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.

Fearing Zika, FDA Asks Two Florida Counties to Halt Blood Donations

After travel and sexual transmissions were ruled out for four Zika cases in Florida counties of Miami-Dade and Broward, fears of infected mosquitos in the United States are mounting. Because the virus does not present symptoms in many cases, it is possible that more people are infected – and may have donated blood after being bitten. The FDA has issued a warning that blood collections in the counties should not resume until they are able to properly test the blood and screen donors; they also recommend that neighboring and other at-risk counties consider taking the same actions.

Read NPR's article on it here.

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Sanders, Other Lawmakers Urge FDA Approval of Generic Crestor

Two months ago, AstraZeneca gained approval for the use of Crestor in children suffering from homozygous familial hypercholesterolemia (HoFH) and, under the Orphan Drug Act (ODA), the drug then qualified for extended market exclusivity for the treatment of this new condition. With the impending loss of patent protection for Crestor’s common use in adults, AstraZeneca has filed a lawsuit accusing the FDA of illegally interpreting a federal law that will allow generic medications to exclude indications for HoFH on their labels. Without the ruling, generic manufacturers would be required to include HoFH dosing and instructions on their labels, therefore violating the exclusivity granted by the ODA and extending AstraZeneca’s market hold. Bernie Sanders, along with several other lawmakers, are petitioning the FDA to approve the generics and offer a lower cost alternative to consumers.

Read the Stat News article on it here.

[Podcast from 2 Docs Talk] Direct-To-Consumer Marketing - Letting the Fox Guard The Henhouse

Summary: Direct-to-consumer drug marketing has, historically, been a controversial topic. In 2002, Merck spent $160 million on a marketing campaign for the new pain medication, Vioxx. Later, the drug was found to increase the risk of stroke and heart attacks and was being used, largely, by individuals who were well-suited for alternative drugs (like ibuprofen). In addition to the increased potential for misuse, many ad claims are misleading for consumers: A reported “significant” increase in length of life for patients on a treatment for lung cancer is actually three months. As pressure builds to regulate, or even halt, these advertising practices, the pharmaceutical industry has a proposed solution. They recommend giving the FDA approval rights for all prescription drug ads prior to their release, funded by manufacturers through a per ad ‘user fee.’ This approach is already used for drug approvals, with manufacturers funding over half of the FDA’s budget; prior to the implementation of these fees in 1993, drug company investment accounted for less than 10% of funds received by the FDA. Opponents of the measure are concerned how the impact of additional pharma industry funding will jeopardize the ultimate efficacy of the FDA’s practices.

Here the podcast from 2 Docs Talk here.