Abstract

FDA Approves New Treatments for nr-axSpA, But Coverage May Be Tricky

July 1, 2020

The FDA’s approval of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis (nr-axSpA) offers providers new options for patients who are intolerant of non-steroidal anti-inflammatory medications (NSAIDs) and other therapies.

Axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine, was reclassified into two categories. In the more commonly known ankylosing spondylitis (AS), also called radiographic axial spondyloarthritis (r-axSpA), damage to the spine is visible on an X-ray. In the earlier-stage form of the disease, non-radiographic axial spondyloarthritis (nr-axSpA), joint deterioration is not yet evident on an X-ray.

By Jane Anderson

The FDA’s approval of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis (nr-axSpA) offers providers new options for patients who are intolerant of non-steroidal anti-inflammatory medications (NSAIDs) and other therapies.

Axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine, was reclassified into two categories. In the more commonly known ankylosing spondylitis (AS), also called radiographic axial spondyloarthritis (r-axSpA), damage to the spine is visible on an X-ray. In the earlier-stage form of the disease, non-radiographic axial spondyloarthritis (nr-axSpA), joint deterioration is not yet evident on an X-ray.

“It’s possible that with the emerging trend of biologics gaining expanded indications to treat non-radiographic axial spondyloarthritis, payers will respond by choosing a preferred agent from the three [biologics] approved,” says Mesfin Tegenu, R.Ph., president of PerformRx. “However, expanded indications for biologics in the treatment of non-radiographic axial spondyloarthritis, being a less advanced form of ankylosing spondyloarthritis, might cause no changes to formularies.”

Nicole Kjesbo, Pharm.D., principal clinical program pharmacist at Prime Therapeutics LLC, says that although Taltz and Cosentyx provide a new mechanism of action to treat nr-axSpA, “at this time, their FDA approvals for this indication will not change the course of therapy, as they were already recommended for off-label use by guidelines.”

The two newly approved biologics are listed in clinical guidelines as third-line treatments, behind NSAIDs and tumor necrosis factor inhibitors (TNFis), Kjesbo says, and according to the guidelines, “TNFis are recommended over Taltz or Cosentyx.”

“NSAIDs are most commonly used for axial SpA (AS and nr-axSpA), and in many patients this is the only drug ever needed,” Tegenu says. “Most NSAIDs are available generically.”

“Second-line therapy is any tumor necrosis factor inhibitor (TNFi),” adds Tegenu. And Kjesbo explains that “TNFi treatment is recommended over treatment with Taltz, Cosentyx or [Pfizer Inc.’s] Xeljanz/XR (tofacitinib).”

Only one other drug was previously labeled to treat nr-axSpA: UCB’s TNFi, Cimzia (certolizumab pegol). In patients who try and fail or have contraindications to NSAIDs and to TNFis, the two IL-17A inhibitors — Taltz and Cosentyx — are indicated for AS, Tegenu says.

Payers Grapple With How to Address Inequality in Health Care

June 30, 2020

COVID-19 has disproportionately infected and killed people of color, causing many health care leaders to renew their focus on racism’s role in social determinants of health (SDOH). Since George Floyd was killed by Minneapolis police and Black Lives Matter protests took over America’s streets, the conversation about racism in health care has become even more urgent.

A June 16 Brookings Institution analysis of data through June 6 from the Centers for Disease Control and Prevention (CDC) found that “the age-adjusted COVID-19 death rate for Black people is 3.6 times that for whites, and the age-adjusted death rate for Hispanic/Latino people is 2.5 times that for whites.”

By Peter Johnson

COVID-19 has disproportionately infected and killed people of color, causing many health care leaders to renew their focus on racism’s role in social determinants of health (SDOH). Since George Floyd was killed by Minneapolis police and Black Lives Matter protests took over America’s streets, the conversation about racism in health care has become even more urgent.

A June 16 Brookings Institution analysis of data through June 6 from the Centers for Disease Control and Prevention (CDC) found that “the age-adjusted COVID-19 death rate for Black people is 3.6 times that for whites, and the age-adjusted death rate for Hispanic/Latino people is 2.5 times that for whites.”

According to Rep. Lauren Underwood (D-Ill.), spotty health insurance coverage is partly to blame for bad COVID-19 outcomes for people of color. “These racial gaps…reflect a deeply entrenched racial inequity throughout our health care system, and one of the key drivers of these disparities is unequal access to care. The uninsured rate for African Americans is more than 1.6 times higher than the uninsured rate for white Americans,” she said during a June 22 meeting of the House Committee on Education and Labor about the pandemic’s impact on education, health care and the workforce.

In a webinar organized by the Alliance for Health Policy, Adaeze Enekwechi, president of health care consultancy IMPAQ International, said expanding coverage is a critical part of improving health outcomes in communities of color going forward. “Whether it’s through Medicaid or some of the other policy discussion points around Medicare, but I think we need to think long and hard about that,” she said.

Wizdom Powell, director of the Health Disparities Institute at the University of Connecticut, argued that recent mass layoffs and furloughs showed the need to improve coverage continuity and portability in general. She observed people of color are more likely than the population at large to be unemployed or work in industries that do not typically offer health care coverage.

During a panel at the recent AHIP Institute & Expo, Kaiser Permanente Executive Director for Strategic Customer Engagement, Product Innovation and Evaluation Jennifer Christian-Herman observed that an intentional focus on SDOH by employers and contracting plans can drive business value.

CVS Health Corp. executive Garth Graham, M.D., agreed and said that many forward-thinking plans are already working on improving housing, nutrition and transportation for low-income members.

CMS Proposes New Medicaid Best Price Rules for Pricey Therapies

June 29, 2020

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

By Peter Johnson

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

New curative therapies present a novel financial challenge for payers. Curative therapies eliminate the need for intensive treatment of chronic and terminal conditions, which create substantial savings for payers, patients and providers alike.

However, their high up-front cost is borne by payers and patients, and the initial payer may not see the entire financial benefit of the curative therapy. What’s more, under a traditional payment model, insurers are unable to recoup costs if a new, experimental therapy with curative potential has limited effect.

In order to spread risk and value across all stakeholders involved, some drug benefit industry leaders have called for broad adoption of the value-based pricing methods CMS’s proposed rule seeks to create, backed by a reinsurance mechanism.

Avalere Health principal Mike Schneider tells AIS Health that, although CMS’s proposal does not include a reinsurance mechanism, it should advance adoption of curative therapies. He says that, as they are currently implemented, Medicaid’s best price rules have made it difficult for commercial payers to negotiate with drug manufacturers to include outcomes and proof of concept in purchasing agreements.

Though the proposed rule applies directly to state Medicaid plans, Schneider says that the rule could have a substantial impact on the commercial market as plans bidding on Medicaid contracts gain experience with the new paradigm.

Still, barriers remain in adopting new curative therapies. Drug Channels Institute CEO Adam Fein points out that the rule does not address the challenge presented by copay accumulators to patients who might benefit from expensive, new specialty drugs — which suggests the rule might not speed up curative therapy adoption as quickly as patients might hope.

Telehealth Regulation and Reimbursement Issue Sparks Debates

June 25, 2020

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

By Peter Johnson

Telehealth use has surged during the COVID-19 pandemic, and is likely to remain higher than it was before the crisis on a permanent basis. However, the difficult work of regulating and establishing rate structure for telehealth beyond the COVID-19 pandemic has only just started.

On June 17, the Senate Health, Education, Labor and Pensions Committee held a hearing about how to consolidate the gains in telehealth made necessary by the pandemic.

The most important policy decision that Congress must make is on reimbursement. CMS has elected to compensate telehealth visits at the same rate as in-person visits for the duration of the pandemic, but whether that will continue is likely to be decided in the coming weeks. At present, commercial plans have a wide variation in telehealth reimbursement amounts.

Providers will likely oppose setting telehealth reimbursement at rates lower than in-person visits, and experts predict the balance of visits will shift more heavily toward remote consultations going forward.

Yet part of the allure of telehealth for payers and patients is that a remote visit generally costs less than an in-person consultation. The stakes are high for the payer industry: Provider services seem to be the main driver behind higher overall health care spending in the last decade. If telehealth visits account for a meaningful share of overall visits across the industry, a lower rate of reimbursement will make a big difference in lowering costs.

The other major regulatory challenge for telehealth is provider licensing. State medical boards exercise control over whether a clinician can practice in their state, and it is typically illegal for a practitioner licensed in one state to care for patients in another.

“We think the best way to handle [state licensure] is through a compact,” said Krista Drobac, the executive director of the Alliance for Connected Care, during a session at America’s Health Insurance Plans’ Institute & Expo. “We would like to see licensure reciprocity or mutual recognition, what we refer to as licensure portability.…Congress can’t step in and take over licensing — that’s just not a federal responsibility.”

Yet Avalere Health founder Dan Mendelson takes a different view. “The licensure issues are problematic. The Congress needs to act more aggressively to make it easier to deliver telemedicine in the United States,” he says.

Highmark Moves to Absorb Leading Western New York Insurer HealthNow

June 24, 2020

In a deal that the companies say was validated by the challenges of the COVID-19 pandemic, HealthNow New York Inc. revealed on June 16 that it will become part of fellow Blue Cross Blue Shield licensee Highmark Inc.

HealthNow, which is headquartered in Buffalo, N.Y., currently operates Blues-licensed health plans in eight counties in western New York and 13 counties in northeastern New York. Pittsburgh-based Highmark operates Blues plans in Delaware, Pennsylvania and West Virginia. Once their combination is completed, the organizations will serve 4.4 million members, according to AIS’s Directory of Health Plans.

By Leslie Small

In a deal that the companies say was validated by the challenges of the COVID-19 pandemic, HealthNow New York Inc. revealed on June 16 that it will become part of fellow Blue Cross Blue Shield licensee Highmark Inc.

HealthNow, which is headquartered in Buffalo, N.Y., currently operates Blues-licensed health plans in eight counties in western New York and 13 counties in northeastern New York. Pittsburgh-based Highmark operates Blues plans in Delaware, Pennsylvania and West Virginia. Once their combination is completed, the organizations will serve 4.4 million members, according to AIS’s Directory of Health Plans.

“This makes a lot of sense, really, for both organizations,” says Dan Mendelson, founder of Avalere Health. “For Highmark, it’s a strategic entry in New York, and it’s a plan of scale — and they’re in the business of building scale.”

For HealthNow, Mendelson says, scale is also the motivator. “For these regional players…it’s hard to be a ‘big small player.’ What that means is when things happen — and COVID-19 is an important example where you need to leverage scale to solve problems regionally — you don’t have that kind of air coverage you get from being part of a large organization,” he says. “And so, I think a lot of the regional players are starting to understand the benefits that come with an affiliation with a larger player.”

Not everyone, though, is convinced of the benefits of scale. “Highmark and HealthNow New York coming together in the name of delivering additional value to beneficiaries is commendable, however, they and all other health care players should be wary of using scale to achieve this goal,” says Rita Numerof, Ph.D., co-founder and president of Numerof & Associates. The notion that “bigger equals better,” she adds, “is a widely held misconception, as size can often get in the way of innovation and rapid adaptations to change.

“In order for this affiliation to be successful, Highmark and HealthNow New York will need to make an early and steadfast commitment to operating in tandem with one another,” Numerof continues. “Their path forward will need to be abundantly clear, their mission and values in total alignment, and beneficiary value at the heart of every effort.”

The deal still must obtain regulatory approvals and meet certain closing conditions before it is completed.

Supreme Court’s Ruling on LGBTQ+ May Supersede HHS Final Rule

June 23, 2020

The Supreme Court’s June 15 ruling on LGBTQ+ workforce protections in Bostock v. Clayton County, Georgia, could supersede a recently finalized rule by HHS’s Office for Civil Rights (OCR) that stripped gender identity protections from anti-discrimination provisions in the Affordable Care Act (ACA), legal experts say.

In Bostock, the Court held that Title VII of the Civil Rights Act of 1964 protects employees from discrimination based on sexual orientation or gender identity. The case originated with Gerald Bostock, who sued his employer, Clayton County, when he was fired after mentioning that he was the member of a gay softball league.

By Peter Johnson

The Supreme Court’s June 15 ruling on LGBTQ+ workforce protections in Bostock v. Clayton County, Georgia, could supersede a recently finalized rule by HHS’s Office for Civil Rights (OCR) that stripped gender identity protections from anti-discrimination provisions in the Affordable Care Act (ACA), legal experts say.

In Bostock, the Court held that Title VII of the Civil Rights Act of 1964 protects employees from discrimination based on sexual orientation or gender identity. The case originated with Gerald Bostock, who sued his employer, Clayton County, when he was fired after mentioning that he was the member of a gay softball league.

“The Court is saying an employment decision based on sexual orientation or identification cannot be applied ‘but for’ the employee’s biological sex,” Raja Sekaran, a partner in Nossaman LLP and former HHS attorney, tells AIS Health via email.

“Granted, this is a relatively subtle point but is nonetheless the one on which the Court’s decision turns, in my view,” Sekaran explains. “In contrast, there is no such subtlety in the Trump Administration’s [final rule] announcement.…In 2016, the Obama administration interpreted sex discrimination under the ACA to include discrimination based on gender identity. Last Friday, [HHS] reversed that position.…It is hard to see how this new final rule can stand in the wake of Bostock because upon application it invariably would fail the ‘but for’ test.”

“This seems like an uphill battle for OCR,” wrote health care attorney Katie Keith, principal at Keith Policy Solutions, LLC, in a blog post for Health Affairs. “We are likely left to waiting to see how various lower courts will now apply the Supreme Court’s ruling…in other contexts.”

In her post, Keith said that the ruling will likely have practical short-term implications for health plans and employers. She said employers may need to update their benefit design to be more inclusive of LGBTQ+ employees.

Keith suggested that the final rule could be withdrawn by HHS if its attorneys think Bostock makes it a moot point. But if it is not withdrawn, Keith said the open question of the ruling’s impact on the final rule is likely to create a chaotic legal environment for health care stakeholders.