Radar on Market Access

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: 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.”

Radar On Market Access: What Is Behind CVS Health’s LTC Woes?

March 7, 2019

Almost four years after CVS Health Corp. spent nearly $13 billion to acquire Omnicare, the long-term-care (LTC) pharmacy business attracted negative attention as a major contributor to “headwinds” in the company’s report on fourth quarter and full-year 2018 financial results, AIS Health reported.

Almost four years after CVS Health Corp. spent nearly $13 billion to acquire Omnicare, the long-term-care (LTC) pharmacy business attracted negative attention as a major contributor to “headwinds” in the company’s report on fourth quarter and full-year 2018 financial results, AIS Health reported.

For the quarter ended Dec. 31, CVS Health reported a net loss of $421 million on revenues that increased 12.5% to $54.4 billion year over year. Losses reflect $2.2 billion in quarterly and $6.1 billion in full-year 2018 “goodwill impairment charges” related to its LTC business, the company said.

“The Omnicare deal made good strategic sense,” says Adam Fein, Ph.D., president of Pembroke Consulting, Inc. and CEO of Drug Channels Institute. “CVS gained a strong position in LTC [long-term care] while also augmenting its already significant specialty pharmacy business.”

“However,” Fein adds, “CVS Health has become a very complex and highly diverse organization. It has struggled against the smaller, nimble local competitors within the LTC industry.”

CVS Health blames “industrywide challenges” in LTC pharmacy as affecting its ability to grow the business at the rate originally estimated when it acquired Omnicare.

“These challenges include lower occupancy rates in skilled nursing facilities, significant deterioration in the financial health of numerous skilled nursing facility customers which resulted in a number of customer bankruptcies in 2018, and continued facility reimbursement pressures,” the company says.

As a result, a goodwill impairment charge of $3.9 billion was recorded during the second quarter of 2018, CVS Health said.

Radar On Market Access: Diplomat Pharmacy Postpones Earnings Release Amid PBM Struggles

March 5, 2019

Diplomat Pharmacy Inc.’s stock value plummeted recently after the company said it would delay the release of its fourth-quarter and full-year earnings results — primarily because of difficulties with its PBM business, AIS Health reported.

Diplomat Pharmacy Inc.’s stock value plummeted recently after the company said it would delay the release of its fourth-quarter and full-year earnings results — primarily because of difficulties with its PBM business, AIS Health reported.

Diplomat entered the PBM space in 2017 when it acquired National Pharmaceutical Services and LDI Integrated Pharmacy Services. The company disclosed in a Feb. 22 press release that it anticipates writing down a “significant portion” of its PBM business’ approximately $630 million in assets. It also said it is withdrawing its preliminary 2019 full-year earnings outlook, in part because it’s seen “additional customer losses in its PBM business since early January,” which combined with a “softer outlook for client wins and other factors” has led to a lower-than-expected outlook for its PBM business in 2019.

Asked why Diplomat’s PBM may be losing customers, William Sullivan, principal consultant at Specialty Pharmacy Solutions LLC, says part of the issue may be that pharmaceutical manufacturers are unsure “how things may shake out” regarding the newly proposed changes to the drug-rebate system. That could mean they want to stick with the “big players who will have the most impact on helping steer potential changes,” he says.

Another factor is the consolidation in the PBM industry — with Cigna Corp. now owning Express Scripts, UnitedHealth Group having its PBM OptumRx, and CVS Health Corp. owning both a PBM and health insurer Aetna Inc.

That “gives them even greater purchasing power which, reciprocally, makes it much harder for the smaller players to cut deals that enable them to be competitive with the big guys,” Sullivan says.

Radar On Market Access: Highmark Expands Proving Ground for Innovative Therapies

February 28, 2019

After Highmark Health expanded from an insurer to an integrated delivery system, the organization decided it was uniquely positioned to launch a platform to test early-stage, FDA-approved medical innovations that were struggling to attain the evidence needed for widespread adoption — and, critically, insurance reimbursement, AIS Health reported.

After Highmark Health expanded from an insurer to an integrated delivery system, the organization decided it was uniquely positioned to launch a platform to test early-stage, FDA-approved medical innovations that were struggling to attain the evidence needed for widespread adoption — and, critically, insurance reimbursement, AIS Health reported.

Nearly four years later, Highmark Health Plan and its affiliate Allegheny Health Network have changed their policies and purchasing contracts to provide therapeutic innovations to members after gathering evidence on their effectiveness. Examples include HeartFlow, which can create a 3D model of coronary arteries and blockages, and FreeSpira, a digital therapeutic that reduces debilitating panic attacks.

Highmark also opted to transform VITAL from an internal platform to a commercial offering — meaning companies pay Highmark to test their products, says Eileen Rodgers, director of Highmark’s VITAL Innovation Program.

Making VITAL a commercial offering, according to Rodgers, helps it source new innovations and make the program a recognizable name out in the marketplace. “Our intent really is to draw new innovations to Highmark Health as kind of a center of gravity,” she says.

For the startup companies that work with VITAL, the services the program offers can be the difference between staying afloat or going under, Rodgers points out.

“A lot of innovations are FDA approved and make it past clinical trials to be commercially available, but because there’s no financing mechanism, the delivery systems are unable to buy them,” she says.

But the real-world evidence VITAL provides can help startups get over that hurdle faster by making payers’ decision to cover their product a safer bet.