Speciality

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.”

Radar On Market Access: Expensive Drugs Launched After OCM Baseline Period Are Hamstringing Providers, Study Shows

July 9, 2019

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

CMS’s Oncology Care Model (OCM) is about halfway through its five-year pilot. Developed by the CMS Center for Medicare & Medicaid Innovation, the voluntary pilot is aimed at providing better quality and more coordinated cancer care for Medicare fee-for-service beneficiaries, as well as other payers, while at a lower cost.

One criticism of the model is that providers’ costs are compared with targeted costs that are based partly on their spending from 2012 to 2015, the OCM baseline period. When the actual costs come in below the targeted costs, that earns providers a performance-based payment. But with so many costly oncology therapies launching after the baseline period, this is making it hard for providers to gain a performance-based payment, AIS Health reported.

That was the focus of a poster presentation by Tennessee Oncology at last month’s American Society of Clinical Oncology meeting. Researchers maintained that “when avoidable inpatient, post-acute, and emergency department (ED) costs are minimized, a practice’s actual costs should be lower than target costs, allowing practices the opportunity for shared and performance-based savings. However, we hypothesized that the ability for an oncology practice to successfully meet target costs may be hampered by the skyrocketing prices of novel therapy drugs implemented into clinical practice after baseline period cost calculations.”

They examined Tennessee Oncology patients with non-small cell lung cancer and bladder cancer treated during the second performance period (January through June 2017). The researchers concluded that the use of expensive novel therapies in concordance with NCCN guidelines in indications approved after the OCM baseline period “poses significant challenges to practices. Future value-based care initiatives in oncology need more accurate ways to account for rising drug costs and expanding treatment indications to prevent penalties for following guideline appropriate care.”

MMIT Reality Check on Psoriatic Arthritis (Jul 2019)

July 5, 2019

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

According to our recent payer coverage analysis for psoriatic arthritis 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 psoriatic arthritis treatments shows that under the pharmacy benefit, about 74% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Manufacturers with franchises across indications often hold contracting power and improved positio, which is everything in this market. In terms of contracting, Humira is the product to beat, and Enbrel battles for the second place.

MMIT Reality Check on Acute Lymphoblastic Leukemia (Jun 2019)

June 28, 2019

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

According to our recent payer coverage analysis for acute lymphoblastic leukemia 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 acute lymphoblastic leukemia treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Kymriah is the first FDA-approved CAR-T cell therapy indicated for patients up to 25 years of age with relapsed or refractory B-cell ALL. Most payers list Kymriah as a drug that needs prior authorization, because a number of restrictions exist when using this medication.

MMIT Reality Check on Hemophilia A or B With Inhibitors (Jun 2019)

June 21, 2019

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

According to our recent payer coverage analysis for hemophilia A or B with inhibitors 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 hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 45% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Hemophilia treatments have focused on procoagulants, but researchers now are looking into therapies that target natural anticoagulants.

Radar On Market Access: Magellan Rx Initiates Oncology Biosimilars Program

June 20, 2019

Magellan Rx Management, the PBM division of Magellan Health, Inc., on June 4 announced its launch of an oncology biosimilars program, preparing its health plan customers for the expected market entry of biosimilars for three cancer-fighting drugs — Herceptin, Rituxan and Avastin — later this year, AIS Health reported.

Magellan Rx Management, the PBM division of Magellan Health, Inc., on June 4 announced its launch of an oncology biosimilars program, preparing its health plan customers for the expected market entry of biosimilars for three cancer-fighting drugs — Herceptin, Rituxan and Avastin — later this year, AIS Health reported.

“Oncology is by far the largest therapeutic area for drug spend on the medical benefit, and it is even higher in Medicare,” Steve Cutts, senior vice president and general manager for Magellan Rx’s specialty drug unit, tells AIS Health. Thus, he says, the PBM will be focusing the oncology biosimilars program “on all lines of business for our clients.”

The three oncology brand drugs together account for $9 billion in U.S. drug sales, and almost $50 million in annual drug spend per 1 million covered commercial lives, Magellan Rx says. The PBM anticipates savings of $5 million to $8 million per 1 million covered lives via its new program but sees “potential for even greater savings based on [its] past successes with biosimilars.”

Under a multi-pronged program, Magellan Rx aims to develop clinical protocols while educating and communicating with network oncologists; incorporate biosimilars into key utilization management programs, such as medical prior authorization and provider reimbursement/fee schedule management; and work continuously with its oncology advisory board.

Cutts notes that Herceptin, Rituxan and Avastin “all have FDA approved biosimilars which are due to be launched and available on the market in 2019, with some speculated to be available as soon as this month.”