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Galapagos and AbbVie Expand Collaboration to Include Crohn's Disease Program

galapagos

Today, Galapagos NV and AbbVie announced that the companies will extend their GLPG0634 clinical development collaboration to include Crohn’s disease.

Under the collaboration, Galapagos will fund and complete a Phase II program in Crohn’s disease. The Phase II program is designed for swift progression into Phase III. Once the company successfully completes the study, AbbVie will pay Galapagos $50 million. The agreed upon terms of the extension are in addition to financial terms previously agreed upon between the two companies. Once progressed beyond Phase II development, AbbVie will be responsible for funding and performing clinical development as well as completing regulatory and commercialization activities.

Initiation of the Phase IIA/B study is expected in early 2014, which will evaluate GLPG0634 for 20 weeks in 180 patients with Crohn’s disease. The study is designed to measure both induction of disease remission and early maintenance of its beneficial effects in Crohn’s disease. Topline results are expected in second quarter 2015. The Phase II study in Crohn’s disease will be performed in parallel with the Phase IIB study in rheumatoid arthritis (RA).

“AbbVie supports the start of this innovative study in Crohn’s disease with GLPG0634. Our experience with gastroenterology combined with a novel alternative treatment for this disease may provide a greater benefit to patients in the future,” Scott Brun, MD, Vice President, Pharmaceutical Development at AbbVie said in a statement.

Crohn’s disease is a serious chronic, inflammatory autoimmune disease of the gastrointestinal tract. It affects millions of people worldwide. GLPG0634 is an orally-available, novel Janus Kinase (JAK) inhibitor, which specifically targets JAK1. JAKs are a family of enzymes that are key in the signaling mechanism used by several cytokines involved in autoimmune diseases.  JAK inhibitors have the potential to become an effective treatment options for Crohn’s with their immune-modulating effects. By inhibiting JAK1, GLPG0634 blocks signaling for several key pro-inflammatory cytokines, while avoiding the inhibition of JAK2, which is beneficial for patients with Crohn’s disease. Previous clinical trials have shown that inhibiting JAK2 can cause anemia and reduced formation of the blood cells, which is a concern for patients with this disease since blood loss through gastrointestinal bleeding already often times causes anemia in these patients. This suggests that the investigational drug may have a better safety profile than other JAK inhibitors.

According to the companies, GLPG0634’s program scope will be expanded into inflammatory bowel disease.

Source: Galapagos NV

Last Updated: 5/17/13; 3:40PM EST

Unraveling Accreditation, Certification, and Certificate Programs

SP

When it comes to the approval or designation of individuals and organizations the terms accreditation, certification, and certificate are all commonly used and misused. Understanding the differences leads to a better understanding of professional credentialing. 

Accreditation 

Accreditation generally applies to an organization (as opposed to a person).  Accreditation can be awarded to a college, a factory, a laboratory, or in this case – a certification program. The Institute of Credentialing Excellence (ICE) defines accreditation as it relates to certification programs as a “voluntary process by which a nongovernmental agency grants a time-limited recognition to an institution, organization, business, or other entity after verifying that it has met predetermined and standardized criteria.”

Accreditation is relevant to specialty pharmacists in many ways: accreditation of pharmacy degree programs, accreditation of continuing education activities for re-licensure, accreditation of pharmacies and accreditation of the entities (Certification Boards) that certify pharmacists. URAC accredits both health care organizations and specified functional areas within the health care organizations. The Joint Commission (JCAHO) accredits a range of health care organizations including hospitals, doctor’s offices, and nursing homes. Often, accreditation of a facility (such as a pharmacy or hospital) requires personnel certification as one aspect of accreditation compliance. For example the American Nurses Credentialing Center Magnet Recognition Program includes the percent of certified nurses its evaluation process. 

Accreditation of Pharmacy Degree Programs 

The Accreditation Council for Pharmacy Education (ACPE) is, according to the ACPE web site, the “national agency for the accreditation of professional degree programs in pharmacy and providers of continuing pharmacy education.” ACPE, like many other organizations that accredit educational institutions or programs, is recognized by the US Department of Education (USDE). 

Accredited Pharmacist Certification Programs 

Accreditation for certification programs is offered by two organizations: the American National Standards Institute (ANSI) and the National Commission for Certifying Agencies (NCCA). Both ANSI and the NCCA have established standards for professional certification programs. Certification programs that apply and document compliance with either the NCCA or ANSI standards are considered to be “accredited certification programs.” This accreditation demonstrates that the certification program is developed and maintained in keeping with best practices. Achieving accreditation is considered the “gold standard” for certification programs.

In the pharmacy industry several certification programs are NCCA accredited, including the Board of Pharmacy Specialties, Commission for Certification in Geriatric Pharmacy, and the Pharmacy Technician Certification Board. The newly formed Specialty Pharmacy Certification Board is developing its Certified Specialty Pharmacist (CSP) program to meet the NCCA accreditation standards. 

Certification 

The NCCA Standards define certification as an often voluntary process by which individuals who have demonstrated the level of knowledge and skill required in the profession, occupation, role, or skill are identified to the public and other stakeholders. All professional certification programs share the following common elements:

  • Certification is time-limited, meaning that the certified individuals must periodically renew or recertify.
  • Certification measures individuals to a pre-determined standard using an assessment, which is most often a standardized exam.
  • Certification is usually voluntary
  • Certification is independent of any one class, course, or training program

Certification programs can be identified by these common elements. If it has a rigorous and standardized exam, an expiration date with required recertification, and eligibility requirements that are not tied to any one training or education program – then it’s probably a professional certification program. Individuals who successfully become certified are granted use of the associated acronym. 

Certificate Programs 

There are many types of certificate programs, but the type most often confused with certification is an assessment-based certificate program – a certificate course that includes a test. By definition, assessment-based certificate programs require completion of a training program or coursework followed by a test or some other demonstration that they met the course objectives.  Certificate programs are often used for continuing education.

The table below illustrates these three credentialing methods: 

Accreditation 

Certification 

Certificate 

Examples 

Accreditation Council for Pharmacy Education 

Certified Pharmacy Technician 

Certified Specialty Pharmacist 

Certified Ambulatory Care Pharmacist 

CPR, First Aid 

Pharmacy-Based Immunization Delivery Certificate 

Applies to 

Organizations/Companies 

Individuals 

Individuals 

Purpose 

Evaluates an entity or degree program against a set of standards 

Tests knowledge and skills related to a specific profession 

Provides training and instruction

Provided by

National associations or non-profit organizations accrediting agencies

National certification boards

Associations, membership organizations, training programs

Relationship to education

Involves evaluation of an educational program or institution

May or may not require education (such as a pharmacy degree) for eligibility. Education is not tied to any one course or provider.

Requires completion of a specific course or training program.

Examination

Not applicable

The Exam measures knowledge and skills required to perform a specific job. Examination is based on a job task analysis study, recognized subject matter experts participate in developing and reviewing the exam, generally accepted psychometric principles are used to develop the exam content, establish the passing score, and analyze test data

The end of course test focuses on the course learning objectives. The test is developed using recognized instructional design practices.

Renewal

Required

Required

Not required

 

References

Institute for Credentialing Excellence (2005). The ICE Guide to Understanding Credentialing Concepts. Washington, DC.

Institute for Credentialing Excellence (2006). NOCA’s Basic Guide to Credentialing Terminology. Washington, DC.

 

http://www.pharmacycredentialing.org/ccp/

National Association of Specialty Pharmacy™ (NASP™) appoints Mark Montgomery, CEO, Axium Healthcare Pharmacy, to Board of Directors

Mark Montgomery

 

TAMPA, Fla., May 16, 2013—The National Association of Specialty Pharmacy™ (NASP™) announced today that Mark Montgomery, President and Chief Executive Officer (CEO) of Axium Healthcare Pharmacy, Inc., has joined the NASP Board of Directors.

Montgomery has more than 25 years of experience in the specialty pharmacy sector of the healthcare industry.  He joined Axium in 2003 as Vice President/General manager overseeing the company’s daily operations and was promoted to President in 2005.  Prior to joining Axium, Montgomery played instrumental roles while employed with leading national specialty pharmacy providers including Accredo Health and Caremark.

Throughout his career, Montgomery has championed the concept of achieving success by achieving the highest standards of outcomes for all specialty pharmacy stakeholders from patients, providers, and payers to manufacturers.

“An organization must focus on specialty pharmacy innovation through people and solution-based methodologies, which involves choosing the right people and the right technologies necessary to redefine how specialty pharmacy is done,” Montgomery said. “This is the same focus that NASP has and serving on the NASP Board of Directors is an exciting opportunity to lend my knowledge and experience to this important task.”

Montgomery also serves on the Board of Directors of the Avant Healthcare and Florida Hospital Cardiovascular Institute, and is accredited by the Accreditation Commission for Health Care (ACHC). He is also a member of the Executive Committee for the 2013 March of Dimes, and actively participates in many Central Florida organizations. In 2012, Mark was recognized as one of the “Top 30 Most Influential People in Specialty Pharmacy” by Specialty Pharmacy Times.

“Mark’s leadership experience in the specialty pharmacy industry will help shape the future direction of this field and contribute to the success of our association,” Gary M. Cohen, BSPharm, RPH, NASP CEO and Co-Founder, said.

NASP, founded in 2012, represents specialty pharmacy professionals in all practice settings and highlights the unique value its members bring to patients and the healthcare system by focusing on building collaboration among all industry associations to improve patient outcomes.  Specialty pharmacy is the fastest growing segment in the industry today and NASP provides valuable benefits to members by creating a strong, unified voice for all stakeholders. Through the Specialty Pharmacy Education Center (SPEC), NASP will be the most comprehensive online source of education specific to specialty pharmacy.  SPEC will also provide education needed to earn and maintain professional certification through the Specialty Pharmacy Certification Board (www.spcboard.org).

Source: National Association of Specialty Pharmacy (www.nasprx.org)

Media Contact: Gary Cohen, This e-mail address is being protected from spambots. You need JavaScript enabled to view it

National Association of Specialty Pharmacy™ (NASP™) Launches the Specialty Pharmacy Education Center™ (SPEC™)

NASP SPECTAMPA, Fla., May 15, 2013—The National Association of Specialty Pharmacy™ (NASP™) announced that the Specialty Pharmacy Education Center (SPEC), an online educational school focused on both clinical and business-related content in more than 20 therapeutic categories, launched today. NASP members enjoy complimentary access to SPEC courses.

“SPEC will transform specialty pharmacy education and training for professionals working in this growing area of the pharmacy industry and allow professionals to expand their knowledge and skills to improve patient outcomes,” Emile J Guillot, BS, Executive Vice President of SPEC, said. “An educated workforce helps to protect the public by improving health outcomes and reducing medication errors.”

SPEC provides educational programming for all healthcare professionals and provides enhanced career development opportunities, including preparation for certification as a Certified Specialty Pharmacist ™ (CSP™, http://www.spcboard.org/).  The goal of the content, developed by leaders in specialty pharmacy and the various therapeutic categories, is to create an awareness of the quality of life issues for the specialty patient and the care management programs to address them.

“Given the fact that 50 percent of the drug spend into the foreseeable future is specialty pharmaceuticals, education is needed for the various stakeholders working together in a collaborative environment in the pursuit of improved outcomes and quality measures,” Burt Zweigenhaft, CEO, Onco360™ and NASP Board Member, said.

“The programs that went live today are only the tip of the iceberg,” Guillot stated. SPEC is currently developing more than 250 hours of specialty pharmacy education with more than 75 faculty experts from pharmacy schools and specialty pharmacies. Each therapeutic area offers a certificate program, and will also qualify for educational requirements for taking the CSP exam, which will be offered in October of this year.

“The content launched today provides participants with a deeper knowledge into rare diseases, drug therapies and specific specialty drug nuances,” Gary M. Cohen, BSPharm, RPh, NASP CEO, said. “One of the most important benefits of NASP membership is complimentary access to this unmatched educational resource.”

NASP, founded in 2012, represents specialty pharmacy professionals in all practice settings and highlights the unique value its members bring to patients and the healthcare system.  Specialty pharmacy is the fastest growing segment in the industry today and NASP provides valuable benefits to members by creating a strong, unified voice for all stakeholders.

Source: National Association of Specialty Pharmacy (www.nasprx.org)

Media Contact: Gary Cohen, This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Study Shows Variance in Initiatives with Specialty Drugs by Health Plan Type

avalere janssen

According to a new study conducted by Avalere Health LLC commissioned by Janssen Biotech, Inc, and Johnson & Johnson Health Care systems, ensuring appropriate use of specialty drugs is a major priority for health plans and will become increasingly important over the next three to five years for future growth. Express Scripts’ report estimated that spending on specialty drugs is expected to grow at 20 percent due to the growth of specialty drugs in medical innovation. This represents a major cost driver for health plans and employers.

This new study is the first in a series of DIMENSIONS of Specialty Pharmaceuticals: Evolving Trends in Market Access. In this study they found that there was a significant variance between national, regional, and integrated systems (IDS) health plans’ view of emerging opportunity areas in this field. The study consisted of 90 respondents engaging in more than 800 activities to manage appropriate use and costs associated with specialty drug utilization.

The study focused on two specific questions: How is access to specialty pharmaceuticals evolving? What kind of initiatives and activities are organizations pursuing to ensure appropriate access to and utilization of these products?

Among the respondents, the researchers found that national plans perceive opportunity areas to be more mature than other plans. Almost all national plans report progress in the integration of delivery system changes; site of care optimization; medication adherence; innovative contracting arrangements; and design benefit and utilization management into specialty pharmaceutical management practices.

When asked why regional and IDS plans are moving slower at pursuing these activities, Leigh-Ann Bruhn, Director at Avalere Health told SpecialtyPharmaJournal, “For the limited instances in which health plans are not involved in emerging opportunity areas, they most commonly cite barriers related to internal variables and value demonstration. For regional plans, lack of organizational interest and the existence of more promising investments are the most frequently cited hurdles, followed by lack of integration within a plan and insufficient IT infrastructure. Similarly for IDSs, high cost, lack of organizational support, and insufficient IT infrastructure are the top reasons for abstaining from an opportunity area. Barriers must also be considered within the context of state insurance requirements and existing contract obligations.”

According to the study, IT infrastructure is a high priority for national plans and IDSs, however nearly a third of regional plans report active investment in IT.

“IT is a growing sector in our industry, especially with the rapid rate at which mobile technology continues to evolve and improve the way we all conduct business,” John Unger, Group Product Director, Payer Marketing at Janssen Biotech Inc. said. “In the DIMENSIONS survey report, the output of a first-of-its kind study that Janssen Biotech and Johnson & Johnson Health Care Systems commissioned through Avalere Health, LLC, we learned that 95% of national plans and 93% of Independent Delivery Systems are prioritizing IT infrastructure versus only 30% of regional plans.”

The study also found that payers are seeing delivery system changes as an area of investment. Approximately 45 percent of national plans report them as established, whereas regional and IDS plans report them as emerging at a rate of 93 percent and 94 percent respectively.

“The research shows that payers are investing in a variety of delivery system changes, including acquisition of provider systems, payer/provider contacts for Centers of Excellence (COE) or preferred treatment site for specialty services, ACO partnerships (with and without risk), and shared savings programs,” Bruhn stated. “Interestingly, contracts for COE were the most often highly rated activity across all 45 activities explored in this research.”

All three health plan types rated provider acceptance as the number one critical success factor for new initiatives. “This is a key finding from the DIMENSIONS research. Now that this is clearly in focus, how to obtain better rates of provider acceptance is a natural follow-on question that is ripe to explore in the future,” said Bruhn.

Source: Dimensions of Specialty Pharmaceuticals: Evolving Trends in Market Access

Last Updated: 5/15/13; 11:30AM EST