MedImmune expects to provide approximately 15 –16 million doses of its trivalent (three-strain) nasal spray flu vaccine for the 2011-2012 influenza season through a variety of private health care practices, public health departments, school-located vaccination programs, military bases, and other venues. Healthcare professionals should refer to FluMist prescribing information for appropriate administration.

FluMist is indicated for eligible individuals 2-49 years of age. The most common side effects of FluMist are runny or stuffy nose; sore throat and fever over 100°F.

This year, flu vaccines contain the three strains recommended by the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and World Health Organization (WHO), including the 2009 H1N1 pandemic strain.

The CDC recommends that flu vaccine be administered to eligible recipients aged six months and older every year as soon as the vaccine becomes available. A MedImmune analysis looking at pediatric populations suggests that starting influenza vaccinations as soon as product is available (July – September) — months earlier than the typical influenza vaccination season — may help reach an additional 10.5 million children at already-scheduled healthcare provider visits.

“MedImmune is committed to supporting public health efforts to initiate seasonal influenza vaccination as early as possible each year, greatly widening the window of opportunity for vaccination,” said Steve Projan, Ph.D, MedImmune’s Senior Vice President, Research & Development. “The data show that vaccination with FluMist in the late summer helps protect against influenza throughout the influenza season, even into the late spring.”

FluMist is available in every state, except South Dakota, through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children. FluMist is also available on the Vaccine for Adults contract allowing state and local immunization programs to access the vaccine at the public-sector price for community vaccination programs focused on young adults and immunization of first-responders and healthcare workers.

Based on a nationally-representative sample of private insurance claims from approximately 50 percent of US patients, FluMist accounted for 34 percent of seasonal influenza vaccinations given to children two through 18 years of age during the 2009-2010 season. FluMist is covered by approximately 99 percent of private health plans which offer immunization benefits.

Important Safety and Eligibility Information for FluMist

What is FluMist^® (Influenza Vaccine Live, Intranasal)?

FluMist is the first and only nasal spray flu vaccine approved in the United States to help prevent influenza and is indicated for the active immunization of eligible individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.  

Who may not be able to get FluMist?

You should not get FluMist if you: are allergic to eggs, gentamicin, gelatin, or arginine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin–children or adolescents should not be given aspirin for 4 weeks after getting FluMist unless your healthcare provider tells you otherwise. Children under 2 years old should not get FluMist because there is a chance they may wheeze (have difficulty with breathing) after getting FluMist.

Tell your healthcare provider if you: are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.

They will decide if FluMist is right for you.

What are the most common side effects of FluMist?

The most common side effects of FluMist are runny or stuffy nose; sore throat; and fever over 100 degrees F.

Please see accompanying complete product information, including patient information at www.medimmune.com.

For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

Background

Children have the highest rates of influenza infection and school-aged children are the major vectors for influenza transmission that spread the virus to adults and the elderly in the community, causing substantial socioeconomic impact.1 For these reasons, the U.S. Centers for Disease Control and Prevention (CDC) recommends annual seasonal influenza vaccination for all eligible persons in the U.S., including eligible children aged 6 months through 18 years of age.2 Despite this, vaccination rates for school-aged children 5 to 17 years of age remain low, ranging from 24.6% (healthy) to 34.7% (high-risk) in the 2008-09 influenza season.2

To increase seasonal influenza vaccination rates, stakeholders have explored new immunization strategies including the routine vaccination of school-aged children.3 Previous research has demonstrated that increased vaccination of children could modulate the spread of influenza in the community. Mass vaccination programs in schools have demonstrated both direct benefits to immunized children and indirect benefits to the community including reduced school absenteeism due to influenza.4,5,6

An example of the benefits of influenza vaccination in school settings is:

• The Knox County (Tennessee) Health Department demonstrated program feasibility in a large public school system by vaccinating 24,198 students (56% among elementary schools, 45% among middle schools, and 30% among high schools) and 3,626 school staff from October to December 2005.7 Similarly, three Minnesota county health departments vaccinated 41% of all school children (K-12) in 2006. The study reported that school-based immunization programs offer the potential to achieve higher vaccination coverage of school children at modest cost.8

Past research supports the feasibility and benefits of conducting school-based influenza vaccination programs in terms of increasing vaccination in children, reducing school absenteeism and protecting the community from influenza. To help ensure pandemic preparedness and to establish an infrastructure for seasonal influenza vaccination of children, states should adopt school-based influenza vaccination programs to protect the public health.

1 Neuzil KM, et.al. Illness among schoolchildren during influenza season: effect on school absenteeism, parental absenteeism from work, and secondary illness in families. Arch Pediatr Adolesc Med 2002;156:986-991.
2 At http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0729a1.htm?s_cid=rr59e0729a1_w. August 10, 2010.
3 Longini IM and Halloran ME. Strategy for distribution of influenza vaccine to high-risk groups and children. Am J Epidemiol 2005;161:303-306.
4 Principi N, et al. Socioeconomic impact of influenza on healthy children and their families. Pediatr Infect Dis J. 2003:22:S207-10.
5 Wiggs-Stayer KS, et al. The impact of mass immunization on school attendance. J School Nursing. 2006;22:219-222.
6 Davis MM, King JC, Moag L, et. al. Countywide school-based influenza immunization: direct and indirect impact on student absenteeism. Pediatrics 2008;122:e260-e265.
7 Carpenter LR, Lott J, Lawson BM, et. al. Mass distribution of free, intranasally administered influenza vaccine in a public school system. Pediatrics 2007;120:e172-e178
8 Hull HF, Frauendienst RS, Gundersen ML, et. al. School-based influenza immunization. Vaccine 2008;26:4312-4313.

Download POSITION ON SCHOOL-BASED INFLUENZA VACCINATION PROGRAMS (PDF, 50.7KB)

Background

“Biologics” are complex medicines that are reviewed and approved by the U.S. Food & Drug Agency (FDA) under the provisions of the Public Health Service Act (PHSA) for use in the United States. The “biological standard” for approval requires demonstration that a biologic is “pure, potent, and safe” and that its manufacturing facility is designed to assure the product continues to be pure, potent, and safe. The recent passage of the Patient Protection and Affordable Care Act (PPACA) established a foundation for biosimilars to enter the U.S. marketplace. While the PPACA created a general framework, the law also provides FDA authority to establish rules and guidance that will govern the specific requirements and procedures for reviewing and approving biosimilars.

The terms “biosimilars” (also called “follow-on biologics”) refer to products that are intended to copy previously-approved, innovator biologics and are submitted for approval based on similarity to the innovator product. Biosimilars are fundamentally different from small molecule generic drugs, which are virtually identical versions of innovator products and can readily be characterized by comparison of the exact chemical composition to the innovator product. As such, even without clinical trials to show safety and efficacy, generic drugs are usually designated to be “therapeutically equivalent” with the innovator drug and therefore interchangeable under FDA generic regulations. Conversely, while a biosimilar may be similar to an innovator product, it currently cannot be proven to be identical based on the current state of science. Thus, there are unique and inherent characteristics of biologics that must be considered as FDA establishes a regulatory pathway for biosimilars:

• Biologics are manufactured using live cells and biologics, such as monoclonal antibodies manufactured by MedImmune, are larger and more complex than small molecule drugs.
• Biologics are more difficult to characterize using laboratory techniques and have a more complex manufacturing process.
• Every biologic is different – even slight differences between biosimilars and innovator biologics, including their manufacturing processes, can result in meaningful differences in the safety and efficacy profile of the products.

What we believe

We support a regulatory pathway for biosimilars that is based on patient safety, product efficacy and continued incentives for innovator companies to invest in the development of novel, life-changing biologic medicines. We believe a biosimilars pathway should ensure:

• Appropriate rigorous scientific standards and a robust regulatory review process;
• A determination that biosimilars demonstrate the purity, potency and safety of innovator biologics as proven through human clinical trials and post-market surveillance; and
• Implementation of effective innovator regulatory exclusivity and patent enforcement provisions.

Below is a detailed look at our position:

Patient Safety
Because of the complexities of biologics, we believe that patient safety must be paramount when evaluating the approval of biosimilars. The introduction of biosimilars into the marketplace must ensure the current purity, potency, and safety standards established for innovator products by FDA. In addition, because the manufacturing process can have a significant impact on a biologic’s structure and activity, a regulatory pathway should ensure a rigorous inspection and control process for the manufacture of biosimilars that is similar to the innovator product standards

Clinical Trials
We believe that all biosimilars applicants should be required to conduct clinical trials that demonstrate sufficiently similar product safety, efficacy and immunogenicity relative to the innovator product. Non-clinical methods of characterizing complex biotechnology drugs have not matured to the point where they can substitute for clinical studies. Therefore, to ensure patient safety, it is essential for biosimilar sponsors to demonstrate product safety and efficacy by testing their product in adequate and well-controlled clinical studies. Furthermore, immunogenicity testing in human subjects, an integral part of biologics drug development, is critical to help measure potential adverse immune response to the biosimilar product. Immunogenicity has been associated with allergic or anaphylactic reactions, as well as reduction in efficacy or autoimmunity. We believe the FDA should issue molecule-by-molecule guidance for clinical trials required for biosimilars to account for the particular characteristics of the product.

Post-Market Risk Management Programs
We believe that biosimilars, once approved, should have FDA-approved risk management plans to ensure the products are rigorously monitored for post-market safety and immunogenicity. If biosimilars are approved with less clinical data than innovator biologics, the FDA should ensure that longer-term post-marketing outcomes for biosimilars remain similar to those with the innovator product.

Interchangeability/Substitution
We do not support interchangeability between an innovator biologic and a biosimilar product. Current regulations allow small molecule generic drugs to be designated as “therapeutically equivalent” and dispensed interchangeably with innovator products without physician’s knowledge. Because biosimilars are not identical to innovator biologics, they should not be deemed therapeutically equivalent and dispensed interchangeably for innovator biologics absent clinical trials that adequately demonstrate such interchangeability.

Unique Naming and Product Identification
Because biosimilars are similar to innovator biologics (rather than identical), we believe biosimilars should have a unique common name to distinguish themselves for prescribing, dispensing and pharmacovigilance purposes. In the interest of patient safety, it is critical that any adverse events be accurately traced to the actual product administered so that the manufacturer can take immediate remedial actions.

Patent Rights
Strong patent protection is the cornerstone of preserving incentive for biologics innovation, and a biosimilars approval pathway must establish a fair, transparent and effective system for all parties to quickly resolve any patent disputes.

Incentives for Innovation
Because biologics generally have substantial research, development and manufacturing periods and costs, a significant period of non-patent data exclusivity for innovator biologics must be provided to maintain an environment that fosters discovery of new and innovative biotechnology therapies. Although patent protection is important, this alone may be insufficient to protect the substantial investment made by innovators. For example, a biosimilar may be similar enough to an innovator biologic to receive regulatory approval, but different enough to circumvent the innovator’s patents. We support the provisions in PPACA that provides a base 12-year period of data exclusivity for innovator biologics plus an additional 6 months for pediatric studies.

Next Generation Improved Biologics
We support measures that protect investment in improvements to innovator biologics through extension of data exclusivity and intellectual property protections. This will help encourage continued investment and discovery of enhanced versions of previously-approved biologics that are safer, more effective, easier to administer and more capable of meeting patient needs. Modifications such as changes in amino acid sequences involve fundamental changes to a biologic’s molecular structure, and generally require clinical trials to gain regulatory approval. The vital, step-by-step process for advancing these medicines is dependent upon continued incentives for next generation biologics.

Conclusion
As new, innovative biologics and biosimilars enter the marketplace, AstraZeneca and MedImmune believe patient safety and product efficacy are of utmost importance. As a result, we support the development of a regulatory pathway for biosimilars that is based on patient safety, product efficacy and incentives for innovation. We will continue to monitor policy discussions and proposed regulations as the FDA moves forward in establishing a biosimilars pathway, and share our expertise and views where appropriate.

Download POSITION ON BIOSIMILARS (PDF, 34KB)

RSV is the Leading Cause of Hospitalization in Infants Less Than 1 Year of Age1

• Respiratory syncytial virus (RSV) is a common, seasonal virus that affects almost all children by the age of two.2, 3 While in most children RSV mimics the common cold or flu, RSV disease can be serious for premature babies, often leading to severe lung infections like pneumonia and bronchiolitis.1, 11
• Each year, severe RSV disease can lead to approximately 400 deaths in infants,7 and causes up to 125,000 infant hospitalizations.8, 9 In children less than one year of age, RSV is the leading cause of viral death,7 and is responsible for one of every 13 pediatrician visits and one of every 38 trips to the ER in children under five years of age.10
• Even babies born just a few weeks early are at an increased risk. A study of infants born between 33‐35 weeks gestational age showed that these late‐preterm infants were two times more likely to become hospitalized by RSV than full‐term infants.11
• This is because babies born prematurely have not received the full transfer of maternal antibodies to protect them against severe RSV disease.3 Additionally, premature birth interrupts the final stages of lung development, leaving preemies with only about half the lung volume of and smaller airways than their full‐term peers.4, 5, 6

The Premature Birth Rate in the U.S. is Significant

• There are more than half a million babies born prematurely in the U.S. each year.12 Across the nation, prematurity rates increased steadily between 1996‐2006.12
• RSV‐related hospitalizations increased from 1997 ‐ 2002 by approximately 25% among all infants under one year of age.8

Prematurity and RSV are Place Burdens on Public Health and Health Care Costs

• On average, preterm infants have much longer birth hospital stays compared to full‐term infants,* resulting in significantly higher hospital costs.13
• In 2003, hospital care for preemies cost $18.1 billion ‐ almost half of the total costs for all infants, despite making up only 9%* of the infant population.13 Recent data show that this cost has since increased to $26.2 billion, or $51,600 per preterm infant.14
• One of the common reasons for hospitalization in preemies is RSV disease; premature infants with RSV use significantly more hospital resources than full‐term infants infected by the virus.16
• While all children are at risk of becoming ill from RSV, high‐risk infants are much more likely to develop serious RSV disease.11, 16
• The average cost of RSV‐related hospitalization is $18,503 for late preterm infants (33‐36 weeks GA) – twice as high as for full‐term infants ($9,014).15

By urging Medicaid to appropriately protect high‐risk infants, we can help decrease RSV related hospitalizations in preterm infants and may reduce the emotional and financial tolls that hospitalization takes on their families.

References:
(1) Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. Pediatr Infect Dis J. 2002;21:629‐632. (2) Holberg CJ, Wright AJ, Martinez FD, et al. Am J Epidemiol. 1991; 133:1135‐1151 (3) Glezen WP, Taber LH, Frank AL, et al. Am J Dis Child. 1986;140:543‐546. (4) Yeung CY, Hobbs JR. Serum‐gamma‐G‐globulin levels in normal premature, post‐mature and “small for dates” newborn babies. Lancet.1968;7557:11 67‐11 70. (5) Moore KL, Persaud TVN. The Developing Human: Clinically Oriented Embryology. 7th ed. Philadelphia, PA: Saunders; 2003:245‐251 (6) Langston C, Kida K, Reed M et al. Am Rev Respir Dis, 1984;129:607‐613. (7) Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003; 289:179‐186. (8) Data on File: McLaurin KK, Leader S. Growing impact of RSV hospitalizations among infants in the US, 1997‐2002 (abstract 936). Presented at Pediatric Academic Societies Annual Meeting, May 14‐17, 2005; Washington, D.C. (9) Shay DK, Holman RC, Newman RD, et al. Bronchiolitis associated hospitalizations among US children. 1980 – 1996. JAMA. 1999; 282:1440‐1446. (10) Hall CB, Weinberg, GA.,Iwane, MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. NEJM, 2009; 360:588‐598 (11) Boyce TG, Mellen BG, Mitchel EF Jr, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000;137:865‐870. (12) March of Dimes. National Center for Health Statistics, Final Natality Data. www.marchofdimes.com/peristats. Accessed: September 21, 2009. (13) Agency for Healthcare Research and Quality, 2003. Nationwide Inpatient Sample. Prepared by March of Dimes Perinatal Data Center, 2006. (14)Behrman RE, Butler AS, eds. Institute of Medicine. Preterm birth:causes, consequences, and prevention. Washington (DC): National Academy Press; 2006. (15) Data on File: Forbes ML, Hall CB, Jackson A, Masaquel AS & Mahadevia PJ. (2009, May). Cost and Resource Utilization of Respiratory Syncytial Virus (RSV) or Winter Unspecified Bronchiolitis or Pneumonia (UBP) Hospitalizations During the First Year of Life Among Late‐preterm and Full‐term Infants. Poster presented at the ISPOR 14th Annual International Meeting, Orlando, FL. (16) Horn SD & Smout RJ. Journal of Pediatrics. 2003; 143: S133‐S141.

*Includes any diagnosis of prematurity/low birthweight
**According to most recent data available (2006)

Policy Position Current on March 10, 2010

Download RSV: RESPIRATORY SYNCYTIAL VIRUS (PDF, 118KB)

Background

Most state Medicaid drug reimbursement formulas are “one size fits all” in that they do not distinguish between biologics and chemical-based pharmaceuticals, nor do they fully recognize the extensive level of support services needed for patients using biologics. It is critical that states change this approach and recognize the unique nature of biologics and implement separate reimbursement mechanisms for biologics, since any reduction in reimbursement for biologics under existing Medicaid reimbursement formulas may result in inadequate compensation for patient support services and thereby reduce patient access to biologics; decrease the number of participating specialty distributor providers; and ultimately, increase costs to the state due to patients’ failure to obtain all necessary prescribed therapies.

Biotechnology drugs, or biologics, offer new hope to patients by providing novel therapies to treat unmet medical needs and debilitating health conditions. Biologics are complex medicines that are markedly different than most traditional chemistry-based pharmaceutical drugs in how they are developed, manufactured, stored, delivered and administered.

• Biologics consist of large, protein-based molecules that are manufactured using living organisms, and as such, are far more complex to produce than small molecule products.
• Biologics are generally prescribed by physician specialists (e.g., oncologists, rheumatologists, dermatologists, pediatricians, etc.) and historically target hard-to-treat diseases for which there are few, if any, effective therapeutic or preventive options.
• Biologics are most commonly administered via injection or infusion.
• Biologics are usually shipped by specialty distributors directly to the healthcare provider to ensure the proper storage and handling (referred to as maintaining proper “cold chain”) from manufacturer to the end user.
• Biologics require a variety of critical support services (often provided by the specialty distributors) to help ensure successful patient outcomes, including:
  • coordination of the drug’s delivery with scheduled patients’ visits to the provider;
  • patient tracking services (requiring compilation of data from several sources) to ensure patients receive follow-up doses as prescribed;
  • patient counseling and compliance education; and
  • educational services and product information for healthcare providers and office staff.

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Policy Position Current on October 1, 2009

Download POSITION ON STATE MEDICAID DRUG REIMBURSEMENT FOR BIOLOGICS (PDF, 30.4KB)