AccessMonitor™
Inform and educate.
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AccessMonitor™ is our bi-weekly intelligence newsletter helping make sense of current development impacting pricing, reimbursement and access of innovative drugs in key markets.
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AccessMonitor™ Newsletter Examples
Medicare Part B and Most-Favored Nation Model Explained
On November 20, 2020, the CMS issued an interim final rule (IFR) to test Part B reimbursement based on International Reference Pricing (IRP) coined “Most Favored Nation” demonstration model (MFN Model). IRP proposals like the MFN model can have significant implications on pricing both here in the US and globally, which we plan to discuss more in subsequent issues.
On November 20, 2020, the CMS issued an interim final rule (IFR) to test Part B reimbursement based on International Reference Pricing (IRP) coined “Most Favored Nation” demonstration model (MFN Model). IRP proposals like the MFN model can have significant implications on pricing both here in the US and globally, which we plan to discuss more in subsequent issues.
The Great Rebate Debate – The Anti-Rebate Rule for Medicare Part D
In the US, the rebates paid to Pharmacy Benefit Managers (PBMs) have come under scrutiny. The recent amendment to the discount safe harbor under the Anti-Kickback Statute (“AKS”) specifically targets the rebates paid between drug manufacturers and PBMs. To fully appreciate the issue, we will take a closer look at the role played by PBMs in the US pharmaceutical supply chain, the benefit design and administration of Medicare Part D, and the rationale and design of the anti-rebate rule and related new safe harbors.
In the US, the rebates paid to Pharmacy Benefit Managers (PBMs) have come under scrutiny. The recent amendment to the discount safe harbor under the Anti-Kickback Statute (“AKS”) specifically targets the rebates paid between drug manufacturers and PBMs. To fully appreciate the issue, we will take a closer look at the role played by PBMs in the US pharmaceutical supply chain, the benefit design and administration of Medicare Part D, and the rationale and design of the anti-rebate rule and related new safe harbors.
Pricing and Reimbursement of Innovative Drugs in China – A Snapshot of Recent Development
China is at a critical stage, as it moves towards its goal of evolving from a generic producer to a pharmaceutical innovator. Pharma companies from Europe, Japan, and the United States will need to decide quickly whether, how, and to what extent they should participate in China’s therapeutic and innovation ecosystems. This newsletter provides a snap shot of recent development across regulatory, pricing, reimbursement and HTA impacting market access of innovative drugs in China.
China is at a critical stage, as it moves towards its goal of evolving from a generic producer to a pharmaceutical innovator. Pharma companies from Europe, Japan, and the United States will need to decide quickly whether, how, and to what extent they should participate in China’s therapeutic and innovation ecosystems. This newsletter provides a snap shot of recent development across regulatory, pricing, reimbursement and HTA impacting market access of innovative drugs in China.
Preparing for ICER Reviews - Understanding ICER Value Assessment Framework
Given the rising influence of ICER, it is important for life sciences leaders across clinical, medical affairs and commercial to better understand ICER’s methods and processes in order to adequately manage the potential exposure and take advantage of the opportunity associated with a potential ICER review. In this newsletter, we will focus on helping broader non-HEOR audiences better under the core elements of ICER value assessment framework. In the next issue, we will focus on ICER review processes and how can manufacturers better prepare for an ICER review.
Given the rising influence of ICER, it is important for life sciences leaders across clinical, medical affairs and commercial to better understand ICER’s methods and processes in order to adequately manage the potential exposure and take advantage of the opportunity associated with a potential ICER review. In this newsletter, we will focus on helping broader non-HEOR audiences better under the core elements of ICER value assessment framework. In the next issue, we will focus on ICER review processes and how can manufacturers better prepare for an ICER review.
eCourses
Making the Case for Product Value – Understanding Health Care Decision-Making
This eCourse introduces key concepts pertaining to "value judgement" in health care decision-making at central, local and patient levels. Examples are also drawn from the US, Europe and Emerging markets to highlight regional/local heterogeneity when it comes to value assessment. Implications on market entry, value proposition, evidence strategy and human capital development are discussed.
This eCourse introduces key concepts pertaining to "value judgement" in health care decision-making at central, local and patient levels. Examples are also drawn from the US, Europe and Emerging markets to highlight regional/local heterogeneity when it comes to value assessment. Implications on market entry, value proposition, evidence strategy and human capital development are discussed.