Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
Financial toxicity, ACO contracts, removing barriers to care.
Currently, the number of patients who are actually utilizing precision cancer care treatments is small, but it is growing fast. As that happens, physicians will need to get comfortable with ordering the right tests, explained Clynt Taylor, chief executive officer of Intervention Insights, and Lee Newcomer, MD, formerly of UnitedHealth Group.
There are, according to Newcomer, 3 big barriers to getting access to diagnostic tests and wider adoption of precision medicines. First is the challenge of figuring out what panel the clinician needs to order. Do they need to order a single-gene or a 7-gene or even a 500-gene panel?
“So, that clinical question is pretty tough for physicians to answer right now,” he said. “All of this is new. It’s evolving. They struggle with it.”
A second barrier is choosing the laboratory that offers the best test for what the physician needs. The third barrier is figuring out which tests are covered by the payer. There is a lot of work on the part of the physician to get through all 3 of those barriers, involving multiple phone calls.
Newcomer is now on the board of Intervention Insights, which has a product, Trapelo, that tries to remove some of those barriers. According to Taylor, there is wide variability in oncologist level of comfort with using precision medicines, which is another barrier that Trapelo tries to overcome.
Intervention Insights had started in the area by developing a knowledge base of all evidence related to genes or biomarkers and their diseases. That information was used to provide a summary for reports coming back from the lab to make it easier for physicians to interpret the results, Taylor explained. Trapelo is the next step and moves downstream a little to help physicians start making decisions around which tests to order.
After working with physicians, the company decided that a single platform could help align the interests of oncologists, laboratories, and payers in real time, “so that our colleagues could look to order from a single place that would help that doctor know, for each patient, what to order, from which labs, what genes
needed to be tested, [and] what would be paid for them,” Taylor said.
This work takes place in the electronic medical record (EMR), and according to Taylor, the company was very aware that Trapelo needed to work very synergistically with the EMR so as not to add more work to the day for oncologists. The usability of the program was key, Newcomer added.
For a while now, the diagnostics field has been tough to reimburse because of the Current Procedural Terminology codes used, Newcomer said. These codes have been nondescript and confusing, and health plans have been looking for vendors who can make it easier to understand what test is being ordered and how to pay for it.
New payment models, such as the Oncology Care Model (OCM), help to get diagnostic tests used more, because OCM rewards practices that are cost-efficient and get better outcomes.
“So, if you were to know in advance from the gene test, that drug probably isn’t going to work, whereas another one will, that’s very useful information…” Newcomer said.
Although the number of accountable care organization (ACO) contracts with downside risk is growing, the majority of ACOs remain in upside-only risk contracts, according to a new study. In 2012, 28% of accountable care organizations (ACOs) had a contract with downside risk. That rate increased modestly to 33% in 2018.
However, according to study researchers, the number of ACOs has increased approximately 5-fold during the time period, which could mean that the number of ACO downside risk contracts also grew significantly.
Although the increase in the amount of ACOs taking on downside risk remains modest, there has been significant growth in not just the number but also the variety of contracts implemented by ACOs, including in the number of payers they contract with. In 2012, 42% of newly formed ACOs had contracts with 2 or more payer types compared with 63% of ACOs in 2018.
As ACOs have emerged as one of the most broadly implemented value-based payment models, CMS has been pushing ACOs to take on more financial risk. In December 2018, the agency finalized Pathways to Success, its overhaul of the Medicare Shared Savings Program, which will push ACOs to assume risk more quickly. Notably, the program replaced the traditional 3 tracks with 2 new tracks in which ACOs will start in a 1-sided model and incrementally phase in higher levels of risk. Down from the current 6 years, ACOs will be able to stay in 1-sided risk for 2 years and existing ACOs will be able to stay for 1 more year.
The researchers of the new study, published in Health Affairs, drew on data from the National Survey of Accountable Care Organizations, finding that ACOs taking on downside risk were more likely to have more experience with other forms of risk-bearing contracts.
“Prior work indicates that ACO participants with risk-bearing experience are more likely to achieve shared savings with the Medicare program,” wrote the researchers. “Therefore, the assumption that inducing more ACOs to bear downside risk would result in increased savings should be questioned, based on what is known to date.”
Among the 419 ACOs that completed the survey in 2018, those assuming downside risk were less likely to be physician led (43% vs 57%) and instead more likely to be jointly led by a hospital and physicians, led by a hospital, or led by another arrangement, including coalitions and regional, county, or state organizations. They were also less likely to be physician owned than other ACOs were (30% vs 39%).
“While similar in proportion of ownership by hospitals, downside-risk ACOs were more likely than other ACOs to be owned by other entities, including public ownership, non-profit ownership, or another privately owned for-profit entity,” reported the researchers.
The survey results also indicated that ACOs taking on downside risk were more likely to:
• Be integrated delivery systems (58% vs 42%) and include a hospital and have a greater number of hospitals
• Directly provide or contract to deliver inpatient rehabilitation, routine specialty care, palliative or hospice care, home health or visiting nurse services, and skilled nursing facility care • Report that 50% to 100% of their primary care patients were covered by an ACO contract.
1. Peck K, Usadi B, Mainor A, Fisher E, Colla C. ACO contracts with downside financial risk growing, but still remain in the minority [published online July 1, 2019]. Health Aff (Millwood). doi: 10.1377/hlthaff.2018.05386.Parth Shah, PharmD, PhD, of the Fred Hutchinson Cancer Research Center, led a session to discuss the uptake challenges of the human papilloma virus (HPV) vaccine at the 2019 Annual Meeting of the American Society of Clinical Oncology.
He began by explaining the known percentages of cancers attributable to the virus in the United States: cervical cancer, 91%; vagina cancer, 75%; and vulva cancer, 69%, among others.
Although multiple cancers are attributable to the virus, explained Shah, of the ages in the United States that should be vaccinated—13 to 17 years—both boys and girls, only 49% receive the vaccine.
The challenges around facilitating larger uptake of a vaccine that prevents cancer can be frustrating for providers. Parents’ hesitancy about the HPV vaccine has been around since it was approved in 2006, although it has garnered more attention as the antivaxxer movement has taken hold in the United States, as seen by the 1044 confirmed cases of measles this year. (This is the greatest number of cases reported in the United States since 1994, and since the disease was declared eradicated in 2000.)
In terms of the low uptake of the HPV vaccine, Shah believes the reasons are multifactorial. Namely, low uptake can be attributed to societal and cultural norms, community, and relational and individual reasons.
“As far as societal reasons, a few states currently have [initiated] or tried to initiate school mandates for the vaccination,” he said. “Not only were they controversial, but they were largely ineffective. When the vaccine came out and school mandates were being discussed, it was largely pushed by the manufacturers, which generated distrust. In terms of community challenges, we’re vaccinating in some schools, but schools are governed by local jurisdictions and sometimes providing preventive services is not a priority. And finally, for relational and individual reasons, you need to consider the parents’ perspective.”
Shah explained that over the past few years, the CDC has collected data on why parents choose to not vaccinate their child for HPV. Top reported reasons include safety concerns, adverse effects, lack of knowledge about the vaccine, not believing it was necessary, and no provider recommendation. Parents also reported that their child was not sexually active, so they did not need it.
Based on prior data and studies, Shah recommended that when speaking with patients who are due for the vaccine and their parents, the physician should make a statement that notes the child’s age, announce that they are due for vaccines that prevent several diseases, place the HPV vaccine in the middle of the list, and say that you’re available to vaccinate today.
Deanna Teoh, MD, MS, FACOG, FACS, of the University of Minnesota, emphasized the impact of social media on vaccination trends. The younger population is more likely to receive their news from social media, while Facebook is the site where adults get most of their news. Multiple social media sites—Facebook, YouTube, Twitter, and more—have been in hot water recently for providing a space for the antivaxxer movement to gain strength. Oversight of inconsistent site governance policies has been attempted since the rise of the measles outbreak.
To offer a different perspective, Ian Frazer, MBBS, MD, DSc, of the University of Queensland in Australia, explained that uptake of the vaccination is not a problem in Australia, in part because “we bribe them to get vaccinated. There is a substantial social security handout if your child is fully vaccinated by 5 years old, so we find that most countrywide vaccination rates are high.”
Frazer and his late colleague, Jian Zhou, PhD, developed and patented the basic technology behind the vaccine. Because most Australians saw the vaccine as a local invention, Frazer explained that uptake was quite good. In fact, the question being asked now in Australia is should it continue with screening for the disease since the vaccination rates are so high.
However, the question is not as straightforward as it seems, because the only screening tool available for HPV is a Papanicolaou (Pap) smear. This presents a problem, as only females, or roughly half the population, can be screened.
An audience member brought the room’s attention to another problem in regard to lack of knowledge about the importance of the vaccine not previously mentioned: “Some patients truly don’t even know that they have an HPV-related cancer. We need to first educate patients about their own disease and then address the fact that there’s a vaccine to prevent it,” she said. This way, they’ll share that information with their loved ones and maybe a greater uptake will start to occur.
Measles cases in 2019. CDC website. cdc.gov/measles/cases-outbreaks.html. Updated June 10, 2019. Accessed June 1, 2019.
Two posters presented at the 2019 Annual Meeting of the American Society of Clinical Oncology discussed the growing issue of financial toxicity and the costs of care in cancer treatment.
In the first poster, researchers selected 4 phase 3 trials of immuno-oncology (IO) treatments for non-small cell lung cancer (NSCLC) in a first-line setting and found that while median progression-free survival has doubled, so did costs. The researchers said the expense has to be quantified in relation to per capita gross national product in the United States ($53,128 in 2017). Costs appear economically unsustainable even when accepting a higher threshold of $100,000 for 1 quality adjusted life year gained, they wrote. But given the significant PFS gains, there is a need to use IOs through innovative cost sharing platforms, they said.1
In the second poster, researchers hypothesized that weight-based dosing of pembrolizumab and nivolumab in order to allow vial sharing among patients would result in substantial cost savings.2 The 2 drugs were originally investigated and FDA-approved with weight-based dosing strategies, but later the approval label was amended to a fixed-dose administration.
Researchers retrospectively examined all outpatient doses of pembrolizumab and nivolumab given at 3 Stanford Medicine infusion centers between July 1, 2018, and October 31, 2018, using the Stanford Medicine Research Data Repository (STARR) database. Cost-minimization analysis was conducted to model the impact of dosing strategies based upon patient weight versus fixed dosing (2 mg/kg vs 200 mg every 3 weeks for pembrolizumab; 3 mg/kg vs 240 mg every 2 weeks or 6 mg/kg vs 480 every 4 weeks for nivolumab).
“Dose-minimization” (DM) was defined as whichever dose was lower (weightbased or fixed dose). The impact of allowing vial sharing (considering commercially available vial sizes) between patients treated at the same site and on the same date was assessed. Average sales price from CMS for Part B drugs was used for cost estimates.
A total of 1029 doses of pembrolizumab or nivolumab were administered across a variety of cancer types. For most doses (n = 789, 77%), the calculated weight-based dose was less than the fixed dose. DM resulted in decreased usage and expenditures of both pembrolizumab and nivolumab, and a further decrease was observed with vial sharing.
Total savings estimated with DM and vial sharing strategy were greater than $1.4 million. This amounted to savings of >22,000 mg of pembrolizumab (112 fixed doses) and >11,000 mg of nivolumab (47 fixed doses). Savings were greatest at the highest volume infusion center.
Alternative dosing strategies of pembrolizumab and nivolumab would result in significantly less drug utilization and pharmaceutical spending, without anticipated impact on efficacy, but there are barriers to this approach, such as existing policies regarding vial sharing and drug vial sizes.
1. Ashraf SMM, Pandita S, Alimpertis E, et al. Progression free survival (PFS) benefits of immuno-oncology agents (IOs) and implications for market cost-sharing inefficiencies. Presented at: American Society of Clinical Oncology Annual Meeting, May 31-June 4, 2019; Chicago, Illinois. Poster 334.
2. Hall ET, Zhang J, Kim EJ, Economic analysis of alternative pembrolizumab and nivolumab dosing strategies at an academic cancer center. Presented at: American Society of Clinical Oncology Annual Meeting, May 31-June 4, 2019; Chicago, Illinois. Abstract 6504.