Should We Use Canada and The WHO's 'Essential Medicines' as Guides for US Drug Pricing?

Revamping our Nation’s approach to drug pricing will be a daunting task and is one that the public is expecting from our next president. Experts suggest a foundation be built from two main sources:

1. The World Health Organization’s (WHO) Essential Medicines list: Containing over 445 medicines deemed as essential in satisfying the priority health care needs of a population, the Essential Medicines list could serve as a model for the U.S. in identifying important drugs that should be protected from price surges and available to the entire population.

1. The Canadian approach to drug pricing includes a review of efficacy, quality and safety; the proposed price by the manufacturer; prices of competing medications; and prices set in other countries. Negotiations for drug prices include the pan-Canadian Pharmaceutical Alliance and a price is determined for all provinces of the country.

Read Stat News' article on it here.

[Podcast] A Powerful Duo Against HIV

Summary: Current treatment for HIV is a lifelong regimen of antiretroviral drugs that place significant economic and clinical stress on the patients being treated. Additionally, if individuals stop taking these drugs, the virus quickly multiplies and rebounds to its original levels. A major component in the weakening of the immune system by the virus occurs through the destruction of immune cells in the gut. The virus targets these cells, forcing the body to work continuously to repair the damage and, subsequently, pulling needed resources from the rest of the immune system. Researchers have developed a therapy to destroy the protein attached to the cells that directs them to the gut and allows the body to mount a system-wide immune response during infection. When used after a course of antiretrovirals, monkeys receiving the new therapy have been able to control the infection without additional treatments for two years. A safety study for use in humans is currently underway.

You can hear the podcast here.

A Cure for a Childhood Cancer - but Will It Last?

Article Summary: CAR-T, an experimental treatment for cancer that supercharges the patient’s immune system by genetically modifying immune cells, has had incredible results at high risks. However, the risks of the treatment include death, though many of them are seen as terminal without the treatment, and a new concern is that the cancer will return. It is unknown if the results of the treatment are permanent or if the cancer will return and, if it does, how quickly this will occur.

You can read MIT Technology Review's article on it here.

Podcast: The Flu, the Shot, the Future

Podcast Summary: The CDC recommends that almost everyone get the flu vaccine. While the inhaled version is currently not recommended, due to ineffectiveness in the past three seasons, the injection method is still only about 63% effective. The probability of contracting the illness might seem high; however, the CDC estimates that the vaccine prevented over seven million flu cases during the 2013/2014 season. For those who contract the illness, questions have arisen regarding the use of Tylenol to reduce fever and how it may impede on the body’s own immune response. While a study in New Zealand indicates that there is no difference in flu duration, concerns regarding the study’s size and compounding factors (including the use of Tamiflu) make the results inconclusive. Further, the effectiveness of Tamiflu is also under fire; an examination of published studies indicating duration and severity reduction revealed improper methodology and consistent bias. Actual review of the data presented to the FDA shows a much lower level of effectiveness than previously thought. As some work to develop effective treatment options, other researchers have identified portions of every flu virus, regardless of seasonal evolution, that remain unchanged. There is hope that if they can develop a vaccine to target these parts of the virus, annual administration with limited effectiveness will no longer be necessary; lifetime immunity similar to that for measles and mumps could be achieved with a single injection.

You can hear the podcast from 2 Docs Talk here.

The Pluses, Minuses of Drugmakers' Discount Cards

While discount cards can assist patients in covering out-of-pocket expenses, their use by drug manufacturers to steer users to more expensive drugs ultimately drives up costs in the healthcare system. Many coupons and discount cards are targeted at expensive brand name medications; while they allow the patient to afford their established copay, the insurer is paying the balances of a significantly more expensive drug than the generic or preferred brand – oftentimes, leading to higher premiums the following years. Further, these discounts are usually limited to a certain number of fills or restricted timeline and cannot be used by patients in federal health plans.

Read Drug Discovery & Development's article on it here.

[Medscape Podcast] Biosimilars: Can They Be Trusted?

Podcast summary: The first biosimilars were released in Europe ten years ago and were based on biologics with fairly simple structures. As technology and understanding expands, manufacturers are approaching a more complex set of drugs; some critics worry that, while researchers are able to easily map the sequence of proteins, the actual structure of a biosimilar may have slight, undetected variations from its counterpart. Industry experts, however, are confident that the advancement of the technology used to compare the chemical makeups is so precise that any undetected structural error would be too minor to impact the drug’s efficacy or safety. Additional concerns stem around clinical trial requirements – while the original biologic required rigorous testing with thousands of people, trials to prove equivalence (rather than efficacy) are typically much smaller in nature. On the other hand, equivalence studies are much more affordable, lending this approach to the cost containment initiatives that make biosimilars attractive in the first place. Further, regulatory agencies will also likely require extensive additional evidence of drug similarities, supplementing required trials, before any approvals are issued.

Hear Medscape's podcast here.

Podcast: Aetna Letter Sparks Controversy

Summary: After announcing an exit from the majority of the healthcare exchanges in which it currently operates, Aetna is receiving criticism over a letter it had previously sent to the Department of Justice (DOJ). In it, Aetna’s CEO stated that if the merger between his organization and Humana was blocked, the company would have to leave the exchange business. Aetna claims to have left due to financial concerns and profitability issues with the program setup, but some wonder if the letter was meant as a veiled threat. Experts point out that if the latter is true, the attempt was misguided – the DOJ typically does not consider political pressures when examining anti-trust cases and is attempting to block the merger regardless of the letter’s intent.

Hear the full podcast from Marketplace here.