Semi Automating REMS: New Solutions Announced

REMS programs for the opioid class of products can have significant inefficiencies.  McKesson recently announced a forward thinking solution leveraging today's technology around adjudication and using NCPDP standards.  A solution worthy of note.  Today in many cases, pharmacy has a very manual process.  The solution detailed below offers a streamlined and transparent approach.

McKesson and RelayHealth continue their success in retail REMS solutions to ensure safety and access for cancer patients
The Woodlands, Texas (Oct. 12, 2011) - Cephalon, Inc. (Frazer, PA), has chosen McKesson Specialty Health to administer its U.S. Food and Drug Administration (FDA)-approved FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] Risk Evaluation and Mitigation Strategy (REMS) programs for management of breakthrough pain in cancer patients.

Building on an established track record as the “go-to” REMS administrator, McKesson Specialty Health will administer the newly-approved Cephalon REMS programs which will replace the prior risk management programs for these medications. Through McKesson Specialty Health’s sister-organization, RelayHealth, patients can have their prescriptions filled at any local retail pharmacy enrolled in the ACTIQ and FENTORA REMS programs.

“As innovators in end-to-end REMS solution, we’re building on a live, proven model in the market place today that works within pharmacy and prescriber management workflow systems to ease the administrative burden on providers,” said Heather Morel, vice president and general manager, Reimbursement, Access and Safety Services | AccessMED, McKesson Specialty Health. “We are very pleased to collaborate with Cephalon to enable safe access to medications that play an important role in patients’ cancer treatment.”

Today, McKesson Specialty Health and RelayHealth administer several FDA-approved REMS with Elements to Assure Safe Use (ETASU) in the retail pharmacy setting making it now possible to help ensure all safe-use conditions are met within the pharmacist workflow rather than increasing the burden on stakeholders or moving REMS products out of the retail channel.

“McKesson Specialty Health’s experience in end-to-end solutions for complex REMS, combined with RelayHealth’s innovative pharmacy network solutions, bring together the right expertise and infrastructure to support the goals of this important REMS program,” said James Ottinger, vice president, Worldwide Regulatory Affairs, Cephalon.

“By leveraging our partnerships with retail pharmacies across the country and existing pharmacy technology in place today, we will help ensure not only safe, but timely, access to Cephalon’s important pain medications,” said Jeff Felton, president, RelayHealth Pharmacy Solutions.

McKesson Specialty Health has extensive experience in designing and administering comprehensive REMS solutions with ETASU for both specialty and retail channels and is the only REMS administrator with multiple active retail-based REMS with ETASU programs that integrate with pharmacy practice management systems in the market today. As part of McKesson Corporation, McKesson Specialty Health and RelayHealth bring a comprehensive, unmatched set of REMS assets and solutions to all stakeholders in healthcare.

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FDA links infections to repackaged Avastin

FDA said at least 12 patients developed serious eye infections, including some leading to vision loss, following intravitreal injections of repackaged Avastin bevacizumab to treat wet age-related macular degeneration at three Florida clinics. The agency traced the bacterial infections to a single pharmacy in Hollywood, Florida, which repackaged the IV cancer drug into single-use syringes for off-label treatment of wet AMD. FDA recalled all Avastin
repackaged at the pharmacy.

The humanized mAb against VEGF from Genentech Inc. is approved for multiple cancers and is used off-label in wet AMD as a cheaper alternative to Genentech's Lucentis ranibizumab, a mAb fragment against VEGF-A. In April, NIH's National Eye Institute reported that Avastin was non-inferior
to Lucentis in the Phase III CATT trial for wet AMD (see BioCentury May 2).

Genentech said in a statement that it does not support or promote the off-label use of Avastin. The company added that other ocular adverse events have been reported from unapproved use of Avastin for eye disorders.

In April 2010, FDA received reports of five eye infections in Tennessee linked to Avastin repackaged at a single compounding pharmacy. Genentech, a unit of Roche (SIX:ROG; OTCQX:RHHBY), markets Avastin and Lucentis in the U.S., while the drugs are marketed elsewhere by Roche and Novartis, respectively.

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NACDS, NCPA Urge Protecting Patient Choice of Pharmacy

NACDS, NCPA Urge Protecting Patient Choice of Pharmacy Amid Studies on Medication Adherence

Alexandria, Va. – National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson, IOM, CAE and National Community Pharmacists Association (NCPA) Executive Vice President and CEO B. Douglas Hoey, RPh, MBA today issued the following statement regarding two recent studies appearing in the Journal of Medical Economics (JME) and the American Journal of Managed Care (AJMC), regarding medication “adherence,” or the proper use of medicine as prescribed by a physician:

“The AJMC study effectively counters the claims in a study published in the JME regarding the uses of mail order versus community pharmacies. Amid these studies, it is safe to say that we have at least one important takeaway lesson: The best way to promote proper adherence to medication and better health outcomes is by ensuring patients’ access to the pharmacy of their choice. Despite repeated financial and other inducements encouraging mail order in Medicare Part D and other health plans, the vast majority of patients opt to continue to rely on their local, community pharmacist to help meet their health needs.

“It’s important to remember that adherence is about more than simply mailing a 90-day supply of prescription medication to a patient.  Possession of prescription drugs alone is not the only factor in measuring adherence. For the full patient health picture, one must take into account whether that medication was actually taken as prescribed, if the patient had an adverse reaction, or if the prescriber stopped or changed the dosage of that medication based on the patient’s need.

“If any of these factors occur, it not only impacts adherence, but also cost.  If a medication is not used properly, then the potential for cost-savings is lost if additional medication, medical tests or even catastrophic and emergency care are needed by a patient, further disrupting patients’ lives and driving up healthcare costs.

“This is also why it is vital to recognize that drug costs cannot be viewed in a vacuum.  Pharmacy services need to be evaluated in terms of their overall ability to bring down healthcare costs across the board and improve patient health.  Pharmacists provide counseling services, medication therapy management and other services that must be considered in any comprehensive cost-benefit analysis.

“The true story of improved medication adherence is the unsurpassed value of community pharmacy and the services it provides.  There is no substitute for the pharmacist-patient face-to-face relationship.  Community pharmacy services help to improve patient health and lower overall healthcare costs. Maintaining patient choice of how to obtain prescription medications is essential.”

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Charlie Bowlus of ECRM Passes

He was a true friend of mine and the industry and the founder of an extraordinary organization.  When I started consulting many years ago it was Charlie that offered me a hand and access to his event so I could network.  I'll be forever grateful for his wisdom and generosity.  Please say a prayer for his family and the extended family of his legacy, his ECRM employees.
Thank you.


Pharma leads July job losses

In July, the US pharmaceutical industry shed 13,493 jobs, more than any other sector, according to an updated Challenger, Gray & Christmas report on employment trends by industry. in job losses. Merck’s announced layoffs, totaling 13,000, brought pharma past government as the leading sector for cuts in July, but government is the runaway leader in total job losses for 2010 (106,896) and 2011 (86,980), so far.

Merck’s ongoing job cuts are the result of a restructuring exercise that began after the company’s merger with Schering-Plough. Consolidation usually results in redundancy, but PhRMA, in a statement released in July, worried about cuts from a different hatchet. The Obama Administration, according to PhRMA, is not only overseeing massive job losses in government; it’s also setting up the pharmaceutical industry for a precipitous decline as the private sector employer of choice, with the highest average wages and benefits of any US industry.

“It’s extremely unfortunate that President Obama continues to push for a policy that could destabilize the successful Medicare Part D program and have a devastating effect on American jobs,” said PhRMA vice president Karl Uhlendorf, in a statement. Citing a recent JAMA study, John Castellani, PhRMA’s president and CEO, underscored the link between Part D “price controls” and American jobs. Government price controls could not only affect patients, “it could also be a devastating blow to our economy and further worsen the jobs crisis,” said Castellani.

PhRMA’s statements about the jobs impact of giving CMS the ability to negotiate drug prices, or demand drug rebates for Medicare/Medicaid duel eligibles, reflects the agenda of Chris Viehbacher, current chair of the PhRMA Board and CEO of Sanofi-Aventis, who wants to put more emphasis on industry’s economic contribution. PhRMA data indicates that for every one job created at a pharmaceutical company, another six jobs in adjacent businesses are created. With ongoing consolidations, new generic competition and a gap in pipeline productivity, however, industry’s argument around positive economic impact is likely to receive a skeptical reception, at least in the short term. Industry messaging should instead focus on the social benefits of innovation, its sole remaining virtue in the public realm. With pharma leading the pack in job cuts for July, and a mandate to curb government spending in congress, job creation isn’t likely to be a reputational selling point any time soon. Innovation, on the other hand, offers the promise of life-saving treatments that combat unmet medical needs, a positive message that regular citizens, also known as constituents, can get behind.

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Wolters Kluwer disengages from pharma market research

The business of analyzing prescriber data is consolidating around IMS Health

Of the three major research companies that collate and mine prescribing data and related market research, two are in the process of merging (with IMS Health acquiring SDI, pending federal approval) and now the third, Wolters Kluwer, is exiting the business altogether. W-K announced that it would divest the pharma part of its Health & Pharma Solutions business, while keeping, and investing in, the Health part that provides clinical decision support, journals and other educational materials. “Moving forward, we are excited about continued opportunities to deliver value to global customers through our portfolio of leading brands in content and clinical decision support, which are well-positioned to benefit from healthcare reform trends globally to support the division's growth strategy," said Bob Becker, president of the health & pharma unit, in a company statement.

Dollar figures were not discussed, but Reuters reported that the company plans to take a €106- million impairment charge (writedown of goodwill) for the divestiture. In 2005, W-K acquired NDC Health for $382 million, adding at the time that the unit was generating revenues of $163 million. (NDC Health focused primarily on prescriber data collection.) Reuters also reported that the W-K will likely sell the pharma business piecemeal; its parts include Source Patient Insights; ProMetis Market Profiler (merging patient, payer and prescriber data); Adis R&D Insight (tracking drug development), drug safety, publishing services and sales training.

If one buys into the proposition that the life sciences industry is becoming more data-intensive and driven by data mining and analytics, the announcement is a surprise. But industry insiders say that W-K tended to be an also-ran, at least for selling prescriber data to manufacturers. Reuters quoted an anonymous industry source saying that the business has been a low-growth, low-margin one for the company. With sales forces shrinking and pharma sales more of a managed-markets business, selling prescriber data on which sales commissions and market forecasts are calculated is trending toward a commodity business; the action has moved on to deeper analytics of patient behavior, payer and outcomes data.

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FDA Posts New Draft Document on 501 (k) Premarket Notifications

FDA developed a draft document to provide guidance to manufacturers on when to submit a premarket notification submission (510(k)) for changes or modifications made to that manufacturer’s1 previously cleared medical device. The underlying principles that FDA uses to determine when a 510(k) is necessary for a modified device are explained, and examples are provided for additional clarity. When final, this guidance will supersede the 1997 version of the guidance document..

While the suggestions are modest in nature we suggest you review this document for importance to your organization.  D2 has a broad network of specialists focus on the commercialization of devices.

For a full review of the draft document please click on http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm#1


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Fresenius announces 1.7B deal for Liberty Dialysis Holdings

Fresenius Medical Care, a German dialysis company, announced a $1.7 billion deal for Liberty Dialysis Holdings, Mercer Island, Wash. The deal must be cleared by antitrust regulators and some facilities may be divested to win approval, according to a Fresenius news release. The transaction, which includes debt, is expected to close early next year, according to the release.

Renal Advantage, which operates under Liberty Dialysis Holdings with a second company named Liberty Dialysis, has already received a $300 million infusion from Fresenius, the release noted. Liberty Dialysis Holdings, backed by private-equity firms KRG Capital Partners and Bain Capital Ventures, reported annual sales of roughly $1 billion and operates about 260 clinics, the release said.

Fresenius employed about 77,000 workers and operated about 2,838 clinics including 1,826 in North America as of the end of June, according to the company. Fresenius also announced in the release that it reached a $385 million deal to acquire American Access Care Holdings, a Glen Rock, Pa.-based outpatient vascular care provider for dialysis patients. Antitrust regulators must approve that deal, as well; the acquisition is expected to close by the end of the year. The deal would add American Access Care's 28 outpatient vascular care centers to the 13 operated by Fresenius, according to the release.

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Rite Aid Shuffles Store Operations, HR Executives

Rite Aid Corp. has made a flurry of executive changes in store operations and human resources. Brian Fiala was named executive VP of human resources, succeeding Steve Parsons, who is leaving the company. Taking over Fiala's former post as executive VP of store operations is Robert Thompson, previously senior VP for the western division. And replacing Thompson is Bill Romine, promoted from group VP for metro New York.

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CMS to Cover Avastin and Provenge

Avastin Coverage For Now Despite FDA Decision

On June 30, 2011, the Centers for Medicare and Medicaid Services (CMS) made announcements on two important cancer drugs. CMS announced a positive national coverage decision on Provenge for the treatment of advanced prostate cancer. This was expected following the CMS Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) draft guidance released in March of this year. Secondly, a spokesman for CMS said the agency would continue to pay for Avastin for breast cancer treatment even if the Food and Drug Administration (FDA) revokes the drug’s approval for this treatment. However, the CMS spokesman said that while there were no plans for national coverage determination (NCD) on this issue right now, he could not rule out that Medicare might one day undertake a NCD to decide whether to pay for Avastin for breast cancer – this process would take at least a year and involve extensive public input.

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