Product Release

Radar On Market Access: Payers Will Likely Use Various Tactics to Manage Zolgensma

June 11, 2019

With the first therapy north of $1 million gaining FDA approval last month, payers likely will implement a variety of strategies to manage Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis company. For now, many uncertainties exist with respect to the new treatment and what its place will be in spinal muscular atrophy (SMA) care, AIS Health reported.

With the first therapy north of $1 million gaining FDA approval last month, payers likely will implement a variety of strategies to manage Zolgensma (onasemnogene abeparvovec-xioi), a one-time gene therapy from AveXis, Inc., a Novartis company. For now, many uncertainties exist with respect to the new treatment and what its place will be in spinal muscular atrophy (SMA) care, AIS Health reported.

According to Lee Newcomer, M.D., principal at Lee N. Newcomer Consulting LLC, payers likely will implement “strict enforcement of the label restrictions, advisory panels to develop clinical criteria for therapy [and] highly specific provider networks to ensure that the therapies are given correctly.”

When it comes to payer strategies, “unlike other conditions, where there might be alternatives that warrant prior authorization or step therapy, here I expect there to be limited management and more care coordination,” Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors, tells AIS Health.

“If I were a payer, I would definitely use prior-authorization for this, but given the nature of the therapy, you can’t use step edits — it doesn’t really make sense clinically,” says an industry expert who declines to be identified. “But prior authorization really needs to occur extremely quickly.”

“Plans will likely implement a medical policy to ensure appropriate use and ensure adequate monitoring,” says April M. Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC. “This is a one-time IV infusion; any repeated administration has not been evaluated and will likely not be covered until there is data to support that use.”

One concern among some payers is whether members will attempt to be treated with both Zolgensma and Spinraza (nusinersen), another expensive therapy for SMA. “It’s not clear yet if the combination or the sequence is better care until further studies are completed,” says Newcomer.

Perspectives on Diabetic Drug’s Kidney Benefit

May 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.”

Radar On Market Access: Generic Advair May Help Reduce COPD Costs

May 21, 2019

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

A new generic alternative for GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) provides payers with the chance to better manage care in chronic obstructive pulmonary disease (COPD), a condition in which high out-of-pocket costs often lead to lower compliance and an increased risk of hospitalization, AIS Health reported.

Advair Diskus, a combination long-acting beta-agonist and an inhaled corticosteroid, has been one of the most common drugs used for COPD, a condition largely dominated by brand products. The generic, marketed by Mylan and approved Jan. 30, joins generics for two additional COPD devices: a generic for Ventolin HFA (albuterol) and one for Proair HFA (albuterol).

All three have the potential to save payers and patients significant money. Charline Shan, R.Ph., vice president, access experience team at payer insights and strategy firm Precision for Value, says plans have multiple options for structuring their formularies with the amount of generic options available.

Generics are typically included, with brand drugs placed on preferred or nonpreferred tiers based on price, “but not all are required or have to be on the formulary since there are many branded and therapeutic equivalent options,” she says.

Most people with COPD are covered by Medicare, and CMS requires that a minimum of two products for each category or class be available on the formulary. However, Medicare Part D plans may also consider additional factors when structuring their formularies for COPD patients, including the total cost of care, and that may lead them to implement more selective branded choices on formularies than commercial plans, Shan says.

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.”