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Trends That Matter for M&A Activity in Specialty Pharmacy and Infusion Therapy Spaces

Posted by Angela Maas on Feb 14, 2019

The specialty pharmacy and infusion therapy spaces have certainly seen their share of merger and acquisition (M&A) activity over the years. Some challenges within those industries may have helped slow down 2018 activity a bit, observes Reg Blackburn, managing director at The Braff Group. And for 2019, we may see more of the same, AIS Health reported.

As far as specialty pharmacy trends in 2018, Blackburn points out that "the largest specialty pharmacies continue to get even larger. Payer- and chain-owned dominate. Most new entity growth is coming from large academic hospitals starting their own specialty pharmacies."
 
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Topics: Data & Analytics, Product Release, Specialty, Industry Trends

Radar On Market Access: Novel Drugs, High Prices, Ways to Manage Them Remain Hot

Posted by Angela Maas on Feb 14, 2019

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

As payers struggle to rein in high specialty drug prices, many have turned to copay accumulator programs, and this trend shows no signs of slowing. "There was an increased focus on copay accumulator programs in 2018," comments Amy Nash, Pharm.D., president of RelianceRx, the specialty pharmacy affiliate of Independent Health. She tells AIS Health she expects to see "further refinement of copay accumulator programs from payers and additional strategies from pharma to prevent them."
 
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Topics: Specialty, Product Release, Payer, Provider, Industry Trends

Radar On Market Access: Biosimilars Market Is Picking Up Steam, Could See Boom Soon

Posted by Angela Maas on Feb 7, 2019

Biosimilars are one way that payers had hoped to bring down spending on pharmaceuticals, but as of yet, these products have had little impact in the United States. As of mid-January, the FDA had approved 17 biosimilars, but only a handful actually are available in the U.S. However, the products may pick up more traction in 2019, with some significant ones potentially coming to market, AIS Health reported.

According to Lynn Nishida, R.Ph., vice president of clinical product at WithMe Health, "More biosimilars are in the pipeline, but, sadly, expect continued issues of patent litigations that delay marketing of biosimilars soon after their approval or force biosimilar manufacturers to consider launching products at risk" before a lawsuit has been settled, potentially setting themselves up to be responsible for paying damages if they lose the case.
 
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Topics: Specialty, Product Release

Radar On Market Access: Specialty Drug Pipeline Holds Promise Amid High Costs

Posted by Judy Packer Tursman on Jan 24, 2019

Blockbuster pharmaceuticals scheduled for launch in 2019 are expected to have a significant impact in treating certain cancers, spinal muscular atrophy, inflammatory conditions and some mental illnesses, according to Express Scripts Holding Co. With specialty medications managed through the pharmacy benefit now accounting for 41% of health plans' total pharmacy spend, the PBM asserts it is crucial for plans to understand the product pipeline and create strategies to manage new, costly drug therapies, AIS Health reported.

On the new drug front, Prime Therapeutics, in its December 2018 monthly update on the specialty pipeline, cites an annual wholesale acquisition cost (WAC) of $203,100 for Pfizer’s Daurismo (glasdegib), an oral drug approved by the FDA in combination with intravenous low-dose cytarabine to treat newly diagnosed acute myeloid leukemia in elderly and certain other adult patients. The Blues-affiliated PBM also points out that Loxo Oncology's Vitrakvi (larotrectinib), approved by the FDA to treat adult and pediatric patients with certain solid tumors, has an average annual WAC for an adult patient of $393,600.
 
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Topics: Specialty, Product Release

Trends That Matter for FDA Orphan Label Application Reviews

Posted by Angela Maas on Jan 17, 2019

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: New Hep C Approach Might Not Save Money, PBM Execs Warn

Posted by Jane Anderson on Jan 10, 2019

A small study suggests it might be possible to shorten the length of expensive drug treatment for chronic hepatitis C virus (HCV), potentially cutting treatment time in half for 50% of patients. But managed care pharmacy clinicians say the results are far from ready to implement widely, and it’s possible the new approach might not even save money, AIS Health reported.

The study, conducted at Loyola University Chicago and three medical centers in Israel, involved only 22 patients. It used a technique called modeling-based response-guided therapy, which estimated how long it would take to completely eliminate the hepatitis C virus.
 
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Topics: Payer, Specialty, Product Release, Data & Analytics

Trends That Matter for Migraine Drugs

Posted by Jane Anderson on Jan 3, 2019

Therapy for chronic migraine — a condition that's been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

These new calcitonin gene-related peptide (CGRP) inhibitors — Amgen, Inc. and Novartis AG’s Aimovig (erenumab), Teva Pharmaceuticals’ Ajovy (fremanezumab) and Eli Lilly and Co.’s Emgality (galcanezumab) — also may usher in an era of value-based contracting for migraine products, with plan sponsors willing to pay more to get better results, Machaon Bonafede, Ph.D., outcomes research practice leader at IBM Watson Health, told attendees Oct. 23 at the Academy of Managed Care Pharmacy Nexus annual meeting, AIS Health reported.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: GAO Recommends FDA Improve Orphan Label Application Reviews

Posted by Angela Maas on Dec 27, 2018

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: FDA Approves Second Tissue-Agnostic Drug; Refund Is Available

Posted by Angela Maas on Dec 18, 2018

As the FDA continues to approve drugs targeted toward specific biomarkers, the agency has granted accelerated approval to another tissue-agnostic oncology treatment. While the gene fusion is fairly rare, Loxo Oncology, Inc. and Bayer Corp.'s Vitrakvi (larotrectinib) has shown high overall response rates across multiple solid tumors. Not surprisingly, the medication comes with a high price tag — but also a refund for qualified patients who do not respond within three months of initiating treatment, AIS Health reported.

On Nov. 26, the FDA gave accelerated approval to Vitrakvi for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative therapies or that have progressed after treatment.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: New Migraine Drugs Could Spark Value-Based Contracting

Posted by Jane Anderson on Nov 29, 2018

Therapy for chronic migraine — a condition that's been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

These new calcitonin gene-related peptide (CGRP) inhibitors — Amgen, Inc. and Novartis AG’s Aimovig (erenumab), Teva Pharmaceuticals’ Ajovy (fremanezumab) and Eli Lilly and Co.’s Emgality (galcanezumab) — also may usher in an era of value-based contracting for migraine products, with plan sponsors willing to pay more to get better results, Machaon Bonafede, Ph.D., outcomes research practice leader at IBM Watson Health, told attendees Oct. 23 at the Academy of Managed Care Pharmacy Nexus annual meeting, AIS Health reported.
 
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Topics: Payer, Specialty, Market Access, Product Release