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MMIT Reality Check on Epilepsy (Jul 2018)

Posted by Matt Breese on Jul 20, 2018

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.

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

Radar On Market Access: CMS Denies Massachusetts' Medicaid Drug Pricing Plan

Posted by Matt Breese on Jul 19, 2018

CMS recently denied a waiver request by Massachusetts to allow its Medicaid program, MassHealth, to use a closed formulary that excludes certain drugs. But the agency, in its June 27 decision, left the door open on the state's pursuit of tighter drug controls, AIS Health reported.
 
"The Massachusetts proposal brought to the table a new approach to increase its leverage to get lower drug prices, but an approach that left many unanswered questions," says Jack Hoadley, Ph.D., a research professor emeritus in Georgetown University’s Health Policy Institute. "Its rejection by CMS should not stop states from continuing to seek new ways to achieve lower prices. The key is how to balance maintaining access to needed drugs with tools to get lower prices."
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Topics: Specialty, Market Access, Product Release

Trends That Matter for Specialty Pharmaceuticals' Managed Care Strategies

Posted by Matt Breese on Jul 19, 2018

A survey by EMD Serono, Inc. revealed that managing oncology drugs and services remains the top challenge for health plans, tied with determining the value of specialty drugs and ensuring clinically appropriate use of specialty therapies. 

Site-of-care programs continue to rise in use, with a 135% increase. Intravenous immune globulin (89%), rheumatoid arthritis/Crohn's (86%) and multiple sclerosis (67%) were the top therapeutic categories for site-of-care strategies.

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Topics: Specialty, Market Access, Data & Analytics, Payer

MMIT Reality Check on Alpha-1 Antitrypsin Deficiency (Jul 2018)

Posted by Matt Breese on Jul 13, 2018

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.

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

MMIT Reality Check on Advanced Prostate Cancer (Jul 2018)

Posted by Matt Breese on Jul 6, 2018

According to our recent payer coverage analysis for advanced 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.

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

Radar On Market Access: Pharma Can Use REMS Programs to its Advantage

Posted by Matt Breese on Jul 5, 2018

For safety concerns, the FDA can require pharmacy manufacturers to have a Risk Evaluation and Mitigation Strategy (REMS) for a therapy in order to manage those risks while still allowing people to have access to it. Although the programs may present challenges to many stakeholders, manufacturers in particular may use them to their advantage, AIS Health reported.
 
One of the top challenges that manufacturers may grapple with is the "increasing complexity of developing and administering" REMS, says Glenn Carroll, principal at Deloitte. "Many of the REMS being developed today are more rigorous to implement than what we’ve seen in the past."
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Topics: Specialty, Industry Trends, Market Access, Product Release

Radar On Market Access: Gene Therapies Pose Challenges

Posted by Matt Breese on Jul 3, 2018

The FDA has multiple pathways for companies to get a review of promising drugs for conditions sorely in need of a treatment earlier in their development process than is typical, based on a surrogate endpoint. Following the FDA's approval of the first three gene therapies last year, the agency recently indicated that it will issue guidance on these products, including their potential approval based on surrogate measures. Yet this accelerated pathway holds challenges for manufacturers and payers, AIS Health reported.
 
The FDA has multiple programs that provide accelerated drug development and review: fast track designation, accelerated approval, breakthrough therapy designation and regenerative medicine advanced therapy (RMAT) designation, which was established in December 2016. The agency in November 2017 released draft guidance on applying the RMAT designation, which some gene therapies may qualify for.
 
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Topics: Specialty, Industry Trends, Product Release, Payer

MMIT Reality Check on Cystic Fibrosis (Jun 2018)

Posted by Matt Breese on Jun 29, 2018

According to our recent payer coverage analysis for cystic fibrosis 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.

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

Radar On Market Access: FDA Acts to Speed Generics to Market

Posted by Matt Breese on Jun 28, 2018

The Trump administration has touted competition as one way to bring down drug prices. With this goal in mind, the FDA recently released a pair of draft guidance documents aimed at helping generics get onto the market sooner while still upholding the focus on safety, AIS Health reported. 
 
One of the documents, titled Development of a Shared System Risk Evaluation and Mitigation Strategy (REMS) (83 Fed. Reg. 25468, June 1, 2018), offers recommendations for developing a shared system REMS for multiple drug products. The other, titled Waivers of the Single, Shared System REMS Requirement (83 Fed. Reg. 25465, June 1, 2018), describes situations in which the agency will waive the requirement that a generic drug and its reference product use a single, shared system (SSS) REMS with Elements to Assure Safe Use.
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Topics: Specialty, Industry Trends, Market Access, Product Release

MMIT Reality Check on Growth Hormones (Jun 2018)

Posted by Matt Breese on Jun 21, 2018

According to our recent payer coverage analysis for growth hormone 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.

Read More

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