U.S. House of Representative Democrats unveiled their bill for health care reform - the America’s Affordable Health Care Choice of 2009. In response, National Community Pharmacists Association (NCPA) Executive Vice President and CEO Bruce T. Roberts, RPh, issued the following statement:

“Community pharmacists play a critical role in the health care system. NCPA is committed to ensuring that any health reform legislation does two things: First, it should utilize medication therapy management and other pharmacist-delivered health care services to improve patient outcomes and reduce overall costs, such as from improper medication use. Second, and more importantly, Congress should assure that there is a viable community pharmacy infrastructure to deliver quality health care to millions of patients across America.

“This is a sweeping legislative proposal that requires additional, careful review. However, we are pleased that the bill begins to reform the system that will be used to pay pharmacies for generic medications dispensed to Medicaid patients. We need to work with the Congress and the states as this bill moves forward to assure that appropriate payment exists for pharmacists to dispense lower-cost generic medications. For Medicaid beneficiaries in underserved rural or urban areas, community pharmacies are often the sole health care provider.

“We also appreciate the inclusion of provisions that exempt community pharmacists who provide durable medical equipment, such as diabetes testing strips, from duplicative and onerous accreditation and surety bond requirements. This will allow for patients to continue accessing these valuable health care products.
“On these and other matters we will continue working with the House, Senate and White House to ensure that health care reform allows community pharmacies to remain a valuable are a valuable cog in America’s health system. When that occurs patients will have better outcomes and costs saving can be found.”

Source
National Community Pharmacists Association

LITTLE FALLS, N.J., July 22 — Two biotechnology companies in Australia have begun the first human trials of a vaccine for the 2009 H1N1 (swine flu) virus.

This week, Adelaide-based Vaxine Pty Ltd and Melbourne-based CSL Biotherapies injected the first adult volunteers in two separate trials starting days apart.

Now in its winter flu season, Australia has reported about 15,000 confirmed cases of the new H1N1 virus and 41 deaths.

“The demand [for a vaccine] was here yesterday,” Nikolai Petrovsky, MBBS, PhD, Vaxine chairman and research director, told the Associated Press.

Vaccine trials are expected to begin shortly in the U.S. The FDA’s Vaccines and Related Biological Products Advisory Committee will meet tomorrow to discuss clinical trials of an H1N1 vaccine and vaccine approval. (See FDA Lays Framework for Expedited H1N1 Vaccine Approvals)

Vaxine began injecting participants in its 300-person trial on Monday with a synthetic vaccine “based on state-of-the-art recombinant protein technology combined with our proprietary polysaccharide adjuvant system,” Dr. Petrovsky said in a statement.

He said preliminary efficacy data should be available in six to eight weeks.

On Wednesday, CSL Biotherapies began administering vaccine in a 240-person trial that is expected to last seven months. The study is being conducted in partnership with CMAX, a clinical research organization, and Royal Adelaide Hospital, according to a company statement.

All of the participants will receive two injections spaced three weeks apart. Half will receive a standard dose and half will receive a double dose.

“We appreciate that new influenza strains like the ’swine flu’ can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans,” Russell Basser, MD, CSL’s global director of clinical development, said in a statement.

“CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu,” he said.

John Treanor, MD, a vaccine researcher at the University of Rochester in New York, said “information from this trial will be very useful for all who are working with novel H1N1 vaccines, especially in determining what kind of response to expect with a single dose.”

Rachel David, MD, CSL’s director of public affairs, told ABC News in Australia that a trial involving 400 children ages 6 months to 9 years will begin next month at Women’s and Children’s Hospital in Adelaide.

She also noted that there was no additional safety risk with this vaccine because it is produced in the same manner as seasonal vaccines.

“The substitution of one strain for another in the vaccine is not considered to be a significant change and, from the experience accrued, this is a reasonable presumption,” commented Donald Henderson, MD, MPH, of the University of Pittsburgh and Johns Hopkins.

CSL has received a $180 million order from the U.S. Department for Health and Human Services for bulk antigen.

In addition, the Australian government has ordered 21 million vaccine doses from CSL, enough for the entire population, according to multiple media reports.

This article was developed in collaboration with ABC News.

Related Article(s):

• FDA Lays Framework for Expedited H1N1 Vaccine Approvals

According to the Department of Health, for every £1 spent on healthcare in the UK, just 12p goes on medicines. Yet when it comes to debate around
NHS finances, it sometimes feels like the price of medicines gets all the attention.

In fact, when you look at how the UK compares to other countries, medicines here are cheaper than elsewhere. The UK is now bottom of the league of 12 comparator countries, behind, for instance, Belgium, Finland and France, and has been sliding down the league table since 2006. (Source: ABPI)

The UK also spends less per head on medicines than many of our European neighbours. In 2008, the UK spent £200 per head on medicines compared to France where they spent £372 (up from £327 in 2007) and in Belgium where they spent £327 (up from £263 in 2007). (Source: IMS, OECD, ONS).

The price of medicines in the UK is controlled by the Department of Health (DH) under a scheme known as the Pharmaceutical Price Regulation Scheme (PPRS), and one of the reasons why medicines in the UK are cheaper than elsewhere is because the DH has demanded sharp cuts in recent years.
In January 2005, the NHS medicines bill was reduced by 7 per cent under the PPRS. In January this year, it was cut by another 3.9 per cent.

With each percentage point cut comes a saving to the NHS of roughly £80m a year. To date, those cuts have saved close to £2bn.

In January 2010, prices will come down again by 1.9 per cent, adding a further £152m to the amount being saved every year. Attention is always focused on cost, rather than around a more holistic perspective of the value that medicines bring. Medicines help keep people out of hospital, out of pain, in work, at home with their families and, in the extreme, alive.

Conditions such as diabetes
and schizophrenia which used to be a life sentence 15 to 20 years ago
are now eminently treatable - all thanks to new medicines. Statins - the new breed of heart drugs which help reduce cholesterol and cut heart disease - alone are estimated to save 10,000 lives a
year.

In the UK, we are lucky to have a National Health Service which allows
the high price of some medicines, particularly those for rare diseases, to
be balanced against the lower cost for the majority of medicines. A key reason for this is the prevalence of generic medicines, cut-price
copies of original, breakthrough medicines that are no longer protected
under patent laws. In 2007, 82.6 per cent of all medicines - a shade
over eight in ten - were prescribed generically in the UK, the highest
rate in Europe.

Over the next three years, there will be even more generic copies as
seven out of the top 20 branded medicines will go off patent. The ABPI
estimates this will save the Department of Health at least £2.9bn by
2012.

Producing generic medicines is cheap but finding the original breakthrough medicines is a risky, costly and painstaking process: investigation into 10,000 compounds is likely to yield just one successful
compound; and first discovery through to bringing a new medicine to
market takes between 10 and 12 years and costs over £500m.

Just three out of ten medicines available to patients ever recoup the cost
of their development, and those that do make money, have to subsidise
the others that don’t, including those serving small patient populations,
rare diseases and paediatric conditions.

Source
ABPI