Month: January 2022

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

At the end of December, the FDA approved yet another biosimilar, Yusimry (adalimumab-aqvh) from Coherus Bioscience. Yusimry is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Yusimry is the seventh biosimilar to be approved for AbbVie’s blockbuster Humira (adalimumab).

This approval marks the thirty third (33) biosimilar in the US and the 7th biosimilar to Humira. None of the Humira biosims are currently available for sale in the US. Per the terms of its agreement with AbbVie, Coherus (as with the others) will launch in the U.S. in July of 2023.

Last year was a lean year for new biosimilar approvals….. only four products. That compares poorly compared with 2019 when 10 biosimilars were approved.

Pricing for Yusimry is unlikely to be released until the product is close to its 2023 launch date.

Last week the FDA approved a new ORAL therapy, Recorlev (levoketoconazole) from Xeris Biopharma Holdings, 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 is a rare disease and Recorlev was granted an Orphan designation. There are fewer than 20,000 individuals with a Cushing’s diagnosis in the US and fewer with the endogenous hypercortisolemia diagnosis. 

Xeris did not announce pricing for Recorlev. The therapy is a next generation version of ketoconazole (tablets), a relatively inexpensive drug but not indicated for endogenous hypercortisolemia. That being said, there are plenty of examples where the new therapy is priced well above its sister legacy formulation. Several therapies have been approved for Cushing’s in recent years and all are considered specialty therapies. 

Xeris did not announce distribution details for Recorlev, however, they have launched a patient support HUB which has all the hallmarks of using the specialty pharmacy channel. Recorlev will be available later in Q1-22.

Click here to access prescribing information

We are catching up on the wave of FDA approvals that happen in the waning hours of the year.

The FDA approved Apretude (cabotegravir), from Viiv, for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is an extended-release injectable suspension as a gluteal intramuscular injection only . It is first administered as two initiation injections one month apart, and then every two months thereafter (total of 6 doses in year 1). Patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Uptake has increased measurably since the introduction of Truvada, an oral medication also indicated for PrEP. However, compliance with the daily oral regimen has not been exemplary. It is believed that a periodic injection of Apretude will increase compliance rates.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. It appears that this testing requirement will mean that patients will be seeing a healthcare professional for the testing and injection.

Apretude has a list price of $3,700 per dose (or $22,200 per year, for six doses). By comparison, Truvada (brand) is priced at $21,000 per year. However, Truvada is also now available as a generic priced at a very low cost of $500 annually with a coupon.

Apretude is expected to ship to wholesalers and specialty distributors in early 2022.

In the final hours of 2021, the FDA approved a number of new drugs. One of these therapies is Adbry (tralokinumab-ldrm) from Leo Pharma. Adbry, an interleukin-13 antagonist, is indicated for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Tralokinumab is a human monoclonal antibody that inhibits interleukin-13 (IL-13), a cytokine which plays a key role in AD inflammation.

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

Leo Pharma did not announce pricing at this time.
ICER published the following price references (including their estimate for Adbry):
Tralokinumab (Adbry) — $25,700-$35,000 per year (estimate)
Abrocitinib — $30,600-$41,800 per year.
Olumiant — $24,400-$33,300 per year (US list price: $29,000)
Rinvoq — $30,400-$41,500 per year (US list price: $64,300)
Dupixent — $29,000-$39,500 per year (US list price: $41,800)

Adbry is supplied in 150 mg pre-filled syringes for Sub-Q administration. The initial dose of 600 mg (four 150 mg injections) is followed by 300 mg (two 150 mg injections) administered every other week.

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022. Given the size of the size of the potential patient population and that the other therapies in this segment are not in limited distribution, it is likely Adbry will not be launched through LD.

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LEO Pharma announces FDA approval of Adbry (tralokinumab-ldrm)

The first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

MADISON, N.J. — December 28, 2021 (BUSINESS WIRE)–LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4

“Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”

“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”

The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1

In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1

In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1

“Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control, but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. “Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”