PharmaVoice - Letter From the Editor - September 2010
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All roads lead to CER... It seems as though the term CER, or comparative effective- ness research, is in the air everywhere I turn these days — it was the subject of nine distinct sessions at the recent DIA 46th Annual Meeting (check out the Editor’s Take videos recorded at the conference at pharmavoice.com) and it will be the focus of the upcoming 4th Annual Comparative Effectiveness Research Summit to be held in Philadelphia this November. And so it is with this issue as well, which is not entirely by happenstance.As this month’s Forum outlines, CER is going to have a huge impact on every stakeholder in healthcare delivery and will require everyone to take a much broader view of the healthcare system. In brief,comparative effectiveness data are geared broadly to multiple decision-makers to pro- vide real-world evidence of the outcomes of various treatments. For physicians, CER is going to provide the ability to analyze treatment choices and pick what’s best for their individual patients. For patients, it’s going to provide them with more information that can help set their expectations for their treatment. For payers, comparative effectiveness will provide support for decision-making about product access and formulary placement that is based on real-world outcomes. (Please turn to the Forum in this issue, for more information.) As a result of comparative effectiveness, the pharmaceutical business model will need to change. According to IMS Health, a more focused effort, or niche model, will address not only what patient populations to target but what populations not to target. Sydney Clark of IMS says companies will need more data to prove clinical and economic value of their drugs, and decision-making will become more complicated. Pharma companies will need to make these tough decisions earlier on in the process so they have the data to convince stake- holders that their drug will be differentiated in the marketplace. (To read more about the emerging niche model, please turn to the article on Nichebusters vs. Blockbusters). The pressure of comparative effectiveness will also have an impact on the discovery pipeline, says Gil Bashe of Makovsky + Company. As government agencies require proof of comparative effectiveness before awarding any government reimbursement, companies will think twice about what types of drugs to bring to market. In the future, he says big pharma will take on a mass-market disease only if it can provide a big step forward in terms of treatment solutions. This sentiment is echoed by the subject of this month’s industry bio, Dr. Leon Smith, who has been practicing medicine for more than 60 years and is a pioneer in infectious disease. One of his greatest concerns is a dearth of research into new drugs, particularly antibiotics in the wake of gram-negative resistance to existing antibiotics. (To read more about his inspiring career, please turn to the feature story The Age of Excellence.) As CER becomes more established and gains acceptance in the United States, the already astronomical cost of drug development is likely to continue to increase due to the need for ever larger studies with potentially longer duration to demonstrate superiority in end points. As Ogilvy CommonHealth thought leaders outline in their VIEW on Med Ed — Comparative Effectiveness Research: Watch and Worry or Weigh In and Leverage? — justification for healthcare choices should include effectiveness, safety, and convenience for an individual patient, in addition to cost. As such, med ed groups will have a great opportunity to partner with manufacturers to educate decision-makers and the general public about the nuanced value of CER. (To read more about the impact of CER on this sector, please reference the VIEW on Med Ed.) Where CER will eventually take us is anybody’s best guess, but the ride will no doubt be interesting. Comparative effectiveness LETTER from the editor PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh MANAGING EDITOR Denise Myshko SENIOR EDITOR Robin Robinson FEATURES EDITOR Kim Ribbink CONTRIBUTING EDITOR Carolyn Gretton DESIGN ASSOCIATE Ariel Medel NATIONAL ACCOUNT MANAGER Cathy Tracy CIRCULATION ASSISTANT Kathy Deiuliis Copyright 2010 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Ten, Number Eight PharmaVOICE (ISSN: 1932961X) is published monthly except joint issues in July/Aug. and Nov./Dec., by PharmaLinx LLC, P.O.Box 327, Titusville, NJ 08560. Periodicals postage paid at Titusville, NJ 08560 and addi- tional mailing offices. Postmaster: Send address changes to PharmaVOICE, P.O. Box 292345, Kettering, OH 45429-0345. PharmaVOICE Coverage and Distribution: Domestic subscriptions are available at $190 for one year (10 issues). Foreign subscriptions: 10 issues US$360. Contact PharmaVOICE at P.O. Box 327, Titusville, NJ 08560. Call us at 609.730.0196 or FAX your order to 609.730.0197. Contributions: PharmaVOICE is not responsible for unsolicited contributions of any type. Unless otherwise agreed in writing, PharmaVOICE retains all rights on material published in PharmaVOICE for a period of six months after publication and reprint rights after that period expires. E-mail: [email protected]. Change of address: Please allow six weeks for a change of address. Send your new address along with your sub- scription label to PharmaVOICE, P.O. Box 292345, Kettering, OH 45429-0345. Call us at 800.607.4410 or FAX your change to 937.890.0221. E-mail: [email protected]. IMPORTANT NOTICE: The post office will not forward copies of this magazine. PharmaVOICE is not respon- sible for replacing undelivered copies due to lack of or late notification of address change. Advertising in PharmaVOICE: To advertise in Pharma- VOICE please contact our Advertising Department at P.O.Box 327, Titusville, NJ 08560, or telephone us at 609.730.0196. E-mail: [email protected]. THE FORUM FOR THE INDUSTRY EXECUTIVE Volume 10 • Number 8 Send your letters to [email protected]. Please include your name, title, company, and busi- ness phone number. Letters chosen for publication may be edited for length and clarity. All submissions become the property of PharmaLinx LLC. Letters Printed on recycled paper 3 PharmaVOICE September 2010
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Transcript of PharmaVoice - Letter From the Editor - September 2010
All roads lead to CER...It seems as though the term CER,or comparative effective-
ness research, is in the air everywhere I turn these days — itwas the subject of nine distinct sessions at the recent DIA 46thAnnual Meeting (check out the Editor’s Take videos recordedat the conference at pharmavoice.com) and it will be the focusof the upcoming 4th Annual Comparative EffectivenessResearch Summit to be held in Philadelphia this November.
And so it is with this issue aswell,which is not entirely by happenstance.As thismonth’sForum outlines, CER is going to have a huge impact on every stakeholder in healthcaredelivery andwill require everyone to take amuchbroader viewof the healthcare system.Inbrief,comparativeeffectivenessdataaregearedbroadly tomultipledecision-makers topro-vide real-worldevidenceof theoutcomesof various treatments.Forphysicians,CER is goingto provide the ability to analyze treatment choices and pick what’s best for their individualpatients. For patients, it’s going to provide them with more information that can help settheir expectations for their treatment. For payers, comparative effectiveness will providesupport for decision-making about product access and formulary placement that is basedon real-world outcomes. (Please turn to the Forum in this issue, for more information.)
As a result of comparative effectiveness,thepharmaceutical businessmodelwill need tochange. According to IMS Health, a more focused effort, or niche model, will address notonlywhat patient populations to target butwhat populations not to target.SydneyClark ofIMSsays companieswill needmoredata toproveclinical andeconomicvalueof theirdrugs,anddecision-makingwill becomemore complicated.Pharmacompanieswill need tomakethese tough decisions earlier on in the process so they have the data to convince stake-holders that their drug will be differentiated in the marketplace. (To read more about theemerging nichemodel,please turn to the article on Nichebusters vs.Blockbusters).
The pressure of comparative effectiveness will also have an impact on the discoverypipeline,says Gil Bashe ofMakovsky +Company.As government agencies require proof ofcomparative effectiveness before awarding any government reimbursement, companieswill think twice about what types of drugs to bring to market. In the future, he says bigpharma will take on a mass-market disease only if it can provide a big step forward interms of treatment solutions.
This sentiment is echoed by the subject of this month’s industry bio, Dr. Leon Smith,who has been practicing medicine for more than 60 years and is a pioneer in infectiousdisease. One of his greatest concerns is a dearth of research into new drugs, particularlyantibiotics in the wake of gram-negative resistance to existing antibiotics. (To read moreabout his inspiring career, please turn to the feature story The Age of Excellence.)
As CER becomes more established and gains acceptance in the United States, thealready astronomical cost of drugdevelopment is likely to continue to increasedue to theneed for ever larger studies with potentially longer duration to demonstrate superiorityin end points.As Ogilvy CommonHealth thought leaders outline in their VIEW onMed Ed— Comparative Effectiveness Research:Watch andWorry or Weigh In and Leverage? —justification for healthcare choices should include effectiveness, safety, and conveniencefor an individual patient, in addition to cost. As such, med ed groups will have a greatopportunity to partner with manufacturers to educate decision-makers and the generalpublic about the nuanced value of CER. (To read more about the impact of CER on thissector, please reference the VIEW onMed Ed.)
Where CER will eventually take us is anybody’s best guess, but the ride will no doubtbe interesting.
Com
parativeeffectiveness
LETTER from the editor
PUBLISHER Lisa BanketEDITOR Taren Grom
CREATIVE DIRECTOR Marah Walsh
MANAGING EDITORDenise MyshkoSENIOR EDITORRobin Robinson
FEATURES EDITORKim Ribbink
CONTRIBUTING EDITORCarolyn Gretton
DESIGN ASSOCIATEAriel Medel
NATIONAL ACCOUNT MANAGERCathy Tracy
CIRCULATION ASSISTANTKathy Deiuliis
Copyright 2010by PharmaLinx LLC, Titusville, NJ
Printed in the U.S.A.Volume Ten, Number Eight
PharmaVOICE (ISSN: 1932961X) is published monthlyexcept joint issues in July/Aug. and Nov./Dec., byPharmaLinx LLC, P.O. Box 327, Titusville, NJ 08560.Periodicals postage paid at Titusville, NJ 08560 and addi-tional mailing offices.
Postmaster: Send address changes to PharmaVOICE,P.O. Box 292345, Kettering, OH 45429-0345.
PharmaVOICE Coverage and Distribution:Domestic subscriptions are available at $190 for oneyear (10 issues). Foreign subscriptions: 10 issuesUS$360. Contact PharmaVOICE at P.O. Box 327,Titusville, NJ 08560. Call us at 609.730.0196 or FAX yourorder to 609.730.0197.
Contributions: PharmaVOICE is not responsible forunsolicited contributions of any type. Unless otherwiseagreed in writing, PharmaVOICE retains all rights onmaterial published in PharmaVOICE for a period of sixmonths after publication and reprint rights after thatperiod expires. E-mail: [email protected].
Change of address: Please allow sixweeks for a changeof address. Send your new address along with your sub-scription label to PharmaVOICE, P.O. Box 292345, Kettering,OH 45429-0345. Call us at 800.607.4410 or FAX your changeto 937.890.0221. E-mail: [email protected].
IMPORTANT NOTICE: The post office will not forwardcopies of this magazine. PharmaVOICE is not respon-sible for replacing undelivered copies due to lack of orlate notification of address change.
Advertising in PharmaVOICE: To advertise in Pharma-VOICE please contact our Advertising Department atP.O. Box 327, Titusville, NJ 08560, or telephone us at609.730.0196. E-mail: [email protected].
THE FORUM FOR THE INDUSTRY EXECUTIVE
Volume 10 • Number 8
Send your letters to [email protected] include your name, title, company, and busi-ness phone number. Letters chosen for publicationmay be edited for length and clarity. All submissionsbecome the property of PharmaLinx LLC.
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