Rachael Zimlich is a freelance writer in Cleveland, Ohio. She writes regularly for Contemporary Pediatrics, Managed Healthcare Executive, and Medical Economics.

Rachael Zimlich, RN, BSN

home

authors

rachael-zimlich-rn-bsn-1

Three out of four patients with non-small cell lung cancer (NSCLC) are now using osimertinib over older tyrosine kinase inhibitors, but the costs associated with this treatment and its uptick in use have skyrocketed.

Originally approved as a second-line therapy for NSCLC in 2015, osimertinib was designated as a preferred first-line agent by the National Comprehensive Cancer Network in 2017, and 

the FDA approved osimertinib as a first-line treatment for NSCLC in 2018

. While patients have benefitted from the first-line designation, costs have skyrocketed. Patient use went from 7% of patients opting for osimertinib in 2017 to 71% by 2019, according to 

. The study also reveals that 129 patients taking osimertinib generated $4 million more in medical costs over just six months compared with patients taking competing medications.

Osimertinib’s efficacy as a first-line treatment was investigated in 

a recent study presented at the European Society for Medical Oncology Congress and published in the 

, and showed that it extended overall survival in patients with NSCLC compared with older tyrosine kinase inhibitors gefitinib and erlotinib. Osimertinib was also effective against the most common mutation responsible for resistance to previous treatments, according to the study, and appears to be effective against brain metastases. Lastly, the study notes that patients taking osimertinib were able to extend their time between treatments, from 13.4 months with prior therapies, to 25.9 months with osimertinib.

Cost is an issue, though. Osimertinib’s wholesale acquisition cost is more than $177,000 per year-1.7 times higher than other EGFR-1 treatments-and the number of patients using osimertinib has increased 10-fold since 2017. This has raised the average cost of care for patients taking osimertinib by more than 100%, according to the study, which reviewed more than 15 million commercial insurance claims.

Altering Drug Dosages Can Benefit Patient’s Pockets

Jeremy Whalen, PharmD, BCOP, specialty clinical program director at Prime Therapeutics, says part of the challenge is that osimertinib was originally approved as a second-line therapy, and therefore was priced for a smaller patient pool. When first-line designation was granted, osimertinib retained its second-line therapy pricing

“When a drug obtains a first-line indication along with substantial utilization increase without a total cost of care offset, payers are obligated to engage with the manufacturer to seek pricing to value,” Whalen says. “Payers need to maintain high-cost drug therapy vigilance, quickly identify utilization changes, assess total cost of care and actively seek out value-based contract opportunities.”

Whalen says one in six patients discontinue therapy with osimertinib during the first six months, highlighting the need for payers to use value-based contracting to recoup the drug cost waste associated with therapy failure.

“Payers can work with manufacturers to help ensure their drugs are priced to value,” he says. “Sound utilization management programs may be employed to make sure the right member is receiving the most appropriate, efficacious therapy.”

Rachael Zimlich, RN, is a writer in Columbia Station, Ohio.

Articles

A new report outlines the sharp cost increase associated with a NSCLC drug’s move from second-line to first-line treatment, and suggests payers work with manufacturers to address treatment pricing.

Payers Should Take Action on Rising NSCLC Costs

With new advances in targeted and immunotherapy treatment for cancers taking the lead in guidelines on solid tumor management, will chemotherapy become a thing of the past?

Probably not, according to new research-or at least not for a long time.

, researchers focused on past, current and future practices in breast cancer management to analyze the past, present and future role of chemotherapy in solid tumor management. The paper concludes that while there are many advances in cancer treatment, reports that chemotherapy is on the way out are greatly exaggerated.

A presentation last year at the American Society of Clinical Oncology (ASCO) Annual Meeting spurred discussion about whether chemotherapy had reached the end of its therapeutic life. Research presented at the conference suggested that patients with some solid tumor cancers may be able to avoid chemotherapy as a first-line treatment as a result of numerous scientific advances in targeted treatments and immunotherapy.

While the idea that chemotherapy-and the adverse effects that come with it-may be replaced by more patent-centric treatment modalities has been met with optimism, this new paper suggests that a world where cancer treatment excludes chemotherapy is still a far way off.

Bruce Feinberg, DO, vice president and chief medical officer at Cardinal Health Specialty Solutions and lead author of the paper, says there have been repeated reports since the 2018 ASCO presentations suggesting an end to the era of chemotherapy.  

“We set out to understand if this was public relations hyperbole, researchers and publishers taking poetic license to draw attention to new work, or rather the collective impact of several drugs with novel mechanisms of action coming to marketing including targeted, immune-oncology and cell/gene therapies,” Feinberg says.

Addressing such a hypothesis led the team to examine one very common cancer-breast-that had seen an explosion of non-chemotherapy MOA drug approvals in recent years, he says.

“Breast cancer is among the most common cancers by both incidence and treatment, and, it often serves as a paradigm for solid tumor research,” Feinberg says. “When considering the full extent of treatment clinical scenarios-neo-adjuvant, adjuvant, first line metastatic and later line metastatic-and when considering chemotherapy alone as well as in combination with novel MOA drugs, it became clear in our research that chemotherapy was likely to remain a critical component of systemic cancer treatment for years, if not decades, to come.”

Chemotherapy has been used to treat breast cancer specifically since the 1950s, according to the paper, and advances have been made in the decades since, with the latest research focused on minimizing chemotherapy toxicity through improved supportive care, or limited exposure with genetic profiling. Still, Feinberg and his team point out in the report that of the 311 ongoing clinical trials identified for metastatic breast cancer at the time of the report, 146 included a chemotherapy component while only 27 were for CDK 4/6 inhibitors without chemotherapy.

Personalized Treatments Could Increase Value of Cancer Care

“The extent to which chemotherapy remains a component of metastatic breast cancer research leaves little doubt as to its critical role for years to come,” the report states.

There is a lot of room for new research, Feinberg says, as evidenced by these trials, but chemotherapy continues-and will likely continue for some time-to play a large role.

“Our research suggests that there is a role for both entirely new molecules, as well as existing molecules that are modified to improve the patient experience through more favorable administration, less toxicity or different toxicity,” Feinberg says. “Our research also suggested a need for a thorough re-evaluation of the current arsenal of drugs through comparative effectiveness research, as many of these drugs were approved two, three or more decades ago without head-to-head comparisons to each other.”

Future research also needs to take into account patient-reported outcomes to understand both quantitative differences in outcomes and patient preferences, he adds. Clinicians favor new treatments for many reasons, Feinberg notes, but there are also many reasons why chemotherapy has for a long time been the backbone of cancer treatment.

“The enthusiasm that clinicians have for novel MOA therapies is understandable-many of these treatments are delivering groundbreaking clinical advances,” Feinberg says. “But in some cases, these products are only effective in targeted populations. So while novel therapies may be the ‘shiny new objects’ in oncology care, chemotherapy continues to play a central role in the arsenal of treatment options.”

Feinberg says he hopes the new report will help advance research into how to make chemotherapy better.

“The purpose of our research was not to be provocative, although the results were certainly interpreted that way,” he adds. “Rather, our hope was to reinvigorate discussions about chemotherapy’s role in a value-based care marketplace, and the need for continued research and development to make the current compounds safer, more effective and more patient friendly.”

Chemotherapy may be the “boomer” to millennial-esque new cancer treatments, but there is a reason the old standard became that way, and isn’t likely to be replaced anytime soon.

Chemotherapy Remains Significant for Cancer Treatment

There are a lot of ideas about ways to increase the value of cancer care, but personalized treatments may be the most significant and immediate.

, particularly for oral chemotherapy, is one area already being explored, but oncology thought leaders say there may be room for increased values in other treatment modalities, as well. Radiology, for example, has the potential to yield substantial savings by personalizing treatments, according to Daniel A. Goldstein, MD, of a medical oncologist at Rabin Medical Center in Israel and lecturer at Tel Aviv University.

"In the era of personalized treatment, one thing research could lead to is the ability to also give personalized treatment frequency," Goldstein says. "We may be able to check the level of drugs in a patient's blood stream and tell then when to get their next treatment."

Goldstein co-authored a study in early 2019

 detailing the potential of hypofractionated radiation. The study focused on localized prostate cancer, for which intensified radiotherapy has been the standard radiation therapy. However, the report notes that several studies have now demonstrated similar results and patient outcomes with moderate hyfractionation. Researchers in this particular study analyzed the cost of external beam radiotherapy (EBRT) for localized prostate cancer, comparing the cost of intense versus moderate hypofractionation. The team found that the cost of standard fractionation was 45 or 39 fractions at a cost of $26,782 and $23,625 per patient, respectively, while the cost of moderate fractionation was 28 or 20 fractions at a cost of $17,793 and $13,402 per patient. The researcher team estimated that this change-which would not compromise survival or tolerability of treatments-could lower the cost of radiation treatments for localized prostate cancer alone by 25% to 50% annually, translating to somewhere between $150 million and $360 million in yearly savings.

Goldstein says he and his colleagues are currently trying to enlist payers who would like to participate in additional trials of programs that used personalized radiation therapy in other types of cancer, as well. 

"It could possibly be used for prostate cancer, breast cancer, and more," Goldstein says. "It's proven that if 40 treatments were standard-but only 20 of a high-dose fractionated therapy-it's more convenient for patients and payers can save a significant amount."

Goldstein says this is just the tip of the iceberg, though, when it comes to finding ways to increase the value of cancer care. In a report published in The Oncologist, also co-authored by Goldstein, researchers discussed the increasing scrutiny of cancer care costs, as well as the many ideas generated to contain costs while improving outcomes. Payer perspectives were addressed in the report, including a suggestion that new regulation is needed to allow public and private payers the right to refuse coverage for expensive therapies that provide only minimal improvement in patient outcomes. A suggestion was also made to cap profits for drug administrations at 18%-a margin authors note is currently the average sales price plus 28% for community physicians to an additional 152% for cancer clinics owned by hospitals at one payer organization. The paper compared several payment models from around the world, as well as the need for clinicians to improve communication with patients about cost. Both financial and physical costs should be a bigger consideration in clinicians' discussions with patients, the paper suggests, adding that earlier referrals to palliative care have been shown to improve both and costs and quality of care. A part of these discussions also should include end-of-life care and timely hospice admissions for patient who have not responded to therapy verses hospitalizations and intensive-care-unit stays or additional invasive treatments that don't benefit patients and only drive costs higher.

While many of these suggestions will take significant changes in the current environment of cancer care, the report also highlights some of the progress that has already been made. This includes advances in precision, early cancer detection, the development of cancer care pathways and new value-based reimbursement models, and efforts to bring down drug prices at the regulatory level. Continued research and trials on personalized drug and radiation regimens in just another piece of the equation, Goldstein says.

There are a lot of ideas about ways to increase the value of cancer care, but personalized treatments may be the most significant and immediate.
	 

As cancer care becomes more effective, patients are living longer, better lives. Paying for cancer care, however, remains a problem, but payers and employers can help by advocating for treatments that provide the best value and creating plans that support the wide-ranging needs of cancer patients and their families.

Cancer deaths have been dropping since the 1990s, according to a report from the National Alliance of Healthcare Purchaser Coalitions, yet costs continue to rise. More than $147 billion was spent on cancer care alone in 2017, according to the report, spurring debate about how best to manage these rising costs. Michael Thompson, president and chief executive officer of the National Alliance of Healthcare Purchaser Coalitions, says his organization has developed an assessment of how health plans are currently managing cancer for their members. The 

 report highlights gaps in treatment, and provides recommendations for purchasers, health, plans, and providers.

“It has become kind of our roadmap for how to help explain to employers how they should be engaging with their health plans,” Thompson says.

In the past, talking about intervening on cancer care was a no-fly zone, he says. It was a hands-off issue for employers, in part because they didn’t want to stand in the way of employees and families receiving life-saving treatments. Now, with so many good, effective options for cancer care, it’s a different story.

“This has evolved in a way that is very healthy and good. Some of it relates to the fact that our ability to treat cancer has never been better,” Thompson says. “And a lot that relates to the progress in the industry on how to treat cancer. But the second is cost.”

The cost of cancer care has increased exponentially, he says, and employers are beginning to discuss quality measures as a way to control costs. Is the diagnosis right? Are tests being done correctly?

“Misdiagnosis is not a rare thing in cancer, and we do want to support getting to the right provider,” Thompson says. “We want to make sure we do right by families and employees and get the care they need. At the same time, we don’t want to waste money on that process.” 

There has been some discussion about care received at community oncology providers versus national centers. In many cases, cancer care can be handled in a very standardized, cost-effective way at community care centers. Employers and payers also realize that there are more rare cancers that require higher cost specialty care, he says. Finding the best ways to support patients while keeping cost in mind is the challenge.

There are a number of recommendations included in the report, such as developing a patient-centered approach for cancer care that offers employees and their families comprehensive support; ensuring care will include support for the cancer patients entire journey, including psychosocial needs, benefits coordination, and planning for a return to the workforce; reviewing benefits coverage to assess for adherence to evidence-based standards while also finding ways to include new treatments at a reasonable cost; include best practices and bundled payment models into payment plans to address both quality and cost; and review high-cost, poor-outcome treatments.

Employers can get frustrated when treatments continue with poor outcomes, but health plans can help support patients to get the right treatment more quickly, and to not throw money at treatments that won’t deliver outcomes, Thompson says.

There is also a push to better support patients and their families outside of medical care.

“One problem is that no matter where you are in the cancer journey, the psychosocial issues really come to the forefront,” Thompson says.

It’s important to consider the patient’s preferences and values in creating treatment plans, he adds. For many patients, the value of treatment isn’t just the physical outcomes, but involves meeting their financial needs and being closer to their families. Employers should also be building plans with the patient’s financial health and support to return to work in mind.

“There’s so much more we can do to support patients with better outcomes and to also optimize experiences during this period,” Thompson says. “At the end of the day, it’s about value. And the numerator of that value is the health and wellbeing of the patient and their family. You’re going to get better outcomes when you think more holistically around the care of the patient.”

A holistic approach provides value and creates plans that support the wide-ranging needs of cancer patients and their families.

Collaboration Key to a Holistic Model of Cancer Care

Not all cancer patients are the same, so why should their drug regimens be?

Cancer care is notoriously expensive, and researchers are investigating ways to cut back on drug costs without sacrificing outcomes.

 published in JAMA Oncology, experts discuss four strategies for interventional pharmoeconomics and how this could help lower cancer care costs while maintaining therapeutic efficacy. Interventional pharmoeconomics investigates ways to make small changes to approved regimens for the same effect.

The first method discussed in the commentary is lowering doses of oncology drugs. The authors give several examples of standard doses of medications compared to reduced doses, as well as offering medication under fasting conditions versus with food.

A second strategy is to change the frequency of dosing. This could reduce both prescribing costs and adverse effects, according to the authors.

Other methods include shorter durations of treatment and therapeutic substitution with approved alternatives.

Managing the Financial Fallout of Cancer Care

Mark J. Ratain, MD, the Leon O. Jacobson professor of medicine, director of the Center for Personalized Therapeutics and associate director of clinical sciences at the Comprehensive Cancer Center at the University of Chicago Medical Center, was one of the commentary authors, and has led other studies investigating the idea of modifying treatment regimens to reduce cost.

 in the Annals of Oncology, Ratain and colleagues revealed that many oral oncology medications are given in doses that are beyond what patients really need, opening the door to value-based dosing.

The study found that the cost of 33 of the 53 oral oncology drugs investigated by the research team could be reduced by 33% or more-with savings of 50% or more possible in 26 of the drugs.

The research team used many of the same methods mentioned in the commentary published in JAMA Oncology, and estimated global savings at more than $12 billion per year.

Daniel A. Goldstein, MD, of a medical oncologist at Rabin Medical Center in Isreal and lecturer at Tel Aviv University, co-authored the commentary with Ratain, and says there are a number of medications that may be able to transition to weight-based dosing instead of a standard dose, such as pembrolizumab. This medication, if changed to weight-based prescribing, has the potential to save lung cancer patients $800 million in the U.S. alone.

“There’s also a number of other drugs where if you take them with food instead of on an empty stomach, you can increase absorption and reduce the dose,” Goldstein says. “We’re trying to work with healthcare payers to develop these studies. If we can prove it, that’s in the interest of healthcare payers.”

“Managed care executives concerned about pharmaceutical costs, particularly in oncology, should consider the opportunity to use results of interventional pharmacoeconomic studies in designing copayment structures,” Ratain says. “Furthermore, such studies are potentially self-funding, since 50% of patients in a randomized trial would receive a much lower dosage. Thus, a network of payers is ideally suited to conduct interventional pharmacoeconomic studies, and to implement the subsequent findings.”

Researchers suggest changing cancer drug regimens could save money without sacrificing quality.

Preparation is underway for a new payment model for cancer care, and the model’s developers are hopeful that it will offer the simplicity and cost-savings that they say other models lack.

The Community Oncology Alliance developed the 

. It’s a payment reform model that tests flexible, universal payment reform templates, recognizes and rewards high-quality and high-value cancer care, promotes reporting simplicity and transparency, and addresses the price of cancer drugs though value-based initiatives. According to the plan’s design, the OCM 2.0 emphasizes value-based clinical decision making with a goal of improving patient outcomes while reducing costs. Bo Gamble, director of strategic practice initiatives for the Community Oncology Alliance says the OCM 2.0 stresses the need for better payment practices when it comes to cancer care.

The model will be tested through June 2021 in 176 practices covering more than 150,000 Medicare beneficiaries.

According to the plan’s design, the OCM 2.0 emphasizes value-based clinical decision making with a goal of improving patient outcomes while reducing costs.

Bo Gamble, director of strategic practice initiatives for the Community Oncology Alliance, says the OCM 2.0 stresses the need for better payment practices when it comes to cancer care.

“This OCM 2.0 model emphasizes the changes that need to be made for universal oncology payment reform and with all payers, including federal, regional, local and employers,” says Gamble. “There are three specific areas of focus-the care delivery, the measures of the quality and value of the care delivered and meaningful payment methodology that rewards outstanding quality and value.”

The goal of the Oncology Care Model 2.0 is to define and implement standards for providing excellent cancer care using a uniform set of measures that would prove-or disprove-whether excellent care was provided, says Gamble.

It also includes a transparent, adaptable payment methodology for rewarding expertise in cancer care.

Five Ways Oncology Has Become More Personalized

“The expected outcomes are an improved experience for patients with cancer, and overall savings to our healthcare system,” says Gamble. “The Oncology Care Model 2.0 is expected to bend the cost curve for cancer care and reduce spending. This is a two-prong approach; emphasis in the total cost of care and incentives designed specifically for treatments so that value that lowers the cost of treatment, is stressed. Lessons learned in these pilots could be implemented more globally.”

The two biggest challenges when it comes to reimbursement are communications and transparency. In terms of transparency, Gamble explains that it can be difficult to compare similar cases in cancer care.

“Each cancer patient is unique, which calls for the expertise and guidance of the oncologist,” he says. “However, the goal of most oncology models is to compare like cases. The logic and algorithms to do this is complicated which reduce the ability of the care team to understand the logic. This is a challenge because the care team needs a working knowledge of these processes so that areas for improvement can be identified and addressed. Similar challenges exist for attribution and patient inclusion in a model. The OCM 2.0 seeks to improve the transparency of all reform models.”

In addressing the issue of communication problems, Gamble says there needs to be more clarity, with timely and appropriate follow-up.

“Past and present reform efforts have suffered from communications issues that impact the ability of the care team to react and address things that are identified. Sometimes teams are told six-plus months after the fact about issues that give them little opportunity to address them. The Oncology Care Model 2.0 addresses communications issues we see in reform efforts, particularly with timeliness and clarity of communications.”

The OCM 2.0 is still in the review process and stakeholder responses are currently being received and evaluated, says Gamble.

“We hope for the Oncology Care Model 2.0 to start a dialogue with all of those involved in the cancer care journey, from patients, to care teams, to payers, to employers and beyond. The Community Oncology Alliance has an ambitious vision for how we can improve cancer care and need support and input to make it a success,” says Gamble. “This is particularly true of employers who are responsible for more and more of the costs of cancer care. Ultimately, the path to universal oncology payment reform will be a long journey, so patience, perseverance, and collaboration will be needed.”

Proposed as an alternative to CMS’ Oncology Care Model, the Community Oncology Alliance is developing its Oncology Care Model 2.0 with the hopes of creating a better, more efficient payment and treatment system for cancer care.