November 2, 2015
Patients, Beware of New Statin Push for PCSK9 Inhibitors
This and the next two blogs are about the newest statins in the PCSK9 class and put on limited use by the FDA.
Amgen and Sanofi/Regeneron, the makers of the two newly approved cholesterol drugs, evolocumab (Repatha) and alirocumab (Praluent), are fueling an explosion of new programs to identify large numbers of new patients who are candidates for the expensive drugs.
An example is a $120 million partnership between Regeneron and Geisinger Health System to broaden the search for genes and drug targets well beyond familial hypercholesterolemia, which is the main indication for PCSK9 inhibitors right now.
By comparing "genetic information against medical histories, Geisinger and Regeneron hope to eventually develop new means of diagnosing, preventing and/or treating medical conditions -- before they cause significant harm. Some participants may also receive information that could be useful in their own medical care."
Peter Berger, MD, who recently became the senior vice president of clinical research at the North Shore-Long Island Jewish Health Care System made comments about the two expensive drugs. Before that, he was at Geisinger, where he was involved in the Regeneron negotiations, though he emphasized that he was not speaking for Geisinger and he was not involved with the final deal. Berger said that at North Shore-LIJ, his main concern is to identify untreated patients who can benefit from treatment, patients who's LDL is way too high on a statin.
Berger then stated, "Most health care institutions, including my own, have too many patients with very high LDLs (for example, greater than 400 mg/dl untreated, or greater than 250 mg/dl on the maximal dose of a potent statin), and do a poor job of screening the family members of such patients."
While it may not matter to the patient what the actual cause of the high LDL is, all the medical people are concerned about at this point is whether they can earn money for getting these patients on the expensive drug. They will bypass any nutritional help and recommend the drug.
“Berger said he reached out to the companies to see if they would help explore the novel use of informatics to help identify such high-risk patients and get them to goal. He said he hopes to establish a program at North Shore-LIJ with industry support to identify such high-risk and insufficiently treated patients. Berger is keenly aware of the potential economic impact of the PCSK9 inhibitors and said that the study he is proposing contains an analysis of the economic impact of the drugs. In fact, he said that the drug companies readily agreed that such an analysis be a part of any study they fund.”
“Berger admitted, he was extremely concerned about the price of drugs in general, including the PCSK9 inhibitors. The pricing of drugs in this country is obscene. In the case of the PCSK9 inhibitors, I hope a third or a fourth PCSK9 inhibitor hits the market and drives the price down."
“But, he said, he's "not concerned at all that by identifying and screening more patients we will be expanding the pool for these drugs," as long as the patients receiving such therapy are appropriately selected." Berger emphasized that all such patients should be counseled about the role of diet and exercise, but did acknowledge, however, that intensive lipid lowering drug therapy is virtually always needed for patients with LDLs in the 400 range.”
All I would add to this is that as long as there is money flowing into his pocket, he will say and advocate for anything.