The FDA recently approved a new oral suspension therapy, Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. Ztalmy was developed by Marinus Pharmaceuticals and is supplied as an oral suspension.

Patients with CDKL5 deficiency disorder (CDD) typically have infantile-onset epilepsy that responds poorly to previously available treatments. Symptoms include hypotonia (poor muscle tone), severe developmental and cognitive delays with little or no speech production, fine and gross motor impairment (including inability to walk for most patients), cortical visual impairment, behavioral abnormalities, and sleep and digestive difficulties. 

CDD is a rare disease with an incidence of between 1 in 40,000-60,000 live births, making it one of the most common genetic forms of epilepsy. This translates into ~6,500 lives in the US.
Marinus announced that Ztalmy will launch in Q3 pending DEA controlled substance approval. It will have a WAC of $133,000 per patient per year and will average $105,000 per patient per year after discounts.

Given the small patient opportunity and clinical complexity of the therapy it is very likely that access to Ztalmy will be limited to a specialty pharmacy.

CLICK HERE to access prescribing information

https://marinuspharma.com/wp-content/uploads/2022/03/prescribing-information.pdf

The FDA recently approved a new infused therapy, Carvykti (iltacabtagene autoleucel), from Janssen Biotech, for the treatment of adult patients with relapsed or refractory multiple myeloma.   The therapy was developed in partnership with Legend Biotech. The partners will share marketing in the US.

Carvykti is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using a patient’s own T-cells, which are collected and genetically modified, and infused back into the patient.

Carvykti will compete in the market with another BCMA-targeted CAR-T drug approved a year ago, Abecma from 2seventy bio. Janssen announced that Carvykti will launch at a wholesale acquisition cost of $465,000 vs. Abecma’s $419,500 list price.

Carvykti was approved with an extensive BOXED WARNING as well as a restrictive access REMS program.

Janssen did not announce details on distribution or whether access would be through a specialty pharmacy distribution program.

CLICK HERE to read the full FDA press release

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.

Soleo Health Selected as Limited Distribution Partner for VYVGART
January 24, 2022 — FRISCO, TX– Soleo Healthannounced today it was selected as a limited distribution partner for VYVGART™ (efgartigimod alfa-fcab) by argenx SE. VYVGART was approved by the U.S. Food & Drug Administration (FDA) on December 17, 2021 for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Soleo Health will manage and administer VYVGART intravenously in patients’ homes or its ambulatory infusion centers nationwide. Patients are supported through Soleo Health’s Myasthenia Gravis Therapeutic Care Management Center (TCMC). The TCMC is staffed with specially trained interdisciplinary teams, comprising experienced therapy care pharmacists, registered nurses, reimbursement specialists and patient care ambassadors dedicated to supporting patients living with myasthenia gravis.

PANTHERx Rare Selected as Exclusive Distribution Partner for FYARRO
Feb. 24, 2022 – PITTSBURGH, PA– PANTHERx Rare announces that it has been selected by Aadi Bioscience as the exclusive U.S. pharmacy distribution partner for new drug FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound). FYARRO, an albumin-bound mTOR inhibitor administered as an injectable suspension, is the first FDA-approved therapy for the treatment of advanced malignant perivascular epithelioid cell neoplasm (PEComa), an ultra-rare sarcoma.

Advanced PEComa is a rare, aggressive subset of soft tissue sarcomas for which there are no other approved therapeutic options. PEComas are composed of histologically and immunohistochemically distinctive epithelioid cells and most commonly arise from visceral, retroperitoneal, and abdominopelvic sites.

Over the past decade more and more specialty pharmacies obtained wholesaler/distributor (WDD / 3pl) licenses in addition to the traditional pharmacy license. Most of the therapies sold under those licenses are direct-to-provider for in office/clinic administration and commonly buy-and-bill. As you probably know, a majority of these meds are very high cost and are related to a limited / exclusive distribution program with the manufacturer.

The FDA is now moving to impose new rules that will supersede state regulations for these transactions, such as requiring national licensing, and ramped up operational standards and more. Legal experts on this matter believe that the proposed rule could have a significant impact on WDD and 3PL business operations. 

This is the time that SPs distributing meds under a state wholesale/distributor licenses to immediately assess all impacts to their business model and submit comments to FDA on the proposed rule changes by June 6, 2022 (Docket No. FDA-2020-N-1663).  You snooze you lose!

The FDA intends to conduct a webinar to provide an overview of the proposed rule to help stakeholders understand the proposed rules and prepare comments. 

The key provisions of the proposed rule include the following:

• Definitions of additional terms to help clarify the requirements of the proposed rule and align with current industry practice and existing law, including “3PL activities”, “key personnel”, “minimal quantities”, “other logistics services”, “other than a consumer or patient”, “product”, and “wholesale distribution”;
• National licensure and application requirements for WDDs and 3PLs, as well as the federal licensure review process;
• Standards and procedures that set forth licensure denial, suspension, reinstatement, revocation, and voluntary termination, including notice and the opportunity to request a formal evidentiary public hearing under existing FDA hearing procedures;
• Requirements for pre-license and post-license inspections;
• Personnel requirements and qualifications necessary for licensure;
• Surety bond requirements for WDDs;
• Requirements to establish good storage practices, including personnel requirements and qualifications necessary for good storage practices compliance;
• Requirements and standards for written policies and procedures to address a product’s sale, purchase, receipt, examination, security, storage, handling, inventory, shipment, transportation, disposition, and distribution;
• Requirements, standards, and procedures for record keeping, document maintenance, and initial and annual reporting; and
• Requirements, standards, and procedures for the FDA’s approval of third-party accreditation or inspection services or programs (“approved organizations” or “AOs”) to review the qualifications of 3PLs for licensure and conduct inspections of 3PL and WDD facilities, including the standards and procedures for organizations whose requests for approval are denied and for AOs whose approvals are suspended or revoked.

CLICK HERE to access the full Proposed FDA Rule

CLICK HERE to read the FDA Press Release including links to related documents 
———————————————————————-

FDA Publishes Proposed Rule on National Standards for The Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers as Required by The Drug Supply Chain Security Act

March 11, 2022 — The US Food and Drug Administration (FDA) published its proposed rule National Standards for the licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security of the US drug supply chain. When finalized and effective, these licensing regulations will preempt state and local licensing standards, requirements, and regulations that are different from these federal requirements.
CLICK HERE to read the full article from the National Law Review

Specialty pharmacies have seen margins shrink in spite of increasing volume. Many SPs turned to automation and clinically intuitive customer service software enabled SPs to improve speed to therapy and maintain quality of care standards. But overhead continues to be very people heavy. In short, bodies in the pharmacy and on the phone with customers are a big $$$ element of the delivery model.

It is not surprising, therefore, that SPs would look to their infantry in the pharmacy, pharmacy technicians, to shoulder a larger role in the delivery model. With tight clinical pharmacist availability and salaries rising, a certified pharmacy tech could be counted on to fill the gap. So, it should be no surprise that SPs interested in promoting their clinical quality would also want their techs to polish their clinical and operational expertise.

As noted in the article below, the CPhT has announced new course ware to enable pharmacy techs to obtain certifications in a variety of professional areas.

The certifications include the following:
– Advanced Certified Pharmacy Technician (CPhT-Adv),
– Board Certified Sterile Compounding Pharmacy Technician (BCSCPT),
– Board Certified Nonsterile Compounding Pharmacy Technician (BCNSPT).
Specialty certificates include:
– Technician Product Verifications (TPV)
– Medication History
– Controlled Substance Diversion Prevention
– Hazardous Drug Management
– Billing & Reimbursement
– Immunization Administration
– Point-of-Care Testing,
– Medication Therapy Management (MTM)
– Regulatory Compliance
– Supply Chain Management

---

Board of Pharmacy Technician Specialties Launches with Three Certifications and 10 Certificates to Advance Technicians’ Careers

New NPTA initiative offering three advanced certifications, including CPhT-Adv, and ten certificates providing increased accessibility and affordability to advance the careers of pharmacy technicians and enhance patient care and pharmacy practice

HOUSTON, Jan. 18, 2022 /PRNewswire/ — The Board of Pharmacy Technicians Specialties (BPTS), an independent initiative of the National Pharmacy Technician Association (NPTA), today launched three new advanced certifications for pharmacy technicians, including the CPhT-Adv, and ten specialty certificates. These new offerings will increase accessibility to credentials that will validate the skills and knowledge for pathways to advance the careers of pharmacy technicians, enhance patient care, and strengthen the workforce for pharmacies.

NPTA has long been the industry leader in advanced training programs and specialty certifications for pharmacy technicians, such as their sterile compounding program where NPTA has trained and certified more than 13,000 individuals. BPTS’s new certifications and certificates expand on NPTA’s mission to support, educate, and advocate for pharmacy technicians.

Exams will be offered at just $49 and be open to individuals certified through either NHA or PTCB to ensure accessibility to career-advancing credentials to all certified pharmacy technicians. The exam fee will include one additional retake at no charge, providing significant value compared to industry alternatives. BPTS has also set eligibility requirements to be more closely aligned with those expected of board-certified pharmacists, where individuals are encouraged but not required to take specific training programs, so long as they have adequate work experience.

“The responsibilities placed on pharmacy technicians to respond to increased patient needs are greater than ever,” said Mike Johnston, CEO of the National Pharmacy Technician Association. “With the launch of BPTS and these new offerings, all certified pharmacy technicians will now have the ability to demonstrate their advanced skills and competencies, earn advanced credentials, and ultimately gain the recognition, respect and compensation they deserve.

Registration for the certifications and certificates is available now, and the first exams will be offered in mid-February. Pharmacy technicians may register today at www.bpts.org.

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.

---

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!

---

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.

---

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.

---

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.

---

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.”