The database contained records of , prescription fills for imatinib, which were made by patients from May through September However, prices for Gleevec and generic imatinib remained high 2 years later. The researchers said the Gleevec case demonstrates several potential barriers to effective generic price competition, including shifts in prescribing toward more expensive brand-name treatments and smaller-than-expected price reductions.
A: Drug adherence is the biggest indicator of how the patient will do in the future. More patients with CML are living longer, so the number of patients with this disease has grown every year.
Prior to the introduction of imatinib, it was 20, people. It is estimated that there will be , people living with CML by A large proportion of these patients will remain on these drugs for many years or their entire lifespan. We are in a vicious cycle in America where patients stop drugs or go into financial ruin just to keep taking their medicine.
One of the arguments for these second- or third-generation drugs is that there is a chance the patients may be able to stop therapy after 5 or 6 years.
Evidence has shown that the second- and third-generation drugs may do better at eradicating residual disease. However, to date, the randomized trials have not shown a difference in PFS or OS between imatinib or the second- or third-generation drugs. So now there is debate about whether to start patients with these new drugs instead of waiting until they progress on imatinib.
It would be simple, but these new drugs are expensive and have considerably more side effects than imatinib. Current guidelines state that you can go either way as long as you are closely monitoring the patient. The biggest issue is the cost. The cost that employers or insurers have passed on to patients has gotten out of control.
A: Data over the last couple of years have shown the reduction of the price of generics has really begun to take hold. By my count, there are 11 companies producing generic imatinib that are approved by the FDA. Gleevec is still out there, but the generics have made major inroads as first-line therapy for CML.
They were first approved in , and the early experience was that they were just as expensive as Gleevec. At the same time, the price in Canada for the patented drug was one-third or one-quarter of the price of the drug in the United States.
The price of the generic was even lower. Finally, the price in the United States for the generic finally seems to be coming down and is more in line with the rest of the world. A: This is a problem unique to the United States. Cancer rates are growing fastest in these populations, and governments are under pressure to better address the health needs of their ailing citizens. India, China, and other emerging nations are expanding coverage of medicines in their public sectors, but expenditures are rising astonishingly fast.
Requiring local production of cancer drugs lowers their cost and also helps domestic manufacturers break into the oncology market, a lucrative therapeutic area in which multinational drug firms are heavily invested. More countries are likely to follow India's lead. Cancer is not the only NCD on the rise in developing countries, with rates of diabetes, cardiovascular, and chronic respiratory illnesses likewise increasing.
This results in more of the drugs that we need, but makes them less accessible to those who need them. The tension becomes greater in the global context because the income disparities between developed and developing country patients are so vast. This tension in the patent system has been exposed before. Those fights subsided when multinational companies donated their drugs, charged rock-bottom prices for them in poor countries, or allowed local companies to make generic versions.
Yet the emerging fight over cancer medicines threatens to be bigger, as it involves the emerging markets and disease groups on which the multinational drug industry has banked its future. The United States, Europe, and other developed countries have too much invested in the intellectual property IP system.
According to the U. On the other hand, countries like India are not about to agree to tightening standards on the flexibilities that the current IP system gives them on patentability and compulsory licensing.
Government programs can help. The U. Second, multinational firms must realize that there are low-income segments of the global marketplace that these firms cannot serve, but whose health needs must be met for international support of the pharmaceutical, trade, and IP system to persist.
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