Shopping around: variations in price for generic clopidogrel

In May of this year, the patent for brand-name clopidogrel (Plavix^®) finally expired, an event that was heralded as a breakthrough in the management of coronary artery disease. As with all newly available generic medications, months may pass before generic clopidogrel becomes considerably less expensive than its brand name counterpart. As generic manufacturers scramble to ramp up production, significant differences in price and availability are likely.

These differences were recently highlighted in the September issue of Consumer Reports, where a variety of pharmacies across the US were surveyed on the price of a 30-day supply of clopidogrel.  The prices ranged anywhere from $15 to $200 -- notably, independent pharmacies consistently quoted a price of around $50, which was often markedly lower than many of their chain and supermarket competitors.

The article also mentions the Plavix^® Choice program, which allows patients to obtain brand-name Plavix^® through the manufacturer at a significantly reduced cost -- $37 in most cases.  Significant restrictions apply, of course; for example, only commercially-insured and cash-paying patients (i.e., no Medicare or Medicaid enrollees) are eligible for the program.  Although the article goes on to claim that the manufacturer picks up the difference, it is not clear from the Bristol-Myers Squibb website that this is the case.  When the patent for brand-name atorvastatin (Lipitor^®) expired in the fall of last year, Pfizer was widely criticized for several controversial financial arrangements with pharmacy benefit managers (PBMs), including a prescription discount program aimed at retaining market share.  Although the program provided some cost-savings for patients, insurers and health-systems were often stuck paying the bill.

In the end, the editors of Consumer Reports recommend that patients "shop around" for generic clopidogrel.  However, as most health care professionals will say, shopping around is rarely the right answer in the long run.  Patients should obtain all of their medications at a single community pharmacy (or pharmacy chain/franchise), as this allows the pharmacist to maintain a complete and accurate medication record, which is critical for evaluating drug-food and drug-drug interactions (see here for an example), responding to requests for medication information from other health care providers, assisting in medication reconciliation when patients are hospitalized, and more. Besides, most pharmacies already offer competitor price-matching programs, so no one should need to obtain their clopidogrel prescription anywhere other than their home pharmacy.

So while it is appropriate to recommend that patients ask around for the lowest price of generic clopidogrel, they should still be encouraged to shop in only one place.

Overcoming the drug shortage challenge: a call to action

For providers working in hospital and health-system settings, drug shortages have become an unfortunate reality of every day practice.  While the lay media has placed much of its emphasis on cancer chemotherapy and other drugs used in oncology practice, cardiology and critical care medicine are two areas that have been hit especially hard by drug shortages. In the last six months, the following intravenous medications have been subject to extended periods of limited to no availability:

• Analgesics (fentanyl, morphine)
• Antibiotics (aminoglycosides, fluoroquinolones)
• Antihypertensives (hydralazine)
• Antiarrhythmics (lidocaine, procainamide)
• Beta blockers (labetalol, metoprolol)
• Benzodiazepines (diazepam, lorazepam, midazolam)
• Calcium channel blockers (diltiazem)
• Loop diuretics (furosemide, bumetanide)
• Nutrition and electrolytes (magnesium, phosphate, sodium bicarbonate)
• Vasopressors (epinephrine, vasopressin)
• ... and many more (antiemetics, other sedatives)

The underlying reasons for these critical drug shortages are complex and multifactorial, and which ones deserve the most blame are largely subject to one's political and economic views. Some have argued that the shortages are a result of failures in the free market, i.e., when a manufacturer decides that a product is no longer profitable, they can cease production without regard to whether patients depend on it or not.  Others argue that the regulatory environment enforced by the US Food & Drug Administration (FDA) is too strict and has made it challenging for companies to stay competitive. The truth is probably somewhere in between, but no matter how you feel about the issue, the consequences are the same: drug shortages significantly impact patient care.

On Thursday, the Senate passed the Food and Drug Administration Safety and Innovation Act of 2012 (S.3187), which reauthorizes the Prescription Drug User Fee Act (PDUFA) and includes several provisions designed to help alleviate drug shortages, including:

• Expedited review of generic drug approvals;
• Incentives for new generic drug manufacturers to enter the market; and,
• Early notification to FDA if an interruption in production is anticipated or production is being discontinued altogether.

The House is expected to vote on their version of the bill next week.  In the meantime, I encourage you to contact your representatives and urge their support for PDUFA, including those provisions specifically designed to address drug shortages.  If you are unsure who these individuals are for your area, please use this free resource developed by the American Society of Health-System Pharmacists (ASHP). Also, for general information and tips for political advocacy, see this toolkit developed by the American Pharmacists Association (APhA).

Sunshine laws for physicians proposed... but what about Pharmacy Benefit Managers (PBMs)?

An article posted recently on the medical news site amednews.com highlights new regulations being considered by the Centers for Medicare & Medicaid Services (CMS) that would require pharmaceutical companies to disclose any financial ties to physicians.  Commonly known as sunshine laws, these regulations are meant to promote transparency and limit the influence of the pharmaceutical industry on clinical practice.  Many academic medical centers have already enacted strict rules on these relationships, some even going as far as having "zero tolerance" policies.

What I find strangely missing from these regulations, however, are rules requiring pharmaceutical companies to reveal their financial dealings with pharmacy benefit managers (PBMs), the third party intermediaries responsible for negotiating drug prices on behalf of health insurance beneficiaries.  Examples include CVS Caremark, Medco, and Express Scripts -- companies that, despite the impending financial crisis facing US health care, consistently rank among the country's most profitable enterprises (all three are ranked among the top 100).  The financial relationships between these companies and the pharmaceutical industry have been the subject of growing public scrutiny, and rightly so.  While PBMs purport to pass the savings earned from the deals they negotiate with pharmaceutical companies on to beneficiaries, there have been numerous instances where these savings have only increased profit margins for the PBMs themselves.

For an example of how these relationships can impact patients and the overall health care system, one only has to look back a month at the controversies that emerged out of the patent expiration for Lipitor^® (atorvastatin), the best-selling drug of all time. Ever since its patent expired in November, Pfizer has gone to unprecedented lengths to protect its market share.  As detailed in this article from the New York Times, some of the arrangements Pfizer has negotiated with PBMs include:

• Requiring community pharmacies to reject prescriptions for generic forms of atorvastatin and only dispensing brand-name  Lipitor^®
• Reducing the insurance copay for brand-name Lipitor^® to $4 in an effort to undercut the anticipated $10 or so its generic rivals would cost patients
• Requiring that PBM mail order services dispense only brand-name  Lipitor^®

As one might expect, these tactics have raised a lot of eyebrows, including those of Senators Baucus (D-MT), Grassley (R-IA), and Kohl (D-WI), who recently submitted letters to Pfizer and five of the country's largest PBMs asking them to reveal the details of these financial relationships.  The PBMs implicated in the letter have assured legislators that they would not reap the benefits of these negotiations at the expense of patients, their employers, or CMS.

The part I find most unfortunate about this entire ordeal is that it took the media breaking the story as well as several high-profile legislators asking questions before these financial dealings were made public.  No matter how you feel about the Affordable Care Act or health care reform in general, I think we can all agree that there is little to be lost from increased transparency within the health care system.  If CMS is proposing sunshine laws as a strategy for accomplishing this, PBMs should be held to the same standards as individual physicians and the pharmaceutical industry.

After all, if there's truly nothing to hide, what would a little sunshine hurt anyway?