‘Breakthrough’ Cystic Fibrosis Drug Could See High Demand

November 14, 2019

The FDA recently approved a drug therapy for cystic fibrosis (CF) that is being viewed as a “game-changer” for the roughly nine in 10 patients with the rare, progressive disease who might benefit from it. Where does this leave payers facing rising specialty drug costs across the board? Industry experts predict that most payers likely will cover this latest cystic fibrosis treatment option despite an annual price tag topping $300,000.

By Judy Packer-Tursman

The FDA recently approved a drug therapy for cystic fibrosis (CF) that is being viewed as a “game-changer” for the roughly nine in 10 patients with the rare, progressive disease who might benefit from it. Where does this leave payers facing rising specialty drug costs across the board? Industry experts predict that most payers likely will cover this latest cystic fibrosis treatment option despite an annual price tag topping $300,000.

Vertex Pharmaceuticals, Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), taken as a twice-daily pill regimen, is the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. The drug directly addresses the underlying cause of the illness — mutations in the CFTR protein.

The FDA approved Trikafta for patients 12 years and older with at least one F508del mutation in the CFTR gene, which is estimated to represent 90% of the cystic fibrosis population — many of whom have had no approved therapeutic options previously.

“From a utilization management standpoint, there is nothing in the marketplace that will be more effective or significantly less costly” than Trikafta, says Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington.

Manu Jain, M.D., professor of medicine and pediatrics at Northwestern University’s Feinberg School of Medicine and director of Northwestern’s adult CF program, expects the payer community generally will approve Trikafta. But coverage “definitely will be uneven,” he says.

According to Jain, certain people on Kalydeco won’t be candidates for the new drug; but most on Symdeko or Orkambi likely will switch to Trikafta.

During Vertex’s third-quarter 2019 earnings call, Vertex’s Chief Commercial Officer Stuart Arbuckle said the first patients have already been prescribed Trikafta by their physicians, “underscoring the strong interest in the medicine.” But he added that such demand for the new product might prompt launch delays.

The Politics of Medicaid Expansion Have Changed

November 13, 2019

Year by year, resistance to extending Medicaid to more low-income Americans in conservative states has given way. That trend seems likely to continue into 2020.

In some states, Democratic governors who favor expansion have replaced Republicans who were stalwart opponents. GOP critics have had a change of heart in some holdout states. And in several Republican-led states, citizen ballot initiatives are driving expansion.

Year by year, resistance to extending Medicaid to more low-income Americans in conservative states has given way. That trend seems likely to continue into 2020.

In some states, Democratic governors who favor expansion have replaced Republicans who were stalwart opponents. GOP critics have had a change of heart in some holdout states. And in several Republican-led states, citizen ballot initiatives are driving expansion.

Serious efforts are underway in Kansas, Missouri, North Carolina and Oklahoma that could add them to the 36 states, plus Washington, D.C., that have opted to expand Medicaid under the Affordable Care Act (ACA), also known as Obamacare. Three of those states adopted the expansion but have yet to implement the program….

Read the full PEW Stateline article

Datapoint: CMS Approves DC Medicaid Waiver

November 13, 2019

CMS last week approved a first-of-its-kind Section 1115 Medicaid waiver in the District of Columbia, which will expand behavioral health access to D.C. Medicaid eligibles residing in inpatient mental health facilities, as well as those suffering from serious mental illnesses or emotional disturbances who may be chronically homeless.

CMS last week approved a first-of-its-kind Section 1115 Medicaid waiver in the District of Columbia, which will expand behavioral health access to D.C. Medicaid eligibles residing in inpatient mental health facilities, as well as those suffering from serious mental illnesses or emotional disturbances who may be chronically homeless. The District currently serves 273,352 Medicaid beneficiaries, with 77.4% enrolled in managed care plans.

Source: AIS’s Directory of Health Plans

Molina Loses Parts of Texas STAR+PLUS Medicaid

November 13, 2019

The Texas Health and Human Services Commission (HHSC) on Oct. 29 delivered the highly anticipated results of its latest managed Medicaid procurement, revealing its intent to award contracts to Aetna Inc., Anthem, Inc., El Paso Health Plan, Molina Healthcare, Inc., Centene Corp.’s Superior Health Plan and UnitedHealthcare to serve approximately 525,000 high-acuity enrollees through the STAR+PLUS program. The news came as a disappointment to Molina, which had been banking on reprocuring its existing business in six regions instead of renewing just one service area and picking up a new zone.

by Lauren Flynn Kelly

The Texas Health and Human Services Commission (HHSC) on Oct. 29 delivered the highly anticipated results of its latest managed Medicaid procurement, revealing its intent to award contracts to Aetna Inc., Anthem, Inc., El Paso Health Plan, Molina Healthcare, Inc., Centene Corp.’s Superior Health Plan and UnitedHealthcare to serve approximately 525,000 high-acuity enrollees through the STAR+PLUS program. The news came as a disappointment to Molina, which had been banking on reprocuring its existing business in six regions instead of renewing just one service area and picking up a new zone.

Molina at its May investor day provided 2020 premium guidance that was above Wall Street consensus and a long-term earnings per-share (EPS) growth target in the range of 12% to 15%. Specifically, the company for 2020 forecast annual premiums of $17.0 billion to $17.3 billion, or 7% to 9% growth, before factoring in the return of the Affordable Care Act health insurer fee.
But that growth included the status quo in Texas, and executives during its latest quarterly earnings call acknowledged that the insurer will have to adjust its expectations for 2020 on account of an anticipated four-month revenue shortfall.

Molina currently serves 86,000 STAR+PLUS members in the Bexar, Dallas, El Paso, Harris, Hidalgo and Jefferson service areas. For the contract starting in 2020, it will retain only the Hidalgo area and add the North East region. The change, if finalized, would mean an annual revenue loss of approximately $930 million.

Jefferies securities analyst David Windley in an Oct. 30 research note wrote that this latest setback “is likely destabilizing” with a negative EPS impact of roughly 4% to 5%.

But Molina CEO Joseph Zubretsky during the earnings call emphasized that Texas is a short-term blip that can be overcome.

For the quarter ending Sept. 30, Molina reported EPS of $2.75 and an improved medical loss ratio of 86.3%. Premium revenue for the recent quarter was $4.1 billion.

Trump Officials Making Changes to Signature Drug Pricing Proposal, Azar Says

November 13, 2019

Secretary of Health and Human Services Alex Azar on Wednesday said that the administration is changing one of its main proposals to lower drug prices because President Trump wants to go further.

The Trump administration last year proposed lowering certain Medicare drug prices by tying the prices to lower prices paid in other developed countries, an idea known as the International Pricing Index.

Secretary of Health and Human Services Alex Azar on Wednesday said that the administration is changing one of its main proposals to lower drug prices because President Trump wants to go further.

The Trump administration last year proposed lowering certain Medicare drug prices by tying the prices to lower prices paid in other developed countries, an idea known as the International Pricing Index.

Under the original proposal, prices would still have been lower than they are now, but would still be a certain percentage higher than they are in other countries. Trump was not satisfied with that idea, Azar said Wednesday, and wanted the proposal changed so that prices in the United States are even lower than they are in other countries. “What we suggested was reducing that 180 percent premium [above other countries] by 30 percent,” Azar said at an event hosted by Axios. “The president did not find that satisfactory. His view, which he has articulated publicly, is that America ought to be getting the best deal among developed countries. That was the terminology of ‘most favored nation status.’ And so that’s the type of proposal we’re working on….”

Read the full The Hill article