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Medical Societies and Industry Sponsorships

May 12, 2011 in Pharmaceuticals | No comments

Maybe money can’t buy you love…but can it buy you influence over physician treatment choices? That’s what many pharmaceutical and medical device firms are betting on.

Concerns about the influence of industry money have prompted universities [10] [10] such as Stanford and the University of Colorado-Denver to ban drug sales representatives from the halls of their hospitals and bar doctors from paid promotional speaking.  Yet, one area of medicine still welcomes the largesse: societies that represent specialists.

…Nearly half the $16 million the heart society collected in 2010 came from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms, the group’s website disclosed.  Officials of the Heart Rhythm Society say industry money does not buy influence and is essential to developing new treatments.

Are these sponsorships a mechanisms for disseminating information to providers on new treatment options or a method of convincing physicians to change their treatment patterns. The distinction between physician education and marketing is often blurred.

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Trends in Medicare Part D

April 25, 2011 in Medicare, Medicare Part D, Pharmaceuticals | 1 comment

Recent research from Avalere Health, LLC using Medicare Part D reveals some interesting trends.  Overall, premiums for fee-for-service prescription drug plans (PDPs) increased by 3%.  For beneficiaries who enrolled in a Top 10 plan, however, premiums actually decreased by 6%.  This result was driven by a 12% decrease in premiums for the largest PDP, AARP MedicareRxPreferred and the recent arrival of the low cost Humana-Walmart-Preferred Rx Plan.

Although the total number of Special Needs Plans (SNP) has held fairly steady over time, the number of enrollees in a dual-eligible SNP has risen by 11% between 2010 and 2011.  Additional information on SNPs is below.

Within the Medicare Advantage program, enrollment in HMO and PPO plans continues to grow as PFFS enrollment declines.

Additional Part D trends are highlighted below.  This spreadsheet provides even more detail.

Plan Consolidation in 2011

  • The top 3 PDP plans made up 45.4% of all PDP enrollees.  The top 10 plans made up 73.2% of all PDP enrollees.
  • CIGNA Medicare Rx Plan One joined the top 10 PDPs as did the Humana Walmart-Preferred Rx Plan.
  • UnitedHealth, Humana, and Kaiser provide MA benefits to 44% of all MA enrollees

Part D Sponsor Acquisition and Plan Consolidation

  • CVS Caremark will acquire Universal American’s PDP plans and members after Q1 of 2011
  • AARP MedicareRxSaver consolidated into AARP MedicareRxPreferred
  • PrescriberRxBronze consolidated into Community CCRxBasic

Prices

  • Overall, PDP premiums increased by 3%.  For beneficiaries who enrolled in a Top 10 plan, however, premiums actually decreased by 6%.  This result was driven by a 12% decrease in premiums for the largest PDP, AARP MedicareRxPreferred and the advent of the low cost Humana-Walmart-Preferred Rx Plan.

Special Needs Plans

According to the CMS website, Special Needs Plans (SNPs) were created by Congress in the Medicare Modernization Act (MMA) of 2003 as a new type of Medicare managed care plan focused on certain vulnerable groups of Medicare beneficiaries: the institutionalized, dual-eligibles and beneficiaries with severe or disabling chronic conditions. These beneficiaries are typically older, with multiple comorbid conditions, and thus are more challenging and costly to treat.  Dual-eligible SNPs also offer the opportunity of enhanced benefits by combining those available through Medicare and Medicaid…Specific legislative and regulatory provisions allow SNPs to focus on specific subsets of the Medicare population with the intent to improve care and control costs for these beneficiaries. Consistent, comparable measures that reflect the service delivery and outcomes important to these populations and that promote quality improvement and maturation of SNP products are necessary.

The fifteen SNP-specific chronic conditions approved for 2010 are: 1) Chronic alcohol and other drug dependence; 2) certain auto-immune disorders; 3) cancer (excluding pre-cancer conditions; 4) certain cardiovascular disorders; 5) chronic heart failure; 6) dementia; 7) diabetes mellitus; 8 ) end-stage liver disease; 9) end-stage renal disease requiring dialysis; 10) certain hematologic disorders; 11) HIV/AIDS; 12) certain chronic lung disorders; 13) certain mental health disorders; 14) certain neurologic disorders; and 15) stroke.

 

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Do the elderly need help managing their prescriptions?

January 10, 2011 in Pharmaceuticals | No comments

According to this study, I would certainly say yes!

“The study reviewed pharmacy claims from the CVS Caremark pharmacy benefit management (PBM) book of business for 1.83 million patients taking statins, and 1.48 million patients taking angiotensen converting enzyme inhibitors (ACE inhibitors) or rennin angiotensen receptor blockers (ARBs) between June 1, 2006 and May 30, 2007…

During a three-month period, patients filled prescriptions for an average of 11 medications representing an average of six different drug classes, the researchers said.  ’More striking, during this 90-day time frame, 10 percent of these patients filled prescriptions for 23 or more medications . . . and 11 or more different drug classes, had prescriptions written by four or more prescribers, filled these prescriptions at two pharmacies and made 11 or more visits to those pharmacies,’ they said.”

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How prevalent are errors in medical research?

December 6, 2010 in Pharmaceuticals, Reviews | 2 comments

The latest issue of The Atlantic has profiles brave thinkers. One of these brave thinkers is Dr. John Ioannidis, who is profiled in “Lies, Damned Lies, and Medical Science.” Dr. Ioannidis challenges much of the medical establishment by charging that most medical studies are biased, misleading, or flat out incorrect. In the article, author David H. Freedman writes that “He [Dr. Ioannidis] charges that as much as 90 percent of teh published medical information that doctors rely on is flawed.”

Today, I review some excerpts from this very interesting article.

Bias in Physician Treatment

One study showed that “…the appendices removed from patients with Albanian names in Greek hospitals were more than three times as likely to be perfectly healthy as those removed from patients with Greek names.”

Bias in Research studies

In a discussion with colleagues, Ioannidis suggested that it could be possible “drug companies were carefully selecting the topics of their studies–for example, comparing their new drugs against those already known to be inferior to others on the market–so that they were ahead of the game even before the data juggling began?” In addition, “drug studies have the added corruptive force of financial conflict of interest.”

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User Fees: A solution to decrease wait times for FDA approval of generic drugs?

October 21, 2010 in Pharmaceuticals, Regulation | 3 comments

The Consumer’s Union used Medicare.gov to show that many people could save $3,500-$5,000 by switching to generics.  Why don’t more people do so?  One reason is the long delays for FDA approval of generics.  The FDA’s Office of Generic Drugs is understaffed and thus generic drug approvals takes much longer than it should.

Brand name pharmaceuticals pay user fees to the FDA to speed up approval time.  Is this a good idea to apply for generics as well?

A Consumer Reports (Nov 2010) editorial states the following:

“In general, we oppose user fees that allow a regulated industry to fund the regulators.  A government agency can become dependent on the companies it’s supposed to objectively regulate , which can influence decision. In a 2006 survey…many FDA employees said they felt pressured to hastily and perhaps improperly approve user-fee drugs.  And at least one felt the agency viewed industry, not the American public, as its client.“

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Patents, Regulation, and Fake Drugs

September 13, 2010 in Pharmaceuticals, Regulation | No comments

The Economist notes that counterfeit drugs are a growing problem.

“Counterfeit drugs can kill. Many are shoddily made, containing the wrong dose of the active ingredient. Taking them instead of the real thing can turn a treatable disease into a fatal one. It can also foster drug resistance among germs.”

Do patents cause and increase or decrease in the provision of unsafe, fake drugs?  Most people will say that patents help protect drug safety.  Drugs sold under patent require FDA approval and are generally safe.  However, these drugs are expensive and many people–especially those without insurance–cannot afford them.  Thus, these individuals may turn to less reliable vendors who promise to provide the same drugs at a lower price.

With shorter patent lengths, reliable companies can begin to produce affordable generics.  Companies can build a reputation for high quality generics, while still selling customers through low prices.  Eventually, these “generic” companies could build a brand name as worthwhile as Pfizer.

Just decreasing patent lengths is not a cure all, however.  People have been selling, drugs, tonics and potions which falsely purport to cure all types of ailments since the beginning of mankind (e.g., snake oil salesmen).

Additional drug safety regulation could improve the safety of marketed drugs, but it would also likely drive up prices, thus forcing more individuals to buy medicines on the black market.  Additional regulation also stymies new treatment innovation due to the extra costs regulation imposes.

Fake drugs are a serious problem; a problem without a simple answer.

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Do Acid Blockers pose health risks

September 10, 2010 in Pharmaceuticals | 2 comments

In 2008, Americans spend over $14 billion on proton pump inhibitors.  These heartburn treatments such as Nexium, Prevacid, and Protonix may put millions of patients at risk.

According to Scientific American, long-term use of these medicines has been linked to “withdrawal symptoms, an increased risk of bacterial infection, hip fracture and even possible nutritional deficiencies.”  Additionally, Doctors sometimes give PPIs to prevent gastrointestinal bleeding or stress ulcers, even though such prescribing is of questionable medical value.  On study by a professor at the University of Michigan Hospital found that their facility spent over $100,000 per year on unnecessary PPI prescriptions.

Surprisingly, a 2009 study in Gastroenterology found that “long-term use of PPIs may cause the very symptoms the drugs are designed to treat.”  After 12 weeks of treatment, 22% of the treatment group receiving PPIs experienced heartburn compared to 2% of the group receiving a placebo.  In fact, St. Paul’s Hospital in Vancouver cut daily medication costs in half by redcing PPI prescribing patterns and did not worsen clinical outcomes whatsoever.

Why are PPIs so popular if they are ineffective?  One doctor claims that they may be addictive.

Should PPIs be prohibited?  I would say not.  However, given the evidence of the ineffectiveness of PPIs, private insurance companies, Medicare and Medicaid should not cover these types of medicines.  Under this logic, patients could still take the medicines if they wished, but this would come at their own cost.  This is one case where President’s Obama’s push for the use of more cost-effectiveness analysis within government health insurance programs could bear cost savings without harming patient health.

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CMS 2010 Requirements for Medicare Part D Plan MTM Programs

September 2, 2010 in Medicare Part D, Pharmaceuticals | 1 comment

In an effort to standardize the provision of medication therapy management (MTM) within Medicare Part D, CMS has outlined specific requirements for Part D Plan MTM programs in 2010.  The APhA’s Medication Therapy Management Digest (March 2010) reviews these requirements.

MTM programs must:

  • Enroll targeted beneficiaries using an opt-out method only (i.e., beneficiaries are automatically enrolled unless they choose not to be)
  • Target beneficiaries for enrollment at least quarterly.
  • Include the following enrollment criteria for targeted beneficiaries:
    • Does not require more than three chronic disease states.
    • Does not require more than eight medications.
    • In defining multiple chronic diseases, sponsors must target at least four of seven core chronic disease states.
    • Likely to incur annual costs of $3,000 for covered Part D drugs (a reduction from the previous requirement of $4,000).

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Beers

August 27, 2010 in Pharmaceuticals | No comments

As a Wisconsin-native, you may be surprised that this is my first post about Beers.  I do like beer.  My preference is for either dark beers (e.g., porters, stouts) or Belgian ales.  Today, however, I am not going to endulge you in a discussion about beer.

Instead, I want to talk about the Beers criteria.  The Beers criteria lists a number of medications that are considered inappropriate to prescribe to the elderly.  Generally, the side effects of these drugs outweigh the potential benefits for more frail seniors.  The list has been updated numerous times, most recently in 1997 and updated in 2003.

Many medication therapy management (MTM) programs use the Beers list to identify high risk drugs.  Computer algorithms can use data on the beneficiary’s age and the drug prescribed to determine if the medication meets the Beers criteria.  If this is the case, the pharmacist can alert the patient and/or prescribing physician in order to alter the treatment plan.

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Will CVS Caremark split up?

May 20, 2010 in Business, Pharmaceuticals | No comments

CVS is the second largest pharmacy in the U.S. with over 7000 stores.  Caremark Pharmacy Services is a pharmacy benefit management (PBM) company, providing benefit management services to health plans.  In March of 2007 the two firms merged.  The combined firm not only has $99 billion in sales, CVS Caremark also has the ability not to recommend drugs to health insurance plans and to dispense them.

Fortune Magazine wonders whether CVS Caremark should in fact be split up.  The Federal Trade Commission is not investigating as to whether the merger results in a conclict of interest.  Critics say this is in fact the case “because PBMs are supposed to be drugstore-agnostic–and Caremark can’t help but favor CVS.  Five pharmacists (NCPA members) have told Fortune that Caremark steers members into CVS stores by offering lower co-payments or automatically filling prescriptions there.”  This follows an earlier $370 million lawsuit that that accused the PBMs (including Caremark) of “…encouraging doctors to switch to brand-name medications and keeping the rebates.”

Regulators may not, in fact, be the ones who break up the organization.  Caremark lost $4.8 billion in contracts this year.  Thus, CVS may not be willing to shoulder these losses much longer and a self-imposed breakup may be in the works.  This breakup of a PBM with a drug supplier will not be the first.  Medco and Merck ended their merger in 2003.

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