Facing an unexpected judicial roadblock in the plan to combine their two business, CVS Health Corp. and Aetna Inc. successfully negotiated a deal to keep their PBM and health insurance operations separate for at least the next few months, AIS Health reported.

At the heart of the holdup is U.S. District Court Judge Richard Leon, who has the right to review the agreement that CVS and Aetna struck with the DOJ to resolve antitrust concerns with their deal.

Topics: Industry Trends, Payer, Provider

According to our recent payer coverage analysis for epilepsy 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.

Topics: Market Access, Branding & Marketing, Specialty, Payer

In the wake of the 2018 midterm elections — which handed Democrats control of the House of Representatives — President Trump said he hoped to work with lawmakers on the other side of the aisle to lower the cost of prescription drugs.

Some industry analysts, though, are skeptical that sentiment will be enough to enact meaningful change, at least on the legislative front, AIS Health reported.

 

Topics: Industry Trends, Provider

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.

 

Topics: Payer, Specialty, Market Access, Product Release

According to our recent payer coverage analysis for alpha-1 antitrypsin deficiency 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.

Topics: Market Access, Branding & Marketing, Specialty, Payer

New biosimilars for Janssen Biotech, Inc.'s Remicade (infliximab) have helped to moderate costs for Crohn's disease as they’ve launched over the last two years, but plans still rely on utilization management strategies to keep the cost of treating the condition under control, experts tell AIS Health.

Additional biosimilars — notably, three biosimilars for AbbVie Inc.'s Humira (adalimumab) — eventually will enter the marketplace as well, but the Humira biosimilars currently are mired in patent litigation and likely won't launch until 2023, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.

Topics: Specialty, Market Access, Payer

Express Scripts Holding Co. and CVS Health Corp. have in recent months unveiled new programs that appear designed to transition away from the PBM status quo, AIS Health reported.

One factor driving both new programs could be a proposed rule that's still under review by the Office of Management and Budget, which might remove prescription drug rebates' safe-harbor protections from the federal antikickback statute. But one industry expert says it looks less likely that may actually transpire.

Topics: Industry Trends, Payer, Specialty, Provider, Data & Analytics

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.

 

Topics: Payer, Specialty, Market Access, Product Release

According to our recent payer coverage analysis for prostate cancer 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.

Topics: Market Access, Branding & Marketing, Specialty, Payer

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx's Dsuvia. He stressed the importance of the painkiller for military use and the "very tight restrictions being placed on the distribution and use of this product," AIS Health reported.

In general, PBM and health plan experts say such restrictions likely will hold and keep the drug within its proper niche, and the regulatory green light for Dsuvia shouldn't interfere with broad ongoing efforts to better manage opioid use in the U.S.

Topics: Payer, Industry Trends, Data & Analytics, Provider