AMCP Special Report: Development of highly innovative drugs continues to decline

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Evaluation of newly released medications for potential formulary inclusion should focus on clinical benefit over product price or rebate. Dossiers are invaluable to the evaluation process, but it's important to note that dossiers obtained from pharmaceutical manufacturers are often incomplete, according to presenters at AMCP's 2005 Educational Conference last month in Nashville, Tenn.

Evaluation of newly released medications for potential formulary inclusion should focus on clinical benefit over product price or rebate. Dossiers are invaluable to the evaluation process, but it's important to note that dossiers obtained from pharmaceutical manufacturers are often incomplete, according to presenters at AMCP's 2005 Educational Conference last month in Nashville, Tenn.

A recent evaluation of newly released medications found that many are "incrementally modified drugs," often referred to as "me too" products that represent no significant advantage over products already on the market. Only 15% of drugs approved between 1989 and 2000 were highly innovative new molecular entities (NMEs), said Atheer A. Kaddis, PharmD, director, clinical program development, Blue Cross Blue Shield of Michigan, Southfield, Mich.

Dr Kaddis predicts that new drug approvals for NMEs and biologics will likely average about 30 to 35 per year over the next few years.

In establishing the value of pharmaceuticals, benefit should be weighed against risk. A benefit-risk evaluation of each new drug should ideally be started before the drug reaches the market, but often this is difficult because of the lack of information available about the agent, Dr Kaddis said. He usually requests a dossier from the manufacturer 2 months before the planned product review.

Manufacturer dossiers, however, are not always comprehensive sources of information. A review of manufacturer dossiers found that nearly half (48%) were of poor or moderate quality, said David L. Clark, BS, MBA, vice president, pharmacy benefits, The Regence Group, Portland, Ore.

"Incomplete dossiers make decision-making difficult," Dr Kaddis said.

The Regence Group reviews the clinical evidence, which includes formulary submission guidelines, clinical study evaluation during which the studies are graded and quantified, and clinical evidence summary. The evaluation process can be described as "triangulation," in which the same clinical evidence is used for new medications but applied to the specific populations of each plan, thereby increasing the efficiency of medication review and valuation.

In reviewing the evidence, an AMCP-compiled dossier is preferred over the manufacturer's, Clark said. "We look for published and unpublished studies," he said. "We have a highly trained clinical team to review the evidence even before the dossier arrives. Reviews are staff-intensive." The clinical team will even make attempts to contact investigators of studies for more information if needed.

The Regence Group attempts to initiate its evaluation 1 year before anticipated product launch, although obtaining data from the manufacturer at this early stage is often difficult.

After the review, a product is placed into categories based on the value it provides, whether it has greater effectiveness, a significant cost advantage, an improvement in safety, enhanced documented persistency with the medication, a convenience advantage, whether or not it's a "me too" product, or no additional value.

An evaluation of newly released medications from 2001 to 2004 found that 19% showed an improvement in effectiveness over available drugs considered the standard of care for a given disease. In reviews conducted during the 1-year period of July 2004–June 2005, more than 60% of new drugs were placed into either the "me too" or "no added-value" categories. "Most were just improvements in convenience," Clark said. "There was little innovation."

Some examples of medications that were considered to have an effectiveness advantage were imatinib (Gleevec, Novartis) for treatment of chronic myelogenous leukemia and GI stromal tumors, tenefovir disoproxil (Viread, Gilead) for treatment of HIV infection, aprepitant (Emend, Merck) for prevention of chemotherapy-induced nausea, buprenorphine (Subutex, Reckitt Benckiser Pharmaceuticals) for treatment of opioid dependence, and adefovir dipivoxil (Hepsera, Gilead) for treatment of resistant hepatitis B infection.

Some medications evaluated that offered a cost advantage were formoterol (Foradil, Schering-Plough), simvastatin/ezetimibe (Vytorin, Merck/Schering-Plough), and olmesartan (Benicar, Sankyo/Forest).

Specific medications evaluated with a safety advantage were ezetimibe (Zetia, Merck/Schering-Plough), eplerenone (Inspra, Pfizer), and nitazoxanide (Alinia, Romark Laboratories).

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