Changing the Adherence Dialog – and going on hiatus

Due to new responsibilities as a Board Member of the Catalent Applied Drug Delivery Institute, as well as activity via other social media including @stamoran on Twitter, I’m suspending posting new comments on this blog for now.  But my attention to improving patient outcomes through better drug design is unchanged, and the need is greater than ever.

I’ve recently come to believe that the way we frame the discussion on adherence is ineffective.  Any other industry that ends up with 8:10 users of the average product NOT receiving the intended (on label) benefit would view this as a design inadequacy.  So framing the patient outcomes debate by putting the burden of compliance with unrealistic regimens, difficult side effects, etc., on the PATIENT rather than driving for better DESIGNED drugs in the first place is fundamentally the wrong approach, in my opinion.

It is CRITICAL that we understand how patients use drug in real world settings, especially since pre-approval clinicals inadequately probe the gap between clinical and real-world adherence. So I’m not dismissing all the great adherence research going on – I just think what we in the industry should do about it – and perhaps the way we frame the debate – needs to change.

I’ll post later this year, once I  get my new “soapbox” blog, focusing  on driving improved patient outcomes through better drug design, up and running.  In the meantime, follow me on Twitter to say current with my views on adherence, pharmaceutical industry strategies and the future.

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ACNE STUDY: Text Reminders Didn’t Help Adherence

In a poster presented at the American Academy of Dermatology’s recent annual meeting, and just published in the April supplement to their journal, twice daily text messaging reminding acne patients to apply their topical meds had very little impact on adherence.

In the study, conducted by a team at the University of Texas Southwestern Medical Center in Dallas, 40 patients ages 12-35 with mild-to-moderate acne were separated into a treatment group and a control group, and treated with two meds daily (one AM, one PM).  Those in treatment group had electronic monitoring caps added to their medication tubes, which monitored every time the cap was opened.  They received two text messages daily reminding them to apply the medication.  Both groups were assessed after 6 and 12 weeks.

Adherence in both groups DECREASED over time (not surprisingly), and the mean adherence for correct administration of both meds was around 35%.  By itself, text messaging had no impact on disease severity.

What can we learn from this?  Two observations:

  • Two medication adherence is always going to be more challenging than one, which wasn’t separately reported on, and undoubtedly led to a lower adherence score than prior Acne studies.
  • Automated e-reminders via texts, emails etc have only delivered mixed results.  And in this patient age group, you’d expect greater technical savvy than other population groups too.

Finally, great jobs to the UT team for putting some rigour around an experiment, and for publishing the results.  There are startup companies receiving early stage funding that have done less research!

Here’s the link to the poster

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Can changing admin route for chemo improve survival odds?

A poster presented at the recent European Breast Cancer Conference, published online today in the European Journal of Cancer, provides fascinating new evidence that dosing design choices can change outcomes.

In this case, a group of researchers at the University of Pavia (Italy) studied nearly 200 metastatic breast cancer patients being treated with either oral or iv chemo agents, across two different treatment regimens (two Phase II trials).  During successive rounds of treatment, they assessed Quality of Life using a standard instrument, which among other things assessed patient opinions (and those of their Docs) on oral vs. IV treatments.

Key findings:  92% reported improved tolerability of oral regimen vs prior treatment methods.  Every degree of improved tolerability reported at the 4th and 6th cycle of treatment was positively associated with progression-free survival.  98.5% saw oral administration as beneficial, due to reduced in-patient stays and more freedom.

They also reported perceived benefits in body image, sexual functioning and future perspectives (optimism?).

To quote the authors

We believe that by giving the patients a choice between oral or i.v. treatment, patients often sense a feeling of control over the treatment and thereby a control over their life.

More control often translates to better patient engagement and thus treatment adherence too.  (And don’t forge tthe reduction in total cost of treatment!)

How many drugs currently injectable or IV might be administerable in a better designed way?  A better route, a compliance-enhanced regimen?  One that improves cancer patients survival?

Another piece of evidence to show how much the industry is still leaving on the table.  Challenge your assumptions.  Is YOUR product designed opimally for patient outcomes?  Could a change to the design of your drug improve patient engagement and optimism?

Something to seriously ponder, I hope.

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Transforming acute Gout treatment to chronic

Didn’t realize it had been so long since I posted!  Please also follow my twitter feed for more frequent but brief thoughts as well!

Came across some interesting comments from a recent call that BioCryst held to discuss clinical results from their clinical phase gout treatment, BCX4208 (See materials here), in combo treatment with current standard of care, allopurinol.  See specifically pages 23 and 30 for key analyses.

Of particular interest to me were the following comments, excerpted from the call transcript:

CHARLES DUNCAN: Another question that I have is why do you think the adherence to study drug is better than the adherence to allopurinol?

WILLIAM SHERIDAN: That’s a very interesting observation and I think we’re speculating but many of these patients have been familiar with allopurinol before, perhaps they’ve had in the past, out of their milieu, if you like, and they’re motivated by a variety of reasons to join a clinical trial and they’re interested in the study drug and perhaps they’re more interested to take the special pill rather than something they’ve had prescribed by their physician in the past.

I’m speculating, we don’t know for sure, but it is an interesting observation.

JON STONEHOUSE: Charles, this is Jon, I think this is another area where there’s real opportunity for better treatment as well. One of the things that we’re finding in digging into the adherence in gout in general is that about 50% of patients take their medication in the early days of treatment and it goes down to as low as 30% over two to three months. So a lot of this is just because gout still looks like something that you take Advil for when you have a flare versus chronically treating the high levels of serum uric acid.

So again, with the right partner doing the right education we think that we can get much better adherence and ultimately more like other chronic diseases like hypertension and hyperlipidaemia.

First, to me there’s a question whether there can be a documented “new trial drug” favorable adherence bias (sort of a clincial “placebo effect”).  Harder to determine given that normal practice is to drop out non-adherent patients.  I’ve not done the digging into trial design, but it is interesting that in this case they are able to measure clinical adherence.

Second, most gout sufferers have complex medication regimens anyway (see p 30 of slides for co-morbidities), and normal conventional FP/GP wisdom is to treat the pain/inflammation symptoms with Rx or OTC NSAIDS (e.g. acute) rather than long-term chronic treatments which inhibit the causes.  Similar to other classes of drugs without immediate self-observable physical effect, discontinuation rates are quite high.  I wonder how a bioerodable implant might fare in this disease state?

The audio of the call is also streamable here.

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Merck adds adherence resources to Consumer website

Pleased to see publicity for a more general approach to improving adherence from a large pharma, not just embedded within individual brand efforts.  I’ll admit I’m a bit disappointed that the concept of adherence is not more readily visible on the home page, and I actually had to hunt for s bit to find the link to their adherence resources page.

Merck has previously discussed their Adherence Estimator (R) tool, and a quick web query shows quite a few health plan sites have already made it available to their patients.  It focuses mostly on patient attitudes, and was developed and supported by a published study.  To me it seems a bit overly simplistic to be truly predictive across disease states, particularly when compared with some of the other current assessment tools in use.  But any tool that gets used is better than nothing!

Great to also see Merck supporting NCL’s Script your Future campaign (see link on Resources page).

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Testosterone delivery – gel better than patch?

That’s what a recently published patent application claims.

Moreover, based on the difference in the weight of the dispensed and returned AND ROGEL® bottles, the mean compliance was 93.1% and 96.0% for the 5.0 g/day and 10.0 g/day ANDROGEL® groups during days 1-90, respectively. Compliance remained at over 93% for the three  ANDROGEL ® groups from days 91-180. In contrast, based on counting the patches returned by the subjects, the testosterone patch compliance was 65% during days 1-90 and 7 4% during days 91-180. The lower compliance in the testosterone patch group was mostly due to skin reactions from the subjects’ records.

With the known substantial variability in dosing of gels/creams/ointments from multi-dose containers (so how much excatly IS a dose the size of a pea?), relying upon empty containers is perhaps a less-than-ideal method to validate how adherent patients actually were.

However, skin irritation arising from traditional transdermal delivery of drugs is well known, so the relative results are probably still relevant.

Another example of direct correlation between administration route, dose form and adherence.  Using the huge body of existing knowledge to optimize adherence design when developing that next product can often play a more impactful role than “aftermarket” fixes.

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UK payors push OFF LABEL use for cost savings

Interesting article in the online Financial Times yesterday which describes the ongoing debate over off-label usage of Avastin(R) in lieu of the much more expensive Lucentis(R) for treatement of wet AMD.  Over the recommendation of their own specialist ophthalmic association!

Further investigation shows that some of the evidence on which the UK team is relying was comparative effectiveness research funded by the US NIH and published in NEJM in May 2011.

I’d already factored the impact of comparative effectiveness research between two products with on-label claims into my mental reimbursement futuring model.  But I’d not yet gotten to the point of looking at similar impacts from off-label studies!

Another reason it’s important to understand current off-label usage practices!

Any other examples of comparative effectivenss reimbursement decisions involving off-label claims?

 

 

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Is non-adherence understated? New study says yes

The current edition of Drug Topics reports on a study (published last month in Annals of Pharmacotherapy) which suggests initial prescription abandonment should be considered non-adherence (I agree!).  And then determines that, based on that principle, adherence rates were overstated between 9-18% in key large therapeutic classes like diabetes (15%) and certain cardiovascular areas (18%).  Definitely worth reading!

I also like the expanded classifications they used for early-stage nonadherent patients:  primary nonadherent (non-fillers) and early nonpersistent (non-refillers).

For a problem this big, this pervasive, it still surprises me sometimes when new pockets of nonadherence are identified!

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New Page for External Adherence Resource Links

I’ve added a new page for web resources on adherence that I find interesting and re-visitable. Single purpose links will continue to show up in posts instead!

If you have suggestions on other high-quality links, please post in comments or send a tweet to @stamoran.  Your input is welcome!

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Anticounterfeiting meets Occam’s Razor

Nice to see some simple approaches designed to combat counterfeit drugs in developing markets.  Forget the complex RFID, symbology driven, high infrastructure cost under discussion for the US market.

Instead, how about scratchoff blisters plus cell phone authentication!  A great simple approach to meet a serious need.

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