Month: April 2022

Limited distribution (LD) has contributed to the growth of a couple dozen specialty pharmacies over the past decade. When a pharmaceutical manufacturer selects a specialty pharmacy as a member of their limited network prescriptions are routinely channeled to these SPs for fulfillment and they enjoy the usually greater revenue associated with these therapies. And, an increasing number of LD therapies have awarded exclusive deals to a single SP. The exclusive deals are most often for a rare/orphan therapy and these are usually among the most costly.

We’ve often written about the benefits that the manufacturers enjoy from these distribution arrangements. But what about the benefits that can accrue to a payor? A recent article was recently published highlighting a variety of benefits…. and even some deliverables that SPs can offer to payors.

Here are the top line benefits that payors should seek in a LD program.

• End-to-end solutions. LDD access allows a specialty pharmacy to meet most of the specialty needs of its clients. For example, if the pharmacy does not have access to a product, it can work directly with the manufacturer to attempt to gain access on behalf of the patient.
• Rapid access to medications. Because there is no delay or expense related to third-party suppliers, payors can quickly access hard-to-find medications. Being part of an exclusive or narrow distribution network can allow pharmacies to have expedient contract additions to its payors. In addition, specialty pharmacies that have deep relationships with pharmaceutical manufacturers can begin discussions early about the specialty drug pipeline and how quickly patients can access drugs once available on the market.
• Greater patient satisfaction. Central and local pharmacies operating under singular clinical programs allow for a consistent patient experience aimed at driving adherence and improving overall treatment experience.
• Reduced costs. When a specialty pharmacy manages the full drug therapy needs of patients, its pharmacists and nurses can support possible medication issues, such as side effects that could lead to nonadherence. In turn, those patients who remain on their drug regimen provide a healthier membership to the payor, potentially reducing overall costs.
• Actionable insights. Specialty pharmacies can provide their payors regular reports outlining utilization and spending of all medications, including LDDs. Many specialty pharmacies offer real-time access to critical information through proprietary client data and insights tools. These tools can often visually transform a payor’s current business data into interactive insights, enabling the payor to best evaluate its overall payor strategy and respond to patient needs and market trends. [This data is also integral to supporting value based contracts.]

Specialty pharmacies should consider the following ways to help payors meet their goals:

• Control costs and improve outcomes. Specialty pharmacies should partner with payors to proactively control costs by delivering actionable insights through unique market-leading programs that complement existing member management solutions.
• Empower patients and providers with an enhanced specialty experience. Consider implementing solutions that can add value to patients and providers. For instance, timely notifications and online refills make it easy for patients to access their medications and manage their conditions. Allowing the patient experience to move from fragmented care to total patient care allows patients to be more proactive in their health management journey.
• Become a trusted partner. Through various partnerships, payors will benefit from understanding the competitive and consolidated healthcare landscape and how it affects drug costs. The goal of specialty pharmacies should be to serve as a strong but nimble partner that understands the changing industry dynamics. By doing so, the relationship between a specialty pharmacy and payors will directly affect—and improve—overall patient experience and outcomes.

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How a Specialty Pharmacy’s Limited Distribution Drug Expertise Benefits Payors

Limited distribution drugs (LDDs) are high-touch medications to which only a handful of specialty pharmacies have access. Because these medications usually have specific requirements, pharmaceutical manufacturers may choose to limit distribution of the drug to only a few specialty pharmacies. Pharmaceutical manufacturers choose a specialty pharmacy as a trusted partner because of its ability to support patients throughout their treatment journey.

CLICK HERE to read the full article

Ana M. Cavanaugh, RPh, MBASenior Director, National Payer Sales and Account Management, Pharmacy ServicesAllianceRx Walgreens Prime

Option Care Health announced that it has acquired the Specialty Pharmacy Nursing Network (SPNN) for $60 million in an all-cash transaction. SPNN will maintain its current operations and continue serving an array of infusion providers, specialty pharmacies and biopharmaceutical manufacturers as a separate enterprise within Option Care Health. This marks the most recent chapter in the 13-year climb from start-up by industry veteran Cheryl Ann Gregory.

Specialty Pharmacy Nursing Network, Inc. (SPNN) is a national network of CRNI, OCN, IgCN, PICC and IV certified specialty nurses who administer specialty pharmacy therapies to patients in the home, physician offices and ambulatory infusion centers (AICs).

Demand has risen significantly for these expert clinicians given the recent proliferation of therapies for rare, chronic, and orphan disorders. SPNN’s professional staff also provides specialty pharmacy therapy education / clinical instruction, clinical call support, and patient outcome reporting.

The last item, patient outcome reporting, has become one of the more valuable services….. especially to pharmaceutical manufacturers. With the growth of value based / outcomes contracting, clinically reliable data has become a critical commodity.

Examples of key data tracking include:
Data Management and Integration
• Aggregated de-identified data reporting compliant with HIPAA regulations
• Assessment and surveys developed based on Best Practice Standards

Administrative Control
• Centralized administration, database management, scheduling
• Fast and reliable response time

Nursing Resources
• Coordination of nursing in/between the home, physician office or AIC
• Customized nursing assessments

Reporting
• Documented patient care services provided following therapy-specific metrics
• Market access, therapy starts/stops, etc.
• Tailored reporting to support manufacturer programs as well as REMS reporting

SPNN has also worked diligently to grow its national geographic footprint to service both urban and rural patient requirements….. an area of great concern for both manufacturers and health plans.

Given demand and related cost of therapy, it is no surprise that Option Care has moved to expand its toolbox through this acquisition.

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Option Care Health Completes Acquisition of Specialty Pharmacy Nursing Network Inc.

BANNOCKBURN, Ill., April 12, 2022 (GLOBE NEWSWIRE) — Option Care Health, Inc. (“Option Care Health”), the largest independent provider of home and alternate site infusion services in the United States, announced today that it has completed the acquisition of Specialty Pharmacy Nursing Network Inc. (“SPNN”). SPNN is a national leader in providing highly skilled specialty nursing resources across a broad portfolio of healthcare providers with over 400 nurses across the country.

The acquisition builds upon the market-leading nursing platform Option Care Health established with its acquisition of Infinity Infusion Nursing LLC (“Infinity”) to expand access to clinical resources across the United States. Leveraging Option Care Health’s national infrastructure, the acquisitions of Infinity and SPNN establish a more comprehensive clinical platform focused on delivering extraordinary care. The consummation of the SPNN acquisition expands Option Care Health’s nursing team to more than 2,900 nurses nationwide.

“I am thrilled to welcome the entire SPNN team to the Option Care Health family. SPNN’s track record of growth and clinical expertise is unsurpassed and highly complementary to our relentless focus on reimagining the infusion care experience. The acquisition is a critical strategic investment to further enable our future growth”, commented John Rademacher, Chief Executive Officer of Option Care Health.

Option Care Health acquired SPNN on April 11, 2022, for $60 million in an all-cash transaction. SPNN will maintain its current operations and continue to serve a broad array of infusion providers, specialty pharmacies and biopharmaceutical manufacturers as a separate enterprise within Option Care Health.

The FDA approved the 35th biosimilar last week, Alymsys (bevacizumab-maly) from Amneal Pharmaceuticals, for seven cancer indications of the reference product, Avastin from Genentech. It is an infused therapy, so specialty pharmacies won’t have much contact with Alymsys.

Alymsys joins two previously approved biosimilars to Avastin. Myvasi (Amgen, approved in 2017) and Zirabev (Pfizer, approved in 2019).

Patent concerns?
Patent battles were in full bore for years but Avastin did not have the dozens of patents to block competitor approvals as seen in other biosim cases. With the final patent issues resolved, doors are now open for the three biosimilars. Inroads into market share were slow on the uptake but are gaining share rapidly as competition will further gain payer preferences.

Follow the Money
Is all the wait worth it? In short, yes….. especially for Amneal which did not have to spend a mountain of cash on legal challenges. These biosimilars are being sold outside the US and are generating revenues for the biosim manufacturers.

Avastin isn’t the most expensive therapy in the cancer toolbox, but it isn’t cheap either at about $4,000 per cycle. Depending on cancer type and other clinical variables, a patient may receive as few as six cycles or as many as 22. By the way….. Avastin is still among the top selling drugs on the market. Nuff said….

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FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly

April 13, 2022 — Amneal said the product, to be sold under the name Alymsys.
It is the second of 3 biosimilars the company expects earn approval in the US this year.

Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).

Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States.

Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.

Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen
First-line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel
Recurrent glioblastoma in adults
Metastatic renal cell carcinoma in combination with interferon alfa
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.

The National Home Infusion Association (NHIA) recently published the results of a survey of patients who had received a home chemotherapy infusion to gauge their level of satisfaction across a number of metrics. The results show that these home infusion patients are very satisfied with services, understand medication instructions, and 89.54% of the patients completed their therapy with only 0.02% adverse reactions related to the administration.

National Home Infusion Association (NHIA) estimates that approximately 132,000+ patients annually received home infusions of chemotherapy agents since 2019 with the trend increasing. Given the criticism of home chemo infusions by hospital-based infusion providers it is not surprising that NHIA would want to ensure that their patients were satisfied with the home infusion experience.

The purpose of this study was to quantify the level of patient satisfaction and to determine any reason for discontinuation from home infusion services. The findings showed a very low rate of discontinuation with more than 90% completing therapy. Of those that did not complete therapy 8+-% died of non-administration-related causes or were hospitalized for non-administration-related causes.

As noted in the published table (click below), patient ratings were very strong in support of home provided services with the majority of metrics in the 90%++ range (strongly agree).

Some deeper evaluation is required related to two outlier results. Question 11, “I was satisfied with the overall quality of the home infusion services provided” dropped precipitously. NHIA points out that when the top two results are combined (Strongly Agree and Mostly Agree) the results increase to 97%. The score in Question 12 – “I would recommend home infusion to family and friends,” similarly suffered but fares much better when the top two options are combined. Future surveys may want to take a deeper dive in these areas to understand patient thinking or rephrasing certain questions.

Several questions relate specifically to the local home infusion company. However, others can be attributable to the specialty pharmacy providing both the therapy and critical services, e.g., authorization and billing (usually worked out before shipment of the drug to the home care company.) For example, in Question 3 patients are asked about delivery of the medication prior to the scheduled appointment. It received the third lowest score and indicates an opportunity for a specialty pharmacy quality improvement assessment.

CLICK HERE to read the full text of the report and VIEW THE TABLE

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Chemo at Home: High Rate of Satisfaction, Low Rate of Discontinuation

Overall, 97% of patients said they were satisfied with at-home chemotherapy infusions.

The following article features coverage from the NCCN 2022 Annual Conference.

Receiving chemotherapy infusions at home appears to be safe, and patients reported a high rate of satisfaction, according to research presented at the NCCN 2022 Annual Conference.

Most patients in the study completed at-home chemotherapy as planned, and none of them stopped treatment because of adverse drug reactions.

In a survey, most patients said they understood their medication instructions, were informed about potential side effects, and were satisfied with at-home chemotherapy.

Researchers assessed the safety of home chemotherapy infusions in 153 patients using 3 parameters — treatment completion, adverse drug reactions, and unplanned hospitalizations.

The researchers also surveyed 328 at-home chemotherapy recipients using a 12-question survey developed by the National Home Infusion Association. The survey responses were submitted between 2019 and 2021.

The survey used a Likert scale (“strongly agree” to “strongly disagree”), and the following answers are the highest rated option (“strongly agree”).

All patients said the home infusion pump was clean when delivered, and 99% said it worked properly. Most patients said they knew who to call for help (98%), responses to after-hours calls met their needs (86%), and the nurse or pharmacist explained the possible side effects of treatment (91%).

Nearly all patients said they understood the instructions on how to wash their hands (98%), give home infusion medications (97%), care for the IV catheter (97%), store their medications (96%), and use the home infusion pump (98%).

Jen Smith for Journal of National Comprehensive Cancer Network

Simpson MC, Haines DJ. Patient satisfaction and reason for discontinuation of home infusion for cancer patients. Presented at NCCN 2022 Annual Conference; March 31 – April 2, 2022. Abstract HSR22-168.

Last week the FDA approved a new ORAL specialty therapy, Vijoice (alpelisib) from Novartis Pharmaceuticals, indicated for breast cancer patients with evidence of mutation in the PIK3CA gene. Vijoice is a PI3K inhibitor that treats PIK3CA-related overgrowth spectrum (PROS) (a term for the rare condition that causes blood vessel abnormalities and overgrowth of tissue.)

Prior to this approval, the only treatment options for PROS were surgery or interventional radiology. Sold as the blockbuster drug Piqray (approved for breast cancer in 2019), alpelisib will be marketed under the brand name Vijoice for severe manifestations of PROS in adults and children two years of age or older. Available dosages of Vijoice differ from that of Piqray. Vijoice is the only drug specifically approved for the condition.

The recommended alpelisib dosage for pediatric patients (2-18 years of age) is 50 mg taken orally. The recommended dosage for adult patients (≥ 18 years) is 250 mg taken orally.

Novartis priced Vijoice at a wholesale cost of $32,500 for a 28-day course of therapy.The cost for Piqray oral tablets is around $19,555 for a 28-day course.

Given the rarity and cost of PROS it is expected that Vijoice will launch into limited distribution.

CLICK HERE to access Vijoice prescribing information

CLICK HERE to access Piqray prescribing information

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FDA approves alpelisib for PIK3CA-related overgrowth spectrum

On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

Efficacy was evaluated using real-world data from EPIK-P1 (NCT04285723), a single-arm clinical study in patients two years of age and older with PROS who received alpelisib as part of an expanded access program for compassionate use. Eligible patients had clinical manifestations of PROS that were assessed by the treating physicians as severe or life-threatening and necessitating systemic treatment and had documented evidence of mutation in the PIK3CA gene. The efficacy of alpelisib was evaluated in a total of 37 patients with at least one target lesion identified on imaging performed within 24 weeks prior to receipt of the first dose.

The major efficacy outcome measure was the proportion of patients with radiological response at week 24 as determined by blinded independent central radiology review, defined as a ≥20% reduction from baseline in the sum of measurable target lesion volume in up to 3 lesions confirmed by at least 1 subsequent imaging assessment. Duration of response was an additional efficacy outcome measure. Of the 37 patients included in the efficacy population, 27% (95% CI: 14, 44) had a radiological response at Week 24. Among responding patients, 60% had a response lasting 12 months or longer. 

The most common (≥ 10%) adverse reactions occurring in patients were diarrhea, stomatitis, and hyperglycemia.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

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

The FDA recently approved Opdualag (nivolumab and relatlimab-rmbw) from Bristol Myers Squibb, a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab1. The indication for this combo therapy is for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

This approval advances the trend toward combo therapies. For example, Opdivo, first approved in December of 2014, paired with Yervoy (another BMS therapy) in late 2020 for Mesothilioma and now the newly approved BMS therapy, relatlimab-rmbw for Melanoma.

Opdualag is an infused therapy administered every four weeks. Since the combo includes both an established therapy and a newly approved therapy the FDA determined that a distinct name and NDC be established. BMS indicated that relatlimab will only be sold in combination with Opdivo.

BMS said that Opdualag will launch at $27,389 for the combination with forecasted sales of $4 billion a year by 2029. Details on channel access / limited distribution were not provided.

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U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma

Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy, an established standard of care

Relatlimab is the third immune checkpoint inhibitor from Bristol Myers Squibb, adding to the Company’s growing and differentiated oncology portfolio

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdualag (nivolumab and relatlimab-rmbw), a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).1,2

The trial met its primary endpoint, progression-free survival (PFS), and Opdualag more than doubled the median PFS when compared to nivolumab monotherapy, 10.1 months (95% Confidence Interval [CI]: 6.4 to 15.7) versus 4.6 months (95% CI: 3.4 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 to 0.92, P=0.0055).1 The Opdualag safety profile was similar to that previously reported for nivolumab.1,2 No new safety events were identified with the combination when compared to nivolumab monotherapy.1,2 Grade 3/4 drug-related adverse events were 18.9% in the Opdualag arm compared to 9.7% in the nivolumab arm.2 Drug-related adverse events leading to discontinuation were 14.6% in the Opdualag arm compared to 6.7% in the nivolumab arm.2

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” said F. Stephen Hodi, M.D., director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute.3 “Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.”1,2

Opdualag is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions (IMARs) including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, myocarditis and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); and embryo-fetal toxicity.1 Please see Important Safety Information below.

“While we have made great progress in the treatment of advanced melanoma over the past decade, we are committed to expanding dual immunotherapy treatment options for these patients,” said Samit Hirawat, chief medical officer, global drug development, Bristol Myers Squibb.3 “Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach that builds on our legacy of bringing innovative immunotherapy options to patients. The approval of a new medicine that includes our third distinct checkpoint inhibitor marks an important step forward in giving patients more options beyond monotherapy treatment.”

HIPAA…. the lurking threat to every specialty pharmacy.

That’s a provocative statement….. but one that rings all too true.

Each year we hear of yet another SP that gets targeted for a HIPAA violation that, more often than not, has resulted in costly fines.

The news report below details yet another lawsuit for a HIPAA violation by a leading specialty pharmacy. Best efforts to prevent all data breaches are nearly impossible to guarantee….. but they can be useful in mitigating the scope of the breach and even the fines that are assessed.

Here are some factoids that are worth remembering…..

·     The largest HIPAA fine paid in the past five years was $16 million by Anthem due to insufficient ePHI Access Controls.

·     The smallest fine last year, $65,000, was paid this past December by an ambulance company.

·     A $100,000 fine was assessed on a company that had closed a year prior.

·     The largest fine paid by a pharmacy, $125,000, was for failure to properly dispose of paper records containing PHI.

·     Between 2009 and 2018 there have been 2,546 healthcare data breaches (involving more than 500 records). Those breaches have resulted in the theft/exposure of 189,945,874 healthcare records. That equates to more than 59% of the population of the United States.

·     Fines and consequences can range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million per year for each violation.

·     The Office for Civil Rights, a division of the Department of Health and Human Service (HHS), is responsible for HIPAA oversight.

Top 10 Most Common HIPAA Violations

1. Keeping Unsecured Records

2. Unencrypted Data

3. Hacking

4. Loss or Theft of Devices

5. Lack of Employee Training

6. Gossiping / Sharing PHI

7. Employee Dishonesty

8. Improper Disposal of Records

9. Unauthorized Release of Information

10. 3rd Party Disclosure of PHI (e.g., Business Associate)

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Florida Pharmacy Services Sued Over HIPAA Violations

The Middle District of Florida has filed a case against BioPlus Specialty Pharmacy Services. The case is related to disclosure of data protected by the Health Insurance Portability and Accountability Act (HIPAA).

The plaintiff was a customer of the defendants; the complaint explained that as a result she provided Personally Identifiable Information (PII) and Personal Health Information (PHI) to the defendant pharmacy. This information included her name, address, and other information.

The complaint said that the defendant was obligated under HIPAA to protect this information which it utilized to process and fulfill pharmacy needs. However, the defendant reported that its network was subject to a data breach and the information was retrieved by an outside party.

The plaintiff accuses the defendant of maintaining insufficient network security and failing to timely notify the potential class of victims of the data breach.

The plaintiff is seeking class certification and suing for negligence and declaratory judgment. They are represented by Morgan & Morgan and Markovits, Stock, & DeMarco LLC.