Valuebasedmedicine.com

Following the Value of Drugs
in AMD and Osteoporosis
Bennett Weintraub, [email protected] Companies MentionedBold Ticker/company name indicates As the cost of drugs continues to rise in the U.S., The Center for Value Based Medicine has built a broad framework for assessing value in medical treatments. Drs. Melissa and Gary Brown presented this framework, which is QLT (QLTI)
based on patient-assessed cost per QALY (quality-adjusted life year).
Genentech (DNA)
Allowing comparisons across therapeutic areas, the framework points to good value of Bausch and Lomb's AREDS vitamins for dry age-related macular Merck (MRK)
degeneration (AMD) and predicts increasing use of QLT's Visudyne for wet Novartis (NVS)
Sanofi Aventis (SNY)
Amgen (AMGN)
In osteoporosis, existing drugs have a high cost/QALY. Generic alendronate Eli Lilly (LLY)
(replacing Merck's Fosamax) will increase value, but will put pressure on otherbranded bisphosphonates and on Amgen's denosumab.
A Value-Based Framework
Expert Opinion:
Although pharmacoeconomic analyses are routinely performed for individual The Center for Value-Based Medicine therapeutics, Drs. Gary and Melissa Brown have developed a framework that allows all marketed drugs in the U.S. to be compared for value and economic costs. Their system, the Pharmaceutical Value Index, uses a patient questionnaire, clinical data, and cost-of-care data. The assessment numerically patient preferences to quantify the quantifies quality of life (QoL) and cost per QALY.
value of healthcare interventions.
Melissa Brown, MD, MN, MBA is the
Director of the Center, and also a
The Value-Based Medicine framework is used by drug developers to determine pricing, and to make a case with the FDA or with CMS for approval and University of Pennsylvania School of reimbursement of drugs. According to Drs. Brown, their index is not yet widely Medicine. Gary Brown, MD, MBA is
adopted by payers, although some pharmacy benefit managers are beginning to co-director of the center and is also inquire about the data. Dr. Melissa Brown expects CMS and Medicare to lead the Chief and Director of the Wills Eye way for value to enter the U.S. healthcare system in a way that is modeled after Institute Retina Service and Professor of Ophthalmology at Jefferson MedicalCollege. Applying the Framework: AMD
As both Melissa and Gary Brown are ophthalmologists, Value-Based Medicine has focused some of its initial work on AMD
therapeutics. For the more common dry AMD, Dr. Melissa Brown sees good value in Bausch and Lomb's AREDS vitamin
formulation, which has been shown to have an impact on dry AMD progression and is available at relatively low cost to patients.
According to Dr. Brown, vitamins are underused by AMD patients.
For the more severe but less common wet form of AMD, Dr. Gary Brown reviewed current use and value in Macugen (OSI),Visudyne (QLT), Lucentis (Genentech), and Avastin (Genentech). Lucentis and Avastin win out on value. Even as an expensivedrug, Lucentis' efficacy trumps its cost. Avastin is much cheaper, but Dr. Brown defers a relative measure of its quality until ahead-to-head comparison, currently ongoing, is completed.
Interestingly, QLT's Visudyne scores relatively highly on the value index. Dr. Brown notes that Visudyne may find use in decreasingthe frequency of Lucentis administration when the two treatments are used in combination.
Applying the Framework: Osteoporosis
In contrast to medicines for AMD, the Pharmaceutical Value Index yields high costs per QALY for most osteoporosis medicines.
Bisphosphonates, including Merck's Fosamax, Sanofi-Aventis' Actonel, Novartis' Reclast, and Roche's Boniva, cost about $150,000
per QALY, although those costs are decreasing with the introduction of generic alendronate (Fosamax). Other osteoporosis drugs,
such as Eli Lilly's Forteo and Evista, score even more poorly. Gary Brown discussed the nature of osteoporosis, a disease that is
silent in many patients, in these assessments.
Because of the high cost / QALY associated with osteoporosis drugs, generic alendronate is likely to be rapidly adopted, and is likelyto impact sales of not only Fosamax but also of Actonel and other bisphosphonates. However, Reclast's unique dosing regimen mayallow it to avoid loss of market share. New drugs, notably Amgen's denosumab, will enter an increasingly value-sensitive market.
The Future of Value
Dr. Melissa Brown and Dr. Gary Brown agree that Medicare and other government payers are likely to lead the charge in evaluating
value in drug pricing. Comparative effectiveness is already a buzzword in Washington, and a Democratic administration next year
would accelerate the trend of taking drug value into account. Although a watchdog similar to U.K.'s NICE would face significant
opposition in the U.S., any traction of such an agency would signal a change in drug pricing.
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