) from Amneal Pharmaceuticals and Kashiv Biosciences. It is the first biosimilar for Amneal, which is in development of two additional biosimilars expected later this year.

Filgrastim-ayow is indicated for febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs, for expedited neutrophil recovery, related clinical sequelae and severe neutropenia.

However, Releuko comes with warnings and precautions such as fatal splenic rupture, acute respiratory distress syndrome, allergic reactions including anaphylaxis, myelodysplastic syndrome, thrombocytopenia, and serious reactions in patients with Sickle cell.

Releuko enters a competitive segment win the market against brand Neupogen and biosims Zarxio (approved 03/2015) and Nivestym (07/2018)and. Releuko pricing was not available at time of the announcement. By way of reference, the approved filgrastim biosimilars, both of which are available commercially, are priced at only ~15% discount to the brand.

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Kashiv, Amneal Receive First FDA Approval for Their Filgrastim Biosimilar

March 3, 2022 — Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022.

The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the third filgrastim biosimilar to be approved for the US market.

The product is also the first biosimilar to receive FDA approval for the Kashiv and Amneal teams and represents the first FDA biosimilar approval of 2022. The companies said that they expect to launch the product during the third quarter of 2022.

“The US approval of our first biosimilar is a very significant milestone for Amneal. Biosimilars represent the next wave of providing access to affordable medicines in the United States. We are building a global biosimilars business by leveraging partner assets to start and then leveraging our own key capabilities over time. Our goal is to become a meaningful long-term player in biosimilars,” said Chirag and Chintu Patel, co–chief executive officers of Amneal, in a statement.

The biosimilar will be used in patients with cancer undergoing chemotherapy who are at risk for developing febrile neutropenia, a common complication related to chemotherapy where the level of neutrophils in a patients’ blood stream are too low.

“It is a proud moment for the Kashiv team and our partners at Amneal to have our first biosimilar, Releuko, approved by the US FDA. Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. Kashiv aims to continue bringing high-quality biosimilars to the global markets over the coming years. I would like to extend a humble ‘thank you’ to our highly talented team, without whom this would not have been possible,” said Chandramauli Rawal, MBBS, chief operating officer for Kashiv, in a statement.

The companies are also working together to develop 2 other oncology biosimilars: a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin. They said they hope to launch them in 2022 and that both are under review by the FDA.

Releuko was approved for administration for intravenous and subcutaneous use, either as single-dose vials or prefilled syringes, both of which come in a 300-mcg/mL dose and 480-mcg/1.6 mL dose.

Under the agreement between Kashiv and Amneal, Kashiv will be handling the US launch and the manufacturing. In January 2021, Amneal and Kashiv announced an agreement under which Amneal would acquire a 98% interest in Kashiv’s specialty pharmaceuticals division. Kashiv Biosciences is headquartered in Piscataway, New Jersey, but has facilities in Chicago, Illinois. Amneal is based in Bridgewater, New Jersey.

Kashiv Biosciences was originally established in 2006 as Therapeutic Proteins, according to founder and consultant for the company, Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board. The company’s name was changed in 2014 to Adello Biologics and then to Kashiv Biosciences.

Skylar Jeremias, Center for BIosimilars

Only the second and third tier specialty pharmacies are crying in their beers last week. It comes on the heels of the FTC Commission’s deadlocked vote to study PBM practices that have had hugely negative financial impacts on those pharmacies. The deadlock effectively stalls any action on the issue. By contrast, the nation’s largest specialty pharmacies, mostly owned and operated by PBMs, sat silent….. to no one’s surprise.

Much has been written about the unfairness of the practice of assessing DIR fees….. so we won’t recap the nitty-gritty details. Curiously, the same big box SPs have been able to exempt themselves from paying these same fees. While relief from paying the DIR fees would be a boon to the SPs now paying fees, the issue is simply too mysterious for the general public to comprehend and ferment activism. In short, the PBM lobby was successful in burying the issue…. at least for the moment.

We expect the fight to go on.
It is lucky we don’t have a pandemic and an invasion to distract attention from this issue…. oh wait!

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FTC Votes Against Investigating PBMs’ Effects on Specialty Pharmacies

02/22/2022 — On Feb. 17, The Federal Trade Commission deadlocked on a vote to study pharmacy benefit managers (PBMs) and how their practices affect independent and specialty practices, effectively killing a probe that pharmacy and patient advocates have said is long overdue.

The 2-2 vote came after nearly two hours of testimony from numerous independent pharmacy representatives, who said PBM tactics—such as low reimbursement rates and affiliations with large retailers—have pushed many small practices out of business. No one testified on behalf of PBMs.

“After hearing hours of testimony by community pharmacists and patients, all of whom painted the same shocking picture about PBM abuse, and not a single witness there to defend the PBM industry, it is inexplicable that two members of the commission could vote against the study,” the National Community Pharmacists Association said in a statement. “We’re grateful to Chairwoman [Lina] Khan for bringing this issue to a vote. We will demand she do so again at the soonest possible opportunity. However, this is extremely disappointing.”

Pharmacy and patient advocacy groups have long called for the federal government to investigate PBMs, saying they have contributed to prescription price increases and fewer marketplace options.

For example, because PBMs set formularies, patient options for medications are limited, pharmacists say. They have also criticized spread pricing, and the growing trend among PBMs to move claims processing from the medication side to the pharmacy side, requiring more white and brown bagging.

In a blog post last week, JC Scott, the president and CEO of the Pharmaceutical Care Management Association, which represents U.S. PBMs, said PBMs “are widely recognized for negotiating directly with pharmaceutical companies to lower drug costs.”

“Through expertise, data, and technology, PBMs pave the way for a seamless pharmacy experience helping patients to get and stay on their medications and through the process, lead healthier lives,” he said.

Last week the FDA approved a new oral therapy, Pyrukynd (mitapivat) from Agios Pharma, to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency. PK is a disorder in which red blood cells are destroyed faster than they can be made.

PK deficiency is rare, with an incidence of three to nine cases per one million people. Best estimates are that PK deficiency affects approximately 3,000 people in the U.S. However, PK deficiency is often misdiagnosed or goes undiagnosed, making it difficult to determine its frequency in the general population.

Pyrukynd became the first FDA-approved medicine for the disorder. It is an inherited disease that can cause lifelong complications including gallstones, pulmonary hypertension, osteoporosis and more. Patients with PK deficiency have a range in severity of symptoms, which include fatigue, unusually pale skin, jaundice (yellowing of skin and eyes), shortness of breath, and a fast heart rate. Patients can also develop an enlarged spleen, too much iron in their blood from repeated blood transfusions, and gallstones (small deposits in the gallbladder or bile ducts).

Pyrukynd must be closely monitored for dose titration from 5 mg up to the maintenance dose of 50 mg over the first 3+ months of therapy.

Pyrukynd will launch at an annual price of $334,880, before insurer’s discounts.

Given its high cost and very small population in the US, it is highly probable that Pyrukynd will be placed into exclusive distribution with a specialty pharmacy.

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FDA approves treatment for anemia in adults with rare inherited disorder

February 17, 2022
Action
FDA has approved Pyrukynd (mitapivat) tablets to treat hemolytic anemia (a disorder in which red blood cells are destroyed faster than they can be made) in adults with pyruvate kinase (PK) deficiency.

Disease or Condition
PK deficiency is an inherited disorder that causes premature red blood cell destruction, which leads to anemia (a decreased number of red blood cells).

PK deficiency is rare. In clinical practice, its frequency is approximately three to nine cases per one million people. However, PK deficiency likely is misdiagnosed or undiagnosed, making it difficult to determine its frequency in the general population.

Effectiveness
The effectiveness of Pyrukynd was evaluated in two studies. One was a randomized, double-blind, placebo-controlled clinical study of 80 adults with PK deficiency who did not receive regular blood transfusions. The other was a single-arm study of 27 adults with PK deficiency who received regular blood transfusions. In these studies, patients received Pyrukynd up to 50 mg orally twice daily after an initial dose titration (adjustment) period. Participants received Pyrukynd for an average duration of about 24 weeks in the randomized study and an average duration of about 40 weeks in the single-arm study.

In the randomized study, the effectiveness of Pyrukynd was based upon hemoglobin response defined as a 1.5 g/dL or greater increase in hemoglobin concentration from the beginning of the study that was sustained at two or more scheduled assessments. Hemoglobin is a measure of the amount of red blood cells that are not destroyed. At the end of the study, 40% of participants receiving Pyrukynd had a hemoglobin response compared with no participants receiving placebo.

In the single-arm study, effectiveness was based on reduction in transfusion burden, defined as at least a 33% reduction in the number of red blood cell units transfused during the last 24 weeks of treatment compared with the historical transfusion burden on the individual participant (standardized to 24 weeks). Thirty-three percent of participants who received Pyrukynd met this reduction in transfusion burden, including 22% of participants who did not require any transfusions over the last 24 weeks of treatment.

Safety Information
Because of drug interactions, patients should either avoid using Pyrukynd with certain other medications or adjust the Pyrukynd dose. Abruptly stopping Pyrukynd could worsen premature red blood cell destruction. Patients should avoid suddenly stopping or pausing Pyrukynd and follow their health care provider’s instructions for discontinuing treatment.

The most common side effects of Pyrukynd are decreases in estrone and estradiol (types of the estrogen hormone) in men, increased urate (a type of salt in the body), back pain, and joint stiffness. The effects of Pyrukynd on estrone and estradiol could not be reliably assessed in women because of normal changes in these hormones during the menstrual cycle and use of hormonal contraception.

Designations
This application received orphan drug designation, fast track designation, and priority review.

Last week we sent you a review of an article detailing the creation of a network of alternate site infusion providers by AscellaHealth. On Friday we ran across the article below detailing a new program, Optum Specialty Infusion.

It is noteworthy that, while the approaches differ, both programs have the same goal…. to contain the skyrocketing cost of specialty infusions. Neither currently appear to rely on benefit changes to drive the change in utilization (at least yet).

Optum is going more high-tech. It appears that when requesting a prior authorization for infused drugs the prescribing physician is presented with a menu detailing the differences, across benefits, for infused medications for the specified indication/diagnosis. Since so many patients are shoulder coinsurance for infused medications, a shift in therapy can make a huge out-of-pocket difference for a patient. Also, patients have been known to skip scheduled infusions because they can’t handle their financial share.

It would be nice to know how much information is available to the physician at the time of processing the prior auth from the ‘menu’. We saw direct links to clinical studies and Journal articles on such platforms some years back when they were first being touted for Oncology. Such detail would further reinforce the selection of a lower cost drug. Also, a reference to ‘across benefits’ suggests that oral meds may be included in the menu. Last thought….. the Optum approach doesn’t shift where the therapy is delivered, which should create less conflict with hospital sites of service.

At this point Optum Specialty Fusion is available only to large health plans.

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Optum Launches Specialty Fusion to Simplify Specialty Care and Lower Costs

First-to-market solution helps health care payers manage the increasing cost of specialty medicines, delivering up to 17% savings across medical and pharmacy spend

February 17, 2022 — EDEN PRAIRIE, MINN. : Optum today announced the launch of Optum Specialty Fusion, a first-of-its-kind specialty medication management solution, to simplify care for patients with complex conditions and lower the cost of expensive specialty drugs.

With specialty drug costs projected to reach $505 billion by 2023, health plans and care providers are seeking ways to ensure people get the treatments they need more affordably. Using Optum’s data and clinical expertise, Specialty Fusion provides health care payers and care providers real-time insight into the most effective specialty treatment at the lowest cost to the patient. Results include a simpler experience for providers and faster treatment approvals for patients, while delivering 17% total cost savings in medical and pharmacy spend.1

“The average specialty patient sees more than five care providers per year, while taking more than 10 drugs on average. They often have to wait for multiple treatment regimens to be approved, and need better support navigating their treatment plan and health benefits,” said Kerri Tanner, senior vice president, Optum Rx. “We developed a new comprehensive, benefit-agnostic solution that supports streamlined treatment decision-making for care providers, helping patients get on their therapies faster, while driving down high costs.”

In line with Optum’s commitment to develop solutions that provide more transparency and better connect the pharmacy and medical benefits across health care, Specialty Fusion was designed to streamline and simplify the medication management process. Using Specialty Fusion, care providers can initiate the approval process for specialty drugs requiring prior authorization using a single portal. Treatment options are then compared against dozens of clinically appropriate, lower-cost options across benefits in seconds. Specialty Fusion eliminates the need for a cross-benefit prior authorization process – a burden for providers – and secures treatment approval in real time. This reduces administrative hassle and results in an expected 50% faster access to therapy for patients, while lowering costs.

For example, when a provider prescribes an immunosuppressive drug on the medical benefit, treatment may cost $1,200. Using Specialty Fusion, a provider can see coverage recommendations and select a therapeutically equivalent treatment for $700 less, on average. Informed by Optum data and insights, Specialty Fusion provides savings options such as preferred products, dosage management policies, best sites of care and additional cost-control levers such as available discounts and pharmacy networks [possibly AscellaHealth??].

“Managing specialty drugs at the earliest possible moment is critical to improving care, clinical outcomes and the patient experience,” said Sarah Dye, senior vice president, Optum Health. “Optum Specialty Fusion uniquely partners with the provider to change the status quo of prior authorization, reduce their administrative pain and ultimately help them provide better care for their patients.”

Payers have been struggling for years to move infusion site of care services out of higher cost hospital outpatient administration to alternate sites….. community physician offices or stand-alone infusion clinics. There is no debate that every patient so moved saves significant dollars with no loss in quality of care and, very often, greater patient convenience. That’s a Win-Win.

So, just like an improvement over sliced bread, AscellaHealth has come up with a bright idea….. create a network of non-hospital infusion providers that allows insurers to more readily push members into the lower cost network sites. It takes the PBM concept and significantly expands its functionality.

It will be interesting to see how benefit design can be crafted to fully complement utilizing the network. Assuming it gains traction, it could be a great model for the future.

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Ascellahealth Makes Case For Alternate Sites

HME News Staff

February 8, 2022 — BERWYN, Pa. – AscellaHealth has released a white paper that details the value of site of care (SOC) optimization for infusion therapies, a leading strategy for reducing the cost of specialty biologic medications, improving outcomes and enhancing access to more convenient, quality focused settings.

“Recognizing the importance of SOC optimization, AscellaHealth offers a Home Infusion Pharmacy Network as part of our overall strategy to cut costs without compromising quality of care,” says Dea Belazi, president and CEO, AscellaHealth. “Our pharmacy providers were chosen for their national reach, high-touch capabilities and thorough home infusion expertise, enabling care delivery in the highest-quality, lowest-cost care settings and enhancing outcomes via increased compliance rates.”

In the four-page paper, “Site of Care Optimization Lowers Specialty Drug Costs, Reduces Hospital Visits, Ensures Care Quality,” AscellaHealth makes the case that the exact same medications, administered using the same method, can be more than two- to three-times more expensive in the hospital setting vs. a standalone infusion center.

“Insurance companies, self-funded companies and other stakeholders will find significant value in applying a high level of expertise to the management of these specialty drugs by working with AscellaHealth and its partners in SOC optimization,” Belazi said. “Flexibility of alternate sites also contributes to a higher quality of life by improving patient access to care, reducing time away from work or school, and offering a degree of independence to patients living under otherwise rigid medical parameters.”

Is it the new ‘must-have’ in specialty pharmacy?
So it would appear……it’s an accreditation in Rare Disease Pharmacy.

A couple of years ago it was bragging rights to be able to say, “My specialty pharmacy is accredited as a Rare Disease Pharmacy.” Well, the numbers are starting to swell, and may eventually dilute that differentiation if too many SPs jump on that band wagon.

A quick Google search popped up 10 SPs that now have the RARE certificate on their lobby walls (from URAC or ACHC). These include Orsini, PantherRx Rare, Soleo Health, Fairview, Accredo, Premier, Vanderbilt, Perform, and Chemistry Rx…. there are likely more. But the number of SPs that are in now process or planning on going the rare route might be more telling.

We have huge admiration for SPs that get accreditation. We’ve guided literally dozens of SPs going through the SP accreditation process….. starting as early as the mid-1990s. The designation is a demonstration of the commitment to quality that every payer and manufacturer has come to regard as a gold standard in the industry.

Manufacturers are more likely to be impressed with the extra accreditation since virtually ALL rare therapies are launched through exclusive or limited distribution. URAC’s web site includes the following as a key benefit of a rare disease accreditation…. “[It] Elevates contracting power, credibility and differentiation over competitors as payers and stakeholders are assured of organizational competency.”

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Evernorth’s Accredo Earns URAC Rare Disease Pharmacy Center of Excellence Designation

BLOOMFIELD, Conn., Feb. 10, 2022 /PRNewswire/ — Accredo®, the specialty pharmacy subsidiary of Evernorth, Cigna Corporation’s health services business, was awarded URAC’s Rare Disease Pharmacy Center of Excellence designation. The URAC accreditation recognizes Accredo for demonstrating commitment to quality health services, patient safety and improved outcomes for patients living with rare diseases.

“The patients we serve are living with the most complex health issues and they deserve the highest quality of specialty care,” said Matt Perlberg, president, pharmacy businesses, Evernorth. “This accreditation is an important indicator of excellence and reflects our ongoing focus on improving health outcomes for patients with rare diseases.”

An estimated 25 to 30 million people in the U.S. suffer from a rare disease and approximately two-thirds are children. Accredo’s rare disease therapeutic resource center provides specialty pharmacy and in-home clinical care for patients living with 23 different rare diseases. The company’s care delivery team includes approximately 500 specialist pharmacists and 600 field-based nurses as well as social workers and dieticians. Accredo has already earned URAC Specialty Pharmacy Accreditation, effective through January 1, 2024.

“Pharmacies and related pharmaceutical services play a critical role in the health care delivery system now more than ever. Given the complicated nature of chronic disease, pharmacies like Accredo do much more than simply fill a prescription. As trusted experts at the frontline of care delivery, they often provide targeted patient support and education to ensure proper medication management,” said URAC President and CEO Shawn Griffin, M.D. “By achieving URAC accreditation, Accredo demonstrates excellence in quality care delivery and their long-term commitment to ensuring patient safety and improving outcomes.”

Curiouser and curiouser…..

There was a time when PBMs condemned the use of Rx discount coupons saying that doing so upsets the delicate balance of reimbursement set by the great minds within the same PBMs.

Well, as Bob Dylan sang, The times they are a changing.

Express Scripts (ESI) now appears to be embracing the concept of Rx discount coupons. They have come to realize that they are losing volume/$$ when consumers access the discounts offered by GoodRx, for example. As we now know, those consumers can save significant out-of-pocket bucks….. even if the spend doesn’t count against their deductible. ESI has partnered with Amazon’s Rx discount card to power the program.

ESI also seems to be in a generous mood.
They say that they will apply those discounted transactions against members’ deductibles and per the member’s benefit.

Is this a PBM gettin’ religion? Maybe not.
It is presumed that ESI will be able to still qualify for a rebate on the transactions that it processes.

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Express Scripts Will Combine Coupons With Pharmacy Benefit

Express Scripts, the PBM subsidiary of Cigna Corp., will allow members to combine prescription drug coupons with their traditional pharmacy benefits. Pharmacy insiders tell AIS Health that the new offering is likely meant to head off competition from GoodRx Inc. and other upstarts.

Program Expands on Cigna’s Amazon Partnership
“Right Price alleviates the need for a member to price shop, and allows for the medication purchase to apply toward their deductible, if they have one,” writes Matt Perlberg, Express Scripts’ senior vice president for supply chain, in a November blog post about the program. He adds that “the claim is processed within the benefit” and “Right Price also allows members to leverage discount card pricing at our industry leading Express Scripts Pharmacy.”

In addition, members using Right Price have access to Amazon.com Inc.’s discount card as part of “our newly expanded relationship with Amazon.”

Is the New Product Just Branding?
Elan Rubinstein, Pharm.D., principal of EB Rubinstein Associates, panned the concept. He suspects the offering is simply a play to ward off GoodRx. “It seems to be a branding exercise,” Rubinstein wrote to AIS Health, a division of MMIT, in an email. He suggested the reason for the product is “perhaps there would be a cost to Express Scripts” if it created a formal arrangement with GoodRx.

“They’re losing customers to GoodRx,” says Ge Bai, Ph.D., a professor at Johns Hopkins University’s schools of business and public health. “Not just Express Scripts — these PBMs are seeing some of their insured patients go to GoodRx to use the cash price — the so-called cash price.”

Express Scripts Seeks to Retain Rebates
“The problem [for Express Scripts] is these patients….They’re bypassing their PBM. So I think this is related to that concern,” Bai explains. She also thinks the partnership with Amazon is significant — in her view, Express Scripts would rather split discount card revenue with Amazon than lose it altogether.
Bai thinks this arrangement could wind up costing plan sponsors. “If they go to GoodRx, the employer doesn’t pay anything,” she says. However, by combining coupon savings with a normal rebate arrangement, Express Scripts still gets its normal cut of the rebate but slightly discounts the cost to the consumer at the point of sale.

by Peter Johnson, Radar on Drug Benefits

We are always on the hunt for stories and events that can be impactful on the specialty pharmacy segment. The story below recently crossed out path and poses some interesting applications.

When you run out of new services to offer your specialty patient with insurance, what else can do you do to keep them connected? How about giving them something that helps them with non-insured services? As detailed below, Hy-Vee Pharmacy has launched such a program, one which their specialty patients may like too.

The recently formed a new subsidiary called RedBox Rx. RedBox Rx doesn’t accept health insurance….. but patients can use HSAs or FSAs to pay for telehealth visits or prescription drugs and other treatments. But it doesn’t stop there.

A telehealth feature and online pharmacy platform are part of the offering. Telehealth has been tried by health care providers in the past but saw relatively slow uptake. It experienced a big leap forward in the past year+ during the pandemic. Connecting customers with the Hy-Vee brand is a logical gateway to build what the marketing folks call brand loyalty.

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Hy-Vee forms telehealth, online pharmacy subsidiary

Dec 14, 2021 – Midwestern food and drug chain Hy-Vee has launched RedBox Rx, a new subsidiary that provides low-cost telehealth and online pharmacy services nationwide.

Hy-Vee said Tuesday that, to keep prices low and “save patients the hassle,” RedBox Rx doesn’t accept health insurance, but patients — who must be ages 18 and older — can use health savings accounts (HSAs) or flexible spending accounts (FSAs) to pay for telehealth visits or prescription drugs. Prescribed treatments are shipped free directly to patients’ homes throughout the United States.

RedBox Rx provides telemedicine services through a partnership with Austin, Texas-based Reliant Immune Diagnostics, which operates the MDbox e-health care platform Hy-Vee said the MDBox technology integrates with RedBox Rx.

Hy-Vee noted that RedBox Rx bypasses insurance as a way to provide fast, convenient and affordable care from health professionals who also can prescribe prescription medication.

“We pride ourselves on being experts in health and wellness, and it’s a major component of what we do every day, whether it be in our retail pharmacies or through our dietetic services,” Hy-Vee Chairman and CEO Randy Edeker said in a statement. “In today’s world, we know that more people are looking for quick, convenient and personalized health care options that can be shipped directly to their homes, and RedBox Rx does exactly that.”

Health care services and treatment plans available from RedBox Rx include men’s health, women’s health, hair and skin, mental health, migraine headaches and common illnesses and ailments, such as allergies, gastrointestinal issues, headaches (including migraine), sinus pressure and infection, nausea and vomiting, and pink eye.

According to Hy-Vee, telehealth consultation fees from RedBox Rx range from free to $39, depending on the type of treatment, and often cost less than typical medical insurance co-payments. The company added that RedBox Rx is also offers a complementary/alternative health care option that businesses can share with their employees, at no cost to the employer.

“Our mission at Reliant Immune Diagnostics with our MDbox platform is to provide affordable health care any place, any time,” stated Henry Legere, founder and CEO of Reliant Immune Diagnostics. “We’re excited to partner with Hy-Vee to provide our nationwide network of 24/7/365 medical professionals and our technologies to support their vision for the future of health care.”

Health care is a pillar of Hy-Vee’s offering, and the company has steadily expanded its array of services. In August, the grocer unveiled Hy-Vee Medicare Aisle, an agency offering Medicare coverage plans. The company’s in-store and freestanding pharmacies already provide a full range of pharmacy care, immunization and wellness services. In addition, Hy-Vee has more than 70 in-store retail health clinics; owns and operates two specialty pharmacies, Amber Pharmacy and Hy-Vee Pharmacy Solutions; and in late 2020 launched its own pharmacy benefits manager (PBM), Vivid Clear Rx.

Overall, Hy-Vee generates annual sales of over $12 billion and operates more than 280 stores in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin.

by Russell Redman, Supermarket News

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are two LD deals that have been recently publicly confirmed subsequent to the approvals.

Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions Selected to Dispense TEZSPIRE™ (tezepelumab) for the Treatment of Severe Asthma
OMAHA, Neb.–(BUSINESS WIRE)–Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions announce today that they are now dispensing TEZSPIRE™ (tezepelumab), the first biologic to significantly reduce exacerbations in broad populations of patients with severe, uncontrolled asthma. TEZSPIRE™ is a collaborative product, developed and manufactured by Amgen and AstraZeneca.

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PANTHERx Rare® Selected by Xeris Pharmaceuticals to Distribute Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome
PANTHERx Rare announces that it has been selected by Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc., as the exclusive U.S. pharmacy distribution partner for a new FDA-approved medication, Recorlev® (levoketoconazole). Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Cushing’s syndrome, a disease associated with increased production of cortisol, occurs most commonly in adults between ages 30-50 and affects women two times more often than men.

The FDA just approved not ONE, but TWO therapies in the already crowded immunology category.

The two include a new NDA for Cibinqo (abrocitinib) from Pfizer and an expanded indication for well established Rinvoq (upadacitinib).

Let’s look first at Cibinqo —

The FDA approved Cibinqo (abrocitinib) from Pfizer, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Cibinqo is a once-daily oral. Like its leading competing therapies, it is a Janus kinase 1 (JAK1) inhibitor. Cibinqo is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.
Cibinqo comes with a boxed warning due to observed risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB), a higher rate of lymphomas and lung cancers, cardiovascular death, myocardial infarction, thrombosis, and stroke.

CIBINQO is not approved for use in RA patients.

Pfizer did not announce distribution details. Given the black box warning and the expected cost for Cibinqo, one might expect that it will launch through specialty pharmacy limited distribution. However, Rinvoq is not in limited distribution.

So what about Rinvoq?

Rinvoq was granted an expanded indication for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD). Since its original approval in 2019 for RA. Rinvoq has since established a strong niche in the marketplace. Efficacy between Cibinqo and Rinvoq are comparable. However, Rinvoq’s approval included children 12 and over (vs. Cibinqo’s approval for adults only) although it also carries a black box warning. 

Oh, and what about Adbry? 

Just last month the FDA approved yet another JAK1 inhibitor therapy, Adbry, also with the AD indication. However, Adbry is an injectable, which may hinder its uptake vs. the newly approved Cibinqo and the newly upgraded Rinvoq….. (both Cibinqo and Rinvoq are orals).

Atopic Dermatitis – 

There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease

What about COST? 

Pricing for Cibinqo was not announced at the time of approval. Various sources suggest the following anticipated price ranges for the leading competing products. 

• Cibinqo       — $35,000-$42,000 per year (estimate) for AD
• Adbry         — $35,000-$40,000 per year (estimate) for AD
• Olumiant    — $24,400-$33,300 per year (US list: $29,000, limited distribution) for RA
• Rinvoq        — $30,400-$41,500 per year (with GoodRx coupon $5500/mo.) for AD and RA
• Dupixent    — $29,000-$39,500 per year ($5300 month, limited distribution) for AD, subQ

CLICK HERE to access Cibinqo prescribing information https://cdn.pfizer.com/pfizercom/USPI_Med_Guide_CIBINQO_Abrocitinib_tablet.pdf

CLICK HERE to access the Pfizer press release for Cibinqohttps://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults