c’s 11th annual Brand of the Year feature, we decided to try something different and change our approach. This year, instead of picking one hot or established product to highlight, we are profiling five brands that are synonymous at the moment with five critical and “brand impact” topics in healthcare and R&D. Selected with the input of our Editorial Advisory Board, these are the products driving much discussion and debate-or are good case studies-in their respective categories. After all, the stories surrounding biopharma brands aren’t just about the sales or the science. Some are lightning rods for the bigger issues affecting public health and drug access. Others represent potential success stories for new care models, or hopeful game-changers in addressing high-risk chronic disease and the life-robbing symptoms of mental illness.

’s five Brands of the Year are profiled ahead. For a look back at each of the first 10 winners and where they stand today, check out our retrospective 

	This year, we didn’t just pick the shining brand stars for our choices to highlight. Rather, we went for “impact” in different commercial areas. Who could argue that Mylan’s challenges with pricing and reimbursement for EpiPen didn’t have an impact on the pharma industry in 2016?

	What began as a pricing issue became a lesson for industry executives. And not only our industry executives, as an 

 from Hospital & Health Networks highlighted in September. Says author and consultant Paul Keckley, “Mylan is a case study worth review by every organization in healthcare. Trust is invaluable in healthcare. It cannot be compromised, and when it is, boards must be attentive and leaders responsive and credible.”

	While Mylan CEO Heather Bresch has not been ousted for the scandal that erupted last August, she has had plenty to say about the supply chain, which she-as one person characterized to 

-threw under the bus. In a January interview with CNBC, Bresch blamed the complex pharmaceutical distribution system, from which all profit from selling drugs. 

	It is true that market access for a drug is not easy-ask any C-suite executive. Patient access is fraught with tiered co-pays, Medicare, prior authorizations, stepped therapy, generics, coupons, rebates…not to mention what Bresch noted in her interview, high-deductible insurance plans. In order to make sure that patients have 

access to their drugs, pharma must engage with pricing plans, operations and implementations with the members of the supply chain-health plans, pharmacy benefit managers and pharmacies. 

	To the high-deductible health plans (HDHP), 29% of Americans are currently enrolled in employer-sponsored HDHPs, up from 4% in 2006. According to the Kaiser Family Foundation and Health Research and Education Trust, Employer Health Benefits Annual Survey 2016, the average family contribution in a HDHP is $4,280. As noted, the high-deductible plans are becoming more popular with employer-sponsored offerings and lead people to pay more for a medication in the first few months of a year, until they reach their deductible and then prices come down. Physicians don’t understand what their patients are going to be charged based on whichever plan they are in-and pharma is now spending time and energy educating and helping physicians understand their individual patient’s pricing. There’s also the realization among biopharma companies that they are having a hard time adjusting their forecasts and programs due to this “seasonality” of access. In a recent discussion, experts explained that to manage those patient payment problems and access issues, companies are trying to time their coupons and rebates for those high-yield months. 

	This is not to say that Bresch be given a pass for the complex supply chain. EpiPen is generic, comes in a two-pack and the drug is only stable for one year. So every year, schools, hospitals, parents and others need to have non-expired EpiPen on hand. Raising the price in advance of another purchase cycle may be good business for the shareholders. But it’s not good business for trust. “Just because you can raise the price, doesn’t mean you should,” one executive told me. “That decision and its impact to your reputation needs to be carefully weighed.” 

	In early September, Brent Saunders, CEO of Allergan, set out the 

 to patients that Allergan would follow, and it did discuss price. Other biopharma executives from AbbVie, NovoNordisk, Valeant and Takeda followed with varying forms of pricing commitments. Others, including Regeneron and Mylan, said 10% limits weren’t the answer to the supply chain problem. Still others believe pharma is stepping it up so it won’t be regulated by the government. 

	In the meantime, Mylan’s share price is bouncing back since the scandal-it was 37.89, as of press time. And there is speculation that Mylan could be an acquisition target, with some reports saying Pfizer was considering.  In mid-December, Mylan launched its generic to EpiPen Auto-Injector, which has the same drug formulation and device functionality as the branded product.

	Mylan’s choice to raise the prices of EpiPen since 2006 have given a great deal of fodder for the public, government, and stakeholders in the drug supply chain to think about. Ex-GSK CEO Andrew Witty changed the company’s portfolio strategy because he believed that increasing prices is not sustainable and volume would win the day. There is definitely more to come on the pricing and market access issues in pharma. 

 Editorial Advisor Cliff Kalb observes, the concept of offering patients a means to control adult-onset diabetes and reduce cardiovascular (CV) mortality has been a goal of many pharma companies for several decades. “It became apparent to the key opinion leaders (KOLs) in endocrinology and cardiovascular disease that documented evidence of hypertension, hypercholesterolemia, diabetes and/or obesity were all contributing CV risk factors that could lead to early death,” he explains. 

	Boehringer Ingelheim (BI) and Eli Lilly’s Jardiance (empagliflozin) was first approved by FDA in 2014 as an adjunct to diet and exercise to improve blood glucose levels in adults with type 2 diabetes (T2D); in its supplemental new drug applications, BI/Lilly sought a new indication that Jardiance also decreased the incidence of CV death and the risk of death or hospitalization for heart failure in patients with T2D. The team at BI and Lilly would be the first to prove to the satisfaction of FDA that a reduction of these risks could be shown in large numbers of patients with one drug. 

	Results from the EMPA-REG OUTCOME trial of over 7,000 adults with T2D and an established history of heart disease showed that Jardiance led to a 38% reduction in risk of heart-related death and a 32% reduction in overall death. In December, FDA approved the new indication for Jardiance to reduce the risk of CV death in adults with T2D and CV disease. Kalb calls BI/Lilly’s efforts “a classical case history of the perseverance of pharma in a Phase IV trial to provide real value to patients of life-extending benefits.”

	Graham Goodrich, BI’s vice president of diabetes marketing, told 

 that he sees Jardiance in the context of past landmark trials in the CV space that have “fundamentally changed the practice of medicine,” such as HOPE (for the ACE inhibitor ramipril) and the 4S trials for simvastatin. He explains: “Any time there has been a major paradigm shift in medicine, three things exist: a dramatic unmet need; a huge financial burden on the healthcare system; and a disruptive innovation, which forces action when the data is truly understood. All these three factors are present in the case of Jardiance.” 

	Effecting a paradigm shift, of course, takes time. “Given that two-thirds of all patients with type 2 diabetes will die from CV disease, there’s an urgency to educate and engage the marketplace about the intersection between type 2 diabetes and elevated cardiovascular risk. We’re broadening the conversation from only a glucose management discussion to one that elevates the importance of CV risk reduction,” says Goodrich. 

“And what we’ve seen is that knowledge is power. When people understand the facts, costs and the data driving Jardiance, they’re compelled to act. Hopefully, that then leads to accelerating that behavior change and ultimately saving lives.”

	Sales of Jardiance reached $460 million last year, but this, as EP Vantage noted last month, was before taking its new CV label into account. Since the new indication approval went public, “the response has been impressive,” says Goodrich. “Within the first four weeks of promotion, we became the NBRx share market leader. We’re number one in terms of new starts with cardiology, endocrinology and we’re about to eclipse the number one in primary care.”

	 The industry press has suggested that Jardiance’s rise could be slowed in the event of positive CV outcomes data for other SGLT2 inhibitor drugs, such as J&J’s Invokana and AstraZeneca’s Farxiga. But Goodrich welcomes the publication of other data. “Patients and clinicians need alternatives,” he says. “What we’ve seen in other categories of diabetes is that these molecules tend to be different, not just from a molecular standpoint but also in terms of differences within class. The more data we have available for clinicians to analyze, the more we will be able to understand those differences and apply them appropriately to patients.”

	BI/Lilly is now running two outcome trials investigating Jardiance for the treatment of people, both with and without T2D, with chronic heart failure. “We see a long runway,” says Goodrich. “In the non-diabetes population, about half of all people who develop heart failure die within five years of diagnosis. There is optimism that Jardiance can extend into this population.” While he is not able at this point to elaborate on the progress of the new trials, Goodrich says that, so far, there are “certainly positive signals that suggest there could be a benefit for what remains a huge unmet need.”

	With that explanation of support for why 

 should choose Narcan as a Brand of the Year, who could say no? For emergency use with people suspected of a heroin or opiate overdose, Narcan injectors work within five minutes. 

	Albert I. Wertheimer, professor and director, pharmaceutical health services research at Temple University and member of the 

 Editorial Advisory Board, said, “Narcan is one of those products that comes along ever so rarely. There are many drugs, some simple and others complex, for acute and chronic diseases, but most of those have alternatives or at least other choices available to the prescriber. For example, there are eight or nine statins, a dozen ACE inhibitors, but there is only one Narcan.”

	Naloxone, the chemical name for Narcan, is a mu-opioid antagonist that was first introduced to the market in 1971 to prevent patients from overdosing on pain medication during and after surgeries in hospitals. It has no-known adverse events and is efficacious. 

	There are other brand names for naloxone, but like epinephrine, it is known more by its brand name. Narcan’s manufacturer, Adapt Pharma, received FDA approval for its 2mg nasal spray at the end of January. The 4mg spray was granted in February 2016 and both dosages are labeled to show response in a patient within two to three minutes. The 4mg dose was fast-tracked and given priority review because the nasal spray delivery was viewed as much easier to administer in emergency situations. The FDA noted in its press release: “In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.” 

	Prior to the FDA approval of the nasal spray, first responders did use a liquid form of naloxone via an atomizer to spray into victim’s nostrils, because that delivery eliminates the use of needles, de-risking accidental needle sticks. 

	Wertheimer further noted of Narcan: “It can be administered by a policeman or fireman or school nurse or practically anyone. It works in nearly all cases immediately and became available to tackle a huge epidemic we don’t usually consider as a major epidemic.” In the 1990s, naloxone’s use was expanded as an emergency remedy for addicts overdosing on opiates. And with the current opioid epidemic, Narcan or naloxone distribution programs, which aim to provide not only emergency personnel with the drug, but also laypersons, has increased. 

	As distribution programs have increased, so have concerns that Narcan is an “enabler” to drug use or overuse. In 2014, according to the Marshall Project, the nation’s largest police department, New York City, purchased 20,000 Narcan kits for its officers. However, some law enforcement departments are not on-board with providing Narcan. Some have stated the logistics of transferring Narcan from officer’s vehicles around shift changes is not manageable; shelf-life issues and restocking (Narcan’s shelf-life is 18 to 24 months, should be stored between 59°F to 86°F and kept away from direct sunlight); and an overall concern that they are not medical professionals-though they typically are first responders-and may not be helping the larger drug problem issue. 

	As stated in the Marshall Project, in Quincy, Mass., a town of 93,000 just south of Boston, police officers have responded to 591 overdoses since they started carrying Narcan in 2010, reversing 418 of them. However, some officers stated that they have “reversed” the same person more than once. And that Narcan doesn’t help people stop being addicts. 

, officers were interviewed on their attitudes around overdose response, with these common themes or results: “….feelings of futility and 

frustration with their current overdose response options, the lack of accessible local drug treatment, the cycle of addiction, and the pervasiveness of easily accessible prescription opioid medications in their communities. Overdose prevention and response, which for some officers included law enforcement-administered naloxone, were viewed as components of community policing and good police-community relations.”

	According to a CDC report on naloxone in 2014 based on 2013 statistics, it found that of 43,982 drug overdose deaths, heroin accounted for 19%, while prescription opioids accounted for 37%. In a flip of statistics, heroin was involved in 81.6% of reported naloxone reversals, while prescription opioids were involved in 14.1%. 

	While heroin and opioid addiction crosses socioeconomic classes, a 2014 report from the Bureau of Justice Assistance stated certain groups, including veterans, residents of rural and tribal areas, recently released inmates, and people completing drug treatment/detox program are at an especially high risk of opioid overdose. 

	However, overall, the increases in heroin and opioid addiction are tragic in the US, with the CDC reporting: “the greatest increases have occurred in demographic groups with historically low rates of heroin use: women, the privately insured, and people with higher incomes. In particular, heroin use has more than doubled in the past decade among young adults ages 18 to 25.”

	At a recent pharmaceutical compliance conference, the opioid epidemic was discussed and members inside and outside of industry urged action from pharma. Prescription opioids are literally the “gateway” drug to heroin, with many addicts starting with oxycodone or percocet received or taken from someone they know, then onto heroin or fentanyl because it is cheaper and readily available.   Prosecutors urged pharma to use data mining to uncover unsafe prescribing habits or zero in on practices that encourage overprescribing, as well as participate in collaborative activities to address the epidemic. 

	As one panel member noted: “The epidemic is spiraling out of control and it’s going to get worse before it gets better. And the public will look to someone to fix it. And they will say to pharma, ‘you should have done more.’” 

	It’s no secret healthcare spending in the US has grown greater than the rate of inflation, with experts warning that even if future legislative and other reforms do succeed in curbing costs to a degree, by 2050, healthcare investment could account for 40% to 50% of the nation’s GDP. Most agree such a path is unsustainable-a realization that has shifted current thinking around healthcare from a volume to a value focus, resulting in the emergence of alternative payment models designed to incentivize product value and true innovation in patient care.

	One such model, though still very much in the proving-ground stages, is value-based contracting, also referred to as outcomes-based or pay-for-performance pricing. Deals struck under these frameworks, between biopharma manufacturers and health insurers and pharmacy benefit managers, offer potentially promising ways to support patient access to novel medicines while demonstrating the real-world benefits of these drugs. Outcomes of therapy effect are measured from payer databases using pharmacy and medical claims. 

	Novartis and its heart failure (HF) drug Entresto, approved  by the FDA in 2015 as a first-in-class angiotensin receptor neprilysin inhibitor, are on the forefront of testing the value-based pricing waters. In May 2016, Novartis inked outcomes-based contracts with Aetna and Cinga, and a month later reached a deal with Harvard Pilgrim Health Care. Each payer is provided a discount on Entresto if the drug reduces hospitalizations for commercially insured patients with congestive HF. In exchange, Entresto becomes a preferred drug, subject to prior authorization, on the insurers’ formularies. In the clinical setting, Entresto, in a trial of 8,442 patients, significantly reduced 30-day hospital readmissions compared to traditional treatment with angiotensin converting enzyme (ACE) inhibitor enalapril. In November, a new analysis on HF readmissions from the study revealed that Entresto reduced the risk of both first and subsequent events of repeat HF hospitalizations and cardiovascular deaths following HF hospitalization-compared to enalapril. 

	A twice-a-day tablet, Entresto was approved in Europe in late 2015. The drug consists of acubitril, a new molecular entity, and the angiotensin II receptor blocker (ARB) valsartan. 

	“Entresto is a good candidate for outcomes-based contracts because there is a measurable outcome and data to evaluate is accessible,” Eric Althoff, Novartis’s head of global media relations, told 

. “By collaborating with payers on solutions-oriented approaches to reimbursement, we believe we are doing our part to help shift the paradigm of pricing in our healthcare system."

found that timely and broad adoption of Entresto by all eligible HF patients with reduced ejection fraction (HFrEF) could prevent or postpone more than 28,000 deaths each year in the US. Novartis, last year, established the FortiHFy clinical program, which it said will include studies designed to collect data on symptom reduction, efficacy, quality-of-life benefits and real-world evidence with Entresto. US guidelines now recommend the drug as standard of care for HFrEF and alternative to ACE inhibitors and ARBs, and urge physicians to switch patients with mild-to-moderate symptoms to Entresto. Updated guidelines from the European Society of Cardiology also recommend Entresto in patients fitting the profile.

	Strong data and endorsements aside, Entresto’s promise in generating value for patients and the  healthcare system will come down to how well it manages the high-risk HF patients intended to benefit the most, experts believe. Specific terms of Novartis’s value-based contracts and the outcomes tracked are confidential.

	“If any of these are going to work, Entresto would be the one,” says Shiraz Hasan, vice president, life science strategy, Capgemini Consulting, referring to the spate of recently announced  industry value-based pricing deals. “It definitely will reduce cost to the overall healthcare system, if it’s used by the right patients.”

	The biggest hurdle for Entresto may be convincing cardiologists, used to prescribing cheaper and often effective generics, to change their prescribing habits. While Entresto’s price tag of $4,500 a year isn’t near the realm of other highly touted drug entries in recent years, the cost could still present a strain for some patients. Hasan notes as well that physicians are reluctant to stray from established, clinical-driven treatment guidelines, concerned that any unfavorable outcome will significantly cut their reimbursement.

	That mindset, however, is changing in some circles, Hasan says. Kaiser Foundation Health Plan and Hospitals, for example, has looked closely at ways to leverage real-world evidence among high-risk patient groups in treatment protocol and guideline decisions. In Entresto’s case, the key will be monitoring such subsets of HF patients who take the drug to determine if reduced hospitalizations are indeed a result of the treatment and not other factors. Hasan notes that the findings could help increase Entresto’s use in broader populations, too, where the healthcare costs and savings could be spread around. 

	Entresto's slow sales uptake since its launch has been attributed to the drug's large proportion of Medicare Part D patients-reportedly 65% of its target reach-where, due to the mechanics in the system, it can typically take between six and 18 months for those patients to get access. Entresto is positioned for a significant revenue jump in the next couple years. According to a report from 

, Novartis expects Entresto to reach sales of more than $500 million in 2017, due to improving access for Medicare and the commercially covered patient population, the latter boosted by the company’s value-based contracting arrangements. 

	"We are committed to continuing our work with customers to identify new approaches that can help improve patient outcomes," says Althoff. "We hope the important progress payers have helped us make on this front will encourage others in the industry to embrace and employ value-based pricing models."

	Despite the attention, the jury is out on just how beneficial these deals will be for patients and healthcare stakeholders. A host of challenges remain, from payers having the appropriate staffing and resources in place to manage very complex datasets and analysis, to concerns over data sharing and trust, and the potential of rebates and claims validation, traditionally processed quarterly, falling outside of payment windows due to the time needed to collect quality measures on outcomes.

	“The drug is only one piece of the equation,” Hasan told 

. “It also has to do with care coordination, doing what’s right for the patients. Investing in it so that the systems that address the physicians and the coordination-their electronic records, how they think about their patients-and provide the best quality of care are bigger factors than the drug itself. … The industry is starting to think about those things, because that’s really what’s ‘beyond the pill.’”

Articles

Features

In its 11th annual feature, Pharm Exec breaks a bit from the norm, to instead profile five products that are shining the spotlight on five critical and highly debated aspects of healthcare and R&D at the moment.

2017 Brands of the Year: 5 Impact Areas

Every year since 2007, Pharm Exec has highlighted a drug, or drugs, as its “Brand of the Year.” With this year

marking our 11th installment, compiled ahead is a review of the first 10 years-reminding why each product was selected, and providing an update on where each one stands today.

annual Brand of the Year feature began, appropriately, with Merck & Co.’s vaccine, Gardasil. It was chosen because of its exemplification as a breakthrough medication, linking between science, commercialization, and humanity. The vaccine helps to empower girls and young women by providing hope in preventing human papillomavirus virus (HPV), which, at the time of the 2007 

write-up, killed an estimated 232,000 every year. Certain strains of HPV can lead to cervical, vaginal, vulvar, and anal cancers, and genital warts in girls and women; and anal cancer and genital warts in boys and men. While it does not treat cancer or genital warts, Gardasil covers a range of disease prevention caused by HPV for male and female patients between age nine and 26.

	Today, Gardasil remains an effective preventative. Patients can choose from the original or the new Gardasil 9. Gardasil 9 is an updated version and can still be administered to both genders. 

	The update includes prevention against five additional types of HPV. Gardasil aids in prevention against types 6, 11, 16, and 18, while Gardasil 9 addresses types 6, 11, 16, 18, 31, 33, 45, 52, and 58, that can lead to certain kinds of cancer and genital warts.

	Pfizer’s breakthrough treatment for nicotine addiction was nothing short of a miracle for smokers looking to kick the harmful habit. Despite an assortment of therapies available (patches, gums, nasal sprays) with success rates between 5% and 10%, Chantix’s success rate surpassed them all, at 22%. 

 was impressed with Pfizer’s approach to branding the drug, remaining consumer-oriented-including a patient education program and additional support-and limiting Chantix’s use to informed and motivated patients. The drug helped an estimated million or more smokers quit sustainably. Pfizer also made aware information about Chantix’s limitations upfront as ”not just a disclaimer, but an essential aspect of marketing,” 

	An uphill battle since 2008, Pfizer continues the fight to convince the FDA, and the world, that Chantix is not the cause for some serious neuropsychiatric events. A win for Pfizer came in 2016 when the outcome of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) prompted the FDA to remove boxed warnings. EAGLES is the largest smoking cessation clinical trial, incorporating both patients with and without psychiatric disorders to determine the safety of Chantix. The study found that patients without a history of psychiatric disorders were not associated with an increase in neuropsychiatric adverse events. 

	AstraZeneca’s cholesterol-lowering statin may not have been a breakthrough therapy, or even new, when

 chose it for its 2009 Brand of the Year, but sales of the drug were something of a marvel and mystery. Crestor made substantial gains and was successful likely due to AstraZeneca’s willingness to take big risks in demonstrating its belief in the treatment’s value. Crestor managed to survive the post-Vioxx storms and become the drug of choice for high-risk patients with cardiovascular disease. 

	Although AstraZeneca had tried to extend its patent for Crestor until 2026, last year it expired and the drug went generic. With its continued significant need, various companies such as Allergan and Mylan have launched Crestor generics (rosuvastatin calcium) in 5, 10, 20, and 40 milligram tablets. Additionally, Cigna entered into a contract with AstraZeneca that will further benefit patient treatment needs. The payer’s customers at risk for atherosclerotic cardiovascular disease, who need to diligently manage their low-density lipoprotein cholesterol, can prescribe and fill Crestor immediately without the need for previous authorization. This allows for high-risk patients to circumvent the “step therapy” process (when a generic substitute is attempted first)-and can save customers on out-of-pocket costs.

	Avastin was chosen Brand of the Year for 2010 because of its success in creating a paradigm shift in clinical cancer treatments, with six indications in five types of tumors. The monoclonal antibody is approved in treating  advanced-stage colorectal cancer, relapsed glioblastoma and renal/kidney tumors, early stage colon/rectal cancer, and cancers of the prostate, ovaries, and gastric system. Roche presently has 30 different ongoing discovery and development programs for Avastin to test its potential against various metastatic tumors, and the FDA has been steadily approving more indications for the drug. Because of its status as a conclusive treatment advancement, complementary strands from the government, academia, and industry have provided valuable research, and many drugs have surfaced in the US market modeled after Avastin.

	Still a crucial player in cancer, the medicine has also gained more indications in combination treatment. Avastin was approved in use with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for second-line treatment of people with colorectal cancer; and with paclitaxel and cisplatin or paclitaxel and topotecan to treat women with recurrent or metastatic carcinoma of the cervix. Currently, Avastin is in Phase II trials in combination with Tecentriq for advanced or metastatic renal cell carcinoma.

	Novartis’s Gilenya (fingolimod), in 2010, became the first FDA-approved oral medication for relapsing multiple sclerosis (MS).  While, of course, not a cure for MS, Gilenya does offer solutions to help manage symptoms and slow the progression of the debilitating disease, while providing patients with a sense of living a fairly normal lifestyle. Marketing a pill vs. a shot was paramount to the improvement of MS drugs. Gilenya set a precedent as an ease-of-use treatment for relapsing MS; several subsequent drugs with similar oral administration have entered the market. 

	Gilenya, involved in claims of adverse reactions and side effects, hasn’t had it easy since 2011. But the drug’s profile in the real-world setting has improved. Data from the ACROSS study-a 10-year observational study of 175 people with relapsing-remitting MS evaluating the efficacy of Gilenya-suggests a long-term effectiveness in significantly lowering disability progression with the continued use of Gilenya, as opposed to interrupting treatment. Additionally, a study in Japan found that long-term treatment with Gilenya limits relapses and detectable lesions in MS patients. Other postmarketing studies have also demonstrated improvement and long-term effectiveness, helping Gilenya capture some of its former glory.

	Ten years after its approval in late 2002, growth for Humira, the rheumatoid arthritis (RA) stalwart, was steady, making it the top contender for Brand of the Year. Along with RA, Humira treats such conditions as juvenile idiopathic arthritis, psoriatic arthritis, and psoriasis, as well as Crohn’s disease and ulcerative colitis. Humira’s effects can mean the difference between a crippling disability and a reasonably normal life for patients. The drug, now manufactured by Abbott Laboratories’ spinoff, AbbVie, was singled out by 

 in 2012 because of Abbott’s then-bold promotional approach with respect to payers, patients, and evidence-driven medicine. Another impetus in choosing Humira was its complete clinical efficacy and success in gaining new indications where others had not. The drug has an extensive coverage of indications and has delivered strong results in long-term safety and outcomes data. 

	Today, the drug also treats chronic inflammatory skin disease, moderate-to severe, hidradenitis suppurativa (also referred to as acne inversa), and moderate-to-severe fingernail psoriasis-becoming the first, and only, biologic to include data on fingernail psoriasis in US prescribing information. The increasing success of Humira has allowed for a greater understanding of the inflammatory process, knowledge that helped usher in newer inflammatory joint disease therapies and widening the choices offered to patients.

	Merck’s Januvia helps to stop the increase of disease on a global basis by tackling what is considered a pandemic issue-type 2 diabetes-putting it on 

’s map for 2013 Brand of the Year. Januvia (sitagliptin), a first-in-class dipeptidyl peptidase-4 (DPP-4) inhibitor, also works as a fixed-dose combination with metformin HCL, known as Janumet, to help lower blood sugar levels in adult patients with type 2 diabetes. In 2013, Seven years after its approval, Januvia/Janumet’s sales were growing by 15% in the US and 25% outside of North America. The combined diabetes franchise  generated $5.7 billion in revenue in 2012, making it Merck’s top selling drug in history. 

	Januvia continues to be a best-seller, totalling $6 billion in sales last year, a 2% increase from 2015. Aiding the drug’s continued momentum was the release of data from a cardiovascular outcomes trial in 2015. Results showed that there were no signs pointing to Januvia being a risk for heart failure. Analysts estimate sales of the drug will increase around 10% by 2020. Merck’s patent for Januvia expires in 2022.

decided to highlight two brands, wanting to equally recognize the power of brand consistency and the clinical and marketing achievement of repurposing older drugs for new indications in rare disease. Teva’s Copaxone, on the market for 17 years at the time, was chosen for its consistent track record in fighting MS, and doing so with virtually no serious side effects emerging. Weeks into its 1997 launch, Copaxone became the most prescribed treatment for patients with relapsing-remitting MS. Its 40-milligram treatment regimen reduced the number of injections from seven a week to three. 

	The future of Copaxone is uncertain as Teva is currently dealing with a mountain of debt, following last year’s acquisition of Allergan’s generics business, and the loss of four patents for the drug. Previously, when Copaxone generics were made for the daily injection, 20-milligram dose, Teva could convince patients to switch to the improved 40-milligram Copaxone; now, the switch to a generic 40-milligram version may put a substantial dent in Teva’s annual overall sales of $20 billion.

	Also chosen in 2014 was Korlym, a repurposed medicine targeting Cushing’s syndrome, a rare metabolic disorder caused by the overproduction of cortisol, a metabolic hormone. Two years earlier, Korlym was approved by the FDA as the first-ever treatment for adults with endogenous Cushing’s syndrome. The drug was picked in part for its advancement in treating a condition that is difficult to diagnose. The pathology of Cushing’s can still be unfamiliar to physicians and can be confused with other, less fatal conditions. Korlym decreases the dangerous side effects of the excess production of cortisol, especially high blood sugar, which can lead to diabetes.

	The drug includes a warning label to women that it would terminate pregnancy. Mifepristone, the active ingredient in Korlym, has been used for years, in combination with misoprostol, to bring about abortion.

	Gilead’s one-two punch of oral treatments, Sovaldi and Harvoni, represented a medical breakthrough, curing the liver-ravaging hepatitis C virus (HCV). First-to-launch, Sovaldi, used in combination with ribavirin or interferon, offered a new lease on life for HCV patients, with an over 90% trial-certified efficacy rate. Sovaldi was the first approved all-oral treatment for genotypes 2 and 3 of the virus. Patients with genotype 1 endured shorter treatment time, in combination with interferon, minimizing side-effects with older medicines. 

	Harvoni, approved in 2014, has a shortened duration to cure and a higher efficacy rate than its predecessor, at 95%. The drug filled in the gaps, combining Sovaldi and ledipasvir, a second inhibitor, without the need for interferon or ribavirin. 

	The drop in sales of the breakthrough duo (Sovaldi posted $10.3 billion in US sales in 2014) amid healthcare access, pricing, and sustainability issues is well documented. In 2016, year-end sales reached $3.2 billion, down from $4.9 billion in 2015. This  was also due to Gilead’s newer HCV drug, Epclusa, launched in 2016.

	Nevertheless, the company has built on its HCV innovators with expanded indications. In the last two years, the FDA approved Harvoni in patients with genotypes 4, 5, and 6 for chronic HCV as well as patients co-infected with HIV. Harvoni and Sovaldi were also approved for chronic HCV infection in adolescents without cirrhosis or with compensated cirrhosis.

	Last year’s Brand of the Year went to BMS’s innovative immuno-oncology drug Opdivo, which has launched in three key cancer fields since 2015-melanoma, lung, and renal. Designed to trigger the immune system to attack cancer cells and prevent or slow their growth and spread in the body, Opdivo,a PD-1 Inhibitor, has demonstrated overall survival benefits for patients-and is predicted to impact the head and neck cancer market as well. 

	Commercially, Opdivo pushed ahead of immunotherapy rival Keytruda in the advanced squamous non-small cell lung cancer space (NSCLC). 

recognized Opdivo’s achievement in bridging personalized care and diagnostics in tandem to offer patients better diagnostics for future treatments.

	Opdivo boosted BMS’s sales by $835 million in 2016. The FDA has since approved the drug for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). It was recommended for approval in the same indication by the European Commission by the Committee for Medical Products for Human Use (CMPH), marking the first positive recommendation from CMPH for a PD-1 inhibitor for SCCHN. 

	In February, Opdvio was approved in the US for intravenous use to treat patients with locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. Opdivo’s early run of success, however, has not been without its setbacks. In August 2016, it was revealed that the drug did not meet the primary endpoint in its Phase III trial as a first-line treatment for advanced NSCLC. Upon news of the failure, BMS’s pre-market trading dropped almost 20% that day. While some analysts predict Merck’s Keytruda may overtake Opdivo in sales in the coming years, BMS says it is determined to evaluate the failed bid as first-line therapy and continue to test Opdivo-including in combination with older immunotherapy Yervoy-for NSCLC indications. 

 EAB members do note Keytruda’s potential edge going forward, due to its application across numerous tumor types and lines of therapy, and its combination approaches and synergies with biomarker testing. In March, Keytruda was approved for treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or those who have relapsed after three or more previous types of therapy.

With this year marking our 11th installment, we look back on Pharm Exec's first 10 Brands of the Year-why they were chosen and the challenges, changes, and successes since.

Brand of the Year: A Retrospective

Diagnosing what ails or strengthens performance in the critical corporate discipline of portfolio management-by peeling back the various contributing dimensions-may give pharma companies better clues on business prognosis. 

	Each year, the average person undertakes an annual physical exam in the hope that their trusted physician will either give them a clean bill of health or diagnose problems early enough for intervention. This exercise-applied in the corporate and business discipline setting-could provide similar answers of well-being. But how often in the world of biopharmaceuticals, for instance, do companies, particularly the smaller-to-mid-sized organizations, perform a Portfolio Management health check to diagnose what’s working well and what isn’t, so that leadership can either intervene expeditiously or recommend expeditious intervention?

	One such approach to better making these determinations is through a Portfolio Management capability maturity model (CMM) diagnostic health check. The examination is conducted across nine primary dimensions and 38 sub-dimensions, enabling a company to self-assess its capability maturity levels on each sub-dimension (see Figure 1; click to enlarge).

	Each sub-dimension is supported by a capability maturity question for which there are five possible definitional answers, each of which represents a capability maturity level on a Level 1-5 scale. Once an assessment of each of the 38 sub-dimensions is completed, the organization receives a diagnostic health check report that highlights capability strengths and weaknesses along with a prescriptive assessment of transition plans that describe how to narrow or close competency gaps. Project & Portfolio Value Creation uses its diagnostic wheel to consolidate each sub-dimensional assessment and provides an overview of each capability at the primary dimensional level (see Figure 2 below). To be sure, no organization is positioned to narrow or close all competency gaps in one fell swoop, so it is incumbent on both advisor and organization to determine how much change management the company can embrace and sustain throughout the journey to improve its capability maturity level. 

	Generally, companies are asked to define a future, temporal state (e.g., 12 months from the date of the current diagnostic assessment) and describe its vision for that state in terms of sub-dimensional competency improvement. Transition plans are then created to ensure the organization can attain these competency

 levelsafter which a further diagnostic check is performed to determine if each competency goal has been attained. And, not surprisingly, in the true spirit of 

, this process of competency amelioration and diagnostic assessment is repeated. 

	While a self-assessment is a good first step toward competency self-improvement, knowing where a company stands with respect to its competition in the discipline of Portfolio Management can be just as important to its health. As a further diagnostic step, therefore, companies can undergo a blinded competitive analysis. This allows  comparisons of the company’s capability level relative to the competition (see Figure 3 below). This can be done on both dimensional and sub-dimensional levels. 

	Should a firm be satisfied if  its as good as the top 20% of  the competition on any capability sub-dimension? Likewise, should it be dissatisfied if  roaming with the bottom 20% of the competition? It depends. While knowing where a company stands with respect to its competition is important, the fundamental question should be, “To what extent does my company’s capability position help or hurt its ability to extract the best value possible from its portfolio on an ongoing basis?” Another words, being in the top 20% on any capability dimension may simply not be enough for the company to continue to thrive in the long-term. Rather, the organization may be required to be in the top 5% to help shape the evolving competitive environment, as it charts its own course in fulfilling its intended mission and goals. 

	At the other end of the spectrum, while being in the bottom 20% of the competition on any capability dimension is surely not a satisfying revelation, the marginal gain from improving this dimension may be less than that from improving a dimension in which a company is already in the top 20% of its class.

	Finally, an informative Portfolio Management health check should lead ultimately to a diagnosis of the health of a biopharma company’s portfolio itself. While there are many ways to “cut the data,” a handful of portfolio questions, if well framed, can lead to insightful analysis. These include:

		What does my waterfall value creation look like? This describes what value (e.g., top-line growth) is being created from where (e.g., early stage development assets) along the value chain.

		What does my waterfall resource consumption tell me? This enunciates how much resource is being consumed by each segment (e.g., discovery) of your value chain and, by inference, how efficient each segment is in delivering value.

		How productive are the assets within each segment of my portfolio? This highlights not only which are the most efficient assets but, more importantly, where the point of diminishing marginal returns begins.

		On both a non risk-adjusted and risk-adjusted basis, how close is the consolidated product portfolio and pipeline portfolio to meeting my annual financial goals? This quantifies the extent to which temporal financial gaps exist and helps frame discussions regarding how these gaps may be filled.

		Within each business unit, what levels of budgetary and human resources are being consumed? This determines the extent to which resources may need to be ring-fenced within business units as well as how much competition between business units for marginal resources may take place.

		Within each business unit and across the enterprise portfolio, how balanced is the portfolio in meeting short-, mid-, and long-term expectations? While certain assets within each business unit represent policy investments (e.g., strategic positioning; critical for financial survival; contractual obligations), successful companies position portfolios in such a way that there is a balance between risk and reward, internal and external investments, and short- and long-term gains.

	While personal physical health checks are optional, even if one are supremely fit and apparently healthy, it makes sense to undergo an annual examination so that a diagnosis of any current or impending health problems can be made. Since all corporate disciplines-including Portfolio Management-need to be built, nurtured, and monitored judiciously, it is no wonder that if left unattended, they can become value 

destructive. And, if allowed to march freely to the beat of their own drums, these disciplines can, in fact, become cancerous. 

	For many companies that were once household names or have been acquired and dissolved into obscurity, there are untold stories of poor business decisions that have their roots well embedded in poor Portfolio Management practices. Repairing some of these approaches  may simply come down to not being satisfied with ‘good enough’ being good enough-and asking where-which dimensions–a company can  do better. 

, PhD, is President and Founder, Project & Portfolio Value Creation. He can be reached at 

s Bio/Pharma Strategic Portfolio Management Summit 2017 will be held at the Courtyard Boston in Cambridge, MA, on August 8-9, 2017. 

For pharma, diagnosing what ails or strengthens performance in this critical corporate discipline may help reshape business prognosis.

Portfolio Management  Health Check

Is a fast launch the only path to a high-value product? Surprisingly, the answer is no. A study by The Boston Consulting Group looks at why a pharma brand’s early sales are not a trusted predictor for total lifetime value-it’s about driving waves of growth. 

	In the biopharmaceutical industry, the common wisdom holds that sales in the first few months after a product launch provide a good indication of a product’s destiny. When companies dream of launching a blockbuster, they envision a drug that launches fast, catches on quickly, and generates massive returns in its first year-and for the next 10 years. But is a fast launch the only path to a high-value product? Surprisingly, the answer is no.

	The Boston Consulting Group (BCG) conducted a comprehensive analysis of approximately 300 biopharmaceutical products that launched in the US between 1996 and 2011, and followed their results through mid-2016, which allowed at least five years of post-launch data (see methodology box for additional details). We found that early sales are not a good predictor for total value created over the product’s lifetime. Among drugs with more than $10 billion in lifetime revenue, there are more that started out slowly than 

there are ones that shot out of the gate (See Figure 1 below). A large number of products that have a fast launch (65%) go on to create tremendous value; a fast launch is clearly desirable. But when we analyze all the products that generated significant sales over their lifetimes ($10 billion or more), most (55%) started out slowly. In short, all is not lost if a launch is slow-the key to generating significant value is a long life.

	To demonstrate the value of a long life, BCG selected the 50 products that reached their peak the fastest and compared them to the 50 that reached it the slowest. The products slowest to reach their peak created double the value over their lifetime than those that ramped up the fastest (see Figure 2 at bottom). Being fast out of the gate is not necessarily the key to long-term value creation. Products that manage to stay on the market and continue to grow throughout their long life generate significantly more value, even if they experienced a slow start.

	Although we can’t yet make judgments about lifetime value for products that have launched since 2012, it’s interesting to note that between 2012 and 2015, we observed the same proportion of fast launches to slow launches as was seen between 1996 and 2011. In both periods, approximately 12% of launches were “fast,” meaning they generated $800 million or more (in 2015 dollars) in their first 18 months on the market. This may come as a surprise, as many in the biopharma industry have expressed concern that launches have slowed in recent years. That may yet turn out to be the case, as payer and regulatory pressures continue to mount. It’s also possible that expectations for launches are ratcheting higher as firms seek growth, resulting in higher expectations and, therefore, a higher number of missed targets.

	What’s more, BCG found that the rate of fast launches in oncology is slower than average (about 7% of cancer drugs have fast launches), but many oncology products go on to produce tremendous value, despite slow starts.

	What allows some slow starters to grow and thrive over a long period of time? And how can analysts and launch teams differentiate between a slow starter with blockbuster potential and a slow starter that will never break out?

No two pharmaceuticals perform exactly alike, but product revenue curves typically fall into one of the following four profiles, classified according to a drug’s early results and the lifetime value: 

 These drugs have a slow launch and fail to grow. Many products fall into this category, but it’s not a desirable place to be.

 These drugs have a fast launch but peter out and lose momentum over time. This is fairly uncommon, but it has been seen with biopharmaceutical products that are eclipsed by a competitor like Incivek or face a safety issue like Vioxx.

 This is the typical blockbuster drug, like Advair, Avastin, Lipitor, or Zyprexa. These products launch fast, drive strong sales, and produce significant value over time. Many biopharma commercial teams have this in mind when they picture a successful launch-a straight line that keeps climbing up and up.

 These drugs have slower starts but ultimately create tremendous value. Products like Enbrel, Herceptin, Lantus, Plavix, Remicade, Rituxan, and Singulair fit this profile. Snowballs will produce revenue curves with an S-shape, rather than the traditional straight line trajectory. 

	The slower growth trajectory of a snowball may be an advantage over the long run, but only if the product continues to grow over time; otherwise, it’s just a minnow. So, how do launch teams and analysts differentiate the snowballs from the minnows? 

	We identified three features characterizing the slow on-ramp products that ultimately produce significant value later in life.

 Some new drugs introduced into the market require clinicians or patients to adapt to a new treatment pattern or protocol-and that takes time. But once physicians and patients adapt to the new model, the drug can gain traction very quickly. For example, when the breast cancer therapy Herceptin was brought to market, it was among the first products to require biomarker testing to identify the patients that would benefit from the drug. This testing increased the effectiveness of Herceptin, but it also took years for clear testing guidelines to be released. There was confusion about the best testing methodology and how to interpret results, and uptake was slow. Once testing guidelines solidified and impressive survival data was published, uptake increased significantly, and Herceptin generated enormous value. Similarly, it took time for physicians to move from solely treating with oral

 therapies to prescribe injectable biologics for the treatment of rheumatoid arthritis. Once physicians recognized the unique benefits of the biologics, drugs like Enbrel, Humira, and Remicade transformed into blockbusters. 

Products with expanded indications over time

: In today’s regulatory environment, it’s becoming increasingly rare for a new product to be approved with a very broad indication. Approvals will typically match the specific patient pools that were in the clinical trials. This is especially common in oncology, but it applies to other therapeutic areas as well, and it can contribute to less initial value. If a product receives approval for only one narrow indication (for relapsed or refractory patients, for example), it takes time to conduct additional trials in order to gain approval for its use on other types of patients (such as first-line patients). Drugs that can gradually gain approval for additional indications-or make the case for broader use with strong real-world evidence post-launch-will likely expand into much larger patient pools over time.

Products that lead to longer duration therapy:

 When a product is first approved, the optimal duration of therapy is not always well-defined. But a drug can prove over time that its benefits extend over a much longer time period than originally anticipated. Gleevec is a good example. Used to treat chronic myeloid leukemia (CML), it had a slow launch given that CML is a rare form of cancer that affects just 5,000 to 8,000 patients each year. But Gleevec transformed a fatal disease into a manageable, chronic condition. Patients with a life expectancy of less than five years were able to live for decades, provided that they continued on the therapy. The drug was also approved for additional indications, including gastrointestinal stromal tumors, acute lymphocytic leukemia, and other blood malignancies. By extending the duration of therapy, Gleevec ultimately generated enormous revenue.

	It’s also worth noting that payers are increasingly contributing to a slow on-ramp for new biopharmaceuticals. New products with higher prices, larger patient pools, and potentially longer treatment durations put pressure on payer budgets. In some cases, payers are responding by placing new products onto less advantaged tiers; adding restrictive utilization management criteria (such as step-throughs or prior authorization requirements); and demanding larger discounts on products. While these hurdles can contribute to a slow launch, payer access restrictions can be overcome by products that demonstrate superior clinical value.

Implications for launch teams and analysts

	While these findings offer good news for biopharmaceutical companies in an era where rock stars are becoming harder to achieve (though they still exist, as we’ve seen with Harvoni, Keytruda, Opdivo, and Sovaldi), management teams need to ensure that they appropriately manage products with snowball potential-or risk languishing in the minnow category. 

	At each point in the product’s lifecycle-from the initial launch to peak sales-companies have critical opportunities to influence a product’s success. The key is to anticipate factors that will affect a product’s uptake and manage its lifecycle to shape a strong trajectory (see Figure 3).

	To help snowballs create maximum value over the long term, manufacturers need a targeted strategy that includes four critical components.

Be clear on product differentiation and which patients and physicians the product can win.

 In a crowded market, launch teams need to be specific and precise about which patients their product is appropriate for so they can articulate this to the right physicians. Teams need solid answers to the following questions: 

		Have we adequately clarified how the new product differs from competitors and what unmet need it addresses? What space will it own in the treatment paradigm? 

		Which patient types are appropriate-initially, and then as physicians gain experience? 

		Which physicians disproportionately treat those patients and will see the value of the product?

		What physician and patient behaviors will need to change in order to drive uptake?  How do we support that change and how long will it take? 

		What are the implications of our positioning for our forecast? 

Craft a forward-thinking reimbursement strategy.

 Clearly, the reimbursement landscape has changed significantly in recent years. Payers are placing more restrictions on which biopharmaceuticals they will cover and excluding certain drugs from formularies, even innovative products with best-in-class efficacy. And many physicians are reluctant to prescribe a medicine if their patients face meaningful payer restrictions. The burden is falling on biopharma companies to prove value. In this climate, launch teams need to ask: 

	Do we have a clear, tested narrative that explains the product’s value, supported by data? 

		Are we planning early enough to generate the outcomes data we need to make the case to payers around the product’s value? 

		What innovative contracting and reimbursement strategies can we implement to accelerate product uptake?

		What is the optimal pricing strategy per country and across countries to optimize revenue, given potential access restrictions and price referencing?

Launches can get lost in the checklist. Teams may strive to be so comprehensive in their launch planning that they fail to identify and prioritize the three or four factors most critical to a product’s long-term success. To support smart and adaptive launch, teams must consider:

		Which two or three aspects of our launch will play the largest role in shaping performance for this product-and have we done everything we can to address them?

		Is our implementation plan designed to encourage the necessary behavior changes we need to drive? 

		Do we have a process to track our launch readiness that will ensure we hit milestones but won’t waste resources on low-value activities?

		How will the product be perceived by patient advocates, care givers, and other influencers, including the media and analysts? Do we need to clarify our message to these stakeholders?

 Launch teams tend to focus on what happens with a product right out of the gate, but it pays to plan for the slower uptake that characterizes snowballs. To plant the seeds for long-term growth, companies need to consider the following:

		Have we determined the key barriers to accelerated uptake and addressed those? 

		Are we collecting and leveraging real-world outcomes data that can help further drive uptake and demonstrate value?

	Many of today’s biopharma launches fail to meet analysts’ expectations in their first year on the market-and slow starts create a great deal of anxiety in an industry challenged by patent cliffs, more generics and biosimilars coming to market, and intense scrutiny from payers. While many in the industry tend to assume that skyrocketing sales the first few months after launch represent the best possible outcome, BCG found that many products that reached their peak more slowly ultimately outperformed those that reached their peak more quickly. 

	Launch teams have an opportunity to create extraordinary value for their companies, shareholders, and patients by nurturing high-impact, slow-to-develop products-but it requires a smart strategy and a willingness to play the long game.

is a Senior Partner and Managing Director and 

is a Principal, both in The Boston Consulting Group’s San Francisco office. 

is a Partner and Managing Director with BCG in Los Angeles. 

is a Partner and Managing Director in the firm’s Chicago office. Authors thank Chris Aakre and Colin Salko for contributions.

Study examines why a pharma brand’s early sales are not a trusted predictor for total lifetime value-it’s about driving waves of growth.

Launch for Long-Term Success

	Merck and Co.’s  recently launched, direct-to-consumer (DTC) television campaign for its shingles vaccine Zostavax sees a deliberate change in tone, with the company trying to connect with patients “on a more personal and emotive level.” 

spoke to Patrick Bergstedt, head of global marketing at Merck Vaccines, about  how the campaign evolved and has been received.

How did the creative process differ from others for the new Zostavax campaign, and why?

This ad follows a cascade of disease awareness ads through a variety of media channels that we have created since 2012. These ads were very effective in educating consumers about shingles and encouraging conversations with their healthcare providers (HCPs) about their risk for shingles.

	 Our last DTC campaign featured NFL analyst and former quarterback Terry Bradshaw, who was a great spokesperson. He brought a lot of pizzazz and personality to our shingles awareness efforts.

	 However, based on research we conducted, we know gaps remain in the conversations taking place between consumers and HCPs. When our team looked at our communication efforts for 2016, we asked: “How do we improve coverage rates; how do we improve education; how do we improve awareness; and, finally, how do we improve people taking action against a preventable disease?”

	 We want to do our best to stimulate a full discussion on the vaccine and the disease to help to ensure that patients’ questions are answered. Closing the conversation gap is where we think using branded messaging around the only, currently approved, one-shot shingles vaccine Zostavax comes best into play. We felt that it was time to become a little more serious in our look and our messaging and really get through to people to say to them, “take action.”

Did you feel it was a risk to evoke an ominous tone in the TV ad?

This is certainly a deliberate change in tone, but we don’t see it as a risk. We are trying to connect at a different level, at more of a personal and emotive level, because of the seriousness of the disease and the fact that it is a preventable disease. Out of all the commercials we tested at Merck, the ads featuring “Linda,” the central character of the campaign, achieved the best feedback when tested with the target demographic.

	 Linda represents an everyday person who’s trying to do what she loves doing. A normal healthy person like her is at risk and this disease can be prevented with the only vaccine available to help prevent it-a vaccine that was approved by the FDA more than 10 years ago.

	I think the message from the ad that should resonate with people is the realization, “I am at risk and if I don’t get vaccinated this disease could really impact my life.”

	 The purpose of the voice-over was to add a more personal appeal speaking to the individual. An appeal that says, “you are at risk, please take action.” It’s more of a human touch, and it’s much more direct. I believe the actor who did the voice-over did a fantastic job at conveying that tone and message. 

What has the reaction been to the campaign so far?

Given that shingles can be a very painful experience, we have received numerous unsolicited letters of appreciation from consumers, who, unfortunately, suffered through shingles. In these letters, these consumers shared their own stories and appreciated the education we are providing to the market. And, so far, the initial results have shown an increase in vaccination rates.

Would you feel confident taking this approach with other disease areas?

: There is no question that vaccination rates for relevant disease categories are low among seniors and adults. I think the initial success of this year’s DTC efforts for Zostavax have taught us to take a more serious approach, striving to achieve stronger physician recommendations and driving consumers to take action has been effective. This is certainly something we will consider in future campaigns for our vaccine portfolio.

’s European and Online Editor. He can be reached at 

Columns

New DTC campaign for its vaccine Zostavax uses a more serious, personal messaging approach-as pharmas look to close the conversation gaps between patients and healthcare providers.     

Merck’s Latest Shot Against Shingles

	One strategy for addressing the national outrage over drug pricing is to shift the discussion from “pay-per-pill” to outcomes-based pricing linked to how well a medicine improves patient health  and reduces cost of treatment. Pharma companies are looking to justify prices by tapping payer data systems to document the effect of a new therapy in the real world. 

Payers and pharma companies seek outcomes data for evidence-based reimbursement deals.

Pharmaceutical Executive-05-01-2017

2017 Brands of the Year: 5 Impact Areas

Brand of the Year: A Retrospective

Portfolio Management Health Check

Launch for Long-Term Success

Merck’s Latest Shot Against Shingles

Measuring the Value of Prescription Drugs

Don’t be the Next #Hashtag

Life Sciences' Shifting Sands: 5 Trends that Threaten the Status Quo

New Life in European Drug Pricing Spat

Country Report: Switzerland

Pharmaceutical Executive, May 2017 Issue (PDF)