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FDA Approves 1st in Class IV Tx for Cervical Cancer – Tivdak

Earlier this month the FDA approved a new Infused therapy, Tivdak (tisotumab vedotin-tftv) from Seagen Inc., for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak is expected to meet the unmet needs of patients with recurrent or metastatic cervical cancer.

Tivdak is a first-in-class antibody-drug conjugate (ADC) that targets tissue factor to induce cancer cell death. The labeling for Tivdak included a boxed warning related to ocular toxicity.

The wholesale acquisition cost (WAC) for Tivdak is $5,885 per 40mg single dose vial. Patient cost is dependent on body weight and duration of therapy. The company estimates an average WAC per patient per month of $34,000, before discounts or rebates. Distribution details were not announced as of this date.

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396). Efficacy was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Sixty-nine percent of patients had received bevacizumab as part of prior systemic therapy. Patients received tisotumab vedotin-tftv 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity.

The main efficacy outcome measures were confirmed objective response rate (ORR) as assessed by an independent review committee (IRC) using RECIST v1.1 and duration of response (DOR). The ORR was 24% (95% CI: 15.9%, 33.3%) with a median response duration of 8.3 months (95% CI: 4.2, not reached).

The most common adverse reactions (≥25%), including laboratory abnormalities, were hemoglobin decreased, fatigue, lymphocytes decreased, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, leukocytes decreased, creatinine increased, dry eye, prothrombin international normalized ratio increased, activated partial thromboplastin time prolonged, diarrhea, and rash. Product labeling includes a boxed warning for ocular toxicity.

The recommended dose is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.


FDA Approves 1st in Class ORAL Tx for NSCLC Subset – Exkivity

Earlier this month the FDA approved a new ORAL specialty therapy, Exkivity (mobocertinib) from Takeda Pharmaceutical, for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) with a specific mutation after platinum-based chemotherapy. A next-generation sequencing companion diagnostic test was approved simultaneously to confirm the genetic mutation.

Exkivity was approved on an accelerated basis following Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years.

A Black box warning was also issued as part of the approval. Exkivity can cause life-threatening heart rate-corrected QT (QTc) prolongation, a rare but serious condition. Dosing instructions indicate drug reduction or a full withhold based on side effects and/or adverse events.

Takeda has not released the cost of Exkivity at this time. While the company did not announce plans for distribution, one specialty pharmacy, Onco360, subsequently issued a press release confirming that they were selected as a limited distribution partner for the new therapy.

Takeda’s Exkivity (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC

September 15, 2021 — OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Exkivity, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

“Patients with EGFR Exon20 insertion+ NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed, but also lacking targeted treatment options that can improve response rates”

“The approval of Exkivity introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer,” said Teresa Bitetti, president, Global Oncology Business Unit, Takeda. “Exkivity is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community.”

The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for Exkivity to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is critical for these patients, as it can enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions.

“EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” said Pasi A. Jänne, MD, PhD, Dana Farber Cancer Institute. “The approval of Exkivity (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”

“Patients with EGFR Exon20 insertion+ NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed, but also lacking targeted treatment options that can improve response rates,” said Marcia Horn, executive director, Exon 20 Group at ICAN, International Cancer Advocacy Network. “As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy.”

The FDA approval is based on results from the platinum-pretreated population in the Phase 1/2 trial of Exkivity, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase 1/2 trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months per IRC.

The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The Exkivity Prescribing Information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

For more information about Exkivity, visit For the Prescribing Information, including the Boxed Warning, please visit


Walgreens Ponies Up Nearly $1 billion for Shields Health

Frequent readers of this report know that one of our favorite topics is health-system-owned specialty pharmacies. So, it was with great interest that we read the press release detailing that Walgreens (WAGS) has increased its stake in Shields Health Solutions to 71% for a total of $970 million.

Readers should recall our January 2021 report detailing Shields’ acquisition of ExceleraRx for an undisclosed amount. ExceleraRx, like Shields, had built a large network of 25 healthcare-system-owned specialty pharmacies. In combination, the expanded Shields network topped 65 hospitals and was forecast to reach $2 billion in specialty network revenue this year….. enough volume to really start impressing payors and manufacturers.

We continue to be puzzled about both the earlier WAGS investment and this week’s doubling down. So, the big question is…. “Where does Shields earn the kind of $$$s to justify nearly a $1 billion investment?”

Shields (as with ExceleraRx) only offers hospitals a service. They build, operationalize and optimize integrated specialty pharmacies. They then can be hired to provide day to day management of the pharmacy. They also promote the SP network to payers to gain pharmacy provider contracts and to manufacturers to gain access to LD drugs.

Shields Health is not listed as a pharmacy license holder by the several state Boards of Pharmacy which we checked today. Rather, the hospitals that they represent in those states hold the community retail pharmacy licenses. So, the money paid for prescriptions dispensed by these hospital pharmacies goes to the hospitals, not Shields.

Little is known about the Shields financial model. Hospitals have a huge advantage as they can acquire drugs under the least expensive hospital-class-of-trade rates. We already know about the price advantages they have under 340b. So, there is a boodle of $$s that a hospital can pay to Shields for managing their specialty pharmacy and running the national network on their behalf. Consider that the valuation of a PBM is calculated in a not too dissimilar fashion.

What does Walgreens see in Shields?
In 2019 WAGS likely saw the writing on the wall….. that hospitals would eventually wise up and open their own specialty pharmacies to recoup lost revenue. WAGS has a history of working with hospitals opening a number of on-campus pharmacies in recent years. The Shields model fit that strategic mindset…. which likely prompted the initial investment. The ExceleraRx acquisition gave the model some serious traction, so this week’s move is less surprising. Last thought…. tactically, WAGS has ensured that they will be at the table with many very influential hospitals, payers, and manufacturers. That’s a good place to be. Just sayin’

Walgreens makes $970 mm investment in specialty pharmacy company Shields Health

Sept 21 (Reuters) – Walgreens Boots Alliance is spending roughly $970 million to acquire a majority stake in Shields Health Solutions to expand its specialty pharmacy business, the companies said on Tuesday.

The investment brings Walgreens’ total stake in Shield to 71%, and the company has an option to acquire the remaining equity interests in the future. The Illinois-based company had taken a minority stake in Shields in 2019.

Founded in 2012, Shields Health Solutions helps hospitals provide specialty pharmacy services.

Specialty pharmacies are designed to deliver medications with unique handling, storage and distribution requirements, often for patients with complex conditions such as cancer, multiple sclerosis or rheumatoid arthritis.

“We’re continuing to make strategic investments in pharmacy and healthcare solutions that can build on our core pharmacy business… The Shields model has shown to improve patient care, and will be complementary to our existing specialty pharmacy offering,” Chief Executive Officer Roz Brewer said in a statement.

The transaction is expected to close by the end of the fiscal second quarter of 2022 and is projected to be modestly accretive in the first full year after completion.


FDA Approves Biosimilar to Lucentis – Byooviz

The FDA approved a new intravitreal injection this week, Byooviz (ranibizumab-nuna) from Samsung Bioepis, as the first ophthalmology biosimilar in the United States. It references brand name Lucentis from Genentech/Roche. Indications include Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).

Byooviz (ranibizumab-nuna) is Samsung Bioepis’ fifth biosimilar approved in the U.S., following the approval of Renflexis (04/2017), Ontruzant (01/2019), Eticovo (04/2019), and Hadlima (07/2019).

How big is the specialty Ophthalmology segment?
— Eylea US sales in 2020: $4.95 billion, ex-US sales: $3 billion.
— Lucentis US sales in 2020: $1.3 billion, ex-US sales: $1.93 billion

Who is developing competitive biosimilars?
— Eylea: Celltrion Healthcare, Alteogen, Sandoz
— Lucentis: Boan Biotech, Formycon, STADA Arzneimittel/Xbrane
— Avastin/bevacizumab: Outlook Therapeutics

The cost of Byooviz was not announced by Samsung Bioepsis. By way of reference, the cost of Lucentis and Eylea is currently between $1,800 and $2,000 a dose and the new biosimilar should drive a 20-30% price reduction. Byooviz will be commercialized by Biogen in the United States. Distribution details were not announced, but it is expected that Byooviz will launch through limited distribution as with Eylea and Lucentis.

FDA Approves Samsung Bioepis and Biogen’s Byooviz, Lucentis Biosimilar (ranibizumab-nuna)

Byooviz becomes the first ophthalmology biosimilar to gain FDA approval in the United States

INCHEON, Korea and CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab)i for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the United States.

“In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the U.S. is a monumental milestone for people living with retinal vascular disorders in the U.S.,” said Kyung-Ah Kim, Senior Vice President and Development Division Leader, at Samsung Bioepis. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world,” she added.

“We are very excited to be able to open a new chapter with the approval of Byooviz in the U.S. This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the U.S.,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “Biosimilars could help broaden patient access to more affordable treatments and generate healthcare savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems.”

In addition to the U.S. approval, Byooviz was approved in Europe, including 27 European Union (EU) member countries on August 18, 2021 and the United Kingdom on August 31, 2021.

The FDA approval of Byooviz was based on a totality of evidence including analytical, non-clinical data, and clinical data. In a randomized, double-masked, parallel group, multicenter Phase 3 study of SB11, the efficacy, safety, pharmacokinetics, and immunogenicity of SB11 was compared to reference ranibizumab in patients with wet AMD. 705 patients were randomized (1:1) to receive SB11 or reference ranibizumab in monthly injections (0.5 mg), and 634 patients continued to receive treatment up to week 48. The Least Squares (LS) mean change in best corrected visual acuity (BCVA) from baseline at week 52 was 9.79 letters for SB11, compared with 10.41 letters for reference ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in central subfield thickness (CST) was −139.55 μm for SB11 vs −124.46 μm for reference ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). PK, safety including incidence of treatment-emergent adverse events, and the immunogenicity profile of SB11 and reference ranibizumab were comparable at all timepoints up to week 52.


FDA Approves IV Tx for Dialysis Related Puritus – Korsuva

The FDA recently approved Cara Therapeutics’s infused drug, Korsuva (difelikefalin), to treat puritus (moderate-to-severe itching) in patients with chronic kidney disease (CKD) undergoing dialysis. It is the first targeted therapy to effectively treat the condition in the United States. Korsuva will be commercialized jointly by Cara and Vifor Pharma.

Korsuva is administered 3X weekly following dialysis. Korsuva reduces sensory nerve response that relays itching from the skin to the brain. Many chronic kidney disease CKD patients with persistent itching currently take depressants, barbiturates, or allergy medications / antihistamines with limited relief.

Cara said that Korsuva will be priced at ~ $17,000 annually. Analyst estimates suggest that Korsuva will garner about $100 million 2022 and grow to about $250 million within the next five years.

Product launch is scheduled for the first quarter of 2022. Details related to distribution were not released. Given the relatively small patient forecast and the site of administration (dialysis clinics) it is likely that Korsuva will be available through traditional distributor channels.


Are Your High-Tech Patient Communication Efforts Working?

Virtually everyone in specialty pharmacy realizes that good patient communications are key contributing factors to improved outcomes. However, the industry has grappled with how to best communicate with patients with many well-intentioned initiatives withering on the vine. Numerous high-tech efforts, such as smart phone apps, have also been tried with mixed results. Let’s not forget that these tech driven initiatives can also be expensive. None the less, the article below is a reminder that….. If at first you don’t succeed, try, try again.

WellDyne (the PBM) presented recently at the 2021 Pharmacy Benefit Management Institute Annual National Conference on the topic of high-tech patient engagement. It seems that they’ve taken patient communications to the extreme by grouping patients using “psychographic segmentation”. Patients were slotted into five groups: direction takers, balance seekers, priority jugglers, self-achievers, and willful endurers. Presumably, the messaging they developed is tailored to each segment and then ‘combobulated’ into a tech delivery utility. I am not saying that this is wrong in any way, but one gets the sense of the difficult currents a specialty pharmacy might need to navigate to achieve such targeted patient engagement.

Of the few examples included in the article, one warrants positive mention….. the concept of a tailored, tech-driven intervention at the 14-day mark following therapy initiation to review side effects. We’ve not heard of any specialty pharmacies going the high-tech route. The timing makes sense….. and the outreach would be clinically justified. Patients that reply to an easy ‘click on all that apply’ list of side effects and acute events (AEs) could be easily flagged for a clinical intervention and could also generate actionable, therapy-specific findings.

High-tech tools engage patients and result in better outcomes

The use of high-cost specialty drugs has put pressure on health plans and PBMs to better manage the pharmacy benefit, and innovative strategies are needed to deal with costs while also meeting patient needs, according to a presentation today by WellDyne executives at the 2021 Pharmacy Benefit Management Institute Annual National Conference

September 14, 2021 — David Skomo, RPh, senior vice president and chief pharmacy operations officer, and Nick Page, Pharm.D., chief pharmacy officer, discussed how approaches that take into account patient preferences can lead to better care and a lower cost trend.

“We’ve built high-tech interventions into our patient care model,” Skomo said. “Providing a variety of options for the patients and how they participate with us empowers patients to take charge of their healthcare. Maybe even more importantly, it encourages patients to partner more closely with the healthcare provider team.”

Technology that supports a two-way flow of information can provide a more holistic view of patient health and behavioral patterns. But the channels need to be personalized and provide patient support to increase adherence and satisfaction, the presenters said.

WellDyne has a care model that provides patients with a wide variety of options and communication channels to participate with the organization, including self-serve options through the telephone as well as a healthcare portal, Skomo said.

Skomo discussed Welldyne’s efforts to tailor it messaging to patients grouped by “psychographic segmentation” and motivate the accordingly. The company has grouped patients into five groups: direction takers, balance seekers, priority jugglers, self-achievers, and willful endurers. Skomo stressed the importance of “marrying” the communication channel with these patient tendencies to motivate people to stay adherent.

“We’ve taken the technology to the next level and introduced digital capabilities through text messaging,” he said. “We can send a request to patients via text asking them to take action — for example, filling a prescription. By deploying that technology, along with additional communication channels, we provide convenience for the patient.”

Page reviewed some of the overall consequences of nonadherence, which he said includes 125,000 death per year and $600 billion in costs. Page said WellDyne’s efforts to more carefully monitor patients and meet their needs results means the company has been successful in lowering specialty drug cost increases to 5%-6%, lower than the industrywide increases of 10%-20%.

WellDyne’s “push technology” has been useful during the COVID-19 pandemic because patients are using drive-through and mail order services more often, Page added. “Many pharmacies are reducing staff, which makes it very difficult for the consumer to be able to access a pharmacist to ask questions,” he said. “Patients may not feel comfortable asking a pharmacist a question with a lot of other people around.”

WellDyne clinicians use digital tools to send out patient assessment questionnaires, Skomo said. “We find that the patients are much more likely to provide responses to those types of assessments,” he said. “It’s not us calling them. Patients can use their smartphones to provide those responses very easily at a time and place most convenient for them.”

Patients, Skomo said, engage with the organization more frequently now because of the digital services. “That allows us to derive much more valuable insights and paints a more robust picture of care for that particular patient.”

Patient adherence has increased since WellDyne began using the digital technology; in fact, according to Skomo, medication adherence rates have increased 36%.

The technology is also driving savings for both the consumer and the plan. “Some of our outreach messages are related to educating members about their health, about their benefit and about lower cost options,” Page said. “We’re able to provide information to the consumer about options they have. But it’s not just about product selection; it’s also about educating patients or reminding them that they have a mail-order benefit.”

Part of the communications includes a follow-up 14 days after a patient starts a new therapy to educate that patient about possible side effects. This, Page said, helps with medication adherence.

WellDyne also provides education related to a patient’s disease or condition through digital channels.

“During Diabetes Awareness Month, for example, we’ll do a lot of campaigns and communications to educate possible undiagnosed diabetics about the risk and provide some short online screening tools to help them know whether they might be at risk,” Page said.

Consumers, Skomo said, are hungry for information. “The push technology tends to get read almost immediately,” he said. “We see much better engagement with that than we typically do with emails or print media mailed to the home.”

But patient communication is not one-size-fits-all. “We make it easy and convenient for patients to engage, but the context of the message, as well as motivating a patient to take action, is very important,” Page said.

Skomo noted that many specialty patients don’t want payers and PBMs communicating with them so often and just want to be left alone. “If we make it easy for patients, they don’t feel like we are a bother.”


What’s Your Value Based Contracting Knowledge Level?

We’ve written numerous times about value-based contracting (VBC). When it emerged a few years ago there was much hope that it would offer some remedy to the acceptance of ultra-high cost therapies that have been the predominant source of new specialty FDA approvals for the last few years. However, relatively few VBCs have been implemented due to their complexity.

Value methodologies have begun to morph. In fact, the term ‘value-based contracting’ is now a bit too high level. Are you familiar with the nuanced differences between value-based pricing (VBP), value-based insurance design (VBID), long-term financing (LTF), and outcomes-based contracts (OBCs)? If not, the time may be neigh to get up to speed.

We ran across an abstract (below) that does a very nice job of taking our understanding of VBC to the next level. It summarizes the views of 22 health plans with multiple lines of business collectively covering more than 34 million beneficiaries. These plans are large enough to have dipped their toes into the VBC pond and/or thought long on the inherent challenges.

The initiative identified four business objectives including access to new therapies, their rising costs, spending variability across the patient spectrum, and the incidence of reduced levels of clinical evidence. Additionally, the initiative selected five operational strategies including developing new UM controls, the need for increased patient engagement, including providers in the risk sharing methodologies, expansion of data analytics unique to each contract, and the need to staff more pharmacists, statisticians, and data scientists to be experts in the unique aspects of managing each contract.

The contracting world is less and less satisfied with rebates and is looking for something else to fuel the specialty pharmacy engine. VBC is a no brainer IF design and implementation can be refined. So, if you want to keep abreast of that trend, consider the lessons offered.

CLICK HERE to access the full abstract.

Value-Based Management of Specialty Drugs: Practical Considerations and Implications for Pharmacy

May 13, 2021 — Policy makers and health plans seek value-based management of specialty drugs. This study examines real-world factors that favor some approaches over others and their potential impact.

Objectives: Concerns about high and rising drug prices have prompted a call to manage prescription drugs according to their value. Although not all proposals referred to as “value based” are well suited to advance this mission, health plans must select among them under the influence of competing demands and constraints of their market and nonmarket environments. To understand the implications for health policy, we sought to explore how health plans might select among and implement these approaches for specialty pharmacy (SP) under the incentives and barriers that these conditions create.


Update on Limited Distribution Partners for 5 New Therapies

We’ve often complained that the names of specialty pharmacies selected as limited distribution partners for new therapies are not released at the time of FDA approval (why that is the case is beyond my understanding). However, we are seeing more manufacturers allowing their SP partners to announce that they are the pharmacy of record for their new LD therapy.

As requested, we are sending an update with information from some recent press releases.
We will periodically send similar updates as information becomes available.

Amber Specialty Pharmacy
Amber Specialty Pharmacy has announced that it has been selected as one of three specialty pharmacy providers for Rezurock (belumosudil) for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (cGVHD).

Biologics by McKesson
Biologics has announced that it has been selected as a specialty pharmacy provider for Rezurock (belumosudil) for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (cGVHD).

Onco360 has been selected by Merck & Co., Inc. to be in the specialty pharmacy network for Welireg (belzutifan), a hypoxia-inducible factor inhibitor indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease.

Orsini Specialty Pharmacy
Orsini has announced that it has been awarded access to three recently approved therapies:
Aduhelm indicated for the treatment of Alzheimer’s.
Nexviazyme (avalglucosidase alfa-ngpt) from Genzyme, indicated to treat patients 1 year of age and older with late-onset Pompe disease.
Tiopronin for the Treatment of Severe Homozygous Cystinuria, the first available generic version of Thiola® (tiopronin).

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