Product Release

Perspectives on the First NASH Drugs

July 11, 2019

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System, says the entry of first-ever NASH medications will “definitely” offer significant benefit to patients. “There’s no question [the drugs will help] — in combination with diet and exercise,” he says. “It will have to be the whole package.”

Multiple drugs are in phase 3 clinical trials for NASH. A front-runner is Intercept Pharmaceuticals, Inc.’s drug, Ocaliva (obeticholic acid), already on the market to treat another liver condition. But the FDA isn’t expected to approve Intercept’s drug for NASH until the second quarter of 2020, Dieterich notes.

Dieterich says he expects NASH medications will “undoubtedly” be marketed as specialty drugs that will be “strictly controlled” by PBMs and insurance companies. He expects such drugs to become available only to the sickest patients, possibly only after a diagnostic liver biopsy is performed.

From a plan perspective, Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington, says NASH “has similarities to other recent new breakthrough therapies where the outcome we are trying to avoid is costly and potentially fatal but not all patients…will even progress to fibrosis. The reason why NASH is more significant is the sheer number of patients that may qualify for treatment.”

Trends That Matter for Oncology

July 3, 2019

The oncology space continued its trend of developing innovative therapies — both those launching and in the pipeline — in 2018. That’s according to a new report from the IQVIA Institute for Human Data Science titled Global Oncology Trends 2019: Therapeutics, Clinical Development and Health System Implications. And while the outlook continues to look promising in terms of the science, it may pose issues to the health care system that need to be resolved in order to take full advantage of next-generation oncology products, AIS Health reported.

The oncology space continued its trend of developing innovative therapies — both those launching and in the pipeline — in 2018. That’s according to a new report from the IQVIA Institute for Human Data Science titled Global Oncology Trends 2019: Therapeutics, Clinical Development and Health System Implications. And while the outlook continues to look promising in terms of the science, it may pose issues to the health care system that need to be resolved in order to take full advantage of next-generation oncology products, AIS Health reported.

The 15 new oncology drugs and one supportive care drug launched last year for 17 tumor types marked a record. “Importantly, one of the new drugs is tissue-agnostic” — Loxo Oncology, Inc. and Bayer Corp.’s Vitrakvi (larotrectinib) — noted Murray Aitken, executive director of the institute, during a May 23 media call to discuss the report’s findings. “Over half of the new drugs are oral therapies, continuing this trend toward more of the targeted, innovative therapies being available in an oral form. Two-thirds of the new drugs have an orphan indication, continuing this trend towards cancer being redefined into narrower segments.”

Among the new drugs, more than half have a predictive biomarker on their label.

“This is a trend, the movement towards precision medicine and the growing role that predictive biomarkers are having, both in the way in which the drugs are tested in the clinic, as well as used in practice, where patients can be tested for a biomarker in advance of being treated with a particular drug,” maintained Aitken.

Radar On Market Access: Payers Are Wary as First NASH Drugs May Hit U.S. Market Soon

June 18, 2019

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Doctors trying to treat patients with nonalcoholic steatohepatitis (NASH) — a serious type of nonalcoholic fatty liver disease (NAFLD) that, if left untreated, may progress to cardiovascular disease, cirrhosis, cancer and possibly the need for a liver transplant — soon may have new options in their arsenal beyond promoting exercise and diet. The first-ever NASH drugs are expected to hit the U.S. market as early as 2020 to help address this increasingly prevalent, complex disease spawned largely by the obesity epidemic and surge of type 2 diabetes in the U.S., AIS Health reported.

Dieterich says the entry of first-ever NASH medications will “definitely” offer significant benefit to patients. “There’s no question [the drugs will help] — in combination with diet and exercise,” says Douglas Dieterich, M.D., director of the Institute for Liver Medicine at Mount Sinai Health System. “It will have to be the whole package.”
Multiple drugs are in phase 3 clinical trials for NASH. A front-runner is Intercept Pharmaceuticals, Inc.’s drug, Ocaliva (obeticholic acid), already on the market to treat another liver condition. But the FDA isn’t expected to approve Intercept’s drug for NASH until the second quarter of 2020, Dieterich notes.

Dieterich says he expects NASH medications will “undoubtedly” be marketed as specialty drugs that will be “strictly controlled” by PBMs and insurance companies. He expects such drugs to become available only to the sickest patients, possibly only after a diagnostic liver biopsy is performed.

From a plan perspective, Yusuf Rashid, R.Ph., vice president of pharmacy and vendor relationship management at Community Health Plan of Washington, says NASH “has similarities to other recent new breakthrough therapies where the outcome we are trying to avoid is costly and potentially fatal but not all patients…will even progress to fibrosis. The reason why NASH is more significant is the sheer number of patients that may qualify for treatment.”

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.