Product Release

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.”

Radar On Market Access: Firms Are Teaming Up to Offer First Digital Oncology Medicine

March 12, 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.

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, explains David Purdie, vice president of medical affairs at Proteus. “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 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.”

Radar On Market Access: As Cystic Fibrosis Costs Rise, Payers Seek New Strategies

February 26, 2019

Payers typically use tools such as prior authorization and utilization review to manage cystic fibrosis treatments, but PBM experts say they are on the cusp of implementing more innovative strategies that might help to improve adherence while addressing the cost of cystic fibrosis drugs, AIS Health reported.

Payers typically use tools such as prior authorization and utilization review to manage cystic fibrosis treatments, but PBM experts say they are on the cusp of implementing more innovative strategies that might help to improve adherence while addressing the cost of cystic fibrosis drugs, AIS Health reported.

Cystic fibrosis, an inherited chronic disease that attacks the lungs and digestive organs, is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. CFTR modulators and other therapies carry a high price tag, typically costing $250,000 to $368,000 per year. Other drugs, most of which do not have generic equivalents, can add tens of thousands of dollars to that total.

The majority of payers use traditional strategies, including pipeline monitoring, pharmacy and therapeutics committee drug review for formulary positioning, and prior authorization to confirm both the diagnosis and the presence of the specific genetic mutation targeted by the cystic fibrosis drugs, says Lynn Nishida, vice president of clinical product at Boston-based WithMe Health.

Still, “a growing number of payers are looking for out-of-the-box solutions for additional strategies in managing these drugs,” Nishida says. Cystic fibrosis drugs typically receive orphan drug status, which means payers cover them because they’re the only option for patients, but it can also mean they’re associated with higher costs, she says.

Payers expect multiple new drugs for cystic fibrosis over the next few years. Among products in the pipeline are more than a dozen agents aimed at restoring CFTR function, five products for clearing mucus, four anti-inflammatories, eight anti-infectives and one nutritional agent.

Managing infections in cystic fibrosis patients is a priority, says Mesfin Tegenu, R.Ph., president of PerformRx. However, effective antibiotics are also a main driver of cost.

Adherence to cystic fibrosis medications can be a challenge to manage, with studies showing a total reported mean adherence rate of 48% and a large drop-off in adherence in the adolescent years.

Nishida says that deploying one-on-one disease management/case management to closely monitor patients can make a significant difference, and might lead to savings in drug costs.

Trends That Matter for M&A Activity in Specialty Pharmacy and Infusion Therapy Spaces

February 14, 2019

The specialty pharmacy and infusion therapy spaces have certainly seen their share of merger and acquisition (M&A) activity over the years. Some challenges within those industries may have helped slow down 2018 activity a bit, observes Reg Blackburn, managing director at The Braff Group. And for 2019, we may see more of the same, AIS Health reported.

The specialty pharmacy and infusion therapy spaces have certainly seen their share of merger and acquisition (M&A) activity over the years. Some challenges within those industries may have helped slow down 2018 activity a bit, observes Reg Blackburn, managing director at The Braff Group. And for 2019, we may see more of the same, AIS Health reported.

As far as specialty pharmacy trends in 2018, Blackburn points out that “the largest specialty pharmacies continue to get even larger. Payer- and chain-owned dominate. Most new entity growth is coming from large academic hospitals starting their own specialty pharmacies.”

Direct and indirect remuneration (DIR) fees in Medicare Part D that include rebates and price concessions occurring after the point of sale have been around since the start of that program more than a decade ago.

But they started really becoming an issue for specialty drugs around 2016, and it doesn’t look like that’s changing any time soon.

Within the specialty pharmacy space, M&A activity “was lower than in past years,” he explains. Through third-quarter 2018, The Braff Group recorded eight specialty pharmacy deals, compared with 18 for full-year 2017, 20 for 2016 and 10 for 2015.

Moving forward into 2019, Blackburn expects to see “continued consolidation at a measured pace.” In addition, he says, “smaller independents will remain under pressure for gross margin and closed networks. They will want to exit, but buyers will be limited.”

Within the infusion therapy space over the past year, observes Blackburn, intravenous immune globulin and other specialty infusion products continue to drive revenue growth.

Radar On Market Access: Novel Drugs, High Prices, Ways to Manage Them Remain Hot

February 14, 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.”

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

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.”