Merck Receives Positive CHMP Opinion in the European Union for ZEPATIER™ (elbasvir and grazoprevir)

Merck Igea Luca Dezzani


May 27, 2016

Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir). This is an investigational, once-daily, fixed-dose combination tablet that is used for the treatment of adult patients suffering from chronic hepatitis C virus (grazoprevir).

The European Commission will review this opinion from the CHMP. If the Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labelling. This is valid in the 28 countries that European Union members, as well as European Economic Area members, Iceland, Norway, and Liechtenstein. Merck expects that the decision of the European Commission will be made in mid-2016. The company also estimates that the product launches will start in the fourth quarter of 2016 or the first quarter of 2017.

As commented by Dr. Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories: “We are pleased with the CHMP’s positive opinion recommending the marketing authorization of ZEPATIER in the European Union, which marks an important step forward in the European regulatory process. Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”


Entresto® of Novartis given strong Class I recommendation for the Treatment of Heart Failure in both US and EU


May 21, 2016

Novartis’ Entresto® (sacubitril/valsartan) has been given a Class I recommendation, the strongest endorsement, in updated clinical practice guidelines simultaneously released by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in the US, and the European Society of Cardiology in the EU.

Entresto is now a standard therapy for heart failure with reduced ejection fraction (HFrEF) in the US as an alternative to an angiotensin II receptor blocker or an ACE inhibitor, given together with a beta blocker and an aldosterone antagonist. Furthermore, the guidelines call for doctors to switch HFrEF patients with mild to moderate symptoms from ARBs or ACEs to Entresto.

“These strong, swift and broad recommendations by US cardiology organizations, redefine the standard of care for how reduced ejection fraction heart failure is treated. We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies,” said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. “

Patient Engagement: A Key Element in Pharmaceutical Marketing Strategy

Igea Luca Dezzani

Patient engagement.  It’s not a new concept; however, with the advances in digital technologies and the ever-evolving healthcare landscape, services focused on increasing patient engagement have propelled into the market.    

A rather broad term encompassing various types of patient-centered services, a 2013 Health Affairs brief defines patient engagement as a concept that combines a patient’s knowledge, skills, ability and willingness to manage his own health and care with interventions designed to increase activation and promote positive patient behaviors.

Patient engagement is a hot topic in today’s healthcare environment.  Due to mounting evidence that patients actively involved in their health care experience better outcomes and incur lower costs, providers are using patient-centered services as a strategy to accomplish these initiatives.

Everyone from providers to payers to marketers are vying to get on the patient engagement bandwagon.  According to MarketandMarkets, “the patient engagement solutions market is projected to reach USD 16.39 Billion by 2020 from USD 6.68 Billion in 2015, at a CAGR of 19.7% from 2015 to 2020.” 


Opportunities in Patient Engagement

Patient engagement is no doubt on the radar of the Pharma Industry.  A recent Accenture survey discovered that almost 91% of pharma companies plan to provide six or more patient-centered services in the next 2 years.   

Well-executed patient-centered services provide several opportunities for pharmaceutical companies:

  1. Improve patient compliance.  An ongoing challenge within this industry, Capgemini Consulting and HealthPrize Technologies reported that non-adherence costs Pharma an estimated $188 Billion in lost revenue per year in the U.S. alone.  Pharmaceutical companies have the opportunity to provide services that reinforce adherence to medications.    
  2. Address “consumerization” of healthcare.  There has been a shift in power toward the patient.    Patients now view themselves as consumers of healthcare.  As such, they expect to take part in treatment decisions with their providers.  Pharma has the opportunity to have a direct, personal relationship with these consumers by providing services to educate them on treatment options – information they can share with their physicians.
  3. Be a partner in healthcare. Today, it is critical for Pharma to be in partnership with providers, patients and payers.  A 2015 WEGO Health study on patient engagement in the pharmaceutical industry revealed a majority of the participants surveyed did not believe the industry works collaboratively with patients and less than 10% felt that the pharmaceutical industry understands and addresses their needs.  Pharma has the opportunity to change these perceptions by providing tools to bring providers and patients together.      

Platforms for Patient Engagement

  1. Mobile Health Technologies, or mHealth, refers to the use of mobile devices to deliver or receive healthcare and preventive health services.  Pharmaceutical companies can offer interactive mHealth Apps and wearable devices to provide tools for patients to track their own health, adhere to medication schedules, and learn about medical conditions and available treatments.
  2. Patient Portals refer to secured websites patients use to access their electronic health records and related services to their care.  Frost & Sullivan reported that the U.S. patient portal market is expected to reach $898.4 million by 2017.  Patient portals are evolving rapidly to adjust to the needs of patients, becoming available on mobile devices as well.  Pharma can use patient portals to promote specific products, encourage medication adherence, and cultivate a relationship with patients.
  3. Online Patient Engagement Platforms, such as online communities and social media networks, offer pharmaceutical companies an opportunity to engage directly with patients and create the dialogue today’s patients expect.    

Execution of Patient Engagement Solutions

Successful implementation of patient-centric solutions requires a shift in traditional Pharma marketing strategies and a deep understanding of the changing healthcare environment. 

Accenture recently surveyed 10,000 patients from the U.S., U.K., France, Germany and Brazil regarding their needs and experiences with patient services.  There were 5 key findings:

  1. Patients want more help before they are being treated
  2. Patients are generally not aware of services available to them
  3. When patients are aware of services, they use them
  4. Patients value services across all disease states
  5. Patients want healthcare providers to be primary source of information on services available.  Of note, digital channels ranked highly as well. 

To be successful, Pharma needs to address these findings when developing patient services.  It is not enough to just develop a patient service and make it available.  Patients need to know the services exist.  A well-executed patient engagement solution needs to address the right needs, be available at the right time and communicate through the right channels.

Pfizer Announces the Acceptance of European Medicines Agency for Reviewing Marketing Authorization Application for TRUMENBA®

Pfizer Igea Luca Dezzani


May 20, 2016

Pfizer Inc. has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TRUMENBA® (Meningococcal Group B Vaccine) for review. This TRUMENBA has been developed for preventing invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and older. This acceptance of this vaccine can be considered as the beginning of the regulatory review process in the EU.

“The EMA’s acceptance of TRUMENBA’s Marketing Authorization Application brings us one step closer to fighting this uncommon yet life-threatening disease worldwide, by helping to protect adolescents and adults who are at risk to contract meningococcal disease caused by serogroup B. At Pfizer we are committed to providing innovative vaccines that help people live the longest, healthiest lives possible,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc.

This MAA for TRUMENBA is based on a clinical trial dataset of nearly 20,800 adolescents and adults aged 10 years and older, which was studied at the global level. This dataset reveals the consistency of immune responses induced by vaccine to diverse disease-causing MnB strains and the well-studied tolerability and safety profile.


Bristol-Myers Squibb and AbbVie Announce the Approval of Empliciti™ (elotuzumab)by European Commission for the Treatment of Multiple Myeloma


May 11, 2016

Bristol-Myers Squibb Company and AbbVie has announced that the European Commission has approved Empliciti™ (elotuzumab) for treating multiple myeloma as combination therapy with dexamethasone and Revlimid® (lenalidomide) in patients who have received at least one prior therapy. Now, Empliciti is the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU).

“At Bristol-Myers Squibb, we are committed to delivering pioneering medicines with the goal of revolutionizing the way cancer is treated for patients who inspire our work each and every day. With the approval of Empliciti in the EU, we are proud to extend our Immuno-Oncology science to multiple myeloma patients in Europe who have received at least one prior therapy,” said Emmanuel Blin, senior vice president and head of Commercialization, Policy and Operations, Bristol-Myers Squibb. “

Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie, commented: “Empliciti represents an important new treatment option for patients with multiple myeloma and healthcare providers who are treating this cancer in Europe. AbbVie is proud to be part of the team that developed Empliciti and pleased to be partnering with Bristol-Myers Squibb to bring this new therapy to previously treated multiple myeloma patients.”

European Commission Approves the Immuno-Oncology Combination, Opdivo® (nivolumab) + Yervoy® (ipilimumab) Regimen of Bristol-Myers Squibb, for Treatment of Advanced Melanoma

BMS Igea Luca Dezzani


May 11, 2016

Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Opdivo in combination with Yervoy for treating advanced (unresectable or metastatic) melanoma in adults. This combination represents the first and only approved combination of two Immuno-Oncology agents in the European Union (EU). Due to this approval, it has become legitimate to market Opdivo + Yervoy Regimen in all 28 Member States of the EU.

Dr. James Larkin, from The Royal Marsden and lead author on CheckMate – 067, the trial that led to this approval, said: “Historically, advanced melanoma has been a very difficult-to-treat disease. Now, with this approval, patients in Europe will have a treatment option combining two Immuno-Oncology therapies, Opdivo and Yervoy, which in a Phase 3 randomized trial has shown its ability to deliver superior efficacy versusYervoy monotherapy in progression-free survival and response. This is truly good news for healthcare providers and the patients they treat, as it represents an important new treatment option with the potential for improved outcomes.”

“Today’s approval of the Opdivo + Yervoy Regimen for advanced melanoma patients supports our goal of developing innovative treatment approaches that have the potential to improve patient outcomes. The Opdivo + YervoyRegimen is the first and only approved Immuno-Oncology combination, and only Regimen to deliver superior efficacy compared to Yervoy, and we are thrilled to make this novel combination treatment available to patients with advanced melanoma in Europe,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb.

Global Healthcare Expenditure in 8 Graphs

healthcare expenditure Igea Luca Dezzani


Healthcare expenditure is the sum of all expenses for products and services related to healthcare in a nation. It includes expenses for drugs, therapeutic procedures, emergency health services, and public service initiatives like family planning, disease prevention, and nutrition. The figure includes all public and private healthcare expenditures in the nation. The major sources for these expenditures are medical insurance, welfare services, and out-of-pocket expenses.

Healthcare expenditure is an important indicator of the development status of a nation. It informs important decisions related to policy, aid, and investment. Furthermore, the size, growth rate, and nature of healthcare spending in a nation is a critical driver for industries like pharmaceuticals, insurance, and medical care.

An analysis of the top-50 nations with the highest healthcare expenditures reveals a huge disparity in the distribution of healthcare spending in the world. In 2014, these top-50 nations were home to 75% of the global population, but accounted for over 96% of the global healthcare expenditure. The top-20 nations had 56% of the population, but 87% of the healthcare expenditure; while the top-10 nations with just 32% of the population accounted for 75% of the global healthcare expenditure. In fact, U.S., which accounted for just 4% of the global population, alone accounted for 39% of all the healthcare expenditure in the world in 2014.

However, the situation is improving. Between 2005 and 2014, the global population increased an annual rate of 1.21%. In the same period, healthcare spending in the world increased at an annual rate of 5.88%. Rapid increase in healthcare spending is dramatically improving access to healthcare worldwide. In fact, China and India, which together account for over a third of the global population, had two of the highest growth rates for healthcare expenditures in the world.

The raw data for healthcare spending, public sector contribution to healthcare, and out-of-pocket expenses, of these 50 nations for all years between 2000 and 2014 can be downloaded here.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

The U.S. spends the highest amount for healthcare in the world. It was responsible for 39% of all healthcare expenditures in the world in 2014. In fact, in 2014, the healthcare expenditure in U.S. was larger than the combined healthcare expenditures of the 10 nations that follow it!


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

However, in terms of 10-year growth rate, China emerges at the top the list. Healthcare expenditure in China grew at a compound annual growth rate (CAGR) of 20.67% between 2005 and 2014. Other nations at the top of this list are three of its four BRICS peers.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

Healthcare expenditures in the U.S. is highly inflated. The average annual per capita healthcare expenditure in the U.S. was USD 9,402.54 – over 9 times higher than the global average of USD 1,060.57.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

And the highest increase is, again, for four of the five BRICS nations.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

Public contribution to healthcare expenditure is an important component of welfare services. This list is dominated by European nations with a long tradition of universal healthcare.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

China is stepping up its game in this field. The growth rate in U.S. too is close to three times the global average.

healthcare expenditure Igea Luca Dezzani


Source: World Bank.

Out-of-pocket healthcare expenditures are direct payments by individual patients for drugs and medical services. High out-of-pocket expenditures are not great. They are an indication of inefficient and inadequate healthcare support. India toped this list in 2014 with a large margin. 62.42% of all healthcare expenditure in India in through out-of-pocket expenses – substantially higher than the global average of 18.30%.


healthcare expenditure Igea Luca Dezzani

Source: World Bank.

The growth of the proportion of out-of-pocket healthcare expenditures across the world has stagnated, growing at an annual rate of just 0.15% between 2005 and 2014. In fact, it’s rapidly dropping in most nation, as access to organized healthcare and medical insurance improves, and decrease the need for out-of-pocket expenditure.



Source: World Bank.


FDA Grants Priority Review for Supplemental Biologics License Application of Amgen for BLINCYTO® (Blinatumomab)

Amgen Igea Luca Dezzani


May 3, 2016 

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for including new data supporting the treatment of adolescent and pediatric patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

“Children and adolescents with ALL who experience a second or greater relapse or are refractory often have a dismal prognosis with survival rates below 10 percent. The FDA’s acceptance of the sBLA submission for BLINCYTO reinforces immunotherapy as a potential option for children in need of new treatments to fight this complex disease and help prevent further relapse,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

Priority review is assigned to applications for drugs that treat serious conditions. Furthermore, if approved, it would provide substantial improvements in the effectiveness or safety of the treatment, diagnosis or prevention of severe conditions. The target action date of the Prescription Drug User Fee Act (PDUFA) is Sept. 1, 2016.

ALL is a rapidly progressing and rare type of cancer of the blood and bone marrow impacting both children and adults. In fact, it is the most common type of cancer in children. Of the approximately 2,500 U.S. children and adolescents diagnosed with B-cell precursor ALL each year, around 15-20 percent (375-500) will experience relapse or fail to achieve recovery.

Taltz® (ixekizumab) Now Available in the U.S. for Treating Plaque Psoriasis


May 2, 2016

Eli Lilly and Company has announced that Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis is now available in the United States by prescription order through a contracted network of specialty pharmacies. Patient support programs are also offered by Lilly for ensuring that eligible patients have access to Taltz and available resources. U.S. FDA approved Taltz in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systematic therapy.

“Many people with moderate-to-severe plaque psoriasis are searching for a treatment that will help them achieve high levels of clear skin. With Taltz now available, physicians and patients have a new treatment option that may help patients experience virtually or completely clear skin. Lilly is committed to providing education and resources to help make Taltz accessible to people with moderate-to-severe plaque psoriasis,” said Alex Azar, president, Lilly USA, LLC.

According to Randy Beranek, president of the National Psoriasis Foundation: “The availability of new treatments like Taltz is vitally important for patients with moderate-to-severe plaque psoriasis. The effects of psoriasis can vary among patients and what works for one patient may not work for another. We are happy to see more options available so patients can continue treating this very difficult disease.”

Novartis Separates its Pharmaceuticals Division into two business units: Novartis Oncology and Novartis Pharmaceuticals


May 17, 2016

Novartis has announced that it has created two business units reporting to the CEO: Novartis Oncology and Novartis Pharmaceuticals. The Innovative Medicines Division at Novartis will be formed by these business units. The Executive Committee of Novartis (ECN) will be effective from July 1, 2016, and the leader of each business will join this committee. Bruno Strigini will become CEO of Novartis Oncology and Paul Hudson will be appointed as CEO of Novartis Pharmaceuticals. Both will report directly to CEO of Novartis, Joseph Jimenez. In the meantime, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis.

Following the successful integration of the oncology assets acquired from GSK, the new structure reveals the importance of oncology to Novartis. The company expects increased focus and improved execution for both the Novartis Oncology and Novartis Pharmaceuticals business units, which will help drive its growth and innovation strategy.

Novartis will continue to have three focused, customer-facing divisions from July 1, 2016: Innovative Medicines (formerly the Novartis Pharmaceuticals division), which will include the Novartis Pharmaceuticals and Novartis Oncology business units; Alcon, the eye care devices division, which includes the Surgical and Vision Care franchises; and Sandoz, the generics and biosimilar division, which includes the Retail Generics, Anti-Infectives and Biopharmaceuticals franchises. Novartis Institutes for BioMedical Research, Global Drug Development and Novartis Operations, which includes Technical Operations and Novartis Business Services, will continue supporting these three divisions.