Industry Trends

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: Insurer Tools Aim to Help Members Save on Prescription Drugs

April 4, 2019

As many Americans continue to struggle to afford their medications, health insurers and their PBMs are responding with tools that help consumers not only understand the cost of drugs before prescriptions are filled, but also find ways to spend less money on them, AIS Health reported.

As many Americans continue to struggle to afford their medications, health insurers and their PBMs are responding with tools that help consumers not only understand the cost of drugs before prescriptions are filled, but also find ways to spend less money on them, AIS Health reported.

However payers choose to design such tools, two keys to their success include making improvements over time and making sure members know about them before they might need them, according to Nathan Foco, senior director of market and sales intelligence for Michigan-based Priority Health.

In late 2017, Priority Health began adding prescription drugs into its Cost Estimator tool to help members understand what they will pay for a prescription and how they could pay less by switching to a lower-priced alternative or opting for home delivery. Use of the prescription drug portion of the Cost Estimator has also increased since it was first rolled out, according to Foco.

“Like a lot of experiences like this, it takes a little while to get going,” he says. “You really can’t undercut the effort that you need to put into promoting and engaging members in the tool.”

Priority Health is not the only payer to offer tools that promote drug-cost transparency. Others include:

Cigna Corp., which in February said its network of health care providers will now have access to Surescripts’ Real-Time Prescription Benefit Tool, which gives them patient-specific medication coverage and cost information within their electronic health record or e-prescribing platform.

Blue Cross Blue Shield of Louisiana in February launched a tool called Rx Savings Solutions, which connects securely with members’ drug claim records and prepares a personalized prescription savings plan for them.

Aetna Inc. offers a tool that provides members with “real-time/moment-in-time drug pricing based on their benefit and status of their deductible,” according to a company spokesperson.

UnitedHealth Group’s OptumRx offers tools that allow enrollees to compare drug costs between generic and brand drugs, identify the lowest-cost option at an in-network retail pharmacy, or enroll in less-expensive home delivery of medications.

Trends That Matter for Cystic Fibrosis Medications

March 28, 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.

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.

 

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: As Insulin Prices Balloon, Insurers Try to Offer Some Relief

March 21, 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.

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.”