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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.”

MMIT Reality Check on Glaucoma (Mar 2019)

March 15, 2019

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for glaucoma treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for glaucoma treatments shows that under the pharmacy benefit, more than 58% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: Prime Therapeutics LLC’s 2019 National NetResults Formulary excludes Rhopressa (netarsudil solution), a new mechanism of action for glaucoma. Via AIS Health.

Radar On Market Access: Oncologists Are Concerned With Patients’ Refusal of Treatment

March 14, 2019

With more targeted and effective therapies launching to treat a variety of cancers, much of the focus has been not only on their efficacy but their costs, particularly to payers. A recent report from the physician perspective highlights their impact as far as cost on not only those stakeholders but also the patients they serve, AIS Health reported.

With more targeted and effective therapies launching to treat a variety of cancers, much of the focus has been not only on their efficacy but their costs, particularly to payers. A recent report from the physician perspective highlights their impact as far as cost on not only those stakeholders but also the patients they serve, AIS Health reported.

The Association of Community Cancer Centers released its 2018 Trending Now in Cancer Care Survey in February. Responding to the survey were 205 individuals from community cancer centers, academic centers, teaching hospitals and independent practices.

Leading the top threats to future growth were payer reimbursement requirements and “cost of drugs and/or new treatment modalities,” both at 48% among those categories ranked among the top five threats. Those were followed by “uncertainties in drug pricing reform policies,” at 40%.

When it came to patients, 49% of respondents said they had had a patient refuse treatment due to financial concerns over the past year, with 32% responding that they were not sure if that had occurred. In addition, 79% of respondents said they were “very” or “somewhat” concerned about patients refusing care due to financial worries.

As far as patients refusing treatment, “these numbers are not surprising,” contends Janet Serluco, vice president and head of oncology at Precision for Value, who tells AIS Health that she “would expect this to be where it is right now, and in fact perhaps higher.” But “the key figure for context is the level of staff concern this raises,” she says about the second issue.

It’s no secret that overall costs for health care have been rising and that much of those costs have been shifted onto patients through higher premiums and greater out-of-pocket expenses.

In addition, benefit designs among commercial insurers have shifted from copayments to include more coinsurance. And “Medicare patients without supplemental plans face a large 20% coinsurance…at the beginning of each year, as new deductibles must be met. According to a recent Kaiser Health System Tracker Report, cost shares have outpaced wage growth, increasing pressures on patients,” Serluco states.

Various stakeholders have “competing priorities and perspectives” that they may bring to discussions about patients’ out-of-pocket costs.

One model that “appears to be a promising approach to lowering overall costs of health care delivery to cancer patients, through better care coordination and patient-centered care,” is CMS’s Oncology Care Model, a Center for Medicare & Medicaid Innovation-developed pilot launched July 1, 2016, says Serluco.

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.”

MMIT Reality Check on Major Depressive Disorder (Mar 2019)

March 8, 2019

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for major depressive disorder treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for major depressive disorder treatments shows that under the pharamcy benefit, more than 47% of the covered lives in commercial formularies have utilization management restrictions.

Trends: In November 2018, CMS issued a proposed rule that would let Medicare Advantage and Part D plans limit coverage of certain drugs in the six “protected classes,” which include antidepressants and antipsychotics. Wall Street analysts viewed the proposal as good news for managed care firms . Via AIS Health.

MMIT Reality Check on Hereditary Angioedema (Mar 2018)

March 1, 2019

According to our recent payer coverage analysis for Hereditary Angioedema (HAE) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for Hereditary Angioedema (HAE) treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: Under the pharmacy benefit, more than 63% of the covered lives under commercial formularies have utilization management restrictions.

Trends: Management of HAE cannot simply be a one-size-fits-all approach, as the condition is variable and patient specific. Via AIS Health.