Keith Loria

Keith Loria is a contributing writer to Medical Economics.

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, vice president of market access for biologics at McKesson, wants people to know that it takes a lot to make patient-centeredness more than just a marketing tagline.

“It is rigor and discipline and continuous learning that helps us get the right drug to the right patient at the right time and once having done that, help the patient match the therapy to optimize their outcome,” Bickley said today during her presentation at the 4th Annual 

, which was held because of the COVID-19 pandemic.

The meeting's theme was “Maintaining Patient-Centeredness,” and Bickley’s talk was titled, “Putting the Patient First.” She discussed the value that specialty pharmacies provide, noting that truly taking care of people in a patient-centered fashion requires collaboration among 13 different types of professionals. 

Bickley sketched the roles of several professionals, from pharmacists doing risk assessments and getting patients starting on therapy to patient care coordinators at specialty pharmacies overseeing refills to business intelligence experts who collecting data that helps the pharmacy team understand early therapy adoption and the payer response to these therapies. Bickley also discussed intake and patient access specialists who help with prior authorization and take steps to mitigate the financial challenges that some patients might have.

Bickley said patient access is a two-sided effort. She said her job is to work with payers and negotiate contracts that give us access to patients through their specialty pharmacy networks. 

“My partners on the biopharma-facing team are responsible for getting access to these products. We call that the barbells of patient access.”

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McKesson VP says implementing patient-centeredness involves 13 different types of professionals.

PBMI Specialty Rx Forum Speaker Paula Bickley: Making Patient-Centeredness More Than Just a Tagline

Will COVID-19 accelerate or put the brakes on the move toward value-based payment? Christopher Chen, M.D., CEO of Miami-based ChenMed, says doctors will embrace value over volume as layoffs and work reductions hit hospitals and medical practices that depend on fee for service. Others expect a tendency to hit the pause button as payers and practices sort through the uncertainty stirred up by the pandemic.

Here are snapshots of four current value-based efforts:

of Massachusetts’ Alternative Quality Contract:

Lauded as one of the earliest and most successful value-based care programs in the country, the Blue Cross Blue Shield of Massachusetts Alternative Quality Contract (AQC) sets a global budget for patient care. In the now-familiar arrangement seen with ACOs, providers receive a percentage of the “savings” if they deliver care below budget and pay out losses if they exceed the budget.

“The program is a pioneer in encouraging providers to treat the whole person — the medical, behavioral and social needs of patients,” says Maria Perrin, chief growth officer of HMS, a population health and healthcare payment company in Irving, Texas. Perrin points to the 2019 study by Zirui Song, M.D., Ph.D., and colleagues AQC saved, on average, $461 per year per member. The study covered an 8-year period from 2009 to 2016.

The AQC was launched in 2009 as a development project by the Massachusetts Blues plan and providers in Massachusetts, a state with a recent history of experimentation and innovation in healthcare coverage and payment. The 2006 law that expanded healthcare coverage in Massachusetts —so-called Romneycare — was a forerunner of the ACA. The AQC program, which is itself a prototype for ACOs, now has more than 80% of Massachusetts providers participating.

“While the results of many value-based care programs are still developing and, in some cases, such as with CMS’ Hospital Readmissions Reduction Program, highly debated, the AQC is an example of a very successful VBC (value-based care) program with clear benefits,” Perrin says. “The AQC was also ahead of trends in recognizing the need for integrated care, addressing medical, behavioral and social determinants. Further, the structure of the AQC is one that does not require regulatory or legislative actions, so it can be adopted by other health plans and health systems with relative ease.”

2. Hospital Readmissions Reduction Program

The CMS Hospital Readmissions Reduction Program is a Medicare value-based program focused on reducing post-discharge readmission rates. Started in 2012 as part of the ACA, the program imposes financial penalties on hospitals with higher-than-expected readmission rates. Last year, 2,583 of 3,129 hospitals, or 83%, were penalized under the program. The penalty, which varies with the readmission rate, is collected by lowering the Medicare payment to hospitals. According to Kaiser Health News, the lower payments will cost the hospitals, collectively, $563 million during the 2020 government fiscal year.

Hospitals have objected to the readmissions program. But John E. Morrone, a partner in the healthcare department of Frier Levitt, explains that the program is intended to connect reimbursement to quality hospital care, prudent discharge planning and better coordination of care with post-discharge providers. The program is limited to several condition and procedures, including acute myocardial infarction, chronic obstructive pulmonary disease, coronary artery bypass surgery and total knee and hip replacements. “Those diagnoses lend themselves to frequent readmission due to poor discharge planning and/or poor post-discharge compliance with drug regimen, physical therapy and behavior modification (such as diet and exercise),” says Morrone. Conversely, he notes, multidisciplinary programs, chronic care management and remote patient monitoring are effective approaches to those conditions and procedures.

Moreover, there is good evidence that some relatively straightforward interventions are associated with fewer readmissions. For example, heart failure patients who are prescribed an ACE inhibitor or an angiotensin receptor blocker when they are discharged from hospital have lower readmission rates than those who don’t get such a prescription.

3. Oncology Care Model and its successor, Oncology Care First

The Oncology Care Model (OCM) is CMS’ most important value-based care payment program in oncology, and it is scheduled to be followed in 2022 by a successor program, the Oncology Care First (OCF) Model. Started in 2016, OCM is a voluntary program that CMS says currently includes 138 practices, down from close to 200 several years ago, and 10 payers. As with many value-based payment arrangements, the practices participating in OCM can earn shared savings if they beat certain financial benchmarks; downside risk, which involves paying a penalty if spending exceeds the target but also a chance at greater shared savings, is an option. The participating practices are also paid a Monthly Enhanced Oncology Services (MEOS) payment of $160 per patient for care coordination and other “care transformation” improvements, such as giving patients around-the-clock access to a clinician who has ready access to their medical services and some patient navigation services.

OCF nudges oncology payment further along toward capitation by combining payment for evaluation and management services and drug administration with the MEOS payment into a single prospective payment. CMS incorporated some other changes into OCF that are generally seen as advantageous to oncology practices, such as considering adjustments for expensive new therapies on a cancer-by-cancer basis instead of grouping them together.

OCM has received mixed reviews, but an evaluation of its first three performance periods that came out in May was quite damning. It found that OCM showed no overall effect on per-episode payments (the modest $145 per-episode decrease was not statistically significant) and little evidence that the program incentives led to less low-value care (some combination of higher expense and poorer outcomes) and more high-value care (lower expense, better outcomes). Moreover, during the first two pay periods, OCM ended up costing the Medicare program money because the small decline in per-episode payment was offset by what it paid out in MEOS payments and performance-based bonuses for beating the financial benchmarks.

Christopher J. Kutner, a partner at New York State law firm Rivkin Radler who represents managed care organizations and physician groups, says commercial payers want to expand value-based models to better predict the cost of care. But he also points out claim systems were designed for fee-for-service reimbursement. “It’s a drastic change and challenging for payers and providers to operate on a bundled case rate or episodic payment structure.”

“Success hinges on oncologists being incentivized and enabled to deliver high-quality care alongside measurable cost savings,” Kutner adds. “Cancer care is extremely expensive, so I am encouraged that there are some emerging opportunities that stakeholders must examine in order to realize value in today’s oncology reimbursement models.”

Between 30% to 40% of hospital inpatients (with or without diabetes) require insulin therapy during their stay. And despite its impact on health outcomes and the fact that it is largely preventable, hypoglycemia remains a very common occurrence. A study published by the Office of Inspector General shows that hypoglycemia is the third most common adverse drug event among Medicare patients.

Robby Booth, senior vice president of research and development and founder of Glytec, a company that sells insulin-dosing technology, says the new CMS hypoglycemia measure will gain a lot of buzz as the industry shifts more toward value-based care models.

“The program is designed to incentivize safer insulin management practices for hospitalized patients in order to reduce the incidence of insulin overdoses and hypoglycemia, which has a significant impact on the quality and cost of care,” Booth says. “The new CMS hypoglycemia measure (will) address these troubling statistics by incentivizing hospitals to implement clinical workflows that reduce the likelihood of hypoglycemia events.”

The measure hasn’t gone into effect yet, but it is in the final approval stages. The program is a stand-alone measure, but Booth expects that it will be followed up by another measure focused on hyperglycemia.

The program requires health systems to report severe hypoglycemia rates that are tied to a bonus payment. If the health systems don’t track the data, they lose the additional money.

“The agency will eventually use the collected data to establish a penalty for hospitals that report high levels of hypoglycemic events, which could add up to millions depending on the size of the health system,” Booth says.

®, is a freelance writer based in the Washington, D.C., area.

The work of moving away from fee for service is in progress. The results so far? Mixed.

Are we there yet? A look at 4 value-based care programs

About six million Americans are currently living with Alzheimer’s disease, and it is now the sixth leading cause of death in the U.S. According to several estimates, the number of Americans living with the condition will almost double by 2050, partly because of the demographic bulge of baby boomers entering their oldest years.

Andrea Pfeifer, Ph.D., CEO and co-founder of AC Immune, a Swiss biotech company that has several Alzheimer’s treatments in development, says dementia is one of the greatest challenges in healthcare.

“Globally, there is a new case of dementia every three seconds, adding up to around 50 million people worldwide, and the global cost of dementia stands at about $1 trillion — and we still don’t have an effective treatment or cure.”

By some accounts, the cupboard is bare because Alzheimer’s researchers have been going after the wrong target. For years, the prevailing theory about the disease has implicated accumulation of beta amyloid plaques in the brain as a primary cause. But agents targeting beta amyloid have fizzled in clinical trials. Researchers — and drug developers — have been forced to reconsider the hypothesis.

Mesfin Tegenu, M.S., R.Ph., president of PerformRx, a PBM in Philadelphia owned by AmeriHealth Caritas, says researchers are now eyeing other targets for treatment. “One such target is the tau protein, which is believed to be integral in the formation of (neurofibrillary) tangles seen in the brains of individuals with Alzheimer’s disease,” he says. The “tauists” have been debating “beta amyloidians” for decades, and beta amyloidians have had the upper hand until recently, particularly with respect to treatments that made it into clinical trials. But there is new interest in tau as a target and in February of this year, 650 people attended Tau2020 in Washington, D.C., a global conference devoted to “taupathies.”

But the turn to tau hasn’t meant a complete about-face on beta amyloid. In fact, the most-watched Alzheimer’s agent right now is Biogen’s aducanumab, a monoclonal antibody that targets beta amyloid. Despite some negative trial results, which Biogen interprets differently, the Boston-based company has forged ahead with seeking FDA approval for aducanumab. And the agency has put aducanumab in its “priority review” approval category, so there should be a decision on whether it is approved or not in March 2021.

Biogen’s aducanumab push is occurring against a backdrop of disappointing news this year about monoclonal antibodies that target beta amyloid. Most conspicuously, investigators announced that solanezumab, a monoclonal antibody, had faltered in a late-phase trial. Results showed no improvement in patients in a composite score of four different cognitive tests.

Gantenerumab, an antibody designed to degrade beta amyloid plaques, was tested in the same trial as solanezumab and, like solanezumab, it also didn’t pass muster with respect to the primary outcome of improved results on cognitive tests. However, other results suggested it still has some promise, and patients in the original trial were invited to participate in an continuing open-label extension.

Jeffrey L. Cummings, M.D., Sc.D., a research professor at the University of Nevada School of Integrated Health Sciences, Las Vegas, and director of the Chambers-Grundy Center for Transformative Neuroscience, says that Alzheimer’s clinical trials over the past five years have shown a “progressive emphasis” on targets other than beta amyloid, including inflammation, synapse and neuronal protection, and vascular factors. Cummings also notes a marked growth in repurposed agents.

Pfeifer, at AC Immune, highlighted semorinemab, an anti-tau antibody that her company is developing in partnership with Genentech, when discussing the products her company has in its pipeline. 

“Tau protein is mostly present in neurons and functions as a component of the cytoskeleton inside the cells and is involved in axonal transport,” Pfeifer explains. “Misfolded tau protein aggregates in AD and other tau-related neurodegenerative diseases (for example, progressive supranuclear palsy, frontotemporal dementia and others). The progression of tau pathology throughout the brain is closely associated with the onset and progression of cognitive decline, underscoring the importance of tau-targeted therapies.”

 and after earlier version of this story appeared in the September print issue of the publication, AC Immune and Genentech announced negative results from a high-profile phase 2 trial of semorinemab called the Tauriel Phase 2 trial. The drug failed to meet its primary endpoint and two secondary endpoints, according to an 

dated September 23. The headlines about the drug described it as a flop and cast tau as another off-base target. "Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer's disease patients," was the first line of the 

 story about the semorinemab results.  Pfeifer was quoted in the prepared statements as saying the news was "surprising and disappointing," but she also spoke of the company's diversified approach to Alzheimer's.

The beta amyloid versus tau divisions may be fading. Pfeifer says opinion leaders in Alzheimer’s have started to float the idea that combination therapies are going to be needed in much the same way they are used to treat HIV, cancer and other diseases.

“We think this will be the case in Alzheimer’s as well because it is a complex disease with many contributing and potentially causal factors,” said Pfeifer in the interview with 

 before the semorinemab phase 2 results came out. “As such, it may be difficult for a drug with a mechanism of action focused on a single part of the disease process, such as beta-amyloid plaques, to make a meaningful impact, especially in symptomatic patients.”

“This is excellent news for everyone involved in Alzheimer’s research, and hence for AC Immune—every new piece of data we build up as an industry is important for informing the search for a successful treatment,” she continued.

Pfeifer sees another development on the horizon: Precision medicine to properly diagnose and treat neurodegenerative diseases, including Alzheimer’s disease. Her company is actively pursuing positron-emission tomography (PET) tracers against multiple relevant targets, including alpha-synuclein and TDP-43, as well as tau.

Tau may be enjoying a star turn, but Pfeifer says the concept that anti-beta amyloid therapies are most effective in the early stage of the disease, and, in particular, in preclinical AD, is still a valid one.

Her company has several active anti-beta amyloid projects, including an anti-beta amyloid antibody, called crenezumab, and an anti-beta amyloid vaccine, called ACI-24. The re-analyses and potential approval of aducanumab could potentially be highly relevant for those products and the beta amyloid approach in general, notes Pfeifer.

“We will have to wait and see how the FDA responds to Biogen’s filing,” she says.

The negative results from the phase 2 trial of semorinemab were reported after this story was published in our September print issue. This version was edited afterward to include information about that trial. 

Negative results for semorinemab have deflated some of the hopes for a tau as a target, although a winning strategy Alzheimer's may involve hitting several targets at once, including tau.

Alzheimer’s Research Shifting to Tau as a Target

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues as well — reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Below are thoughts from five experts on these challenges and how they might be met.

Oncologists hired New Century Health in Brea, California, to help them navigate the CMS Oncology Care Model and other new ways of paying for cancer care. This gave the company’s chief medical officer, Andrew Hertler, M.D., FACP, a front-row seat in the struggle to bring value-based care to organized oncology, which he views as being a long time coming.

“Today’s fee-for-service oncology business model misaligns incentives by rewarding practices for keeping margins and service volumes high — even when it’s wasteful — rather than for optimizing patient outcomes,” he says. “While discussions of drug pricing dominate the cost- control conversation, we as practitioners have been abdicating responsibility and missing the opportunity to address cancer’s financial toxicity.” The term “financial toxicity” was coined to describe the health effects that high out-of-pocket costs can have on patients if they skip treatment, as well as the financial distress itself as they go through their life savings to cover their treatment costs.

In 2018, spending on cancer drugs in the U.S. reached $57 billion, double the total from 2013. The average cost of a new cancer drug was $150,000 in 2017. Under the buy-and-bill system used in Medicare Part B, CMS pays physicians the average sales price (ASP) of a drug, plus a markup, which had been traditionally been set at 6% but is now 4.3%. It is a common critique of buy-and-bill that it creates an incentive to prescribe more expensive drugs (or, at the very least, that it removes any incentive to prescribe less expensive ones) because the markup is a percentage of that higher cost. Moreover, some physicians and hospital outpatient departments get drugs below the ASP.

Hertler says that some of the expensive oncology drugs, old and new, are true game changers that have extended lives by many years. “But oncology is also rife with examples of therapies that dramatically increase the costs to our healthcare system while bringing relatively minor improvements,” he says.

“If you’re among the two additional individuals in every 100 who benefit, it’s a winning proposition,” Hertler continues. “But on a population level, however, the costs to our healthcare system and to society can be significant if we routinely make this decision for all cancers.”

That is why, in his opinion, continuing this reimbursement model of rewarding the selection of more expensive, less efficacious drugs is not sustainable or acceptable, and if unchecked will ultimately limit patient access to care.

New Century Health and Hertler see clinical pathways as a way to deal with drug costs. “These care pathways guide oncologists in their selection of treatment regimens based on the latest clinical data and help prioritize the most effective treatments with the fewest side effects and lowest cost,” says Hertler, who also talks about the need to engage oncologists and keep them involved. “Taken together, this approach is key for allowing oncology practices to take costs into their own hands and drive savings and improvements across the patient journey,” he says.

Jeff Patton, M.D., CEO of OneOncology, believes the biggest issue facing oncology is the high cost of specialty drugs.

“It’s unsustainable for patients, physicians, employers and even health plans,” says Patton, who was named CEO of the large specialty network headquartered in Nashville, Tennessee, in May. “Even when community oncologists don’t bill for their work, the cost of therapies causes too much financial toxicity for patients and difficult decisions about coverage and value for employers and plans.” Also, says Patton, an analysis by OneOncology showed that the high cost of specialty drugs “poses challenges” for practices in value-based care arrangements, such as the CMS’ Oncology Care Model.

Patton says drugmakers could fix the problem of high prices with more rational pricing — or Congress should give CMS the power to negotiate prices.

Dane Dickson, M.D., a practicing oncologist and CEO and founder of Taproot Health in Salt Lake City says oncologists are being asked to do so much more with so much less.

“Decreasing reimbursement, increasing regulations, endless payer requirements and difficulties accessing needed drugs — not to mention the challenges of COVID-19 — are critical problems on their own,” he says. “As oncologists, our priority has always been to patients. How can we provide excellent care for today’s patients, plus participate in valuable cancer research initiatives to help the patients of tomorrow, when reimbursement is being slashed and administrative burdens are outrageous?”

Dickson believes the real-world data that clinics generate can become a powerful method of advancing cancer research and provide financial resources to clinics.

“But (these) data (have) to be organized and shared to have the greatest value,” he says. “Data (are) a commodity worth billions of dollars, yet many oncology clinics ignore this potential revenue stream and may allow it to be siphoned off by others. Oncology clinics need transparent solutions to empower them to collect and share quality data.”

Speaking of data, Dickson pointed to its ownership and patient consent as another trouble spot in oncology. Should patients be asked before their data are taken and sold for private gain? Should clinics have transparent control over the data they are generating?

“Currently, most of the real-world data being provided to third parties is being done without patient consent,” he says. “Some patients may have agreed to a vague disclaimer in any of the endless forms they have to sign before receiving care, but this is not informed consent by any stretch.”

This issue is further complicated by genetic-testing data, which could easily identify patients, especially those with rare cancers.

“The right thing to do is ask patients and clinics if we can collect, organize and transparently share data, so all parties know how their information is being used,” Dickson says.

According to Claire F. Verschraegen, M.D., director of the Division of Medical Oncology at The Ohio State University College of Medicine, even although oncology is seeing the approval of many new drugs, there’s a need to simplify clinical trials. There are a lot of new approvals for new drugs in oncology, and the complexity of the approval process is still challenging. “I feel like we’ve created a monster of administration when we run clinical trials,” she says.

For example, a randomized phase 3 trial may be conducted worldwide at hundreds of sites. Verschraegen believes fewer sites are needed. She also says researchers could pare down the amount of data they are collecting. “If the goal of the study is to measure these 10 items, why are we recording all the things that happen that may have no bearing on the study? Why don’t we just focus on the essentials?” she asks. “I think we should come up with an international reorganization of how we run clinical trials to make them more efficient.”

COVID-19 is certainly important. But oncologists, people with cancer, and complex ecosystem of cancer care in the U.S. are grappling with other important issues such as reimbursement, distorted incentives, the implications of the massive amount of data that is available, and, of course, high costs and prices. Included are thoughts from five experts on these challenges and how they might be met.

Author | Keith Loria

Articles

PBMI Specialty Rx Forum Speaker Paula Bickley: Making Patient-Centeredness More Than Just a Tagline

Are we there yet? A look at 4 value-based care programs

Alzheimer’s Research Shifting to Tau as a Target

5 Changes That Should be Made in Oncology