Month: October 2020

The article below, How Specialty Pharmacies Can Safeguard Against Fraud When Using Patient Assistance Programs, details yet another case including a specialty pharmacy. In this instance the SP was pinched by the feds for participating in a scheme to mickey with patient co-pay programs for Copaxone. Advanced Care Scripts, an Orlando based specialty pharmacy, was recently fined $3.5 million!

The details of the case are summarized in the article (link below)… but here’s the bottom line. If you want to avoid a big financial penalty, don’t step over well-defined lines of business behavior to collude with a manufacturer to violate laws.

Here are some best practices from the article that can keep specialty pharmacies (you) out of hot water related to patient assistance programs:
Carefully review data elements provided to drug manufacturers in data reports to ensure information about charitable support or status of a charitable support request is not provided.
Do not enter into contractual arrangements with drug manufacturers to coordinate charitable foundation support. Assisting patients in identifying such funding should be conducted as part of the pharmacy’s core services and not as directed by a drug manufacturer.
Train staff to avoid any coordination with pharmaceutical manufacturers on the provision of charitable funding to patients. This includes not only through contractual agreements but also by avoiding such discussions informally or in scheduled business reviews.
Ensure robust contractual language is in place clearly prohibiting pharmaceutical manufacturers from utilizing data provided by the specialty pharmacy to make charitable funding decisions.

One need not have been a lawyer to know when lines had been crossed in the ACS/TEVA case. Since $3.5 million is a whole lot bigger number than, say, $5000-$10,000 in legal fees, having your SP’s lawyer on speed dial might be the very next thing you do today.

Click here to read the complete article from Bass, Berry & Sims PLC

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Anton RX Reports are copyrighted by Anton Health, LLC.

HIPAA…. We all know everything there is to know about HIPAA, right??
…… Wrong.

One aspect of HIPAA that gets almost all the attention is how to prevent breaches of private healthcare information. If your specialty pharmacy is accredited, you have been through a bunch of orientations pounding the requirements into your brain.

But, how many orientations have you survived that focus on what to do after a breach of private information? We’ve provided a link to a good, but lengthy, article for your reading pleasure….. Ensuring Transparency: Language to Avoid in HIPAA Breach Notifications. The article is well worth a read if you are a specialty pharmacy professional….. for HIPAA compliance officers this should be a must read.

The author correctly states, “Breach notifications [to patients following a breach] often contain wishy-washy wording… while it may meet the minimum legal requirements, it doesn’t really tell people what actually happened to their personal information.”

In terms of transparency when it comes to HIPAA, notifications must include a brief description of the breach, types of information involved, steps affected patients should take to protect against potential harm, and what the covered entity is doing to both investigate the breach – and to prevent future incidents. Notices must also include contact information.

Health care providers should also be aware that HIPAA is not the only regulation that should govern their response to a security incident. States, federal regulations, and even foreign laws like the General Data Protection Regulation, may also govern the appropriate response.

So, is that it? Oh, no it is not.

The primary requirement in the aftermath of a breach is to be transparent in the notice to impacted patients. The secondary requirement is to know what language to avoid when making those communications.

Here are some highlights—-
avoid language that creates more uncertainty or anxiety
focus on what is known, not what is unknown , do not engage in speculation
avoid unsubstantiated facts….. but state (when pertinent) that certain facts may not known or are being withheld for security, legal or other reasons and provide supplemental notifications when more facts are known and can be shared
avoid deflecting blame for the incident by accepting qualified responsibility
don’t attempt to place the blame on another entity, such as the threat actor or a third-party vendor.

The article finishes with a section on best practices.

Click here to read the full article

Specialty pharmacies don’t think much at all about sales tax on prescriptions. That’s because only two states, Illinois and Minnesota, impose a sales tax on legend drugs. That might be the end of the story….. but there is more, so read on.

Walgreens Specialty Pharmacy, as an out-of-state pharmacy, had been dispensing millions of $$$s worth of prescription drugs over a five year period. They were assessed the state sales tax but requested a credit for those taxes thinking that they were an out-of-state vendor. However, the tax court felt differently and it ended up in the MN Supreme Court.

In Walgreens Specialty Pharmacy v. Commissioner of Revenue, the court held that Minnesota’s 2% gross receipts tax on sales of prescription drugs could be imposed on out of state pharmacies selling to Minnesota residents. OUCH!!

So, SPs may want to assess their own financial exposure to sales tax as an out-of-state vendor…. at least in Minnesota. More states may start taxing prescriptions given their dire financial straights caused by the pandemic.

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Do Prescription Drug Sales Taxes Apply to Out-of-State Pharmacies?

Issue of the Case
When an out-of-state specialty pharmacy distributes medications to residents of a state that has enacted a legend drug tax, is that out-of-state vendor subject to the 2% tax assessment?

Facts of the Case
A national pharmacy chain operated a multisite specialty pharmacy with dispensing locations in 6 states, but it did not have a location in the state that enacted a 2% legend drug tax, the state where this litigation arose. The state’s board of pharmacy had issued pharmacy permits to all the pharmacy locations operated by the firm, allowing it to ship medications to residents of the state. However, the specialty pharmacy did not own or rent any locations in the state, nor did it have employees there.

The firm did employ an in-state representative to promote its services to institutions, prescribers, and others. It did have contracts in place with health insurers and others to sell legend pharmaceuticals prescribed by in-state prescribers to in-state patients. It maintained a website that patients could use to request refills. During the 5-year period that was the focus of this litigation, the pharmacy provided hundreds of thousands of prescriptions to citizens of the state worth hundreds of millions of dollars.

The prescription orders were fulfilled with legend drugs obtained from manufacturers or wholesalers located outside the state. The specialty pharmacy would present the prepared medications to a common carrier, such as Federal Express or United Parcel Service, which would deliver them to the patient’s home or a treatment facility where they were to be administered.

The specialty pharmacy operated as a limited liability company and filed amended tax returns with the state’s department of revenue requesting a refund of the 2% legend drug taxes that it had paid on its wholesale cost for the prescription medications that it had sold to patients in the state during the 5-year period.

The commissioner of revenue denied the claimed refund, so the specialty pharmacy appealed the decision to the state’s tax court. That judicial entity agreed with the pharmacy, ruling that the tax did not apply to these wholesale transactions because the pharmacy had received the medications outside the state.

In the course of announcing its decision, the tax court recognized that a provision in the relevant state tax statute “provides that delivery of drugs with the state can trigger liability for the tax.”

However, this court ruled that the statute imposes tax “solely on the receipt of drugs.”

That meant the specialty pharmacy was due the claimed refund because it received the drugs outside the state. The commissioner of revenue disagreed and took the case to the state Supreme Court.

The Ruling
The highest court of the state disagreed with the tax court, ruling in favor of the commissioner of revenue’s interpretation that the tax assessment did apply to the specialty pharmacy.

The Court’s Reasoning
The state Supreme Court pointed out that the statute in question, the legend drug tax, was one of a number of state statutes creating provider taxes applicable to the gross revenues of hospitals, pharmaceutical wholesalers, and surgery centers to fund a state-level health insurance initiative for individuals with low incomes. This program supplements the state’s Medicaid program because it has higher income limits than Medicaid.

In the case of pharmaceuticals, the tax is calculated at 2% of the “price paid [wholesale cost]” by those who deliver or receive legend drugs in the state.

The court clearly demarcated the line of division between the parties: The pharmacy argued that the statutory tax applies only to the receipt of drugs in the state, whereas the revenue department took the position that the tax assessment applies to in-state sale or delivery of the medications.

The court turned to 2 accepted principles of statutory interpretation: First, when the intent of the legislature is clear from unambiguous language of the statute, the statute is to be applied according to its plain meaning; and second, statutes are to be interpreted to give effect to all their provisions and assume that the legislature does not intend to enact unconstitutional statutes.

Applying those principles, the state’s highest court concluded that “The plain language of the statute at issue here encompasses out-of-state pharmacies that deliver legend drugs to in-state patients for use within the state.”

Joseph L. Fink III, BSPHARM, JD, DSC (HON), FAPHA

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For more information contact:
Jim Larweth
Anton Health
773-230-2525
Jim.Larweth@AntonHealth.com

www.AntonHealth.com

Anton Health is pleased to announce its recent acquisition of the assets of Specialty Pharmacy Solutions (SRx), a strategic planning, marketing, and operations consulting organization exclusively focused on the Specialty Pharmacy segment.

Since its founding in 2018, Anton Health has become one of the healthcare industry’s most respected consulting organizations, offering highly tailored support services to pharmaceutical manufacturers seeking to develop strategically sound marketing strategies.

Anton Health’s Executive Vice President, Jim Larweth, said “The acquisition of Specialty Pharmacy Solutions not only allows Anton Health to greatly expand its service offerings to our pharmaceutical manufacturer clients, but also supports our partnership expansion with Health Plans and Specialty Pharmacies.”

Increasing demand for specialty drugs to treat complex or serious chronic conditions, and how to pay for them, has become a central concern for both pharmaceutical manufacturers as well as payers.

Since 2005, Specialty Pharmacy Solutions has published an online journal, the SRx Client Alerts. Over that period, SRx has published more than 3,000 Alerts covering virtually every significant development in the Specialty Pharmacy industry, offering its subscribers expert insight into the significance of each development. Going forward, the SRx Client Alerts will be rebranded as the Anton Rx Report.

“I’m excited to join the team at Anton Health, and to continue writing content for the expanding Anton Rx Report”, said SRx President Bill “Sully” Sullivan. “We plan to bring even greater value to the thousands of managed care industry professionals that we reach on a weekly basis by not only sharing breaking news, but adding actionable insights.”

About Anton Health
Anton Health was designed specifically to help pharmaceutical manufacturers navigate the evolving payer landscape. Whether gaining expert insights via the Anton Health Network™, or accessing real-time market intelligence via their RapidApp™, Anton Health works closely with clients to formulate contracting strategies, gain feedback on pre-launch product positioning, and monitor the competitive landscape for improved profitability.

About Specialty Pharmacy Solutions (SRx)
SRx provides expert consulting support to the Specialty Pharmacy industry. Over the past eighteen years, SRx has counted virtually all of the top fifty specialty pharmacies as clients. Working with pharmaceutical manufacturers, SRx has been involved with the launch of more than twenty specialty therapies to the marketplace. It has also designed and launched specialty pharmacy networks for national payer organizations and PBMs.

For more information contact:
Jim Larweth
Anton Health
773-230-2525
Jim.Larweth@AntonHealth.com

www.AntonHealth.com

If you did a side by side comparison of the leading PBM Annual Trend Reports you would be challenged to see much difference when compared to the 2019 reports recently published by CVS, Express Scripts and Prime Therapeutics. In the past these reports would run upwards of a hundred pages chock full of data and charts…. today we are lucky to get a dozen or so pages with watered down, executive level summaries. Our Alert unapologetically offers an even more watered down summary for your reading pleasure (at least it is a relatively fast read)…. and, we also include some provocative questions to ponder. We’ve also provided links to the three PBM reports below.

For most of the past decade, traditional drugs shrank to low single digit or negative trend rates. But specialty is now racking up lower than historic trend increases for a two key reasons.

• Utilization – It spiked in 2019…. but less than most years since 2010. We attribute that to the number of lives newly insured in 2019. Lots of people (especially uninsured / not eligible for Medicaid) took jobs offering health insurance last year. Also, a number of next generation / first-in-class therapies approved last year likely added new patients previously on non-specialty maintenance therapies. Although the numbers of patients may be low for these (mostly orphan) drugs, their average cost was significantly higher. It will be very interesting to see the impact of the Corona virus driven by job layoffs and disruption in healthcare access.
• Unit Cost – Specialty saw hefty unit cost increases for mostly new product launches in 2019. Conversely, 2019 saw one of the lowest price increase trends for established therapies over the past decade….. perhaps driven by manufacturers seeking to deflect congressional intervention, a hot topic last year.

What noteworthy items jumped out of these trend reports?

• First…. both ESI and CVS spotlighted their ‘tightly managed’ specialty programs. While granular details were not provided, the results were eye popping. For example, ESI touted a -5.2% (yes, a YoY reduction) for participating plans in their SaveonSP® specialty patient assistance solution (sounds almost philanthropic) program vs. 12.3% for nonparticipating plans! That’s huge. By comparison, CVS touted a specialty trend of +8.9% in their tightly managed program and 13.2% trend in their non-managed program. CVS took a big red pencil to their specialty formulary for 2019 and deleted a number of specialty products (they did that again for 2020).
• Second….. no information was provided related to rebates and how they are reflected – or not – in the published trend numbers.
• Third….. the reports suggested that plan member out-of-pocket contributions were at record lows. However, we’ve seen that these large plans have implemented copay accumulator and copay maximizer programs that essentially shift a lot of $$$s off the books. The amount of that $$ shift is a big unknown and may be sweetening the trend numbers.

Yes, time to groan, another missive on the 340b program. At least there are some new statistics about the program that should wake up the majority of specialty pharmacies that aren’t skimming the cream off this program unlike a few others. The 340b program has come under the most intense scrutiny that we’ve seen in years. As we mentioned in our last Alert, the full court press by Pharma (against 340b) and the hospital industry, lobbying just as hard to preserve 340b, is fierce. Key findings from the referenced report (Note, it was sponsored by Pharma) show that many retail pharmacies and other third parties have taken advantage of and financially benefited from the 340B program’s contract pharmacy arrangements: — The data showed an average profit margin of 72% on 340B medicines commonly dispensed through contract pharmacies vs. a margin of 22% for non-340B medicines dispensed through independent pharmacies. — 340b covered entities and their contract pharmacies generated an estimated $13 billion in gross profits on 340b purchased medicines in 2018, which represents more than 25% of pharmacies’ and providers’ total profits from dispensing or administering brand medicines. — Following HRSA’s expansion of the contract pharmacy program in March 2010, contract pharmacy participation grew a staggering 4,228% between April 2010 and April 2020. While over 27,000 distinct pharmacies participate in the 340B program today, over half of the 340B profits retained by contract pharmacies are concentrated in just four pharmacy chains – Walgreens, Walmart, CVS Health and Cigna’s Accredo specialty pharmacy. A word on specialty pharmacy participation. Statistics were not available to adequately break out SP revenues by pharmacy type (SP vs. retail/chain). We believe that the lion’s share of specialty prescriptions is being filled by the handful of big box SPs. That’s not surprising as a hospital is likely to select a primary pharmacy partner to consolidate all its 340b transactions into one, more manageable relationship (just like a manufacturer selecting a limited distribution partner for a newly launched drug.) Click here to read the full report , “For-Profit Pharmacy Participation in the 340B Program” __________________________________________________________________________ New Analysis Shows Contract Pharmacies Financially Gain From 340B Program with No Clear Benefit to Patients New Analysis Shows Contract Pharmacies Financially Gain From 340B Program With No Clear Benefit to Patients WASHINGTON, Oct. 8, 2020 /PRNewswire/ — Today, the Berkeley Research Group (BRG) published an analysis of historical trends in 340B contract pharmacy arrangements. The findings conclude that the growth in the number of these arrangements is fueling explosive growth in the program at large and driving the 340B program farther and farther away from its original intended goal of providing discounted medicines to safety-net entities treating uninsured and vulnerable patients. Congress created the 340B program to help safety-net providers, including certain qualifying hospitals and federally funded clinics, access discounts on prescription medicines for low-income or uninsured patients. In 2010, a Health Resources and Services Administration (HRSA) policy opened the door to allow all 340B entities to contract with an unlimited number of for-profit retail pharmacies (e.g., CVS, Walgreens) to dispense 340B medicines. While this policy may have been intended to improve patient access to needed medications, it had the misguided effect of creating an opening that allowed for-profit vendors, pharmacies and pharmacy benefit managers to exploit the program and make a profit on 340B sales – sales intended to benefit low-income and vulnerable patients. “It is clear that contract pharmacies have leveraged market power to drive unprecedented program growth and siphon money out of the program and away from vulnerable patients,” said Stephen J. Ubl, president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA). “I urge lawmakers to consider the results of this analysis and pursue policies that ensure the 340B program benefits vulnerable patients rather than just line the pockets of for-profit corporations.” Analysis after analysis shows there is explosive growth in the program, but there is little to no clear evidence that this growth has benefited low-income and vulnerable patients. Even the New England Journal of Medicine found no evidence that expansion of the 340B program has resulted in improved care or lower mortality among low-income patients. These new findings build upon a mounting body of evidence from the Government Accountability Office (GAO) and HHS Office of the Inspector General, which show hospitals are taking advantage of contract pharmacy arrangements to generate additional revenue through 340B without ensuring that low-income patients are benefiting from manufacturer discounts. GAO found that more than half of 340B hospitals surveyed reported that they did not share discounts with patients at their contract pharmacies. OIG found similar evidence, noting some 340B hospitals “do not offer the 340B price to uninsured patients in any of their contract pharmacy arrangements. … [I]f covered entities do not, their uninsured patients pay the full non-340B price for prescriptions filled at contract pharmacies.” To learn more about the 340B program and ways to fix the program, visit PhRMA.org/340B. About PhRMA The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested nearly $1 trillion in the search for new treatments and cures, including an estimated $83 billion in 2019 alone. Source: Pharmaceutical Research and Manufacturers of America (PhRMA)

Many are starting to question whether there will be a future for specialty pharmacy…. at least how we know it today. That being said, an optimist would say that even a buggy whip company could remain viable after the arrival of the automobile with enough innovation.

Specialty pharmacies don’t have mush room left to be innovative. Much of that innovation has already taken place with the emergence of advanced data management capabilities, integrated electronic health records to expedite and monitor patient status through artificial intelligence, tailored therapy-specific care management protocols, numerous operational efficiencies, etc. But one area still remains an opportunity for improvement and innovation, Value Based Initiatives.

The article below is a good overview of how and where specialty pharmacies may develop that innovation and ensure that their businesses will not go the way of the buggy whip company. “Working with patients, caregivers, prescribers, payers, and pharmaceutical drug manufacturers, specialty pharmacies promote value by coordinating care for complex health conditions across a diverse range of stakeholders and uniting patient touch points within a fragmented health care system.”

As the concept of value-based arrangements is evolving, the interest level by health plans is climbing. Value based deals are still tough to measure since results may need to be based on long timelines (years?) and metrics need to be precise (not easy…. but that’s where a specialty pharmacy can best participate, especially under the medical benefit which has historically been a black hole.)

The article spotlights a framework and five elements for specialty pharmacies to pursue.
— Understanding Shared Health Needs of Patients
— Designing Comprehensive Solutions to Improve Health Outcomes
— Integrating Learning Teams Measuring Health
— [Linking] Outcomes and Costs
— Expanding Partnerships

These elements add up to a more powerful model for specialty pharmacy that should be sustainable for the foreseeable future.

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How Specialty Pharmacy Will Thrive in the Value Era

2020-10-08 The era of fee-for-service health care is nearing an end. In its place, value-based initiatives seek to improve patient outcomes, reduce cost, and increase transparency in health care. These changes represent significant opportunity for specialty pharmacies to demonstrate their ability to create sustainable value across the health care continuum.

The Need for Value-Based Initiatives
The United States spends more per capita on health care than any other developed nation. According to the CMS, National Health Expenditures (NHE) in the US are predicted to outpace the growth of GDP through 2027 when health spending is predicted to exceed $6 trillion.

Despite spending the most, the US falls behind other developed countries in several key health indicators. The US has the highest incidence of chronic disease burden, the highest rates of obesity, and among the largest numbers of both preventable hospitalizations and avoidable deaths. Coupled with an aging population, rapidly expanding drug portfolios, and a fragmented health care system that tends to promote volume over outcomes, it’s clear why there is a push for change.

A Framework for Value
Michael Porter is a Harvard Business School professor whose extensive work in economics, strategy, and social causes has earned worldwide recognition. Porter and Elizabeth Teisberg wrote the book Redefining Healthcare, providing a widely accepted framework for a value-based health care system. They define value in health care as “The measured improvement in a patient’s health outcomes for the cost of achieving that improvement.”

In addition to defining value in health care, Porter describes a “paradox” in the US health care system which focuses on shifting cost and increasing bargaining power while restricting patient choice—none of which ultimately create value for the patient. Porter proposed a set of principles focused on high-quality, less costly care, improving value for patients, advancing unrestricted competition based on results, focusing on the full cycle of care, and value that is driven by provider experience, regional and national competition, transparency, and strongly rewarding innovation.

In a recent article in the Journal of the Association of American Medical Colleges, Teisberg et. al provide a strategic framework for implementing value-based health care. The framework includes 5 broad imperatives for value: understanding shared health needs of patients, designing comprehensive solutions to improve health outcomes, integrating learning teams, measuring health outcomes and costs, and expanding partnerships. These 5 imperatives have significant implications for health care delivery and defines a space where specialty pharmacy has opportunity to act as a driver of value within the broader health care system.

Value Based Care and Specialty Pharmacy
Specialty pharmacies are uniquely positioned to thrive in the era of value-based health care. Working with patients, caregivers, prescribers, payers, and pharmaceutical drug manufacturers, specialty pharmacies promote value by coordinating care for complex health conditions across a diverse range of stakeholders and uniting patient touchpoints within a fragmented health care system. Driving positive patient outcomes and managing costs are at the core of specialty pharmacy services.

As the Medicare Access and CHIP Reauthorization Act of 2015 and other federal legislation seeks to fundamentally change health care delivery and payment for health care services, specialty pharmacies are successful because of their proven ability to drive value in spite of the existing health “paradox” as described by Porter. Independently owned specialty pharmacies in particular are in a unique position in the current shift to value-based care because they are already organized around the imperatives as outlined by Teisberg while functioning outside of health systems and third-party payer organizations more closely tied to the fee-for-service system.

Specialty pharmacies align under Teisberg’s 5-point framework as follows:

Imperative 1: Understanding Shared Health Needs of Patients
Specialty pharmacies understand the unique clinical needs of patients with complex, often chronic health conditions and the drugs used to treat them. Specialty pharmacies build clinical programs with clinicians and staff who have extensive training and experience with specific disease states, drug classes, and comorbid conditions. Specialty pharmacists take the time to understand the unique clinical, psychosocial, and financial needs of the patient groups they serve, promoting continuity and establishing relationships based on trust and mutual understanding. Understanding the broad needs associated with a particular condition such as hemophilia or drug class such as IV/SC-Ig allows experienced clinicians to deliver targeted, individualized care to a specific group or groups of patients.

Imperative 2: Designing Comprehensive Solutions to Improve Health Outcomes
Specialty pharmacies use medication therapy management (MTM) to coordinate comprehensive care for patients and improve health outcomes. MTM employs a range of clinical tools to improve outcomes and promote value, including therapeutically focused clinical assessments, validated quality of life measures, detailed medication reconciliation, monitoring adverse effects, connecting patients to educational resources, peer-based support programs, and access to need-based financial resources reducing barriers to care. Specialty pharmacies provide patient level support reducing health system and therapy complexity by explaining benefits and coverage, coordinating the best site of care for injected or infused medication, providing drug administration training, adherence support, and resources empowering patients to independently manage complex, persistent treatment plans.

Imperative 3: Integrating Learning Teams
Specialty pharmacies leverage highly experienced, multi-disciplinary teams to promote value. By integrating clinical teams with intake, billing and care coordination specialists, specialty pharmacies speed access to care, remove barriers to treatment, and reduce therapy abandonment. Integrating clinical and nonclinical teams create synergies that do more than promote access and positive outcomes for patients. Aligning teams around shared goals creates a workplace culture focused on process improvement, cross-functional learning, and organizational efficiency.

Imperative 4: Measuring Health Outcomes and Costs
Specialty pharmacies have long been required to demonstrate their ability to improve outcomes and reduce cost to be included in payer networks, earn referrals from prescribers, and obtain Limited Drug Distribution agreements from pharmaceutical manufacturers. Specialty pharmacies are also required to measure outcomes to maintain accreditation from leading health care accreditation agencies. Specialty pharmacies employ sophisticated software and tools to track response to therapy, monitor dosing, utilization, and adverse effects while tracking costs. These tools allow pharmacists to deliver data-driven interventions, reducing unnecessary hospitalizations or adverse events.

Data collected by specialty pharmacies drive value across stakeholder groups: patients better understand the benefits and outcomes of their treatment plan, prescribers receive a complete picture of response to therapy for a patient or group of patients, pharmaceutical manufacturers discern insights into the efficacy of their product, and payers develop deep insight into cost and cost drivers for high-dollar health conditions.

Imperative 5: Expanding Partnerships
Specialty pharmacies work with an array of stakeholders across the health care continuum to drive value. In a fragmented health care system, specialty pharmacies use these partnerships to promote continuity and facilitate a better understanding of patient-level needs and experiences across stakeholder groups. By expanding partnerships with each of the traditional health care stakeholders and developing relationships in new areas, including patient advocacy groups, government organizations, and a growing digital health industry, specialty pharmacies have significant opportunity to improve patient care, scale operations, and reduce complexity in the health care system.

Toward a Better Future
Porter affirms, “Value in health care is determined in addressing the patient’s particular medical condition over the full cycle of care, from monitoring and prevention to treatment to ongoing disease management.”4

Specialty pharmacies will thrive in the era of value-based health care because their business model is already firmly centered in creating value. As health systems, independent physician practices, payers, pharmaceutical manufacturers, and patients navigate this new environment, specialty pharmacies are uniquely positioned to lead as a valued, experienced member of a multi-disciplinary, multi-stakeholder team facilitating a shift to a paradox free, value-based healthcare system.

JUSTIN LINDHORST, MBA,
BioMatrix Specialty Pharmacy.
Published 10/2020 Pharmacy Times

Earlier this week we sent an Alert talking about Specialty Generics. Today we’re talking about another emerging trend in specialty, combination therapies.

The FDA just approved yet another combo last week. This one pairs Opdivo with Yervoy for the first-line treatment of adults with malignant pleural mesothelioma, a type of cancer caused by inhaling asbestos fibers, that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and only the second approved therapy for mesothelioma. Curiously, the FDA approved pemetrexed in combination with cisplatin for this same indication sixteen years ago (not such a new idea, huh?)

Unlike most recent combo therapy approvals this one will not launch under a new name or a single NDC. The approval is essentially for the new indication and related dosing and safety guidelines. According to our records, Yervoy is available only through limited distribution.

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FDA Approves Drug Combination for Treating Mesothelioma

October 02, 2020 — Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.

“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

Malignant pleural mesothelioma (MPM) is a life-threatening cancer of the lungs’ lining caused by inhaling asbestos fibers that about 20,000 Americans are diagnosed with each year. MPM accounts for most mesothelioma diagnoses, and most patients have an unresectable (unable to be removed with surgery) tumor at time of diagnosis. With currently available therapy, overall survival is generally poor. Opdivo and Yervoy are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function.

This combination therapy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients received intravenous infusions of Opdivo every two weeks with intravenous infusions of Yervoy every six weeks for up to two years, or platinum-doublet chemotherapy for up to six cycles. Treatment continued until disease progression, unacceptable toxicity or completion of two years. The objective was to determine if Opdivo in combination with Yervoy improved overall survival compared to chemotherapy. At the time of the analysis, patients who received Opdivo in combination with Yervoy survived a median of 18.1 months while patients who underwent chemotherapy survived a median of 14.1 months.

The most common side effects of Opdivo in combination with Yervoy in patients with MPM include: fatigue, musculoskeletal pain, rash, diarrhea, dyspnea (difficulty breathing), nausea, decreased appetite, cough and pruritis (itching). Yervoy can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs, such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Patients should tell their healthcare providers if they have immune system problems, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant or plan to become pregnant before starting treatment.

The FDA granted approval to Bristol-Myers Squibb Company.