The OBR Blog

October 13, 2015 - 09:10 am Posted in Featured comments0 Comments

by Gena Cook, CEO, Navigating Cancer

Last week, the road ahead for healthcare technology received a flurry of attention, as CMS and the Office of the National Coordinator for Health Information Technology (ONC) released, in one day, an updated version of nearly every document relevant to the healthcare technology sector: Final rules for Stage 3, Final rules for the 2015 EHR certification criteria and the Final version of  the interoperability roadmap from the Office of the National Coordinator for Health Information Technology (ONC). As part of these announcements, CMS included a 60-day public comment period to inform future policy developments, in particular with regard to implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). And one week prior, CMS put out a request for public comments on the MACRA provisions for the Merit-based Incentive Payment System (MIPS), Alternative Payment Models (APMs), and physician-focused payment models (PFPMs).

As our understanding of this whirlwind of information takes shape, we are encouraged to see that the one thing that will truly move the needle on interoperability will now be a requirement in Stage 3: application program interfaces (APIs).

An API is a set of programming instructions that allows two software programs to communicate with each other. According to the recently-released Stage 3 rules, access to health information through an API is one of the basic actions that a patient should be able to take. For patients, this means the ability to engage in their personal health information via the program of their choosing. For providers, aside from the obvious advantage of no longer being limited to only a fragment of their patient’s actual EHR, this means the opportunity to add-on the modular solutions needed to demonstrate better outcomes and meet the requirements of Alternative Payment Models (APMs) such as Chronic Care Management or the upcoming Oncology Care Model.

But this is only what it means, in theory. As a modular, EHR-agnostic health IT vendor, with boots on the ground in the struggle for interoperability, we know that the devil is in the details of how interoperability is defined.

From our experience, what we have learned is that practices are being made to invest considerable time and energy into getting their current EHR vendors to allow interoperability with other vendors. And if they are not careful during the contracting process to ensure that protective language around interoperability be included, practices find themselves subject to information blocking. Some EHR companies have flat out refused to interface with our application, even with signed contracts in place from healthcare professionals. Just as this restricts patients who want to access their electronic health information to the use of suboptimal products today, it impedes practices that want to meet the requirements of new APMs sooner instead of later.

As described in the Report to Congress on Health Information Blocking, submitted by ONC in April of this year,  economic and market conditions have resulted in business incentives for some entities to exercise control over electronic health information in ways that unreasonably limit its availability and use. And in the Senate HELP Committee hearings on October 1st, ranking member Patty Murray (D-WA) said, “We need to prioritize standards so that increasingly systems developed by different vendors and used by different doctors are actually able to speak to each other. These standards would not only support important research, but they would also cut down the amount of time providers spend on administrative tasks and allow them to focus resources on providing care.”

Within a short timespan, an individual diagnosed with cancer will interact with multiple care providers. Cancer patients may be seen by their primary care doctor, surgeon, radiation oncologist, medical oncologist and potentially others. We frequently hear from patients who are frustrated by the need to use multiple patient portals or online systems to access their disparate health information – sometimes even within the same health system. While even healthy individuals are challenged to remember multiple logins and product interfaces, cancer patients newly diagnosed and/or in the midst of intensive therapies and subsequent side effects can find it especially difficult to recall and navigate multiple systems of varying designs.

So, our response to the new regulations that CMS just introduced is this: The API requirement is a great start. Now, specifications around API standardization need to be clearer and tougher. Without this clarity, vendors will be able to create APIs that allow them to check the box but that aren’t actually useful.

Through the HITECH Act, the federal government has spent more than $30B in EHR meaningful use incentive payments to hospitals and healthcare professionals. But HITECH failed to mandate that EHRs interoperate with other technology solutions. Thus, federal money that was intended to foster an interconnected web of better healthcare delivery instead subsidized the creation of “information silos”: new and formidable hurdles to true patient engagement and care coordination. With the MACRA, congress took a first step by stating that doctors and hospitals that receive EHR bonus payments cannot deliberately block the sharing of information. But these requirements need to hold EHR vendors accountable, not providers.

We are encouraged by the recent introduction of the bipartisan TRUST IT Act of 2015, also announced on October 6th, which is designed to bring accountability and transparency to health IT vendors insofar as interoperability.

Now is the time to get the specifications right, and finally realize the promise of health IT.

To achieve the healthcare transformation that will lead to better outcomes and greater patient satisfaction at economically-sustainable costs, physician practices and hospitals will need more than just the digitization of their clinic workflow that we have now; they will need innovative technologies that truly engage patients and manage high-risk patient populations relative to nationwide benchmarks. API standardization is a landmark opportunity to open up the health IT marketplace and dramatically improve the experience for cancer patients and everyone involved in their care.

October 06, 2015 - 10:10 am Posted in Featured comments0 Comments

By: Cory Lewis, Ph.D.

Immunotherapy is shining through in the crowded space that is oncology, over 6,000 oncology drugs are in development with more than 2,400 different mechanisms of action (MOAs).  Immunotherapies have started to enter the mainstream, with many headlines touting immunotherapy as the Holy Grail of cancer treatment. The immunotherapy market includes more than 75 drugs in development for oncology. The race is now on for the next FDA-approved immunotherapy in cancer as well as expanded indications for the approved immunotherapies, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo and Yervoy.

Kantar Health’s newly developed CancerLandscape™ platform identified eight immunotherapy drugs in Phase 3 clinical trials in the U.S., with 13 in Phase 2 and 17 in Phase 1; 41 drugs that target PD-1 alone are in various stages of development, many in preclinical development that may never make it to clinical trials. Given the positive data and recent approvals, companies are trying to expand immunotherapies to other indications. Just looking at Keytruda (Merck & Co.), Opdivo (BMS), atezolizumab (Roche), and Yervoy (BMS) more than 422 trials are currently ongoing. This equates to more than 80,350 patients participating in trials in over 60 different tumor types. Add on top of this, newer target indications that appear almost daily.

Immunotherapies could completely change treatment paradigms within a tumor. In melanoma, for example, the best option before immunotherapy was interleukin-2, which had an only 6% complete response rate1 with a very large side-effect profile. The level of unmet need was high, and Yervoy was able to reduce the risk of death by 32% in these patients. Recently, Opdivo showed an overall response rate of 32% in advanced melanoma patients and a one-year survival rate of 73%.2,3 In an indication with very few options and dismal outcomes, immunotherapy is allowing patients to live longer.

Not only are immunotherapies improving clinical outcomes, they also show the potential to affect management of cancer patients in other areas. With immunotherapies moving further up in lines of therapies and quickly becoming the go-to option over chemotherapies, what will happen to the supportive care market? Supportive care drugs used to combat nasty side effects of chemotherapy could see a shrinking market as patients move to immunotherapies with fewer (or at least different) side effects. For example, some supportive care drugs are aimed at neutropenia, but the current approved immunotherapy drugs don’t show a significant amount of neutropenia, and as immunotherapies become more ubiquitous the supportive care market for neutropenia in cancer could shrink.

  • How will immunotherapies change biomarker testing? Specifically, in melanoma, immunotherapy is moving earlier within the treatment paradigm, and treatments are efficacious regardless of BRAF. Will patients still need BRAF testing? If immunotherapy becomes standard of care in first- and second-line in melanoma, where does BRAF testing fit in?
  • What about histology? Immunotherapies in lung cancer seem equally effective in squamous and non-squamous subsets. If immunotherapies become the major treatment in lung cancer does it become necessary to separate the two by histology? Immunotherapy has the ability to not only completely shift a treatment paradigm within a tumor but also to affect other markets and possibly how patients are diagnosed.

Time will tell how immunotherapies will shape treatment paradigms. However, treatments that powerful have caught the eyes of most companies. According to an in-depth analysis using our CancerLandscape™ platform, of more than 6,000 oncology drugs in development, 77 companies have immunotherapy drugs in their pipelines. Not only is the number of companies with immunotherapy drugs growing but so is the number of clinical trials with existing immunotherapies. Keeping track of who owns which drug and in which indication has become a difficult task with what seems to be a different licensing deal or acquisition every day as companies jockey to have the most promising immuno-oncology drug.

CTLA4 and PD-1 have been shown to work as targets in several indications. Now we are waiting to see what other indications these targets will work in. The science predicts there may only be a few (those tumors with high tumor burden), but we will have to wait on the data from clinical trials to see if this holds true. Of the new targets on the horizon, what will be next: OX40, LAG-3 or second-generation immuno-oncology agents such as cyclic dinucleotides directed toward the stimulator of interferon genes receptor (STING)? These second-generation compounds provide many more possibilities to investigate and many indications to investigate them in. Agents designed to target natural killer cells and macrophages are in early stages and a new take on immunotherapy drugs in cancer. Will these be able to match the PD-1 data? It will be a fun ride in which some are sure to rise to the top while others may be geared toward niche patient populations. One thing is for sure: immunotherapy will have a long-lasting effect on oncology pipelines.

References:

1. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000 Feb; 6 suppl (1):S11-4.

2. Bristol-Myers Squibb Company. (2014). Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.

3. Bristol-Myers Squibb Company. (2015). Press release June 19. Princeton, NJ: Bristol-Myers Squibb Company.

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