본문영역
해외 램시마 런칭 관련 글이네여~~
100milll
2016/11/22 00:19 (223.33.***.27)
댓글 4개 조회 4,998 추천 16 반대 1
Home About AIS Contact AIS Customer Service Advertising & Sponsorships
My Account My Cart Log In
Search
AISHealth.com
All-New 2016 Edition of AIS's Directory of Health Plans Is Shipping Now!
Upcoming Webinar - Nov 28, 2016
Using Telehealth to Expand Networks and Deliver Quality Care: Case Studies From Molina and Capital…
Already a member? Log in
MarketPlace
AIS Blogs
E-Newsletters
Search
Renewal Center
Advertising & Sponsorships
Archive › How Should Payers Be Preparing For Biosimilar Remicade Launch?
Featured Health Business Daily Story, Nov. 21, 2016
How Should Payers Be Preparing For Biosimilar Remicade Launch?
Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, specialty pharmacies, pharma companies, providers and employers contain costs and improve outcomes related to high-cost specialty products. Sign up for an $84 two-month trial subscription today.
By Angela Maas, Managing Editor
November 2016Volume 13Issue 11PrintPrint
The second FDA-approved biosimilar is set to hit the U.S. market by the end of this month. Inflectra (infliximab-dyyb) will launch at a 15% discount to the wholesale acquisition cost of Janssen Biotech, Inc.’s reference drug Remicade (infliximab), according to Pfizer Inc., which will market the biosimilar in the U.S. While that discount may not be as much as industry experts had expected, the drug still should offer some savings.
In this year’s Magellan Rx Management Medical Pharmacy Trend Report, Remicade ranks No. 1 among commercial plans’ top medical benefit drugs by allowed amount per member per month and cost per patient. Express Scripts Holding Co. has estimated that a biosimilar version of Remicade could produce $17 billion in savings over its first decade on the U.S. market. The estimate assumes a 30% discount in price for the biosimilar and use by 30% of patients new to therapy rather than people switching over from Remicade.
The FDA approved Inflectra April 5 to treat moderately to severely active Crohn’s disease in adults and children, moderately to severely active ulcerative colitis in adults, moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and chronic severe plaque psoriasis (SPN 4/16, p. 1).
Specialty Pharmacy News
Josh Golden, area senior vice president for Solid Benefit Guidance, tells SPN that “there are a number of things that payers should be doing to prepare for the launch of this product. The first step is to confirm that their delegated P&T [i.e., pharmacy and therapeutics] committee has conducted a clinical review of Inflectra, to determine how best to cover and position this drug relative to other biologics with similar indications. Appropriate coverage criteria should be considered, to ensure safe and cost-effective use.”
Payers should be “evaluating Inflectra’s rather limited economic and clinical data…to understand in what cases it makes sense to put it ahead of Janssen’s product,” says Mike Kuchenreuther, Ph.D., a research analyst at Numerof and Associates. They should “also look at the real-world evidence from overseas.…This can inform decision making.”
In addition, Golden says, “It’s also critically important for payers to scrutinize their vendor contracts to gain a clear understanding of how biosimilar rebates are accounted for. Unlike oral generics, many biosimilars and follow-on biologics can generate significant rebates. Yet many contracts are silent on how these dollars should be handled — or worse, they exclude biosimilars from the vendor’s rebate pass-through commitments. Finally, payers should make efforts to educate physicians and plan members, to encourage the acceptance and adoption of biosimilars as viable, cost-effective treatment options.”
Products Also Should Be ‘Market Similar’
Kuchenreuther points to the idea of Inflectra “not just being a biosimilar but making sure the product is market similar.” He explains that Janssen has “plenty of value-added programs,” such as financial-assistance programs. Biosimilar manufacturers, he tells SPN, “need to ensure…they have similar services to be able to compete on these fronts as well,” for example in educational support for patients and providers and drug-distribution strategies. Payers will “want to educate patients and physicians as much as they can.” If these kinds of strategies are in place, “payers, I think, are going to be able to strike similar deals” with biosimilar companies as they have with innovator product manufacturers.
Noting that Inflectra will come to market with a price tag that’s a 15% discount off Remicade’s, Kuchenreuther points out that “if you look back one year ago, Janssen’s price for Remicade was 15% less than it is now.” If manufacturers continue to be able to consistently raise prices for their drugs, payers are likely to want biosimilars to drive their prices much lower than a 15% discount. And payers “are contracting with Janssen already” on Remicade.
Although Kuchenreuther says he thinks most payers have already done this, he says that payers will want to have “processes in place around P&T committees” as far as how they review biosimilars, including the “right questions” to ask about them. “Payers really need streamlined ways of conducting these reviews.”
Having a biosimilar Remicade is important to various stakeholders for different reasons, says Kuchenreuther. Remicade had about $4.5 billion in sales last year, and competition could help pick up some of those sales. “Payers are getting very good at playing drugs off one another,” he points out. They find the idea of having competition for these high-cost drugs “attractive; payers are excited for it.”
“A single dose of Remicade can cost from $1,300 to $2,500,” says Stephen Cichy, founder and managing director of Monarch Specialty Group, LLC, with the number of vials varying due to the patient’s weight.
The patient perspective “could go one of two ways,” Kuchenreuther says. On the one hand, “the idea of biosimilars, of a cheaper alternative” is attractive because of its “potential to reduce costs. But there are financial-assistance programs for biologics,” and when “Inflectra comes to market, I’m not sure if the programs will be structured the same way and be as robust.”
Anti-Inflammatories Dominate Biosimilar Arena
Three of the four FDA-approved biosimilars are in the anti-inflammatory class. In addition to Inflectra, the agency approved Erelzi (etanercept-szzs), a biosimilar Enbrel (etanercept), in August (SPN 9/16, p. 7), and Amjevita (adalimumab-atto), a biosimilar Humira (adalimumab), in late September (SPN 10/16, p. 6). This, Kuchenreuther says, is “very noteworthy…when you consider that anti-inflammatory biologics hold the largest share” in terms of spend among biologics, at about 50%. Conditions such as “lupus, celiac disease, psoriasis, inflammatory bowel disease and rheumatoid arthritis are all within the group of anti-inflammatories.” These, he notes, “are more niche areas,” unlike conditions such as diabetes and cardiovascular conditions, and there’s “not a whole lot of competition. This is a hospitable environment for biosimilars in the eyes of payers.”
Having three biosimilars “is a significant development for the anti-inflammatory drug class,” says Orestis Mavroudis-Chocholis, director of biosimilars at Decision Resources Group. “Payers are excited…because of the potential cost savings, but they are not able to reap the benefits yet.” When they will be able to do that is the big question, he says, as multiple patent infringement lawsuits have stalled biosimilars’ launches (SPN 9/16, p. 9). But “when they do launch, the impact will be massive,” he tells SPN, noting that Humira, Enbrel and Remicade had combined 2015 U.S. sales of $16 billion. “This translates to big dollars…if you’re talking about a 10% discount.” Those savings could create a “$1.5 billion or $1.6 billion space in the budget where payers can reimburse other drugs and fund other areas of treatment.”
With CVS Health and UnitedHealthcare already preferring the biosimilar Zarxio (filgrastim-sndz) over reference product Neupogen (filgrastim) (SPN 8/16, p. 1), other companies likely will begin taking similar steps, says Mavroudis-Chocholis. “There will be a push for biosimilar use to maximize cost savings.” And with the FDA’s recent contention that it expects to issue proposed guidance around interchangeability by the end of this year, “We’ll probably start seeing a little movement toward switching” with those guidelines, he says.
The relatively large number of biosimilar anti-inflammatories is likely due in part to how profitable the innovator products have been, says Kuchenreuther. “The potential for sales is a key driver.…This is part of the reason why we’re seeing major global pharmaceutical companies getting involved” with biosimilars.
The anti-inflammatory space “is a lucrative market,” agrees Mavroudis-Chocholis. “There is space for many biosimilar companies to compete.…Even a small slice of the pie means considerable dollars.”
In addition, “patent expiration plays a role,” Kuchenreuther tells SPN. However, “some manufacturers are trying to bring biosimilars to market before” the reference drugs’ patents expire, “so this is not as big a factor.”
So when could we see the other two anti-inflammatories on the U.S. market? Mavroudis-Chocholis estimates that Amjevita could launch in the first or second quarter of 2017, after manufacturer Amgen Inc. has waited 180 days after FDA approval. Erelzi “could launch early next year,” but Enbrel has “two patents that run to 2028 and 2029, so it depends on how successful” Erelzi manufacturer Sandoz Inc. is in its patent battle with Amgen. Mavroudis-Chocholis points out that the Enbrel patents “have been invalidated in Europe, but if they hold in the U.S., we will not see Erelzi until the end of the next decade.”
“It all comes down to patent litigation and how aggressive companies are,” he maintains. “Unless there is an injunction saying they can’t launch,” biosimilars can launch at risk six months after FDA approval, meaning that their manufacturers would be on the hook for treble damages if they are found to have infringed upon the reference drug’s patent. “It depends on how comfortable they are with their litigation strategy and the patents, and how aggressive they want to be.”
ⓒ 2016 by Atlantic Information Services, Inc. All Rights Reserved.
At The AIS Marketplace — Specialty Pharmacy Trends and Strategies covers the most relevant topics in the specialty pharmacy arena, with details on the latest trends in: biosimilars; hepatitis C management; management of PCSK9 inhibitors; cost-control tactics such as formulary exclusions and placement; oncology management; specialty benefit design for commercial health plans; value-based specialty pharmacy initiatives; personalized medicine; the specialty pharmacy pipeline and other new products; and more. Click here for more information and to order the all-new 2016-2017 edition today!
It's quick and easy to sign up for FREE access to AISHealth.com!
Why do I need to register?
Subscriber Services
Specialty Pharmacy News Home Page
Latest Issue
Back Issue Archives
Search Specialty Pharmacy News Articles
Quarterly Survey Results
Recent E-Alerts
From the Editor: Archive
Your Subscription
Contact Customer Service
More from Specialty Pharmacy News
MedPAC Recommends Dramatic Part D Proposals in Latest Report
Outlook 2016: As Patents Expire, Payers Are Bullish on Price-Reducing Potential of Biosimilars (with Table: Biosimilars Could Provide an Offset to Specialty Inflation)
PhRMA: Hundreds of Drugs Are in Development for Orphan Diseases
Generic Gleevec Should Lessen Costs for Rare but Costly CML
First DMD Drug Will Cost About $300,000, Be New Therapy for Specialty Pharmacies
Featured Pharmacy Benefit Management Products
12 PBM Contracting Pitfalls Health Plans Should Avoid
Specialty Pharmacy Trends and Strategies: 2016-2017 Edition
Specialty Pharmacy News
Drug Benefit News
Visit the MarketPlace
Resources for Paid Subscribers
AIS's Value-Based Care News (Formerly ACO Business News)
The AIS Report on Blue Cross and Blue Shield Plans
Drug Benefit News
Health Plan Week
Inside Health Insurance Exchanges
Medicare Advantage News
Report on Medicare Compliance
Report on Patient Privacy
Specialty Pharmacy News
Report on Research Compliance
Not a Paid Subscriber?
Check out all of the benefits, sample issues & more!
Let AIS Sponsor and Manage Your Organization’s Webinar
PBM Formulary Exclusions: Bottom-Line Strategies for Health Plans
Other Free Resources
People on the Move
Government and Industry Links
The AIS Bookshelf
Health Business Data
Customer Service
Customer Assistance
Renew Your Subscription
FAQs
Four Powerful Training Modules on Oncology Therapies, Utilization Management, Genetic Testing & Specialty Pharmacy
Specialty Pharmacy News
Search More Than 10,000 Health Care Business Stories Back to 2008!
Marketplace About AIS Contact AIS Press Releases Customer Service Renew Subscription Advertising & Sponsorships FAQs My Cart
Atlantic Information Services, Inc. - 1100 17th Street NW, Suite 300, Washington, DC 20036 - 800-521-4323
Copyright ⓒ 2016 Atlantic Information Services, Inc. All Rights Reserved.
SitemapPrivacy PolicyBack to Top
Find AISHealth.com on Facebook
My Account My Cart Log In
Search
AISHealth.com
All-New 2016 Edition of AIS's Directory of Health Plans Is Shipping Now!
Upcoming Webinar - Nov 28, 2016
Using Telehealth to Expand Networks and Deliver Quality Care: Case Studies From Molina and Capital…
Already a member? Log in
MarketPlace
AIS Blogs
E-Newsletters
Search
Renewal Center
Advertising & Sponsorships
Archive › How Should Payers Be Preparing For Biosimilar Remicade Launch?
Featured Health Business Daily Story, Nov. 21, 2016
How Should Payers Be Preparing For Biosimilar Remicade Launch?
Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, specialty pharmacies, pharma companies, providers and employers contain costs and improve outcomes related to high-cost specialty products. Sign up for an $84 two-month trial subscription today.
By Angela Maas, Managing Editor
November 2016Volume 13Issue 11PrintPrint
The second FDA-approved biosimilar is set to hit the U.S. market by the end of this month. Inflectra (infliximab-dyyb) will launch at a 15% discount to the wholesale acquisition cost of Janssen Biotech, Inc.’s reference drug Remicade (infliximab), according to Pfizer Inc., which will market the biosimilar in the U.S. While that discount may not be as much as industry experts had expected, the drug still should offer some savings.
In this year’s Magellan Rx Management Medical Pharmacy Trend Report, Remicade ranks No. 1 among commercial plans’ top medical benefit drugs by allowed amount per member per month and cost per patient. Express Scripts Holding Co. has estimated that a biosimilar version of Remicade could produce $17 billion in savings over its first decade on the U.S. market. The estimate assumes a 30% discount in price for the biosimilar and use by 30% of patients new to therapy rather than people switching over from Remicade.
The FDA approved Inflectra April 5 to treat moderately to severely active Crohn’s disease in adults and children, moderately to severely active ulcerative colitis in adults, moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and chronic severe plaque psoriasis (SPN 4/16, p. 1).
Specialty Pharmacy News
Josh Golden, area senior vice president for Solid Benefit Guidance, tells SPN that “there are a number of things that payers should be doing to prepare for the launch of this product. The first step is to confirm that their delegated P&T [i.e., pharmacy and therapeutics] committee has conducted a clinical review of Inflectra, to determine how best to cover and position this drug relative to other biologics with similar indications. Appropriate coverage criteria should be considered, to ensure safe and cost-effective use.”
Payers should be “evaluating Inflectra’s rather limited economic and clinical data…to understand in what cases it makes sense to put it ahead of Janssen’s product,” says Mike Kuchenreuther, Ph.D., a research analyst at Numerof and Associates. They should “also look at the real-world evidence from overseas.…This can inform decision making.”
In addition, Golden says, “It’s also critically important for payers to scrutinize their vendor contracts to gain a clear understanding of how biosimilar rebates are accounted for. Unlike oral generics, many biosimilars and follow-on biologics can generate significant rebates. Yet many contracts are silent on how these dollars should be handled — or worse, they exclude biosimilars from the vendor’s rebate pass-through commitments. Finally, payers should make efforts to educate physicians and plan members, to encourage the acceptance and adoption of biosimilars as viable, cost-effective treatment options.”
Products Also Should Be ‘Market Similar’
Kuchenreuther points to the idea of Inflectra “not just being a biosimilar but making sure the product is market similar.” He explains that Janssen has “plenty of value-added programs,” such as financial-assistance programs. Biosimilar manufacturers, he tells SPN, “need to ensure…they have similar services to be able to compete on these fronts as well,” for example in educational support for patients and providers and drug-distribution strategies. Payers will “want to educate patients and physicians as much as they can.” If these kinds of strategies are in place, “payers, I think, are going to be able to strike similar deals” with biosimilar companies as they have with innovator product manufacturers.
Noting that Inflectra will come to market with a price tag that’s a 15% discount off Remicade’s, Kuchenreuther points out that “if you look back one year ago, Janssen’s price for Remicade was 15% less than it is now.” If manufacturers continue to be able to consistently raise prices for their drugs, payers are likely to want biosimilars to drive their prices much lower than a 15% discount. And payers “are contracting with Janssen already” on Remicade.
Although Kuchenreuther says he thinks most payers have already done this, he says that payers will want to have “processes in place around P&T committees” as far as how they review biosimilars, including the “right questions” to ask about them. “Payers really need streamlined ways of conducting these reviews.”
Having a biosimilar Remicade is important to various stakeholders for different reasons, says Kuchenreuther. Remicade had about $4.5 billion in sales last year, and competition could help pick up some of those sales. “Payers are getting very good at playing drugs off one another,” he points out. They find the idea of having competition for these high-cost drugs “attractive; payers are excited for it.”
“A single dose of Remicade can cost from $1,300 to $2,500,” says Stephen Cichy, founder and managing director of Monarch Specialty Group, LLC, with the number of vials varying due to the patient’s weight.
The patient perspective “could go one of two ways,” Kuchenreuther says. On the one hand, “the idea of biosimilars, of a cheaper alternative” is attractive because of its “potential to reduce costs. But there are financial-assistance programs for biologics,” and when “Inflectra comes to market, I’m not sure if the programs will be structured the same way and be as robust.”
Anti-Inflammatories Dominate Biosimilar Arena
Three of the four FDA-approved biosimilars are in the anti-inflammatory class. In addition to Inflectra, the agency approved Erelzi (etanercept-szzs), a biosimilar Enbrel (etanercept), in August (SPN 9/16, p. 7), and Amjevita (adalimumab-atto), a biosimilar Humira (adalimumab), in late September (SPN 10/16, p. 6). This, Kuchenreuther says, is “very noteworthy…when you consider that anti-inflammatory biologics hold the largest share” in terms of spend among biologics, at about 50%. Conditions such as “lupus, celiac disease, psoriasis, inflammatory bowel disease and rheumatoid arthritis are all within the group of anti-inflammatories.” These, he notes, “are more niche areas,” unlike conditions such as diabetes and cardiovascular conditions, and there’s “not a whole lot of competition. This is a hospitable environment for biosimilars in the eyes of payers.”
Having three biosimilars “is a significant development for the anti-inflammatory drug class,” says Orestis Mavroudis-Chocholis, director of biosimilars at Decision Resources Group. “Payers are excited…because of the potential cost savings, but they are not able to reap the benefits yet.” When they will be able to do that is the big question, he says, as multiple patent infringement lawsuits have stalled biosimilars’ launches (SPN 9/16, p. 9). But “when they do launch, the impact will be massive,” he tells SPN, noting that Humira, Enbrel and Remicade had combined 2015 U.S. sales of $16 billion. “This translates to big dollars…if you’re talking about a 10% discount.” Those savings could create a “$1.5 billion or $1.6 billion space in the budget where payers can reimburse other drugs and fund other areas of treatment.”
With CVS Health and UnitedHealthcare already preferring the biosimilar Zarxio (filgrastim-sndz) over reference product Neupogen (filgrastim) (SPN 8/16, p. 1), other companies likely will begin taking similar steps, says Mavroudis-Chocholis. “There will be a push for biosimilar use to maximize cost savings.” And with the FDA’s recent contention that it expects to issue proposed guidance around interchangeability by the end of this year, “We’ll probably start seeing a little movement toward switching” with those guidelines, he says.
The relatively large number of biosimilar anti-inflammatories is likely due in part to how profitable the innovator products have been, says Kuchenreuther. “The potential for sales is a key driver.…This is part of the reason why we’re seeing major global pharmaceutical companies getting involved” with biosimilars.
The anti-inflammatory space “is a lucrative market,” agrees Mavroudis-Chocholis. “There is space for many biosimilar companies to compete.…Even a small slice of the pie means considerable dollars.”
In addition, “patent expiration plays a role,” Kuchenreuther tells SPN. However, “some manufacturers are trying to bring biosimilars to market before” the reference drugs’ patents expire, “so this is not as big a factor.”
So when could we see the other two anti-inflammatories on the U.S. market? Mavroudis-Chocholis estimates that Amjevita could launch in the first or second quarter of 2017, after manufacturer Amgen Inc. has waited 180 days after FDA approval. Erelzi “could launch early next year,” but Enbrel has “two patents that run to 2028 and 2029, so it depends on how successful” Erelzi manufacturer Sandoz Inc. is in its patent battle with Amgen. Mavroudis-Chocholis points out that the Enbrel patents “have been invalidated in Europe, but if they hold in the U.S., we will not see Erelzi until the end of the next decade.”
“It all comes down to patent litigation and how aggressive companies are,” he maintains. “Unless there is an injunction saying they can’t launch,” biosimilars can launch at risk six months after FDA approval, meaning that their manufacturers would be on the hook for treble damages if they are found to have infringed upon the reference drug’s patent. “It depends on how comfortable they are with their litigation strategy and the patents, and how aggressive they want to be.”
ⓒ 2016 by Atlantic Information Services, Inc. All Rights Reserved.
At The AIS Marketplace — Specialty Pharmacy Trends and Strategies covers the most relevant topics in the specialty pharmacy arena, with details on the latest trends in: biosimilars; hepatitis C management; management of PCSK9 inhibitors; cost-control tactics such as formulary exclusions and placement; oncology management; specialty benefit design for commercial health plans; value-based specialty pharmacy initiatives; personalized medicine; the specialty pharmacy pipeline and other new products; and more. Click here for more information and to order the all-new 2016-2017 edition today!
It's quick and easy to sign up for FREE access to AISHealth.com!
Why do I need to register?
Subscriber Services
Specialty Pharmacy News Home Page
Latest Issue
Back Issue Archives
Search Specialty Pharmacy News Articles
Quarterly Survey Results
Recent E-Alerts
From the Editor: Archive
Your Subscription
Contact Customer Service
More from Specialty Pharmacy News
MedPAC Recommends Dramatic Part D Proposals in Latest Report
Outlook 2016: As Patents Expire, Payers Are Bullish on Price-Reducing Potential of Biosimilars (with Table: Biosimilars Could Provide an Offset to Specialty Inflation)
PhRMA: Hundreds of Drugs Are in Development for Orphan Diseases
Generic Gleevec Should Lessen Costs for Rare but Costly CML
First DMD Drug Will Cost About $300,000, Be New Therapy for Specialty Pharmacies
Featured Pharmacy Benefit Management Products
12 PBM Contracting Pitfalls Health Plans Should Avoid
Specialty Pharmacy Trends and Strategies: 2016-2017 Edition
Specialty Pharmacy News
Drug Benefit News
Visit the MarketPlace
Resources for Paid Subscribers
AIS's Value-Based Care News (Formerly ACO Business News)
The AIS Report on Blue Cross and Blue Shield Plans
Drug Benefit News
Health Plan Week
Inside Health Insurance Exchanges
Medicare Advantage News
Report on Medicare Compliance
Report on Patient Privacy
Specialty Pharmacy News
Report on Research Compliance
Not a Paid Subscriber?
Check out all of the benefits, sample issues & more!
Let AIS Sponsor and Manage Your Organization’s Webinar
PBM Formulary Exclusions: Bottom-Line Strategies for Health Plans
Other Free Resources
People on the Move
Government and Industry Links
The AIS Bookshelf
Health Business Data
Customer Service
Customer Assistance
Renew Your Subscription
FAQs
Four Powerful Training Modules on Oncology Therapies, Utilization Management, Genetic Testing & Specialty Pharmacy
Specialty Pharmacy News
Search More Than 10,000 Health Care Business Stories Back to 2008!
Marketplace About AIS Contact AIS Press Releases Customer Service Renew Subscription Advertising & Sponsorships FAQs My Cart
Atlantic Information Services, Inc. - 1100 17th Street NW, Suite 300, Washington, DC 20036 - 800-521-4323
Copyright ⓒ 2016 Atlantic Information Services, Inc. All Rights Reserved.
SitemapPrivacy PolicyBack to Top
Find AISHealth.com on Facebook
100milll
님
관심회원수 0 쪽지보내기
작성자 최신글
작성자 최신글이 없습니다.
운영배심원 의견
신고
댓글 댓글접기 댓글펼침