Product Release

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.”

Radar On Market Access: Diabetic Drug’s Kidney Benefit May Not Be Game-Changer

April 30, 2019

The potential use of Invokana (canagliflozin) for chronic kidney disease as well as type 2 diabetes, its current indicated use, recently attracted national headlines. If Janssen Pharmaceuticals, Inc.’s supplemental indication for its medication is approved by the FDA, “it would be the first new treatment for diabetic kidney disease in decades,” the National Kidney Foundation said.

The potential use of Invokana (canagliflozin) for chronic kidney disease as well as type 2 diabetes, its current indicated use, recently attracted national headlines. If Janssen Pharmaceuticals, Inc.’s supplemental indication for its medication is approved by the FDA, “it would be the first new treatment for diabetic kidney disease in decades,” the National Kidney Foundation said.

The kidney foundation points out that diabetes is a key risk factor for chronic kidney disease. The group says it anticipates strong uptake of Invokana by clinicians and payers facing “high costs and management challenges” in treating advanced kidney disease in people with type 2 diabetes, AIS Health reported.

But Mesfin Tegenu, R.Ph., president of PerformRx, LLC, doesn’t expect a major impact on treatment. That’s because Invokana joins Jardiance (empagliflozin) and Farxiga (dapagliflozin), among others, in a class of type 2 diabetes medications called SGLT2 inhibitors — and some rival products already provide similar benefits, he says.

In 2018, the American Diabetes Association and European Association for the Study of Diabetes issued a consensus statement that “already recommends Jardiance in diabetic CKD [i.e., chronic kidney disease] patients due to the renal benefit,” Tegenu adds.

In the recently announced results for Invokana’s CREDENCE study, Invokana was found to reduce the risk of dialysis or the need for a kidney transplant, which Tegenu says is “good news for plan payers and patients since in addition cardiovascular benefits were also found.”

“However,” he adds, “[cardiovascular] benefits have been known for at least a year and guidelines already recommend these drugs in [chronic kidney disease] patients.”

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.”

Radar On Market Access: New Postpartum Depression Drug Presents Payer Challenges

April 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.

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, says Dea Belazi, Pharm.D., president and CEO of AscellaHealth. Moreover, he says, 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 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.”

Radar On Market Access: Civica Rx Aims to Provide 14 Drugs in Short Supply in ’19

March 19, 2019

Since its launch in 2018, Civica Rx, the new not-for-profit generic drug and pharmaceutical company run by health systems and hospitals, tells AIS Health it has made solid progress in its ongoing effort to address persistent shortages of certain drugs administered within hospitals’ four walls.

Since its launch in 2018, Civica Rx, the new not-for-profit generic drug and pharmaceutical company run by health systems and hospitals, tells AIS Health it has made solid progress in its ongoing effort to address persistent shortages of certain drugs administered within hospitals’ four walls.

According to Civica spokesperson Debbi Ford, Civica first aims to provide 14 vital drugs, “mostly sterile injectables such as anesthesia medications, antibiotics, and pain medications and expects to deliver these products this year,” she says.

Ford explained that for many generic injectable drugs undergoing a shortage, there often are one or two viable generic drug manufacturers that capture most of the market. However, she said, there are multiple other generic drug manufacturers that have an FDA-approved Abbreviated New Drug Application (ANDA) and have “capable manufacturing facilities and capacity to produce the drug undergoing shortages, yet are dormant due to business and/or other reasons.”

Ford said that any disruption in the supply chain for a drug that has only one or two manufacturers “almost immediately leads to a drug shortage, which is difficult to recover from because no other manufacturer can readily produce the required inventory.”

Civica is taking a three-pronged approach to its manufacturing strategy:

Work with several manufacturers, “including the dormant manufacturers who have the U.S. FDA approval, capable manufacturing facilities and capacity to produce Civica-labeled generic drugs, allowing manufacturers to re-enter the market,” Ford said.
The development and/or purchase of ANDAs for generic drugs and work with contract manufacturing organizations to produce Civica products.
The purchase and/or building of Civica manufacturing facilities using Civica’s ANDAs.
Will the cost of drugs go down because of Civica’s efforts? Probably not, says Bill Oldham, chairman and chief financial officer of AscellaHealth. Will drug costs go up? Maybe. In any event, “there will be a new game in town,” he says. “Whether it will have an enormous impact or not is anyone’s guess.”