ACR Poster on Gout Treatment Costs

In late 2013, Aaron Davis presented his poster on Gout treatment costs and regional variations.  Contact me if you want a copy.  Slide1

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The burden of poor patient compliance in CVD risk and diabetes – an M2 whitepaper

In association with our partners at MEMOTEXT, Metabolic Markets has produced a whitepaper review on the clinical and economic burden of poor patient compliance in cardiovascular disease risk and diabetes.  Click HERE to access the whitepaper.

Some important data points about patient compliance in diabetes

  • Patients with medical possession ratios less than 80% had 2.5 times the risk of hospitalization for reasons either directly related to diabetes or to cardiovascular disease6
  • Increased antidiabetic MPR was the strongest predictor of decreased total annual healthcare costs, 8.6% to 28.9% decrease in annual total healthcare costs in annual total healthcare costs for every 10% increase in MPR 7
  • Each additional prescription fill by users of older (metformin or SFU) antidiabetes agents reduced hospitalization risk by 0.3%, reduced the number of hospital days by 0.04 days, and reduced Medicare spending by $71 per refill8

Read our work. Call us to discuss.  Our partner MEMOTEXT is the best in patient adherence technology to address the needs of manufacturers and payers.

 

 

 

Poor patient compliance – the great consistent – inconsistency

Years ago when I was a forecasting geek, I could build the best model ever, based on sound data, and well thought through assumptions. Time after time, the most controversial subject would be the patient compliance/adherence assumption. Brand leadership wanting to show a bigger number would always argue that “patients are going to love this drug, they will be incredibly adherent.” A senior VP with deep experience, would always say “Set it at 50%, it is always 50%.” I had to smile today when I read the headline “Half of heart patients don’t stick to their meds” –

I also had to smile when reading the quotes in the article searching for answers to the patent engagement issue, knowing that MEMOTEXT, the best in class compliance/adherence platform, fits that exact need.

For more information about MEMOTEXT, drop me a line at aaron@metabolicmarkets.com

 

 

Compliance tied to employee production

The healthcare costs of compliance have been generally well characterized. Some interesting work done by CVS pharmacy tied chronic care medication compliance into employee absenteeism. In short, employees who take their medications are less likely to miss work, up to a difference of 7 days per year. Doesn’t sound like much, but aggregated for a large employer, compliance has a direct tie to productivity and efficiency.
We believe this underscores the need for compliance program investment that is tailored to how the employee needs to be communicated, which the MEMOTEXT platform provides. Read more about the CVS study at http://www.prnewswire.com/news-releases/cvs-caremark-research-identifies-positive-link-between-medication-adherence-and-employee-productivity-162571036.html

MEMOTEXT® and Metabolic Markets, LLC announce strategic partnership

 

MEMOTEXT and Metabolic Markets have entered into a strategic partnership, integrating MEMOTEXT’s best-in-class patient adherence platform into the Metabolic Markets’ client offerings.

“Patient compliance and adherence has long been one of the biggest challenges in chronic disease management.  MEMOTEXT’s unique, customized programs aimed at individualizing and increasing patient engagement, result in improved compliance and provide significant value to the healthcare system by reducing the overall impact and increased positive patient outcomes” stated Metabolic Markets partner Dr. Damon Tanton.

MEMOTEXT CEO Amos Adler commented, “Integrating Metabolic Markets clinical and health system expertise further enhances the delivery of MEMOTEXT’S adherence solution to patients, health care providers and payers.  We look forward to expanding the utilization of MEMOTEXT’s platform throughout the health care continuum with the Metabolic Markets partnership.”

Metabolic Markets will promote { MEMOTEXT’s patient compliance platform across its client base of manufacturers, managed care organizations and government health systems.

About MEMOTEXT

MEMOTEXT® integrates behavior modification, patient education and real-time patient support into the everyday lives of patients. This approach improves adherence using interactive multimedia assessment and telecommunications tools. www.memotext.com

About Metabolic Markets

Metabolic Markets is the first strategic sale/marketing/reimbursement consulting company to focus on the unique commercial challenges in diabetes, obesity and other metabolic disorders.

Metabolic Markets was founded by Aaron Davis and Dr. Damon Tanton under the belief that bringing commercial and clinical expertise together in a focused consultancy will deliver enhanced value to clients, improving access and increasing treatment modalities in the global healthcare crisis of diabetes and obesity.  www.metabolicmarkets.com

The next item up for bid: Amylin Pharmaceuticals, who, if anyone, wants them?

The rumor mill has cranked up once again with a leaked story that Amylin has brought Goldman Sachs and Credit Suisse aboard to market the sale of the company.  

The usual suspects have been identified by the anointed experts analyst world: BMS, Sanofi, Takeda, Merck, AstraZeneca.

Has Amylin leaked their interests to sell in order to pacify Carl Icahn, when they have little intention of selling?

Or has the trajectory of Bydureon, the burden of their balance sheet, and the lack of interest in OUS partnership have forced their hand, and acquisition is the only path for shareholder value creation?    It is interesting to note that the roughly 50% appreciation in value is on takeover rumors only.  This Thursday, April 26, Amylin will announce first quarter earnings.  The investor call will be fascinating to listen how Amylin positions the early Bydureon sales and addresses, or more likely avoids, the acquisition rumors.

Is it possible that despite considerable rumor-mongering and arm-chair strategic planning, Amylin will not be sold?  It would be somewhat hard to imagine that a company with three approved products in a competitive, but growing disease category, could not find a suitor.  As mentioned, Amylin has appreciated 50% in the last  month on takeover speculation, driving the market capitalization to $4.2 billion.  Add a balance sheet that lists $1.6 Billion in long term debt, and is Amylin really that attractive?  Symlin has struggled historically, Byetta is holding onto market share, for now, but has had its well known issues over the years, and Bydureon’s potential is debatable at best in the presence of increased competition.  All of the potential acquirers have large presences in primary care, but do any of them want to sell injectable agents with those sales forces with their essentially oral portfolios?  And Sanofi, how would they reconcile two GLP-1 agents against Lantus, while developing their own GLP-1 for much less than what Amylin would cost, and the ability to control the positioning?  Balance Amylin’s challenges with the desperation of big-pharma to fill revenue holes, and we may see an acquisition that makes little sense.

There is a potential third path, that I have called for years the “Back to the Future Strategy.”  What if they sell off the rights to exenatide only, restructure the balance sheet, return cash to shareholders through a special one-time dividend, and essentially re-start the company again around Symlin and soon to come Metre-leptin?  What is left of Amylin is much of what people loved years ago: a small, but passionate group of employees, a small commercial presence in niche disease categories that command ultra-high premium pricing, going back to where Amylin began, and where biotech does very well.

Any betting is for sport only, but feel free to pass along your predictions to me at aaron@metabolicmarkets.com.

Express Scripts as Compliance Police

Patient compliance with treatment regimens is a well established challenge in chronic disease, with diabetes, asthma and hypertension having the worse patient compliance track records.
One of the largest Pharmacy Benefit Managers, Express Scripts, will be more actively monitoring patients for compliance and contacting if they fall behind in their treatment. http://www.stltoday.com/business/local/express-scripts-to-spot-pill-skippers-with-new-program/article_8b90b844-87ea-11e1-ab90-0019bb30f31a.html

What is interesting is that they will be packaging and selling to employers as a service offering.

And it only benefits Express scripts to encourage refills.

Is there a novel path for Obesity development? – Hope springs eternal with the FDA

 

Limited use.  Targeted populations.  Smaller trial sizes.  Faster approvals.  These are the traits of cancer drug development, not obesity, correct?

The FDA’s top drug administrator Janet Woodcock, made comments in support of legislation that would potentially include obesity in a regulatory world typically reserved for smaller populations.   Article text below.

The cynical FDA observer may say “easy to say, but let’s see if they follow through.”  Nevertheless, is it possible to promote any development in obesity with the austere and costly regulatory pathway established?  Recent history would say no.  If the FDA is open to the Special Population designation reinvigorate development  in novel injectable/peptide development and away from the re-packaging of older, albeit safety-challenged, small molecules currently in front of the FDA?

WOODCOCK FLOATS OBESITY DRUGS AS CANDIDATE FOR LIMITED USE DESIGNATION

 

SECTION: Vol. 18 No. 11

 

LENGTH: 768 words

 

FDA’s top drug official signaled support for a legislative proposal to approve drugs limited to targeted patient populations based on smaller clinical trials, saying obesity drugs could also be a candidate for the designation, although companies and physicians would have to assume responsibility for ensuring that only patients designated by the limited approval would receive the drug. An obesity treatment advocate said the new pathway could be valuable for obesity drugs so long as it is not too restrictive.

Drug center chief Janet Woodcock said the proposed new approval designation, which was recently floated by the Infectious Diseases Society of America to facilitate antibiotic development, could be useful for drugs beyond antibiotics.

“It’s a solution to a problem we have in multiple disease areas, the problem of drugdevelopment,” Woodcock said. “For example, with obesity drugs that raised blood pressure, we’d have to have a gigantic cardiovascular study potentially to rule out the kind of effects we saw with sibutramine. But it might be, if you studied people that had severe symptomatic diseases, that uncertainty would be tolerable.”

Ahead of a congressional hearing on the Prescription Drug User Fee Act Thursday (March 8), the IDSA proposed a new FDA approval mechanism and is seeking its inclusion in the Generating Antibiotic Incentives Now (GAIN) Act, which outlines incentives to foster the development of antibiotics. IDSA said the Special Population Limited Medical Use (SPLMU) designation would mimic orphan drug destinations and accelerate antibiotic development by allowing companies to conduct smaller, more targeted clinical trials. FDA would give thedrugs a special logo and labeling to outline their intended population. IDSA crafted the proposal to spur the development of antibiotics targeting serious infections that lack treatments.

The limited use idea could fit nicely with obesity drugs. Woodcock said obesity that has progressed to the point where a person is no longer mobile is an example of a symptomatic disease and that the benefit risk issues would be different for people with severe obesity than the general population, with the ability to walk around being a possible clinical endpoint. But she emphasized that FDA would try to restrict use of the medication and the manufacturer would have to conduct safety studies in a broader population before it could be approved for general use.

“In the meantime, though, those people who really needed it and had the tremendous burden of disease would actually be able to get that effective treatment,” she said after the hearing.

In the case of antibiotics, infectious disease experts expect the limited use antibiotics to be more expensive and have a less-known risk profile because approvals would be based on small clinical trials. Therefore, the limited use approvals would likely foster judicious use programs among payors and healthcare providers.

Woodcock said FDA has been discussing different ways to stage small development programs and that several had been pitched to the agency by industry without the inclusion of restrictions or special designations, but the agency wanted a “big flag” about how the drugsshould be used. She said the agency is receptive to the IDSA proposal but it will require a social contract between the agency, industry and infectious disease control formularies against off-label prescribing.

An advocate for obesity treatment said the special use designation could help get obesity medications out faster to those who need them most but said he was concerned that restricting the drugs to very small populations would do little to resolve the problem. “If this represents a means to obtaining more treatment options for the obese people who were most in need of treatment, it would be good,” said Patrick O’Neil, president of The Obesity Society.

O’Neil said SPLMU could be a valuable pathway for obese drugs but that if the targeted population were too small, drugs approved through the small development program would do little to address the needs of obese people, who he said account for one-third of the U.S. population.

O’Neil said there is a risk of misuse or inappropriate prescribing with any medication and agreed with the agency’s stance on off-label use of drugs like obesity medications, which have a high potential for misuse and carry cardiovascular risks. “The level of restrictiveness of prescribing should reflect the demonstrated risk of inappropriate prescribing and also the consequences to patients who receive those prescriptions,” he said. — Stephanie Beasley

Good Lancet Article on Qnexa

 

Metabolic Markets commented a few months about about the structure of the risk mitigation approach from both a label and distribution control standpoint for Qnexa and what approach would would give the FDA confidence (code for: “political cover”) to approve.   An article in the LANCET recently dove into the advisory panel vote.  In particular, it was interesting to note the comments of the Qnexa panel chair, “”This risk mitigation strategy probably is what was most important in terms of swaying the vote”, says Abraham Thomas, endocrinologist at Henry Ford Hospital, Detroit, MI, USA, and chairman of the advisory panel.”

We still have about 5 weeks until the FDA is scheduled to render a decision on Qnexa.  While Wall Street seems to be convinced of an approval, we are not as bullish, but two powerful forces, time and bureaucracy, will soon tell.

Two other  important dates upcoming for industry are the panel FDA public discussion on obesity / cardiovascular safety trial design and a report to the Senate on how the  FDA is taking steps toward obesity agent development.

Below is the full Lancet text

Panel meeting prompts excitement for antiobesity drug

Asher Mullard

pg. 882 Vol. 379 No. 9819 ISSN: 0140-6736

 

An FDA advisory panel has recommended approving Vivus’s weight-loss drug, potentially paving the way for the first new obesity drug in the USA in 13 years. Asher Mullard reports.

In a highly anticipated US Food and Drug Administration (FDA) panel meeting about Vivus’s antiobesity therapy Qnexa at the end of last month, independent advisers voted 20-2 in favour of approving the therapy. The final decision now lies with the FDA, who are due to either approve or reject the drug by mid-April, but the vote nevertheless raised hopes that new antiobesity agents are on the horizon.

“I think it will now be approved, but probably with a label that restricts use and advises patients to discontinue treatment early if they aren’t losing weight”, says Arne Astrup, anobesity expert at the University of Copenhagen, who has acted as a consultant for drug developers including Vivus.

Vivus’s Qnexa is a combination of the appetite suppressant phentermine and the antiepileptic topiramate. In clinical trials it induced average placebo-adjusted weight-loss of up to 9·3% of bodyweight, leading to a first filing with the FDA in 2009. At a panel meeting held at the time, experts voted 10-6 against the drug, noting that it increased pulse rate, carried a risk of cleft palette in babies conceived by mothers on the drug, could potentially cause memory problems and depression, and induced a teratogenicity signal in rats, leading the agency to reject the drug.The therapy was refiled last year, however, leading to a second advisory meeting in February, 2012.

Although many of the same key concerns remain-including lingering uncertainty over Qnexa’s cardiovascular profile and birth defects-Vivus presented some new data that shed new light on the risks. The company also proposed a strategy to minimise adverse events by educating patients and physicians, limiting drug dispensing to specified mail-order pharmacies, and recommending monthly pregnancy tests. “This risk mitigation strategy probably is what was most important in terms of swaying the vote”, says Abraham Thomas, endocrinologist at Henry Ford Hospital, Detroit, MI, USA, and chairman of the advisory panel.

Vivus also said it is possible to identify non-responders early on, which could further minimise risks. And it plans to run an 11 000 patient trial to resolve the heart safety uncertainty issues. Panellists agreed that such a trial will be necessary, and most felt that given thedrug’s clear efficacy signal it could be started after approval.

Although the final positive tally of the vote suggests that the combination therapy should now be a shoe in for approval, the numbers belie the complexity of the debate. “I was surprised that the vote was so overwhelmingly positive”, said Thomas. The final decision, consequently, remains far from certain. The agency rejected another antiobesity agent, Orexigen’s Contrave, in 2011, despite a positive advisory panel vote.

Because just over a third of the US adult population is considered to be obese, and because an approved drug could be misused, regulators have historically held antiobesity agents to particularly high standards. Even the few products that have run the gauntlet have struggled to gain a foothold. GlaxoSmithKline and Roche’s lipase inhibitor orlistat, as well as generic phentermine as a monotherapy, have had limited uptake due to their side-effects. Abbott’s serotonin-norepinephrine reuptake inhibitor sibutramine was withdrawn by regulators in 2010 after it was linked to heart attacks and stroke. And Sanofi’s cannabinoid receptor rimonabant was pulled off the market in the European Union in 2008 after it was linked to severe depression and suicidal thoughts (the drug never got the green light in the USA).

Some hope that an approval for Qnexa might represent a shift in the regulatory stance to antiobesity drugs, although each drug is of course reviewed on its own benefit:risk merits. Arena is pushing for approval of its serotonin receptor agonist lorcaserin. The drug, which has the lowest efficacy of the potential newcomers, was first filed in 2009 as well, but was rejected due to carcinogenicity and efficacy concerns. Lorcaserin was resubmitted with the FDA last year, and a decision is now expected by the end of June. Orexigen, meanwhile, will run a 10 000 patient study to address the cardiovascular safety of Contrave, a combination of opioid receptor antagonist naltrexone and antidepressant bupropion, potentially paving the way for a 2014 approval. Other upcoming events may also help broadly define the future for antiobesity agents. At the end of March, the FDA will hold a 2-day public panel meeting with its independent advisers to discuss the cardiovascular safety requirements for weight-loss drugs, potentially defining the safety benchmarks for experimental agents. The agency is also due to report to the Senate Appropriations Committee on the steps it is taking to support the development of antiobesitydrugs by March 30, reflecting the growing governmental pressure to address the obesity endemic.

Post-Qnexa Panel, is the FDA bamboo or will they finally break in obesity?

The surprising 20-2 advisory panel vote in favor of Qnexa’s approval has uncorked media coverage of the obesity issue.  Countless news stories and editorials have been published in the last week.

The overwhelming vote may have forced the FDA’s hand to approve Qnexa, breaking under  the mounting pressures in recent years to approve an obesity agent.  This returns to a refrain of Metabolic Markets for some time, is Qnexa the drug the agency wants to have as the first obesity agent in 13 years?

It will be interesting to watch the news flow and messages coming from the popular press until the FDA action in April.  It already feels like increasingly articles detailing the concerns and potential issues are replacing the exuberance of last week.  Please read this story from Fox News today (I know it is Fox, but stay with me).    It is a very direct discussion highlighting the risks associated with Qnexa and the challenges for Vivus or the FDA to control inappropriate utilization?  And if inappropriately used, does this re-open the pandora’s box of litigation seen post phen-fen, and likely delaying or raising the regulatory bar on a truly novel obesity agent even further?