Keith Loria is a contributing writer to Medical Economics.

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The ACA set national network adequacy standards, but since 2018 the responsibility has devolved to each state. The result is a patchwork of standards, many of them vague, according to a report published in 

Catherine Moore, M.D., at George Washington University School of Medicine in Washington, D.C., and David I. Shalowitz, M.D, M.S.H.P., of the Wake Forest School of Medicine, contacted representatives of the insurance departments in every state and Washington, D.C., and combed through information on state websites to gather network adequacy standards for cancer care.

They found that 16 states used only qualitative standards for access to an oncologist, such as health plan members must have “reasonable access” to oncologists or care. Seven states had quantitative elements, such as travel distance or a ratio of providers to members. Twenty-four states had network adequacy standards with both qualitative and quantitative elements.

“We found that states’ standards currently are highly variable,” Shalowitz says. “Unclear network adequacy standards for insurance plans may put patients at risk for poor access to cancer care.”

According to Shalowitz, it’s important for states to ensure that robust, transparent protections exist so that patients can access high-quality cancer care without having to go to a provider that is out of network, which may result in large medical bills that many people couldn’t afford to pay.

“While a single network adequacy standard may be neither possible nor desirable for all states and insurance markets, states should collaborate with patient advocates and cancer professionals who have knowledge of local markets and patients’ needs to develop basic standards for insurance coverage,” he says. “Transparent standards will also permit study of cancer care delivery outcomes related to network adequacy, improvement in access to high-quality care and minimization of the sometimes disastrous financial consequences of out-of-network billing.”

Shalowitz would also like to see additional research conducted to determine how network adequacy standards can be applied to rare or complex cancers and how they might improve equity in access
to care.

Results of a number of studies have shown that nearly 1 in 5 emergency department visits involve a patient unknowingly being treated by an out-of-network provider, which led to unanticipated medical bills. The American Society of Clinical Oncology (ASCO) has pushed for legislation to address surprise billing for cancer patients. A spokesperson for ASCO confirmed that the organization is still pushing CMS to enact network adequacy standards for Medicaid managed care enrollees so they can access high-quality cancer care and all the oncology specialties in a timely fashion.

“Although our study did not address the issue of surprise billing specifically, we are concerned that patients may be at higher risk for receiving catastrophic medical bills if their insurance plan does not provide adequate access to cancer care,” Shalowitz says.

Network adequacy can be a major issue for patients with rare cancers. In a previous study, Shalowitz found that 27% of plans sold on insurance exchanges didn’t have an in-network specialist in gynecologic cancers, despite evidence that treatment by a specialist improves survival for patients with those types of cancers.

“Policy makers must ensure that insurance plans uniformly offer adequate coverage for cancer care to ensure that patients with these diseases are able to access high-quality treatment,” Shalowitz says.

 is a freelance writer in the Washington, D.C., area.Many states only have vaguely worded qualitative standards for network adequacy for cancer care. Others have quantitative standards based on distance or waiting time.

Articles

Many states only have vaguely worded qualitative standards for network adequacy for cancer care. Others have quantitative standards based on distance or waiting time. 

Oncology: Network Adequacy Rules for Cancer Care are Often Inadequate

More than 30 million Americans have diabetes, according to the American Diabetes Association, and many rely on insulin.

But insulin prices have been rising in recent years, and that has put many people with diabetes at risk because the price leads to people skipping doses or not taking insulin altogether.

The latest figures from the American Action Forum show that the price of insulin rose 14% a year, on average, between 2012 and 2018, and the past few years have followed this growth trajectory.

Many patients, policy makers and experts blame companies that manufacture insulin for dialing up the price of an established therapy. Sally Pipes, president and CEO of the Pacific Research Institute, a California-based think tank that favors free markets and limited government, says it’s easy to point the finger at pharmaceutical companies, but she finds fault elsewhere: in a dysfunctional market for insulin and many other prescription drugs and in pharmacy benefit managers.

“Pharmacy benefit managers — middlemen hired by insurance companies to manage their prescription drug plans — are driving those list prices up,” she asserts. The Pharmaceutical Care Management Association, the trade group for PBMs, says its member have done quite the opposite with programs that cap out-of-pocket costs or eliminate them. A spokesperson for the group says insulin makers have used patent extensions to avoid competiton.

In the summer of 2020, then-President Donald Trump signed an executive order aimed at reining in prescription drug costs, requiring federally qualified health centers and hospitals, which purchase insulin through the 340B Drug Pricing Program, to pass along any savings they receive from discounted drug prices to medically underserved patients. The Biden administration halted its implementation. The National Association of Community Health Centers, among others, expressed support for the new administration’s move, saying the Trump rule would not have lowered the cost of insulin (and EpiPens) for most Americans.

Some states are moving to control insulin prices. This summer, Colorado joined Illinois in passing legislation that caps out-of-pocket costs of insulin. Maine, New Mexico, New York, Utah, Washington and West Virginia are considering
similar legislation.

Prices may also come down if interchangeable biosimilars start coming on the market. In July 2021, the FDA designated Semglee (insulin glargine-yfgn) as an interchangeable biosimilar to Lantus (insulin glargine), a long-acting insulin analog. The designation means a pharmacist can switch the brand-name product for the presumably less expensive biosimilar, although state pharmacy laws can put some limits on interchangeability. Even so, the FDA approval should result in some competition between Semglee and Lantus and price decreases for patients and payers 

Keith Loria is a freelance writer in the Washington, D.C., area.

States are putting caps on prices, and Semglee, the first interchangeable biosimilar in the United States, may exert some downward pressure. 

Stemming the Rising Tide of Insulin Prices 

Healthcare costs are increasing, but when it comes to drug expenditures, it’s only a small fraction of utilizers that account for more than half of their clients’ pharmacy spend, explained Joshua Fredell, Pharm.D., vice president of product development for CVS Health, in his presentation at the third and final day of the 2021 Pharmacy Benefit Management Institute® Annual National Conference.

New specialty treatments that can transform the lives of some patients are coming to market with increasingly higher price tags — some costing hundreds of thousands per year, Fredell noted.

“This means that cost management strategies must evolve to meet next-generation needs: a deliberate focus on curbing specialty spend without compromising plan member outcomes,” said his co-presenter, Tierra Ford, Pharm.D., senior clinical adviser, specialty client solutions, at CVS Health.

In their presentation, Fredell and Ford stressed how digital tools and platforms and connectivity are key to an effective utilization management strategy, so that the member gets the most clinically effective therapy while payers realize durable savings. 

Fredell emphasized the importance of connectivity  and that the CVS' specialty drug managers have connectivity, or access, to 70% of  electronic health record of providers and "digital connectivity" to 85% of members that can be used to go beyond routine messaging around issues like refill reminders.  

Fredell also listed three principles that CVS' management of specialty drugs follow: start with therapy with certainty,  eliminate waste throughout treatment (he mentioned earlier that 89% of the specialty drug spend is on existing treatment) and intervene when needed. Ford gave some examples of the principles in action. About 30% of Stelara (ustekinumab) may be on a higher dose than necessary. CVS member dosing limits to significant drop in high-dose prescriptions, resulting in $21.1 in gross savings.

Fredell also discussed several pilot projects, including one that provides support to rheumatoid arthritis on oral therapy with the goal of avoiding more expensive therapy if the oral therapy fails. Another pilot project is promoting phototherapy for psoriasis, which is a recognized, effective therapy that is under utilized, Fredell said. 

“Proactive monitoring and interventions, powered by advanced data analytics, can engage members with their treatment plans while preventing wasteful spend throughout the duration of therapy,” Fredell said. “(With) an integrated approach to specialty that goes beyond utilization, management can identify more opportunities to manage costs, improve member care and create a more seamless and connected experience for both members and providers.”

Fredell and Ford also discussed how clinically rigorous utilization management builds the foundation for a strong specialty cost-management program.

“Electronic health record connectivity enables greater visibility to accurate clinical data, including the exact diagnosis and most appropriate therapy for each member,” Ford said. “This makes the prior authorization approval more efficient and minimizes the need for additional provider outreach, supporting a more timely start to the most clinically appropriate therapy while eliminating waste and helping lower payer cost.”

“With specialty drugs accounting for a disproportionate share of the drug development pipeline, formulary and utilization management enhancements ensure that we drive to lowest net cost and get plan members started on a treatment plan based on clinical evidence,” Ford said. “Targeted interventions enabled by proactive monitoring and advanced analytics can help support better health outcomes by identifying members who may not be benefitting from their therapy, (maybe experiencing side effects or a worsening of their symptoms or are at risk for an adverse event.”

The pharmaceutical marketplace is dynamic, and specialty cost-management tactics must evolve to help payer stay ahead of trends and manage rapidly rising costs, Fredell said.

“Doing so effectively demands new approaches that go beyond traditional strategies and aggressive therapy denials, which may not deliver lasting savings,” Fredell continued. “Starting on the most appropriate therapy, ongoing monitoring, and intervening when needed to prevent and eliminate wasteful spend throughout the duration of therapy can help lower payer costs and support plan member health.”

CVS’ Joshua Fredell, Pharm.D., and Tierra Ford, Pharm.D., described how an integrated, proactive approach can engage members and rein in costs.

What “Next Gen” Specialty Drug Cost Management Looks Like

In lung cancer especially, the ability to identify genomic alterations in patients’ tissue or blood samples has opened the door for more widespread adoption of targeted and immunotherapies, says Luca Quagliata, Ph.D., BCMAS, vice president and global head of medical affairs at Thermo Fisher Scientific, a healthcare tech and testing company headquartered in suburban Boston. Therapies tailored to lung cancers with certain genomic signatures have replaced chemotherapy as a first-line treatment for patients with lung cancer, he says, and advances in biomarker testing have decreased the turnaround time for results.

“We are no longer trying to convince people that genomic testing is valuable in lung cancer,” Quagliata says. “There is enough evidence to show its clinical utility.”

Quagliata also says testing has shifted from being done almost exclusively for patients with late-stage cancer to those with cancers diagnosed at an early stage as more targeted treatments prove to be effective in patients who are treated with surgery. This move “upstream” means fewer patients need to be treated with chemotherapy and radiation. Quagliata is also upbeat about the future of liquid biopsies, which detect early signs of cancer in blood samples rather than on samples of tissue from site of the tumor. “The value of liquid biopsy is that it is much less invasive to patients and has a simpler laboratory workflow when compared to acquiring and testing tissue samples,” Quagliata says. “ Thermo Fisher has a liquid biopsy product.

Raymond U. Osarogiagbon, M.D., FACP, the director of the multidisciplinary thoracic oncology program at the Baptist Cancer Center in Memphis, Tennessee, notes that as recently as 2012, almost half of advanced nonsquamous non-small cell lung cancers (NSCLCs) had no known biomarker that could be targeted for treatment. Now only about 1 in 10 of such cancers lacks biomarkers, he says, and the list of biomarkers — typically, a mutated gene — for which there are FDA-approved has grown from just two treatments to 10.

Targeted therapy for certain subsets of biomarker-specified lung cancer significantly improve survival. But Osarogiagbon says use of targeted therapy in patients lacking the specific target can cause harm. If the cancer doesn’t have the target, a targeted therapy is tantamount to no treatment. The longer that continues, the greater the harm. Therefore, biomarker testing is a key, fundamental part of successful targeted therapy. Several of the biomarker-delineated subsets of lung cancer are infrequent, occurring in fewer than 5% of all patients, notes Osargiagbon. “There is no clinical means of identifying patients with the relevant biomarker-delineated subsets. Therefore, there is the need for comprehensive genomic testing, so no patient gets left behind.” 

Additionally, there’s evidence that immune checkpoint inhibitor therapy, with drugs such as Keytruda (pembrolizumab) and Yervoy (ipilimumab), is ineffective in patients whose cancer is driven by certain genomic abnormalities, such as EGFR and ALK gene mutations. “Prior therapy with immune checkpoint inhibitors seems to significantly increase the danger of pneumonitis (inflammation of the lungs) — which can be debilitating, even life-threatening — when the correct targeted oral therapy agent is subsequently used,” Osarogiagbon says.

When it approves a targeted therapy, the FDA also often approves a companion test that can identify the biomarker for that targeted therapy. There are also tests developed by researchers and laboratories that haven’t been approved by the agency. “For companion diagnostic tests, the FDA has set the bar very high for accuracy and validation,” Quagliata says. “For assays that are not FDA approved, including LDTs (laboratory developed tests), Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (there are) standards for high-complexity laboratories to safeguard the quality of tests.”

When it comes to the expense of testing, Quagliata says it is essential to pull back and the see the situation from a broader perspective. “Rather than put patients on inefficient therapies as a first-line treatment, genetic testing allows clinicians to make more informed decisions, becoming more efficient in their prescribing, thus helping save on downstream treatment costs,” Quagliata says.

Osarogiagbon says American healthcare is moving rapidly from tests for a single biomarker to comprehensive genomic testing because the broader approach is faster, safer and more cost-effective for patients. “Unfortunately, even though the cost of so-called next generation sequencing (NGS) is dropping as more testing options and vendors enter the market, there remains the perception that these tests are expensive and might not be paid for by third-party payers,” he says. Another major concern is the turnaround time. Getting an NGS result can take several weeks.

Insurance coverage of biomarker testing is a wild card into biomarker testing. “Reimbursement has become a complex matter as even within the non-small cell lung cancer space, differences exist in several areas that impact payer coverage, including sample type, test size, test content, use case, and the stage of disease,” Quagliata says. In general, among patients with late-stage NSCLC, Medicare provides coverage, Medicaid does not, and commercial plans vary, according to Quagliata.

But as more studies are done, Quagliata believes the evidence for NGS being more efficient and cost-effective will get stronger. Matching patients with targeted therapies at an earlier stage will reduce unnecessary spending for payers and patients.

Andrew Hertler, M.D., chief medical officer at New Century Health, a subsidiary of Evolent Health, says the cost of the biomarker testing ranges from $2,000 to $4,000, though there can be additional costs if there’s a need to re-biopsy the tumor. Hertler sees a challenge in making sure the tests are accurate. “There have been some very disturbing studies done where people have sent the same specimen out to multiple different laboratories and not had consistent results — I think somewhere on the order of 50% of the time — so we clearly still badly need to come up with standardized validated reliable procedures,” he says. But Hertler notes that variability may also be in the cancer itself. “We know cancers are genetically unstable.”

The challenge in getting biomarker testing and targeted therapy is not so much with the patients as with their doctors and the healthcare systems in which they practice, as well as third-party coverage policies for these rapidly emerging options. Osarogiagbon is an adviser on the No One Missed campaign by LUNGevity Foundation, which brings essential education to the public around comprehensive biomarker testing in lung cancer.

“Patients quickly understand the benefit of this approach, given the striking improvements in results and greater convenience,” he says. “The main barriers are not patient-level; they are provider-, institutional- and social policy-level.”

Most clinicians are recommending comprehensive biomarker testing, which includes NGS and PDL1 Tumor Proportion Score testing.

“Single-gene tests waste time and expose patients to the danger of inordinate delay in identifying potentially lifesaving biomarkers that guide treatment,” Osarogiagbon says. “Ideally, these tests should be done reflexively when the patient diagnosed and the testing is automatically ordered, thereby saving precious time.”

Hertler says that when talking with patients, providers should explain biomarker testing methods clearly and note that targeted therapies don’t work for everybody, and even when they do work, the enthusiasm can have people carried away about the prospects. “People are doing better and have less side effects from their therapy and can live a more normal life, but we don’t have
a cure.”

Keith Loria is a freelance medical writer in the Washington, D.C., area.

Treatments aimed at certain mutations have proliferated and moved upstream to earlier-stage lung cancers. But there are many questions about insurance coverage and which tests to use to identify the biomarkers that help guide treatment. 

Keith Loria

Articles

Oncology: Network Adequacy Rules for Cancer Care are Often Inadequate

Stemming the Rising Tide of Insulin Prices

What “Next Gen” Specialty Drug Cost Management Looks Like

The Mainstreaming of Targeted Lung Cancer Treatment