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Archive for the ‘Generics’ Category

News from China  gives us even more pause to reflect on the access to medicines scenario. The situation in the US where there are no good excuses for unaffordable medicines, pales in comparison to this chilling tale of a patient whose actions to secure the life-saving drug imatinib mesylate at an affordable price, has resulted in his criminal prosecution.

Veenat400mgTo prosecutors, a leukemia patient named Lu Yong is a criminal involved in credit card fraud and a counterfeit drug scam. But to 1,000 fellow leukemia patients in China, Lu is an unsung hero for helping them get access to cheap, life-saving generic medicines from India.

His crime?  Selling fake drugs and breaking a law about purchase of international credit cards.  What Lu did was considered criminal because any drug  produced in or imported into China without the government’s approval is classified as a “fake drug,”  and Lu purchased international credit cards online to facilitate the transactions. China.org.cn reported that:

The defendant, Lu Yong, was diagnosed with chronic myelocytic leukemia in 2002. He was prescribed Gleevec, a drug produced by Swiss drug-maker Novartis, which cost 23,500 yuan (US$ 3,775) per month, far too expensive for average Chinese families. Lu was even more depressed since the expenses of treating leukemia are not covered by China’s medical insurance system.

Lu later found out that India produced a generic drug which was comparable to Gleevec but which cost only 4,000 yuan, about 17 percent of the cost of Gleevec. He took the medicine himself and found it effective. Later, Lu began helping several thousand fellow patients buy the drug, since the purchasing process was difficult and some patients were not able to fill out the English purchase forms.

Meanwhile, Lu’s trial has been postponed due to his health problems, and some 300 fellow patients with CML have signed an online petition asking for his release.

Also of significance is the astronomical price of Gleevec in China,  said to be the highest in the world, which led  Lu to seek an alternative.  As a point of comparison, Costco’s US online pharmacy is now selling a 30-day supply of the standard 400mg dose of Gleevec for $9022.05.

Glivec400mg

 

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A bevy of news stories local and national have highlighted the ever-worsening situation for consumers , especially  for folks who need so-called specialty drugs but also for the much larger segment of the population who use plain old generic medicines.  While raising awareness is essential, mostly what we are seeing, is increased an amount of talk about the problem, but less often are suggestions being offered in the way of sustainable solutions. Shock over the price for new Hepatitis C drug Sovaldi  was a wake-up call for policy makers and the public; it remains to be seen what will be prescribed as a remedy.  Here’s a sampling of  some more recent headlines:

Small group of specialty drugs could make up half of total pharmacy spending by 2018

Prices Soaring for Specialty Drugs, Researchers Find

Generic drug prices skyrocket in past year

Will Rising Prices for Some Generic Drugs Never End? Monthly Cost for One Heart Drug Can Approach $1,200

Pharmacists Report Soaring Generic Drug Purchasing Prices Impacting Patients, Pharmacies

New strategies needed to curb specialty drug costs

While some in Congress have been asking why in 2014, it remains to be seen if the political will can be mustered anytime soon to secure pricing changes from Big Biopharma.

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Recent news of note:

Report: Debt Collectors Work In Emergency Rooms, Demand Payment Before Patients Receive Care

Abbott To Pay $1.6 Billion To Settle Depakote Probes

Discrepancies on Medical Bills Can Leave a Credit Stain

American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics

Insurers back FDA plan for new drug category

Patients Share Of Expensive Specialty Drugs Is Rising

Racial, Socioeconomic Disparities Alleged In Autism Spending

Premera tries to gut drug benefits, Kreidler says no 

and a shout out to an excellent source of news and analysis with a focus on Oregon and the broader context:

The Lund Report: Unlocking Oregon’s Healthcare System

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Those who have been following the saga of the leukemia wonder drug imatinib mesylate or Glivec (spelled Gleevec in North America to standardize pronunciation) may recall that it was said to be the first medicine for which a global price was set. At the time of its 2001 FDA approval, the worldwide price was US$2400/month, for  a base dosage of  a 30 day supply of 400mg caps.  Indeed, Novartis CEO  Daniel Vasella went to great lengths to discuss and justify both the high price and the pricing decision in his subsequent infomercial-type book  Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical HistoryThe Gleevec story is notable too in that the typical pharma claim that the price is justified by R & D costs, was refuted by researcher Brian Druker MD, who detailed how most of the initial work on imatinib was publicly funded and he had to convince Novartis to  produce enough of it to begin clinical trials with CML patients. Dr. Druker has also gone on record to criticize  the price being charged for Glivec.

Since then patients in wealthy countries mostly have been clamoring for their  public or private insurance to cover  the drug (and its second-line successors) not that something be done about the price that is exorbitant even in their economies. Novartis  invested heavily in worldwide patient relationship marketing for Glivec , which has contributed to this phenomenon, a topic  explored previously in this blog. In recent years,  it has become much more common to hear complaints from US patients and even some of the big-box disease associations, about the escalating price of  drugs like Glivec and  especially for new biologics. But it has  been rare to to hear demands that something be done about drug prices.

So the recent posting of a patient petition on change.org calling for action to reduce the price of Gleevec is notable:  Novartis and US Representatives in Congress: Reduce to patients the cost of the drug, Gleevec.

The introduction of the petition reads:

Novartis developed this drug in the 1990s. In the years since then the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost

Setting aside the issue of  misunderstanding that there are no price controls on prescription drugs in the US open market and that the FDA does not regulate drug prices, the petition is significant as a reflection of the increasing desperation of middle-class privately insured patients. They are among the majority here whose insurance status and/or income levels typically disqualify them for the patient assistance programs much touted by Novartis, whose global Gleevec sales generated $4.7B in 2011.   Many US patients are now finding that the Gleevec price has skyrocketed at the same time that insurers are requiring them  to pay a much larger share of its  hefty price tag.  The situation is quite simply unsustainable.

One person who signed the online petition shared:

I started taking Gleevec June 1, 2001, when it was first approved by the FDA. It cost $2400 for 30 pills. Now, these same pills cost $7367 per month. I pay $1035 per month for insurance to cover this cost. My insurance Co. gets billed for the drug. Why has Novartis raised the price so much? …

A look at  Costco’s online pharmacy, which has a reputation, anecdotal at least, for offering “good value” retail prices on Rx meds in the US, found the following cash price for a month’s supply of an  average dose (dosage  is individualized) of  30 tabs :  GLEEVEC 400 MG TABLET      $6,264.59

While Novartis is continuing its drag on its patent fight to combat the imatinib generics already on the market in India, these cannot yet be exported to the US.  The original  US patent for Glivec expires in 2015. In 2009, Sun Pharma  filed for and received tentative FDA approval for a generic imatinib for when that day comes.

Given the power of the pharma lobby the future remains very uncertain for any relief on the price of Gleevec , but the clamor of voices from the grassroots is a healthy development.

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Recent developments in Washington and neighboring Oregon are reminders of the clout and lobbying power of Big Pharma on the local level.

Seattle City Councilmember Tom Rasmussen announced that he was working to implement a  discounted prescription drug program for Seattlites , a program of the National League of Cities.  At first glance this might seem like a boon most of us, cash-strapped and increasingly uninsured and underinsured, but in reality the plan is not needed, won’t offer much in the way of bargains, and is linked to a questionable PBM. With all due respect to Rasmussen, who undoubtedly has good intentions , he seems unaware that we already have a drug discount program available at no charge to all state residents, the Washington Prescription Drug Program , which offers discounts up to 60% on generics and 20% on branded drugs, while the NLC program  offers maximum discounts up to 23% of full retail prices.  Another concern is that the NLC card is an offering of CVS Caremark, the mega-PBM which has earned itself notoriety for  unethical business practices, including overcharging government employee health plans ( including the federal plan) for Rx medicines and drug-switching on scripts. The Seattle-only program is due to start next month, so now is a good time to weigh in with Rasmussen and his fellow City Councilmembers , as well as with Mayor Mike McGinn on the issue.  In addition to helping to increase awareness of the WPDP, our city elected officials could really offer a public service by creating a drug price comparison tool that surveys Seattle pharmacies.

And in the Washington Legislature, among several bills dealing with prescription drugs ( look for my comments in the future), for the third year in a row we saw  Drug Companies Fight Take-Back Program for Unused Medicine. They claim that take-back programs, which they would be required to help pay for, would do little to stop  abuse of prescription drugs and that environmental concerns about trashing meds are essentially bogus. Take Back Your Meds, a group of over 260 health organizations, police, drugstores, local governments, environmental groups and concerned individuals vows to keep up the fight.

In Oregon, a legislative defeat with direct negative impact there and for partner WA in the Northwest  Drug Purchasing Consortium , pharma and insurance industry muscle united to make sure that  Oregon Prescription Drug Program Bill Dies a Second Death. SB 1577 would have required all state agencies to purchase medicines for beneficiaries through the Oregon Prescription Drug Program, reversing the current optional  status.  When the OPDP and the WPDP were created in 2005, they formed the Northwest Prescription Drug Purchasing Consortium to achieve better prices through pooled volume purchasing but left participation optional for state agencies. In both states, for example,  the Dept. of Corrections does not participate.  And with efforts to control Rx costs stymied, we are seeing scenarios such as this year’s state budget proposal in Washington to eliminate completely prescription drug coverage for adults in the Medicaid program, only now with some hope of possible mitigation if competitive bidding for generic drugs is approved by the Legislature now in Special Session.

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Recent news and commentary of note on US and global issues related to health and well-being:

Medicare Part D Ups Patient Compliance, Reduces Hospital Costs

Why do 70 dead in Norway rank higher than tens of thousands in Somalia?

For-Profit Hospices Keep Patients Longer, Push Costs Up

Where’s the Advocacy, Komen?

Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

Big Pharma wants to ‘friend’ you

Drug prices to plummet in wave of expiring patents

Two Steps Forward, One Step Back on Hospital Transparency

The most and least expensive cities for health care

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Beyond the challenges planned to overturn the Affordable Care Act in the US, we need to keep abreast of news  from around the world affecting access to care , such as these headline stories:

HIV Patients May Soon Face a Choice: Full Price Meds or No Meds At All

U.S. Backs Drug Firms in Lawsuit Over Prices

Deadly Spin Strikes a Chord

Firms fight move to obtain cheap anti-blindness drug Avastin

and from North America, illustrating that it’s not only quality control and manufacturing issues, but the profit motive that contributes to shortages of important drugs:

Report warns of medication shortages across Canada

A push to ease prescription drug shortages: Sen. Klobuchar to propose easing imports of medication from abroad

Darcy Malard-Johnson, a pharmacist at the University of Minnesota’s cancer clinic, said 13 of the 150 drugs on the current shortage list are cancer drugs. Most have been around for years, she said, and that may be one of the problems. Because they’re generic, they’re not as profitable to make or sell as newer drugs. And there’s no way of knowing when a company will simply decide to stop making it.

The shortage of oncology drugs in particular was also highlighted in NCI Cancer Bulletin in an article entitled Continued Shortage of Chemotherapy Drugs Causing Concern.

The FDA’s Drug Shortages  website includes current shortages, status updates, and a list of drugs to be  discontinued, per the following terms:

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only.

Health Canada currently does not conduct such monitoring or provide information on drug shortages, actions that the Canadian Pharmacists Association has urged the government to take on quickly to address the serious and growing problem.

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