Eye On Healthcare

 
Eye On Healthcare is a team of reporters which strives to provide unbiased and independent views on major healthcare  events. Our team is dedicated to identify emerging trends, analyze new clinical data and develop insights on topics that are of high importance in healthcare.  

 

Advamed Medical Devices Annual Meeting 2011

Healthcare Reform 1 Year Later: Uncertainty Is the Biggest Concern

September 26, 2011

Advamed hosted three chief executive officers (CEOs) Mr. Caroll H. Neubauer, Mr. John L. Bishop and Mr Michael A. Mussallem, and legal expert Mr. Patrick Morrisey, for a panel discussion on healthcare reform and its implications for the medical device industry. We have summarized here our key takeaways from the discussion.

 

  • The first question asked by the moderator Mr, Paul H. Keckley was "What is it that keeps you up at night?". Interestingly, all of the panelists echoed the same answer that their biggest worry is the uncertainty facing the medical device industry. They said it is not clear how the bundled payments, healthcare insurance exchanges, ACOs and some of the other aspects of healthcare reform will be implemented during next few years. 

  • Panelists said due to the uncertainty in the US market, their top priority is now to first market the products internationally and then think about the US. 

  • Adding to the concerns regarding the US market, one of the panelists added that their is almost 50% likelihood that some elements of the healthcare reform will be repealed. It was mentioned that currently there are 26 law suits related to the healthcare reform.

  • When asked if doctors and hospitals will be sharing more risk in the future, one of the panelists answered that for the future his concern is that the physician autonomy is at danger. Other panelists reiterated that current trends are forcing provides to cut costs, while also lowering the quality of care. 

  • "We are not good at measuring quality", mentioned one of the panelists. He said their is so much emphasis on cutting cost, while the trend should have been to implement consumer driven healthcare. 

  • Links

  • Advamed 2011

  • Session web page

 

 

Epilepsy

August 10, 2011

Recently IOM hosted a meeting on Epilepsy, where all top stakeholders discussed unmet need and issues facing patients with this disease. Our key thoughts are summarized below. Please contact us if you need more details.

  • While epilepsy is not known as a common disease, it is surprisingly highly prevalent with almost
    3 million Americans affected by epilepsy and seizers. The annual incidence is 300,000 for patients who have their first convulsion. So, why has this disease been ignored by big pharma and device companies? 

  • Majority of current surgical, device and drug therapies do not work in most patients. Inability to control seizers often leads to many other psychiatric, cognitive and social debilitations, which severely affect patient and their family's quality of life. 

  • Science has made major progress in uncovering novel mechanisms and pathways, but those have not yet translated into effective therapies.

  • Several panelists expressed huge concern regarding lack of evidence for safety and effectiveness of generics for epilepsy patients. "Generics" was also raised as an issue by FDA representative, who expressed that there is a strong need to understand data for generics. 

  • One presenter mentioned that it takes on average five years before an epilepsy patient sees a doctor, implying urgent need to improve diagnosis and referral process. It seems like that most patients and their families do not know that "epitomologist" exists.

  • Access to drugs was mentioned  as a major barrier. Several presenters mentioned that due to low awareness of this disease, many payers do not cover therapies, making it difficult for patients to try and find the right therapy for them.

  • Though personalized therapy is generally brought up in all discussions, in this case it was mentioned as a key thing to find most effective and efficient therapy for patients. It can often take few years before a patient is able to find the right therapy. 

 

 

Major Changes to CMS Coming Sooner Than Expected

January 3, 2011

Last month the ASN Renal Week was held in Denver, CO. This meeting is rapidly evolving as a major extravaganza, almost mirroring ASCO's annual meeting. Surprisingly not many people know that prevalence of kidney disease is almost the same as diabetes. We attended several sessions at this meeting. Here we will highlight the key things from few presentations on US Healthcare Reform and upcoming changes at CMS. 

CMS is the world's largest single healthcare payer

  • CMS is the world's largest single healthcare payer. In 2008, the total spending of Medicare and Medicaid programs crossed $800 billion mark ($469.2 billion for Medicare and $344.3 billion for Medicaid). If we combine all the publicly funded programs, the government spending crossed $1 trillion mark in 2008.

Upcoming changes to CMS

  • One major change as a result of the healthcare reform is the expansion of Medicaid. Some of the previously uninsured patients will be now covered by Medicaid program, making it larger than Medicare, in terms of number of enrollees. For 2011 budget year, Medicare will cover 48.1 million and Medicaid will cover 56.1 million beneficiaries. How will this impact you? It depends, if you are a provider or if you are a drug/device manufacturer with significant exposure to Medicare and Medicare programs. 

  • In one of the presentations, a senior executive from CMS strongly stated "We cannot take 3-4 years to implement changes, it has to be 3-6 months...and that's what we will see in coming years".

  • An interesting thing mentioned was "For the first time the President of the USA will be chairing one of the healthcare committees for quality improvement". 

  • There was lot of emphasis on "value based purchasing", community clinics, accountability care organizations (ACOs) and CMI. What are ACOs? What is CMI?

  • Some say that ACO is a new concept, others say it is the old concept of HMO, re-packaged as ACO. The real definition is not clear. It was repeatedly mentioned that ACOs are coming to us in a big way. There are some pilots which are currently on-going and will further shape this concept. There were some NEJM articles which were published recently on this topic (referenced below). 

  • Some in the audience asked if ACOs will be like Kaiser Permanente? We do not know. It supposedly is a virtual network that will enable CMS to negotiate reimbursement rates and quality metrics with a group of providers. In some ways, it sounds like the on-going healthcare reform in the UK, where they are dismantling PCTs and creating 500-1000 GP consortiums. 

  • Salaried doctors! Yes, this was mentioned as the likely trend in the future. How will this happen? It will happen slowly with payment reforms which will transform  business models. A great example is the upcoming bundling of payment of dialysis centers, which is likely to promote further consolidation among dialysis providers. How will AMA respond to it [Remember the universal coverage healthcare bill proposed in 1910-1920s and AMA's response]? It will be interesting, especially if the economy stays weak for next 10-15 years then it will be tough for lobbying groups to oppose any payment reforms. 

  • What is CMI? This is the new kid on the block. CMS has created a new center with quite a lot of funding ($10 billion over next 10 years) to develop innovative payment methods. 

 

 

AASLD 2010-Lots of Good News for Hepatitis C patients

December 2, 2010

In October this year the AASLD annual meeting was held in Boston , MA . The key highlight of this meeting was the release of clinical data for emerging novel direct acting agents (DAAs) for treatment of chronic Hepatitis C virus (HCV) infection. This year marked an important milestone as Phase III data for two late-stage drug candidates were presented at this meeting. Other highlights of this meeting were Phase 1 clinical data for new class of drugs and genomic data for IL-28B marker. Based on our attendance at this meeting we have summarized here some of the highlights. 
Two promising protease inhibitors for HCV
  • Telaprevir and boceprevir are peptidomimetic molecules which inhibit NS3-4A protease. They are in late-stages of development for treatment of chronic Hepatitis C. Their Phase III data was released at this AASLD meeting.
  • The use of these agents in combination with peginterefeon and ribavarin has shown up to 75% SVR in TN, and 30% to 85% SVR in TE genotype 1 patients.
  • This triple combination could also reduce treatment duration from current 48 weeks to 24 weeks or shorter, depending upon patient’s early viral response.
  • Based on the history of several drug launches, these two drugs would represent major advancement to the current standard of care.
Personalized medicine in HCV
  • It seems like that treatment for HCV is setting the stage for one of the best examples of personalized treatment using genomic host data. In the past, patients were tested for genotype of their virus, whether it is 1, 2, 3 or 4. From this year’s presentations it seems like that now patients need to be tested for many other types of genomic data, such as their sub-type (1a versus 1b) and IL-28B alleles. Though in early stages, these data are likely to be used for customizing therapy for individual patients.
  • Another good news for HCV patients is the possibility of shorter duration of treatment. Clinical studies with novel DAAs are showing that for almost two-third of the patients, their treatment duration can be reduced to 12 or 24 weeks, if they achieve rapid virological response (RVR). Until now, one year treatment with Peg-Interferon and ribavarin has been problematic for several patients, either due to intolerability of interferon, side effects or in-general adherence to one-year regimen. If treatment duration could be reduced to half or one-third time, it would enable many more patients to initiate and complete treatment to achieve SVR. 
  • What factor would drive personalized treatment in HCV? Testing for sub-types of HCV , IL -28B alleles and customizing based on RVR.
  • What are the challenges in personalized treatment? One challenge is the need for infrastructure to measure and collect all this data, provide individualized guidance and treatment to patients. It is estimated that ~80% of 3 million chronically infected hepatitis C patients are un-diagnosed. As more patients are diagnosed and initiate treatment it would create need for resources to provide personalized care.  
  • According to one potential treatment algorithm presented at this meeting, treatment naïve patients with IL-28B CC allele and fibrosis stages F3-4, could be treated now with Peg IFN+RBV, whereas patients with IL-28B TC/TT allele and fibrosis stages 0-2, could wait for DAAs.
One common theme at this AASLD: “IL-28B”
  • There were more than fifty studies focusing on IL-28B. This marker has gained enormous interest since last year’s meeting.
  • IL-28B is a gene that codes for Interferon lamba and it has been shown that there is strong correlation between its alleles (TT, TC or CC) and SVR with standard of care.
  • What’s new at this year’s meeting for IL-28B? One is more data from other retrospective studies showing that IL-28B alleles have strong correlation to response. In the future, IL-28B genotype testing can be potentially used to predict outcomes and hence customize regimens for various patients.
  • Are doctors using it? Interestingly, answer seems to be yes. In one session three prominent investigators mentioned that they are testing all of their patients for IL-28B genotype. Though its not clear how it will be exactly used in treatment decision making, but doctors admitted that since there is data showing its correlation to response, they have to do testing, for clinical and liability reasons. 
  • From this year’s presentation its looks like IL-28B is going to be important in the future for clinical trial design, patient stratification and clinical decision making

 
Outstanding challenges in treating Hepatitis C patients

While there are several promising therapies that are on the horizon, there are still several challenges facing treatment for HCV patients.  

  • First challenge is screening and diagnosing these patients before it is too late to treat them. At this meeting, CDC presented their proposal to screen patients based on birth-year cohort (~65% of HCV patients were born during 1945-1965). How soon and effectively we can diagnose these patients during next 2-5 years is an unknown at this stage.
  • Patient education could be a challenge, as more genomic and response data would be used to customize therapy for patients. For the near term it seems like that with telaprevir and boceprevir, patients will have high pill burden. I think it would be valuable to have patient counselors who can educate and guide HCV patients and keep them adherent on triple combinations. In HIV, patient survivors have been very successful in acting as counselors for newly diagnosed patients. I would recommend state and federal agencies and drug manufacturers to train HCV-survivors as counselors for these baby-boomers who would receive treatment during next 2-5 years. 
  • Cost of treatment: This could be an issue for low-middle income patients, especially if they have to pay 10-20% of cost for triple combination regimen.
  • Payers: Several investigators raised the issue that in the future payers might play a role in determining whether patients should continue one versus another regimen. This is especially possible for patients who do not achieve RVR and would have only 4-5% chance of achieving SVR with complete regimen. 
  • Lead in or no lead in: Two different strategies were used for Phase III clinical trial design for telaprevir and boceprevir. One used RVR with triple combination, while other used Lead-in with Peg-infereon and ribavarin, followed by triple combination. Which one is better? How do we define better? Is it based on efficacy, safety, cost, patient genotype or patient convenience?  I think in this case all of them would be important. 
  • Despite the significantly high efficacy of telaprevir and boceprevir there is still large unmet need for newer therapies in HCV. What are those areas? Well, immediate ones are:

Treatment options for genotype 1 null-responses

Treatment options for patients who would fail on new triple combinations

New therapies are needed for genotype 4 patients

Strategies to reduce pill burden with triple combination

Interferon free regimens 

 
References

 

 

 

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