FDA Approves First Oral Treatment for HAE Attack Prevention

January 12, 2021

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc’s Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

By Angela Maas

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc’s Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

Orladeyo will compete against Cinryze, Haegarda (C1 esterase inhibitor [human]) and Takhzyro (lanadelumab-flyo) to prevent HAE attacks.

For the Managed Care Biologics and Injectables Index: Q1 2020, between Feb. 25, 2020, and April 1, 2020, Zitter surveyed 51 commercial payers with 138.1 million covered lives about their anticipated management of Orladeyo. Payers covering 93% of lives said they likely would manage it to label and not allow off-label use.

Among 46 commercial payers with 130.3 million covered lives surveyed during the same time period, payers with 74% of covered lives said they were likely to manage Orladeyo at parity to the prophylactic therapies. And even though it is the only oral HAE drug, payers with 80% of lives said they were unlikely to manage it separately from the other drugs based on route of administration.

Among providers who would transition current patients to Orladeyo, the most likely prophylactic agent to transfer from was Cinryze, cited by 42%; followed by Haegarda, at 25%; and Takhzyro at 8%.

BioCryst has priced Orladeyo at $485,000 per person per year, which is slightly more than the $450,000 PPPY that Evercore ISI expected, according to analyst Liisa Bayko in a Dec. 4 research note. That price, though, is lower than Haegarda’s $510,000 PPPY and Takhzyro’s $566,000, she pointed out.

“As an oral, once-daily option, Orladeyo provides significant attack reduction without the burden associated with injectables — the hallmark of treatment options,” wrote Bayko. “Our market research showed that patients and physicians were eagerly awaiting an oral option, with anticipated use of Orladeyo reaching 34% of prophylaxis HAE market by [year-end] 2021 — driven by switching and growth of the market with use of prophylaxis rising from 60% to 80% over time.”

Datapoint: Tufts, Harvard Pilgrim Complete Merger

January 11, 2021

Two of the largest insurers in New England, Tufts Health Plan and Harvard Pilgrim Health Care, have officially combined, according to a Jan. 4 press release. The new organization now serves 2,136,047 lives in five states, with 85.2% of members concentrated in Massachusetts. The two insurers announced their intent to merge in August 2019.

Two of the largest insurers in New England, Tufts Health Plan and Harvard Pilgrim Health Care, have officially combined, according to a Jan. 4 press release. The new organization now serves 2,136,047 lives in five states, with 85.2% of members concentrated in Massachusetts. The two insurers announced their intent to merge in August 2019.

Source: AIS’s Directory of Health Plans

Medicaid MCOs Continue to Advocate for FMAP Increase in 2021

January 11, 2021

As the novel coronavirus erupted across the U.S. and created a widespread economic downturn, it led to increased enrollment in state Medicaid programs and created devastating budget shortfalls for states. Yet Congress’ latest pandemic relief effort — the Consolidated Appropriations Act signed by President Donald Trump on Dec. 27 — does not include direct financial help for states, which are now rolling out newly authorized COVID-19 vaccines with limited resources and guidance from the federal government.

Earlier legislation, the Families First Coronavirus Response Act, afforded states a temporary increase of 6.2% in their federal match rate, yet multiple stakeholders have beseeched Congress to enact another temporary boost during the public health emergency.

By Lauren Flynn Kelly

As the novel coronavirus erupted across the U.S. and created a widespread economic downturn, it led to increased enrollment in state Medicaid programs and created devastating budget shortfalls for states. Yet Congress’ latest pandemic relief effort — the Consolidated Appropriations Act signed by President Donald Trump on Dec. 27 — does not include direct financial help for states, which are now rolling out newly authorized COVID-19 vaccines with limited resources and guidance from the federal government.

Earlier legislation, the Families First Coronavirus Response Act, afforded states a temporary increase of 6.2% in their federal match rate, yet multiple stakeholders have beseeched Congress to enact another temporary boost during the public health emergency.

In a Dec. 14 letter to President-elect Joe Biden, Medicaid Health Plans of America President and CEO Craig Kennedy said that securing an additional Federal Medical Assistance Percentage (FMAP) increase of at least 5.8% (for a total increase of 12%) remains the trade group’s top legislative priority. To minimize disruptions in care, MHPA urged the incoming administration to immediately extend the public health emergency beyond its Jan. 20 expiration date and enact an additional FMAP increase at least through September 2021.

“There is no question that the new administration will push hard to increase funding for state Medicaid,” predicts Avalere Health Founder Dan Mendelson. “Generally, the new administration will want to expand coverage and work with the states to get that done.”

Jerry Vitti, CEO and founder of Healthcare Financial, Inc., agrees that making states whole will be a Biden priority. “This is not a blue state/red state divide. Every state has these problems, and it’s the double whammy of the decreased revenue at a time where your expenses are going way up because people need social services programs, they need Medicaid, their health care systems are strained, they have to distribute vaccines — all these associated costs need to be covered.”

Meanwhile, as the COVID-19 pandemic has highlighted so many disparities in health care, Medicaid MCOs will be expected to take concrete action to bridge care gaps, especially in communities of color, experts agree.

“With people of color comprising over half of Medicaid enrollees, 2020 has been a reckoning: COVID-19 and health disparities have made it so much more deadly for them….Medicaid MCOs will need to innovate to address equity issues,” says Abner Mason, founder and CEO of ConsejoSano.

People on the Move

January 8, 2021

CMS COVID Snapshot Highlights Heightened Risks for Duals, Minorities, Older Beneficiaries

January 8, 2021

In a preliminary analysis — or snapshot — of fee-for-service Medicare claims and Medicare Advantage encounter data from Jan. 1 to Sept. 12, 2020, CMS reported 1.19 million COVID-19 cases and 332,672 related hospitalizations among all 62.3 million beneficiaries. That’s a rate of 517 hospitalizations per 100,000 lives. The data puts into stark clarity what is already suspected about the virus: those at the highest risk of developing severe complications are older, lower income, have preexisting conditions and (with the exception of Asian beneficiaries) are more likely to be racial minorities. Cases requiring hospitalization were strikingly prevalent among Medicare-Medicaid dual eligibles, particularly those who identify as Black or Hispanic. As of the snapshot’s latest update, Medicare has paid $5.1 billion in fee-for-service claims for COVID hospitalizations, or $24,659 per hospitalization. Just under half (49%) of all hospitalizations were seven days or fewer. See a condensed summary of the snapshot below.

by Carina Belles

In a preliminary analysis — or snapshot — of fee-for-service Medicare claims and Medicare Advantage encounter data from Jan. 1 to Sept. 12, 2020, CMS reported 1.19 million COVID-19 cases and 332,672 related hospitalizations among all 62.3 million beneficiaries. That’s a rate of 517 hospitalizations per 100,000 lives. The data puts into stark clarity what is already suspected about the virus: those at the highest risk of developing severe complications are older, lower income, have preexisting conditions and (with the exception of Asian beneficiaries) are more likely to be racial minorities. Cases requiring hospitalization were strikingly prevalent among Medicare-Medicaid dual eligibles, particularly those who identify as Black or Hispanic. As of the snapshot’s latest update, Medicare has paid $5.1 billion in fee-for-service claims for COVID hospitalizations, or $24,659 per hospitalization. Just under half (49%) of all hospitalizations were seven days or fewer. See a condensed summary of the snapshot below.

NOTES: CMS notes that its claims and encounter data are typically not used for public health surveillance due to lag times between when a beneficiary receives care, and when the claim or encounter is logged in the database. Lag times vary by service and program, and the pandemic’s impact may have caused longer-than-usual delays. Fee-for-service claims are submitted within three months, while 90% of MA encounters are reported within 12 months. All data in the snapshot is preliminary and will be adjusted as the agency continues to process additional claims and encounters.
AI/AN = American Indian/Alaska Native.

SOURCE: Preliminary Medicare COVID-19 Data Snapshot, CMS. View the full snapshot here: https://go.cms.gov/3mYxRZA.

Datapoint: Centene Strikes $2.2 Billion Deal for Magellan

January 7, 2021

Centene Corp. on Monday said it has entered an agreement to acquire Magellan Health, one of the largest independent providers of behavioral health services in the U.S. Its payer clients include Blue Cross and Blue Shield of Texas (5.9 million lives) Blue Shield of California (3.3 million lives) and Independence Blue Cross (1.8 million lives). Centene operates its own in-house behavioral health unit, Cenpatico, which serves most of its 20.0 million lives. The deal, valued at $2.2 billion, is expected to close in the second half of 2021, pending regulatory approval.

Centene Corp. on Monday said it has entered an agreement to acquire Magellan Health, one of the largest independent providers of behavioral health services in the U.S. Its payer clients include Blue Cross and Blue Shield of Texas (5.9 million lives) Blue Shield of California (3.3 million lives) and Independence Blue Cross (1.8 million lives). Centene operates its own in-house behavioral health unit, Cenpatico, which serves most of its 20.0 million lives. The deal, valued at $2.2 billion, is expected to close in the second half of 2021, pending regulatory approval.

Source: AIS’s Directory of Health Plans

With New Majority, Here’s What Democrats Can (and Can’t) Do on Health Care

January 7, 2021

The Democrats’ new congressional majority puts a variety of health policy ideas suddenly into reach, even if big structural changes remain unlikely.

A series of tweaks bolstering the Affordable Care Act stands the best chance of passage. Legislators could make insurance subsidies more generous, get coverage to low-income Americans in states that haven’t expanded Medicaid, and render moot a pending Supreme Court lawsuit that aims to overturn the entire law.

The Democrats’ new congressional majority puts a variety of health policy ideas suddenly into reach, even if big structural changes remain unlikely.

A series of tweaks bolstering the Affordable Care Act stands the best chance of passage. Legislators could make insurance subsidies more generous, get coverage to low-income Americans in states that haven’t expanded Medicaid, and render moot a pending Supreme Court lawsuit that aims to overturn the entire law.

But structural overhauls like “Medicare for all,” which would move all Americans to a government-run health plan, face a much tougher road. So would elements of Joe Biden’s health agenda, such as a public option, which would give Americans a choice between a new public plan and private insurance….

Read the full The New York Times article

Advocates, Providers Urge State Medicaid Programs to Extend Postpartum Coverage

January 7, 2021

As states face intense budget pressures during the COVID-19 pandemic and beneficiary advocates urge the federal government to provide additional financial support to state Medicaid programs, extending postpartum care access would resolve a longstanding issue impacting children and families and close a significant gap in coverage during the pandemic and beyond, according to advocates and providers.

Roughly 700 women die each year due to pregnancy-related complications, and about 60% of cases are preventable, according to the Centers for Disease Control and Prevention (CDC). The CDC also estimates that more than 44,000 pregnant women have become infected with the coronavirus this year, resulting in an estimated 8,500 hospitalizations. Medicaid is the largest payer of maternity care in the U.S., yet current law does not require state Medicaid programs to cover women for more than 60 days after childbirth, and states must seek waiver approval to use federal matching funds to extend coverage.

By Lauren Flynn Kelly

As states face intense budget pressures during the COVID-19 pandemic and beneficiary advocates urge the federal government to provide additional financial support to state Medicaid programs, extending postpartum care access would resolve a longstanding issue impacting children and families and close a significant gap in coverage during the pandemic and beyond, according to advocates and providers.

Roughly 700 women die each year due to pregnancy-related complications, and about 60% of cases are preventable, according to the Centers for Disease Control and Prevention (CDC). The CDC also estimates that more than 44,000 pregnant women have become infected with the coronavirus this year, resulting in an estimated 8,500 hospitalizations. Medicaid is the largest payer of maternity care in the U.S., yet current law does not require state Medicaid programs to cover women for more than 60 days after childbirth, and states must seek waiver approval to use federal matching funds to extend coverage.

During the public health emergency, states may not disenroll women from their Medicaid programs at 60 days postpartum. But this is only a temporary policy, and groups are urging CMS and Congress to protect access to continuous postpartum care once the crisis ends.

Prior to the pandemic, three states — Illinois, Missouri and New Jersey — submitted 1115 waivers to extend postpartum coverage, according to a Dec. 8 Health Affairs article authored by ACOG Senior Health Policy Analyst Emily Eckert. And during the pandemic, Indiana submitted a waiver seeking approval to implement a coverage extension for women with SUD.

Yet CMS has not cleared any of those waiver requests, despite its recent approval of Medicaid work requirement waivers in Georgia and Nebraska, pointed out Eckert.

During a teleconference to discuss a new report from The Commonwealth Fund and the Georgetown University McCourt School of Public Policy, public health experts on Dec. 9 explained how making short-term cuts to Medicaid to deal with budget shortfalls brought on by the pandemic could have long-term impacts to children and families, especially in communities of color. Research has shown that continued insurance coverage for children can have a wide range of long-term benefits, including better health outcomes, higher education attainment, improved earnings, reduced use of government programs as an adult and lower mortality, observed the report.

Biden’s Health Agenda is About to Get Bigger

January 6, 2021

BIDEN’s HEALTH AMBITIONS JUST GOT BIGGER — If Democrats’ lead in a Georgia runoff holds, it would give Biden 50 votes in the Senate – and breathe a whole lot of life into his administration’s health care plans.

— The immediate impact: Biden gets his Cabinet. Adding Raphael Warnock and Jon Ossoff to the Senate means that suddenly Republicans’ threats to block HHS nominee Xavier Becerra from confirmation over his abortion rights record don’t mean much of anything. And that would go doubly for Neera Tanden, the Office of Management and Budget pick whose nomination many Republicans (and quietly, several Democrats) deemed dead on arrival just a few weeks ago.

BIDEN’s HEALTH AMBITIONS JUST GOT BIGGER — If Democrats’ lead in a Georgia runoff holds, it would give Biden 50 votes in the Senate – and breathe a whole lot of life into his administration’s health care plans.

— The immediate impact: Biden gets his Cabinet. Adding Raphael Warnock and Jon Ossoff to the Senate means that suddenly Republicans’ threats to block HHS nominee Xavier Becerra from confirmation over his abortion rights record don’t mean much of anything. And that would go doubly for Neera Tanden, the Office of Management and Budget pick whose nomination many Republicans (and quietly, several Democrats) deemed dead on arrival just a few weeks ago.

Instead, they’d only need to convince 50 Democrats to back them, a process that a newly Democratic-controlled Senate will be eager to speed along….

Read the full Politico article

Walgreens to Sell Drug Wholesale Business for $6.5B

January 6, 2021

Walgreens Boots Alliance will sell its pharmaceutical wholesale business to AmerisourceBergen in a $6.5 billion cash and stock deal.

Pharmaceutical wholesalers essentially act as middlemen, purchasing drugs from manufacturers and then distributing them to customers like drugstore chains, hospitals and doctor’s offices.

Walgreens said Wednesday that the deal will allow it to focus more on expanding its core retail pharmacy business which, like others, has been rattled by the COVID-19 pandemic.

Walgreens Boots Alliance will sell its pharmaceutical wholesale business to AmerisourceBergen in a $6.5 billion cash and stock deal.

Pharmaceutical wholesalers essentially act as middlemen, purchasing drugs from manufacturers and then distributing them to customers like drugstore chains, hospitals and doctor’s offices.

Walgreens said Wednesday that the deal will allow it to focus more on expanding its core retail pharmacy business which, like others, has been rattled by the COVID-19 pandemic.

Drugstore chains and other retailers were hit hard, particularly last spring, when the pandemic forced shoppers to stay home and away from their stores….

Read the full The Associated Press article