Trends That Matter

Trends That Matter for RM/AT Products

September 12, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.

The Alliance for Regenerative Medicine published the report, titled Quarterly Global Regenerative Medicine Sector Report: Q2 2019, on Aug. 1. It shows there are 1,069 clinical trials using specific RM/AT technologies, which include gene therapy, gene-modified cell therapy, cell therapy and tissue engineering. Ninety-four of those products are in Phase III trials.

Trends That Matter for Hepatitis C Drugs

August 29, 2019

Beginning last month, Louisiana has been able to treat hundreds of patients who were waiting to receive a pricey cure for hepatitis C thanks to after hammering out an innovative payment model with a drug manufacturer, AIS Health reported.

Beginning last month, Louisiana has been able to treat hundreds of patients who were waiting to receive a pricey cure for hepatitis C thanks to after hammering out an innovative payment model with a drug manufacturer, AIS Health reported.

But the road to get there was long and difficult, according to Rebekah Gee, M.D., secretary of the Louisiana Dept. of Health, who, during a July 22 event hosted by the Brookings Institution, detailed the challenges she faced in trying to get a costly curative therapy to more people while facing down a $2 billion budget deficit. “We were told ‘No’ at least 50 times from a variety of people, whether it was the industry, or policymakers or individuals at the CDC…because it had never been done before,” she said.

Here’s how the “modified subscription model” works: The state pays a fixed amount to Asegua Therapeutics LLC, a subsidiary of Gilead Sciences, Inc., for the authorized generic of Epclusa (sofosbuvir/velpatasvir tablets), up to a set spending cap, and in return gets unlimited access to the therapy for Medicaid beneficiaries.

For states that want to successfully replicate what Louisiana has done, not only do they need a solid partnership with CMS, but they must understand that price is not the only barrier to expanding treatment, said Neeraj Sood, a professor at the University of Southern California, who helped develop the model.

The graphic below show the current market access to hepatitis C drugs across the Medicaid formularies.

Trends That Matter for Medicare Part D Costs

August 15, 2019

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

The study found that, assuming a 61% discount between brand-name and generic drugs, Part D beneficiaries with prescriptions costing between $22,000 and $80,000 per year would have lower out-of-pocket spending if they use brand-name drugs over a generic, AIS Health reported.

The graphics below show the annual out-of-pocket savings associated with generic drugs and the median-point-of-sale price differences of brand-name drugs and their generic counterparts.

Trends That Matter for CMS’s Oncology Care Model

August 1, 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 (NSCLC) and bladder cancer treated during the second performance period (January through June 2017). Among researchers’ findings:

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.”

Trends That Matter for Oncology Biosimilars Management

July 18, 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.”

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.”

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.