Perspectives

Perspectives on New Postpartum Depression Drug

May 2, 2019

The FDA’s recent approval of the first medication specifically aimed at treating postpartum depression is drawing a favorable response from clinicians, while payers could face challenges.

The FDA’s recent approval of the first medication specifically aimed at treating postpartum depression is drawing a favorable response from clinicians, while payers could face challenges.

PBM executives tell AIS Health that the postpartum depression drug, Zulresso (brexanolone) injection, is likely to be covered under the medical, not the pharmacy, side of the benefit.

Zulresso’s initial U.S. list price “will be $7,450 per vial, resulting in a projected average course of therapy cost of $34,000 per patient before discounts,” says Alexis Smith, a spokesperson for Zulresso’s manufacturer, Sage Therapeutics, Inc.

Dea Belazi, Pharm.D., president and CEO of AscellaHealth, says as the medication must be administered as a 60-hour continuous intravenous infusion, it’s a challenge for a new mother to be hospitalized in an approved facility for two-and-a-half days for an IV infusion. Moreover, there is “the fact that there are possible extensive side effects and the data on its [Zulresso’s] effectiveness [are] moderately better than placebo. The cost will also play a barrier,” he adds.

Camille Hoffman, M.D., associate professor in the University of Colorado’s Department of Ob/Gyn, describes the newly approved drug as “a breakthrough medication” that “rapidly improves postpartum depression out to, at least, 30 days following the one-time treatment.”

She acknowledges that the need to administer Zulresso via a 60-hour IV drip and its restricted distribution might present challenges. However, she says, “I hope that payers will consider these potential barriers in light of how quickly it acts to help women with severe postpartum depression.”

Perspectives on Insulin Management

April 18, 2019

Amid increasing public scrutiny of rising insulin prices, some health insurers are taking matters into their own hands to help their diabetic members afford the lifesaving medications, AIS Health reported.

Amid increasing public scrutiny of rising insulin prices, some health insurers are taking matters into their own hands to help their diabetic members afford the lifesaving medications, AIS Health reported.

At the integrated health system HealthPartners, the members who are hardest hit by rising insulin prices are those in high-deductible health plans, says Young Fried, vice president of pharmacy plan services. But she says insulin affordability is also an issue for Medicare members who are in the Part D “doughnut hole.”

One tactic that the organization’s health plan deploys to ease the burden on members is a policy called “plan pay the difference,” Fried says. If a brand drug becomes cheaper than the generic version after rebates, “we would actually have the member pay the generic copay instead of the brand, and then we would reimburse the pharmacy the brand cost, so that they’re made whole as well,” she says.

At Geisinger Health Plan, Medicare enrollees are the ones who have the most trouble paying for their insulin, according to Jamie Miller, the health plan’s system director of managed care pharmacy. Overall, Geisinger saw its spending in the diabetes drug class rise 13.8% between 2017 and 2018, she adds.

As Geisinger works out what it wants its Medicare benefit to look like in 2020, Miller says one goal is to make insulin more affordable for its senior members. Thus, the health plan is considering adding a sixth, “zero-dollar” tier to its Part D formulary where it would put insulin and select other drugs.

Perspectives on the First-Ever Digital Oncology Medicine

April 4, 2019

As innovations in digital capabilities continue to be used with various health care products, Proteus Digital Health, Inc. is developing a suite of what it terms digital medicines. And while the company has been working on such products for a few years, it recently came out with the first such product within the oncology space, AIS Health reported.

As innovations in digital capabilities continue to be used with various health care products, Proteus Digital Health, Inc. is developing a suite of what it terms digital medicines. And while the company has been working on such products for a few years, it recently came out with the first such product within the oncology space, AIS Health reported.

Proteus is partnering with Fairview Health Services and the University of Minnesota Health to offer oral capecitabine combined with an ingestible sensor to treat stage 3 and stage 4 colorectal cancer patients.

David Purdie, vice president of medical affairs at Proteus, explains that through an open capsulation process, a pharmacist will place a capecitabine pill and a sensor within a capsule and then seal it. The capsule dissolves within a person’s stomach within a minute or so after it’s ingested. “Each sensor has a unique identifier,” and after the capsule dissolves, an app on a mobile device transmits data such as the time of the dose, the medication taken, the dosage of the drug and certain patient reactions to the drug to the cloud, where the information matches up with a database. “Every pill is uniquely identified,” so if someone takes 30 different pills at one time, the database will be able to know exactly what each medication is.

Asked how his company decided to launch the oncology program, Purdie replies, the main reason “is oncology traditionally has been an infused medication space.” But there’s been a huge increase in the number of FDA-approved oral oncology drugs since then, which allows patients to “medicate at home,” he notes.

“With oncology drugs, every patient is kind of different” in their response, Purdie explains. “It’s important that providers give enough drug so the disease is going to be killed but not enough that patients are so sick they cannot function.”

“With the increase in the number of oral chemotherapy agents being approved and utilized in cancer care, adherence needs to be a key focus for the patient and care team,” says Darcy Malard Johnson, Pharm.D., oncology pharmacy program manager at Fairview and University of Minnesota Health Cancer Care. “Oral chemotherapy puts more accountability onto the patient. A device like this gives both the patient and the care team insight into patient adherence by providing a clear picture of how the medication is being taken. By understanding patient-specific adherence, we can help the patient manage adherence for the best possible clinical outcome.”

Perspectives on Novel Drug Management in 2019

March 21, 2019

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

As payers struggle to rein in high specialty drug prices, many have turned to copay accumulator programs, and this trend shows no signs of slowing. “There was an increased focus on copay accumulator programs in 2018,” comments Amy Nash, Pharm.D., president of RelianceRx, the specialty pharmacy affiliate of Independent Health. She tells AIS Health she expects to see “further refinement of copay accumulator programs from payers and additional strategies from pharma to prevent them.”

Moving forward, Nash tells AIS Health, “specialty drug price increases will likely continue to be less frequent and at a lower percentage increase than previous years. We will likely see newly approved products priced lower than competitors to drive utilization.”

The industry could see “a handful of novel gene therapies with curative intent,” says Mesfin Tegenu, president of PerformRx. However, as the prices of these drugs and other innovative treatments continue to grow, “The high prices will necessitate a paradigm shift in the way medicines are paid for….Unsustainable price increases [are] forcing new payment models and novel cost controls.”

According to Jeremy Schafer, Pharm.D., senior vice president, director, payer access solutions at Precision for Value, “Gene therapies may experience the biggest paradigm shift we will see in the near future.”

In the oncology space, the FDA last year approved the second tissue-agnostic drug: Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib).

In 2019, Tegenu tells AIS Health, “We may see many new agents with new mechanisms of action, particularly site-agnostic chemotherapeutic agents….Cancer continues to be the most targeted therapeutic area of focus in terms of drug development.”

Perspectives on Biosimilars Market in 2019

March 7, 2019

Biosimilars are one way that payers had hoped to bring down spending on pharmaceuticals, but as of yet, these products have had little impact in the United States. As of mid-January, the FDA had approved 17 biosimilars, but only a handful actually are available in the U.S. However, the products may pick up more traction in 2019, with some significant ones potentially coming to market, AIS Health reported.

Biosimilars are one way that payers had hoped to bring down spending on pharmaceuticals, but as of yet, these products have had little impact in the United States. As of mid-January, the FDA had approved 17 biosimilars, but only a handful actually are available in the U.S. However, the products may pick up more traction in 2019, with some significant ones potentially coming to market, AIS Health reported.

According to Lynn Nishida, R.Ph., vice president of clinical product at WithMe Health, “More biosimilars are in the pipeline, but, sadly, expect continued issues of patent litigations that delay marketing of biosimilars soon after their approval or force biosimilar manufacturers to consider launching products at risk” before a lawsuit has been settled, potentially setting themselves up to be responsible for paying damages if they lose the case.

“Biosimilars will face continued slow uptake in utilization; however, there will likely be additional biosimilar approvals with future potential for utilization,” says Amy Nash, Pharm.D., president of RelianceRx, the specialty pharmacy affiliate of Independent Health. “Oncology-related biosimilars will likely have increased utilization.”

Mesfin Tegenu, president of PerformRx, tells AIS Health that he expects “a slow but steady increase in the availability of marketed biosimilars.” Among the biosimilars his company is watching in 2019 are the following:

• Cyltezo (adalimumab-adbm) from Boehringer Ingelheim Pharmaceuticals, Inc.

• Erelzi (etanercept-szzs) from Sandoz Inc.

• Herzuma (trastuzumab-pkrb) from Celltrion Inc.

• Mvasi (bevacizumab-awwb) from Amgen

• Two biosimilar Neupogens (filgrastim)

“I think some doom-and-gloom statements about biosimilars were a bit premature,” Jeremy Schafer, Pharm.D., senior vice president, director, payer access solutions at Precision for Value, says. “Biosimilars have definitely had a challenging market entry, but we need to remember we are still in the early days of a very new industry. In addition, signs indicate that biosimilars in important categories are gaining more traction, and I expect them to continue to do so.”

Perspectives on California’s Plan to Move Medicaid Pharmacy Purchasing to FFS

February 21, 2019

Under the direction of its new governor, Democrat Gavin Newsom, California is planning to take control of the pharmacy benefit for all of the state’s Medi-Cal beneficiaries — the vast majority of which currently have that part of their care administered by private insurers and their PBMs, AIS Health reported. What’s more, the order directs state agencies to create bulk-purchasing arrangements for high-priority drugs and establish a framework for letting private businesses and insurers join the state’s buying pool.

Under the direction of its new governor, Democrat Gavin Newsom, California is planning to take control of the pharmacy benefit for all of the state’s Medi-Cal beneficiaries — the vast majority of which currently have that part of their care administered by private insurers and their PBMs, AIS Health reported. What’s more, the order directs state agencies to create bulk-purchasing arrangements for high-priority drugs and establish a framework for letting private businesses and insurers join the state’s buying pool.

The idea of the state’s Medicaid program shifting to an entirely fee-for-service drug benefits system is already sparking worries about what it will do to PBMs’ bottom lines.

“We suspect that the fee-for-service aspect [of the executive order] may have an adverse impact on PBMs and potentially MCOs that provide managed Medicaid services in the state,” RBC Capital Markets, LLC analyst George Hill wrote in a research note. Currently, California’s Medicaid managed care organizations contract with 10 different PBMs to administer the pharmacy benefit for 10.64 million managed Medicaid lives — which comprise nearly 90% of the state’s total Medicaid lives.

According to L.A. Care CEO John Baackes, one concern for managed care plans is the fact that carving out benefits makes it more difficult to coordinate care.

“I think one of the advantages of a managed Medi-Cal plan like ours is that for people who are in very difficult circumstances health-wise, we do provide an element of care management that’s important,” he says. “And if there’s an element of the benefit that we don’t control, then it’s awkward.”

Regarding the the concept of California starting a bulk-pharmaceutical buying program, Andrey Ostrovsky, M.D., former chief medical officer at CMS’s Center for Medicaid and CHIP Services and current CMO at Solera Health, says it could indeed help drive down prices, since the PBMs that currently serve the state operate independently.

But other experts aren’t so sure.

“If you’re negotiating directly with the manufacturers on drug prices, how’s the delivery system of that going to work, and how are the pharmacies, at the local level, going to be able to maintain a profit and not lose money?” asks Brian Anderson, a principal with Milliman, Inc. Just because a state can negotiate a large rebate from drug manufacturers doesn’t necessarily mean it’s negotiating a lower drug price, he adds.