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Perspectives on REMS Programs

Posted by Matt Breese on Aug 9, 2018

The FDA’s Risk Evaluation and Mitigation Strategy initiative — under which the agency requires pharmacy manufacturers to develop a REMS program for certain therapies in order to manage risks while still allowing people to have access to it — may present challenges to many stakeholders. But manufacturers in particular may use REMS to their advantage, AIS Health reported.
 
According to Glenn Carroll, principal at Deloitte, one of the top challenges that manufacturers may grapple with is the "increasing complexity of developing and administering" REMS. He says, "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, Provider, Payer

Radar On Market Access: Drug-Diagnostic Co-Development

Posted by Matt Breese on Aug 7, 2018

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostic but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach, AIS Health reported.
 
Previously some companies would develop both the drug and the diagnostic, but the number that now do so has declined. According to Amit Agarwal at Deloitte Consulting LLP, "diagnostic is a very different margin and business model than the pharmaceutical industry….The economics of it differ pretty dramatically."
 
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Topics: Specialty, Industry Trends, Product Release, Provider

Perspectives on Amazon/PillPack Deal

Posted by Matt Breese on Jul 26, 2018

Amazon recently unveiled its plan to purchase PillPack — a tech-enabled startup that offers pre-sorted dose packaging and home delivery of prescription drugs for those taking multiple medications — yet industry analysts do not appear convinced that the acquisition will have a significant effect on PBMs or health insurers, at least not in the short term, AIS Health reported.
 
Credit Suisse's A.J. Rice wrote in a research note, "We do not expect any material impact on our financial expectations for the MCOs we cover and thus we make no change to our estimates or ratings." 
 
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Topics: Industry Trends, Market Access, Provider, Payer, Branding & Marketing

Perspectives on Value-Based Contracts

Posted by Matt Breese on Jul 12, 2018

As pharma manufacturers strive to demonstrate to payers their products' efficacy in the face of backlash against rising drug prices, one effective tactic may be to enter into value-based contracts. It's crucial for manufacturers to understand how other entities they wish to partner with approach value and to start preparing that value proposition early in the drug development process, AIS Health reported.
 
Different payers will come at value from different perspectives. "A standalone Medicare Part D plan has very different priorities than an integrated health system," says Larry Blandford, Pharm.D., an executive vice president at Precision for Value.  
 
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Topics: Industry Trends, Provider, Payer

Perspectives on Outcomes-Based Drug Pricing

Posted by Matt Breese on Jun 28, 2018

While outcomes-based contracts for prescription drugs are a continual hot topic in the health care industry, experts who spoke on a panel at the World Health Care Congress cited several barriers that are keeping these contracts from proliferating widely: chiefly, not enough reliable data and regulatory issues such as the federal antikickback statute.
 
"The beautiful thing about value-based contracts is we are basically putting the patient at the center of everything," said Enrique A. Conterno, senior vice president of Eli Lilly and Co.  
 
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Topics: Industry Trends, Data & Analytics, Provider, Payer

Radar On Market Access: FDA Guidance Give More Comfort for Payer VBCs

Posted by Matt Breese on Jun 26, 2018

The FDA recently issued final guidance that seems likely to pave the way for smoother negotiations between pharmaceutical manufacturers and health plans over agreements tying payment to a drug's performance on cost-effectiveness and quality measures, AIS Health reported.
 
In it, the FDA clarifies that drugmakers and medical device manufacturers may provide "health care economic information," which may not be found in the medical product's labeling, to payers and other "sophisticated" entities — and offers recommendations on how to disseminate it properly.
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Topics: Industry Trends, Market Access, Provider, Payer

Radar On Market Access: Biosimilars' Change in Part D

Posted by Matt Breese on Jun 19, 2018

In just a little more than six months, biosimilars reimbursed in Medicare Part D will get a boost from legislation passed earlier this year. Plans and patients also stand to win, but manufacturers, not so much, industry experts told AIS Health.
 
In Part D, beneficiaries consistently pay a 25% cost share until they hit the catastrophic phase, when their responsibility decreases to 5% of the drug. During the initial coverage period, plan sponsors are responsible for 75% of a drug's cost; during the "donut hole" coverage gap, brand-name drugs' manufacturers must pay 50% of the drugs' cost, while plan sponsors' responsibility drops to 25%. Biosimilar manufacturers, by contrast, are excluded from having to provide this discount, leaving plan sponsors' responsibility at 75%. Yet as of 2019, biosimilars will be treated the same as brand-name drugs rather than as generics in the coverage gap.
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Topics: Industry Trends, Market Access, Provider, Payer

Radar On Market Access: In Value-Based Deals, Idea of Value Differs Among Firms

Posted by Matt Breese on Jun 7, 2018

As pharma manufacturers strive to demonstrate to payers their products' efficacy in the face of backlash against rising drug prices, one effective tactic may be to enter into value-based contracts. It's crucial for manufacturers to understand how other entities they wish to partner with approach value and to start preparing that value proposition early in the drug development process, AIS Health reported.
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Topics: Industry Trends, Market Access, Provider, Payer

Radar On Market Access: Pharma Faces Limits When Providing Payers Drug Information

Posted by Matt Breese on May 31, 2018

Payers increasingly are looking to pharma to provide evidence that a drug will provide value, yet some restrictions still limit what information manufacturers actually can provide to payers, AIS Health reported.
 
"Generally, drug companies cannot talk to stakeholders about unapproved products outside of 'coming soon' ads and scientific exchange," says Ernest Voyard, a director in Avalere Health’s regulatory strategy practice. "However, FDA issued a draft guidance last year that included direction for conversations with payers that included safe harbors for conversations about investigational products, recognizing a need for payors to plan for the future."  
 
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Topics: Industry Trends, Provider, Payer

Radar On Market Access: Express Scripts Inks Deal with Praluent Manufacturers

Posted by Matt Breese on May 29, 2018

Express Scripts Holding Co. has struck a deal with the manufacturers of Praluent (alirocumab), one of two pricey PCSK9 inhibitors on the market, that will give the PBM a lower net price on the drug in exchange for streamlined patient access and an exclusive spot on the Express Scripts national formulary, AIS Health reported.
 
The pact, unveiled May 1, comes after Regeneron and Sanofi announced in March that they would lower the net price of Praluent for payers willing to reduce access barriers for appropriate patients.
 
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Topics: Industry Trends, Market Access, Provider