Specialty Drugs: Getting What We Asked For

January 7, 2015 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Innovation, Politics, Therapeutic Substitution & Interchange / 1 Comment

The cost of so-called specialty drugs has become a major health policy issue largely because of spending projections for new medicines for chronic hepatitis C infection and cancers. Having worked on issues related to the development, approval, availability, use, and cost of medical treatments for more than 25 years, I’ve noted with concern and bemusement how cost and value issues are being discussed and presented in public debates and policy circles.

The Intense Debate About New Biopharmaceuticals Was Predictable

The introduction of significant new specialty medicines is reasonably predictable because information about biomedical research and the developmental status of new drugs and biologics is publically available from the FDA and company press releases.…

Improving Cancer Care in Medicare

May 5, 2009 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, Innovation, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange / 1 Comment

This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA). The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature. This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited. …

New Challenges for Life Sciences Companies to Communicate Value

October 16, 2008 / Michael D. Miller MD / Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Health System Reform, Information & Communications, Therapeutic Substitution & Interchange / No Comments

Life sciences companies have always faced challenges communicating the clinical and economic value of their products and services to different groups of stakeholders. These challenges arise from the technical nature of research information, the different perspectives of various groups, (e.g. clinicians, payers and patients), and marketing regulations. However, with costs continuing to rise, political, business and advocacy leaders are all agreeing that health care spending is growing out of control. Therefore, no matter who wins the White House in November, “cost containment” will be the embodiment of “change” for health care in 2009 and beyond – and the current economic downturn and expanding government deficits will only fan those flames.…

Pfizer Exiting Heart Disease Research – What about Heart Failure?

October 1, 2008 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Innovation, Quality of Care & Safety, Therapeutic Substitution & Interchange / 1 Comment

It was reported yesterday that Pfizer will stop doing research and development in heart disease, anemia and osteoporosis to concentrate in other areas such as cancer, diabetes, and immunology/inflammatory diseases.

This is interesting since Pfizer has (and had) a large number of products in heart disease, including Lipitor, and pharmaceutical companies have typically continued to do research in areas where they have had products because they have established sales people who are knowledgeable about the disease area and have relationships with clinicians in those areas. The countervailing force is that many effective medicines to treat heart conditions (like high blood pressure and high cholesterol) are available in generic forms and thus the value bar (benefit/cost ratio) that new medicines must reach to be competitive is much higher than when they competing against other non-generic medicines.…

Digesting Medical Progress

September 1, 2008 / Michael D. Miller MD / Health System Reform, Information & Communications, Innovation, Miscellaneous, Nutrition, Public Health, Therapeutic Substitution & Interchange / No Comments

One of the challenges for improving the healthcare system is creating a vision for what is achievable in a timeframe of months or years. The first step for creating such a realistic vision is to understand how progress has been made in the past.

A microcosm of such progress was described in a recent article in The Economist. This article describes advances in our understanding of stomach ailments – one of my favorite areas of biomedical progress because in the last several decades dramatic changes have occurred in our basic knowledge about this area, and so many people can relate to stomach problems.…

Changing Life Sciences Communications Environment for 2009

August 25, 2008 / Michael D. Miller MD / Comparative Effectiveness, Economics & Financing, Information & Communications, Innovation, Therapeutic Substitution & Interchange / No Comments

Cost containment is becoming an increasingly powerful force in shaping the environment for life sciences companies – as well as other parts of the healthcare system. In addition, more sophisticated tools for analyzing and demonstrating the clinical and economic value of medical treatments are making it more challenging for life sciences companies to communicate the value of their new products to all types of audiences, including clinicians, payers, patients and regulators.

These new tools and the changing environment are requiring life sciences companies to think about developing more sophisticated messages to reach these audiences. I recently recorded a short 6 minute discussion about these topics with Jeff Sandman, CEO of Hyde Park Communications – where I am also a Senior Counselor. …

Questions and Answers About Pay-For-Performance (P4P)

August 14, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Health System Reform, Information & Communications, Therapeutic Substitution & Interchange / 1 Comment

An article in the July/August Health Affairs about Massachusetts health plans implementing Pay-for-Performance (P4P) incentives for physicians raised more questions than it answered.

The study found that P4P programs from 5 private sector payers “wasn’t associated with greater improvement in quality” compared to the overall upward trend in the factors measured. But the study didn’t address some overarching questions and basic realities about P4P, such as:

How the payers P4P incentives to the physician groups was actually translated into incentives for the individual physicians – or smaller groups of physicians inside the larger groups?
How the P4P incentives compared to the other financial incentives the physicians are facing?

…

Canada’s Proposal for Subsequent Entry Biologics

April 1, 2008 / Michael D. Miller MD / Economics & Financing, FDA, Patents & IP, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange / No Comments

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

“SEBs are not ‘generic biologics'”
Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act.…

Safety, Costs and Quality of Medicines

March 25, 2008 / Michael D. Miller MD / Delivery of Healthcare, FDA, Politics, Public Health, Quality of Care & Safety, Therapeutic Substitution & Interchange / 1 Comment

I’ve been trying to figure out how to write something meaningful about the many reports over the last several months about the safety, costs and quality of medicines. I finally concluded that rather than a too lengthy blog post, a series of snapshots would create a good description of the situation – sort of like a slide show rather than a feature film:

Safety of Generic Drugs: A recent LA Times article discussed patients who had adverse reactions when switched from a brand name to a generic medicine. This article includes physicians’ experiences with several types of generic medicines, e.g. for epilepsy, depression, high blood pressure, irregular heart rhythms, and to prevent rejection of organ transplants.…

Evidence Based Medicine – NICE or Nasty?

February 27, 2008 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Economics & Financing, Federal Healthcare Reform, Politics, Therapeutic Substitution & Interchange, VA/DoD / 4 Comments

The US Medicare Payment Advisory Commission (MedPAC) recently released a report on “Creating a Center for Evidence-Based Medicine” that was prepared by an outside analysis group. Before dissecting the MedPAC report, let me just lay out some of the more controversial aspects of evidence-based medicine (EBM):

How are the results of EBM research used for coverage or payment?
Are the EBM conclusions based upon reviews of prior studies or on research done specifically for the EBM analyses?
Are the EBM conclusions relevant only for a clinical research situation, or do they reflect real-world practices?
All medical practices evolve and “best medical practices” are reflected last in textbooks…..

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Comparative Effectiveness in Healthcare Session at AAAS Meeting

February 15, 2008 / Michael D. Miller MD / Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Therapeutic Substitution & Interchange / 1 Comment

I attended the annual meeting of the American Association for the Advancement of Science today to hear a session titled “Health Economic Evaluations of Medical Technologies: Is the Cost Worth the Cure?” The topic of this session was really about comparative effectiveness of medical interventions – particularly pharmaceuticals. The panel was a substantial group of physicians and health services researchers/regulators:

Milton C. Weinstein, Harvard School of Public Health
Michael F. Drummond, University of York, United Kingdom & NICE (National Institute for Health and Clinical Excellence)
Jeffrey Kelman, Chief Medical Officer at CMS
Marc Berger, Eli Lilly
Tracy A.

…

Denial of Off-Label Medicines in Medicare Part D

February 5, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicare, Therapeutic Substitution & Interchange / No Comments

I have been helping the Medicare Rights Center (MRC) with some appeals of Medicare Part D plans denying coverage for off-label uses of FDA approved medicines. These denials are based on a very detailed provision in the 2003 Medicare Modernization Act that the Centers for Medicare and Medicaid Services (CMS) interprets to mean that Part D can only cover FDA approved medicines for off-labeled uses that are listed in at least one of three specific compendia.

I became involved with the MRC’s work on this issue because as a Congressional staff person I had helped write a 1993 law that expanded coverage for cancer treatments under Medicare Part B (that’s “B” as in ball) to specifically include off-label uses listed in the compendia OR supported by articles published in peer reviewed literature.…