In the past two weeks AdverseEvents has been invited to share our drug safety analytics and insight on two different panel discussions focused on the new hepatitis C medications. Two things really struck me about this.

First, it’s encouraging to see that the industry as a whole accepts the fundamental premise that there is a gap when it comes to real-world, independent comparative safety research. Second, not only do they recognize the gap, they are minding it by asking organizations like ours to participate in the discussion.


Related Read: Post Approval Adverse Events... What's the Real World Impact? [INFOGRAPHIC]


In the past, it was easy for health industry insiders to say that real-world drug safety data was either unavailable or unreliable, so post-marketing safety issues rarely factored into formulary/prescribing decisions. It is satisfying to observe that these same insiders now see that such information is both available and reliable as a result of the work AdverseEvents has undertaken over the past four years.


Related Read: RxOutcome - A New Paradigm in Drug Safety


The first panel I participated in was hosted by The American Journal of Managed Care (AJMC) and I was joined by the CMO of Express Scripts, Dr. Steven Miller; Ed Cohen, PharmD, FAPhA, Senior Clinical Director, Walgreens; and Matthew D. Harman, PharmD, MPH, Director, Clinical Pharmacy Strategies, Employers Health.

It was a great discussion and included Dr. Miller’s outline of Express Scripts’ rationale for choosing AbbVie’s Vikiera Pak. While we don’t agree with the PBM’s ultimate choice, or exclusivity deals in general, it was interesting to hear about his organization’s decision process.

AJMC has posted the discussion in thirteen distinct segments here.

Of particular interest are segments 7 and 8:

Segment 7: Comparing Known Adverse Events of HCV Drugs
“A recent report from Adverse Events suggests that based on the pre-approval adverse events listed for Viekira Pak that Harvoni and Sovaldi may be safer, according to Keith B. Hoffman, PhD, VP.”

Segment 8: Putting Patient Safety and Outcomes First in HCV Decisions
“Although the Adverse Events report found Viekira Pak may not be as safe as Sovaldi and Harvoni, Express Scripts complimented that information with its own real-world data from 85 million patients, before choosing Viekira Pak. Express Scripts found that patients getting Sovaldi with ribavirin only had a 3% discontinuation rate due to the ribavirin. In addition, the company looked at how many hepatitis C patients were on other drugs that could result in potential drug-drug interactions. He added that they use their own research, reports from companies like Adverse Events, and data from the FDA to make formulary decision."

The comments in segment 8 were fascinating. It was clear that Express Scripts did their homework before making their exclusivity choice and I commend such efforts. In my opinion, however, the industry in general still tends to be motivated primarily by immediate price savings and does not put enough focus on long term, downstream costs of side effects and poor patient outcomes.

The second panel discussion I participated in was held in NYC at the Bloomberg State of Healthcare Conference on February 13th. The other panelists were: Dr. Hillel Tobias, NYU; Dr. Robert S. Brown, New York-Presbyterian Hospital/Columbia; and Dr. M. Isabel Fiel, Mt. Sinai. The focus of the discussion was more from an investment perspective. It is clear that the new generation of drugs for hepatitis C are dramatically safer and more effective than older interferon-based treatments and it appears that Sovaldi/Harvoni may end up having a better post-marketing safety profile than the other new medications, which bodes well for Gilead’s market share battle. But what was also clear, is that the financial industry is clearly concerned about the effects of very expensive drugs on an already heavily burdened healthcare system, and that the need for clarity and insight into efficacy, safety and the downstream costs of drugs (including readmissions, hospitalizations etc.) is going to be a determining factor into the overall success of individual drugs on the market.

Again, it was great to have a seat at the table and contribute to the discussions. With more specialty drugs on the horizon such as the cholesterol-lowering PCSK-9’s that are already creating controversy we are confident that the data, analytics, and insight that we are able to provide will be used to make the best formulary and prescribing decisions possible.

Breaking news as I was drafting this post… via our Freedom of Information requests program we are now the proud recipients of the very first batch of post-marketing safety data on Harvoni. While we only have 328 “primary suspect” cases so far, these data support our earlier assertions that Harvoni was likely to be one of the safest drugs of the new hepatitis C medications.



 Drug Safety Monitor Report - Viekira Pak Hepatitis C

Keith Hoffman

Keith Hoffman, PhD

Vice President, Scientific Affairs

Keith Hoffman Linkedin Keith Hoffman Twitter

Topics: Drug / Indication Information

Dr. Keith Hoffman

Written by Dr. Keith Hoffman