Immunization Practices (ACIP) met today to vote on recommendations that will be approved by the Centers for Disease Control and Prevention (CDC) on which populations should be prioritised when the influenza A(H1N1) vaccination becomes available this fall.
The committee reviewed the epidemiology and the science and recommended 5 target groups for focus of immunisation:
· Pregnant women
· Household contacts of children aged younger than 6 months of age
· Children and adults aged 6 months to 24 years
· Healthcare and emergency workers
· Individuals aged 25 to 64 years who have underlying conditions that put them at risk for complications and/or hospitalisation from the A(H1N1) flu.
Underlying conditions include chronic kidney disease and chronic pulmonary/respiratory disorders; cardiovascular, hepatic, haematological, neurological, and neuromuscular conditions; and metabolic disorders or immunosuppression.
Vaccinating household contacts of infants aged younger than 6 months will protect them from possible hospitalisation since they themselves cannot be vaccinated/protected.
Healthy individuals aged 25 to 64 years can be offered the vaccine after the first 5 groups are promoted and targeted, said Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, Georgia.
The same goes for individuals aged 65 years and older. Although elders are at high risk for complications from seasonal influenza, the A(H1N1) virus has spared this population. Therefore, they are also being considered a sequential group and will be offered the vaccine after the other groups are promoted. The CDC does recommend that this group continue to receive the seasonal influenza vaccine.
Prioritising within the 5 groups is not recommended. However, in a case scenario where supplies are very limited, prioritisation will be given to: (1) pregnant women; (2) household contacts of children aged younger than 6 months of age; (3) subset of healthcare and emergency workers; (4) children aged 6 months to 4 years; (5) children aged 5 to 18 years who have underlying conditions or risk factors.
Clinical trials of the vaccine will be launched shortly in the United States. However, the US Food and Drug Administration may license the vaccine without data from the clinical trials, said Dr. Schuchat. The vaccine will be tested in pregnant women.
The CDC is expecting approximately 120 million doses in the fall. “We do think it’s likely most people will need 2 doses of this vaccine,” said Dr. Schuchat.
The committee strongly recommends the 2009-2010 seasonal influenza vaccine for all individuals.
The ACIP recommendations will be reviewed quickly by the CDC and will be disseminated to hospitals and private and public health sectors, according to Dr. Schuchat.
The ACIP comprises 15 experts in fields associated with immunisation who have been selected by the Secretary of the United States Department of Health and Human Services to provide advice and guidance to the Secretary of Health, the Assistant Secretary for Health, and the CDC on the control of vaccine-preventable diseases.
SOURCE: Centers for Disease Control and Prevention Media Briefing

Novel H1N1 Vaccination Recommendations

With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months and some uncertainty about what the upcoming flu season might bring, CDC’s Advisory Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1 vaccination effort to counter a possibly severe upcoming flu season. On July 29, ACIP met to consider who should receive novel H1N1 vaccine when it becomes available.

Novel H1N1 Vaccine

Every flu season has the potential to cause a lot of illness, doctor’s visits, hospitalizations and deaths.  CDC is concerned that the new H1N1 flu virus could result in a particularly severe flu season this year.  Vaccines are the best tool we have to prevent influenza.  CDC hopes that people will start to go out and get vaccinated against seasonal influenza as soon as vaccines become available at their doctor’s offices and in their communities (this may be as early as August for some).  The seasonal flu vaccine is unlikely to provide protection against novel H1N1 influenza.  However a novel H1N1 vaccine is currently in production and may be ready for the public in the fall. The novel H1N1 vaccine is not intended to replace the seasonal flu vaccine – it is intended to be used along-side seasonal flu vaccine. 

CDC’s Advisory Committee on Immunization Practices (ACIP), a panel made up of medical and public health experts, met July 29, 2009, to make recommendations on who should receive the new H1N1 vaccine when it becomes available.  While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.

The groups recommended to receive the novel H1N1 influenza vaccine include:

• Pregnant women because they are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated;
• Household contacts and caregivers for children younger than 6 months of age because younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants less than 6 months old might help protect infants by “cocooning” them from the virus;
• Healthcare and emergency medical services personnel because infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity;
• All people from 6 months through 24 years of age
  • Children from 6 months through 18 years of age because we have seen many cases of novel H1N1 influenza in children and they are in close contact with each other in school and day care settings, which increases the likelihood of disease spread, and
  • Young adults 19 through 24 years of age because we have seen many cases of novel H1N1 influenza in these healthy young adults and they often live, work, and study in close proximity, and they are a frequently mobile population; and,
• Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.

We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities.  So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1.  

Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older.

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This is from the CSL Behring Advocacy Newsletter:

Health Care Reform - Will Plasma and Recombinant Therapies be Protected?

CSL Behring Public Affairs

CSL Behring is committed to educating decision-makers and impacting public policies that affect patient access to care. The company has an active public affairs group in the United States including Dennis Jackman, Sr. Vice President for Public Affairs; Patrick Collins, Director, Public Affairs; Kim Isenberg, Manager State Government Affairs and Ryan Faden, Manager State Government Affairs. All four have extensive public policy backgrounds and work closely with affected stakeholders and political thought leaders to affect change. Please contact them with any comments you may have regarding public policy issues.

As part of his platform in running for the presidency, Barack Obama pledged to reform the health care system in the United States. Now that he is in office, President Obama is strongly advocating for such reform as his highest domestic priority. With a supportive Democratic Congress, the chances for reform are very possible.

What does health care reform mean in terms of accessing life-saving plasma and recombinant therapies? Moreover, how will such reform impact the patient populations who rely on these therapies?

Several issues currently being debated as part of health care reform are of specific interest to the plasma and recombinant user communities. They include the following:

Increasing the Medicaid Drug Rebate
All manufacturers of drugs and biologics, including those who produce plasma and recombinant therapies, pay a rebate to the federal government in order to have state Medicaid programs cover their therapies. This rebate is currently 15.1% of the Average Manufacturers Price for the individual therapy. The President proposed increasing this percentage to 22.1% to raise revenue in large part to extend health care coverage to the uninsured. Such a proposal will not only raise the rebate to be paid in order to have Medicaid cover such therapies, but it will also increase the discount institutions within the 340B Public Health Service (PHS) pricing program acquire therapies. These entities, including a majority of hemophilia treatment centers, purchase product at the PHS mandated discount rate – which is identical to the Medicaid rebate.

This proposal would raise revenue but there are some unintended consequences that could ensue. They include a potential negative impact on research and development into new product formulations and rare disease therapies. This is due to the onerous financial burden that might be placed on manufacturers of new therapies for small patient populations of which a high percentage are enrolled in Medicaid or obtain their therapy from PHS programs.

President Obama signing
legislation into law

CSL Behring is participating in a collaborative effort with patient advocacy organizations and industry to ensure that consideration for a rebate increase for orphan populations – populations with fewer than 200,000 people with the disease — takes into account the impact of small patient populations that rely on plasma and recombinant therapies.

Comparative Effectiveness Research
As part of the stimulus package approved by the Congress, the Comparative Effectiveness Research Institute was created. President Obama and the Democrats in Congress are pushing comparative effectiveness as a way to save money for larger health care reform efforts while obtaining clinical data on how different treatments work for the individual.

Comparative effectiveness research would analyze different brands of therapy within a class of therapies to determine which brands work best. This may seem ideal for large chemical compound drugs, but for biologics such as plasma and recombinant therapies, we have seen that a “one size fits all” approach does not work. The concern with comparative effectiveness is that such clinical findings will be used to create restrictive formularies and preferred drug lists, as has occurred in the United Kingdom and France. This could prove devastating to patients in the United States if implemented for biologics such as plasma and recombinant therapies, since the possibility exists that decision making would be taken out of the hands of physicians. This is very dangerous for rare diseases where biologic therapies do not work identically for everyone and where physician/patient access to the most appropriate therapies is needed.

Accelerating Access to Generic Biologics
President Obama and the Congress also propose the creation of an accelerated pathway to generic biologics (also called follow-on biologics) as a way to save on health care costs. At present, there is no approval process for generic biologics. A pathway for generic biologics will need to ensure protections for patent rights of branded therapies for a reasonable period of time, in order to ensure an adequate return on the investments by creating innovative therapies, while also adhering to clinical trial requirements to ensure product safety.

There are two proposals currently active within Congress. One version of the legislation would create a viable generic biologics pathway similar to that for drugs, with a data exclusivity period of 12 years. All safety measures associated with the clinical trial process would remain in place. This provision would protect patients through appropriate safety measures and innovation by allowing manufacturers the opportunity to recoup their investment after years of developing a therapy for a small patient population. Without such protections, there is a real risk that biologics companies will no longer innovate and pursue new therapies.

The other proposal, which would allow only five years of exclusivity and is similar to the Obama Administration proposal, calls for seven years exclusivity. This proposal does not require as many safety protections for generics as what currently exist within a branded therapy clinical trial process. As a result, this proposal would make it far easier to create generic biologics for sale in the United States — albeit with reduced safety assurance.

Removal of Lifetime Caps on Private Health Plans
Many private insurance plans have in place a lifetime ceiling on costs for the individual, with some caps as low as $1 million or less. For those with a rare disease, such as those reliant on plasma and recombinant therapies, an individual can reach their cap quickly. This could result in a person having their therapy rejected by their existing health plan.

Both the Obama Administration and the Democrats in Congress have proposed completely removing lifetime insurance caps on private health insurance plans. This is a very positive step toward improving coverage for those with rare conditions reliant on plasma and recombinant therapies.

Patient organizations reliant on plasma and recombinant therapies have re-enlisted the Plasma User Coalition to ensure that access to therapy is not adversely impacted. The removal of such caps addresses one of the Coalition’s general principles.

Plasma User Coalition General Principles

1. Recognition that one size does not fit all in terms of treatment

2. Individuals with rare diseases must have access to: appropriate specialized treatment, centers of excellence; full range of treatments determined by the physician; timely treatment and affordable coverage.

3. Removal of lifetime insurance caps and unreasonable out of pocket expenses.

Over the course of the summer, the Congress will attempt to reach agreement on health care reform. It is imperative that those who rely on plasma and recombinant therapies make their voices heard so their representatives will ensure continued access to these therapies.