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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Radar On Market Access: More Than 1,000 RM/AT Products Are in Pipeline

Posted by Angela Maas on Aug 15, 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.

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.
 
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Topics: Specialty, Industry Trends, Market Access, Provider, Payer

Radar On Market Access: Senate Drug Pricing Legislation Takes Wide-Reaching Approach

Posted by Angela Maas on Aug 8, 2019

While there is certainly no shortage of proposals on drug pricing from the administration, a proposed Senate bill is taking a multipronged approach to the issue. The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. According to a preliminary estimate by the Congressional Budget Office (CBO), 10-year savings to the federal government would total more than $100 billion, AIS Health reported.

Proposals within the bill include caps on drug price increases in both Part B and Part D, as well as caps on out-of-pocket (OOP) spend for beneficiaries via a complete restructuring of Part D. It also proposes including patient coupons within the average sales price calculation, boosting the add-on payment for a Part B biosimilar from 6% of the reference drug’s ASP to 8% for a five-year period and banning spread pricing in Medicaid.
 
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Topics: Industry Trends, Provider, Payer

Trends That Matter for CMS's Oncology Care Model

Posted by Angela Maas on Aug 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.

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.
 
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Topics: Industry Trends, Product Release, Data & Analytics

Radar On Market Access: Plans Must Cover PrEP at No Cost After USPSTF Recommendation

Posted by Angela Maas on Jul 11, 2019

A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections, AIS Health reported.

The FDA initially approved Gilead Sciences, Inc.'s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in 2004 to treat HIV infection. But in 2012, the agency approved it to reduce the risk of HIV infection in adults, the only therapy indicted for this use.
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Topics: Industry Trends, Market Access, Provider, Payer

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

Posted by Angela Maas on Jul 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.

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.
 
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Topics: Specialty, Industry Trends, Market Access, Provider, Payer

Trends That Matter for Oncology

Posted by Angela Maas on Jul 4, 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 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."
 
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Topics: Industry Trends, Product Release, Data & Analytics

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

Posted by Angela Maas on Jun 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.

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."
 
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Topics: Specialty, Industry Trends, Market Access, Product Release, Provider, Payer

Trends That Matter for Use of Biologics

Posted by Angela Maas on Jun 6, 2019

Almost 5.8 billion prescriptions were dispensed in the United States in 2018, an increase of 2.7% over the previous year, according to the IQVIA Institute for Human Data Science’s report Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023, AIS Health reported.

Retail and mail pharmacies dispensed 127 million specialty prescriptions last year, an increase of 15 million since 2014. In 2018, for the second year in a row, specialty prescription volume grew more than 5% although the medicines accounted for only 2.2% of prescriptions overall. With an increase in the availability of oral and self-injected specialty therapies, these drugs "are increasingly dispensed through retail pharmacies," said Murray Aitken, executive director of the institute, during a May 6 press call.
 
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Topics: Industry Trends, Data & Analytics

Radar On Market Access: Oncology Is Experiencing Surge Of Innovation — and Prices

Posted by Angela Maas on Jun 6, 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 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."
 
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Topics: Industry Trends, Market Access, Data & Analytics

Radar On Market Access: Study Examines Effects of Strategies in SBS Management

Posted by Angela Maas on May 23, 2019

People with short bowel syndrome (SBS) need a high-touch approach to be effectively managed. Option Care Enterprises, Inc. has a nutritional support team providing clinical interventions, and it recently released a study showing that this approach can save millions of dollars in costs per year, AIS Health reported.

People with SBS have a hard time absorbing nutrients and maintaining hydration and electrolyte balance, and diarrhea is common. Dehydration is a common, even fatal, aspect of this condition, and it often results in hospitalization with an average three-day length of stay.
 
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Topics: Data & Analytics