Reimbursement from Elsevier Business Intelligence

Japan Pharma Annual Meeting Snapshot: Eisai, Dainippon, Shionogi, Ajinomoto, Astellas

Tue, 21 May 2013 10:55:01 -0400

The annual earnings meetings of Eisai, Dainippon Sumitomo, Shionogi, Ajinomoto and Astellas highlight critical issues impacting Japanese pharma, from the evolving domestic generics market, choosing whether to enter the biosimiliars fray and the impact of yen depreciation on reimbursement pricing.

Turkey’s Drug Bill Dips In 2012; Industry Blames Unsustainable Pressure, Government Cites Efficiencies

Mon, 20 May 2013 01:05:01 -0400

Turkey’s spending on drug reimbursement dropped last year as pressure was brought by government price cuts, but manufacturers say the trend is unsustainable. The government says some of the $747 million it saved was because of heightened use of electronic tracking for prescriptions.

German State Court Ruling Against Novartis Confirms Legality of HTA For Older Products

Fri, 17 May 2013 14:00:00 -0400

A State Social Court of Berlin-Brandenburg ruling against Novartis means that Germany's reimbursement bodies can move forward with the benefit assessment of older pharmaceutical products.

Reimbursement In Brief

Mon, 13 May 2013 00:00:37 -0400

HHS Office of Inspector General says Illinois should reduce Medicaid rates for diabetes test strips, and that Medicare is paying so-called G modifier claims inappropriately in reports last week. More reimbursement news.

Sequester May Further Depress AmerisourceBergen’s Oncology Drug Sales

Mon, 13 May 2013 00:00:07 -0400

Wholesalers AmerisourceBergen and McKesson discuss the potential impact of the federal budget sequester and the resulting cut to Part B drug reimbursement on oncology drug sales.

Medical Device Innovation Consortium Sets Priorities To Advance Regulatory Science

Fri, 26 Apr 2013 00:00:41 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month: Heads of the newly formed private-public partnership comprising industry, academia, and FDA describe the group’s top three projects to advance medical device regulatory science.

Congress Pressing CMS To Alleviate Part B Drug Cuts Under Sequester

Thu, 25 Apr 2013 15:45:00 -0400

A bipartisan group of 124 House members tells CMS in a recent letter that the reimbursement cuts required by sequestration are being applied in a way that may force oncology providers to turn away Medicare patients or go out of business.

BIO 2013 Tuesday Roundup: Reimbursement Reigns, Industry Innovation, New Antibodies

Tue, 23 Apr 2013 23:20:00 -0400

Our survey of news and notes from the second day of the BIO conference includes discussions of changes in the way pharma negotiates milestones, big ambitious projects to solve industry “dysfunction,” and a next-generation antibody developer pushing toward the clinic.

Germany's G-BA Sets Out Financial-Based Criteria For Assessing Drugs Already On The Market

Fri, 19 Apr 2013 15:30:02 -0400

Germany's senior reimbursement body, the G-BA, has set out criteria – based on the financial success of products – to evaluate drugs already on the market.

[Abbott Molecular] to create companion diagnostic for [Epizyme]'s cancer compound

Thu, 18 Apr 2013 19:01:00 -0400

[Abbott Molecular Inc.] will create a companion molecular diagnostic for use with personalized cancer therapies developer [Epizyme Inc.]’s lead compound, Phase I EPZ5676.

Updated Qsymia REMS In Hand, Reimbursement and Partner Are Next For Vivus

Wed, 17 Apr 2013 19:15:01 -0400

The most efficacious weight loss drug reviewed recently by FDA, Qsymia, remains mired in commercial issues despite a REMS that now allows for retail pharmacy sales. Vivus’ biggest investor continues to be highly critical of the biotech, having proposed its own board slate last month.

Swiss Agreement Sees Drug Prices Fall But Access Accelerated

Tue, 16 Apr 2013 15:00:00 -0400

The Swiss government and the pharmaceutical industry have reached an agreement that will see prices slashed by 20% over the next three years, but reimbursement decisions to be accelerated by over 300%.

Boehringer’s Trajenta Enters China As DPP-4 Latecomer, But Playing Field Still Level

Tue, 16 Apr 2013 11:35:00 -0400

Boehringer Ingelheim’s first diabetes product, Trajenta, has been approved in China. It enters China as the fourth DPP-4, but it may not have far to catch up given the reimbursement landscape.

Clinical Lab And DME Payments Face Cuts Under Obama Budget

Mon, 15 Apr 2013 00:05:12 -0400

The 2014 federal budget request submitted by President Obama April 10 includes proposals to cut clinical lab services and to limit Medicaid reimbursement for durable medical equipment, among other cuts that would affect the medtech industry.

Raising Part D Donut Hole Discounts To 75% Proposed By President

Mon, 15 Apr 2013 00:04:48 -0400

Raising Part D Donut Hole Discounts To 75% Proposed By President

Wed, 10 Apr 2013 16:45:00 -0400

President Obama’s 2014 budget plan contains some new drug reimbursement ideas, including increasing the brand drug discount used in the Medicare Part D donut hole to 75% and slashing the Part B drug rate to ASP+3%. Many familiar proposals are reprised – a stronger IPAB, mandatory drug rebates for Medicare/Medicaid dual-eligibles, eliminating pay-for-delay generic drug deals and reducing biologic product exclusivity.

[Roche] options [Isis]’ antisense candidates for Huntington’s

Tue, 09 Apr 2013 19:02:00 -0400

[Isis Pharmaceuticals Inc.] (inhibition of disease-causing proteins) has granted [Roche] options to license early-stage antisense therapeutics for Huntington’s disease (HD).

Shanghai Lifts Rebate Cap For Urban Worker Health Insurance

Tue, 02 Apr 2013 21:35:00 -0400

The maximum reimbursement amount of Shanghai’s urban employee health insurance will increase from RMB 280,000 to RMB 340,000 from April 2013 through March 2014.

Reimbursement In Brief

Mon, 01 Apr 2013 00:01:56 -0400

Labs cite problems with molecular diagnostics payment-setting process. PCORI panels include device, diagnostic appointees.

Washington Roundup, March 2013

Wed, 27 Mar 2013 00:00:09 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”

Almirall May Pull Sativex After German Arbitration Board Pricing Decision

Tue, 26 Mar 2013 16:40:00 -0400

Germany’s reimbursement arbitration board has proposed a rock bottom price for GW Pharmaceuticals/Almirall’s cannabinoid preparation Sativex (nabiximols) for MS-related spasticity.

Ilhan Takes Over Hot Seat At Turkey’s Drug Reimbursement Agency

Tue, 26 Mar 2013 06:45:00 -0400

Turkey’s Social Security Institution (SGK), the payer for about 80% of the drugs consumed in the country, this month saw Yadigar Gokalp Ilhan become its first woman president, and her knowledge from a previous post as coordinator for the government’s Health Transformation Program is crucial as the agency faces criticism over drug shortages due to low prices.

Bayer’s Eylea Shot Down By IQWiG On A Technicality

Mon, 25 Mar 2013 11:35:00 -0400

Germany’s IQWiG has tightened the screw on reimbursement submissions, rejecting Bayer’s Eylea for AMD on technical grounds concerning its comparator.

Device Industry Sees Opportunities In Brazil, Despite Trade Barriers

Mon, 18 Mar 2013 00:05:09 -0400

Recent visits to Brazil by three medical device trade groups are telling of the opportunities there for U.S. device companies, in spite of barriers related to regulation, reimbursement and compliance.

Reimbursement In Brief

Mon, 18 Mar 2013 00:01:14 -0400

CMS issues proposed decision memo for PET for solid tumors and sends letter to Smith & Nephew clarifying G codes for negative pressure wound therapies. More reimbursement news.

International News In Brief

Mon, 18 Mar 2013 00:00:46 -0400

British regulators offer chance for early dialogue on requirements for innovative devices. Eucomed launches publication series on reimbursement systems in European countries.

Guangzhou Today, China Tomorrow? A Closer Look At Reimbursement Pilots For Iressa, Tarceva

Wed, 13 Mar 2013 13:25:00 -0400

AstraZeneca CEO Pascal Soriot sees tremendous potential for Iressa in China, where Roche’s Herceptin grew over 20% in 2012. Both companies have their high-priced targeted therapies in China’s first-ever reimbursement pilot in Guangzhou.

TranS1 Seeks Transformation With Baxano Buy

Mon, 11 Mar 2013 00:01:22 -0400

Just two months after the company secured a long sought after reimbursement code for its Axial Lumbar Interbody Fusion (AxiaLIF) system, TranS1 announced its plans to acquire privately held spinal surgical tool maker Baxano Inc.

TranS1 Seeks Transformation With Baxano Buy

Mon, 11 Mar 2013 00:01:04 -0400

Reimbursement In Brief

Mon, 04 Mar 2013 00:01:25 -0500

GAO finds Medicare still a high-risk program. AMA and McKesson partner on molecular diagnostic coding and tracking system.

Sequestration And Medicare

Fri, 01 Mar 2013 16:50:00 -0500

Payments to Medicare Part D plans and Part B providers will be cut by 2%, but CMS has not yet provided details on how much it will cut reimbursement for Part B drugs.

Pfizer Works With Roche To Increase Diagnostic Services For Xalkori Launch In China’s Self-Pay Market

Fri, 01 Mar 2013 15:40:00 -0500

Despite no reimbursement in sight, Pfizer still sees a huge potential for targeted lung cancer drug Xalkori in China. To quickly ramp up eligible patients, Pfizer is working with Roche to offer discounted diagnostic services to identify best responders.

Pfizer Works With Roche To Increase Diagnostic Services For Xalkori Launch In China’s Self-Pay Market

Fri, 01 Mar 2013 11:50:06 -0500

China Aims At Hospitalization Rebates Of 60-75% In Rural Areas In 2013

Wed, 27 Feb 2013 00:20:12 -0500

China’s Health Minister Chen Zhu laid out goals for rural healthcare, including 60% and 75% hospitalization reimbursement rates and expanding other payment and insurance options.

CMS Plans To Include DME-Infused Drugs In Future Round Of Competitive Bidding

Wed, 27 Feb 2013 00:00:41 -0500

An Inspector General report reveals CMS’ plans to include Part B drugs infused in conjunction with durable medical equipment as part of the DME competitive bidding process, but did not state when it would happen. OIG said that based on the AWP-based reimbursement for DME-infused drugs compared to ASP-based reimbursement it believes should be used, Medicare overpaid $334 million for DME-infused drugs from 2005-2011.

Washington Roundup, February 2013

Wed, 27 Feb 2013 00:00:29 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”

CMS Plans To Include DME-Infused Drugs In Future Round Of Competitive Bidding

Mon, 25 Feb 2013 18:00:04 -0500

Reimbursement In Brief

Mon, 25 Feb 2013 00:01:06 -0500

CMS posts its report to Congress on NCDs for FY 2011. MedCAC announces meeting on genetic cancer tests.

EndoGastric Solutions Rewrites Playbook In Bid To Build GERD Business

Tue, 19 Feb 2013 12:00:00 -0500

Founded in 2001, EndoGastric Solutions Inc., a mature medical device company with $140 million in venture backing, hasn’t been able to secure a reliable source of reimbursement dollars for its EsophyX endoscopic treatment for GERD. Under new management, EGS is recommitting itself to collecting necessary clinical data and operating as a lean start-up as it makes its case for coverage and reimbursement with insurers.

MOH To Add Drugs, Rebates, Diseases In Health Insurance

Fri, 15 Feb 2013 00:55:06 -0500

China’s Health Minister Chen Zhu plans to increase the overall health insurance reimbursement rate by 5% in 2013, particularly for chronic diseases.

Jakavi’s UK Reimbursement Could Hinge On End-of-life Data After NICE Knockdown

Wed, 13 Feb 2013 23:05:01 -0500

With no other innovative products for myelofibrosis on NICE’s radar at present, Novartis should have time to rescue the situation.

Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve

Mon, 11 Feb 2013 10:06:00 -0500

It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.

Reimbursement In Brief

Mon, 11 Feb 2013 00:00:55 -0500

CMS opens national coverage analysis on VADs, proposes regulatory reform and announces new ESRD initiative. More reimbursement news.

STS, ACC Gain IDE Approval To Study New Access Methods For Edward’s Sapien Valve

Fri, 08 Feb 2013 00:00:04 -0500

It’s the first time the societies have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.

Cross Tasman Sea Changes As NZ’s PHARMAC Extends Writ And Australia Makes Reimbursement A Poll Issue

Fri, 01 Feb 2013 11:30:01 -0500

New Zealand’s PHARMAC says it will funnel savings achieved by standardizing medicines across all New Zealand hospitals into introducing new drugs in the market as the body prepares a list of medicines available for July 1 release. Across the Tasman Sea, approvals and reimbursement will be spotlighted in a federal election called for in September.

Roche’s Oncology Output Could Lead To Reimbursement Problems Down The Line

Wed, 30 Jan 2013 18:45:00 -0500

Roche posted solid 2012 results and development of new cancer drugs continues apace, forecasting further sales and profit gains in 2013 and beyond – as long as government insurers can handle the abundance.

Washington Roundup, January 2013

Wed, 30 Jan 2013 00:00:16 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.

Reimbursement In Brief

Mon, 28 Jan 2013 00:00:35 -0500

CMS issues proposed decision memo on ocular photodynamic therapy and opens national coverage analyses for cardiac pacemakers and bariatric surgery. GAO denies Palmetto’s Medicare award protest.

Japan Pharma Gearing Up For Battle In Reimbursement Talks As Tax Landscape Shifts

Fri, 25 Jan 2013 16:20:01 -0500

Increased consumption tax and tax credits for R&D offer a new playing field as 2014 price revision talks take shape.

Trends In Diagnostics – 2012

Fri, 25 Jan 2013 00:00:49 -0500

Diagnostics industry trends include the increasing adoption of genomics in clinical testing and with it a focus on services and workflow more so than differentiated technology; a slowdown in M&A activity, partly to allow the digestion of assets acquired in 2010-11; and the ongoing uncertainties of regulation and reimbursement of high-value molecular tests.