Drugmaker Genentech’s new promotion to get eye doctors to use the expensive injectable drug Lucentis for macular degeneration offers rebates to top-prescribing practices based on bulk and rate of increased use, the New York Times reports, despite little evidence that the drug works better than another far less-costly drug, Avastin.

The rebates may be designed to win or keep prescribers from Genentech’s Avastin, a similar drug indicated for cancer that some physicians say works equally well and costs about one percent of what Lucentis does.  A head-to-head trial between the two drugs is underway and some suggest the Lucentis promotion is a way of creating customers for the more expensive drug in the lead-up to the trial results.

The Lucentis rebate to physicians is based on volume but also increase in use—something that sounds all right enough for a coffee customer card, but disturbing for a drug. The program is a top-users club to begin with, only offered to the top 300 using practices in the country. Even with lattes, there’s a finite number of espresso shots one can or should have in a day/week/month, and reward for increase in use is a problematic model because it suggests a curve of infinite consumption.

More disturbing? The company has been explicit in keeping the program a secret. The Times reports that “doctors who have signed up for the rebates are not allowed to acknowledge even the existence of the program, let alone to talk about the specific terms,” in accordance with a company-proffered contract that practices must sign. That’s definitely not how they do the coffee cards.

Lucentis and Avastin are injectables, meaning a doctor must administer the doses rather than a patient going to a pharmacy to get a drug, and as with other injectables, Medicare reimburses doctors for buying the drugs. A rebate or bulk discount program offered by a drug company such as this one boosts the potential money a doctor can make and ties physician payment directly to frequency and volume of a drug used, which is one reason for the federal anti-kickback statute.

According to a calculation by the Times, the volume rebates combined with the increased usage rebates on offer could net a practice meeting the minimum requirements in the biggest rebate category $58,000 per quarter. U.S. sales of Lucentis went up nearly 30 percent in the first three quarters of 2010, to $1.1 billion, and though Medicare reimbursed for less fewer Lucentis injections in 2008, it paid a whole lot more for them: $537 million that year compared to $20 million for Avastin.

Whether these types of rebates violate anti-fraud and anti-kickback laws may depend both on whether they were properly disclosed to government payors, and on how they were promoted to providers. But putting that question aside, news of the program is worrisome from a medical standpoint. Here is a company promoting its (very costly) medicine based on some hybrid of the Starbucks/Costco philosophy—the more and more frequently you buy, the more you save!—and not on the efficacy or merits of the medicine, or on clinical trials and guidelines that demonstrate superiority to comparable drugs or optimum treatment regimens. And where is the patient in all this? Eyes open, and paying the bills.

–Kate Petersen, PostScript blogger

–by Jonas Hines

The New York Times reported this weekend about a newly-approved cancer drug, Folotyn, for a deadly blood cancer. The catch? It costs about $30,000 per month. Per month. Oh, and it did not prolong life expectancy for patients (though it did shrink tumor size) in the trial that led to its FDA approval in September.

And, as the Times reported last month, the cost of drugs is on the rise—nine percent last year, the highest rate of inflation since 1992. Big Pharma says, predictably, such hikes are necessary for the research of novel drugs (such as Folotyn?). Interestingly, last time major legislation that could impact the cost of drugs was on the table –in 2006 with Medicare Part D– the cost of drugs went up, too.  Is this ramp up simply in anticipation of health care reform legislation? One thing is for sure: The cost of health care is only going up as long as we are using $30,000-a-month drugs to shrink tumors.

As for the drug maker’s take on the cost of its drug? The Times reports: “Mr. Caruso [CEO of Allos Therapeutics, who makes Folotyn] also said the price of Folotyn was not out of line with that of other drugs for rare cancers. Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said.”

In other words, because the drug doesn’t prolong life, the exorbitant cost is self-limited.

Jonas Hines is a medical student in New Mexico and a member of the American Medical Student Association. Previously, he held a fellowship at Public Citizen in Washington D.C.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.

In the afterglow (or for some, aftermath) of the election, PostScript thought it was worth scanning the federal policy horizon for any Rx out there.

And it’s hard to say anything about prescription drug policy in the next Congress without first talking about health reform.

With an early break from the gate, Senate Finance Committee Chair Max Baucus (D-MT) released a white paper last week entitled “Call to Action: Health Reform 2009.” The paper was the first look at an issue that lawmakers and President-elect Obama have both named as a priority when Congress reconvenes. It included provisions for comparative effectiveness, coverage-guarantee for those with pre-existing conditions, and would allow people age 55-64 to buy into Medicare early.

While passing health care reform is going to take broad consensus, and others such as Sen. Edward Kennedy (D-MA) and President-elect Obama are working on comprehensive plans of their own, we were encouraged to see that the Baucus paper recommends public disclosure of the financial relationships between industry and the medical profession. The paper referenced the recommendations MedPAC approved last week (see our earlier post) as well as S.2029, the Physician Payments Sunshine Act, though it doesn’t recommend specific reporting thresholds as MedPAC and PPSA have.

And right after Who Will Be the Next Commish, a little game being played at all the right blogs and Beltway dinner parties this season, we see two major FDA questions facing the Congress in its next term:

Q: With drugs coming from everywhere on the planet, how do we make sure they are safe enough to go into American medicine cabinets?

(Probable) A: The FDA Globalization Act. Ever since the heparin-from-China scare of 2008, interest in having a better handle on where our drugs are coming from and a bill that would shore up oversight, require new country-of-origin labeling, provide more resources for inspections of foreign manufacturing plants, and grant the agency subpoena power many other federal agencies charged with protecting the public already have. Both a House and Senate version were introduced in 2008.

Q: What happens to biotech drugs after the patent runs out?

(Right now) A: Nothing, and that’s an expensive answer both for consumers and the future of the drug pipeline, as R&D turns more and more to biologic therapies. Currently, four draft bills on the creating a pathway for biogenerics (also called “follow on biologics”) are circulating. The version introduced by Rep. Henry Waxman (D-CA) is widely considered to be the most consumer-friendly.

Only 64 days till the 111th is sworn in, so stay tuned – we sure will.

Boston Globe coverage of the progress of the Massachusetts health cost containment and quality bill, which was debated in the House yesterday, runneth over –

The gist

The letters

Lisa Kaplan Howe, Health Care for All

Brian Hurley, American Medical Student Association

The outcome

Now the omnibus bill (56 sections!) goes to conference, where the Sen. President’s version including a complete gift ban, disclosure and academic detailing should keep things interesting.

Singing the PhRMA Code Blues

This week, the head of a Kaiser Permanente’s physician network, the largest of its kind in the U.S., spoke out against the revised PhRMA code in the pages of the San Francisco Chronicle, calling it “nothing more than window dressing,” and “a weak, transparent move by an industry that is pretending to take strong action.”

Dr. Pearl, CEO and executive director of The Permanente Medical Group, a 6000-physician network that serves 3.3 million patients in northern California and abides its own pharmfree code, said that instead of relying on the profit-driven drug industry to police itself, physicians must collectively take responsibility for limiting the influence of pharmaceutical marketing on the medicine they practice, writing that “we cannot abdicate our responsibility as professionals – whose duty is to put patients’ interest first – by relying on the industry that benefits from those inducements to self-regulate.”

Rx realignment

Times of London columnist Carl Mortished says that in a convergence unseen in ElectionLand in recent years, both presumptive U.S. presidential candidates have angled to take on big Pharma: Obama has talked about allowing Medicare to negotiate drug prices, and both he and McCain have been seen stumping drug reimportation, which has had banana-peel traction under the current administration.

Though the Times online headline, “Barack Obama and John McCain go to war with Big Pharma” probably overstates things a bit, the article takes a good look at how U.S. politics may feed and shape bigger Western pharma trends.

Legislative affairs

As part of his continuing inquiry into medical conflicts of interest and financial ties to the pharmaceutical industry, Sen. Chuck Grassley (R-IA) has asked the American Psychiatric Association to submit to him its financial statements, citing concern that the degree of support the specialty society receives from commercial interests is causing field-wide bias.

Here’s coverage in the New York Times, and an opinion piece in the Boston Globe by former New England Journal of Medicine editor Dr. Arnold S. Relman discussing the proper source of incentives in academic research.

And in the San Francisco Chronicle, Dr. Lawrence Diller, a UCSF-affiliated pediatrician writes:

“The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.”

Maple Leaf Rag

The Canadians have found us! Proof in the pages of this month’s Canadian Medical Association Journal.  Thanks, Canada. We’ll watch hockey this year, promise.

And these last two are from the Wall Street Journal Healthblog. The first told us more than we knew about PhRMA chief Billy Tauzin and his history on the Hill, and the second – well, though the Healthblog wasn’t first to pick it up, we liked the desk-cowering image: Turns out injury-by-spacecraft has its own diagnostic code.

Lends a whole new meaning to Universal health care.

Medpin, or medicine for people in need, began in 1999 as a project of the Public Health Institute. During its eight-year tenure, Medpin worked with a broad group of California clinics, pharmacy schools, and health care foundations to get people appropriate medications in safety net settings. PostScript recently talked with Kathryn Saenz Duke, director of Medpin until it closed under funding challenges late last year. In the aftermath of the California showdown over health reform, PostScript asked Saenz Duke about what the defeat of universal coverage means for Californians who can’t afford their prescription drugs.

PS: What was your background before Medpin?  How did you get interested in prescription drug access issues? 

KSD: As a senior staffer on the California State Select Committee on AIDS in the 1980s, our committee worked with a broad spectrum of patients, advocates, and political groups to create new laws and policies, sometimes finding common ground and unexpected allies.  After the Senate, I joined a University of California research team looking at managed care’s impact on safety net providers. 

From there, I moved to the California Medical Association, where I met many doctors who felt caught between rapidly increasing direct-to-consumer drug advertising, formularies, and their relationship with patients.  All those experiences brought me in 1999 to the project that became Medicine for People in Need (Medpin).

PS: Is there a short version of what Medpin was, and what happened to it? 

KSD: Medpin’s first project was based on a cy pres litigation settlement in which all parties agreed to have an independent nonprofit organization distribute more than $170 million worth of diverse brand name drugs from 25 companies at no charge to recipients. 

We worked with 150 California public hospitals and community clinics caring for uninsured people, designed and operated a new, award-winning drug order and distribution system, and helped safety net providers fill 2,600,000 one-month medication supplies for indigent patients who might otherwise not have received those medications. 

Those were real achievements.  But we were also committed to bringing longer term benefits to safety net clinics.  We introduced many to the federal 340B discount program, promoted greater awareness and use of generic drugs, and helped the clinics better use drug companies’ patient assistance programs.  We sponsored California’s law allowing expanded use of 340B with community pharmacies, and created new working relationships among California’s large county indigent care systems, nonprofit community clinics, and faculty from California’s seven pharmacy schools.

PS: Will the needs Medpin met be met by something/someone else, or is that still unclear?

KSD: When the decision was made to close Medpin due to funding challenges, we were pleased to look back at how much of our past work has ongoing impact, and to know that many of the other nonprofits we have partnered with continue their work. 

But important work remains, and many of our former partners are facing their own funding difficulties.  

PS: Is the pharmaceutical industry doing its part to help patients in need? 

KSD: Medpin has always encouraged safety net providers to avoid confusing patient assistance programs with drug samples, which are part of drug companies’ marketing efforts.  It’s interesting that Medicare Part D’s infusion of federal funds into prescription drug spending has brought greater scrutiny to the design of patient assistance programs and their impact on that federal spending. 

This new legal attention is especially important for safety net providers, who feel pressure to accept much-needed financial help for many of their low-income patients, including from drug companies through patient assistance programs (and for some clinics, through drug samples).  There is tension between using this short term help vs. moving toward evidence-based prescribing that may favor lower cost, generic drugs that aren’t “free,” but can offer better overall value.  

PS: Is the government doing its part to help patients in need? Where’s the slack? 

KSD: Two existing federal programs immediately come to mind as needing more government attention and support:  Part D Low Income Subsidies, and “340B.”  (The 340B program helps uninsured and Medicaid patients by requiring significant purchase discounts for their safety net providers).

With this being such an exciting election year, maybe there’s a chance that policy leaders can engage people to think broadly about what government should be doing to help all of us improve our health, and particularly those in most need. 

PS: How did Medpin relate to pharmaceutical companies?

KSD: When I started with Medpin, I assumed we would eventually come together with PhRMA to identify and pursue some common interests, while agreeing to disagree on other matters. 

But I soon realized that PhRMA didn’t need or want to work with us. It’s more comfortable for them to purchase communications, outreach, or other assistance than to develop a relationship with an independent nonprofit like Medpin. 

Someone once commented to me that “Drug companies don’t understand and therefore don’t trust a nonprofit organization.”  At first I scoffed at this, but later came to see it as an insight into our experience with them.

We did interact with a few individual drug companies.  For instance, we gave several awards each year of the cy pres project to companies judged to have been most constructive in providing good products for uninsured patients. 

After that project ended, a few drug companies—most notably Merck and AstraZeneca—responded to our invitation for dialogue about continuing some portion of the work we had done together.  But these conversations did not progress, partly because Medpin decided to proceed only if a larger number of companies agreed to move ahead, and that never happened.

PS: Did Medpin work with patient advocacy groups? Considering that they are powerful consumer voices, but that some take funding from PhRMA members, what do you think their net effect has been on the conversation around prescribing and access?

KSD: Medpin’s focus has been on helping vulnerable patients by working with health care professionals in “safety net” settings.  We have promoted evidence-based prescribing through drug monographs, guidelines, and other materials we’ve developed with two pharmacy schools and our statewide group of safety net pharmacists and physicians. 

As for groups taking PhRMA funding, I believe that leaders from a number of “disease groups” are trying to think carefully about whether and how it’s possible to accept drug company funding while staying independent of pressure–however subtle or self-generated–to avoid ruffling their funders’ feathers.  Do I think there could be more self-examination on this issue?  Absolutely, yes.

PS: What does the defeat of California Health Reform mean for patients who can’t afford their prescription drugs and the community health clinics that serve them? 

KSD: Watching California’s recent health care reform efforts has been déjà vu for those of us who followed this state’s earlier drama over drug pricing.  We had several years of high-profile legislative efforts to address drug costs in California, followed by a confusing and expensive ($80 million) campaign in 2005 involving two drug discount program ballot initiatives. 

After voters failed to approve either measure, our Governor and legislative leaders enacted the bipartisan California Discount Prescription Drug Program in early 2006, which blended elements from both initiatives.  But that law failed to include any funding, and we’re waiting to see if anything comes from all the money and political negotiating invested these past years. 

Uninsured people will continue to need care and help on their drug costs from safety net providers.  There is some good news these days because a number of medications that used to be high priced are now available generically at much lower cost.  The bad news is that effective pharmaceutical care must be set within larger medical care and health promotion activities, and our state and national leaders are still trying to patch together financing and delivery system for those activities. 

Right now California’s public officials face a $16 billion budget deficit, so I don’t expect health reform here anytime soon.  

A final thought: Just as pharmaceutical care should be only one part of effective medical care, so should medical spending and attention be put into a larger framework of topics not typically considered medical or health-related. 

Recent writing by Michael Pollan, Steve Schroeder, Dick Jackson, and other thoughtful observers should move us all to pay more attention to our food, the built environment of our communities, tobacco use, and other factors whose combined power to help or hurt our health status is greater than the impact of medical care. 

How ironic it would be if we in the U.S. achieve access to appropriate medication at affordable prices for everyone, but see growing numbers of people eating fast food, smoking cigarettes, and living in communities designed more for cars than humans. I think sometimes we need to step back and at least acknowledge this bigger picture of “health.”

Renee Rulin, Medical Director at Commonwealth Care Alliance and a clinical professor of family medicine at Brown University, talked to PostScript about the way pharmaceutical companies affected her days in private practice, and the work CCA is doing now.  She says that just showing up is often the biggest weapon in a drug reps arsenal.

PS: As medical director of Commonwealth Care Alliance, how does pharmaceutical marketing influence the work you do?

RR: Well, as vendors for Medicare and Medicaid, we have a pretty standard formulary, and we negotiate with the drug companies through our Pharmacy Benefit Manager.  So the pharmaceutical companies interact with our PBM, who then selects drugs for the CCA formulary based on our requests.  But a lot of times the way drugs are “bundled” by pharmaceutical companies creates a formulary based more on cost than clinical relevance. 

Despite this, our formulary is broad and follows our philosophy of giving all the authority and decision making back to the doctor, who does the best job of patient care.  We want to get the doctors free to do what they do best.  We really try to get out of the way.

PS: So do doctors make their own decisions about drug reps, or does CCA have a policy?

RR: CCA does not have such a policy.  Our docs make their own decisions.

PS: As a physician and a professor now at Brown, have you seen any shift in how the pharmaceutical companies operate throughout your training and teaching?

RR: Over time, AMCs have really tried to keep Pharma out.  Faculty have begun to see the magnitude of influence they exert in teaching hospitals and in the wards, and are making efforts to replace drug rep visits and CME with real teaching, evidence-based teaching.

But when I was in private practice, every pen was from a drug company, every post-it note.  And that’s true in every private practice, you always end up in a negotiated relationship with the drug reps.

PS: In every practice?  What do you mean by a negotiated relationship?

RR: They would just show up constantly–constantly.  They just sail in, sweet talk the receptionist.  “Can I see the doctor?”  You try to restrict them as much as possible, but they bring lunch for your staff, chocolate chip cookies, and the samples, of course.  I mean, it’s like a gift to have some one show up and  tell you something you want to and need to  know, on your schedule. 

They are generally attractive, well-dressed, and articulate and mostly they are there, willing to talk to you whenever you have a minute.  And all of that is very attractive.  So you sort of delude yourself, saying you’ll pull out those nuggets of information you can use and ignore the marketing.  And it is, it’s a delusion.

Frankly, the docs tend to like that conversation; they like to hear from drug reps.  I think that if academics could counter-detail in the very same way–to really meet docs where they are–they’d do very well.

PS: So when it comes to Academic Medical Centers, you mentioned you see somewhat of a turning tide.

RR: Yes.  They are much more conscientious about keeping out the drug representatives—all the time. 

For instance, the Family Care Center at Memorial Hospital (Brown Family Medicine Residency training program) does not allow pharmaceutical reps into the clinic.

PS: Did you have any particular interactions with drug reps that stand out?

RR: I was no longer a resident, I was a clinical precept, but the reps brought in a lasagna for the whole teaching hospital and gave half of all family medicine residents salmonella.  Half the staff couldn’t work for two months.

Then there are docs that say, “I read the Medical Letter, and I let the drug reps in.”  And I think there are probably people who do that—who get their information independently, take their food and free samples, maybe argue with them.  But I think they are the exception, not the rule. 

PS: So beyond the Medical Letter, are there other good alternatives to detailing out there?

RR: Yes, I think that information is out there: online, in organized courses, in publications such as the Medical Letter.  The thing about drug reps is they just show up, and they have goodies.  And it’s tough to push back against that, it just is.