The FDA recently approved a new infused therapy, Xenpozyme (olipudase-alfa) from Genzyme , for pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death.  Xenpozyme is the first approved medication to treat symptoms that are not related to the central nervous system in patients with ASMD. 

ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, that accumulates in the liver, spleen, lung, and brain. Patients with ASMD have enlarged abdomens that can cause pain, vomiting, feeding difficulties, and falls. They also have abnormal liver and blood tests. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age. Other patients may survive into adulthood but die prematurely from respiratory failure.

The U.S. list price of Xenpozyme is $7,142.00 per vial.  Xenpozyme comes with a complicated, weight-based dose escalation schedule – biweekly for the first 14 weeks and then bi-weekly thereafter upon sustaining the recommended full dose (see prescribing information). 

Xenpozyme is supplied in a 20 mg vial and one may guesstimate that 26 vials (biweekly) will be utilized during a year resulting in an annual cost of approx. $185,000.

No details were announced relating to distribution. Given its cost and the need to monitor patient response it may be likely that this ‘rare’ therapy will launch through specialty pharmacy distribution.

CLICK HERE for full prescribing information

The FDA recently approved a novel infused therapy, Spevigo (spesolimab-sbzo) from Boehringer Ingelheim), with an indication for the treatment of generalized pustular psoriasis (GPP) flares in adults. Unlike virtually all non-gene therapy approvals in the specialty infusion segment, Spevigo is a ‘1 and done’ therapy (although a second dose may be warranted based on patient response.) Efficacy is considered high with 54% of trial participants showing no visible pustules after one dose.

GPP incidence is 1 in 10,000 people in the US. The condition has proven difficult to both diagnose and manage with available therapy. Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares (episodes of widespread eruptions of painful, sterile pustules all over the body).  Severity of GPP flares can vary, but complications such as sepsis and multisystem organ failure can occur. Patients also experience severe quality of life impacts.

Boehringer Ingelheim did not release pricing information at time of approval. 

Analysts suggest that the price for the single infusion will ring in at about $58,000.

As a rare condition, with fewer than 30,000 potential patients, it would not be surprising to see this infused therapy launched through a specialty pharmacy distribution model.

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FDA Approves Spevigo for Treatment of Generalized Pustular Psoriasis Flares in Adults

Boehringer Ingelheim’s monoclonal antibody inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for this indication.

The FDA approved spesolimab (Spevigo; Boehringer Ingelheim) as treatment for generalized pustular psoriasis (GPP) flares in adults, which marks its first approval by a regulatory authority for this indication.

Spesolimab is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), which is a pathway in the immune system that is involved in the pathogenesis of GPP.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” Mark Lebwohl, MD, Dean for clinical therapeutics at Icahn School of Medicine at Mount Sinai’s Kimberly and Eric J. Waldman Department of Dermatology, New York.

“The approval of spesolimab is a turning point for dermatologists and [physicians]. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares,” Lebwohl said.

The approval is based on results from the EFFISAYIL (NCT03782792) phase 2 clinical trial, where individuals experiencing a GPP flare were treated with either spesolimab or a placebo for 12 weeks.

At the outset of the trial, most individuals had a high or very high density pustules, and impaired quality of life.

Investigators said that after 1 week, 54% individuals treated with spesolimab showed no visible pustules compared with 6% taking the placebo, investigators said.

Investigators randomly assigned individuals 2 to 1 either a single 900-mg dose of spesolimab or the placebo.

Adverse events (AEs) were reported in 66% of individuals with spesolimab and 56% of those on the placebo after 1 week.

Investigators also reported that 17% and 6% of individuals, respectively, had infections after 1 week.

Serious AEs were reported in 6% of individuals taking spesolimab.

Spesolimab is also under review by other regulatory authorities. It has received breakthrough designation in China, Taiwan, and the United States; priority review in China and the United States; orphan drug designation in Australia, Korea, Switzerland, and the United States; and rare disease designation and fast track in Taiwan, for the treatment of GPP flares.

In October 2021, the European Medicines Agency validated the marketing authorization application, and the submission for spesolimab is under review.

https://www.pharmacytimes.com/view/fda-approves-spevigo-for-treatment-of-generalized-pustular-psoriasis-flares-in-adults

The FDA recently approved the fourth biosimilar to Genentech’s Avastin, Vegzelma (bevacizumab-adcd) from Celltrion USA.  Vegzelma is an infused therapy administered by a healthcare professional. 

Vegzelma is indicated for the treatment of patients with:

• metastatic colorectal cancer (mCRC);
• recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC);
• recurrent glioblastoma (GBM);
• metastatic renal cell carcinoma (mRCC); 
• persistent, recurrent, or metastatic cervical cancer (CC);
• epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vegzelma is Celltrion’s third oncology biosimilar approved for use in the U.S., following the approval of Truxima (rituximab-abbs) and Herzuma (trastuzumab-pkrb).

Approval did not include an interchangeable designation.

According to IQVIA, U.S. annual sales for bevacizumab for the 12 months ended February 2022 were $2.6 billion, $1.6 billion of which represented biosimilar sales. 

Celltrion did not disclose pricing at this time. 

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Celltrion USA Receives U.S. FDA Approval for its Oncology Biosimilar Vegzelma (bevacizumab-adcd) for the Treatment of Six Types of Cancer

# Vegzelma is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA

# Vegzelma offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment option

September 28, 2022  — CHICAGO–(BUSINESS WIRE)–Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved Vegzelma (bevacizumab-adcd), a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

“Biosimilars have been used in many disease areas including oncology and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Professor Claire Verschraegen, Director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, Columbus, OH. “With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”

The FDA approval of Vegzelma was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.

“The approval of Vegzelma is an important milestone in the U.S. which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care,” said Jaeik Shim, Chief Operating Officer at Celltrion USA. “As a leading force in the global biopharmaceutical industry, we look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the U.S. and contribute to a more sustainable healthcare system for the future.”

Vegzelma is an anti-cancer monoclonal antibody treatment biosimilar to Avastin® (bevacizumab). Vegzelma is a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. In the U.S., 

CLICK HERE to access the full press release

The FDA recently approved a novel infused therapy, Terlivaz (terlipressin) from Mallinckrodt, with an indication for hepatorenal syndrome (HRS) with rapid reduction in kidney function. 

There are between 30,000 and 40,000 adults in the US that have HRS with rapid reduction in kidney function, a condition that occurs in patients with advanced liver disease. Left untreated, the median survival time is 2 weeks, and more than 80% of patients die within 3 months.

Over more than a decade, Terlivaz faced many obstacles to reach approval including four complete response letters. It was finally green-lighted when the most recent Phase III trial reached its primary endpoint of renal function improvement, avoidance of dialysis and short-term survival.  Regardless, the label includes a BLACK BOX WARNING of serious or fatal respiratory failure.

Mallinckrodt did not release pricing at this time. 

Given the need for ongoing patient monitoring and a dosing schedule of every six hours it is presumed that this therapy will be limited to hospital administration.

CLICK HERE to access prescribing information

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FDA approves treatment to improve kidney function in adults with hepatorenal syndrome

FDA has approved Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. Terlivaz is the first FDA-approved medication for this condition.

Disease or Condition

HRS is characterized by a progressive deterioration in kidney function in people with advanced liver disease. This is most common in those with advanced cirrhosis (liver scarring) and ascites, an abnormal buildup of fluid in the abdomen that is often related to liver disease. The prognosis is very poor, particularly if patients’ liver disease is not treated with liver transplantation. Rising levels of serum creatinine (a waste product in the blood) in patients with HRS can indicate worsening kidney function.

Effectiveness

The effectiveness of Terlivaz was assessed in a double-blind study. Participants with HRS with rapid reduction in kidney function were randomly assigned to receive Terlivaz (199 participants) or a placebo (101 participants). Participants received either 0.85 mg of Terlivaz or a placebo every six hours as an injection in the vein for a maximum of 14 days. The dose was adjusted based on changes in kidney function.

The primary effectiveness outcome was the percentage of patients who had kidney function improvement, defined by two consecutive days of serum creatinine levels of 1.5 mg/dL or less, obtained at least two hours apart, by day 14 or the participant’s final day in the study. Twenty-nine percent of participants in the Terlivaz group had kidney function improvement compared to 16 percent of participants in the placebo group.

People with serum creatinine levels of 5 mg/dL or greater should not take Terlivaz because they are unlikely to benefit from treatment.

Safety Information

Terlivaz increases the risk of serious or fatal respiratory (breathing) failure. Patients with low oxygen in their blood should not start the medication. During treatment, patients should be monitored for breathing problems with a pulse oximeter — a tool that measures oxygen levels in the blood.

The FDA recently approved a BLA for Rolvedon (eflapegrastim-xnst) from Spectrum Pharmaceuticals. It has an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Rolvedon is a recombinant human granulocyte-colony stimulating factor (G‐CSF). Spectrum said the FDA action marks the first novel long-acting GCSF (LA-GCSF) product approval in over 20 years.

Spectrum did not release pricing for the new therapy. Although it is a long-acting formulation, market pick-up remains to be seen given the range of available colony stimulation options. The company plans to commercially launch the injection in Q4.

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FDA Approves Eflapegrastim for Chemo-Induced Neutropenia

by Chris Ryan

The FDA has approved eflapegrastim-xnst injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

The FDA has approved injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.1

The approval was supported by data from the phase 3 ADVANCE (NCT02643420) and RECOVER (NCT02953340) trials, where eflapegrastim demonstrated the pre-specified hypothesis of non-inferiority vs pegfilgrastim (Neulasta) in mean duration of severe neutropenia with a similar safety profile to pegfilgrastim.

“Eflapegrastim’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals, stated in a news release. “This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. On behalf of Spectrum, I would like to thank all of the patients, families, health care providers, and our own team members for bringing this goal to fruition.”

The ADVANCE and RECOVER trials both evaluated the efficacy and safety of eflapegrastim vs pegfilgrastim in the management of neutropenia in patients with breast cancer receiving docetaxel and cyclophosphamide.

ADVANCE and RECOVER enrolled patients with early-stage breast cancer who were randomly assigned to fixed‐dose eflapegrastim at 13.2 mg/0.6 mL(3.6 mg G‐CSF) or standard pegfilgrastim (6 mg G‐CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles.3,4 Subcutaneous injections of eflapegrastim or pegfilgrastim were administered on day 2 of each cycle, approximately 24 hours after chemotherapy. Patients received 75 mg/m2 of intravenous (IV) docetaxel and 600 mg/m2 of IV cyclophosphamide on day 1 of every 21-day cycle.

The FDA has just approved an oral suspension therapy, Relyvrio from Amylyx Pharmaceuticals, for ALS (amyotrophic lateral sclerosis or Lou Gehrig’s disease). Relyvrio joins a surprisingly competitive market for this rare condition. Five drugs were previously approved to treat ALS and its symptoms and include Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta. 

What is noteworthy about Relyvrio is that it is a combo therapy created by combining two, long available ingredients. The first, taurursodiol, is an over-the-counter supplement sometimes used to regulate liver enzymes. The other component is sodium phenylbutyrate, a prescription medication for a pediatric urea disorder. 

With fewer than 25,000 or so eligible patients in the US, Relyvrio will need to slug it out to gain market share. However, Relyvrio was approved with no black box warnings and a history of off label utilization within the ALS population. The FDA must have felt comfortable as it granted approval well before clinical trials were completed citing the demand for incremental options for patient relief.

Relyvrio will hit the streets at a cool $158,000 annually….. slightly less costly than its nearest competitor, Radicava. Given the rare status of the disease it is expected that Relyvrio will launch through limited distribution.

CLICK HERE to access prescribing information

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The new drug, marketed as Relyvrio, has a list price of $158,000 a year.

By Pam Belluck

Sept. 30, 2022

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

Relyvrio was approved by the Food and Drug Administration on Thursday, even though the agency’s analysis concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.

The F.D.A. decided to greenlight the drug instead of waiting until 2024 for results of a large clinical trial partly because the treatment is considered to be safe. The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.”

A.L.S., or amyotrophic lateral sclerosis — also called Lou Gehrig’s disease — often strikes patients in the prime of life and frequently causes death within two to five years. It is diagnosed in about 6,000 people worldwide each year, and Amylyx estimates that there are about 29,000 people living with the disease in the United States.

The Fight Against A.L.S.

The illness, also called Lou Gehrig’s disease, robs people of their ability to move, speak, eat and ultimately breathe.

Relyvrio: The experimental treatment for A.L.S. conceived a decade ago by two college students received the Food and Drug Administration’s approval, despite questions about its effectiveness.

A Runner’s Mission: After surpassing the average life expectancy for people with the disease, Andrea Peet decided to race a new kind of clock: 50 marathons in 50 states.

Brain Implant: A man who is fully paralyzed by A.L.S. was able to communicate using only his thoughts.

Rethinking Care: In 2017, Brian Wallach was diagnosed with A.L.S. Now, his startup aims to help other patients make the most of their time.

Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, both private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.

Still, the list price is much higher than that recommended by the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the value of medicines. In a statement, the group’s chief medical officer, Dr. David Rind, said that while “there are clear benefits to patients with a rapidly fatal disease to have early access to a safe therapy,” his organization had concluded that “an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works.”

Dr. Rind added that “while awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio rather than a price more than five times higher than the top of a value-based range.”

During an investor conference call on Friday, Justin Klee, a founder of Amylyx, said the price was chosen after meeting with insurers, patients, doctors and others. He said the company considered what would allow it to “invest in new treatments so that A.L.S. first becomes a manageable chronic condition and ultimately is cured,” and added that the price “allows Amylyx to sustain programs to help people who can benefit from Relyvrio access it.”

Her Face Started Drooping. What Was Wrong?

The F.D.A. has approved only two other A.L.S. medications. Riluzole, a tablet approved in 1995, can extend survival by several months and generally costs significantly less than $10,000 a year. Edaravone, marketed as Radicava, can slow symptom progression by about 33 percent. Radicava, which was originally approved in 2017 as an intravenous infusion, was approved this year in an oral form that carries a list price of $171,000 a year. Amylyx officials said they expected that, as in the company’s clinical trials, many patients would take Relyvrio, a powder that is mixed with water, along with one or both of the other medications.

Relyvrio was conceived by the founders of Amylyx, Mr. Klee and Joshua Cohen, when they were undergraduate students at Brown University less than a decade ago. They proposed that combining taurursodiol, an over-the-counter supplement sometimes used to regulate liver enzymes, and sodium phenylbutyrate, a prescription medication for a pediatric urea disorder, could protect neurons in the brain from damage in diseases like A.L.S. by preventing dysfunction of two structures in cells: mitochondria and the endoplasmic reticulum.

In an interview, Mr. Klee said the company expected that private insurers would cover the drug with no co-payments for patients, and he said that Amylyx would work to make it affordable for people on Medicare or Medicaid and provide it free to those without insurance who are financially struggling. Mr. Klee noted that patients had been obtaining the ingredients on their own for some time, buying the taurursodiol supplement from Amazon and paying up to $11,000 a month for the sodium phenylbutyrate.

“Now that our product is approved, we have to be laser-focused on making sure that people can access it,” Mr. Klee said.

Relyvrio’s clinical trials included patients who developed symptoms of A.L.S. within 18 months before the trial and were affected in at least three body regions, which is generally a sign of fast-progressing disease. The F.D.A.’s approval did not restrict which patients could use the medication. Mr. Cohen said in an interview that Amylyx didn’t have projections of how many would.

“There are patients who are just receiving the diagnosis today, and there are patients who are making end-of-life decisions today, and I think that people in different circumstances are going to make very different treatment decisions,” he said.

Amylyx has also conducted a small trial of Relyvrio in Alzheimer’s patients, and Mr. Cohen discussed plans to test it for other neurodevelopmental disorders.

A few weeks ago, a press release from Shields Health announced that it had obtained accreditation from URAC…… not as a dispensing specialty pharmacy but, rather, as a non-dispensing pharmacy(yes, there is such a thing). That was going to be the lead for today’s Report but, as things would have it, that news pales by even bigger news about Shields. 

The headline of greater significance is that Walgreens, which had already bought 71% of Shields for just under $1 billion, had plunked down yet another $1.37 billion for the remaining 29%!!! Yes, a grand total of about $2.3 billion.

We’ve rerun our Report issued in September 2021 (below) as it says all that needs be said about this latest bonanza for Shields. Bottom line, they are still not a pharmacy and they don’t seem to own any tangible assets. So, “Where’s the beef?” to warrant such a huge payday? That $2 billion is approximately 100% of total Rx revenue forecasted to be billed by all their contract hospitals in 2022…… not EBIDTA! 

From Anton R_x Report September 23,2021

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’

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Walgreens Boots Alliance is buying the rest of the specialty pharmacy company Shields Health Solutions for $1.37 billion.

September 20, 2022 — The nation’s largest drugstore chain said it has “entered into a definitive agreement to acquire the remaining 30% stake” of Shields from equity holders in the specialty pharmacy company that include private equity firm Welsh, Carson, Anderson & Stowe and the company’s founder and board chairman Jack Shields. The deal is expected to close by the end of the 2022 calendar year.

Specialty pharmacies are an increasingly important player in the U.S. health system given the flood of expensive drugs on the market derived from biotechnology. Such medicines are more complicated than pills and capsules picked up at the corner drugstore and often require specialty administration, refrigeration, package and patient instructions.

“Our full acquisition of Shields will complete another major milestone as part of our consumer-centric healthcare strategy to drive sustainable long-term growth, and we are very pleased with our partnership and integration with Shields,” Walgreens chief executive Roz Brewer said Tuesday. “We can now make further progress on our strategy through Shields’ integrated model, increasing our value to health systems, expanding access to payor partners and supporting improved outcomes and lower costs.”

Shields has nearly 80 health system partners representing approximately 1,000 hospitals nationwide that serve more than 1 million patients, the companies said. Walgreens made its initial investment in Shields in 2019.

“Shields will continue as a distinct business and brand within Walgreens,” Walgreens said in a statement. “John Lucey, co-founder and current president of Shields, will lead the organization as CEO of Shields, and current Shields CEO Lee Cooper will take on a new executive role within WBA. Lucey partnered with Jack Shields 10 years ago to start the business and has led its operations for most of that time.”

And, if you are interested in the footnote story related to Accreditation, here it is……

Shields Health Solutions Earns URAC Accreditation in Specialty Pharmacy Services

STOUGHTON, Mass., August 17, 2022–(BUSINESS WIRE)–Shields Health Solutions, the premier specialty pharmacy accelerator in the country, is proud to announce that it has earned URAC accreditation in specialty pharmacy services. URAC is the independent leader in promoting health care quality by setting high standards for clinical practice, consumer protections, performance measurement, operations infrastructure and risk management. By achieving this status, Shields Health Solutions demonstrates commitment to quality care, enhanced processes, patient safety and improved outcomes.

Shields currently partners with more than 70 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery, often within two days, and improved medication adherence greater than 90 percent on average.

“Shields Health Solutions has a deep commitment to excellence in specialty pharmacy and the URAC accreditation marks another milestone in recognizing our high quality of care,” said Kate Campagnola, Director of Accreditation. “By continuing to improve patient access to care and supporting complex patients through an integrated care model, we are excited to continue our mission to improve health outcomes and decrease costs for complex patients.”

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

About Shields Health Solutions

Shields Health Solutions is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system.

CLICK HERE to view Standards for the Specialty Pharmacy Services (non-dispensing) Accreditation

We reviewed a report from the Office of Disease Prevention and Health Promotion, a part of the U.S. Department of Health and Human Services some time ago and thought it was something worth refreshing. It detailed a variety of access barriers and we suggested that better understanding the scope of access challenges would be useful knowledge for anyone working in the specialty pharmacy segment, especially those that work in marketing, communications and web messaging. Today we turn up the heat.

Results from an AllianceRx Walgreen’s pilot program in 2021 also offer deep dive insights into the social determinants of health and, specifically, how these determinants impact patient access to health.

Here are the key areas of inquiry…..

• Safe housing, transportation, and neighborhoods

• Racism, discrimination, and violence

• Education access, job opportunities, and income

• Access to nutritious foods and physical activity opportunities

• Polluted air and water

• Language and literacy skills

The findings are highly insightful and are appropriate for leadership in specialty pharmacies as well as those involved in communications to better know their customers.

CLICK HERE to access the report findings 

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How Specialty Pharmacies Address Social Determinants of Health

Specialty pharmacies are uniquely positioned to identify social determinants of health that could impact medication adherence and health outcomes.

Specialty pharmacies play an integral role in ensuring patients receive, understand, and adhere to medications prescribed by their providers. This role also includes coordinating the numerous aspects of patient care and disease management.

“Specialty pharmacies are responsible for assisting patients through their treatment journey, which in many cases may be a lifelong journey with many complexities and challenges,” says AllianceRx Walgreens Prime Vice President of Clinical and Professional Services Rick Miller, MS Pharm, MBA, BS Pharm, CSP.

Article continues…………

CLICK HERE to read the full article

It’s been a rocky road for CVS of late. In July, CVS was assessed a multi-million $ fine in an arbitration case filed by a small specialty pharmacy (see our report on 7/14/2022) and now, CVS is facing a major anti-trust suit by the State if New York relating to how it self-directed prescriptions for Part D members.

Here’s the skinny…..

On July 28, 2022, the Attorney General of the State of New York (NYOAG) brought an antitrust suit against CVS Health in Manhattan state court. The NYOAG accused CVS of violating the Donnelly Act, New York’s state antitrust law, by illegally tying access to contract pharmacy services at CVS retail and specialty pharmacies to the use of a third-party administrator (TPA) called Wellpartner, a company CVS acquired in 2017. The business segment in question is the CVS Silverscripts Part D membership and also the the role played by CVS Caremark, its PBM.

The NYOAG requests civil monetary penalties and to enjoin CVS’s anticompetitive conduct and require CVS to notify New York 340B hospitals that exclusive use of Wellpartner is no longer required. More surprisingly, the NYOAG also seeks “equitable relief which could include an injunction and an order of divestiture” of the Wellpartner business.”

Oh what a tangled web…….

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Whistleblower suit: CVS prevented Part D members from accessing generics

A lawsuit against CVS Health comes as policymakers are turning up the heat on pharmacy benefit managers. 

A newly unsealed whistleblower suit claims that multiple CVS Health subsidiaries coordinated to prevent members from accessing generic drugs in a bid to boost the bottom line.

The suit was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. When she reported the behavior to a superior, she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught.

Miller claims that CVS’ SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.

Members were also often kept in the dark about potential authorized generic medications or identical drugs that are produced by the same manufacturer but offered at a lower cost.

The company violated Medicare regulations by…………. 

CLICK HERE to read the full article

We’ve written numerous times about value-based contracting (VBC)….. including earlier this week. When it emerged a few years ago there was much hope that VBC 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. 

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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.

CLICK HERE to access the full abstract.