Reimbursement from Elsevier Business Intelligence

Washington Roundup, May 2012

Fri, 25 May 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on the new Medicare coverage policy for transcatheter aortic valve replacement and Medicare latest hospital inpatient payment proposal.

Drug Shortages Proposal From Sen. Hatch Offers 7-Year Economic Incentives

Fri, 25 May 2012 00:00:00 -0400

The Utah Republican’s draft bill would encourage industry to increase its capacity to manufacture sterile injectable drug products by providing higher reimbursement rates and exclusivity incentives. House Republicans continue to pursue economic options, but time and jurisdictional factors could work against such measures to address shortages.

Ikaria’s Hybrid Business Model Taps Big Pharma Trends

Wed, 23 May 2012 00:00:00 -0400

Although Ikaria focuses on a highly specialized segment of the hospital market, its integrated business model offers insights into continuum of care strategies that pharma companies are evaluating in a reimbursement-focused world. The company’s promising strategy could get a boost from key trial read-outs as soon as late 2012.

“Next Phase” For CED Should Focus On Treatments That Lower Cost, MEDCAC Told

Mon, 21 May 2012 00:00:00 -0400

The next iteration of CMS’ Medicare coverage with evidence development policy should limit application of the reimbursement tool to treatments that can lower overall health care spending, Center for Medical Technology Policy CEO Sean Tunis told the Medicare advisory committee.

Reimbursement In Brief

Mon, 07 May 2012 00:00:00 -0400

Medicare will cover clinical trials of extracorporeal photopheresis in lung transplant recipients. Government Accountability Office reports on GPO oversight.

Medicare Inpatient Proposal: Modest Pay Increases, Longer-Term Reforms

Mon, 30 Apr 2012 00:00:00 -0400

Device-heavy procedures would see reimbursement increases in fiscal 2013 under the CMS inpatient payment proposal, as readmission and value-based purchasing policies are set in place.

Reimbursement of Biosimilar and Biosimilar-similar ESAs

Mon, 30 Apr 2012 00:00:00 -0400

Affymax received FDA approval for the first new ESA in years. Now the company is trying to secure favorable reimbursement for its product, Omontys.

Reimbursement News, In Brief

Mon, 30 Apr 2012 00:00:00 -0400

Only 11% of physicians plan to apply for EHR federal incentives and appeared about to meet about two-thirds of “meaningful use” requirements, Health Affairs analysis finds; Part D expenditures are increasing by almost 9% annually and rebates are about 11%.

Washington Roundup, April 2012

Wed, 25 Apr 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover CDRH’s plans to expand its Medical Device Epidemiology Network and the potential impact of the JOBS Act on life sciences start-up companies.

MS Boon: Many Drugs On The Way, But Will Payors Swallow The Cost?

Mon, 23 Apr 2012 00:00:00 -0400

Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.

Drug Shortages Proposal From Sen. Hatch Offers 7-Year Economic Incentives

Mon, 23 Apr 2012 00:00:00 -0400

The Utah Republican’s draft bill would provide higher reimbursement rates for sterile injectable products and provide exclusivity incentives. House Republicans continue to pursue economic options, but time and jurisdictional factors could work against such measures to address shortages.

Lilly Gains Amyvid Approval, But Reimbursement Still A Hurdle

Mon, 09 Apr 2012 00:00:00 -0400

Lilly’s Avid has gained approval for its imaging agent Amyvid, a new tool in the Alzheimer’s disease diagnosis arsenal.

Medical Device Market & Industry Briefs, March 2012

Wed, 28 Mar 2012 00:00:00 -0400

Brief summaries of recent medtech market and industry developments. This month we cover new scrutiny of metal-on-metal hip implants, new developments in reimbursement for carotid artery stenting, and a new report on shifting hospital purchasing patterns.

Washington Roundup, March 2012

Wed, 28 Mar 2012 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposed comprehensive postmarket surveillance strategy, as well as updates on proposed 510(k) reforms and device user fees.

Europe For Pharma Mid-Caps: Tough But Necessary

Mon, 26 Mar 2012 00:00:00 -0400

Europe’s growing reimbursement hurdles and falling prices, compounded by a currency and sovereign debt crisis, mean the region’s no longer a strategic priority for Big Pharma. But while major pharmaceutical firms have sufficient scale and reach to continue to move jobs abroad and step up their emerging markets activities if conditions don’t improve closer to home, most of the rest of industry’s smaller commercial players – including the Big Biotechs – don’t.

Maintaining a Sustainable Environment for Innovation: Ending the Evidence Arms Race for Regulatory and Reimbursement Decision-Making

Mon, 26 Mar 2012 00:00:00 -0400

Increasing attention on containing healthcare costs has spurred new business opportunities in data aggregation, real-time analytics, and rapid translation of data into evidence on the value of new innovation. This has become a race for more and faster evidence.

While Some Pharma Firms Contemplate A Move From Europe, Lilly Plants More R&D Roots

Wed, 29 Feb 2012 00:00:00 -0500

Pricing and reimbursement concerns in Europe could have a knock-on effect on R&D there, but with new academic tie-ups, Lilly says this is the time to invest.

Regulatory & Reimbursement News, In Brief

Mon, 27 Feb 2012 00:00:00 -0500

Some AHRQ research activities expected to shift to PCORI in White House 2013 budget request. Confusion over non-preferred pharmacy networks in Medicare Part D noted by CMS.

A Call For Action: Pharma Strategies For Development Of Payor Evidence Programs

Fri, 24 Feb 2012 00:00:00 -0500

The biopharma industry invests substantially in post-approval studies to convey information about the value of its products to constituents, but the majority of these efforts do not address core, real-world questions raised by payors. A new business model recognizing the strategic value of medical affairs to market access is needed to stem the tide of disappointing reimbursement decisions.

Washington Roundup

Fri, 24 Feb 2012 00:00:00 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover the device industry’s reaction to doubled user fees, and new developments in medical device taxes.

Congress Passes Lab Cuts; Obama Budget Targets Include Imaging, DME

Tue, 21 Feb 2012 00:00:00 -0500

Labs and test makers were caught off guard by a significant reimbursement cut passed in a payroll tax cut/physician payment fix bill. The same week, President Obama submitted a 2013 budget request that targets imaging and durable medical equipment with cuts and restrictions.

Congress Passes Lab Cuts; Obama Budget Targets Include Imaging, DME

Mon, 20 Feb 2012 00:00:00 -0500

HHS Will Delay ICD-10 Coding Expansion, Citing Provider Burden

Mon, 20 Feb 2012 00:00:00 -0500

The government will push back its October 2013 compliance date for switching from ICD-9 to the much-expanded ICD-10 reimbursement codes in response to providers’ arguments that near-term transition would disrupt care. The device industry supports a quicker move to ICD-10.

HHS Will Delay ICD-10 Coding Expansion, Citing Provider Burden

Fri, 17 Feb 2012 00:00:00 -0500

CMS Considers New Strategies For Reviewing IDE Trials

Mon, 13 Feb 2012 00:00:00 -0500

The Medicare agency is looking at ways to streamline reimbursement reviews of investigational device trials.

GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification

Mon, 13 Feb 2012 00:00:00 -0500

House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.

China’s Health Ministry Unveils Key Healthcare Initiatives For 2012

Fri, 10 Feb 2012 00:00:00 -0500

The government will boost insurance premiums and maximum reimbursement for rural populations, and it sets its eyes on reforming hospital compensation.

CMS Considers New Strategies For Reviewing IDE Trials

Fri, 10 Feb 2012 00:00:00 -0500

The Medicare agency is looking at ways to streamline reimbursement reviews of investigational device trials and improve communication with industry.

Germany To Disclose Rx Pricing Discounts, Setting A Potential Benchmark For Europe

Tue, 07 Feb 2012 00:00:00 -0500

The Germany health ministry’s decision to continue the 16% rebate and price moratorium for another year was disappointing for industry, yet predictable. More distressing is the decision to publicly release the final prices – which will likely have a domino effect on reimbursement in other EU member states.

European HTA Round-Up: NICE Focuses On Cost Effectiveness, IQWiG On Clinical Benefit, But Convergence May Come

Mon, 06 Feb 2012 00:00:00 -0500

It is becoming increasingly clear that NICE and IQWiG have very different concerns on the reimbursement front, but it is only a matter of time before IQWiG gets its teeth into cost-benefit analyses

Reimbursement In Brief

Mon, 06 Feb 2012 00:00:00 -0500

Latest news from the Medicare agency and other payers.

AZ, IMS To Build Disparate Data Sets Into Broader Outcomes Consensus

Mon, 30 Jan 2012 00:00:00 -0500

Individual deals with payers or information providers won’t provide pharma with the breadth of outcomes data they need to secure reimbursement for their drugs. A far broader stakeholder consensus is required.

Shortage Notification May Have Legislative Momentum Again After BIO Questions Reimbursement Fix

Mon, 30 Jan 2012 00:00:00 -0500

Preventing shortages through increased communications with manufacturers could gain the upper hand in part because creating economic incentives may prove too difficult and controversial.

Washington Roundup

Fri, 27 Jan 2012 00:00:00 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover new FDA guidance on manufacturers’ responses to unsolicited requests for off-label information, and FDA’s de novo draft guidance.

Japan Will Grapple With Mixed Reimbursement Policy In The Year Ahead

Fri, 20 Jan 2012 00:00:00 -0500

A Supreme court decision and TPP negotiations all point to further discussion around kongo shinryo – or mixed reimbursement – for treatments.

TPP Discussions Heat Up in Japan As Impact On Insurance And Reimbursement Begins To Take Shape

Thu, 19 Jan 2012 00:00:00 -0500

Japan’s domestic medical community fears the Trans-Pacific Partnership Trade Agreement could hurt its national health insurance system, and it does not want private insurance to compromise its public healthcare system.

Xarelto And Pradaxa Stumble At High U.K. Reimbursement Hurdles

Tue, 17 Jan 2012 00:00:00 -0500

NICE issues draft rejection of Bayer's blood thinner Xarelto for use in preventing stroke associated with atrial fibrillation, while a U.K. payer fights a positive recommendation for Boehringer Ingelheim's Pradaxa in the same indication.

OIG Report Highlights Difficulty In Measuring “Widely Available Market Price” For Drugs

Mon, 16 Jan 2012 00:00:00 -0500

Limitations and irregularities in sales data prevent an accurate comparison of average sales price and widely available market price for Medicare Part B drugs, a differential that can be the basis for modifying reimbursement.

Japan 2012 NHI Price Revision Takes Shape, Long-Listed Products See Smaller Cuts Than Expected

Wed, 11 Jan 2012 00:00:00 -0500

Japan's MHLW and Finance Ministry face off on the steps needed to shave reimbursement costs.

Xarelto And Pradaxa Stumble At High U.K. Reimbursement Hurdles

Tue, 10 Jan 2012 00:00:00 -0500

Dendreon Rebounds In Q4 2011, But Can It Keep It Up In 2012?

Tue, 10 Jan 2012 00:00:00 -0500

The biotech reported gross product revenue for Provenge of approximately $82 million in Q4 2011, better than doubling Q4 2010 sales. Management credits improved reimbursement dynamics and sales execution.

Clinical, Not Real-World, Data is Still The Key To On- And Off-Label Reimbursement (Part 2)

Mon, 09 Jan 2012 00:00:00 -0500

While payers have ever-more sophisticated datasets for observing drug use in the clinic, such information generally is “inconclusive” for reimbursement decisions, a managed care executive cautions.

European Health Technology Assessment

Mon, 09 Jan 2012 00:00:00 -0500

Chart provides a side-by-side comparison of key assessment factors in seven nations and how those factors play into drug reimbursement decisions.

Clinuvel Has Done Its Reimbursement Homework For Orphan Drug Scenesse, But Can It Make Money?

Tue, 03 Jan 2012 00:00:00 -0500

As Australia-listed Clinuvel prepares to file its porphyria drug in Europe, it’s confident the orphan treatment will win reimbursement. But the firm will have to exploit larger indications like vitiligo in order to provide a return for investors.

Waiting For Blockbusters: Osteoporosis Market Burdened With Black Box Warnings, Reimbursement Woes, And Spare Pipelines

Mon, 02 Jan 2012 00:00:00 -0500

It’s laden with unmet need and potentially one of the largest and fastest-growing pharmaceutical markets in the world. Unfortunately pharmaceutical manufacturers have found osteoporosis a very difficult disease to treat satisfactorily.

Reimbursement In Brief

Mon, 02 Jan 2012 00:00:00 -0500

The latest news from Medicare and other health care payers.

Grunenthal CEO Claims German Reimbursement Hurdle Is Fair, As Pain Drug Palexia Rolls Out Across Europe

Mon, 02 Jan 2012 00:00:00 -0500

German reimbursement authority’s strong emphasis on drugs’ added benefit is logical, opines Grunenthal CEO Harald Stock. And all health care systems will eventually move the same way.

Owning the Disease: A New Business Model For Medical Technology Companies

Tue, 27 Dec 2011 00:00:00 -0500

The convergence of expanded access, lower reimbursement rates, higher velocity of innovation, diminished pools of venture capital, the advent of personalized care and a growing demand for improved patient outcomes has created ripples that already are altering the economics and operating dynamics of health care. To survive the coming storm, biomedical companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than the traditional R&D department approaches.

AZ’s Brilinta Is First Drug To Clear AMNOG Assessment, While Merck’s Victrelis Limps Forward

Mon, 19 Dec 2011 00:00:00 -0500

Lack of consistent approach in IQWiG/G-BA AMNOG-based decisions leaves industry confused about new reimbursement route.

“Comprehensive” Drug Shortage Mitigation Bill Under Development In House

Mon, 19 Dec 2011 00:00:00 -0500

Like the Senate proposal, it could include reimbursement rate adjustments in addition to requiring early notification of shortages by manufacturers, but questions remain about ensuring there are no unintended consequences.