Washington Report: Hard Evidence - Pharmaceutical Executive

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Washington Report: Hard Evidence
The push for more useful information on medication effectiveness is shaping drug development and reimbursement.


Pharmaceutical Executive


Comparing Effectiveness

AHRQ's Effective Health Program also operates a network of Evidence-based Practice Centers (EPCs) that are beginning to roll out comparative effectiveness reviews of widely used drug classes. A May report by the EPC, operated by the Blue Cross and Blue Shield Association's Technology Evaluation Center, finds little differences in safety and effectiveness profiles of drugs to treat anemia in cancer patients. This comparison of epoetin (Epogen and Procrit) and darbepoetin (Aranesp) concluded that both drugs equally boost hemoglobin concentration in the blood and reduce the need for blood transfusions related to chemotherapy; neither particularly improves tumor response or patient survival. Adverse events such as blood clotting are similar, as well as quality-of-life measures.

Another report comparing the effectiveness of a dozen depression therapies is expected to document few significant differences among second-generation antidepressants. A draft report, which was issued in May by the RTI International-University of North Carolina EPC, reveals only modest differences in onset of action, adverse events, and quality-of-life measures. The analysis recommends additional head-to-head studies, plus research on whether extended-release formulations or combination treatment might have added benefits. While further studies might uncover notable therapeutic differences, the current conclusions present a challenge to the CMS requirement that Medicare drug plans cover "all or substantially all" antidepressants (one of six therapeutic classes with this universal coverage requirement).

In addition to CMS and AHRQ, states and consumers are seeking more evidence to support the use of new medical products and treatments. The Drug Effectiveness Review Program (DERP), administered by the Oregon Health & Science University (OHSU) Center for Evidence-Based Policy, provides pharmacy clinical reviews to 15 state Medicaid programs and other organizations. This information from DERP, plus additional assessments by third-party vendor First Health, helps states compile preferred drug lists for Medicaid and other state pharmacy programs. Consumers Union also taps DERP reviews in identifying the best and most cost-effective drugs for its Best Buy Drugs program.

NICE Evidence

In the international arena, the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has made cost-effectiveness analysis an acceptable part of the evaluation process for drugs, particularly those that raise coverage questions due to high cost or uncertain effectiveness. NICE technical appraisals of new drugs and medical procedures consider both clinical and economic issues, a key difference from AHRQ-sponsored reviews that explicitly exclude cost comparisons. The UK agency then recommends routine or selective use of a drug, or use only in a research setting.

In response to complaints that NICE reviews can delay patient access to important new medicines, the agency has established a shorter assessment process to get new treatments to patients faster. A recent "fast track" assessment that appeared in May (2006) recommends use of aromatese inhibitors to treat beast cancer. NICE also issued a guidance last month, on appropriate use of Herceptin for early-stage breast cancer, an issue that made headlines in the United Kingdom several months ago, when a woman successfully sued her local health service to obtain such coverage. The court ruling, though, raised concerns among British health officials that a requirement to cover this costly drug more broadly would limit treatments for other patients. Because the UK health system has a fixed budget, "we have a responsibility to make hard decisions," said NICE chief executive Andrew Dillon, at the CED conference. If a local health service wants to pay for a very costly drug, it has to cut back somewhere else.

Jill Wechsler is Pharm Exec's Washingtoncorrespondent. She can be reached at


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