Behind The Counter (BTC) Drugs: Are We There Yet?

Drug products typically fit into two segments: over-the-counter and prescription. However there are a small number of drugs that fit in a segment called “behind the counter.” These drugs require the consumer to get the attention of the pharmacy staff in order to obtain the medicine.  Typically a drug would not need the high level of doctor supervision but still raises concern for direct consumer access.

 The FDA has been discussing the possibility of formalizing a behind-the-counter (BTC) product segment since the 1970’s. Even without specifically establishing a third class of drugs, there is potentially more pharmacists can do to help patients. Currently there are select products such as Mucinex, a cough medicine, and Plan B, an emergency contraceptive, available through BTC status. These products can be purchased without a prescription and customers have better access to them than prescription products.

In mid 2002, Adams Laboratories made a bold move to put its new cough tablet Mucinex in this unique third drug category. For the first time, consumers can buy a cough medicine tablet that contains guaifenesin, a powerful phlegm-releasing ingredient. The drug is available OTC but can be obtained only by getting the attention of someone at the pharmacy counter.  The company considered placing the product next to the standard OTC cough preparations such as Vicks and Robitussin, but that would have required the company to spend millions of dollars in print and TV ads. The company opted for the third drug category, dispatching its sales force to lobby doctors about Mucinex and its unusual location in stores.

Drugs containing pseudoephedrine (a decongestant found in various OTC and prescription products), ephedrine and phenylpropanolamine have been moved behind the counter due to use in illegal methamphetamine production. This process was started in 2005 and continued in 2006 with the Patriot Act signed by President Bush in March of 2006. Some states in the U.S. have required that products containing the drug be limited to prescriptions only.

Another argument for the addition of BTC products is the availability of more products at lower prices.  The growing consumer trend in using OTC products would also be seen in the BTC category. The improved access over prescription medicines could provide consumers with a source for treatments that only requires a kiosk or pharmacist involvement. Pharmacists could potentially provide support either through counseling before the purchase or by limiting the purchase quantities. Pharmacists have the knowledge to advise patients about drug interactions as well.

Drug companies have also shown an interest in a BTC option for marketing a product. This may be a good way to provide access in a way that fits products better, and gives companies more options. In effect a product may not be safe enough for OTC status but not unsafe enough for physician monitoring.

The FDA has continued to look at several ways to increase access to medicines but also remove the burden on physicians. Physicians offices must take time to see a patient, send in prescriptions orders, or schedule a second visit even for some routine cases which takes time away from more critically ill patients. Physicians are considered the most qualified personnel to make health decisions but there is continued pressure to change the system in a safe and effective manner. 

Insurance companies have reported mixed feelings about reimbursement for BTC medicines. Some companies say that if the medication is medically necessary and/or covered under the patient’s formulary, they would provide reimbursement. However, other health insurers may be less likely to provide reimbursement if this segment of medicine materializes. Some of the reimbursement options would likely follow a certain decision by the FDA concerning the specific type of access granted. 

Product classes which could benefit from a third class of drug include oral contraceptives, influenza antivirals, sexual dysfunction treatments, bladder treatments, osteoporosis prevention, and hormone replacement drugs.

An industry evaluation of these potential costs savings indicates that some of the savings would be shifted to the pharmacists to pay for added consultation and to the manufacturers. If a product requires diagnostics the savings may be limited. Expanding OTC access is likely to be more beneficial on a product-by-product basis. If a consumer is looking for a simple product that requires only a kiosk, the costs could be less than if they require a blood test administered at a pharmacy. 

Kalorama's Reprot, Rx to OTC Switches, discusses this topic.  

Retail Clinics: Build It, They Will Come?

The Amednews.com site of the American Medical Association Journal noted our study of adults (http://www.ama-assn.org/amednews/2012/12/17/bibf1217.htm#1) and the results that more adults are visiting clinics.  The AMA is no friend to retail clinics, and has strong criticism of them for breaking the continuance of care, as a patient may see a doctor, then visit a clinic, then see a doctor again, without each entity knowing about the other visit.  Once of the things that Amednews noted is that usage is up where more clinics are located.  Patients will visit if a clinic is near their home and makes themselves available as a physicians' office.

Several studies have found that patients who live near retail clinics are more likely to use them. According to Merchant Medicine, a retail medicine consultancy based in Shoreview, Minn., 1,420 retail clinics operated in 39 states as of early December. In October 2006, there were 202 such clinics across the country.

Patient Satisfaction May Impact Testing Markets

In the Kalorama Linked In Group we discuss the pressures of patient satisfaction for doctors and healthcare organizations.

Our discussion is based on an article in The American Medical News of the American Medical Association. regarding the focus on keeping patients happy in healthcare organizations.  The AMA article relates the pressure that doctors feel to keep patients happy, which is often in direct conflict with treatment procedures and According to one physician quoted in the article:

"If I feel the patient is not an appropriate candidate for opioids, I should say no,” she says. “But in the back of my mind, the question can arise, ‘What will the patient do with that?’ Especially since the No. 1 question on our patient-satisfaction survey is, ‘Are you happy with the way the physician treated your pain?’ ”

This is an especially important trend because  patient satisfaction could have a direct impact on doctor's salaries, according to the article.

For Dr. Zgierska and a growing number of physicians, saying no could carry a price tag. The University of Wisconsin Medical Foundation, the clinical practice organization for UW faculty physicians, recently created a new compensation plan for its primary care doctors. They can receive a 5% increase in their base pay if they meet benchmarks on certain performance measures, including patient-satisfaction metrics.

If this trend holds that patient satisfaction is winning out over cost-cutting. We note that it could have interesting ramifications for diagnostic market forecasts.  Diagnostics is expected to be a cost saver - the idea is that tests save because you test a patient for appropriate treatment before using.  But if doctors skip steps for patient satisfaction reasons, this may hurt testing markets.    At the highest level, the idea of advanced pharmacogenomic testing is to reduce costs by keeping a therapeutic to patients most able to use.  But there again if the introduction of a companion test causes patient satisfaction problems.

Our personalized medicine report takes a look at market for diagnostic tests intended to target a specific patient with the most effective therapy.

Mixed Reviews on Final Medical Device Tax Rules

Is the medical device industry full of cheer about the newly-defined healthcare tax parameters?  Yes and no.  The IRS released its guidelines for how the 2.3% excise tax associated with the Patient Protection and Affordable Care Act of 2010 will be implemented.  This was anticipated by an industry that is soon to face the impact of the taxes.  The guidelines were met with a mixed reaction from device companies.   Some breathed a sigh of relief, others still are concerned about the tax's impact.

On one hand, the IRS waived some late fees and clarified the policy on prepackaged kits (in most cases, if a product within a kit already incurred a tax liability, companies would not be double-taxed.) and clarified on combination drugs (in most cases, combo drug/device products would not be taxed.  

On the other hand, some things the industry wanted such as a delay in implementation, a waiver for dental products, and an exemption for leased products were rejected by the IRS.

Major device companies still say profits and layoffs will be impacted by the tax.  Cook Medical's CEO recently indicated his company would not expand manufacturing in the United States given the tax policy.

Kalorama Information's The Global Market for Medical Devices 3rd Edition examines the overall medical device market and assesses the impact of the tax on several companies.    

The Next Wave in Cancer Treatment

 Historically, cancer treatments have been very invasive and detrimental to the body as a whole. However, there are numerous new techniques available for those with cancer that are not as invasive and detrimental to the body as a whole. These treatments range from the severely alternative to the more traditional.   Kinase Inhibitors are one of these treatments known to mitigate the spread of cancerous cells.   In the past, the treatment of choice was to remove the cancer and as much of the surrounding normal tissue as possible. Therefore most of the surgical procedures used were considered to be radical in nature. In the mid-1950s even though the radical procedures were technically sophisticated, the mortality rates associated with certain cancer sites were not improving. Many cancers that were thought to be local disease processes were found to be systemic diseases with metastatic lesions located in anatomic sites other than the site of the primary disease. On analysis of these findings, it became obvious that surgery alone regardless of the extent of the procedure was not an effective treatment for every type of cancer. 

There have been many cancer therapeutics approved over the last 50+ years for a wide range of cancer indications. The largest numbers of treatments approved are for breast cancer, leukemia, lung cancer, and lymphoma. 
The market for one type of these treatments, kinase inhibitors is heating up.   Although the market is becoming more established and several billion dollar drugs have emerged this segment has enormous room for growth.  

Several factors continue to influence the double-digit growth this market has experienced, including the continued success of targeted therapy in cancer treatment, rising incidence of cancer, and increased cost for newly approved therapies in the advanced treatment area.   

Our new Kalorama Information market research report – The Next Wave in Cancer Treatment--Kinase Inhibitors - is focused on a growing area of cancer treatment, kinase inhibitors. Several cancers are being treated with these newer therapies, which provide a focus of cancer profiled in this report, including:

• Breast
• Colorectal
• Head/Neck
• Kidney
• Leukemia
• Liver
• Lung
• Melanoma
• Ovarian
• Pancreatic
• Prostate
• Stomach

DNA Sequencing Market Report Cited in Live Scientist

An article in Live Scientist quotes Kalorama Information's DNA Sequencing Report 

The market for DNA sequencers increased in the last year with the introduction of new systems and a growing demand for sequencing, according to Kalorama Information.

The healthcare market research publisher said that the introductions of the Ion Torrent PGM, PacBio RS and MiSeq grew the sequencer market nearly 5 per cent to US$560m (EUR429m) in 2011. More new technologies are expected from Ion Torrent as well as from Oxford Nanopore that may further change the market and introduce price changes, according to Kalorama's report, 'DNA sequencing equipment and services markets, 3rd edition'.

"This was getting to be a stable market, but that changed in the last two years," said Justin Saeks, Kalorama analyst and author of the report. "Now it's more volatile and complicated; we think customers will acquire new systems, but pricing and feature preferences will get interesting."

More here

View our report on DNA Sequencing.

Kalorama Finds 21% of U.S. Adults Have Visited a Retail Clinic

 The number of adults who are familiar with retail clinics and have used them has increased greatly in the past five years, according to Kalorama Information.  The healthcare market research firm conducted a survey of 2,000 U.S. adults and found  21.3% of those surveyed have visited a retail clinic.  The Kalorama survey result is a significant increase over polls six years ago which showed less than 10%.     

Take Care Clinic Locations in Atlanta

We've studied retail clinics in depth since 2007.  We attribute the result to the growth of stores at top retail chains, growth of clinic traffic and the bunching of clinics in certain cities.  The finding was made in our complete market research survey on retail clinics, Retail Clinics 2012: Growth of Stores, Consumer Opinion Surveys, Winning Competitors, Supplier Sales of Products to Clinics, Clinic Sales Forecasts and Trends.

Retail clinics, also called convenience clinics, are mostly located in drug stores but also in retailers such as Walmarts and Targets, grocery stores and even malls.

  The basic premise is that they take advantage of the retailers traffic, and provide defined services generally though a nurse practitioner or a physician assistant..  Especially attractive to customers, they offer walk in service, better hours than the average physician office, and lower costs.  The concept survived the recession, the opposition of medical associations and state legislatures.  A shortage of primary care physicians, rising concerns about access and costs, and now a health reform plan which has so met political and constitutional challenges, is expected to send new patients to clinics.   

 This and the ever-older Baby Boomer population have combined to create a unique prescription for success.  Most importantly, drug stores embraced the concept and the two largest drugstore chains in the United States, CVS and Walgreens are behind the concept. 

The other side of the survey result, of course, is that nearly eighty percent have not visited a clinic There has been improvement in popular opinion, though there is still room to grow.  Almost all surveys show high satisfaction with retail clinics.   There are over 1,300 retail clinics, and we expect that number to grow, but growth in the amount of stores that house clinics has never been linear, and store count went down in the midst of the recession.   Stores have struggled with getting patients in summer and spring months.   Some well-known chains closed clinics in their stores.  These developments could produce a misinterpretation that the concept was on the decline.  But there are counter-developments to such a decline.  Prestigious academic medical centers entered the retail clinic business at the same time a number of chains dropped the idea.   

Physician practice and urgent care competition, labor shortages, competition for retail space and even limited non-clinic drugstore care options such as flu shot stations administered by pharmacies and patient management are limiting growth of clinics in stores.  

Kalorama’s report, Retail Clinics 2012 is a detailed look at the market for clinics in retail settings.  The report can be obtained at