It’s that time again: open enrollment for Medicare Part D. Ordinarily, items such as this don’t really generate newsworthiness. However, these aren’t ordinary times; given the state of the (healthcare) economy, anytime one connects the dots between the country’s largest care guarantor and the potential for greater coverage pools — it’s time for intense wonkishness to rear its ugly head yet again.

The big question is whether or not Part D makes sense for the consumer. New this enrollment period: (1) premiums will rise another 10% percent;^[1] (2) the vast majority of standalone prescription drug plans (60% or so) will require a deductible in ‘10, maxing out at just over $300; (3) finally, with respect to so-called “benchmark” plans,^[2] qualified beneficiaries will still have to pony up a percentage of their premium if they want to stay in their plan or will have to switch plans altogether.

Bottom line, it’s all about cost-sharing as a mechanism for controlling costs, at least with respect to Pharma and Medicare Advantage plans; and, in a pharma marketplace which is forecasted to remain rather staid next year,^[3] profits have to be generated from many levels. Medicare Part D has its share of choices for the beneficiary, but due diligence will be the guide to retaining skin in the game for the patient as savvy health care consumer. | LINK

1. up 50% overall from when MMA (2003) created the part D provision for launch in ‘06 [↩]
2. those in which basic Part D is offered for those who qualify for a premium [↩]
3. Many popular brand name medications are scheduled for generic release in 2010. [↩]

Sometimes the fastest way from an NDA to market is to manufacture the combination of two popular drugs into one. Pharma benefits from a new patent; healthplan formularies benefit from aggressive DTC patient marketing, and the patient ostensibly benefits from a better, cheaper alternative. Usually, the combined agent is two drugs — usually taken together for the treatment of some clinical syndrome. Rarely, three drugs may be combined. But, have you heard of four or even five compounds in a single tablet to treat the number one killer in this country — heart disease? Well, study researchers in Canada and India certainly have. Dubbed the “polypill”, the studied drug is composed of a cholesterol agent, aspirin, and three compounds to control blood pressure. Sure, a 5-in-1 pill enhances patient compliance and would be of low cost (as all drugs would be generic). But medicine is as much an art as it is a science, and one drug — no matter how all inclusive it tries to be — is not all things to all people.  | LINK

• Popular anticonvulsant (with a multitude of off-label pain uses) gains approval to go generic.
• A Web-based provider of care analytics has come up with a prostate cancer screen. The cynic in me says it’s a new look to an old unresolved problem.

Through a web-based tool, men enter the results of their PSA test history and personal information such as height, weight and health history. This information is compared with up to a million case studies and outcomes from other men with various prostate conditions. Finally, the system may suggest a medical detective process for doctors and their patients in their efforts to detect non-cancerous prostate conditions and improve prostate cancer screening, the company said.

• Lilly is trying very hard to get a novel neuroleptic to market; it’s not going too well.
• Crestor, an popular cholesterol drug, to protect against venous blood clots? | VIDEO
• CA spice company linked to Salmonella outbreak. | LINK

We all know that the swift development of an electronic medical records universe constitutes one of President Obama’s major benchmarks of healthcare reform in the coming decade. Corporate behemoths like Google have embraced electronic health record (EHR) technology, paving the way for a market, though nascent, that is ripe for vigorous growth. Now you can count another herculean player using its heft in entering the healthcare marketplace via EHR distribution — WalMart.

The big box discount retailer is partnering with Dell computers and an IT company to deliver its brand of EHR to physicians and healthcare organizations. You may recall that WalMart spearheaded and has successfully negotiated the resale of bargain basement generic medications for patients, invigorating the market for non-branded pharmaceuticals. It plans a similar trajectory with this venture, which will be marketed to smaller healthcare organizations and physicians in small group or solo practices. | LINK

Two-thousand nine is being dubbed “the year of the generic”. Two senators are trying to keep it that way, citing the potential for Pharma (and its branded, patent-extending reformulations) to simply pay off the manufacturers of generics in an effort to halt their production. It is the aim of the Preserve Access to Affordable Generics Act to abolish the so-called “pay-to-delay” actions of drug manufacturers in which massive financial buyouts are given to generic drugmakers while they wait to market their product, guaranteeing patent extensions. But is this legislation really necessary? Not according to some critics who say that it is in the best  interest of Pharma to invest in next-generation research and development, as such buyouts targeted by the legislature in this case are “last-ditch” efforts by some manufacturers to stifle generic competition. | LINK

To go along with all of the planning in deciding just how to cover a balooning Boomer population, healthcare policy wonks and legislators now have to consider the future costs of cancer drugs into the mix. 

Medicare has quietly expanded its coverage for cancer drugs to include some treatments that haven’t gotten the Food and Drug Administration’s full seal of approval.

The change was announced last summer with little fanfare and took effect in the fall. It means that doctors and patients seeking Medicare reimbursement for certain novel treatments won’t have to negotiate with the billing department for payment. But it’s also certain to increase Medicare spending, since cancer medications often cost thousands of dollars a month.

Cancer and other high-profile illnesses of aging constantly receive press similar to this item. Isn’t it time for legislators and third parties to sit down and discuss coverage of aging HIV+ patients? Although sheer numbers may argue otherwise, one cannot deny the unforseen consequences patients in the latter population will have on the financing of chronic care. | LINK

It’s been said by many a healthcare policy wonk this year: 2008 is the year of the generic drug.  You don’t need to go any further to see evidence of this crystal clear assessment.  Widespread adoption of a generic formulary in many Medicare Part D plans leads the charge in the raw numbers of prescriptions written this year by providers.  Even outsourcing figures into the enormity of this country’s supply of generics. India leads a list of low-cost worldwide suppliers.  Of course, the issue of drug contamination cannot be ignored. | LINK