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Biotech: the new frontier.

Not long ago, the first human recombinant insulin protein became available as a substitute for insulin products extracted from porcine or bovine sources. Today, animal-extracted insulin products are obsolete. It took about 20 years, however, for biotechnology to bring to market a wide range of proteins that are effective and safe for human therapies.

Bioanalytical innovations and a number of scientific breakthroughs in the translation of molecular and cellular technologies for transforming novel proteins with therapeutic potential in a reproducible production scale made this progress possible. Many biotechnology drugs or protein-based biotherapeutic products--including new therapeutics for multiple sclerosis, cardiovascular disease, autoimmune disorders and even cancers--are making an impact on human health.

According to a 2007 report from Wolters Kluwer, six of the top 10 drugs used in hospitals are biotherapeutics, with three having a wholesale cost of over $1 billion each. In all, 25 of the top 200 chugs used in hospitals are protein or peptide drugs.

With growing pressure from consumers and third-party payers to reduce hospital stays and institutional health care costs, many clinical procedures are now shifting to an outpatient setting. The continued effort to accommodate this, and to implement third-party payment structures, creates new opportunities for retail pharmacy to provide prescription services related to biotherapeutic treatments.

This trend is reflected in total retail dollars for the years 2007 and 2008, with biotechnology drugs accounting for about 16 of the top 200 prescriptions. These drugs comprise a diverse class of proteins, including antibodies and derivatives (e.g., Humira, Herceptin, Enbrel), interferons (e.g., Pegasys, Betaseron, Avonex) and peptides (e.g., Forteo and Fuzeon).

Accounting for those that are not on the top 200 drugs, biotherapeutics captured about $6.5 billion to $7 billion in annual pharmacy retail volume for the past two years. Thus, there is a growing need to prepare pharmacists and pharmacy students entering the work force so that they can better serve patients as well as communicate with third-party payers--insurance providers, Medicare and Medicaid.

While there is no question that biotechnology products have made possible new treatment modalities that are unattainable with chemical drugs, the cost of biotech therapies is significantly higher. To justify the cost and approval for reimbursement by third parties and government health care payers, analyses of the cost-effectiveness of most of these drugs have been provided, in order to develop pricing. In the current economically challenging climate, consumers as well as third-party payers are under pressure to reduce overall health care costs, and reduction of medication costs is a part of this effort.

On July 9, 2008, the Senate passed a bill (H.R. 6331) that included e-script incentives as part of the Medicare Part D payment structure. While the intent was to provide incentive to transition to e-scripts in order to reduce medication errors, improve health care quality and reduce costs, the bill also prompted hospitals and physicians to require patients to fill biopharmaceutical prescriptions for self-administration as a part of an allowable payment structure.

However, for elderly patients and those with chronic diseases that are not able to be self-administered, the biopharmaceutical prescription dispensed in the pharmacy must be brought back to clinics for injection. In such cases, the biotech drugs dispensed may be exposed to light, as well as mechanical (shaking) and temperature fluctuations in transit (e.g., left inside a car parked under the hot sun), which may lead to inactivation and unintended immuno or other delayed toxicities.

Inactivation or alteration of protein pharmaceuticals may lead to immune-related dire consequences. Therefore, prevention of such events through education of staff and patients is the key to overall safety and efficacy and may have a significant impact on overall cost savings in health care.

Unlike most medicines available as oral dosages and derived from small chemical compounds, biotechnology products composed of proteins and peptides, including insulin and antibody derivatives, are formulated as sterile injectable solutions. Therefore, the unique stability of protein therapeutics as well as the sterility, storage and handling of injectable dosage forms (unit dose or injectable solution in appropriate vials) requires additional staff training and patient education.

For example, inappropriate shaking of protein pharmaceuticals may induce foaming of the solution, which significantly reduces protein drug potency. Foaming and deactivation of protein drugs can also lead to immune induction.

This consequence in patients is poignantly demonstrated by the report of severe aplastic anemia in patients treated with certain batches of Eprex unit-dose preparations. Since the antibody to Eprex also neutralizes patients' endogenous human erythropoietin, which is essential for making natural red blood cells, blood infusion for life is the only available option for the affected individuals.

Recognizing and anticipating immune-related long-term consequences and other key issues, the University of Washington School of Pharmacy has incorporated several of these topics into its curriculum. With more biotech products being developed to address new therapeutic targets, the need for training pharmacists (both in retail and institutional practices), as well as the knowledge base for patient counseling related to these drugs, will likely grow.

Because about 25% to 40% of new drugs approved by the Food and Drug Administration are biotechnology products, and many more are in development, we must implement consistent training plans for future pharmacists to be experts in biotherapeutics.

In terms of cost, substitution of brand drugs with generic products can provide substantial cost savings for chemical drugs. However, in the case of biotechnology products, the production costs are much higher and the regulatory approval process for biogenerics (or follow-on products) is not well defined.

After many years of debate and regulatory holds, the first human follow-on growth hormone product, Genotropin, gained FDA approval in 2006 with much fanfare. However, the cost-savings aspect of the follow-on remains questionable, as Genotropin costs about the same as the original brand Omnitrope ($1,599, compared with $1,691 for six units of 5.8 mg).

While there is a continued call by Congress for the FDA to provide a follow-on or generic protein pharmaceutical approval process similar to the abbreviated new drug application (ANDA) process for chemical drugs, it is unlikely that similar cost savings could be realized in biotechnology products, even with an improved and well-defined regulatory approval path.

Other avenues for cost containment and continued improvement in the quality of care should be explored. One area is to prescribe and dispense the right medications and doses to the right patients. While it is attractive in principle, a number of issues relating to identifying the right medication and dose for the patient profile have caused this technically challenging process to be perceived as cumbersome and time-consuming.

Phenotyping of patients with probe drugs to determine correct dosages of chemotherapeutic agents will not be appropriate in retail pharmacy settings. However, with recent advancements in rapid and simple diagnosis procedures at the point of care, pharmacokinetics and therapeutic profiling could be done effectively at a clinic.

Prescribing wrong doses or wrong medications may have more severe consequences in the elderly and patients with chronic diseases, who may have variability in plasma drug levels as well as in pharmacologic responses at the same drug levels.

As these technologies become more affordable, easier and more practical for use in community settings, we will not only reap more cost-effective preventive care managed through retail and chain pharmacies but also make significant contributions toward improving the quality of life for patients.

Meanwhile, with today's economic challenges and third-party payers intent to contain medical costs, pharmacists and pharmaceutical companies as well as the entire health care community must play pivotal roles in providing the highest quality of care through active participation in policy development and delivering the right medication and dose to the right patients.

As we develop cost-saving plans, we must be creative and attentive to the safety and efficacy of pharmaceuticals, especially biotherapeutics that need additional care in dispensing and administration, where any mishandling among prescriber, patients, pharmacists and staff at injection clinics could pose lifelong and serious life-altering consequences.

Through organized, systematic and integrated training, practice and community involvement, as well as proper counseling and education of patients (which is not standard across all states), we will make a significant impact on improving the quality of care to the patients we are committed to serve.

Dr. Rodney J.Y. Ho is the Milo Gibaldi Endowed Professor of Pharmaceutics at the University of Washington. He is also director of the university's center for DNA sequencing and gene analysis.
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Title Annotation:Focus
Author:Ho, Rodney J.Y.
Publication:Chain Drug Review
Date:Aug 3, 2009
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