Getting FDA approval on a brand name for vandetanib, AstraZeneca’s very first orphan drug, isn’t the only challenge the company has faced during launch. The size of the patient population eligible for Caprelsa is decidedly small, but ultimately fuzzy. “We don’t really know how many patients there are at any given time,” says Eric Vogel, executive director of oncology, at AstraZeneca. “In some reports its 1,000 [in the US], and the FDA thinks it may be 2,000 to 2,500.” Compounding the difficulties presented by a tiny patient population, relatively speaking, is the fact that not all medullary thyroid cancer patients would benefit from Caprelsa; the drug is indicated only for patients whose cancer “has progressed to the point where surgery is no longer an option.”

Vogel says the company is “learning as we go” during the launch. “We believe that roughly half of the patient population will end up in the major treatment centers around the country, but that the other half may or may not continue to be followed by the community endocrinologist or medical oncologist,” says Vogel. Traditional market research hasn’t uncovered a network of physicians treating medullary thyroid cancer, since Caprelsa represents the first pharmaceutical treatment option for those patients, says Vogel. “There are some things that we can do to find physicians that look like they might be treating [medullary thyroid cancer], but it’s an inexact science at this point.”

AstraZeneca signed an exclusive distribution deal with Biologics, an oncology management company and specialty pharmacy, last April. Biologics also distributes AstraZeneca’s Arimidex, as well as Novartis’ Afinitor, Gleevec and Tasigna, Bayer/Onyx’s Nexavar, Celgene’s Revlimid, BMS/Otsuka’s Sprycel, Pfizer’s Stutent, Merck’s Zolinza, Roche/Genentech’s Xeloda and others, according to an “in stock” list on the company’s website. The decision to partner with Biologics for distribution had to do with the size of the patient population, and the amount of support that patients using Caprelsa would need, says Vogel. “We’re pleased with the relationship. [Biologics] spends 45 minutes, on average, with each patient, according to the reports we get from them,” Vogel says. Biologics, for its part, provided a team of 10 nurse liaisons tasked with educating physicians about the drug, and easing the administrative burden on the physician’s practice, Dan Duffy, executive VP and general manager, oncology pharmacy services group, told PharmExec.

In addition to Biologics’ nurse liaisons, AstraZeneca has deployed “regional scientific managers” – physician and/or nurse-facing individuals, to “communicate to our HCP audience about risks associated with Caprelsa, the REMS programs and all of the precautions, as well as any questions they might have around the efficacy or safety of the product,” says Vogel. The REMS program has helped AstraZeneca identify customers, since physicians have to become certified through REMS before prescribing the drug. “Down the road, we may broaden our reach out to community oncologists, those who we’re already calling on with our sales forces for Faslodex,” says Vogel.

The company hopes new indications will be forthcoming, and is currently looking to Europe for the next Caprelsa launch. Laura Woodin, senior manager, corporate affairs, said in an email that Caprelsa is being evaluated in “more than 40 early-stage studies” and various tumor types, including pancreatic, glioblastoma (brain), biliary tract (liver duct), as well as two other forms of thyroid cancer, papillary and follicular. “We’re trying to take our learnings from the US and apply those to other markets,” says Vogel. In terms of a possible launch in the EU, Vogel says the patient population size across Europe is roughly the same as the US patient size, but right now, “it’s not efficient to commercialize [Caprelsa] country by country.” “We will commercialize it country by country as we get new indications, but we have to look at it more broadly by much larger markets” for now, says Vogel.

Caprelsa is currently under review with the European Medicines Agency (EMA) and Health Canada, according to Woodin.

With Big Pharma sales teams awash with iPads and 72% of US doctors now armed with smartphones for professional use, are we finally approaching the day when the rep is replaced by digital technology?  And if so, is it a good idea?

The number of pharma sales reps industry has fallen by more than 25,000 employees since 2006. And for those who remain, it’s getting harder to see the doctor. The Wall Street Journal (WSJ) Online points to a 2009 report, which revealed that 1 in 5 doctors would not meet with reps in a traditional office visit — decrying them as intrusive and irritating — and says about three-quarters of industry visits to US doctors’ offices fail to result in a face-to-face meeting.

In announcing plans to reduce its workforce by 16%, AstraZeneca is jumping on the digital marketing bandwagon with the introduction of AZ Touchpoints, a website offering ordering information, insurance coverage and answering doctor’s questions; Sanofi-Aventis’s www.ipractice.com and Merck & Co’s www.merckservices.com are similar services.

But as WSJ points out, the use of technology is not a complete alternative to a sales department. Systems can contract viruses and are at risk of being hacked. One of the biggest data breaches in history, the recent hacking of the Sony Playstation Network, left 77 million customers in the dark. GlaxoSmithKline’s (GSK) email database was also hacked earlier this year by an unauthorized third party. The hackers sent spam to consumers who had signed up to the GSK product website.

Where human staff can cost the company in vacation time and sick days, securing a qualified specialist to eradicate computer viruses or tighten up security systems can also be time-consuming and costly.

And not all pharma firms are replacing their reps with technology, WSJ reminds us. Danish drugmaker Novo Nordisk AS introduced a new iPad/iPhone app called Coags Uncomplicated to plug its drug NovoSeven, but left its US sales force alone.  Eli Lilly has closed down its lillyconnect.com portal, the channel it established in 2002 for marketing its drugs to doctors.

The future clearly lies in using these new sales tools, but it seems it isn’t necessary or wise to cut thousands of rep jobs to make way for them. Instead, the sales people and their digital counterparts just need to be able to work together.

Last week brought a small but dedicated group of sales professionals to a CBI conference in San Diego with a clear mandate: to rate the future of the “detail man” — dead or alive?

Surprisingly, the consensus was that the function still retains its value, even as e-detailing and other online technologies are transforming the traditional way the industry interacts with healthcare professionals. One interesting data point is how provider attitudes toward working with sales representatives vary with the nature of the practice: survey research presented at the conference showed that while roughly a quarter of all physicians in the US now ban rep calls, including the bulk of all primary care professionals, 74 percent of specialist physicians still prefer that face-to-face contact.

What matters today is the relevance and quality of the interchange, and what physicians want most is the most current information available on the progress of clinical trial studies. This is no doubt a consequence of pressures from patients, which is why a key element in the curriculum of the new sales rep should be how to  build ties to disease groups and patient advocacy organizations. Another trend is making the rep more engaged in market access support through better awareness of the reimbursement policies and options set forth by payers. As this task of “fighting the insurance companies” takes a good deal of a physician’s time, the ability of the rep to synthesize and explain the rules on P&R can free the physician for the clinical interventions that save or extend lives.

The other topic for debate was the merits of GSK’s new formula for calculating performance bonuses among its US sales teams. It focuses heavily on informal feedback from healthcare professionals as to the quality and breadth of information received from the individual rep, rather than the traditional approach based on hard targets like scrip volume within each rep’s territory. GSK says its compensation plan will significantly reduce the potential for compliance problems, such as when sales reps skirt illegal behavior by promoting off-label prescribing.

That said, participants at the CBI event asked whether customer feedback is sufficient to ensure that the process of awarding bonuses will be objective and transparent. What happens when this subjective assessment of performance is at odds with the sales and revenue numbers? And does any of this really matter when payers are driving the agenda so completely in managing pricing and access?  There were no hard and fast answers, except for the premise that the safest ground is for the rep to link his own performance to the interests of the patient in getting timely access to the right drug at a reasonable price.

The survey incorporated responses from more than 4,000 physicians worldwide. Reps were rated on a number of criteria such as objective and ethical behavior, quality of medical information, and professional relationship. Physicians were asked to rank the leading three companies by the above criteria, according to their experience and perception.

In India, when physicians were queried about “quality of professional relationship”, domestic companies received better ratings, with Mankind, Cipla, Lilly and Lupin topping the rankings; in China, doctors rated domestic player Yangtze River well when it came to objective and ethical behavior, but also gave high marks for western companies like GlaxoSmithKline, Merck, and Pfizer.

In Brazil, Eurofarma, GlaxoSmithKline and Bayer scored best among secondary care specialists, while in Japan, when asked about quality of information provided, primary care doctors gave Tsumura, GlaxoSmithKline, AstraZeneca, Takeda and Shionogi the highest ratings.

“[T]he companies that have risen to the top have honed their ability and skills in terms of what doctors want,” Christopher Wooden, Cegedim Strategic Data’s director of global sales and marketing told Pharmaceutical Executive. “In the emerging markets they are taking their experience with them.”

For further survey results, click here.

As we all know, the industry is facing trends that will continue to erode profitability if the sales and marketing model does not change. The image of a new commercial model is now starting to emerge – and although the details are far from clear, the basic components are there in terms of some of the things that the industry needs to achieve.

One of the trends in the new commercial model is for companies to make smarter sales and marketing decisions based on deeper analytical insights—and to develop these competencies in house to create a clear and distinct competitive advantage. Organizations that use business analytics today drive value and better decisions across the business—and those that make the better decisions now are the ones who will ultimately succeed in the new commercial model. The Webcast will help corporate decision makers like you better understand why transformational business analytics is a game changer for Pharma that will:

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A spokesperson told Pharm Exec that some reps will be moved to the company’s expanding vaccine sales group. Additionally, GSK will be designating its North Carolina location as its sole headquarters.

While some pharma companies are moving to a geographic sales structure, GSK chose to reorganize reps by therapeutic areas. “In the past, some of our teams were organized by where they reported to, whether it be Philadelphia or Research Triangle Park,” GSK spokesperson Mary Anne Rhyne told Pharm Exec. “Geography is still a concern in terms of making sure that reps are in the right places in the country, but we think this plan will allow us to provide healthcare professionals with more of the specialized information that they are looking for.”

For example, a rep could visit with a doctor and discuss all of GSK’s respiratory medicines instead of just Advair. This gives the company a corps of specialized sales reps who know a lot about a few drugs rather than a little bit about everything.

There are no plans to outsource positions to a contract organization as other pharma companies have recently done.

“This is about trimming the people that we have and making sure that they have the absolutely best training to offer this kind of information,” Rhyne said. “Our marketplace and portfolio are evolving. In the past year we had four different medicines that we lost to generics, but at the same time, we’ve added two new vaccines in the last quarter, and we’ve launched six different products in the last year. We need the kind of flexibility to be able to take those medicines to the sales staff so they can talk to the doctors about them.”

The restructuring is expected to be complete by the end of the year. GSK recently restructured its oncology division by merging the discovery and development divisions.

Correction and Update: GSK will not be eliminating its Philadelphia branch. The company has designated North Carolina as its headquarters but we will continue to have a significant presence in Philadelphia. No employees will be moved or released from the Philadelphia location.