#37: When Equal is Not Equal: Issues with Prescribing Generic Drugs

[AdminWolf]

Episode 37: When Equal is Not Equal: Issues with Prescribing Generic Drugs
(aka -- "what you don't know about generics and were afraid to ask")

with Drs. Mel Friedman and Agustin Gonzalez

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We're taught in school that generic drugs are identical to their brand-name equivalents.

But is that true? Are generics actually identical, or do differences in their composition and production processes lead to different clinical outcomes?

In this important ODwire.org Radio show, experienced clinicians Drs. Mel Friedman and Agustin Gonzalez talk about their research into this issue, and what you as a clinician should know when you write for generics vs. branded pharmaceuticals.

If you engage in patient care (or regularly take pharmaceuticals yourself), this is one episode you won't want to miss!

 

[AdminWolf]

Thanks again to Agustin & Mel for a fun talk, lets use this thread to discuss this important issue.

ad

 

[AdminWolf]

This is the recent case I mentioned in the show.

It is interesting that these things are happening more frequently -- is the quality getting worse, or are more people just noticing?

 

[Agustin Gonzalez]

This was fun! Thanks Adam and Paul for hosting us.

 

[Paul Farkas]

Prescribing brand name drugs? Any questions from insurance carriers?

An Op/Ed piece in the 8/4/14 edition of the New York Times...


Adventures in ‘Prior Authorization’
By DANIELLE OFRI

Photo

• 
  “DEAR Doctor,” the letter from the insurance company began. “We are writing to inform you that a prior authorization is required for the medication you prescribed.”
  
  That’s usually where I stop reading. Thousands of these letters arrive daily in doctors’ offices across the country. They are attempts by insurance companies to prod doctors away from more expensive treatments and toward less expensive alternatives. To use the pricier option, you need to provide a compelling clinical reason.
  
  In theory, this is a reasonable way to control costs by making it harder to prescribe costlier medications. In practice, it is a wasteful administrative nightmare, a cavalcade of recurring paperwork, lengthy phone calls and bureaucratic battles.
  
  One study estimated that on average, prior authorization requests consumed about 20 hours a week per medical practice: one hour of the doctor’s time, nearly six hours of clerical time, plus 13 hours of nurses’ time. Other studies have suggested that prior authorizations could cost individual practices tens of thousands of dollars a year.
  
  The letter in my hand concerned one of my patients, Mr. V., who suffers from stubborn hypertension. His chart is a veritable tome, documenting the years of effort it took to find the combination of four different blood-pressure medications that controls his hypertension without upsetting hisdiabetes, kidney disease and valvular heart disease or making his life miserable from side effects. We’ve been on stable ground for a few years now, a state neither of us takes for granted.
  
  But Mr. V. had changed insurance companies, and now one of his medications required a prior authorization. The last thing I wanted was for him to be turned away at his pharmacy and have his blood pressure spiral out of control, so I called right away to sort things out.
  
  Twenty minutes of phone tree later, I discovered that the problem was that I had exceeded a pill limit for one of his medications. Mr. V. needed to take 90 of those pills each month for the high dosage that his blood pressure required. I patiently explained this to the customer-care representative.
  
  Equally patiently, she told me that 45 pills a month was the maximum allowed for this particular medication.
  
  Three more phone trees and three more customer-care representatives later, my patience was flagging. Apparently a request for 90 pills was flummoxing the system. Representative No. 4 asked me to list all the blood-pressure medications that Mr. V. had been on in the past, including dates of initiation and relevant lab values, a request of epic proportions in his case.
  
  The representative went down her checklist. “Would taking 45 pills per month instead of 90 pills adversely affect Mr. V.’s health?” she asked.
  
  At first I thought she was joking. “Well,” I replied, “it would probably make his blood pressure shoot up in the second half of the month.”
  
  She paused, then asked her next question with the encouraging uplift of suggestion. “Has Mr. V. ever tried 45 pills per month instead of 90 pills?”
  
  Then I realized that she was not joking. “Are you out of your mind?” I hollered into the phone. “It’s taken years — years! — to find the right combination of meds to control his blood pressure without killing his kidneys or making him dizzy or nauseated or depressed or ruining his libido or running his potassium off the charts or breaking his bank account. Do you really think I’m going to randomly jiggle the dosages just for the hell of it?”
  
  
  One study examined the records of more than 4,000 patients with Type 2 diabetes who were prescribed medications requiring prior authorizations. Those who were denied the medications had higher overall medical costs during the following year; not getting the medications probably worsened their conditions.
  
  
  I bit my tongue for the remainder of my conversation with the insurance company, holding back long enough to obtain the prior authorization that would allow Mr. V. the 90 pills he needed each month. I tried not to break the phone when I finally slammed down the receiver.
  
  I’m all for controlling medical costs and trying to apply rational rules to our use of expensive medications and procedures. But in the current system, everything seems to be in service of the corporate side of medicine, not the patient. The clinical rationale and the actual patient — not to mention the doctors and nurses involved in the care — are at best secondary concerns.
  
  In the end, we were able to keep Mr. V.’s blood pressure under control. My blood pressure, however, was a different story.
  
  Danielle Ofri, an associate professor at New York University School of Medicine,”

 

[Agustin Gonzalez]

This is the single biggest problem facing healthcare nowadays, the insurance companies dictating tot he doctor what they can and can't prescribe.

 

[Jeanne I. Ruff OD]

Rxd Pred Forte for k edema second to sterile ulcer. Pt returned for fu and declined brand at $150. Generic $15 copay. I cringed. The edema is taking much longer to resolve vs with my experience with Brand. Insurance industry are crooks!


Sent from the ODwire.org Mobile App

 

[Agustin Gonzalez]

Dr Ruff, thanks for sharing, we see this often.

Predisolone acetate has a higher bioavailability than the phosphate form and is actually milled into a fine powder before creating the suspension. For best results in generics have the patient shake it vigorously and place two drops instead of one.

The generic Pred acetate has a tendency to precipitate because the powder is usually coarser and also "cakes" in the dropper tip delivering less volume of drop. Both of these problems lead to lower concentrations in drop form.

Consider this: perhaps an increase in visit (1 or 2 extra) and delayed treatment (few days) would a better value be the branded product?

 

[Mel Friedman]

There is too much assumption that the generic dug is of the same equivalence as the branded co

Prescribing brand name drugs? Any questions from insurance carriers?

An Op/Ed piece in the 8/4/14 edition of the New York Times...


Adventures in ‘Prior Authorization’
By DANIELLE OFRI

Photo

• 
  “DEAR Doctor,” the letter from the insurance company began. “We are writing to inform you that a prior authorization is required for the medication you prescribed.”
  
  That’s usually where I stop reading. Thousands of these letters arrive daily in doctors’ offices across the country. They are attempts by insurance companies to prod doctors away from more expensive treatments and toward less expensive alternatives. To use the pricier option, you need to provide a compelling clinical reason.
  
  In theory, this is a reasonable way to control costs by making it harder to prescribe costlier medications. In practice, it is a wasteful administrative nightmare, a cavalcade of recurring paperwork, lengthy phone calls and bureaucratic battles.
  
  One study estimated that on average, prior authorization requests consumed about 20 hours a week per medical practice: one hour of the doctor’s time, nearly six hours of clerical time, plus 13 hours of nurses’ time. Other studies have suggested that prior authorizations could cost individual practices tens of thousands of dollars a year.
  
  The letter in my hand concerned one of my patients, Mr. V., who suffers from stubborn hypertension. His chart is a veritable tome, documenting the years of effort it took to find the combination of four different blood-pressure medications that controls his hypertension without upsetting hisdiabetes, kidney disease and valvular heart disease or making his life miserable from side effects. We’ve been on stable ground for a few years now, a state neither of us takes for granted.
  
  But Mr. V. had changed insurance companies, and now one of his medications required a prior authorization. The last thing I wanted was for him to be turned away at his pharmacy and have his blood pressure spiral out of control, so I called right away to sort things out.
  
  Twenty minutes of phone tree later, I discovered that the problem was that I had exceeded a pill limit for one of his medications. Mr. V. needed to take 90 of those pills each month for the high dosage that his blood pressure required. I patiently explained this to the customer-care representative.
  
  Equally patiently, she told me that 45 pills a month was the maximum allowed for this particular medication.
  
  Three more phone trees and three more customer-care representatives later, my patience was flagging. Apparently a request for 90 pills was flummoxing the system. Representative No. 4 asked me to list all the blood-pressure medications that Mr. V. had been on in the past, including dates of initiation and relevant lab values, a request of epic proportions in his case.
  
  The representative went down her checklist. “Would taking 45 pills per month instead of 90 pills adversely affect Mr. V.’s health?” she asked.
  
  At first I thought she was joking. “Well,” I replied, “it would probably make his blood pressure shoot up in the second half of the month.”
  
  She paused, then asked her next question with the encouraging uplift of suggestion. “Has Mr. V. ever tried 45 pills per month instead of 90 pills?”
  
  Then I realized that she was not joking. “Are you out of your mind?” I hollered into the phone. “It’s taken years — years! — to find the right combination of meds to control his blood pressure without killing his kidneys or making him dizzy or nauseated or depressed or ruining his libido or running his potassium off the charts or breaking his bank account. Do you really think I’m going to randomly jiggle the dosages just for the hell of it?”
  
  
  One study examined the records of more than 4,000 patients with Type 2 diabetes who were prescribed medications requiring prior authorizations. Those who were denied the medications had higher overall medical costs during the following year; not getting the medications probably worsened their conditions.
  
  
  I bit my tongue for the remainder of my conversation with the insurance company, holding back long enough to obtain the prior authorization that would allow Mr. V. the 90 pills he needed each month. I tried not to break the phone when I finally slammed down the receiver.
  
  I’m all for controlling medical costs and trying to apply rational rules to our use of expensive medications and procedures. But in the current system, everything seems to be in service of the corporate side of medicine, not the patient. The clinical rationale and the actual patient — not to mention the doctors and nurses involved in the care — are at best secondary concerns.
  
  In the end, we were able to keep Mr. V.’s blood pressure under control. My blood pressure, however, was a different story.
  
  Danielle Ofri, an associate professor at New York University School of Medicine,”

Rxd Pred Forte for k edema second to sterile ulcer. Pt returned for fu and declined brand at $150. Generic $15 copay. I cringed. The edema is taking much longer to resolve vs with my experience with Brand. Insurance industry are crooks!


Sent from the ODwire.org Mobile App

Dr. Ruff is absolutely correct when he says that generic Pred acetate does not respond nearly as well as branded. One begins to wonder who is treating the patient , you( the physician ) or the insurance co.
A recent study by Stringer and Bryant showed that branded pred. acetate takes up to 8 days to get full medical efficacy and that generic was even longer to get too a sufficient medical level in order to be effective.
One way that I was able to get around the insurance companies was to use agents that do not have generic counterparts.

 

[Paul Farkas]

A report in the AOA's First Look 9/16/14...

Study: Patients More Likely To Take Medicines If They Are Cheaper Generic Statins.

TIME (9/16) reports patients given cholesterol-lowering medications are more likely to fill their prescriptions if the medications are cheaper generic brands, citing a study in the Annals of Internal Medicine. “Initiating a generic versus a brand-name statin seems to be associated with lower out-of-pocket costs, improved adherence to therapy, and improved clinical outcomes,” the study said.

HealthDay (9/16) reports the study was funded by Teva Pharmaceuticals. The article notes that at issue “are the cholesterol-lowering drugs known as statins,” with brands such as Crestor (rosuvastatin calcium) and Lipitor (atorvastatin calcium). The article notes that researchers looked at “the prescription records of more than 90,000 people aged 65 and over who were on Medicare. All were prescribed statins between 2006 and 2008 – the most recent time period for which numbers are available.”

According to MedPage Today (9/16), “although the distinction was generic versus brand-name in the study, ‘the operating factor for patients is affordability,’” citing Walter Cullen, MD, of University College Dublin, and colleagues in an accompanying editorial. The piece notes that “the average out-of-pocket cost to fill a statin prescriptions was $10 for generics compared with $48 for brand-name drugs.” The article notes that “while the findings weren’t surprising, since prior studies have generally shown a direct relation between higher copayments and lower adherence, they might have been the first to assess the actual clinical effect of the decision to initiate a brand-name or generic medication.”

 

[Agustin Gonzalez]

Paul,

I agree, when presented as "equal products" the consumer will choose the less expensive. yesterday I had two interesting patents, one an oncologist the other a pharmacist.

While the oncologist acknowledge he does see a difference in the therapeutic outcome of brands and the need for lower dosages and faster outcomes he stated that the hospital he works for demands he use generics.

The other, a pharmacist, had no clue of the legal implications to physicians of the Supreme Court decisions we discuss in the radio podcast.

Meanwhile, patient advocates are screaming and no one is listening, it is an interesting world.

 

[Paul Farkas]

Generic drug prices getting out of control. A report in the 10/2/14 MedPage Today...

What is going on with generic drug prices?

A COUNTRY DOCTOR, MD

Fran Barker called today. She was in a panic because the cost of her monthly prescription of 150 mg amitriptyline tablets had gone up to $130 from $13 the month before.

Amitriptyline has been available in this country since 1961, and the 100 mg strength was on Walmart’s list of $4/month drugs the last time I looked at it a few months ago.


I called Fran’s pharmacy. Two of the 75 mg tablets would be less expensive, about $75 for a one month supply, but this would still be a hardship for Fran, who is disabled and lacks prescription coverage.

A few months ago I read that the older, generic statin drugs for cholesterol were suddenly not on Walmart’s $4 list due to sudden price increases by the manufacturers.

Something similar happened to insulin a few years ago — it went from a few dollars to $80 per vial without any explanation that I was aware of.

I have Googled around a few times to try to find out what is happening, or what people think is happening, but the dramatic price increases I have run into don’t seem to be getting much press.

It appears to me that the pharmaceutical companies have stopped their price competition, possibly by secretly dividing up the market and definitely by limiting supplies. If that is true, antitrust laws are likely being broken. Meanwhile, people with chronic illnesses are being squeezed financially even more than they already have been.

Generic drugs used to be a low margin product for manufacturers, but a major profit for drug stores. With newer generics, whose brand name competitors are still on the market, pharmacies may buy them for 10% of what they pay for the brand and sell them for 70% of the brand name price. Now, with their purchase prices going up on one generic after another, their markup is likely shrinking to the levels of brand name drugs. This will likely drive independent pharmacies out of business.

We already had a great deal of mystery and intrigue around pharmaceutical pricing and actual insurance payments for prescription drugs. Just like doctors and patients have trouble figuring out how much MRIs and artificial knee joints cost, the real cost of pharmaceuticals is often unobtainable. I can try to choose lower cost medications by looking up the average retail cost on Epocrates, but insurance companies and drug manufacturers often negotiate deals that make favored otherwise expensive drugs cost less than non-favored drugs with lower published prices.

This whole drug price situation is really the stuff of mobster movies. Or imagine a sitcom about what happens when gasoline (petrol) prices increase by 900% overnight. That wouldn’t be funny for very long. People would complain loudly about being held hostage or extorted.

But is anybody complaining about what is happening now with drug prices? Am I just not hearing about it because I gave up watching TV? Or am I an early voice in the wilderness? You tell me.

“A Country Doctor” is a family physician

 

[Agustin Gonzalez]

Partly is the lobby they are setting up to avoid changing the current US supreme court rulings, the fines they have had to pay and the standards they are now required to follow. The FDA is looking that way and it is going to be expensive!

 

[Paul Farkas]

A disturbing report in the 101/13/14 MedPage Today...

Two-tiered generic drugs will lower quality of care
TRUDY LIEBERMAN

As we head into health insurance enrollment season, which opens in November, consumers/patients will face yet another challenge in selecting the best health plan. Sorting through policies was tough already, but now insurers are making it even harder by changing the way they will cover generic drugs.

It used to be that opting for generics was a snap. Health plans usually offered three or four tiers of drugs — one for preferred brand drugs, one for non-preferred drugs, a category for the expensive specialty drugs and another for low-cost generics. The advice was to always buy generics if you could.

An editorial in the Journal of Managed Care revealed that some insurers are now splitting their generic tiers. There will be a preferred group of generics that will cost less for consumers and a non-preferred tier of generics that will be pricier. In essence, some generics are now becoming like brand-name drugs.

For years, insurers have tried to persuade consumers to pick low-cost generics over preferred brand drugs as a way to reduce the national health care tab, a strategy that also lowered their outlay. When consumers chose lower-priced drugs, the portion of the drug that insurers paid for was lower too.

But there may be greater fallout from this new plan than making consumers dig deeper in their pocketbooks to pay the additional cost. There’s a real danger patients won’t buy the prescribed drug and will go without it.

There’s plenty of evidence this happens: “There’s strong evidence that even a $1 difference in out-of-pocket expenditures changes (medical) behavior,” says Dr. A. Mark Fendrick, who directs the Center for Value-Based Insurance Design at the University of Michigan, a group that’s trying to encourage the use of medical treatments based on clinical and scientific evidence rather than advertising claims.

And RAND Corp. studies similarly show that even small price increases are enough to make patients stop buying a drug. Congress also recognizes that cost increases and co-pays can keep people from getting needed care, particularly people with low incomes. That’s why the Affordable Care Act reduces cost sharing requirements on policies sold to low-income consumers and eliminates coinsurance and co-pays for many preventive services. “We should have low or no barriers as opposed to high barriers,” Fendrick said.

I thought of all those newly insured Medicaid recipients brought into the health system, especially in states like Iowa and Arkansas, which have expanded their programs but require a nominal contribution. While they may seem trivial to Beltway policymakers, even small co-pays are a barrier for the poor. It is possible consumers could even abandon health insurance coverage. As Daniel Riley, the CFO of the University of Arkansas for Medical Sciences Medical Center in Little Rock, told Modern Health Care, “We’re already seeing in those eligible for subsidized exchange coverage, that when they have to pay a co-pay, even if it’s just a little bit, they are not signing up.”

For those who do have health insurance and face two-tiered arrangements for generics, there’s an additional challenge. Will this new strategy result in lower quality care?

Possibly, says Fendrick. A study by Policy Analysis, Inc. found that some drugs that are the standard of care for many ailments, such as metformin to treat diabetes, are not always in an insurer’s preferred generic tier. “This is something that makes it more difficult to provide high quality care,” Fendrick told me. “It will harm national efforts to put incentives in place to improve care.”

Fendrick has a point. The Affordable Care Act was all about improving access and quality of health care. But it was silent on what happens when those goals conflict with the bottom-line demands of the medical marketplace.

Trudy Lieberman is a journalist and an adjunct associate professor of public health, Hunter College, New York, NY.

 

[AdminWolf]

This will show you everything you need to know about how monopolies price:

http://www.sanders.senate.gov/download/letter-to-mr-saunders-ceo-and-president-actavis?inline=file

Notice what happens when a single company goes unchecked.....