Author: Randy Chase

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.

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.

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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.”

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.

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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.

ABSTRACT
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.

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
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).

Ambulatory Infusion Centers (AICs) are once again gaining traction….. but not for the first time. AICs have actually been around for a very long time. They were popular back at the end of the last century (1980s-90s) but came under fire by the same entities who are now looking at them to slay the cost dragon related to site of service. Back then payers accused AICs of creating derived utilization…. i.e., self referral. In response AICs encountered a wall of contracting resistance with payers…. but, the unintended consequence was to see that spend shift to the hospital outpatient department…. Ouch!

There was actually a resurgence in AICs in the early 2000s, but payers had yet to decide on a contracting strategy to contain infusion delivery costs. So, that brings us to the 2020s and AICs are now regaining their lost luster as payers have finally gotten serious about moving patients to lower cost sites of care.

The article below offers a good recap for the market dynamics pushing the AIC resurgence. Many specialty pharmacies have integrated home infusion into their service models and an AIC presents both a threat and opportunity for them. They might lose home infusion patients to an AIC (especially if the AIC facility is accessible and comfy) or they can offer their own AIC solutions and ingratiate themselves with payers to provide turnkey access to specialty medications and infusion delivery solutions. Given the number of new, very high cost infused specialty meds should also get SPs thinking. Just sayin’

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It’s Prime Time For Ambulatory Infusion Centers

AUGUST 25, 2021 — The time is ripe for ambulatory infusion centers (AICs) to gain a stronger foothold in U.S. health care, a panel of experts said during the MHA 2021 Business Summit, held virtually.

“There’s a lot of tailwinds in this industry,” said Reece Norris, JD, a co-founder and the CEO of WeInfuse, an infusion software and consulting company. Payors and health plans are looking for sites of care (SOC) for infusion therapies that are more cost-effective than hospitals without compromising care, Mr. Norris said. With many autoimmune biologic specialty drugs having a limited distribution, the logistics of getting this in the home can be so burdensome that “it makes sense” to administer them in AICs, he noted.

“We are seeing payors push patients out of the hospital into more cost-effective sites of care,” Mr. Norris said. “We see this space continuing to expand, especially as the formulary of drugs gets larger.”

The SOC optimization trend has been building for several years, said Logan Davis, PharmD, MBA, the director of franchise development for Vital Care Infusion Services, in Meridian, Miss. The COVID-19 pandemic further demonstrated to the industry that being dependent on hospital-based infusion centers isn’t ideal, he said.

“There just isn’t enough capacity in the country at the moment” for stand-alone infusion centers, added Bryan Johnson, a co-founder and the CEO of WeInfuse, echoing the push by insurers to administer infused medications outside the hospital setting. “Wherever we can get a chair, an IV pole and a nurse, let’s try to make that site accessible to a patient, whether that’s in a home or through a management company. You’ll continue to see that—there’s just a lot of pressure coming down from the top.”

Adding to the market opportunity for expansion is a robust pipeline of specialty infusion drugs, including aducanumab (Aduhelm, Biogen), approved in June for the treatment of Alzheimer’s disease (see page 20 for more coverage), and several others still in trials for Parkinson’s disease, the panelists said. The boundaries are blurring among specialties, medications and diseases, Mr. Johnson noted. For example, infliximab (Remicade, Janssen) is being used for both gastrointestinal and rheumatic conditions. Medical specialists accustomed to having few infusion medications available aren’t likely to have office-based infusion suites, he added, and as specialty infusion medications cross into more common diseases covering more people, the demand for services will continue to rise.

Payors are reaching out to urgent care center chains, home infusion pharmacies and other regional service providers to open capacity to treat specialty medication patients in AICs, Mr. Norris said. In addition, some home infusion pharmacies are building infusion suites to capture the medical benefit market they could not traditionally access through the pharmacy benefit. Some home infusion pharmacies are adding infusion management services to their list of offerings. The infusion space is experiencing significant investment from both private equity and industry, Mr. Johnson added.

Why Launch?
There are numerous reasons to launch an infusion clinic, Dr. Davis said. Some of his franchisees wanted to be able to accept more referrals in their markets, access Medicare Part B benefits for referred patients, access drugs and better pricing limited to the infusion clinic class of trade, and access commercial payor contracts available to infusion clinics. But a sharp marketing and sales strategy is critical to success when starting out, the panelists said.

“This is not a ‘build it and they will come’ space,” Mr. Norris said. “You can have the best nurses, the nicest building and the finest equipment, but you have to earn the trust in the community from referring providers.” This can involve the hard work of cold calling, creating medication-specific order forms to ease work for referring physicians and treating referrals as gold. Communicate back to referring physicians how the infusion went, he advised, even if it’s just a quick treatment note.

When thinking about the physical space and build-out, most operators focus on factors such as infection control and meeting codes. But it’s equally important to consider patient amenities such as great parking, expanded hours, free Wi-Fi and coffee, Mr. Johnson said.

“Think more Starbucks and less stainless steel,” he said. “These patients have chronic conditions they will visit you with every few weeks, maybe for the rest of their lives. They want to be comfortable. You want them to look forward to coming to your facility.”

Mr. Johnson suggested these additional operational strategies:
Consult resources such as the National Infusion Center Association or the Infusion Nurses Society to note best practices and standards.
Hire a licensed professional (e.g., a physician, physician assistant or nurse practitioner) for clinical leadership. Their expertise will be needed in updating and maintaining protocols as well as dealing with any adverse events and communicating with other health care professionals.
Write and review emergency protocols and post them clearly for your clinical team.

Although the infusion itself is the same whether it’s administered in a hospital or another setting, AICs are different in terms of their regulation, reimbursements and class of trade, commented David Franklin, the president of Advanced Care Consulting Services, in Ray, Mich.

“There’s a really interesting new hybrid where independent infusion centers are partnering with physicians,” he said, “where physicians hold stock in the company, but they partner with independent infusion centers to operate the services through management contracts. That’s what’s going on now more than anything.”

Still, some of these independent infusion centers are facing reimbursement challenges because they may not be recognized by Medicare and Medicaid, Mr. Franklin noted.

Most insurance programs still place provider administered medications under the medical benefit requiring that the meds be billed to the payer in the traditional claims submission process, not via the PBM. The efficiency of PBM adjudication is not at question. However, moving meds from the medical benefit to the pharmacy benefit is easier said than done. At least two big issues need to be overcome. First, most states require that a substantive change in the contract be approved by the insurance commission and that can take a lot of time. Secondly, the technology needs to be adapted to adjudicate using different reimbursement methodology that can vary from provider contract to contract.

The article below details a possible solution, one which PBMs have been talking about for more than a decade….. but have not yet delivered. TransactRx is launching a program to tackle the challenges related to claim adjudication for medical provider administered medications.

TransactRx cites an example where they have “moved 100% of specialty medications for a payer’s commercial lives from the medical benefit to the pharmacy benefit while retaining the providers’ buy-and-bill drug acquisition model and maintaining all sites of care for their patients.” That is no small feat…. if it is as simple as stated. It also requires that all providers in the ‘network’ submit standard pharmacy (NCPDP) claims, which would present major operational and technical changes for the practices.

It will be interesting to see if TransactRx is able to overcome the challenges and finally offer a sustainable alternative to traditional billing under the medical benefit.

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TransactRx Launches SpecialtyXB, a better way to manage buy-and-bill medical benefit specialty drugs

MIAMI, Aug. 11, 2021 /PRNewswire/ — TransactRx announces the launch of SpecialtyXB an innovative solution for payers to move the coverage of medical provider administered specialty drugs from the medical benefit to the pharmacy benefit. TransactRx provides an integrated set of consulting services, provider network management and technology to enable medical providers across all places of service to submit claims and receive payments for provider purchased specialty drugs administered to patients. SpecialtyXB is the newest of the TransactRx cross benefit solutions that manage drug spend across medical and pharmacy benefits.

With SpecialtyXB everyone wins: Payers, Providers and Patients
Specialty medications represent nearly half of the drug spend in the US and are expected to increase by more than 11% this year. Just under 50% of the specialty drugs are administered by hospital outpatient clinics, infusion centers and medical providers that purchase the drugs and are billed under the medical benefit (a model called buy-and-bill). Over the past 10 years the PMPM dollars spent on commercial lives for these medical benefit specialty drugs is up almost 90%. The increases in medical drug spend create several challenges for payers as the utilization data is captured from batch medical claims and adjudicated on platforms that don’t have the same utilization management tools available on PBM platforms used to adjudicate pharmacy claims.

“To respond to these rising costs and management challenges some payers have started to move medical specialty drugs to a white-bagging model or a home infusion model which has decreased costs but has introduced issues with providers and with patients”, said Jack Guinan, CEO, TransactRx. “Our SpecialtyXB service provides an alternative solution that has proven to reduce costs, provide transparency to data, maintains provider relationships and supports the highest level of patient quality of care.”

SpecialtyXB is implemented on the TransactRx Cross-Benefit platform which seamlessly integrates medical and pharmacy systems to enable provider administered specialty drugs to be billed and reimbursed as standard pharmacy (NCPDP) claims. The solution includes the implementation of a medical provider pharmacy network managed by TransactRx which contracts with the payer’s PBM. The experienced TransactRx team, with over a decade of managing medical provider administered drug reimbursement, works with the payer, providers and pharmacy benefit manager to implement and operate the solution.

TransactRx successfully implemented SpecialtyXB with a regional Blue Cross and Blue Shield payer contracting with over 2700 medical providers that support their 640K commercial lives. The implementation resulted in moving 100% of specialty medications for the payer’s commercial lives from the medical benefit to the pharmacy benefit while retaining the providers’ buy-and-bill drug acquisition model and maintaining all sites of care for their patients. TransactRx is in discussions to launch SpecialtyXB with several other payers

For more information how TransactRx can help manage medical provider administered specialty drugs please visit our website www.transactrx.com/specialtyxb.

About TransactRx
TransactRx provides Cross Benefit Drug Reimbursement Solutions where everyone wins; payers, providers and patients. TransactRx has developed and operates its patented Cross Benefit Clearinghouse platform, operates national scale provider networks and provides consulting services that enable medical providers to be reimbursed for products and services covered under pharmacy benefits and enables pharmacy providers to be reimbursed for products and services covered under medical benefits.

Hospital / Health System Owned Specialty Pharmacies (HHOSPs) have been saying that they are better qualified than independent SPs because they are integrated, essentially bolted to the hip of the hospital clinical team. The reality is that the hospital pharmacy is still the primary source of meds for inpatients, not the HHOSP. So, the claim about better integration leading to better outcomes may be a bit of editorial license.

We’ve been alert to claims in the HHOSP segment that validate enhanced differentiation. The article below details a program offered by Excelera that actually does show differentiation. They are sponsoring a “new specialty-pharmacy-focused educational offering in partnership with Aptitude Health, which provides critical insights for life sciences companies and healthcare professionals to improve cancer care and outcomes.” As described, the program seems to offer tangible content in hematology and oncology, arguably the most challenging area in specialty pharmacy and where specialty needs to be at the peak of its game.

It is also noteworthy that Excelera has partnered with Aptitude Health, which is closely aligned with pharmaceutical companies. Aptitude Health claims to be “…the global market leader in evidence-based solutions for life science companies seeking to identify, develop, and commercialize oncology and hematology innovations.” Independent SPs might do well to take a cue from the competition.

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Excelera and Aptitude Health Offer New Specialty Pharmacy Focused Educational Resources for Cancer Care

August 05, 2021 — MINNEAPOLIS–(BUSINESS WIRE)–Excelera, a wholly-owned subsidiary of Shields Health Solutions and the company behind the Excelera Network, announced today a new specialty pharmacy-focused educational offering in partnership with Aptitude Health, which provides critical insights for life sciences companies and healthcare professionals to improve cancer care and outcomes. Together, the companies will publish key takeaways and potential implications for pharmacy professionals from Aptitude’s Evolving Paradigms in Care (EPICS) programs, which include congresses and global perspectives focused on major solid tumor and hematologic malignancies and the incorporation of new clinical data in disease management and treatment approaches. The new initiative underscores the importance of extending disease state-specific hematology and oncology insights in support of the integrated health system model and its multi-disciplinary approach to patient care.

“This collaboration with Excelera to create EPICS program content specifically for specialty pharmacy providers is exciting because it allows the pharmacy audience to benefit from insights into the emerging trends in the landscape and potential changes in prescribing patterns that might result from paradigm-changing studies in oncology and supportive care,” said Kerry Bradley, Vice President of Payor and Market Access, Aptitude Health.

Each EPICS report is based on the outcomes from closed-door roundtable discussions featuring clinical experts engaged in disease-specific discussions on translational and therapeutic advances and their application to clinical decision-making. Aptitude Health produces a high-level summary of the program discussion, as well as an Insights Report, which includes updates on drug development, patient management, strategic recommendations and the current and future disease landscape. The collaborations between Aptitude Health and Excelera will be triggered when information from the syndicated portions of these reports have potential importance for the pharmacy community.

“Excelera established its partnership with Aptitude Health in 2020 to leverage and share the expertise of healthcare providers specializing in cancer care with the specialty pharmacies in the Excelera Network,” said Diane Wolfe, VP Network Strategy at Excelera. “We are pleased to enhance that partnership with content developed from the perspective of specialty pharmacy experts in hematology and oncology who are aligned with academic medical centers, health systems and IDNs.”

About Aptitude Health
Aptitude Health is the global market leader in evidence-based solutions for life science companies seeking to identify, develop, and commercialize oncology and hematology innovations. With a proven track record of success, we transform the world’s growing scientific and clinical knowledge into better patient outcomes. The expertise of our team is backed by unparalleled access to global disease-state experts and healthcare professionals, making Aptitude Health the strategic partner of choice for the world’s most successful life science companies.

Last week the FDA approved a new ORAL therapy, Welireg (belzutifan) from Merck, for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Welireg is the first systemic treatment for cancers linked to VHL which affects about 10,000 Americans annually.

Welireg works by blocking a protein known as HIF-2 alpha which limits the expression of certain genes associated with cellular proliferation and tumor growth. Welireg is administered once daily until disease progression or unacceptable toxicity. There is a serious risk of embryo-fetal harm which led the FDA to require a black box warning.

Merck confirmed that it will launch Welireg at a wholesale price of $26,400 monthly. Details relating to access were not released. However, it is highly likely to be placed in limited distribution due to the relatively small patient population and need to monitor patients for serious side effects and adverse events.

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FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

On August 13, 2021, the Food and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Belzutifan was investigated in the ongoing Study 004 (NCT03401788), an open-label clinical trial in 61 patients with VHL-associated RCC (VHL-RCC) diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNET.

The primary efficacy endpoint was overall response rate (ORR) measured by radiology assessment, as assessed by an independent review committee using RECIST v1.1. Additional efficacy endpoints included duration of response (DoR), and time- to- response (TTR). An ORR of 49% (95% CI:36, 62) was reported in patients with VHL-associated RCC. All patients with VHL-RCC with a response were followed for a minimum of 18 months from the start of treatment. The median DoR was not reached; 56% of responders had DoR ≥ 12 months and a median TTR of 8 months. In patients with other VHL-associated non-RCC tumors, 24 patients with measurable CNS hemangioblastomas had an ORR of 63% and 12 patients with measurable pNET had an ORR of 83%. Median DoR was not reached, with 73% and 50% of patients having response durations ≥ 12 months for CNS hemangioblastomas and pNET, respectively.

The most common adverse reactions, including laboratory abnormalities, reported in ≥ 20% of patients who received belzutifan were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea. Anemia and hypoxia from belzutifan use can be severe. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. Patients should be transfused as clinically indicated. The use of erythropoiesis stimulating agents for treatment of anemia is not recommended in patients treated with belzutifan. In Study 004, hypoxia occurred in 1.6% of patients. Belzutifan can render some hormonal contraceptives ineffective, and belzutifan exposure during pregnancy can cause embryo-fetal harm.

The recommended belzutifan dosage is 120 mg administered orally once daily with or without food.

If you have made healthcare a career then you are likely to be familiar with NCQA. They’ve been around since the early 1990s measuring and then accrediting health plans. The NCQA designation continues to do for healthcare what the Good Housekeeping Seal of Approval does (since 1885) for home products…. spotlighting those organizations / manufacturers that meet exceptional quality standards. NCQA uses measurements, transparency and accountability to not only recognize top health plans, medical providers, and practices but to drive ongoing improvement.

It is with some surprise that NCQA has announced that it will start to offer an accreditation in specialty pharmacy as detailed in the press release below. First, there are a number of highly reputable accrediting organizations that health plans and manufacturers are familiar with and, more importantly, trust. Secondly, there has been a decline in the number of pharmacies breaking into specialty, so, attracting new signups may prove to be a challenge (refer to last week’s Report on URAC accreditations and discounts through ABC).

When a new competitor enters the market, they usually seek to differentiate themselves. But the key differentiation highlighted in the press release relates to value-based contracting (VBC). To be sure, VBC is an admirable quality measure…. but it is still a somewhat minor piece in the specialty pharmacy model.

It will be interesting to see if NCQA SP accreditation is embraced by the marketplace. Since most SPs already have several accreditations the big question will be “Is there room for one more?”

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New NCQA Program Highlights Specialty Pharmacies for Commitment to Quality

WASHINGTON, Aug. 10, 2021 /PRNewswire/ — Today NCQA launched Specialty Pharmacy Accreditation, a service to help distinguish quality leaders and support value-based contracting in the rapidly growing field of specialty pharmacy.

“Specialty Pharmacy Accreditation addresses intersecting needs,” said Brad Ryan, MD, Chief Product Officer of NCQA. “Specialty pharmacies want to showcase their quality to stand out from peers so they can gain access to networks and pharmaceutical products. Drug manufacturers want to trust a specialty pharmacy can manage their products appropriately. And payers want to trust a specialty pharmacy can provide quality care to their members.”

In addition to helping pharmacies demonstrate their commitment to quality improvement and show they can be strong partners for value-based contracts, the new program helps pharmacies identify barriers to therapy initiation and adherence.

Organizations interested in NCQA Specialty Pharmacy Accreditation also stand to make meaningful improvements and contributions to quality by participating in a first-of-its-kind Measurement Lab.

The NCQA Specialty Pharmacy Measurement Lab is a collaborative working group composed of quality leaders from specialty pharmacies, health plans, pharmacy benefit managers, manufacturers and other industry stakeholders. Measurement Lab members learn best practices, pilot performance measures and influence the creation of digital measures as benchmarking and performance-based accreditation evolve.

Diverse organizations like those comprising the Measurement Lab helped design the new accreditation program. Organizations NCQA consulted include 11 specialty pharmacies, 9 health plans, 9 drug manufacturers, 6 pharmacy benefit managers and 3 patient advocacy groups. A 14-member Advisory Committee representing those industries—plus academia and CMS—developed the accreditation standards.

Pharmacies meet standards in four areas to earn Specialty Pharmacy Accreditation:
Patient Programs standards evaluate how well pharmacies support patients through the script journey—how patient-centered a pharmacy is and how it ensures patients experience their medications’ intended benefits.
Organization, Administration and Compliance standards evaluate how pharmacies train their staff and align with regulators and other stakeholders.
Specialty Pharmacy Operations standards consider how well pharmacies procure, secure, dispense and ship products to ensure product integrity.
Quality and Performance Improvement standards unify and build on the previous three standards to assess how pharmacies organize and measure continuous improvement.

Eligible organizations are licensed pharmacies that contract with drug manufacturers, health plans or pharmaceutical benefits managers to dispense specialty medications and provide supporting services. Accreditation surveys, which may be virtual or in-person, will begin in early 2022. NCQA determines accreditation status within 34 days after a survey. Specialty Pharmacy Accreditation lasts three years.

About NCQA
NCQA is a private, nonprofit organization dedicated to improving health care quality. NCQA Accredits and Certifies a wide range of health care organizations. It also recognizes clinicians and practices in key areas of performance. NCQA’s Healthcare Effectiveness Data and Information Set (HEDIS®) is the most widely used performance measurement tool in health care. NCQA’s website (ncqa.org) contains information to help consumers, employers and others make informed health care choices. NCQA can also be found on Twitter @ncqa, on Facebook at facebook.com/NCQA.org and on LinkedIn at linkedin.com/company/ncqa.

Now here’s something ya don’t see every day….. a leading accreditation body cutting a deal to offer a discount on specialty pharmacy accreditation.

Yes, URAC has hitched up with AmerisourceBergen (ASB) to offer a special rate for specialty pharmacy accreditation. It would appear that the discount is available to those pharmacies that use ASB as their wholesaler of record, which gives that pharmacy access to the ASB PSAO portfolio. It is not clear whether this is an offer for new (first time) URAC accreditations or if renewals are also included. Since the cost of a new and renewal accreditation can be pricey any savings could be welcome.

So why offer discounts at all?
The value of a specialty pharmacy accreditation is now well established. In fact, most SPs now obtain two or more accreditations….. often from competing agencies. In prior years we received many inquiries from pharmacies seeking to enter the SP segment….. and accreditation was always a key consideration. But, in the last 24 months, the number of pharmacies making the leap into SP has significantly dried up. That would have an impact on the number of new SP accreditations. As with any business, when market dynamics change marketing tactics respond to those changes. Just sayin’.

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URAC and AmerisourceBergen Announce Strategic Relationship

Washington, DC, (GLOBE NEWSWIRE) — URAC, the nation’s largest independent health care accreditation organization and recognized leader in pharmacy accreditation, announced today that is has entered into an agreement with global health care company, AmerisourceBergen to provide discounted pricing on URAC accreditation and designation programs, as well as value-added services to AmerisourceBergen’s dispensing provider customers seeking new accreditation.

This relationship exemplifies URAC’s continuing goal of improving the quality of health care across the country, by making its meaningful accreditation programs available to even more organizations.

“Providers, hospitals and health systems are increasingly building specialty pharmacy and telehealth capabilities, and it’s vitally important they are accredited, so as to ensure the best outcomes for their patients,” said Shawn Griffin, MD, URAC’s President and CEO. “We are really excited about how this partnership will allow us to accredit more provider and hospitals pharmacies and telehealth practices.”

“URAC is glad to work with a world-class organization like AmerisourceBergen that shares the same goal of improving health care for individuals,” concluded Griffin.

“Improving health and wellness of patients through quality care is the cornerstone of our partnership with URAC,” said John Ryan, Vice President of Service Solutions and Operations at AmerisourceBergen. “We understand the critical role accreditation plays in enhancing patient outcomes, and we’re excited to offer this opportunity to our customers and assist them in the accreditation process.”

“We’re hopeful that this relationship will continue to enable pharmacies to provide accessible community-based care and create new and improved opportunities to access the medications their patients need.”

About URAC
Founded in 1990 as a non-profit organization, URAC is the independent leader in promoting health care quality and patient safety through renowned accreditation programs. We develop our evidence-based standards in collaboration with a wide array of stakeholders and industry experts. Our portfolio of accreditation and certification programs span the health care industry, addressing pharmacies, health care management and operations, telehealth, health plans, medical practices and more. URAC accreditation is a symbol of excellence for organizations to showcase their validated commitment to quality and accountability.